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1.
Zhongguo Zhong Yao Za Zhi ; 47(20): 5642-5653, 2022 Oct.
Article in Chinese | MEDLINE | ID: mdl-36471982

ABSTRACT

This study analyzed the outcome indicators in randomized controlled trial(RCT) on Chinese medicine as adjuvant therapy for severe pneumonia in the past years, laying a foundation for the design of clinical trials on and construction of core outcome set(COS) for severe pneumonia. To be specific, related RCT was retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, Chinese Clinical Trial Registry, and ClinicalTrials.gov(from January 1,2011 to April 9,2022). Then data in the trials were extracted, and the quality of included RCT was assessed according to Cochrane handbook, followed by descriptive analysis of the use of outcome indicators. A total of 11 833 articles were screened out, and finally 34 RCTs were included(2 were protocols). The included trials involved 109 outcome indicators with emergence frequency of 320, which were mainly classified into 9 categories: physicochemical indicators(54, frequency 167), time to achieve the efficacy(15, frequency 38), clinical effective rate(10, frequency 36), quality of life(11, frequency 35), symptoms and signs(7, frequency 18), traditional Chinese medicine(TCM) syndrome(4, frequency 13), safety(3, frequency 8), economic evaluation(1, frequency 1), other indicators(4, frequency 4). The indicators with high frequency followed the order: total effective rate, arterial oxygen partial pressure, C-reactive protein, white blood cell count, arterial blood carbon dioxide partial pressure. A total of 5 articles(14.71%) reported the main outcome indicators and 11 articles(32.35%) adopted the efficacy on TCM syndromes as the outcome indicator. There are many problems in the selection of outcome indicators in RCT on the treatment of severe pneumonia with Chinese medicine, mainly manifested as the disregard of clinical endpoint indicators, the inappropriate selection of surrogate indicators, and the non-standard evaluation criteria for the efficacy on TCM syndrome. It is suggested that the evaluation system for the efficacy of Chinese medicine on severe pneumonia should be established in accordance with the method for international COS to improve the quality of clinical trials.


Subject(s)
Drugs, Chinese Herbal , Pneumonia , Humans , Medicine, Chinese Traditional , Drugs, Chinese Herbal/therapeutic use , Quality of Life , Combined Modality Therapy , Pneumonia/drug therapy
2.
Medicine (Baltimore) ; 101(41): e31036, 2022 Oct 14.
Article in English | MEDLINE | ID: mdl-36253977

ABSTRACT

BACKGROUND: Coronary heart disease (CHD) is a cardiovascular disease caused by myocardial ischemia. In China, safflor yellow and artemisinin-based combination therapies have been extensively used to treat angina pectoris. METHODS: Efficacies were provided by a network meta-analysis following the PRISMA 2020 checklist. Cost-effectiveness analysis was based on patient perspectives. Two-way and probabilistic sensitivity analyses were conducted to assess the robustness of the study results. RESULTS: Conventional treatment combined with safflower is a better choice against angina pectoris. Sensitivity analysis showed that the model was sensitive to the treatment efficacy rather than the drug cost. CONCLUSION: Conventional treatment combined with safflower injection is suggested to treat angina pectoris. Low molecular weight heparin or compound Danshen-dropping pills can be used to increase the recovery rate of angina pectoris, according to conventional treatment combined with safflower injection.


Subject(s)
Artemisinins , Drugs, Chinese Herbal , Angina Pectoris/drug therapy , Artemisinins/therapeutic use , Drugs, Chinese Herbal/therapeutic use , Economics, Pharmaceutical , Heparin, Low-Molecular-Weight/therapeutic use , Humans , Network Meta-Analysis
3.
Zhongguo Zhong Yao Za Zhi ; 47(17): 4778-4788, 2022 Sep.
Article in Chinese | MEDLINE | ID: mdl-36164885

