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.
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.
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.
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.
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.
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.
Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.
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.