青藤碱制剂治疗强直性脊柱炎随机对照试验的系统评价

Treating ankylosing spondylitis with sinomenine by systematic reiview of randomized controlled trial

[目的]系统评价青藤碱(SIN)制剂治疗强直性脊柱炎(AS)的疗效及安全性。[方法]手工和在线检索SIN制剂治疗AS的随机对照试验文献,电子数据库包括中国知网数据库、万方数据、中国生物医学文献服务系统、重庆维普、PubMed、CENTRAL,时间从建库截至2013年3月。筛选合格研究,提取数据并交差核对,应用Cochrane协作组评分方法进行方法学质量评价和偏倚风险评估,应用Revman软件实施异质性检验、Meta分析、绘制倒置漏斗图等方法分析相关数据。[结果]纳入7篇临床研究文献,其中6个研究报道了有效率,全部研究均报道了不良反应率,Meta分析结果显示SIN制剂治疗AS有效率与对照组相比较高[OR=2.48,95%CI(1.49,4.11)],但两组不良反应率差异无统计学意义[OR=1.06,95%CI(0.67,1.68)]。试验组枕壁距小于对照组、Schober试验结果大于对照组,但两组扩胸度、指地距结果差异无统计学意义。试验组ESR、CRP低于对照组。[结论]基于目前证据,青藤碱制剂可以有效治疗强直性脊柱炎,安全性较好,但鉴于较低的纳入研究质量以及本研究的局限性,目前证据尚难以得出较可靠的结论。

[Objective] To investigate the safety and efficiency of sinomenine （SIN） on Ankylosing Spondylitis （AS）. [Method] Alone with hand searches, systematic searches on line were conducted on China National Knowledge Infrastructure, Wanfang Data, China Biology Medicine disc, Chongqing database for Chinese Technical Periodicals, PubMed and Cochrane Central Register of Controlled Trials until March 2013. Literatures of randomized controlled trials （RCTs） involving SIN alone or with other treatment for AS. According to the Cochrane Handbook version 5.1, all the data were extracted from the selected studies independently with strict screening and crosschecking. Then the methodological quality evaluation of trials and the risk assessment of bias were undertaken with Cochrane Collaboration＇s tool. Rev Man was employed to estimate the heterogeneity and carry out the meta-analyses and the funnel plot. [Results] Seven studies were included, all of which had reported the adverse effects. Six studies reported the effective rate. The results of meta-analysis suggested that the effective rate of SIN treating group was high than the control group [OR=2.48, 95% CI （1.49,4.11）]. There was no statistical difference between the rates of adverse events of groups [OR=1.06, 95%CI （0.67, 1.68）]. The occiput-to-wall distance was shorter and Schober＇ s test resulted better in the SIN treating group. There was no significant difference of the cbest expansion and finger-to-floor distance between two groups. The ESR and CRP were lower in the SIN treating group. [Conclusion] Based on the evidences available, SIN is effective and safe for treating AS. But it is still difficult to draw a dependable conclusion from the evidence at present, considering the limitations and bias of the system analysis and the included studies.