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1.
Article in Chinese | WPRIM | ID: wpr-936359

ABSTRACT

OBJECTIVE@#To evaluate the clinical efficacy of Huangqi Sijunzi decoction (HQSJZD) for treating cancer-related fatigue (CRF) of spleen and stomach Qi deficiency type after chemotherapy in patients with breast cancer.@*METHODS@#A total of 94 breast cancer patients who developed CRF of spleen and stomach Qi deficiency type after chemotherapy were randomized into chemotherapy group (n=47) and traditional Chinese medicine (TCM) + chemotherapy group (n=47). The patients in chemotherapy group received the AC or EC regimen and non-drug interventions including psychological counseling, and those in TCM + chemotherapy group received oral administration of HQSJZD in addition to chemotherapy for 21 days as a treatment cycle, after which improvement of fatigue was assessed using Modified Piper Fatigue Scale. The active ingredients and targets of HQSJZD were screened using the TCM System Pharmacology Analysis Platform (TCMSP); the CRF- and breast cancer-related disease targets were retrieved based on data from the GeneCards, NCBI gene and OMIM databases to construct the component-target network and the protein-protein interaction (PPI) network. GO functional enrichment analysis and Kyoto Encyclopedia of Genes and Genomes KEGG pathway enrichment analysis of the target genes were performed to construct the component-disease-pathway-target biological network. The binding strength of the major drug ingredients and CRF key targets were predicted using AutoDock software.@*RESULTS@#The scores for somatic fatigue, emotional fatigue and cognitive fatigue, along with the overall fatigue score, showed more significant improvements in TCM+chemotherapy group than in chemotherapy group (P < 0.001), and the response rate reached 89.4% in the combined treatment group. We identified 250 targets for HQSJZD, 2653 CRF-related genes, 15 329 breast cancer-related genes and 161 prescription-disease intersected targets, from which topological analysis identified 66 potential key targets. GO and KEGG enrichment analyses predicted multiple pathways related with the disease. Molecular docking results suggested that the core ingredients of HQSJZD showed high affinities to the key targets AKT1, CASP3, IL6, JUN and VEGFA, among which AKT1 might be the most important target for HQSJZD to treat CRF.@*CONCLUSION@#HQSJZD can obviously improve CRF symptoms in breast cancer patients possibly by regulating multiple signaling pathways including PI3K-Akt through AKT1.


Subject(s)
Breast Neoplasms/drug therapy , Drugs, Chinese Herbal/pharmacology , Female , Humans , Medicine, Chinese Traditional , Molecular Docking Simulation , Network Pharmacology , Phosphatidylinositol 3-Kinases
2.
Article in Chinese | WPRIM | ID: wpr-936100

ABSTRACT

Objective: To explore the feasibility and preliminary technical experience of the double-tract reconstruction combined with π-shaped esophagojejunal anastomosis after total laparoscopic proximal gastrectomy (TLPG) in the treatment of adenocarcinoma of esophagogastric junction (AEG). Methods: A descriptive case series study method was used. Clinical data of 12 AEG patients who underwent the double-tract reconstruction combined with π-shaped esophagojejunal anastomosis after TLPG from January 2021 to June 2021 at the Department of General Surgery, First Medical Center, PLA General Hospital were retrospectively analyzed. Among the 12 patients, the median tumor diameter was 2.0 (1.5-2.9) cm, and the pathological stage was T1-3N0-3aM0. All the patients routinely underwent TLPG and D2 lymph node dissection with double-tract reconstruction combined with π-shaped esophagojejunal anastomosis: (1) Double-tract reconstruction combined with π-shaped esophagojejunal anastomosis: mesentery 25 cm away from the Trevor ligament was treated, and an incision of about 1 cm was made on the mesenteric border of the intestinal wall and the right wall of the esophagus, two arms of the linear cutting closure were inserted, and esophagojejunal side-to-side anastomosis was performed. A linear stapler was used to cut off the lower edge of the anastomosis and close the common opening to complete the esophagojejunal π-shaped anastomosis. (2) Side-to-side gastrojejunostomy anastomosis: an incision of about 1 cm was made at the jejunum to mesenteric border and at the greater curvature of the remnant stomach 15 cm from the esophagojejunostomy, and a linear stapler was inserted to complete the gastrojejunostomy side-to-side anastomosis. (3) Side-to-side jejunojejunal anastomosis: an incision of about 1 cm was made at the proximal and distal jejunum to the mesangial border 40 cm from the esophagojejunostomy, and two arms of the linear stapler were inserted respectively to complete the side-to-side jejunojejunal anastomosis. A midline incision about 4-6 cm in the upper abdomen was conducted to take out the specimen, and an abdominal drainage tube was placed, then layer-by-layer abdominal closure was performed.@*INDICATIONS@#(1) adenocarcinoma of esophagogastric junction (Seiwert type II-III) was diagnosed by endoscopy and pathological examination; (2) ability to preserve at least 1/2 of the distal stomach after R0 resection of proximal stomach was evaluated preoperatively.@*CONTRAINDICATIONS@#(1) evaluation indicated distant metastasis of tumor or invasion of other organs; (2) short abdominal esophagus or existence of diaphragmatic hiatal hernia was assessed during the operation; (3) mesentery was too short or the tension was too high; (4) existence of severe comorbidities before surgery; (5) only palliative surgery was required in preoperative evaluation; (6) poor nutritional status.@*MAIN OUTCOME MEASURES@#operation time, intraoperative blood loss, postoperative complications, time to first flatus and time to start liquid diet, postoperative hospital stay, operation cost, etc. Continuous variables that conformed to normal distribution were presented as mean ± standard deviation, and those that did not conform to normal distribution were presented as median (Q1,Q3). Results: All the patients successfully completed TLPG with double-tract reconstruction combined with π-shaped esophagojejunal anastomosis, and postoperative pathology showed that no cancer cells were found on the upper incision margin. The operation time was (247.9±62.4) minutes, the median intraoperative blood loss was 100.0 (62.5, 100.0) ml, no intraoperative blood transfusion was required, the incision length was (4.9±1.0) cm, and the operation cost was (55.5±0.7) thousand yuan. The median time to start liquid diet was 1.0 (1.0, 2.0) days, and the mean time to flatus was (3.1±0.9) days. All the patients were discharged uneventfully. Only 1 patient developed postoperative paralytic ileus and infectious pneumonia with Clavien-Dindo classification of grade II. The patient recovered after conservative treatment. There was no surgery-related death. The postoperative hospital stay was (8.3±2.1) days. Conclusion: The double-tract reconstruction combined with π-shaped esophagojejunal anastomosis after TLPG is safe and feasible, which can minimize surgical trauma and accelerate postoperative recovery.


