雷公藤多苷片治疗强直性脊柱炎疗效及安全性的系统评价

Meta-analysis on Efficacy and Safety of Tripterygium Glycosides Tablets in Treatment of Ankylosing Spondylitis

目的：系统评价雷公藤多苷片治疗强直性脊柱炎的疗效及安全性。方法：计算机检索Pub Med、Cochrane、Sciencedirect、中国期刊全文数据库、万方数据库,检索时限均为从建库至2015年12月。由2名评价者按照纳入标准与排除标准以及Cochrane协作网推荐的方法独立筛选文献、提取资料并评价纳入文献的方法学质量后,采用Rev Man 5.1软件进行文献荟萃（Meta）分析。结果：共纳入14篇文献、996例患者。Meta分析结果显示,疗效方面,雷公藤多苷片组与化学药组患者在总有效率、Bath强直性脊柱炎疾病活动指数、Bath强直性脊柱炎功能指数、C反应蛋白、Schober试验指标等方面的差异无统计学意义（P〉0.05）;雷公藤多苷片组患者的总有效率明显低于中药复方组,且C反应蛋白、Schober试验指标的均数明显小于中药复方组,差异均有统计学意义（P〈0.05）,2组患者其他指标的差异无统计学意义（P〉0.05）。安全性方面,雷公藤多苷片组患者不良反应发生率明显高于化学药组（OR=2.30,95%CI=1.23~4.29,P=0.009）,且明显高于中药复方组（OR=2.85,95%CI=1.54~5.26,P=0.000 8）,差异均有统计学意义。结论：雷公藤多苷片对强直性脊柱炎的治疗是有效的,疗效与化学药相当,但雷公藤多苷片的不良反应较多;尚需合理设计、严格执行的多中心、大样本且随访时间足够长的高质量随机对照试验进一步证实。

OBJECTIVE： To systematic review the efficacy and safety of Tripterygium glycosides tablets in treatment of ankylosing spondylitis. METHODS： Pub Med,Cochrane library,Sciencedirect,CNKI and Wanfang data base were electronically searched for relevant studies from inception to Dec. 2015. According to the inclusion and exclusion criteria as well as the methods recommended by the Cochrane Collaboration,two reviewers independently screened literature to extract data and assess the methodological quality of the included the study. Then,meta-analysis was performed by using Rev Man5. 1. RESULTS： 14 studies involving 996 patients were included. According to Meta-analysis,as for efficacy,there was no significant difference in total efficiency,BASDAI,BASFI,CRP,Schober test between the Tripterygium Glycosides tablets group and the western medicine group（ P〉0. 05）. Compared with the traditional Chinese medicine group,the total efficiency was significantly low in the Tripterygium glycosides tablets group,and the CRP and Schober test indicators were less than the traditional Chinese medicine group,with statistical significance（ P〈0. 05）; there was no statistically significant difference among the other indicators（ P〉0. 05）. As for safety,the incidence of adverse drug reactions in Tripterygium glycosides tablets group was significantly higher than that of western medicine group（ OR = 2. 30,95% CI =1. 23-4. 29,P = 0. 009）,also significantly higher than that of traditional Chinese medicine group（ OR = 2. 85,95% CI = 1. 54-5. 26,P = 0. 000 8）,with statistical significance. CONCLUSIONS： Tripterygium glycosides tablets is effective in treatment of ankylosing spondylitis,and the therapeutic effects of Tripterygium glycosides tablets and western medicine have nodifference,tet Tripterygium glycosides tablets have more adverse drug reactions. Therefore,it still need the reasonable design,strict implementation of multi center large sample and long enough follow-up time of the high quality randomized controlled experiment to further confirmed.