ABSTRACT

This study evaluated and compared the efficacy, safety and economy of four Chinese patent medicines(CPMs) in the treatment of functional dyspepsia(FD) using the method of rapid health technology assessment. It aims to provide decision-makers with rapid decision-making information. The eight Chinese and English databases were comprehensively and systematically searched for the relevant clinical research. Studies were screened and evaluated. A total of 110 studies were identified, including 95 randomized controlled trials(RCTs), 7 controlled clinical trials(CCTs), 7 systematic review/Meta-analysis and 1 economic evaluation, among which 28 were Dalitong Granules, 49 were Zhizhu Kuanzhong Capsules, 3 were Biling Weitong Granules and 30 were Qizhi Weitong Granules(Tablets/Capsules). The quality of the included literature was generally low. The efficacy of four CPMs alone or combined with western medicine in the treatment of FD is different. Dalitong Granules was used to treat motility disorder in FD. Zhizhu Kuanzhong Capsules and Qizhi Weitong Granules(Tablets/Capsules) can treat FD patients with anxiety and depression. Qizhi Weitong Granules(Tablets/Capsules) were mainly used in FD for perimenopausal patients. There were no serious adverse reactions in the clinical study of four CPMs in the treatment of FD. Dalitong Granules has better effects than mosapride in the treatment of FD, but the cost is slightly higher. The cost-effectiveness ratio of Zhizhu Kuanzhong Capsules in the treatment of FD patients with anxiety and depression was lower than that of Domperidone. In terms of average daily price, Qizhi Weitong Tablets has the highest price(27.00 yuan per day), Qizhi Weitong Granules has the lowest price(5.04 yuan per day), Biling Weitong Granules has a relatively high price(15.53 yuan per day), followed by Dalitong Granules(13.03 yuan per day). The evidence of Dalitong Granules covered the efficacy, safety and economy, which is relatively complete compared with the other three drugs. It has effective potential in the treatment of motility disorder in FD. Further research in this field in the future is needed.


Subject(s)
Drugs, Chinese Herbal , Dyspepsia , Capsules , China , Chlorobenzenes , Domperidone/therapeutic use , Drugs, Chinese Herbal/therapeutic use , Dyspepsia/drug therapy , Humans , Nonprescription Drugs/therapeutic use , Stomach , Sulfides , Tablets , Technology Assessment, Biomedical
4.
Zhongguo Zhong Yao Za Zhi ; 47(18): 5088-5096, 2022 Sep.
Article in Chinese | MEDLINE | ID: mdl-36164919

ABSTRACT

This study aims to analyze the outcome indicators of randomized controlled trial(RCT) on traditional Chinese medicine(TCM) intervention of sepsis-induced myocardial injury(SIMI) in recent five years, which is expected to lay a basis for the construction of core outcome set(COS) for this disease treated by TCM. To be specific, RCT on the treatment of SIMI with TCM was retrieved from 4 Chinese databases, 3 English databases, and 2 clinical trial protocol registries. The quality of the included studies was evaluated with Cochrane risk-of-bias(ROB) tool, and the outcome indicators were analyzed. Finally, 42 RCTs were included, of which 2 were clinical trial registration schemes. The study found that 42 RCTs had a high risk of bias, and reported a total of 86 indicators in "clinical effective rate, disease severity, TCM syndrome score, inflammation, myocardium, cardiac structure and hemodynamics, electrocardiogram, immunology, metabolism and liver and kidney function, and safety". Outcome indicators on myocardium had the highest emergence frequency, followed by indicators on the cardiac structure and hemodynamics. A total of 8 RCTs reported TCM syndrome scores. Further analysis suggested the following problems in the selection of outcome indicators in the RCTs on TCM intervention of SIMI: no classification of primary and secondary indicators, disregard of endpoint indicators, irrational selection of alternative indicators, neglection of TCM characteristics, no assessment of patients' immune status, and no emphasis on economic indicators and safety indicators. Therefore, according to the recommendations of the core outcome measures in effectiveness trials(COMET) working group, a COS for TCM intervention of TCM for SIMI should be developed, so as to facilitate clinical researchers to select appropriate outcome indicators, the combination of conclusions of similar clinical studies, and the promotion of TCM interventions.