Subject(s)
Adenocarcinoma/surgery , Anastomosis, Surgical/methods , Blood Loss, Surgical , Esophagogastric Junction/surgery , Flatulence , Gastrectomy/methods , Humans , Laparoscopy , Retrospective Studies , Stomach Neoplasms/surgery
3.
Article in Chinese | WPRIM | ID: wpr-936059

ABSTRACT

Objective: To explore the differences of short-term outcomes and quality of life (QoL) for gastric cancer patients between totally laparoscopic total gastrectomy using an endoscopic linear stapler and laparoscopic-assisted total gastrectomy using a circular stapler. Methods: A retrospective cohort study was conducted. Clinicopathological data of patients with stage I to III gastric adenocarcinoma who underwent laparoscopic total gastrectomy from January 2017 to January 2020 were retrospectively collected. Those who were ≥80 years old, had serious complications that could affect the quality of life, underwent multi-organ resections, palliative surgery, emergency surgery due to gastrointestinal perforation, obstruction, bleeding, died or lost to follow-up within 1 year after surgery were excluded. A total of 130 patients were enrolled and divided into circular stapler group (CS group, 77 cases) and linear stapler group (LS group, 53 cases) according to the surgical method. The differences of age, gender, body mass index, number of comorbidities, history of abdominal surgery, ASA, tumor location, degree of differentiation, tumor length, tumor T stage, tumor N stage, tumor pathological stage and preoperative quality of life between the two groups were not statistically significant (all P>0.05). The observation indicators: (1) Surgery and postoperative conditions. (2) Postoperative complications: Any adverse conditions that require conservative treatment or surgical intervention after surgery were defined as postoperative complications, of which, complications occurring within 30 days after surgery were defined as early complications; complications occurring within 30 days to 1 year after surgery were defined as late complications. (3) Postoperative quality of life was assessed by the quality of life core scale (QLQ-C30) and gastric cancer specific module scale (QLQ-STO22). The higher the scores of functional scales and global health status, the better the corresponding quality of life. The higher the scores of symptoms scales, the worse the corresponding quality of life. Results: (1) Surgery and postoperative conditions: Compared with the CS group, the LS group presented less intraoperative blood loss [50.0 (50.0-100.0) ml vs. 100.0 (100.0-100.0) ml, Z=-3.111, P=0.002] and earlier time to flatus [(3.1±0.8) days vs. (3.5±1.1) days, t=-2.490, P=0.014]. However, there were no statistically significant differences between two groups of patients in terms of operation time, time to start a liquid diet and postoperative hospital stay (all P>0.05). (2) Postoperative complications: The early complication rates of the CS group and the LS group were 22.1% (17/77) and 18.9% (10/53), respectively, while the late complication rate were 18.2% (14/77) and 15.1% (8/53), respectively, whose differences were not statistically significant (all P>0.05). (3) Postoperative quality of life: After 1-year follow-up, 7 (5.4%) patients were lost, including 5 in CS group and 2 in LS group. One year after operation, the QLQ-C30 scale showed that the score of financial difficulty of the LS group was significantly higher than that of the CS group [33.3 (0 to 33.3) vs.0 (0 to 33.3), Z=-1.972, P=0.049] with statistically significant difference, and there were no statistically significant differences in the scores of other functional fields and symptom fields between the two groups (all P>0.05). The QLQ-STO22 scale showed that the scores of dysphagia [0 (0 to 5.6) vs. 0 (0 to 11.1), Z=-2.094, P=0.036] and eating restriction were significantly lower [0 (0 to 4.2) vs. 0 (0 to 8.3), Z=-2.011, P=0.044] in patients of the LS group than those of the CS group. There were no significant differences in scores of other symptoms between two groups (all P>0.05). Conclusions: Compared with the circular stapler, the esophagojejunostomy with linear stapler for gastric cancer patients can reduce intraoperative blood loss, shorten the time to flatus after operation, alleviate the symptoms of dysphagia and eating restriction but increase the economic burden to a certain degree.


Subject(s)
Aged, 80 and over , Gastrectomy/methods , Humans , Laparoscopy/methods , Quality of Life , Retrospective Studies , Stomach Neoplasms/pathology , Treatment Outcome
4.
Frontiers of Medicine ; (4): 126-138, 2022.
Article in English | WPRIM | ID: wpr-929192

ABSTRACT

This cross-sectional study aimed to investigate the quality of care of diabetes in Shanghai, China. A total of 173 235 patients with type 2 diabetes in 2017 were included in the analysis. Profiles of risk factors and intermediate outcomes were determined. The patients had a mean age of 66.43 ± 8.12 (standard deviation (SD)) years and a mean diabetes duration of 7.95 ± 5.53 (SD) years. The percentage of patients who achieved the target level for HbA1c (< 7.0%) was 48.6%. Patients who achieved the target levels for blood pressure (BP) < 130/80 mmHg and low-density lipoprotein-cholesterol (LDL-c) < 2.6 mmol/L reached 17.5% and 34.0%, respectively. A total of 3.8% achieved all three target levels, and the value increased to 6.8% with an adaptation of the BP target level (< 140/90 mmHg) for those over 65 years. Multivariable analysis identified the factors associated with a great likelihood of achieving all three target levels: male, young age, short diabetes duration, low body mass index, macrovascular complications, no microvascular complications, prescribed with lipid-lowering medication, and no prescription of antihypertensive medication. In conclusion, nearly 50% and one-third of the patients with diabetes met the target levels for HbA1c and LDL-c, respectively, with a low percentage achieving the BP target level. The percentage of patients who achieved all three target levels needs significant improvement.


