Onset and Recurrence Characteristics of Chinese Patients with Noncardiogenic Ischemic Stroke in Chinese Medicine Hospital / 中国结合医学杂志

OBJECTIVE@#To delineate the onset and recurrence characteristics of noncardiogenic ischemic stroke patients in China.@*METHODS@#A prospective, multicenter and registry study was carried out in 2,558 patients at 7 representative clinical sub-centers during November 3, 2016 to February 17, 2019. A questionnaire was used to collect information of patients regarding CM syndromes and constitutions and associated risk factors. Additionally, stroke recurrence was defined as a primary outcome indicator.@*RESULTS@#A total of 327 (12.78 %) patients endured recurrence events, 1,681 (65.72%) were men, and the average age was 63.33 ± 9.45 years. Totally 1,741 (68.06%) patients suffered first-ever ischemic stroke, 1,772 (69.27%) patients reported to have hypertension, and 1,640 (64.11%) of them reported dyslipidemia, 1,595 (62.35%) patients exhibited small-artery occlusion by The Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification. Specifically, 1,271 (49.69%) patients were considered as qi-deficient constitution, and 1,227 (47.97%) patients were determined as stagnant blood constitution. There were 1,303 (50.94%) patients diagnosed as blood stasis syndrome, 1,280 (50.04%) patients exhibited phlegm and dampness syndrome and 1,012 (39.56%) patients demonstrated qi deficiency syndrome. And 1,033 (40.38%) patients declared intracranial artery stenosis, and 478 (18.69%) patients reported carotid artery stenosis. The plaque in 1,508 (41.36%) patients were of mixed. Particularly, 41.09% of them demonstrated abnormal levels of glycated hemoglobin levels.@*CONCLUSIONS@#Recurrence in minor and small-artery stroke cannot be ignored. Hypertension, dyslipidemia, abnormal HbA1c, intracranial artery stenosis and carotid plaque were more common in stroke patients. Particularly, phlegm-dampness and blood stasis syndromes, as well as qi deficiency and blood stasis constitutions, were still the main manifestations of stroke. (Trial registration at ClinicalTrials.gov No. NCT03174535).

Clinical practice guideline for postmenopausal osteoporosis with traditional Chinese medicine / 中国中药杂志

The editorial group of the clinical practice guideline for postmenopausal osteoporosis(PMOP) with traditional Chinese medicine(TCM)(hereinafter referred to as "guideline") is composed of experts specialized in TCM orthopedics, TCM gynecology, clinical epidemiology, etc. The guideline was formulated through registration, collection and selection of clinical issues/outcome indicators, evidence retrieval and screening, preparation of systematic reviews, evaluation of evidence quality, formation of recommendations, drafting, and peer review. The syndromes and treatment of PMOP are elaborated in detail. Specifically, Liuwei Dihuang Pills and Zuogui Pills are recommended for PMOP with Yin deficiency in the liver and kidney, Qing'e Pills for PMOP with kidney deficiency and blood stasis, Yougui Pills and Jingui Shenqi Pills for PMOP with Yang deficiency in the spleen and kidney, and Er'xian Decoction for PMOP with Yin and Yang deficiency in the kidney. In addition, Duhuo Jisheng Decoction can be used to relieve pain. The commonly used Chinese patent medicines include Xianling Gubao Capsules, Qianggu Capsules, Jintiange Capsules, Gushukang Capsules, Hugu Capsules, Jinwu Gutong Capsules, and Guyuling Capsules. Acupuncture and moxibustion are also effective approaches for PMOP. The rehabilitation and daily management were carried out by exercise therapies such as Baduanjin(eight-section brocade), Wuqinxi(five-animal exercises), and Taijiquan(Tai Chi), Chinese medicine diet, health education, and fall prevention. The promotion and application of this guideline will facilitate the implementation of TCM prevention and treatment of PMOP, ensure the quality of life of PMOP patients, provide effective and safe TCM treatment measures for PMOP, and reduce the risk of fracture complications.