Subject(s)
Drugs, Chinese Herbal , Sepsis , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic , Sepsis/complications , Sepsis/drug therapy , Treatment Outcome
5.
Zhongguo Zhong Yao Za Zhi ; 47(10): 2833-2840, 2022 May.
Article in Chinese | MEDLINE | ID: mdl-35718504

ABSTRACT

The clinical comprehensive evaluation of Chinese patent medicine is an important direction in the evaluation of traditional Chinese medicine(TCM), which positively promotes the development of TCM industry. The evaluation system of Chinese patent medicine is helpful to comprehensively evaluate the clinical value of different Chinese patent medicine in the same category, different dosage forms, and specifications, from different manufacturers on the basis of evidence and value. The establishment of a scientific and reasonable comprehensive evaluation index system for Chinese patent medicine is an important prerequisite to ensure clinical value. However, there has been neither a recognized systematic review on the clinical comprehensive evaluation of Chinese patent medicine nor a methodological system used for reference. The evidence and value: impact on decision-making(EVIDEM), developed by the international research team, is used to evaluate the comprehensive value of medical interventions. EVIDEM provides a methodological tool for scientific decision-making to evaluate evidence and value for health technologies on the basis of the multi-criteria decision analysis(MCDA) model and health technology assessment(HTA). Based on the ongoing EVIDEM research, the present study put forward that EVIDEM-based clinical comprehensive evaluation of Chinese patent medicine consisted of four aspects, seven modules, and ten steps, which is expected to references and practical experience for the follow-up comprehensive evaluation of Chinese patent medicine in the TCM field.


Subject(s)
Drugs, Chinese Herbal , Nonprescription Drugs , China , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Technology Assessment, Biomedical
6.
J Tradit Chin Med ; 42(3): 472-478, 2022 06.
Article in English | MEDLINE | ID: mdl-35610019

ABSTRACT

OBJECTIVE: To explore the advantages of Traditional Chinese Medicine (TCM) in "prevention" and "control" of coronavirus disease 2019 (COVID-19) pandemic. METHODS: In this paper, we wish to estimate the effect on the virus transmission of scenarios assuming TCM were used to build the first defense line at the very early stage of the spread in Wuhan. We therefore first developed a classic susceptible infected removed (susceptible infected removed, SIR) transmission model based on the national data in China and then updated it to a TCM-SIR model to assess the potential impact of such assumptions, i.e. the underlying risk of lives lost and social economy loss. RESULTS: (a) With the nationwide community lockdown, the risk value was from 90 000 to 250 000 without TCM intervention and the risk value was from 70 000 to 220 000 with TCM intervention; (b) Based the risk assessment method, we forecasted that the infections peak would be 58016 without TCM intervention, which happened on February 17 2020. However, the infections peak would be 45713 with TCM intervention, which happened on 16 February 2020. CONCLUSIONS: The adoption of nationwide community lockdown is conducive to timely control the epidemic and protect people's lives and safety. At the same time, we can get lower infections if TCM intervention can be considered. We can also get the benefits from TCM prevention of COVID-19 pandemic by the basic number of infections.


Subject(s)
COVID-19 , Drugs, Chinese Herbal , China , Communicable Disease Control , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Pandemics , Risk Assessment , SARS-CoV-2
7.
Zhongguo Zhong Yao Za Zhi ; 47(9): 2338-2342, 2022 May.
Article in Chinese | MEDLINE | ID: mdl-35531681

ABSTRACT

The clinical randomized controlled trial(RCT) of Chinese patent medicine in the treatment of influenza were reviewed and analyzed to provide basic information for clinical decision and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, and Cochrane Library were searched for RCTs of Chinese patent medicine for influenza published from database inception to July 25, 2021. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. Ninety-two RCTs of Chinese patent medicine for influenza published between 2005 and 2021, were included, among which 17 RCTs(18.48%) had a sample size higher than 200 and the average sample size was about 145. Twenty-seven Chinese patent medicines were involved, including twenty-one oral medicines and six injections. The Chinese patent medicines in trials reported in more than five papers included Lianhua Qingwen Capsules/Gra-nules, Tanreqing Injection, and Reduning Injection. Fourteen intervention protocols were reported, of which Chinese patent medicine+western medicine+conventional treatment vs western medicine+conventional treatment(20.65%) was the most frequently employed. Additionally, 85.87% of the RCTs reported the course of treatment, and 80.43% of the RCTs determined 3-7 d as the intervention course. Forty-five outcome indicators were extracted, which were used 434 times, including symptoms/signs, physicochemical detection, safety events, TCM symptoms/syndromes, quality of life, long-term prognosis, and economic evaluation. Symptoms/signs(61.52%) exhibited the highest frequency. Methodological problems were prevalent in the included trials. The findings reveal that there are few clinical trials on influenza treatment by Chinese patent medicine, and the methodological problems are prominent, affec-ting the reliability and practicability of the trials. In the future research, the value characteristics of Chinese patent medicine should be highlighted and the quality control in the whole process should be strengthened based on the scientific and rigorous design.


