数字中医药（英文）2025，Vol.8Issue(2)：123-136,14.DOI:10.1016/j.dcmed.2025.06.001
中成药及中医经典名方临床研究报告(2023)
Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions(2023)
摘要
Abstract
Objective Randomized controlled trials(RCTs)of Chinese patent medicines and classic tra-ditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023.A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments.This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence. Methods RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evi-dence Database for Chinese Patent Medicine(AICED-CPM),with supplementary searches conducted in China National Knowledge Infrastructure(CNKI),Wanfang Data,Chinese Sci-ence and Technology Journal Database(VIP),Chinese Biomedical Literature Database(SinoMed),Cochrane Library,PubMed,Embase,and Web of Science.The study characteris-tics and methodological quality of these RCTs were systematically analyzed and evaluated. Results A total of 1 443 RCTs of Chinese patent medicines were included,comprising 1 399 Chinese articles and 44 English articles.Additionally,334 RCTs of classic traditional Chinese medicine prescriptions were found,with 331 published in Chinese and 3 in English.196 567 participants were included,covering 585 types of Chinese patent medicines(487 oral,61 in-jectable,and 37 topical)and 179 classic traditional Chinese medicine prescriptions.The in-volved studies encompassed 22 types of diseases,with research primarily focusing on dis-eases of the circulatory system,the respiratory system,and the genitourinary system.The sample sizes ranged from 18 to 3 777 participants,and most studies were conducted at a sin-gle center.Methodologically,the implementation of allocation concealment and blinding re-mained insufficiently emphasized. Conclusion Overall,compared with 2022,both the number of RCT publications and their methodological quality have improved in 2023,with heightened attention to research on diseases of the genitourinary system.However,quality control and standardized manage-ment in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.关键词
中医药/中成药/中医经典名方/随机对照试验/循证医学Key words
Traditional Chinese medicine/Chinese patent medicine/Classic traditional Chinese medicine prescriptions/Randomized controlled trials(RCTs)/Evidence-based medicine引用本文复制引用
吴晓蕾,季昭臣,胡海殷,王玥彤,Alice Josephine Fauci,张雅姿,宋雯婷,杨丰文,张伯礼,张俊华..中成药及中医经典名方临床研究报告(2023)[J].数字中医药（英文）,2025,8(2):123-136,14.基金项目
National Multidisciplinary Innovation Team of Tradition-al Chinese Medicine(ZYYCXTD-D-202204),and Science and Technology Project of Haihe Laboratory of Modern Chinese Medicine(22HHZYSS00013). （ZYYCXTD-D-202204）