Subject(s)
Aged , Blood Pressure , China/epidemiology , Cholesterol, LDL/therapeutic use , Cross-Sectional Studies , Diabetes Mellitus, Type 2/drug therapy , Glycated Hemoglobin A/analysis , Humans , Male , Middle Aged
5.
China Pharmacy ; (12): 2124-2128, 2022.
Article in Chinese | WPRIM | ID: wpr-941454

ABSTRACT

OBJECTIVE To evaluat e the cost-effectiveness of Keluoxin capsule combi ned with chemical medicine in the treatment of diabetic kidney disease (DKD)from the perspective of the whole society. METHODS Six-state Markov model with 1 year cycle and 40 years time horizon was constructed by means of secondary literature review ,medical record analysis of sample hospital and clinical expert consultation. The cost-effectiveness of Keluoxin capsule combined with chemical medicine versus chemical medicine alone for DKD was evaluated by taking the quality-adjusted life year (QALY)as the output index ,setting the discount rate as 5%,and taking one time domestic gross domestic product (GDP)per capita in 2020 of China as the judgement threshold of incremental cost-effectiveness ratio (ICER). RESULTS Within 40 years,Keluoxin capsule combined with chemical medicine group spent 8 644.09 yuan per capita more than chemical medicine alone group ,and gained more 0.143 QALYs;ICER was 60 460.25 yuan/QALY,which was less than one times GDP per capita of China in 2020(72 447 yuan). The results of sensitivity analysis showed that the annual days of using Keluoxin capsule ,the health utility value of DKD at early stage had a great influence on the results of cost-effectiveness analysis. The results of probabilistic sensitivity analysis suggested that the basic analysis results of this study were robust. CONCLUSIONS At the current price level ,Keluoxin capsule combined with chemical medicine is more cost-effective to treat DKD than chemical medicine alone. The dosage of Keluoxin capsule and health utility value should be paid attention in specific decision- bjmu.edu.cn making scenarios.

6.
Article in Chinese | WPRIM | ID: wpr-940802

ABSTRACT

ObjectiveTo further assess the safety of clinical application of Shujin Jianyao pills after marketing and find its potential risk factors as early as possible, to obtain the real world medication situation of Shujin Jianyao pills and its incidence of adverse reactions and clinical characteristics, and to explore the factors affecting the occurrence of adverse drug reactions (ADR). MethodIn this study, prospective, large-sample, multi-center and intensive whole-hospital monitoring with continuous registration was carried out, combined with telephone follow-up visits 2-4 weeks after the end of medication, for whole treatment course monitoring among patients. In addition, the three-level quality control was strictly implemented in the monitoring process. The study used a proprietary electronic data management system for data management, and SAS 9.4 and R software were used for statistical analysis. ResultFrom May 2018 to July 2020, the study completed the safety monitoring of 3 033 patients taking Shujin Jianyao pills in 30 clinical departments of 25 hospitals in China. A total of 36 ADR cases (49 times) were confirmed by expert assessment on data and supervision quality and expert interpretation of ADR. ConclusionAccording to the World Health Organization (WHO), the symptoms of adverse reactions were mainly classified into occasional adverse reactions (0.1%≤ADR<1%: abdominal distension, oral ulcer, dry mouth, constipation) and rare adverse reactions (0.01%≤ADR<0.1%: loss of appetite, rash, fatigue, increased ALT, increased creatinine, dizziness, stomachache, stomach distension, liver discomfort, pruritus, dysphoria, acid regurgitation, numbness in mouth, abdominal pain, sore throat, earache, tinnitus). Moreover, through the synthetic minority oversampling technique (SOMTE) combined with logistic regression, the following factors might affect ADR: taking Shujin Jianyao pills for 1-14 days, aged 46-65, 66-80 and 81 and above as well as combined use of atorvastatin, cobamamide, calcitriol capsules, Gushukang capsules, glucosamine, nifedipine, methylcobalamin, metformin, Tenghuang Jiangu pills, Bugu tablets, and diclofenac sodium sustained-release tablets. This study provided a real world basis for the safety and standardized use of Shujin Jianyao pills in clinical practice.

7.
Article in Chinese | WPRIM | ID: wpr-928125

ABSTRACT

In view of the longevity and innate immune escape of red blood cells, this study designed the red blood cell membrane-coated paclitaxel nanosuspension [RBC-(PTX)NS] and investigated its physicochemical properties and antitumor effect in vitro. Paclitaxel nanosuspension [(PTX)NS] was prepared by ultrasonic precipitation and then RBC-(PTX)NS by ultrasonic coating. The formulation of(PTX)NS was optimized with Box-Behnken method and indexes of particle diameter, zeta potential, and stability. The morphology, particle diameter, stability, in vitro dissolution, and antitumor effect of(PTX)NS and RBC-(PTX)NS were characterized. The results showed that the particle diameter and zeta potential were(129.38±0.92) nm and(-22.41±0.48) mV, respectively, for the optimized(PTX)NS, while(142.5±0.68) nm and(-29.85±0.53) mV, respectively, for RBC-(PTX)NS. Under the transmission electron microscope,(PTX)NS was spherical and RBC-(PTX)NS had obvious core-shell structure. RBC-(PTX)NS remained stable for 5 days at 4 ℃. The in vitro dissolution test demonstrated that the cumulative release rate of RBC-(PTX)NS reached 79% within 20 min, which was significantly higher than that(25%) of(PTX)NS(P<0.05). As evidenced by MTT assay, RBC-(PTX)NS highly inhibited the proliferation of HepG2 cells in a dose-dependent manner. The cell membrane-coated nano-preparation preparation method is simple and reproducible. It improves the solubility of PTX and endows RBC-(PTX)NS with higher stability and stronger cytotoxicity. Thus, it is a new method for the delivery of PTX via nanocrystallization.