Subject(s)
Drugs, Chinese Herbal , Influenza, Human , China , Clinical Trials as Topic , Drugs, Chinese Herbal/therapeutic use , Humans , Influenza, Human/drug therapy , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Quality of Life , Reproducibility of Results
8.
Zhongguo Zhong Yao Za Zhi ; 47(8): 2008-2014, 2022 Apr.
Article in Chinese | MEDLINE | ID: mdl-35531715

ABSTRACT

Chinese medicine dispensing granules, the result of the efforts to transform Chinese medicinal decoction pieces in China, features portability and ease of storage. Thus, it is destined to be an indispensible dosage form in the modernization drive of Chinese medicine. The Announcement on Ending the Pilot Project of Chinese Medicine Dispensing Granules was released in February 2021 and relevant regulations went into force in November 2021, which marks the a new journey for the development of Chinese medicine dispensing granules and the beginning of the "post-pilot era". However, it faces the challenges in quality and standard. This study reviewed the history of Chinese medicine dispensing granules, analyzed the technical progress, market, and main problems in development, and proposed suggestions and prospects for its development in the "post-pilot era", which is expected to serve as a reference for its industry development and rational use.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , China , Drugs, Chinese Herbal/therapeutic use , Industrial Development , Pilot Projects
9.
Zhongguo Zhong Yao Za Zhi ; 47(6): 1493-1500, 2022 Mar.
Article in Chinese | MEDLINE | ID: mdl-35347948

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)
Drugs, Chinese Herbal , Ginkgolides , Case-Control Studies , Cerebral Infarction/drug therapy , Drugs, Chinese Herbal/therapeutic use , Ginkgolides/therapeutic use , Humans , Medicine, Chinese Traditional
10.
PLoS One ; 17(3): e0264720, 2022.
Article in English | MEDLINE | ID: mdl-35303006

ABSTRACT

OBJECTIVE: Sijunzi decoction (SJZD) was used to treat patients with colorectal cancer (CRC) as an adjuvant method. The aim of the study was to investigate the therapeutic targets and pathways of SJZD towards the tumor microenvironment of CRC via network pharmacology and the ESTIMATE algorithm. METHODS: The ESTIMATE algorithm was used to calculate immune and stromal scores to predict the level of infiltrating immune and stromal cells. The active targets of SJZD were searched in the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) and UniProt database. The core targets were obtained by matching the differentially expressed genes in CRC tissues and the targets of SJZD. Then, GO, KEGG and validation in TCGA were carried out. RESULTS: According to the ESTIMATE algorithm and survival analysis, the median survival time of the low stromal score group was significantly higher than that of the high stromal score group (P = 0.018), while the patients showed no significant difference of OS between different immune groups (P = 0.19). A total of 929 genes were upregulated and 115 genes were downregulated between the stromal score groups (|logFC| > 2, adjusted P < 0.05); 357 genes were upregulated and 472 genes were downregulated between the immune score groups. The component-target network included 139 active components and 52 related targets. The core targets were HSPB1, SPP1, IGFBP3, and TGFB1, which were significantly associated with poor prognosis in TCGA validation. GO terms included the response to hypoxia, the extracellular space, protein binding and the TNF signaling pathway. Immunoreaction was the main enriched pathway identified by KEGG analysis. CONCLUSION: The core genes (HSPB1, SPP1, IGFBP3 and TGFB1) affected CRC development and prognosis by regulating hypoxia, protein binding and epithelial-mesenchymal transition in the extracellular matrix.


Subject(s)
Colorectal Neoplasms , Drugs, Chinese Herbal , Algorithms , Colorectal Neoplasms/drug therapy , Colorectal Neoplasms/genetics , Drugs, Chinese Herbal/pharmacology , Drugs, Chinese Herbal/therapeutic use , Humans , Hypoxia/drug therapy , Tumor Microenvironment/genetics
11.
J Ethnopharmacol ; 297: 115109, 2022 Oct 28.
Article in English | MEDLINE | ID: mdl-35227780