Evaluation of bone mass and relevance ratio of osteoporosis among middle aged and elderly population in Beijing community / 中国骨伤

OBJECTIVE@#To investigate the relevance ratio of osteoporosis and bone mass of middle aged and elderly people in Beijing communities, in order to understand occurrence and development trend of abnormality of bone mass in high-risk population from community.@*METHODS@#Based on the method of cross-sectional investigation, the information data of 1 540 middle-aged and elderly people from 10 communities were collected, including 415 males and 1 125 females, aged from 45 to 80 years old with the average of (63.02±7.15) years old; the height was (161.34±7.24) cm, the weight was (65.90±10.19) kg, body mass index was (25.29±3.32) kg /m2. Bone mineral density (BMD) of lumbar vertebrae (L@*RESULTS@#The level of β-CTX was(0.27±0.12) ng /ml, procollanen type 1 N-terminal propeptide(P1NP) was(51.03± 22.36) ng /ml, 25(OH) D3 was (16.68±6.24) ng /ml, serum calcium was(2.34±0.09) mmol / L, blood phosphorus was (1.43± 0.37) mmol / L, and blood magnesium was (0.94±0.07) mmol / L, alkaline phosphatase was (79.28±20.48) U/ L, parathyroid hormone was (3.09±1.60) pmol / L, osteocalcin was (13.29±6.65) ng /ml. Except for blood magnesium, the other indexes had significant differences between different sex groups(@*CONCLUSION@#There are obvious differences in relevance ratio of osteoporosis and low bone mass among different sites. It is suggested that the clinical diagnosis of osteoporosis should be combined with bone mineral density and bone metabolic markers. With the increasing prevalence of osteoporosis among middle aged and elderly people in Beijing community, continuous follow-up research based on community primary health care units could promote early examination, early diagnosis, and early treatment of middle aged and elderly people at high risk of osteoporosis in community.

Post-marketing pharmaco-economics evaluation of Jinye Baidu Granules / 中国中药杂志

To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.

Technical specifications for hospital-based intensive monitoring of post-marketing Chinese patent medicine / 中国中药杂志

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.

Expert consensus statement on Danshen Chuanxiongqin Injection in clinical practice / 中国中药杂志

Danshen Chuanxiongqin Injection is a commonly used medicine in cerebral infarction and coronary heart disease,which is recommended by many disease guidelines/consensus for cardiovascular and cerebrovascular diseases. However,there are irrational drug using in clinic,which affects the efficacy and brings safety risks. Based on clinical research evidence and expert experience,recommendations/consensus suggestion are determined through the nominal group method. The expert consensus recommends the indications,intervention time for treatment,route of drug administration,usage and dosage,course of treatment and introduces the safety in clinical application,which could provide reference for clinical use of Danshen Chuanxiongqin Injection.

Systemic review of Jintiange Capsules in treatment of postmenopausal osteoporosis / 中国中药杂志

To systemically evaluate the efficacy and safety of Jintiange Capsules in the treatment of postmenopausal osteoporosis(PMOP).Seven literature databases were retrieved systematically,and two reviewers independently searched and screened studies,extracted data,and included all the randomized controlled trials on Jintiange Capsules in the treatment of PMOP.Interventions included comparison of Jintiange Capsules with placebo and routine treatment,and the studies on Jintiange Capsules combined with routine treatment versus conventional treatment were also included.The evaluation indicators of the study included at least one of the followings:fracture,quality of life,daily living ability,clinical symptoms,death,adverse events/adverse reactions,bone density,and bone metabolism indexes.The original study quality evaluation was conducted by following the Cochrane Handbook standard and statistical analysis was performed by using Rev Man 5.2.A total of 7 randomized controlled trials were included and the study quality was low.Meta-analysis showed that as compared with conventional treatment alone,Jintiange Capsules combined with conventional treatment showed more obvious effects in pain relief(MD=-0.98,95% CI[-1.55,-0.41],P=0.000 8),increasing blood calcium levels(MD=0.05,95% CI[0.02,0.09],P=0.003) and lowering serum alkaline phosphatase levels(MD=-12.92,95% CI[-24.09,-1.75],P=0.02).In addition,the Chinese patent medicine alone or in combination with conventional treatment was relatively safe.In conclusion,Jintiange Capsules has a certain effect in treating PMOP,but the quality of evidence is low.It is necessary to conduct well designed randomized controlled trials and select recognized evaluation indicators,especially the end outcomes in order to further improve the clinical evidence.

