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，复方夏天无片可满足临床医患用药需求；说明书、标签等宣传资料准确完整，无夸大误导现象，总体适宜性较好，评价为B级。与同类药价格相比，该药品价格便宜，在全国28个省市有销售，但部分药材为动物药及代用品，各级医院配备比较低，可获得性一般，可及性评为B级。复方夏天无片是古代经典名方大活络丹的改制方，在原方基础上进行了化裁；"君、臣、佐、使"配伍严谨，针对"风寒湿三气杂至，合而为痹"的中医病因理论组方，在中医药理论方面有独特之处；其主药余江夏天无是地理标志产品，为江西代表性地方药材，中医药特色较突出，中医特色评为B级。综合复方夏天无片"6+1"维度的证据评价结果，临床价值综合评价为B级。结论 复方夏天无片治疗类风湿性关节炎临床价值较好，中医药特色较突出，建议按程序转化为基本临床用药管理的相关政策结果。

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 v2 0 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 of pharmacoeconomic research showed that the minimum cost analysis method was used to find that the efficacy and adverse reactions of Compound Tianxiawu Tablets and Compound Fengshining Tablets (复方风湿宁片) were similar, but Compound Tianxiawu Tablets has a certain cost advantage. It was considered that Compound Tianxiawu Tablets has a good economic result in the treatment of rheumatoid arthritis. It can explain the relative economy according to the existing evidence, and was rated as grade B. In terms of innovation, Compound Tianxiawu Tablets takes local medicine Yujiang Xiatianwu (Corydalis Decumbentis Rhizoma) as the main drug, aiming at the main pathogenesis of rheumatoid arthritis, wind, cold, dampness, blood stasis and pain; There were also good innovative measures in the pharmaceutical industry and ensuring supply. The overall evaluation was innovative and rated as grade B. The results of the questionnaire showed that Compound Tianxiawu Tablets could meet the drug needs of clinical doctors and patients; The brochures, labels and other publicity materials are accurate and complete without exaggeration and misleading. The overall suitability was good, and the evaluation was grade B. Compared with the price of similar drugs, Compound Tianxiawu Tablets was cheap and sold in 28 provinces and cities across the country, but some medicinal materials were animal drugs and substitutes. Hospitals at all levels were equipped with relatively low equipment, with general availability and accessibility rated as grade B. Compound Tianxiawu Tablets was a modified prescription of Dahuoluodan (大活络丹), an ancient classic prescription, which has been cut on the basis of the original prescription; The compatibility of monarchs, ministers and envoys was rigorous. Aiming at the Chinese medicine etiology theory of "wind, cold and dampness are mixed, and the combination is arthralgia", has its own uniqueness in the theory of traditional Chinese medicine (TCM); Yujiang Corydalis Decumbentis Rhizoma was a geographical indication product, and it was a representative local medicinal materials in Jiangxi, it had the prominent characteristics of TCM, and its characteristics of traditional Chinese medicine were rated as grade B. Based on the evidence evaluation results of "6 + 1" dimension of Compound Tianxiawu Tablets, the comprehensive evaluation of clinical value was B grade. Conclusion The clinical value of Compound Tianxiawu Tablets in the treatment of rheumatoid arthritis is good, and the characteristics of traditional Chinese medicine are prominent. It is suggested to convert it into the relevant policy results of basic clinical medication management according to the procedure.

R285.64

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）