痹祺胶囊单用或联合甲氨蝶呤治疗类风湿关节炎有效性及安全性的Meta分析  

Meta-analysis of Clinical Effect and Safety of Biqi Capsule(痹祺胶囊)Combined with Methotrexate or Single Use in Treatment of Rheumatoid Arthritis

作　　者：吕柳 吕静 孙清露[1] 梅曼 顾文政 王海隆 LYU Liu;LYU Jing;SUN Qinglu;MEI Man;GU Wenzheng;WANG Hailong(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Wuhan Hospital of Chinese Medicine,Wuhan 430014,Hubei,China;The First Teaching Hospital of Tianjin University of Chinese Medicine,Tianjin 300190,China)

机构地区：[1]北京中医药大学东直门医院,北京100700 [2]武汉市中医医院,湖北武汉430014 [3]天津中医药大学第一附属医院,天津300190

出　　处：《辽宁中医杂志》2023年第7期8-15,I0001,共9页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(82104652,82174336);国家重点研发计划项目(2022YFC3501202,2022YFC3501203);首都卫生发展科研专项(CFH2022-2-7087);北京市通州区科技计划(KJ2022CX045)。

摘　　要：目的系统评价痹祺胶囊单用或联合甲氨蝶呤(MTX)治疗类风湿关节炎(RA)的临床疗效。方法系统检索中国知网(CNKI)、万方数据库、重庆维普数据库、PubMed、EMbase、Cochrane Library数据库(建库至2021年12月)痹祺胶囊单用或联合MTX治疗RA的随机对照试验(RCTs)文献,对符合纳入标准的文献应用Cochrane协作网推荐的RevMan 5.4.1软件对所提取的数据进行统计学分析。结果纳入15篇文献,共1636例患者,痹祺胶囊单用或联合MTX治疗RA临床疗效更优[RR=1.19,95%CI(1.12,1.27),P<0.00001],差异有极显著统计学意义(P<0.00001),且在关节肿胀数、关节疼痛数、类风湿因子(RF)、血沉(ESR)、C反应蛋白(CRP)方面优于对照组,但存在一定安全性问题。结论痹祺胶囊单用或联合MTX治疗类风湿关节炎疗效显著,但不能完全证明痹祺胶囊的安全性,需更多中心、大样本、高质量的随机对照试验提供高级别循证医学证据。Objective To systematically evaluate the clinical efficacy of Biqi Capsule(痹祺胶囊)alone or combined with methotrexate(MTX)in the treatment of rheumatoid arthritis(RA).Methods Randomized controlled trials(RCTs)on Biqi Capsules alone or in combination with MTX in the treatment of RA were systematically searched from CNKI,Wanfang database,Chongqing VIP database,PubMed,EMbase and Cochrane Library(from established time until December 2021).For the literatures that met the inclusion criteria,RevMan 5.4.1 software recommended by the Cochrane Collaboration was used for statistical analysis of the extracted data.Results A total of 1636 patients were included in 15 literatures.Biqi Capsule alone or combined with MTX had better clinical efficacy in RA treatment[RR=1.19,95%CI(1.12,1.27),P<0.00001],and the difference was statistically significant(P<0.00001).The joint swelling number,joint pain number,rheumatoid factor(RF),erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP)were better than those of the control group,but there were some safety problems.Conclusion Biqi Capsule alone or combined with MTX has significant efficacy in the treatment of rheumatoid arthritis,but it cannot completely prove the safety of Biqi Capsule.More centers,large samples and high-quality RCTs are needed to provide high-level evidence-based medical evidence.

关 键 词：痹祺胶囊 类风湿关节炎 甲氨蝶呤 安全性 META分析 

分 类 号：R593.22[医药卫生—内科学]