Subject(s)
Erythrocyte Membrane , Nanoparticles/chemistry , Paclitaxel/pharmacology , Particle Size , Suspensions
8.
Article in Chinese | WPRIM | ID: wpr-928080

ABSTRACT

This study systematically sorted out the existing studies about Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), and conducted comprehensive clinical evaluation through "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) to embody the advantages and characteristics and clarify the precise clinical position of Tianshu Capsules. The value of each dimension was calculated via health technology assessment, the multi-criteria decision analysis(MCDA) mo-del and CSC v2.0 software. The results were graded into four levels of A, B, C, or D from high to low. According to the available studies, Tianshu Capsules had low and controllable risks, with the safety rated as A. The drug has obvious clinical significance in the treatment of migraine(syndrome of blood stasis blocking collaterals, syndrome of ascendant hyperactivity of liver Yang), with the effectiveness rated as A. It has clear economic results, with the economy rated as B. The clinical innovation, service system innovation, and industrial innovation are all good, and thus the innovation of Tianshu Capsules is grade A. The drug can meet clinical medication demand of medical care and patients, and thus its suitability is grade A. In view of the reasonable drug price, affordability, and availability, the accessibility is grade A. The prescription originated from the Daxiong Pills recorded in the classic Comprehensive Recording of Sage-like Benefit. In clinical trials, 4 675 patients have used Tianshu Capsules, which indicates rich experience in human administration, and the characteristics of traditional Chinese medicine is grade B. The statutory drug information complies with national stan-dards, and the non-statutory information is standard and accurate. Based on the comprehensive evaluation results of various dimensions of evidence, the clinical value of Tianshu Capsules in the treatment of migraine(syndrome of blood stasis blocking collaterals and syndrome of ascendant hyperactivity of liver Yang) is class A. According to the Comprehensive Clinical Evaluation Management Guidelines of Drugs(trial version 2021) issued by the National Health Commission of the People's Republic of China, we recommend that Tianshu Capsules treating migraine can be transformed into relevant policy results for clinical medication management according to procedures.


Subject(s)
Capsules , Humans , Liver , Medicine, Chinese Traditional , Migraine Disorders/drug therapy , Syndrome
9.
Article in Chinese | WPRIM | ID: wpr-928079

ABSTRACT

This clinical value-oriented comprehensive evaluation of drugs was carried out in accordance with Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), with the qualitative and quantitative evaluation methods adopted. Based on the evidence-based medicine, epidemiology, clinical medicine, pharmacoeconomics, mathematical statistics, and health technology evaluation(HTA), the clinical value of Ginkgolide Injection was evaluated from the "6+1" dimension by giving weight to the criterion level and index level and calculating with multi-criteria decision analysis(MCDA) model and CSC v2.0. After entering the market, Ginkgolide Injection has been subjected to phase Ⅳ clinical trial, spontaneous reporting system(SRS)-based data monitoring, systematic review and Meta-analysis, acute toxicity and long-term toxicity assays, active monitoring, and RCTs, and the evidence of safety was sufficient. The results of active monitoring showed that the incidence of adverse reactions was 0.09%(rare), mainly manifested as flushing, dizziness, rash, nausea, and vomiting. According to the nested case-control study, the adverse reactions of this drug had nothing to do with the product batch, implying that the drug quality was controllable. The adverse reactions mainly resulted from the pharmacodynamic reactions. Because the drug was effective in resisting platelet aggregation, the resulting adverse reactions such as flushing, dizziness, headache, and phlebitis were caused by vasodilation. Skin rash and gastrointestinal symptoms were mainly attributed to the patients' sensitivity to drugs and their own allergic constitution. According to the sufficiency of evidence and the incidence of adverse reactions in the safety research, the safety of Ginkgolide Injection was grade A. The results of Meta-analysis showed that Ginkgolide Injection combined with conventional western medicine was superior to conventional western medicine in improving the clinical effective rate, neurological function score, and activity of daily living score of patients with cerebral infarction. The validity evidence was evaluated according to the PICO principle to be high. According to the GREAD evaluation principle, the quality of such evidence as clinical effective rate, National Institute of Health stroke scale(NIHSS), and Barthel Index(BI) was evaluated, and the results demonstrated that the evidence quality of clinical effective rate and activity of daily living score was medium. The effectiveness of Ginkgolide Injection was grade A. According to the economic report of Ginkgolide Injection, it had short-term and long-term pharmacoeconomic advantages in the treatment of ischemic stroke, and the economic evidence value was good. According to the CASP economic evaluation checklist, the overall quality evaluation results of the economic report are basically clear. To be specific, the economic evidence quality was high. Based on the comprehensive economic evidence quality and economic value, the economy of this drug was grade A. The innovation of this product was evaluated from three aspects: clinical innovation, enterprise service system innovation, and industrial innovation. Ginkgolide Injection could be used 24 h after intravenous thrombolysis for improving patients' neurological function without increasing bleeding, indicating its important clinical innovation. There were many innovations in ensuring drug supply, especially at the grass roots, drug safety, effectiveness, and reasonable price, which has provided reference for establishing enterprise philosophy, managing drug resources, developing process and technology, and determining enterprise management and marketing. Therefore, its innovation was grade A. The drug had no special medication plan in use, exhibiting good suitability for doctors, nurses, and patients. The suitability was grade B. Compared with similar drugs, its price was at a medium level, meaning good affordability, sufficient production capacity, and easy accessibility. Its accessibility was therefore grade B. This drug belonged to Chinese medicinal injection. The large-sample real-world research revealed rich human use experience, so it was grade C for the traditional Chinese medicine characteristic. According to the comprehensive evaluation, the clinical value of Ginkgolide Injection in the treatment of cerebral infarction fell into class A. It is suggested that it can be transformed into the relevant policy results of basic clinical medication management according to the procedure.


