It is very important to develop and revise expert panel consensus on Chinese patent medical clinical application. The contents of the expert panel consensus include determination of the subject, clarity of the application scope, indications, dosage and administration, and safety of Chinese patent medicine. In the process, clinical researchers establish project team, formulate clinical management questions, select the outcome index, retrieve and make the evidence, and develop expert consensus with consensus methods strictly according to the requirements of methodology.
摘要:目的:分析妇科口服中成药的用药情况,为临床合理用药提供依据。方法:对我院2007～2008年妇科口服中成药用的种类、用量、销售金额、用药频度、日均费用等进行分析。结果:妇康丸、益母草胶囊、五加生化胶囊临床应用广泛,而宫血宁胶囊受同类西药品种的影响,其用药量呈大幅下降趋势,一些新进药品如大黄蛰虫片使用量呈快速上升趋势。结论:我院妇科口服中成药使用情况基本合理。Abstract: Objective: To analyze the utilization of Gynecological oral Chinese patent medicines in our hospital for reference of their rational use. Methods:Gynecological oral Chinese patent medicines used in our hospital during 20072008 were analyzed in terms of drug varieties,consumption quantity,consumption sum, defined daily dose(DDDs)and defined daily cost(DDC)etc.Results:There was a widespread application of Fukang pills, Yimucao capsules and Wujia Shenghua capsules.The consumption of Gongxuening capsules witnessed a great reduction on account of western medicine.Some new Chinese patent medicines such as Dahuang zhechong tablets assumed fast increaseing tendency in consumption quantity. Conclusion:The utilization of Gynecological oral Chinese patent medicines in our hospital was basically rational.
Objective To systematically evaluate the quality of published pharmacoeconomics studies on Chinese patent medicines for neoplasms. Methods Datasets including CNKI, WanFang Data, VIP, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase were searched to collect pharmacoeconomics studies of Chinese patent medicines in neoplasms from the establishment of the database to September 30, 2022. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) and quality of health economics studies (QHES) were used to evaluate the reporting quality and methodological quality. Results A total of 25 studies were included, with an average CHEERS 2022 coincidence rate of 40.09% and an average QHES score of 53.2. Conclusion The quantity and quality of pharmacoeconomics studies on Chinese patent medicines in neoplasms are insufficient and flawed. It is suggested to strenthen the collaboration between scientific research institutions and hospitals and standardize the pharmacoeconomics studies on Chinese patent medicines in neoplasms to provide hygienic decision-making evidence for Chinese patent medicines in neoplasms.
The number of clinical practice guidelines for traditional Chinese patent medicine has been increasing recently. However, the quality of guidelines was still low compared to international guidelines. Considering the characteristics of traditional Chinese patent medicine, we suggested the following items should be taken into account when developing traditional Chinese patent medicine guidelines: ensuring the standardized guidelines of traditional Chinese patent medicine research problem is scientific based on reliable evidence; identifying the common questions according to these research problems; understanding the strength of evidence and how to recommend correctly; inviting some experts in other fields to take part in the development of guidelines; paying more attention on the changes of disease burden and the impact of new methods and technologies when developing the guideline; paying more attention to the non-consensus opinions and evidence supporting these opinions; insisting on quality is the priority, while speed is secondary.
Objective To evaluate the effectiveness and safety of Chinese medicine treatment of cholelithiasis. Methods We searched electronic databases including MEDLINE (1966 to Feb. 2009), EMbase (1974 to Feb. 2009), The Cochrane Library (Issue 4, 2008), Chinese Biomedical Literature Database (CBM, 1978 to Feb. 2009), CJFD (CNKI, 1994 to Feb. 2009), the Chinese Scientific and Technical Journals database (VIP, 1989 to Feb. 2009), and a database of Chinese biomedical journals (CMCC, 1994 to Feb. 2009). At the same time, we searched references of the included studies. Metaanalysis was performed using RevMan 5 if there was no significant heterogeneity. We described the date which could not be combined. Results A total of 18 randomized controlled trials involving 2 276 patients were included. According to measurement indicators and interventions, subgroup analysis was performed. Efficacy was reported in 10 studies, which showed that part of proprietary Chinese medicines had a higher efficiency for cholelithiasis. Gallbladder emptying index and the trend of bile into the stone were compared in 5 studies, suggesting that the bile of proprietary Chinese medicines reduced the stone index, which eased the bile tendency to rock. Three studies reported the rate of cholecystokinin. Metaanalysis results suggested that the difference was significant. Two studies reported adverse drug reactions (ADRs), such as epigastric discomfort and diarrhea. Most ADRs were slight, and could be self relieved. Conclusion Results suggest that Chinese medicines produce effects on clinical symptoms of cholelithiasis, gallbladder function and reduce the trend of bile into stones. However, the therapeutic effects for long-term are rarely reported. The conclusion needs further verification due to low methodological quality and apparent heterogeneity.
