正清风痛宁治疗类风湿关节炎有效性及安全性的系统评价  

Systematic Review of Zhengqing Fengtongning on Treatment of Rheumatoid Arthritis

作　　者：王宝新[1,2] 李鑫[1,2] 谷捷[1,2] 黄惠勇[1,2] 王建国[1,2] 范伏元[3] 蔡雄[1,2] 

机构地区：[1]湖南中医药大学中医诊断研究所,湖南长沙410007 [2]中医诊断学湖南省重点实验室,湖南长沙410007 [3]湖南中医药大学第一附属医院,湖南长沙410007

出　　处：《湖南中医药大学学报》2015年第3期67-71,共5页Journal of Hunan University of Chinese Medicine

基　　金：国家自然科学基金项目(81373540);湖南省科技厅科研项目(2012TF-1005);湖南省中医药科研计划项目(201308);湖南省教育厅科学研究重点项目(12A107);湖南中医药大学中医诊断学国家重点学科开放基金项目(2013ZYZD10)

摘　　要：目的评价正清风痛宁治疗类风湿关节炎(Rheumatoid Arthritis,RA)的疗效及安全性。方法全面检索中国期刊全文数据库、维普中文科技期刊全文数据库、中国生物医学文献服务系统、万方医药期刊数据库、Pub Med等数据库中正清风痛宁治疗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协作员手册(5.0.1)评价符合纳入标准的文献质量,采用Review Manger 5.2软件进行统计分析。结果最终纳入6个随机对照试验,共476例研究对象。结果显示,与单独使用西药相比,口服正清风痛宁单独或辅助治疗RA在改善血沉方面具有效果(P<0.05),在改善晨僵、类风湿因子、C反应蛋白等方面效果不明显(P>0.05);可以降低不良反应发生率(P<0.05)。结论基于目前证据,正清风痛宁治疗RA疗效尚未证实,但能降低西药不良反应发生率。由于评价所纳入的文献存在质量缺陷及异质性,需开展多中心、大样本、双盲、双模拟的随机对照试验全面评价正清风痛宁治疗RA的临床疗效。Objective To evaluate the efficacy and safety of Zhengqing Fengtongning（ZQFTN） in rheumatoid arthritis（RA）. Methods Literature databases of CNKI, VIP, Wan Fang, Sino Med, and Pub Med and journals related with the clinical control experiment of ZQFTN were collected. The quality assessment of literatures of these databases was done by the Cochrane Handbook for Systematic Reviews of Interventions（5.0.1）, and qualified literatures were reviewed and analyzed by using the Review Manger 5.2 Statistical Software. Results Six randomized controlled trials with total of 476 cases met the inclusion criteria. Results showed that as compared with the treatment of Western drugs alone, oral administration of ZQFTN alone or as an adjuvant therapy significantly improved erythrocyte sedimentation rate（ESR）（P〈0.05）; But the morning stiffness,rheumatoid factor（RF）, and C-reactive protein（CRP） were not significant（P〉0.05）; It could reduce the frequency of adverse events（P 0.05）. Conclusion Our study indicated that the efficacy of ZQFTN in RA are not established based on data currently available, but ZQFTN did reduce the frequency of adverse events. Multi-center, large-sample, double-blinded,and double-simulated randomized controlled trials are still required to confirm the efficacy and safety of ZQFTN in the treatment of RA.

关 键 词：正清风痛宁 类风湿关节炎 随机对照试验 系统评价 META分析 

分 类 号：R255.6[医药卫生—中医内科学]