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: The recommendation of herbal prescriptions is a focus of research in traditional Chinese medicine (TCM). Artificial intelligence (AI) algorithms can generate prescriptions by analysing symptom data. Current models mainly focus on the binary relationships between a group of symptoms and a group of TCM herbs. A smaller number of existing models focus on the ternary relationships between TCM symptoms, syndrome-types and herbs. However, the process of TCM diagnosis (symptom analysis) and treatment (prescription) is, in essence, a "multi-ary" (n-ary) relationship. Present models fall short of considering the n-ary relationships between symptoms, state-elements, syndrome-types and herbs. Therefore, there is room for improvement in TCM herbal prescription recommendation models. PURPOSE: To portray the n-ary relationship, this study proposes a prescription recommendation model based on a multigraph convolutional network (MGCN). It introduces two essential components of the TCM diagnosis process: state-elements and syndrome-types. METHODS: The MGCN consists of two modules: a TCM feature-aggregation module and a herbal medicine prediction module. The TCM feature-aggregation module simulates the n-ary relationships between symptoms and prescriptions by constructing a symptom-'state element'-symptom graph (Se) and a symptom-'syndrome-type'-symptom graph (Ts). The herbal medicine prediction module inputs state-elements, syndrome-types and symptom data and uses a multilayer perceptron (MLP) to predict a corresponding herbal prescription. To verify the effectiveness of the proposed model, numerous quantitative and qualitative experiments were conducted on the Treatise on Febrile Diseases dataset. RESULTS: In the experiments, the MGCN outperformed three other algorithms used for comparison. In addition, the experimental data shows that, of these three algorithms, the SVM performed best. The MGCN was 4.51%, 6.45% and 5.31% higher in Precision@5, Recall@5 and F1-score@5, respectively, than the SVM. We set the K-value to 5 and conducted two qualitative experiments. In the first case, all five herbs in the label were correctly predicted by the MGCN. In the second case, four of the five herbs were correctly predicted. CONCLUSIONS: Compared with existing AI algorithms, the MGCN significantly improved the accuracy of TCM herbal prescription recommendations. In addition, the MGCN provides a more accurate TCM prescription herbal recommendation scheme, giving it great practical application value.


Subject(s)
Drugs, Chinese Herbal , Plants, Medicinal , Artificial Intelligence , Drug Prescriptions , Drugs, Chinese Herbal/pharmacology , Drugs, Chinese Herbal/therapeutic use , Eye Diseases, Hereditary , Genetic Diseases, X-Linked , Medicine, Chinese Traditional
12.
Zhongguo Zhong Yao Za Zhi ; 47(1): 244-252, 2022 Jan.
Article in Chinese | MEDLINE | ID: mdl-35178936

ABSTRACT

The present study analyzed the efficacy evaluation indexes of the randomized controlled trials(RCTs) of Chinese medi-cine in the treatment of rheumatic heart disease to lay the foundation for the construction of the corresponding core outcome index set. Clinical RCTs with a definite diagnosis of rheumatic heart disease were retrieved from CNKI, Wanfang, VIP, Sino Med, Pub Med, EMbase, and Cochrane Library from January 1, 2010, to December 31, 2020. Thirty-five RCTs were included, involving 3 314 patients and 41 efficacy evaluation indexes, which covered seven domains [traditional Chinese medicine(TCM) symptoms/syndromes, symp-toms/signs, physical and chemical examination, quality of life, long-term prognosis, economic evaluation, and safety events]. Physi-cal and chemical examination(56. 91%) and symptoms/signs(29. 27%) were the more frequently applied. The number of indexes used in a single trial ranged from 1 to 15, with an average of 4. The measurement time points of the top five indexes in the frequency of use were as follows: total response rate was reported at five measurement time points, ranging from 14 days to 6 months; left ventri-cular ejection fraction was measured at eight time points ranging from 5 days to 6 months; left ventricular end systolic diameter was measured at six time points, ranging from 5 days to 6 months; interleukin-2(IL-2) and tumor necrosis factor-α(TNF-α) were repor-ted 28 days after treatment. At present, there are many problems in the efficacy outcome indexes of RCTs in the treatment of rheumatic heart disease with TCM, such as large difference in quantity, unclear primary and secondary indexes, unreasonable selection of " surro-gate indexes", insufficient attention to long-term prognostic indexes and safety event indexes, non-standard application of composite in-dexes, long measurement period, and lack of TCM characteristics. It is urgent to establish the core outcome set for TCM treatment of rheumatic heart disease.