Study on mechanism of Drynariae Rhizoma in treating osteoporosis with integrative pharmacology perspective / 中国中药杂志

Drynariae Rhizoma has great significance in the clinical practice of osteoporosis treatment. Based on the perspective of integrative pharmacology, the study explored the mechanism of action of Drynariae Rhizoma in the treatment of osteoporosis. Six active components in Drynariae Rhizoma were obtained, mainly including glycosides and sterols. Taking the median of 2 times of "node connectivity" as the card value, the core node of the Chinese medicine target disease gene interaction network was selected. Based on this, three topological structural eigenvalues, such as "node connectivity" "node tightness" and "node connectivity" were calculated, thereby screening out four core targets of Drynariae Rhizoma treatment for osteoporosis, including thyroid parathyroid hormone 1 receptor (PTH1R), parathyroid hormone 2 receptor (PTH2R), calcitonin receptor gene (CALCR), and SPTBN1 gene (SPTBN1). Based on the gene ontology database GO and KEGG pathway database, the molecular function, intracellular localization, and biological reactions and pathways of proteins encoded by drug target genes were determined. Combined with enrichment calculation, it is predicted that osteoporosis may play a role in biosynthetic processes, such as circulatory system, nervous system, energy metabolism, prolactin signal pathway, GnRH signaling pathway, neurotrophic factor signaling pathway and other pathway. The conclusion of this study is certain with the existing research results, and the new target and new pathway could also be used as a theoretical basis for the further verification of osteoporosis.

Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica / 中国中药杂志

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions.

How to draft editorial explanation for transparent and concise guideline on clinical practice--Case analysis / 中国中药杂志

Clinical practice guideline (CPG) should be concise and readability, which can be possible to implement CPG into practice smoothly. A formal published CPG can't load its developing process and details. An editorial explanation of CPG is much useful to show details and logic process of developing CPG. Although there are many different standards for developing CPG, being nothing to do with process management of CPG. By referring to editorial explanation on international standards, a request for CPG was investigated in this study. An editorial explanation for clinical practice guideline should be transparency, logic and traceable. A good editorial explanation could make users or readers to learn what goes on behind the scenes. A standardized editorial explanation could supervise the GCP developing and improve the quality of GCP.

Study of Jinye Baidu granule in treatment of wind-warmth lung heat disease (heat in lung-wei pattern)： a randomized, double-blind, parallel-controlled trial / 中国中药杂志

A randomized, double-blind, active parallel controlled trial will be conducted to include patients with acute upper respiratory infection and wind-warmth lung heat disease (heat in lung-wei pattern). Patients with serious bacterial infection (white blood cell count>1.2×1010, neutrophil>80%) will be excluded.so as to further identify Jinye Baidu Granule indications of Wind-warmth lung heat disease (heat in lung-wei pattern).According to the subjects of symptoms of fever and sore throats,Patients will be divided into three blocks： fever, swelling and sore throat, combined fever and swelling and sore throat. Subjects in three blocks will be divided into treatment group and control group with stratified blocked randomization. The treatment group will be treated with Jinye Baidu Granule, and the control group will be treated with Fufang Shuanghua granule. Primary outcome measure of patients with fever will be body temperature recovery time. Primary outcome measure of patients with swelling and sore throat will be throat symptom score. Primary outcome measures of patients combined with fever and swelling and sore throat will be body temperature recovery time and throat symptom score. Before and after all of the patients in the group were collected blood and urine routine, liver and renal function, electrocardiogram (ECG) data as the safety index while observing it adverse events. A total of 623 patients were included. Compared with control group,sore throat symptoms of patients with sore throat and pharyngeal symptoms total score have significantly different. so Jinny Baidu granule have a significant advantage in the treatment of sore throat. All of the experiments showed that the safety of the drug was good. Nausea, vomiting, stomach pain, diarrhea, digestive tract symptoms may occur only occasionally. We should pay attention to the changes when using in patients with spleen deficiency cold to avoid adverse reaction.

Intensive hospital monitoring of Shuxuening injection in 30 209 cases / 中国中药杂志

In order to obtain the characteristics and incidence of adverse reactions of Shuxuening injection (Xingxue), the design method of a multi-center, large sample intensive monitoring in the hospitals was adopted. The hospitalized patients with use of Shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle. The main content of monitoring included the patients' general information, diagnostic information, medication information, and adverse event information. A total of 30 209 patients with Shuxuening injection were enrolled; adverse reactions occurred in 34 cases, with an incidence of 0.113%, which belonged to the rare adverse reactions. Adverse reactions were characterized by headache, dizziness, pruritus, palpitations, nausea, et al. All the above results showed that Xingxue Shuxuening injection had high safety in clinical application.

