以延参健胃胶囊为例探讨中成药临床应用专家共识制定中的文献预检索  

Pre-searching during formulation of expert consensus on clinical application of Chinese patent medicines:Yanshen Jianwei Capsules as example

作　　者：冯雪 段笑娇 孙静文 郭宇博[1] FENG Xue;DUAN Xiao-jiao;SUN Jing-wen;GUO Yu-bo(Standardization Department,China Association of Chinese Medicine,Beijing 100029,China)

机构地区：[1]中华中医药学会标准化办公室,北京100029

出　　处：《中国中药杂志》2021年第16期4287-4292,共6页China Journal of Chinese Materia Medica

基　　金：国家中医药管理局委托办事经费任务项目(GZT-FJS-2020-024)。

摘　　要：中成药临床应用专家共识通过探索经验与证据的有效结合,形成一种符合中成药自身特点的研究方式,是中成药临床研究的重要过渡阶段。文献预检索是中成药临床应用专家共识制定流程中新增的步骤,在专家访谈和临床应用调研前,对品种及同类中成药的文献发表情况、品种相关经典名方的文献发表情况、同类中成药进入指南或专家共识情况、相关疾病指南中推荐的用药方案进行文献预检索,了解文献中报道的品种及相关品种的优势及存在的问题,更有助于找准中成药的临床定位和构建合理的临床问题,并为正式的文献检索提供思路。但文献预检索并不是形成临床问题的直接依据,仍然需要通过专家访谈和临床应用调研进一步明确品种的临床定位,构建合理的临床问题。该文以延参健胃胶囊治疗慢性萎缩性胃炎临床应用专家共识为例,对中成药临床应用专家共识中文献预检索的流程和方法进行介绍,并对构建临床问题的作用包括研究对象、干预措施、对照措施、结局指标的选择进行探讨。The formulation of expert consensus on clinical application of Chinese patent medicines, in means of exploring the effective combination of experience and evidence to form a research method in line with the characteristics of Chinese patent medicines, is an important transitional stage for clinical researches on Chinese patent medicines. Pre-searching is a new step in the formulation of expert consensus on clinical application of Chinese patent medicines. Before steps of interview and investigation on clinical application, pre-searching is conducted to collect publications and literature on certain variety and similar Chinese patent medicines;the publications on related medical classics and formulas of this variety;the recommendation condition of this variety in clinical practice guidelines and expert consensus;and the medication regimens recommended in disease-specific guidelines. Pre-searching is designed to know about the advantages of certain variety of Chinese patent medicine as well as its potential problems recorded in the literature, which is helpful to find out the clinical positioning of Chinese patent medicines, develop reasonable clinical questions and provide ideas for formal literature searching. However, it is not the direct basis for developing clinical questions. Moreover, interviews and investigations are still needed to further clarify the clinical positioning of Chinese patent medicines and develop reasonable questions. This paper took expert consensus on clinical application of Yanshen Jianwei Capsules as an example to introduce the pre-searching process and methods used during formulation of expert consensus on clinical application of Chinese patent medicines, and to further discuss the role of pre-searching to facilitate the formulation of clinical questions on selection of participants, interventions, controls and outcomes.

关 键 词：中成药 专家共识 预检索 

分 类 号：R286[医药卫生—中药学]