Subject(s)
Drugs, Chinese Herbal , Rheumatic Heart Disease , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality of Life , Randomized Controlled Trials as Topic , Rheumatic Heart Disease/drug therapy , Treatment Outcome
13.
Zhongguo Zhong Yao Za Zhi ; 47(3): 819-828, 2022 Feb.
Article in Chinese | MEDLINE | ID: mdl-35178965

ABSTRACT

The purpose of the study is to analyze the outcomes of randomized controlled trial(RCT) of Chinese herbal medicine formula(CHMF) in the treatment of gastrointestinal dysfunction in sepsis in recent two years. We systematically searched four Chinese databases, three English databases, and two clinical trial registries to analyze the reports of outcome indicators of clinical trials, and evaluated the risk of bias by using the ROB tool of Cochrane Collaboration. After screening, 55 clinical RCTs were included. The results showed that the current clinical studies of gastrointestinal dysfunction in sepsis reported the efficacy and safety indicators. The efficacy indicators included APACHE Ⅱ scores, gastrointestinal dysfunction scores, bowel sound scores, and inflammatory indicator such as C-reactive protein and procalcitonin. The safety indicators mainly include gastrointestinal reactions, skin reactions, and other adverse events and adverse reactions. However, there was no distinction between primary and secondary outcomes. The relevant indicators of health economics were not reported, and the quality of research methodology was poor. Therefore, we suggest that future researchers should be well prepared in the top-level design stage and actively construct the core outcome set, so as to improve the quality of clinical trials.


Subject(s)
Drugs, Chinese Herbal , Gastrointestinal Diseases , Sepsis , Drugs, Chinese Herbal/therapeutic use , Gastrointestinal Diseases/drug therapy , Humans , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic , Research Design , Sepsis/drug therapy
14.
Zhongguo Zhong Yao Za Zhi ; 47(3): 829-835, 2022 Feb.
Article in Chinese | MEDLINE | ID: mdl-35178966

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)
Drugs, Chinese Herbal , Myocarditis , Cost-Benefit Analysis , Drugs, Chinese Herbal/therapeutic use , Economics, Pharmaceutical , Humans , Myocarditis/drug therapy , Qi , Yin Deficiency/drug therapy
15.
Artif Intell Med ; 124: 102232, 2022 02.
Article in English | MEDLINE | ID: mdl-35115127

ABSTRACT

Traditional Chinese medicine (TCM) is an essential part of the world's traditional medicine. However, there are still many issues in the promotion and development of TCM, such as a lot of unique TCM treatments are taught only between the master and an apprentice in practice, it takes dozens of years for a TCM practitioner to master them and the complicated TCM treatment principles. Intelligent TCM models, as a promising method, can overcome these issues. The performance of previously proposed AI models for intelligent TCM is restricted since they rely on clinical medical records, which are limited, hard to collect, and unavailable for intelligent TCM researchers. In this work, we propose a two-stage transfer learning model to generate TCM prescriptions from a few medical records and TCM documentary resources, called TCMBERT for short. First, the TCMBERT is trained on TCM books. Then, it is fine-tuned on a limited number of medical records to generate TCM prescriptions. The experimental results show that the proposed model outperforms the state-of-the-art methods in all comparison baselines on the TCM prescription generation task. The TCMBERT and the training process can be used in TCM tasks and other medical tasks for dealing with textual resources.


Subject(s)
Drugs, Chinese Herbal , Drug Prescriptions , Drugs, Chinese Herbal/therapeutic use , Herbal Medicine , Machine Learning , Medicine, Chinese Traditional/methods
16.
Zhongguo Zhong Yao Za Zhi ; 47(23): 6278-6286, 2022 Dec.
Article in Chinese | MEDLINE | ID: mdl-36604872

ABSTRACT

Rare and endangered animal medicine, a kind of important Chinese medicine, plays an irreplaceable role in the prevention and treatment of serious acute and chronic diseases and major diseases. Due to resource limitation and depletion and the increasing demand, rare and endangered medicinal animal resources have been drastically reduced or even extinct, which threatens the inheritance of traditional Chinese medicine, the integrity of clinical medicine, and the development of the traditional Chinese medicine industry. For the protection and sustainable utilization of Chinese medicinal resources, artificial substitutes came into being. However, there is still a lack of systematic research on the pharmacological effects and clinical applications of artificial substitutes and whether they can completely replace the original medicinal materials in clinical practice. Therefore, this study focuses on the status quo of rare and endangered animal medicinal materials and their artificial substitutes that have been marketed. To be specific, the two were compared and whether the artificial substitutes can completely replace the original medicinal materials was analyzed. In addition, constructive suggestions on the industrialization of artificial substitutes were put forward, which was expected to promote the sustainable development of Chinese medicinal resources.