Subject(s)
Case-Control Studies , Cerebral Infarction/drug therapy , Drugs, Chinese Herbal/therapeutic use , Ginkgolides/therapeutic use , Humans , Medicine, Chinese Traditional
10.
Article in Chinese | WPRIM | ID: wpr-928077

ABSTRACT

This study systematically sorted out the evidence data of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) with the qualitative and quantitative evaluation methods adopted. Based on evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, and health technology evalua-tion(HTA), the clinical value of Reyanning Mixture was evaluated using multi-criteria decision analysis(MCDA) model, Chinese patent medicine clinical evidence, and value evaluation software(CSC v2.0). The SRS monitoring data, Meta-analysis, and other safety evidence showed that the main adverse reactions of Reyanning Mixture were nausea, diarrhea, and rash, and no serious adverse reactions were found. The pharmacovigilance system was sound, and the system was perfect. There was no recall, notification, or interview for unqualified products. Based on the existing research, the evidence was sufficient, and the risk was controllable. Hence, its safety was grade A. Meta-analysis showed that in the treatment of acute upper respiratory tract infection, Reyanning Mixture combined with Amoxicillin Capsules was better than Amoxicillin Capsules alone in shortening the complete fever relief time and improving the cure rate. Besides, it was superior to Shuanghuanglian Granules in shortening the complete fever relief time, cough relief time, nasal congestion relief time, and pharyngeal congestion relief time. The Meta-analysis was conducted based on AMSTAR standard, and its ove-rall quality was proved good. The evidence quality in GRADE system evaluation was medium and low. The quality of evidence was medium, and the clinical value was obvious. Hence, its effectiveness was grade A. The results of pharmacoeconomic research showed that compared with Amoxicillin Capsules, Reyanning Mixture alone or in combination with Amoxicillin Capsules had cost-effectiveness advantages in the treatment of acute upper respiratory tract infection, and the results were stable in sensitivity analysis. According to the CASP economic evaluation checklist, the research problems were clear and the results were reliable. As revealed by the comprehensive evaluation, the evidence quality was sufficient and the result was clear. Its economy was grade B. Reyanning Mixture had multiple therapeutic targets like anti-virus, anti-bacteria, antipyresis, and anti-cough, with good clinical innovation. There were many innovative initiatives in ensuring drug supply, especially at the grass roots, drug safety, and effectiveness, and also multiple innovative contributions to production technology, quality control, scientific and technological research and development, and enterprise management and marketing. Therefore, its innovation was grade B. The dosage form of Reyanning was mixture, which made it convenient for storage and transportation. The usage was easy to be mastered and accepted by doctors and nurses, exhibiting good suitability for clinicians, nurses, pharmacists, and patients who received this drug and basically meeting the needs of clinical medication. The suitability was grade B. The average daily cost of this drug was 8.082 yuan, and the price was low. The treatment cost accounted for a small proportion of the annual disposable income of urban and rural residents, indicating that it was affordable. Reyanning Mixture was available in 31 provinces, cities and autonomous regions, covering 6 910 hospitals. The allocation of hospitals at all levels was more than 50%. There was no shortage or supply restriction of medicinal material resources. The annual production capacity was sufficient to meet the supply demand, so its accessibility was grade A. Reyanning Mixture, sourced from "pneumonia Ⅲ", has been subjected to a real-world study of its clinical application, with 4 367 cases involved, and the characteristic of TCM was grade B. The comprehensive evaluation results demonstrated that the clinical value score of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) was 0.80, making it rated class A. According to the Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), it is recommended to convert it into the relevant policy results of basic clinical medication management according to the procedures.


Subject(s)
Hot Temperature , Humans , Lung , Medicine, Chinese Traditional , Respiratory Tract Infections/drug therapy , Syndrome
11.
Article in Chinese | WPRIM | ID: wpr-928076

ABSTRACT

This study aims to comprehensively summarize articles on the treatment of coronary heart disease angina pectoris with heart blood stasis syndrome(CHD-AP-HBSS) by Guanxin Shutong Capsules(GSC), and comprehensively evaluate the evidence and value of the formula in "6+1" dimensions based on multi-criteria decision analysis(MCDA) model and Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021) with quantitative and qualitative methods, which is expected to highlight the clinical characteristics and advantages of the prescription and serve as a reference for medical and health departments. The dimensions are grade A, B, C, or D. In terms of safety, according to the reports from the spontaneous reporting system of National Center for ADR Monitoring, and literature analysis, GSC mainly results in the adverse reactions of mild or moderate nausea, diarrhea, rash, palpitation, and headache, with favorable prognosis in patients. Nevertheless, severe adverse reactions have been reported after marketing. Thus, additional evidence for its safety should be accumulated, and the current safety is grade B. Meta-analysis proves that GSC in combination with conventional treatment is superior to conventional treatment alone in alleviating AP and symptoms indicated by electrocardiogram(ECG). Therefore, the effectiveness of the medicine is grade A. As for the pharmacoeconomic value, based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold, it is more economical for CHD-AP patients to use GSC combined with conventional treatment than conventional treatment alone. However, as the currently available clinical parameters fail to support the difference in indirect cost between the two groups, the accuracy in the cost of intervention plan needs to be further improved. Therefore, the economy of the prescription is grade B. GSC has been awarded 13 national invention patents and 1 utility model patent, and won a lot of national and provincial patent awards, marking the enterprise service awareness and innovativeness. As a result, it is grade A in aspect of innovation. A questionnaire on the suitability of GSC suggests that publicity and promotion influence patients' choice and thus additional efforts should be made in this aspect. The suitability of this formula is grade B. Both rural and urban residents can afford the medicine for the whole course and the price is close to that of similar Chinese patent medicines. In addition, it is accessible regardless of season and place, so accessibility is grade A. As a Mongolian empirical formula destined to treat heart stabbing pain, it has the effects of activating blood and resolving stasis, dredging channels and activating collaterals, and moving Qi to relieve pain, and boasts the empirical evidence of more than 2 000 human cases. With prominent characteristics of traditional Chinese medicine, it is grade B. Based on the MCDA model and CSC v2.0, GSC is comprehensively class A in the treatment of CHD-AP-HBSS. The result can serve as a reference for basic clinical medication management.


