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ObjectiveTo clarify the development and methodological research status of clinical comprehensive evaluation of Chinese patent medicines in China and identify the problems and difficulties in the evaluation， so as to provide a reference for promoting the subsequent evaluation. MethodFirstly， we analyzed the current situation of clinical comprehensive evaluation in China by reviewing the articles about the process of clinical comprehensive evaluation of drugs and the process of clinical comprehensive evaluation of Chinese patent medicines. Secondly， we comprehensively summarized the formulation background and key points of policies related to clinical comprehensive evaluation of Chinese patent medicines and then show the development status in this field at the national and provincial levels. ResultThe comprehensive clinical evaluation of Chinese patent medicines is still in its infancy in China， and 32 articles of specific evaluation of Chinese patent medicines were included in the study. The dosage forms were mainly capsules （15 articles， 46.88%） and injections （28.13%）. The evaluation mainly involved diseases such as the nervous system （10 articles， 31.25%）， digestive system （5 articles， 15.63%）， and respiratory system （5 articles， 15.63%）. The research results of clinical comprehensive evaluation of Chinese patent medicines were mainly from relevant societies and research institutions. Different research teams have developed technical guidelines or specifications for the evaluation， while the government-leading evaluation guidelines remained to be formulated at the national and provincial levels. In addition， the research articles in this field mainly concentrated on the application of evaluation methods， the building of evaluation index systems， and completed evaluation reports. ConclusionTo reflect the unique value and advantages of Chinese patent medicines， the government needs to build technical guidelines for the clinical comprehensive evaluation of Chinese patent medicines on the basis of the clinical comprehensive evaluation of drugs and create a favorable policy environment for the evaluation work.
RESUMO
OBJECTIVE To evaluate the quality of research literature on pharmacoeconomics of traditional Chinese medicine （TCM） in China from 2018 to 2022， to understand the development status and problems of TCM pharmacoeconomic research in China， and to provide a reference for future standardized research on this field. METHODS The systematic search of relevant databases at home and abroad was conducted to obtain the published literature on TCM pharmacoeconomic research in China from January 1， 2018 to November 21， 2022 to summarize the basic information of the literature， the research profile， the method and content of pharmacoeconomic evaluation and to evaluate the quality of the literature by using the CHEERS 2022 checklist； calculate the total literature score by counting the scores of the specific entries of each piece of literature and classifying the quality of the literature as excellent， good， qualified， and unqualified. RESULTS A total of 71 studies were included， involving 60 in Chinese and 11 in English， and 53.52% of the literature was supported by grants； the most studied TCM dosage form was injection （31.03%）； less than half （46.48%） of the literature reported the study angle； short-term economic evaluation was predominantly used （69.01%）； the Chinese studies were dominated by cost-effectiveness analyses （70.00%）， and the English studies were dominated by cost-utility analysis （54.55%）. The average score of literature quality evaluation was 11.02， with two （2.82%） of the literature being of good quality， nine （12.68%） of the literature being of qualified quality， and the majority of the literature （84.51%） being of unqualified quality. The average score of Chinese literature was 9.98， and the average score of English literature was 16.73， with the quality of the latter being significantly better than that of the former. CONCLUSIONS At present， the pharmacoeconomic researches of TCM mainly has problems such as lack of scientific selection of intervention in the control group， nonstandard cost measurement， unreasonable selection of research time limit， quality of evidence for health output indicators to be improved， selection of evaluation methods to be improved， and lack of scientific basis for threshold selection. In order to support the implementation and development of high-level pharmacoeconomics research on TCM， policymakers need to create a favorable policy environment and formulate pharmacoeconomic evaluation guidelines that meet the characteristics of TCM， so as to promote the application and transformation of evaluation results.
RESUMO
ObjectiveTo carry out the clinical comprehensive evaluation of Biantong capsules and Biantong tablets in the treatment of constipation guided by the clinical value of drugs， and to provide a scientific basis for the rational pricing， rational use， and cataloging of Biantong capsules/tablets. MethodThe available evidence and survey data were used for the clinical comprehensive evaluation of Biantong capsules/tablets and three control drugs in the treatment of constipation in terms of the six dimensions including effectiveness， safety， economics， innovation， suitability， and accessibility. ResultIn terms of effectiveness， Biantong capsules/tablets can improve the response rate， with clear pharmacological mechanism. In terms of safety， the absence of toxic reaction， the mild adverse reactions， and the favorable prognosis indicate high safety. In terms of economics， the average daily cost of Biantong capsules/tablets is the lowest among the tested drugs， which indicates a cost-effectiveness advantage. In terms of innovation， Biantong capsules/tablets have been authorized patents in China and listed as members in the third category of new drugs of traditional Chinese medicine/ninth new drugs of traditional Chinese medicine. In terms of suitability， Biantong capsules/tablets are convenient to store and take and have good suitability in terms of drug technical characteristics and drug usage. In terms of accessibility， Biantong capsules/tablets have a wide coverage in hospitals， sufficient capacity， low patient burden， extensive drug catalogue coverage， and no major environmental risk for long-term application. The comprehensive values of the tested drugs follow a descending order of control drug B （84.27 score）， Biantong capsules/tablets （82.47 score）， control drug A （70.47 score）， and control drug C （59.46 score）. The recommendations of the expert panel are Class A （18/18）， which can be directly converted into decision-making. ConclusionBiantong capsules/tablets demonstrate a high clinical comprehensive value in the treatment of constipation， providing a reference for the rational pricing， rational use， and cataloging of drugs.