来氟米特治疗强直性脊柱炎疗效的Meta分析

Efficacy and Safety of Leflunomide for Ankylosing Spondylitis:A Meta-analysis

目的:系统评价来氟米特(LEF)治疗强直性脊柱炎(AS)的临床疗效与安全性。方法:检索Cochrane图书馆、PubMed、Embase、万方数据库、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBMdisc)、维普中文科技期刊数据库1974年1月-2010年7月关于LEF治疗AS的随机对照研究(RCT),对纳入的研究进行Meta分析。结果:共纳入8项研究,438例患者。与对照组比较,24周时LEF显著降低红细胞沉降率(ESR)[WMD=-3.94,95%CI(-5.71,-1.17)],但对C反应蛋白(CRP)水平无明显降低,2组有效率比较差异无统计学意义;48周时,LEF显著降低ESR[WMD=-5.80,95%C(I-8.71,-4.88)]、CRP[WMD=-5.11,95%CI(-7.99,-4.22)],对BathAS疾病活动指数(BASDAI)、BathAS功能指数(BASFI)改善无明显优势。2组失访/退出率比较差异有统计学意义[WMD=1.01,95%CI(0.38,2.71)],胃肠道不良反应发生率比较差异无统计学意义。结论:LEF较对照组有效降低ESR、CRP,没有明显改善BASDAI及BASFI。现有有限数据尚不能证明LEF疗效优于对照组,2组安全性比较差异无统计学意义。

OBJECTIVE：To evaluate the clinical efficacy and safety of leflunomide（LEF） for ankylosing spondylitis（AS）.METHODS：Retrieved from Cochrane library,PubMed,Embase,VIP,CNKI,CBMdisc,etc.,RCTs about LEF in the treatment of AS were collected.Meta-analysis of included studies was conducted.RESULTS：8 RCTs were included,involving a total of 438 patients.Compared with control group,after 24 weeks the meta-analysis showed ESR was significantly lowered [WMD=-3.94,95%CI（-5.71,-1.17）] while CRP had no significant decrease,there was no significant difference in effective rate.After 48 weeks,ESR [WMD=-5.80,95%CI（-8.71,-4.88）] and CRP [WMD=-5.11,95%CI（-7.99,-4.22）] were significantly lowered,while BASDAI and BASFI had no significant improvement.There was no significant difference in the incidence rate of dropouts [WMD=1.01,95%CI（0.38,2.71）].There was no significant difference in the incidence rate of gastrointestinal disorders.CONCLUSION：Compared with control group,LEF can decrease ESR and CRP significantly.There was no significant improvement in BASDAI and BASDFI.However,current data are not enough to confirm that LEF is better than placebo.There is similar safety of drugs between 2 groups.