Clinical characteristics and drug combination analysis in patients with inflammatory bowel disease based on real world HIS data of 14 758 cases / 中国中药杂志

To analyze the characteristics and clinical medicine for inflammatory bowel disease based on the diagnostic information and medical advice information in hospital information system of 20 3A hospitals. Frequency analysis and correlation analysis results showed that the most common complications for inflammatory bowel disease included hypertension (2 058 cases, 13.94%), chronic superficial gastritis (1 611 cases, 10.92%), bowel benign tumor (1 351 cases, 9.51%), coronary heart disease (1 346 cases, 9.15%), chronic gastritis (1 044 cases, 7.07%), stomachache (1 030 cases, 6.98%), chronic antrum gastritis (988 cases, 6.69%), type 2 diabetes mellitus (956 cases, 6.48%), upper respiratory infection (816 cases, 5.53%) and gastrointestinal bleeding (784 cases, 5.31%). The most-frequently-used drug combination was montmorillonite powder-berberine hydrochloride tablets (35.56%), followed by glycyrrhiza compound-ambroxol (29.8%), Yunnan Baiyao-hemocoagulase (28.8%), and berberine hydrochloride tablets-aspirin (27.91%). The study indicated that the complications of inflammatory bowel disease had their own features, so we should attach importance to the treatment of these complications. Meanwhile, Chinese medicine accounted for a high proportion in the drug combinations for inflammatory bowel disease, thus importance shall be attached to integrative Chinese and western medicine to achieve ideal treatment effect.

32 546 intensive hospital monitoring cases of Shuxuetong injection / 中国中药杂志

This study adopted multi-center and large sample design to understand the incidence, characteristics and other information about adverse reaction of Shuxuetong injection. In 54 medical institutions, use of Shuxuetong injection of entire treatment period was monitored, including patients' general information, diagnostic information, medication, adverse reaction/event information, etc. Sixty four cases of adverse reactions in 32 546 patients was monitored, adverse rate was 0.197%, mainly characterized by skin itching, rash, flu-like, dyspnea, palpitations, headache, chest tightness and other allergic reactions. Adverse reaction occurred mainly in elderly patients and medication was consistent with the instruction. Based on these results, safety of Shuxuetong injection in clinical application is excellent.

Clinical medication characteristics of Shuxuening injection in treatment of cerebral infarction research based on registration / 中国中药杂志

To understand the medication characteristics of Xingxue@Shuxuening solutions in the real world, multi-center, large-sample-size registration design method is adopted in this study. Between October 2012 and October 2015, hospitalized patients in 27 medical institutions who used Shuxuening and diagnosed as cerebral infarction were observed, including their general information, diagnosis information and medication information. Totally 9 473 cases of cerebral infarction were included, with old people as the majority, and males were slightly more men than females; they were complicated with coronary heart disease, vertebrobasilar artery insufficiency, transient brain ischemia and other cerebrovascular diseases; the medication duration was mostly within 14 days; the dosage was mainly 8-20 mL; 0.9%NS, 5%GS were the main solvent; commonly used drug combination was Ozagrel sodium injection, Shuxuetong injection, Alprostadil injection and other medicines for inhibiting platelet aggregation and blood vessel dilatation, and Cytidine diphosphate choline injection, Edaravone injection, Oxiracetam injection and other brain protective agents. The above results indicate that the clinical medication characteristics of Shuxuening are basically consistent with the package insert, except for the solvent; combined medicine is dominated by antiplatelet drugs; for old patients, various anticoagulant drugs shall selected according to their specific conditions to avoid the occurrence of adverse reactions.

