《中成药治疗冠心病临床应用指南》临床问题的构建

Construction of Clinical Questions within Clinical Application Guidelines on Chinese Patent Medicine in the Treatment for Coronary Artery Disease

采用PICO模式将临床问题转化为研究问题,通过文献研究、问卷调查及专家共识,确定研究人群,遴选中成药品种,评选结局指标及其重要性,以此构建《中成药治疗冠心病临床应用指南》的临床问题。结果筛选出与冠心病适应证相关,兼具证据充分、应用广泛、专家及患者认可等特点,同时满足应用特点、证据质量及证候分型等临床需求的中成药共15种,分别为口服制剂11种(丹蒌片、复方丹参滴丸、脑心通胶囊、芪参益气滴丸、芪苈强心胶囊、参松养心胶囊、麝香保心丸、速效救心丸、通心络胶囊、稳心颗粒、血府逐瘀胶囊),注射制剂3种(丹红注射液、红花注射液、参麦注射液),气雾剂1种(宽胸气雾剂);结合中成药治疗确定稳定性心绞痛、不稳定性心绞痛、急性心肌梗死、围介入手术期、冠心病心律失常、冠心病心力衰竭、心绞痛急性发作7类优势人群定位,以及问卷调查得出的结局指标及重要性排序,构建出《中成药治疗冠心病临床应用指南》的7个临床问题。

The PICO framework was used to transform clinical questions into research problems.Through literature review,questionnaire survey and experts’consensus,the population was defined;the Chinese patent medicine were selected;and the outcomes with importance ranking were formed to construct the clinical questions of the Clinical Application Guidelines on Chinese Patent Medicine in the treatment for Coronary Artery Disease(abbreviated as Guideline).Fifteen Chinese patent medicines having the indications of coronary artery disease(CAD),and with sufficient evidence,wide application as well as acceptance from experts and patients were selected,which also meet the clinical needs in terms of application characteristics,evidence quality and syndrome classification.Eleven oral preparations including Danlou Tablet(丹蒌片),Compound Danshen Dropping Pill(复方丹参滴丸),Naoxintong Capsule(脑心通胶囊),Qishen Yiqi Dropping Pill(芪参益气滴丸),Qili Qiangxin Capsule(芪苈强心胶囊),Shensong Yangxin Capsule(参松养心胶囊),Shexiang Baoxin Pill(麝香保心丸),Suxiao Jiuxin Pill(速效救心丸),Tongxinluo Capsule(通心络胶囊),Wenxin Granule(稳心颗粒),Xuefu Zhuyu Capsule(血府逐瘀胶囊),three intravenous preparalions including Danhong Injection(丹红注射液),Honghua Injection(红花注射液)and Shenmai Injection(参麦注射液)and one aerosol,Kuanxiong Aerosol(宽胸气雾剂)were involved.Considering the functions of the selected Chinese patent medicine,seven diseases including stable angina,unstable angina,acute myocardial infarction,peri-interventional surgery,CAD-associated arrhythmia,CAD-associated heart failure,acute angina pectoris were defined as the dominant population,and the importance of the outcomes were obtained through questionnaire survey;all of these were based to construct seven clinical questions of the Guideline.