复方夏天无片治疗类风湿性关节炎的临床综合评价  

Clinical comprehensive evaluation of Compound Xiatianwu Tablets in treatment of rheumatoidarthritis

作　　者：雷超 张强 王志飞[1] 谢雁鸣[1] LEI Chao;ZHANG Qiang;WANG Zhi-fei;XIE Yan-ming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中草药》2022年第21期6810-6819,共10页Chinese Traditional and Herbal Drugs

基　　金：中国中医科学院科技创新工程重大攻关项目(CI2021A00702);国家重点研发计划项目(2018YFC1707400)。

摘　　要：目的对复方夏天无片治疗类风湿性关节炎进行临床综合评价,为医疗机构药品遴选及合理用药提供参考。方法参照《药品临床综合评价管理指南(2021年版试行)》及《中成药临床综合评价报告规范》标准,基于循证医学、临床流行病学、临床医学、循证药学、药物经济学等,利用公开数据、文献数据、药学研究、问卷调查等信息,采用多准则决策分析(multi criteria decision analysis,MCDA)模型及CSC V2.0软件从安全性、有效性、经济性、创新性、适宜性、可及性和中医药特色("6+1"个维度)对复方夏天无片进行临床综合评价。结果自发呈报系统(spontaneous reporting system,SRS)监测数据、文献报道显示,复方夏天无片的主要不良反应为恶心、呕吐、腹痛、腹泻等胃肠系统反应,其次为皮肤及附件损害如皮疹、瘙痒等,基于现有研究,认为风险较可控,安全性较好,评价为B级。Meta分析结果显示,复方夏天无片联合常规治疗方案在降低血沉(erythrocyte sedimentation rate,ESR)、C反应蛋白(C-reaction protein,CRP),缩短关节压痛时间、晨僵时间,改善关节肿胀指数和提高显效率方面优于单独常规治疗;但在改善握力方面与单独常规治疗无差异。综合考察有效性证据质量及其临床价值,认为证据有临床意义,评价为C级。药物经济学研究结果表明,采用最小成本分析法,发现复方夏天无片与复方风湿宁片疗效相近,不良反应相仿,但复方夏天无片具有一定的成本优势,认为其治疗类风湿性关节炎经济性结果较好,能够根据现有证据说明相对经济性,评价为B级。创新性方面,复方夏天无片以地方药材余江夏天无为主药,针对类风湿关节炎风寒湿痹主要病机风、寒、湿、瘀、痛整体治疗,具有一定的临床创新性;在制药工业和保障供应上也有较好的创新性举措;总体评价创新性较好,评价为B级。调查问卷结果表明,复方�Objective To make a comprehensive clinical evaluation of Compound Xiatianwu Tablets(复方夏天无片)in the treatment of rheumatoid arthritis,so as to provide relevant references for drug selection and rational drug use in medical institutions.Methods Based on evidence-based medicine,clinical epidemiology,clinical medicine,evidence-based pharmacy and pharmacoeconomics,using public data,literature data,pharmaceutical research,questionnaire survey and other information,multi criteria decision analysis(MCDA)model and CSC v20 software was used to make a comprehensive clinical evaluation of Compound Xiatianwu Tablets from the"6+1"dimensions of safety,effectiveness,economy,innovation,suitability,accessibility and characteristics of traditional Chinese medicine,according to the Guidelines for the Management of Comprehensive Clinical Evaluation of Pharmaceutical Products(trial version 2021)and the Standards of Clinical Comprehensive Evaluation Report of Chinese Patent Medicine.Results According to the monitoring data of spontaneous reporting system(SRS)and literature reports,the main adverse reactions of Compound Xiatianwu Tablets were gastrointestinal reactions such as nausea,vomiting,abdominal pain and diarrhea,followed by skin and accessory damage such as rash and pruritus.Based on the existing research,it was considered that the risk was controllable and the safety was good,which was evaluated as grade B.The results of Meta-analysis showed that Compound Xiatianwu Tablets combined with conventional treatment was superior to conventional treatment alone in reducing erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),shortening joint tenderness time,morning stiffness time,improving joint swelling index and increasing apparent efficiency;However,there was no difference in improving grip strength with conventional treatment alone.Comprehensively investigate the effectiveness,evidence quality and clinical value,it was considered that the evidence had clinical significance and was evaluated as grade C.The results

关 键 词：复方夏天无片 类风湿性关节炎 临床证据 临床综合评价 多准则决策分析 

分 类 号：R285.64[医药卫生—中药学]