口服中成药治疗便秘临床研究证据的概况性综述

Clinical Evidence of Treatment of Constipation with Oral Chinese Patent Medicine:A Scoping Review

该研究通过对已发表的治疗便秘中成药的临床研究证据进行系统全面的梳理,以期为未来该领域的临床研究及用药提供决策依据。基于概况性综述的方法,对三大药物目录中治疗便秘的中成药进行检索,获得待评价的中成药,然后基于8个中英文数据库对相关中成药治疗便秘的临床研究进行了全面系统的检索,对纳入的研究进行整合分析,结合可视化图表对结果进行展示。本研究共纳入34种中成药,118篇研究,按功效将中成药分为消积通便、泻火通便、行气通便、润肠通便4大类,涉及125味中药。便秘研究的关注度整体呈升高趋势,关注度最高的是麻仁丸(颗粒、软胶囊),发文量达42篇,随后依次是芪蓉润肠口服液21篇,便通片(胶囊)19篇,苁蓉通便口服液10篇,有17种中成药没有相应的临床研究;研究设计类型共8种,除当归龙荟丸仅有1篇病例系列研究外,各个药物均以随机对照试验为主;干预类型中中成药对比西药的干预方式最多,关注度最高的结局指标是有效率、安全性评价和主证症状或评分,缺乏统一的核心结局指标集,不良反应和经济学研究较少,仅11.86%的研究获得了资金资助。临床上中成药治疗便秘的应用较为广泛,近年来相关研究数量呈升高趋势,然而仍然还有一部分中成药缺乏相应的临床研究证据,已发表的研究在设计上存在设计不严谨,疗效评价标准不一,缺乏证据综合的研究、资金资助较少等问题。希望未来在该领域加大投入,提高对研究相对空白的药物及药物较少的便秘证型的关注度,积极开展系统综述等证据综合类研究,同时应规范研究设计,开展更多高质量的研究,为中成药治疗便秘提供可靠证据。

This study systematically and comprehensively sorted out the application status of Chinese patent medicines for the treatment of constipation in the clinic,to provide scientific evidence for future research directions and clinical drug use in this field.Based on the method of scoping review,the Chinese patent medicines for the treatment of constipation were retrieved from three drug lists to obtain the medicines that needed to be evaluated.A comprehensive and systematic search was carried out on the included studies on the treatment of constipation by Chinese patent medicines through eight Chinese and English databases,and the included studies were integrated and analyzed.The results were displayed in combination with charts.Thirty-four Chinese patent medicines and 118 studies were included in this study.According to the efficacies,Chinese patent medicines were divided into 4 categories,namely eliminating accumulation,purging fire,promoting Qi,and moistening bowels,involving 125 Chinese medicines.The overall attention of constipation research is on the rise.Marenwan(granules or soft capsules)gained the highest attention,with 42 studies,followed by Qirong Runchang oral liquid,with 21 studies,and Biantong tablets(capsules),with 19 studies.There are 10 studies on Congrong Tongbian oral liquid.Seventeen Chinese patent medicines had no corresponding clinical research.There were 8 study design types,and all drugs were mainly randomized controlled trials except Danggui Longhui pill.Among the intervention types,the comparison between Chinese patent medicines and western medicines was the most.The highest outcome indicators were efficacy,safety evaluation,and main symptoms or scores,and there was a lack of a unified core outcome indicator set.There were few studies on adverse reactions and the economy.Only 11.86%of the studies were funded.Clinically,Chinese patent medicines are widely used in the treatment of constipation,and the amount of related research shows an increasing trend.However,some Chinese patent medicines lack corresponding clinical evidence,and the published research has problems such as unrigorous design,ununified criteria for efficacy evaluation,lack of comprehensive evidence studies,and insufficient funds.It is hoped that more investment will be made in this field in the future,and more attention will be paid to drugs with relatively blank research and constipation syndromes with few treatments.Comprehensive evidence studies such as systematic reviews should be carried out actively.And the study design should be standardized to provide reliable evidence for the treatment of constipation with Chinese patent medicines.