Subject(s)
Angina Pectoris/drug therapy , Capsules , Coronary Disease/drug therapy , Drugs, Chinese Herbal/adverse effects , Humans
12.
Article in Chinese | WPRIM | ID: wpr-928075

ABSTRACT

The present study systematically sorted out the existing research on Qilong Capsules in the treatment of ischemic stroke with Qi deficiency and blood stasis syndrome and comprehensively evaluated its clinical evidence and value to highlight the advantages and characteristics of products and provide references for the decision-making of national pharmaceutical management departments. Based on the evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, and pharmacoeconomics, the qualitative and quantitative evaluation of "6+1" dimensions of safety, effectiveness, economy, innovation, suitability, and accessibility, as well as characteristics of traditional Chinese medicine(TCM) was performed with multi-criteria decision analysis(MCDA) mo-del using the information, such as public data, literature data, pharmaceutical research, and questionnaire survey, and CSC v2.0 was used to calculate the clinical value of Qilong Capsules. The evaluation results were grade A, B, C, or D. Spontaneous reporting system(SRS) monitoring data, literature reports, clinical trials, and other multi-source safety evidence showed that the main adverse reactions of this drug included dry mouth, nausea, and rash, and no severe adverse reactions was found. The evidence was sufficient with small and controllable known risks, and the safety was grade A. Meta-analysis showed that Qilong Capsules combined with conventional western medicine in the treatment of acute ischemic stroke was superior to the control group in improving neurological deficits, clinical total response rate, patients' activities of daily living, and hemorheological indexes. The level of evidence was high with manifest clinical significance, and the effectiveness was grade A. The results of pharmacoeconomic research showed that Qilong Capsules combined with conventional western medicine in the treatment of ischemic stroke were advantageous in cost-effectiveness as compared with conventional western medicine alone, but the incremental effect was not significant. The quality evaluation results of the economic report were comparatively clear, and the economy was grade B. Aiming at major cerebrovascular diseases in the society and giving full play to the advantages of TCM, Qilong Capsules focused on the inheritance of classics and scientific and technological innovation, and innovation was grade B. The results of the questionnaire survey showed that the technical characteristics and drug application could meet the medication needs of clinical doctors and patients, and the suitability was grade B. The price level of this drug was comparatively high and the affordability was good since the treatment cost accounted for a small proportion of disposable income. The drug accessibility was good with a wide range of drug sales, sufficient production capacity, and sustainable medicinal materials resources, and was grade B. This drug was derived from the classic prescription Buyang Huanwu Decoction with rich experience of human application, which could regulate Qi and blood circulation, and the section of TCM characteristics was grade B. Based on the evidence evaluation results of "6+1" dimensions of Qilong Capsules, the comprehensive evaluation of clinical value was class A. It is suggested that it can be transformed into relevant policy results of basic clinical medication management according to procedures.


Subject(s)
Activities of Daily Living , Capsules , Humans , Ischemic Stroke , Medicine, Chinese Traditional , Qi
13.
Article in Chinese | WPRIM | ID: wpr-927966

ABSTRACT

To evaluate the pharmacoeconomic value of Qidong Yixin Oral Liquid in the treatment of viral myocarditis(Qi-Yin deficiency syndrome) by supplementing Qi, nourishing the heart, calming the mind, and relieving palpitation, the present study performed the Meta-analysis based on the published papers on Qidong Yixin Oral Liquid by AMSTAR and carried out pharmacoeconomic evaluation using TreeAge Pro by the cost-effectiveness analysis. The results showed that the quality of the included papers was good. After four weeks of treatment, Qidong Yixin Oral Liquid combined with the conventional treatment regimen was superior to the conventional treatment in improving creatine kinase isoenzyme, and the difference was statistically significant. Furthermore, the treatment cost was also higher than that of conventional treatment, with an incremental cost-effectiveness ratio of CNY 95.89, accounting for 0.30% of per capita disposable income. The results of sensitivity analysis showed that the research results were robust. Therefore, based on the assumption that the per capita disposable income in 2020 was the threshold of patients' willingness to pay, it is more economical for patients with viral myocarditis to use Qidong Yixin Oral Liquid combined with conventional secondary prevention regimen than conventio-nal secondary prevention regimen alone. The economic evaluation of Qidong Yixin Oral Liquid in the treatment of viral myocarditis will help physicians and patients choose optimal treatment options, improve rational clinical medication, and provide references for the efficient allocation and utilization of medical resources in China.