Objective The modification of Chinese patent medicines (CPM) instructions is currently the focus of national drug regulation, with policies and regulations being established. Nevertheless, the policies pertaining to CPM instructions have not been thoroughly investigated. This study analyzes the direction and current issues with existing policy items to give a reference for future optimization and adjustment of policies linked to CPM instructions. Methods The official website of the National Medical Products Administration (NMPA) and National Health Commission (NHC) were searched to collect policy documents related to the CPM instructions issued at the national level in China from January 1st 2000 to June 1st 2024. Based on the classification of policy tools (supply-based policy tools, demand-based policy tools, environment-based policy tools) and the dimension of policy development (policy planning, policy implementation, policy supervision, and policy evaluation ), a two-dimensional analytical framework of "policy tools and policy process" was constructed by using the content analysis method and the quantitative analysis method, and policy documents were analyzed. Results The 27 policy texts included in the analysis generated 104 policy entries in total, wherein, environment-based policy tools (74.04%) were used the most in the dimension of policy tools, followed by demand-based policy tools (24.04%) and supply-based policy tools (1.92%). In the dimension of policy development, policy planning tools, policy implementation tools, policy supervision tools, and policy evaluation tools accounted for 24.04%, 52.88%, 17.31%, and 5.77%, respectively. An in-depth analysis of the content of the policy entries discovered that the existing policy took into account the specification of the content of the instruction and the standardization of the expression of writing, the instruction application guidance, etc, and more and more attention was being paid to the content of the characteristics of TCM in the instruction. Conclusion Currently, there is an insufficient amount of policy documents on CPM standards, which are overly focused on environment-based policy tools and the policy implementation process. To achieve the policy goal of regulating and applying CPM specifications, it is recommended to create a balanced and coordinated structure of policy instruments, emphasise the direct promotion and pulling effect of supply and demand, increase the weight of policy evaluation and supervision, and develop a standard system for evaluating CPM specifications.
ObjectiveTo systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. MethodsThe PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. ResultsA total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. ConclusionThe research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.
The preferred reporting items for comprehensive evaluation of Chinese patent medicine (PRICE-CPM) were developed, and comprised six domains, 21 items and 72 sub-items. The EQUATOR collaboration network for the formulation and revision of reporting specifications was referred to and the final report list items were established by adopting the literature analysis method, the expert committee discussion and the Delphi method, and considering the characteristics of CPM evaluation.
Objective To evaluate the efficacy and safety of Chinese medicine for the treatment of angina pectoris. Methods PubMed, EMbase, The Cochrane Library (Issue 11, 2015), VIP, WanFang Data and CNKI databases were used to evaluate the curative effect and safety of proprietary Chinese medicine in the treatment of angina pectoris. The retrieval time was up to November 2015. Two reviewers screened literatures, extracted data and assessed the methodological quality of included studies, and then the GRADE evaluation system was used to assess the quality of evidence. Results A total of 42 systematic reviews/Meta-analysises were included in the study. There were 15 kinds of proprietary Chinese medicines, and the drugs published most were compound composite salvia. AMSTAR evaluation results showed that the quality of all studies were low. The main problems were: ① no consideration was given to the publication of the inclusion criteria (eg, gray literature); ② only the list of articles included in the study literature was not available; ③ all articles did not describe the relevant conflicts of interest. The results of GRADE systems showed that: ① as to the total effective rate: musk pills (RR=3.44, 95%CI 2.99 to 3.96,P=0.08) and suxiaojiuxin Pills (RR=4.25, 95% CI 3.31 to 5.47,P<0.01) were superior to Western medicine, and the level of evidence was very low. ② As to the ECG changes efficiency rate: Puerarin (RR=3.61, 95% CI 2.95 to 4.42,P=0.05), Musk pill (RR=2.48, 95%CI 2.12 to 2.91,P<0.01) and Shuxuening (RR=1.62, 95% CI 1.33 to1.97,P<0.01) were superior to Western medicine, and the evidence level was low. The level of evidence was low for the remaining effective rate of proprietary Chinese medicine; ③ as to the adverse reactions: the musk Baoxin pill (RR=0.05, 95% CI 0.01 to 0.37,P=0.04) was less than Western medicine, and the evidence level was low. Conclusion Although the number of systematic reviews of published proprietary Chinese medicines for angina pectoris is high, but the methodological quality and evidence level are low. There are serious defects in the low quality of the original research literature and the systematic evaluation method. We suggest future studies to improve for two aspects: ① reasonable design to reduce the selective bias, to carry out the required clinical trials to reduce the implementation bias, the implementation of multi-center, the sample size of sufficient randomized controlled clinical trials to reduce the number of patients into the group less resulting in the loss of bias, strict implementation of the standard data collection methods to reduce the occurrence of measurement bias; ② in accordance with the requirements of clinical trials to report to improve the report quality of the literature.
Comprehensive evaluation research of Chinese patent medicine (CPM) is performed to demonstrate the comprehensive value of CPM from multiple dimensions and to clarify the clinical value and positioning, so as to provide references for decision-making in health or drug policies. Therefore, to standardize and promote comprehensive evaluation studies on CPM, the current guideline introduced the specific requirements on the applicable subject, basic principles, and major evaluation content, thereby providing guidance for researchers in the future.