正清风痛宁联合化学药物治疗类风湿关节炎随机对照试验的系统评价  

Systematic Review of Randomized Controlled Trials of Combination Therapy of Zhengqing Fengtongning and Chemical Drugs on Rheumatoid Arthritis

作　　者：李鑫[1] 王宝新[1,2] 李如意[1] 王莘智[2] 谷捷[1] 魏艳霞[1] 余黄合[1] 彭璐[1,2] 宋厚盼[1] 黄惠勇[1] 范伏元[2] 蔡雄[1] 

机构地区：[1]湖南中医药大学中医诊断学湖南省重点实验室,药学院,长沙410208 [2]湖南中医药大学附属第一医院,长沙410208

出　　处：《中国实验方剂学杂志》2016年第16期205-210,共6页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(81373540);湖南省战略性新兴产业科技攻关类重大核心技术类项目(2014GK1058);湖南省中医药科研计划项目(201308);湖南省研究生科研创新项目(CX2014B362)

摘　　要：目的:系统评估正清风痛宁联合化学药物治疗类风湿关节炎(rheumatoid arthritis,RA)的有效性及安全性。方法:全面检索CNKI中国期刊全文数据库,维普中文科技期刊全文数据库,万方医药期刊数据库,Sino Med,Pub Med等数据库中正清风痛宁联合化学药物治疗RA的临床随机对照试验研究文献,同时手工检索相关杂志。按Cochrane评价员手册5.1.0评价符合纳入标准的文献质量,采用Review Manger 5.3.5软件进行统计分析。结果:最终共纳入8个随机对照试验,共708例研究对象。结果显示,正清风痛宁联合化学药物治疗RA的总疗效优于单独使用化学药物(Z=3.64,P=0.0003);对晨僵[MD=-13.29,95%CI(-24.66,-1.92),P=0.02]及关节压痛指数[MD=-0.94,95%CI(-1.82,-0.07),P=0.03]改善效果优于单独使用化学药物;正清风痛宁联合组不良反应发生率显著低于单独使用化学药物(P<0.000 01)。结论:当前循证证据显示,正清风痛宁联合化学药物治疗RA不仅可以提高化学药物的临床疗效,而且可以显著地降低化学药物的不良反应发生率。受纳入研究文献数量和质量限制,尚需要进一步开展多中心、大样本、双盲、双模拟的高质量临床随机对照试验,以系统评价正清风痛宁联合化学药物治疗RA的有效性及安全性。Objective： To evaluate the efficacy and safety of combination therapy of Zhengqing Fengtongning （ZQFTN） and chemical drugs on rheumatoid arthritis （RA）. Method： Literature databases of CNKI, VIP, WanFang, SinoMed, and PubMed were included in the study. The quality assessment of literatures was done by the Cochrane Evaluation Handbook 5.1.0, and qualified literatures were reviewed and analyzed by using the Review Manger 5.3.5 Statistical Software. Result： Eight randomized controlled trials with total of 708 cases met the inclusion criteria, and were enrolled in the meta-analysis. Results showed that the efficacy of combination therapy of ZQFTN and chemical drugs for 12 weeks was significantly superior to that of chemical drugs alone （P =0.0003）. Morning stiffness[MD=-13.29,95%CI （-24.66,-1.92）,P=0.02]and joint tenderness index[MD=-0.94,95%CI （-1.82,-0.07）,P=0.03]of patients treated with combination of ZQFTN and chemical drugs were more significantly improved than those treated with chemical drugs alone. Combination therapy of ZQFTN and chemical drugs also reduced the frequency of adverse events （P〈0.000 01）. Conclusion： Current clinical studies demonstrate the efficacy and safety of combination therapy of ZQFTN and chemical drugs in RA is superior to that of chemical drugs alone. However, multicenter, large-scale, double-blinded, double-simulated and high-quality randomized controlled trials are necessary to support the widespread use of combination therapy of ZQFTN and chemical drugs in RA.

关 键 词：正清风痛宁 联合用药 类风湿关节炎 随机对照试验 系统评价 

分 类 号：R287[医药卫生—中药学]