摘要
目的参考概况性综述的方法及流程,系统梳理口服中成药治疗功能性消化不良(Functional dyspepsia,FD)的说明书信息及临床研究现况,发掘用药规律及存在的问题。方法首先检索公认且具有法律效力的药品目录,同时查阅说明书对治疗FD的中成药进行筛选;继而检索中英文数据库对临床文献进行系统回顾,结合可视化图表对中成药的基本信息、临床研究证据进行数据分析和展示。结果研究纳入42种治疗FD的中成药,药物组成中陈皮、木香、茯苓、甘草、白术、六神曲等出现频次较多。纳入文献96篇,涉及中成药21种,其中枳术宽中胶囊、六味安消胶囊、达利通颗粒的临床文献数量较多。分析纳入的96篇口服中成药治疗FD的临床研究发现,中西医结合是主要的干预措施,有效率、临床症状积分及不良反应是主要关注的结局指标。此外,超说明书治疗疾病的研究8篇,涉及乌灵胶囊治疗伴或不伴抑郁焦虑症状的FD和枳术宽中胶囊治疗伴有焦虑抑郁状态的FD。尽管乌灵胶囊和枳术宽中胶囊的临床应用存在超说明书的现象,但并没有超指南用药。结论治疗成人FD的常用中药以理气、健脾、消食类为主。近年来,治疗成人FD的中成药临床研究证据逐渐增多,但存在中成药治疗特色体现度不足;结局指标主次之分不明确,复合指标居多;说明书内容缺乏明确针对FD或其症状的信息等问题有待未来改善。
Objective To systematically review the present status of oral Chinese patent medicines(CPMs)for treating functional dyspepsia(FD),explore the formation rules of CPMs,and reveal the potential problems by referring to the methods and procedures of Scoping review.Methods First,we screened all CPMs from the domestic-related drug catalogs which are generally accepted and own the force of law,then we sorted the CPMs based on the drug instructions while carrying out Chinese and English database document retrieval to review the clinical studies.Descriptive analysis of the basic feature and clinical research evidence of CPMs was performed combined with visual charts.Results This study included 42 CPMs for treating FD.Among the formulas of CPMs,Tangerine peel,Radices saussureae,Poria cocos,Glycyrrhiza,Atractylodes macrocephala,and Six Divine Qu appeared frequently.In addition,96 studies involving 21 CPMs were included,among which Zhizhu Kuanzhong Capsule,Liuwei Anxiao capsule,and Dalitong granules had more clinical literature.By analyzing the included 96 clinical studies,we found that the combination of Chinese and Western medicine was the main intervention,and the effective rate,clinical symptom score,and adverse reactions were the main outcomes that were concerned.In addition,8 studies had off-label use of diseases,involving the Wuling capsule to treat the FD whether the disease was accompanied by depression and anxiety symptoms or not,and Zhizhu Kuanzhong Capsule to treat the FD with anxiety and depression.Although the Wuling capsule and Zhizhu Kuanzhong capsule were off-label used in clinical practice,there was no beyond the scope of the guideline.Conclusion The qi-regulating drug,spleen-strengthening drug and digestant drugs are the usual Chinese medicines used for treating adult FD.In recent years,research on CPMs for treating adult FD has increased rapidly.But there is insufficient reflection of CPMs treatment characteristics,ambiguous differences from the primary and secondary outcomes,multiple composite outcomes,and not explicit information on FD or its symptoms in drug package insert,which needs to be improved in the future.
作者
李苗苗
赵晖
吴雪
戴泽琦
徐思敏
唐旭东
廖星
Li Miaomiao;Zhao Hui;Wu Yue;Dai Zeqi;Xu Simin;Tang Xudong;Liao Xing(Center for Evidence Based Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Basic Theory for Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;China Center for Evidence Based Traditional Chinese Medicine,Beijing 100700,China;Institue of Digestive Diseases,Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2023年第8期2840-2850,共11页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家自然科学基金委员会面上项目(82174239):基于EVIDEM(证据和价值)框架构建中成药临床综合评价指标体系研究,负责人:廖星
中国中医科学院科技创新工程(中医临床基础)(CI2021A00701-3):中医药循证及标准化方法学研究与应用平台建设·中医药卫生技术评估方法及示范研究,负责人:廖星。
关键词
口服中成药
功能性消化不良
循证决策
概况性综述
临床研究
Oral Chinese patent medicines(CPMs)
Functional dyspepsia(FD)
Evidence-based decision making
Scoping review
Clinical research
作者简介
通讯作者:廖星,研究员,博士研究生导师,主要研究方向:中医药循证评价研究;通讯作者:唐旭东,本刊编委,首席研究员,博士研究生导师,主要研究方向:中医脾胃理论研究、中西医结合消化系统疾病的基础与临床研究、中医临床疗效评价方法学研究。