Subject(s)
Cost-Benefit Analysis , Drugs, Chinese Herbal/therapeutic use , Economics, Pharmaceutical , Humans , Myocarditis/drug therapy , Qi , Yin Deficiency/drug therapy
14.
Article in Chinese | WPRIM | ID: wpr-906441

ABSTRACT

Objective:To elucidate the potential molecular markers and drug-compound-target mechanism of Epimedii Folium intervention on breast cancer stem cells(BCSCs) through chip analysis combined with network pharmacology and experimental validation. Method:Relevant drug information was retrieved in Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) to obtain the active components and potential targets of Epimedii Folium. "Breast Cancer Stem Cells" were searched in Gene Expression Omnibus(GEO)database,and GSE98239 chip data were obtained through analysis and screening. Then GEO2R online analysis tool was used to obtain the differential genes to draw differential gene heat map and volcano map. The differential gene network map of Epimedii Folium intervention for breast cancer stem cells was constructed by Cytoscape 3.8.0,and Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analysis of drug and disease genes were performed. Human breast cancer MDA-MB-231 cells were divided into 20%,40%,60% Epimedii Folium drug-containing serum group and control group. Cell counting kit-8(CCK-8),and Western blot were used to detect the effect of Epimedii Folium drug-containing serum intervention on cell activity and target protein expression in breast cancer cells. Result:Twenty-three active components including flavones,sterols,alkaloids and sesquiterpenoids were obtained from Epimedii Folium. It was found that Epimedii Folium interacted with B-cell lymphoma-2-like protein 1(BCL2L1),matrix metallopeptidase 2(MMP2),prostaglandin-endoperoxide synthase 2(PTGS2),vascular endothelial growth factor A(VEGFA),transforming growth factor beta receptor 1(TGFBR1) and other pivotal genes in breast cancer stem cells,participated in the induction of new angiogenesis and cell migration,enabled the continuous self-renewal of BCSCs,decreased apoptosis and cell migration,thus promoting the recurrence and metastasis of breast cancer. KEGG results showed that Epimedii Folium intervened in multiple differential expressed genes(DEGs)of transforming growth factor-<italic>β</italic>(TGF-<italic>β</italic>),vascular endothelial growth factor(VEGF),phosphoinositide 3kinase/protein kenase B(PI3K/Akt),mitogen-activated protein kinese(MAPK)and mammalian target of rapamycin(mTOR)subpathways in cancer signaling pathways to exert its efficacy in intervening breast cancer stem cells. Experiments showed that the survival rate of breast cancer cells was significantly reduced and the expression levels of TGFBR1 and Smad2 in breast cancer cells significantly decreased after the intervention of Epimedii Folium drug-containing serum(<italic>P</italic><0.01). Conclusion:Several components in different concentrations of drug-containing serum of Epimedii Folium can synergistically act on target differentially expressed genes of breast cancer stem cells,and inhibit the proliferation of breast cancer cells by down-regulating the expression levels of TGFBR1,a key molecule in the TGF-<italic>β</italic> pathway,and Smad2,a downstream signal.

15.
Article in Chinese | WPRIM | ID: wpr-921769

ABSTRACT

Clinical comprehensive evaluation was conducted in "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.0 were used for calculations to evaluate the clinical value of Diemailing~® Kudiezi Injection. The existing evidence showed that active monitoring and a number of randomized controlled trials(RCTs) have been carried out after the listing of Diemailing~® Kudiezi Injection. Since the total incidence of adverse reactions is 0.099% and the incidence of adverse drug reactions(ADR) is rare, the safety evaluation is grade A. The evidence value of effectiveness demonstrated that Diemailing~® Kudiezi Injection combined with conventional western medicine improves the total effective rate of neurological deficit score and quality of daily life in the acute stage of cerebral infarction, which is superior to that in the conventional western medicine treatment group, and the level of evidence is high. Therefore, its efficacy is assessed as grade A. According to the results of economic research, when Diemailing~® Kudiezi Injection combined with conventional western medicine treatment is compared with conventional western medicine treatment, the Diemailing~® Kudiezi Injection group has a greater incremental effect, but the cost is affordable. Given the overall quality evaluation results of economic report is clear, it is evaluated as grade B. The innovation is grade A. The drug is favorable for clinical operation by medical staff and can be accepted by patients due to easy usage without special technical and management requirements. Since the drug exhibits good suitability for clinicians, nurses, pharmacists, and patients, it is evaluated as grade B. Considering its moderate price among similar drugs and good affordability and availability, it is evaluated as grade B. Diemailing~® Kudiezi Injection can evidently improve the clinical symptoms and neurological deficits of fire toxin syndrome of acute cerebral infarction, and this medicine belongs to ethnic medicine. Large-sample active monitoring research has been conducted with rich experience in human use. Therefore, the characteristics of traditional Chinese medicine are evaluated as grade A. The comprehensive clinical evaluation of Diemailing~® Kudiezi Injection is class A. We suggest that it can be directly transformed into relevant policy results of basic clinical medication management by procedure.


Subject(s)
Cerebral Infarction/drug therapy , Drugs, Chinese Herbal/therapeutic use , Humans , Injections , Medicine, Chinese Traditional
16.
Article in Chinese | WPRIM | ID: wpr-921768

ABSTRACT

This study systematically reviewed the existing research on Danhong Injection in the treatment of stroke with blood stasis syndrome. The methods of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, drug economics, mathematical statistics, and health technology assessment(HTA) were employed to qualitatively and quantitatively evaluate the "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) of Danhong Injection through questionnaire survey, public information, real world data, and secondary evaluation of literature. With the weights given by experts, the multi-criteria decision analysis(MCDA) model was employed to measure each dimension and highlight the clinical value of Danhong Injection. Multi-source safety evidence showed that Danhong Injection had been fully monitored and studied. The severity of adverse reactions was mostly moderate or mild, and the prognosis was good. So it was rated as grade A for safety. Compared with Ligustrazine Injection, Fufang Danshen Injection and conventional treatment of western medicine, Danhong Injection had obvious advantages in clinical response rate and NIHSS score improvement in the treatment of stroke with blood stasis syndrome. So it was rated as grade A for effectiveness. Compared with Ligustrazine Injection and Yinxing Damo Injection, Danhong Injection had a cost-effectiveness advantage in the treatment of stroke with blood stasis syndrome, and the economic results were good. According to the existing evidence, the Danhong Injection was rated as grade B for economy. Danhong Injection had won a number of national patents, which was rated as grade A for its good innovation in guaranteeing supply measures, scalability of production capacity, and production process. It had good suitability for clinicians, nurses, pharmacists, and patients using the drug, and met the needs of clinical medication, so it was rated as grade B for suitability. Danhong Injection is rich in medicinal materials, stable in price, and sustainable. However, its availability needed to be further improved due to the limitation of prescription use, so it was rated as grade B for accessibility. Danhong Injection can promote blood circulation, resolve blood stasis, warm vessels, and smooth collaterals. It had accumulated more than 30 000 pieces of empirical evidence for human use in the real world. It had prominent characteristics of traditional Chinese medicine and was rated as grade B. CSC v2.0 was used for calculation, and the clinical value of Danhong Injection was comprehensively evaluated as class A, which could be directly translated into relevant policy results of basic clinical medication management according to the Guidelines for the Management Clinical Comprehensive Evaluation of Drugs(trial version 2021).


