口服中成药治疗痛经及其临床研究现状的概况性综述  

Oral Chinese patent medicines in treatment of dysmenorrhea and clinical research status:a scoping review

作　　者：卜小钧 李知然 王文雅 刘瑞雪 任菁钰 徐琳 廖星[3] 孙伟伟[2] BU Xiao-jun;LI Zhi-ran;WANG Wen-ya;LIU Rui-xue;REN Jing-yu;XU Lin;LIAO Xing;SUN Wei-wei(Graduate School of Beijing University of Chinese Medicine,Bejing 100029,China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Center for Evidence-based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Community Health Service Center of Qingta Street,Fengtai District,Bejing 100141,China)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]中国中医科学院广安门医院,北京100053 [3]中国中医科学院中医临床基础医学研究所循证医学基础研究室,北京100700 [4]北京市丰台区青塔街道社区卫生服务中心,北京100141

出　　处：《中国中药杂志》2025年第3期787-797,共11页China Journal of Chinese Materia Medica

基　　金：中国中医科学院科技创新工程项目(CI2022E027XB03,CI2022E027XB)。

摘　　要：采用概况性综述对治疗痛经的口服中成药及其临床研究进行系统检索、分析与总结。通过筛选三大药物目录、指南、教材中治疗痛经的口服中成药,制定检索策略后对8个中英文数据库中相关的临床研究进行检索筛选,提取纳入研究的关键信息并进行可视化分析。最终纳入中成药50种,其中针对气滞血瘀型痛经的口服中成药占比最高,各中成药日均费用相差悬殊。共纳入文献150篇,涉及22种中成药,其中桂枝茯苓胶囊/丸、散结镇痛胶囊、丹莪妇康煎膏相关文献最多,研究类型以随机对照试验(RCT)为主,最常见的干预措施为中成药+西药vs西药,样本量以51~100例文献最多,高频结局指标包括治疗有效率、不良反应、实验室检查等9个方面。结果表明,口服中成药治疗痛经具有优势,相关临床研究的年发表量总体呈增长趋势,但中成药说明书尚存在安全信息不足、中医证型描述模糊等问题,临床研究存在中成药分布不均、研究规模有限、方法学严谨性欠佳、结局指标标准化不足等短板。未来需深化高质量临床研究的开展,完善说明书内容,以确保治疗痛经的口服中成药临床应用的有效性与安全性。A scoping review was performed to systematically search and summarize the clinical research in the treatment of dysmenorrhea with oral Chinese patent medicines.The oral Chinese patent medicines for treating dysmenorrhea in three major drug lists,guidelines,and textbooks were screened,and the relevant clinical trials were retrieved from eight Chinese and English databases.The key information of the included trials was extracted and visually analyzed.A total of 50 Chinese patent medicines were included,among which oral Chinese patent medicines for the dysmenorrhea patients with the syndrome of Qi stagnation and blood stasis accounted for the highest proportion,and the average daily cost varied greatly among Chinese patent medicines.A total of 150 articles were included,involving 22 Chinese patent medicines,among which Guizhi Fuling Capsules/Pills,Sanjie Zhentong Capsules,and Dan′e Fukang Soft Extract were the most frequently studied.These articles mainly reported randomized controlled trial(RCT),which mainly focused on the comparison of the intervention effect between Chinese patent medicines combined with western medicine and western medicine alone,and the sample size was generally 51-100 cases.The high-frequency outcome indicators belonged to nine domains such as effective rate,adverse reactions,and laboratory examinations.This study showed that oral Chinese patent medicines had advantages in the treatment of dysmenorrhea,and the annual number of related clinical trials showed an overall growing trend.However,there were still problems such as insufficient safety information and vague description of traditional Chinese medicine(TCM)syndromes types in the instructions of Chinese patent medicines.The available clinical research had shortcomings such as uneven distribution of Chinese patent medicines,limited research scale,poor methodological rigor,and insufficient standardization of outcome indicators.In the future,it is necessary to deepen the development of high-quality clinical research and improve the contents

关 键 词：概况性综述 合理用药 口服中成药 临床研究 痛经 

分 类 号：R271.113[医药卫生—中医妇科学]