HIS-based analysis of clinical characteristics and combined treatment of Chinese and western medicine in diabetes deaths / 中国中药杂志

To understand the clinical characteristics and distribution of combined treatment of Chinese and western medicine in diabetes deaths, the hospitalization information of diabetes deaths from HIS system of 20 national 3A-grade general hospitals. Then the frequency statistics and association rules analysis were used to analyze the general information, complications, combined treatment, death time and other information of the patients died from diabetes. The results showed that most of the diabetes deaths were of middle aged and elderly people, more often in males than females. The complications with higher incidence included hypertension, pulmonary infection, coronary heart disease, cerebral infarction and renal inadequacy. In combined treatment rules, western medicines insulin, cefuroxime, furosemide, dopamine, nikethamide and sodium bicarbonate were used in combination at highest frequencies, followed by the combinations of traditional Chinese medicines panax notoginseng, radix bupleuri and western medicines, and the combinations between Chinese medicines had the lowest use frequency. Most of the diabetes deaths were of middle aged and elderly people, more often in males than females. They mainly died from 3 pm to 5 pm and from 5 pm to 7 pm. Therefore, the diabetes deaths often had complications of cardiovascular and cerebrovascular diseases, and early prevention shall be noted in clinics; the clinical treatment plan was basically in accordance with the guidelines for clinical treatment of diabetes; the drugs with promoting blood circulation to remove blood stasis and soothing liver-qi stagnation effects were the common Chinese medicines in treatment of diabetes.

Study design and implementation for population pharmacokinetics of Chinese medicine: An expert consensus / 中国结合医学杂志

Although many population pharmacokinetics (PPK) researches have been conducted on chemical drugs, few have been in the field of Chinese medicine (CM). Each ingredient in CMs possesses different pharmacokinetic characteristics, therefore, it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations. To develop an expert consensus on study design and implementation for PPK of CM, in August 2013, 6 experts in the field of PPK, CMs pharmacology, and statistics discussed problems on the PPK research protocol of CMs, and a consensus was reached. The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected. The compositions with definite therapeutic effects were selected as indices, and specific time points and sample sizes were designed according to standard PPK design methods. Target components were tested through various chromatography methods. Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifies the study design and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, in vivo investigations related to the metabolism in different populations, and development and clinical adjustment of dosages of CMs.

Analysis of the allergic reaction types of Chinese medicine injection based on immunotoxicty / 中国中药杂志

The purpose of the study is to find the allergic reaction types and characteristics of Chinese medicine injection ( CMI). The authors monitored patients who used Shuxuetong injection, Dengzhan Xixin injection, Shenqi Fuzheng injection, Shenmai injection, Ciwujia injection, Shuxuening injection, Tanreqing injection, Reduning injection, a total of 150,000 cases were monitored. They used a nested case-control design to group the patients and obtained the serum samples from 14 allergic patients and 55 matched patients. They used enzyme-linked immunosorbent assay (ELISA) to detect serum C3, C4, IgE, IgG, MCT-P, and judge the allergic reaction types: Shuxuetong injection hypersensitivity (1 case), can not determine (1 case); Dengzhan Xixin injection hypersensitivity (1 case), hypersensitivity & anaphylactoid reaction (1 case), can not determine (1 case); Shenqi Fuzheng injection hypersensitivity (3 cases), can not determine (1 case); Shenmai injection anaphylactoid reaction (1 case); Ciwujia injection can not determine (1 case), Shuxuening injection can not determine (1 case), Tanreqing injection can not determine (1 case), Reduning injection can not determine (1 case). The results showed that the main type of allergic reaction of CMI was hypersensitivity, the type of allergic reaction was closely related to the varieties of CMI, the hypersensitivity and anaphylactoid reaction might occur in one patient at the same time which used Dengzhan Xixin injection.

Construction and implementation of quality control index for clinical safety of Chinese medicine injection / 中国中药杂志

In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.

Advantages of population pharmacokinetics and its application in the field of traditional Chinese medicine / 中国中药杂志

The accurate medical treatment is based on the information of the genome, which is the best treatment for the patients. Population pharmacokinetic study can be formulated according to the individual differences of patients to the dose, in the accurate medical model which has a unique advantage. At present, there are many problems such as adverse drug reaction in Chinese traditional medicine, and it is necessary to introduce a group of medicine on the basis of precise medical treatment. However, due to the different characteristics of traditional Chinese medicine and chemical medicine, it is necessary to combine the population pharmacokinetics, genetics and statistical methods to establish a research method which is in line with the characteristics of Chinese medicine. The key scientific problem is to make clear the active components of Chinese medicine metabolism of the drug metabolic enzyme gene, and pay attention to the analysis of the polymorphism of the overall role of drug metabolism enzymes in the human body. Clear key scientific issues and break through the bottleneck, so as to achieve the precise medical treatment, to international.