Subject(s)
Drugs, Chinese Herbal , Humans , Injections , Medicine, Chinese Traditional , Stroke/drug therapy
17.
Article in Chinese | WPRIM | ID: wpr-921766

ABSTRACT

This study explored the clinical comprehensive evaluation of Mudan Granules, aiming to promote the safe, effective and rational use of Mudan Granules, reflect its clinical value and provide a basis for medical decision-making. The safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Mudan Granules were combed, and the multi-criteria decision analysis(MCDA) model was used to carry out comprehensive evaluation on each dimension. In terms of safety, multiple sources of evidence showed that the adverse reactions of Mudan Granules mainly involved gastrointestinal system, with controllable safety risk rated as grade B. In terms of effectiveness, Mudan Granules can significantly alleviate the diabetic peripheral neuropathy(Qi-deficiency and collateral stagnation syndrome), limb and trunk numbness, pain and sensory abnormalities and other clinical symptoms, exhibiting positive curative effect rated as grade A. In terms of economy, Mudan Granules combined with Mecobalamin and other conventional western medicines is economical compared with the western medicine alone group, which is supported by sufficient evidence and clear results, rated as grade B. In terms of innovation, Mudan Granules is the only Chinese patent medicine with the indication of benefiting Qi for activating blood circulation and dredging collaterals in the Medicine Catalogue for National Basic Medical Insurance, Industrial Injury Insurance, and Maternity Insurance. It has important clinical innovation and is evaluated as grade A. In the aspect of suitability, Mudan Granules has good suitability in ADR treatment, drug characteristics and usage, and is rated as grade B. In terms of accessibility, Mudan Granules has the price level comparable to that of similar drugs, with good affordability. The resources of medicinal materials for the preparation of Mudan Granules are abundant and available, which is rated grade B. Moreover, Mudan Granules, as a hospital preparation with both functions of tonification and purgation, reflects the combination between syndrome differentiation and disease differentiation as well as the combination between overall and local characteristics, and has prominent Chinese medicine features. According to the above dimensions, we suggest to classify Mudan Granules as a class A preparation which can be directly included the policy results of basic clinical drug administration.


Subject(s)
Diabetes Mellitus , Diabetic Neuropathies , Drugs, Chinese Herbal/therapeutic use , Female , Humans , Medicine, Chinese Traditional , Pregnancy , Qi , Syndrome
18.
Article in Chinese | WPRIM | ID: wpr-921765

ABSTRACT

This study evaluated the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Wenxin Granules in the treatment of arrhythmia(ventricular premature beat and atrial premature beat) with deficiency of Qi and Yin. The multi-criteria decision analysis(MCDA) model was adopted, and the criterion layer and index layer were weighted by experts. CSC v2.0 was used for clinical comprehensive evaluation. This study embodies the clinical value of Wenxin Granules, promotes its safe, effective and rational use, and provides a basis for national medical decision-making. The multi-source evidence shows that the major adverse reaction of Wenxin Granules is gastrointestinal damage. According to the available studies, Wenxin Granules has controllable risk and thus is rated as grade B in terms of safety. The systematic evaluation of effectiveness shows that compared with antiarrhythmic western medicine, Wenxin Granules demonstrates improved clinical efficacy and electrocardiogram efficacy, which is supported by high-quality evidence, and thus the effectiveness of Wenxin Granules is evaluated as grade A. Economic research shows that Wenxin Granules is more economical than antiarrhythmic western medicine, which is supported by sufficient evidence and clear results, and thus the economy of this preparation is rated as grade B. The indications and contraindications of Wenxin Granules are clear and detailed to different types of arrhythmia, which, together with the precise positioning and prominent clinical innovation and industrial innovation, rates it as grade A in terms of innovation. The suitability of drug storage, prescription circulation, dosage form and course of treatment basically meet the clinical medication needs of doctors and patients, and thus the suitability of Wenxin Granules is evaluated as grade B. Because of the few restrictions and the sustainable resources of medicinal materials, the accessibility of Wenxin Granules is evaluated as grade A. The prescription compatibility focuses on the pathogenesis characteristics of deficiency of Qi and Yin, and there are more than 3 000 cases studied. Therefore, the characteristics of traditional Chinese medicine of Wenxin Granules are evaluated as grade B. Based on the evidence from all the above dimensions, Wenxin Granules has the clinical comprehensive value of class A and prominent characteristics of traditional Chinese medicine. It is suggested to include Wenxin Granules into the policy results related to basic clinical medication management according to the procedure.


Subject(s)
Anti-Arrhythmia Agents , Humans , Medicine, Chinese Traditional , Qi , Treatment Outcome , Ventricular Premature Complexes , Yin Deficiency
19.
Article in Chinese | WPRIM | ID: wpr-921764

ABSTRACT

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.


Subject(s)
China , Drugs, Chinese Herbal , Information Storage and Retrieval , Medicine, Chinese Traditional , Nonprescription Drugs , Quality Control
20.
Article in Chinese | WPRIM | ID: wpr-921726

ABSTRACT

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.


Subject(s)
Adverse Drug Reaction Reporting Systems , Books , Drug-Related Side Effects and Adverse Reactions/epidemiology , European Union , Humans , Medicine, Chinese Traditional , Pharmacovigilance
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