摘要
目的了解中成药(CPD)治疗糖尿病(DM)的临床研究证据,展示CPD治疗DM的临床研究进展。方法查找明确提到治疗DM、消渴的CPD,通过检索数据库2016年1月1日至2022年11月7日的相关文献,采用文字描述结合Excel表格和数据图的形式分析检索所得纳入文献。并分析所纳入CPD的基本信息、研究人群中医证型及结局指标。结果纳入研究的有75种治疗DM的口服CPD,其中70种皆为纯中药组成,主要功效为益气、生津、养阴、止渴。共纳入315篇相关文献,气阴两虚证型最为多见;在结局指标的选择上,西医结局指标占大多数。结论CPD说明书中安全使用信息不全;CPD说明书表述笼统、适应证不明确;临床研究试验设计未突出中医药治疗方法和特点;结局指标选择种类较多,除血糖控制情况,对中医结局指标的关注略显不足。CPD的组方设计具有一定的局限性,中医结局指标使用较少,西医结局指标是该领域研究趋势。
Objective To understand the clinical research evidence of Chinese patent drugs(CPD)in the treatment of diabetes mellitus(DM)and show the clinical research progress of CPD in the treatment of DM.Methods The CPD that could treat DM were found,and the related literature was retrieved in the databases,with the retrieval duration from January 1,2016 to November 7,2022.The retrieved literature was analyzed using the forms of text description combined with Excel form and data map and included in the study.The basic information of included CPD,and traditional Chinese medicine syndrome types and outcome indicators of the research population were analyzed.Results A total of 75 oral CPD for treating DM were included in the study.Among them,70 were all composed of pure traditional Chinese medicine,and the main effects are to tonifying qi,engendering liquid,nourishing yin,and quenching thirst.A total of 315 relevant articles were included.The syndrome of deficiency of both qi and yin was the most common,and in the selection of outcome indicators,Western medicine outcome indicators accounted for the majority.Conclusion The safe use information in the instructions for CPD is incomplete.The description of CPD instructions is general and the indications are not clear.The clinical research experimental design does not highlight the treatment methods and characteristics of traditional Chinese medicine.There are many types of selections of outcome indicators,but apart from blood glucose control,there is a slight lack of attention to traditional Chinese medicine outcome indicators.The prescription design of CPD has certain limitations.The traditional Chinese medicine outcome indicators are seldom used,while the Western medicine outcome indicators are the research trend in this field.
作者
苏莹璐
郑曙琴
SU Yingu;ZHENG Shuqin(Liaoning University of Traditional Chinese Medicine,Liaoning,Shenyang 110847,China;The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Liaoning,Shenyang 110032,China)
出处
《中国医药科学》
2024年第5期98-101,140,共5页
China Medicine And Pharmacy
基金
全国名老中医专家传承工作室建设项目(国中医药人教函[2022]75号)。
关键词
中成药
糖尿病
证据图
循证医学
临床研究
Chinese patent drugs
Diabetes mellitus
Evidence map
Evidence-based medicine
Clinical research
