The western medicine are main drugs in treatment of infectious diseases, but the combination of Traditional Chinese and western medicine are used in China. In recent years, proportion of proprietary Chinese medicine increased significantly in this field. However, the classification of proprietary Chinese medicine and matching with the counterparts of western medicine were difficult, and the package inserts were less scientific and normative. By searching the terms of "Qing kai ling" and "Infection", the paper found the quality of post-marketing clinical researches was low. The use proportion of Qing kai ling combined with other drugs was more than 50%, 70% of which was western medicine. The further studies are needed to explore some proprietary Chinese medicine with obvious competitive advantage and improve the quality of methodology and reporting, in order to standardize and guide the rational use of proprietary Chinese medicine in infectious diseases.
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.
A comprehensive evaluation system of Chinese patent medicine (CPM) is considered as a critical tool to measure the value of CPM. The "guideline for multi-dimensional and multi-criteria comprehensive evaluation for Chinese patent medicine" (abbreviated as guideline) has been released, proposing a comprehensive evaluation system of CPM (1st) comprising six aspects: safety, effectiveness, economy, applicability, scientificity and standardization. This paper elaborated the development method and explained the evaluation dimensions and criteria, so as to help the researchers understand and use the comprehensive evaluation system in the future when evaluating CPM.
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.
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.
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.
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.
ObjectiveTo construct the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, to determine the weight of indicators, and to provide references for the comprehensive evaluation of the efficacy, safety, and economy of Chinese patent medicines.MethodsTwo rounds of expert consultation by Delphi method were applied to establish the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, and the weight of each indicator was determined by the analytic hierarchy process method.ResultsQuestionnaire recovery rates of 2 rounds were 92.59% and 96.00%, the expert authority coefficient was greater than 0.7, and the coordination coefficients of experts in the total index were 0.224 and 0.370 (P<0.001). A three-level comprehensive evaluation indicator system for Chinese patent medicines for ischemic stroke was established and the three first-level indicators included efficacy, safety, and economy. And there were 15 second-level indicators, and 33 third-level indicators. Through the analytic hierarchy process method, the weights of each first-level indicator were 0.626 4, 0.301 2, and 0.072 4, respectively.ConclusionThe comprehensive evaluation indicator system contains efficacy, safety and economy, and provides a basis for a comprehensive evaluation of Chinese patent medicines for ischemic stroke. The indicator system is of great significance for the design of outcomes for clinical trials of ischemic stroke, the conduction of systematic reviews, and the development of clinical practice guidelines for ischemic stroke patients when selecting study outcomes.
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.