Subject(s)
Conservation of Natural Resources , Drugs, Chinese Herbal , Animals , Industrial Development , Medicine, Chinese Traditional , Sustainable Development , Drugs, Chinese Herbal/pharmacology , Drugs, Chinese Herbal/therapeutic use , China
17.
Medicine (Baltimore) ; 100(29): e26699, 2021 Jul 23.
Article in English | MEDLINE | ID: mdl-34398042

ABSTRACT

BACKGROUND: Endometriosis (EMs) affects about 10% of women of childbearing age. It is defined as functional endometrial tissue appearing in other parts of the uterine cavity, manifested by varying degrees of pelvic pain and pelvic mass, etc. Therefore, to improve the therapeutic effect of endometriosis, we must constantly explore new ways to treat the disease. The purpose of this study is to evaluate the effectiveness and safety of the combined use of laparoscopy and traditional Chinese medicine in the treatment of patients with EMs. METHODS: A systematic literature search will be conducted at China National Knowledge Infrastructure, WanFang databases, VIP, SinoMed, PubMed, Embase, Web of Science, and the Cochrane library. The search period limit is from the time the date of database establishment to June 21, 2021. To ensure the comprehensiveness of the search, relevant references and conference literature are also included. The risk of bias in the final included studies will be evaluated based on the guidelines of the Cochrane Handbook for Systematic Reviews of Interventions. The RevMan software will be employed to perform data synthesis and statistical analysis. RESULTS: The effectiveness and safety of laparoscopic surgery combined with traditional Chinese medicine decoction in the treatment of patients with EMs will be systematically evaluated. CONCLUSION: The results of this study will provide strong evidence for judging whether laparoscopy combined with traditional Chinese medicine decoction is an effective strategy for the treatment of patients with EMs.


Subject(s)
Drugs, Chinese Herbal/therapeutic use , Endometriosis/drug therapy , Combined Modality Therapy , Drugs, Chinese Herbal/administration & dosage , Endometriosis/surgery , Female , Humans , Laparoscopy , Phytotherapy , Research Design
18.
J Sep Sci ; 44(17): 3229-3236, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34240804

ABSTRACT

Semen of Cuscuta chinensis has been reported to have an anti-osteoporosis effect, however, the components which account for the anti-osteoporosis effect have not been clarified. In this work we propose a biochemometrics strategy that integrates quantitation, anti-osteoporosis evaluation in zebrafish, and grey relationship analysis for the identification of anti-osteoporosis components from the semen of Cuscuta chinensis. In the beginning, a precise and accurate liquid chromatography-tandem mass spectrometry method was established for simultaneous quantitation of seven major components in crude and salt-processed Cuscuta chinensis. The mode of multiple reaction monitoring was used. Chloramphenicol was selected as the internal standard. The method showed good linearity and repeatability. The recovery rates of each component ranged from 95.4 to 103.9%. The precisions of intra-day and inter-day were all within 5.0%. The method was then applied for quantitation of the seven major components in 11 batches of crude and salt-processed Cuscuta chinensis. Subsequently, the anti-osteoporosis effects of crude and salt-processed Cuscuta chinensis were evaluated in zebrafish. Principle component analysis, grey relationship analysis, and partial least squares regression were applied for deciphering the relationship between the contents of seven major components and the anti-osteoporosis effects. Hyperin, p-hydroxycinnamic acid, and astragalin were found to be the major anti-osteoporosis components.


Subject(s)
Cuscuta/chemistry , Drugs, Chinese Herbal/therapeutic use , Osteoporosis/drug therapy , Plant Extracts/therapeutic use , Semen/chemistry , Animals , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/chemistry , Drugs, Chinese Herbal/isolation & purification , Medicine, Chinese Traditional , Multivariate Analysis , Plant Extracts/chemistry , Plant Extracts/isolation & purification , Salts/chemistry , Tandem Mass Spectrometry , Ultrasonic Waves , Zebrafish
19.
Zhongguo Zhong Yao Za Zhi ; 46(10): 2588-2593, 2021 May.
Article in Chinese | MEDLINE | ID: mdl-34047107

ABSTRACT

To evaluate the economics of Suhuang Zhike Capsules in the treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD) for inpatients. Based on the published clinical research data, cost-utility analysis was used in this study to evaluate the pharmacoeconomics of Suhuang Zhike Capsules in treatment of AECOPD inpatients from the perspective of medical insu-rance. The test group was treated with Suhuang Zhike Capsules combined with conventional Western medicine, and the control group was treated with conventional Western medicine alone. Treeage software was used to construct a pharmacoeconomic model and perform simulation analysis. The results showed that the cost and output of Suhuang Zhike Capsules combined with the conventional Western medicine were 60 010.18 yuan and 1.92 quality adjusted life year(QALYs), respectively in the simulated 3 years of disease treatment. The cost and output of the conventional Western medicine were 96 730.60 yuan and 1.90 QALYs respectively. Suhuang Zhike Capsules combined with conventional Western medicine required lower cost but achieved higher output, showing cost-utility advantages, so this drug combination was a plan with pharmacoeconomic advantages. The sensitivity analysis results showed that the conclusion was relatively stable. Based on the above results, it is believed that as compared with the conventional Western medicine, Suhuang Zhike Capsules combined with conventional Western medicine have lower cost and higher output for the treatment of AECOPD inpatients, and it is a treatment plan with pharmacoeconomic advantages.


Subject(s)
Drugs, Chinese Herbal , Pulmonary Disease, Chronic Obstructive , Capsules , Drugs, Chinese Herbal/therapeutic use , Economics, Pharmaceutical , Humans , Inpatients , Pulmonary Disease, Chronic Obstructive/drug therapy
20.
Zhongguo Zhong Yao Za Zhi ; 46(9): 2309-2316, 2021 May.
Article in Chinese | MEDLINE | ID: mdl-34047135

ABSTRACT

The increasing burden of cardiovascular disease in China has become a major public health problem, and the prevention and treatment of cardiovascular disease is in urgent need. For the reality of integrated Chinese and Western medicine in the Chinese health care system, we can consider the service ability of traditional Chinese medicine. Xueshuan Xinmaining Tablet is a kind of Chinese patent medicine commonly used in the treatment of recovery stage of ischemic stroke and angina pectoris of coronary heart disease. Based on the data of hospitalized patients covered by national urban basic medical insurance of China Medical Insurance Research Association in 2013, this study evaluated the treatment cost and detailed composition of the cost for the patients with cerebral infarction and coronary heart disease treated by Xueshuan Xinmaining Tablets. At the same time, the differences in disease burden and direct medical expenses among Xueshuan Xinmaining Tablets group, Western medicine group and another commonly used Chinese patent medicine group were analyzed. Among the three groups of patients with cerebral infarction and coronary heart disease, the hospitalization rates caused by various causes(44.4% and 29.6%) and diseases(20.8% and 5.2%) in Xueshuan Xinmaining Tablets group were the lowest(all P<0.01), and the number of hospitalization times in half a year was highest in the common Chinese patent medicine group(all P<0.01). In patients with cerebral infarction, the median annual total outpatient expenses were 7 476.8, 7 601.8, 15 650.1 yuan respectively in Western medicine group, Xueshuan Xinmaining Tablets group and the common Chinese patent medicine group(P<0.01), and the median hospitalization expenses were 11 620.2, 14 988.9, 13 325.6 yuan respectively(P=0.058). In patients with coronary heart disease, the total outpatient expenses of the three groups were 6 831.4, 10 228.6, 13 132.4 yuan respectively(P<0.01), and the total hospitalization expenses were 13 354.7, 14 911.5, 15 725.3 yuan respectively(P=0.134). The results showed that in patients with cerebral infarction and coronary heart disease, the hospitalization rate was lowest in Xueshuan Xinmaining Tablets group, beneficial to the turnover of hospital beds and full use of hospital medical resources. The total annual outpatient cost of Xueshuan Xinmaining Tablets group was lower than that of common Chinese patent medicine group, beneficial to reduce the burden of disease.


Subject(s)
Coronary Disease , Drugs, Chinese Herbal , Cerebral Infarction/drug therapy , China , Coronary Disease/drug therapy , Cost of Illness , Drugs, Chinese Herbal/therapeutic use , Humans , Tablets
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