补肾强督方联合柳氮磺砒啶治疗强直性脊柱炎有效性和安全性系统评价

Systematic Evaluation of Clinical Efficacy and Safety of Bushen Qiangdu Recipe Combined with Sulfasalazine for Treatment of Ankylosing Spondylitis

检索中国知网(CNKI)、维普(VIP)、中国生物医学文献数据库(CBM)、万方数据库(Wanfang Data)、PubMed、CENTRAL、EMbase、Cochrane Library等国内外主要数据库中有关补肾强督方联合柳氮磺砒啶(试验组)对比单用柳氮磺砒啶(对照组)治疗强直性脊柱炎的临床对照试验,采用Revman 5.3软件对该联合疗法的有效性与安全性进行系统评价。结局指标涉及Bath强直性脊柱炎功能指数(BASFI)、Bath强直性脊柱炎病情活动指数(BASDAI)、血沉(ESR)水平、C反应蛋白(CRP)水平、脊柱痛、不良事件。结果共得到4篇符合纳入和排除标准的文献,包括1165例患者。Meta分析结果显示:试验组对BASFI的改善作用(WMD=-0.23,95%CI[-0.38,-0.08],P=0.002)及对脊柱痛的改善作用(WMD=-0.33,95%CI[-0.64,-0.03],P=0.03)均优于对照组,而对改善患者的BASDAI(WMD=-0.44,95%CI[-1.3,0.41],P=0.08)、ESR(WMD=-7.21,95%CI[-18.04,3.62],P<0.00001)、CRP(WMD=-13.93,95%CI[-32.18,4.32],P<0.00001)可能有一定优势(尤其是对ESR和CRP),但由于经敏感性分析后仍具有较显著的异质性,不足以证明其改善是否可供参考。两组的不良反应均主要为胃肠道反应。分析结果提示补肾强督方联合柳氮磺砒啶治疗强直性脊柱炎对于改善BASFI和脊柱痛较单用柳氮磺砒啶有一定优势,但由于本系统评价纳入的文献数量少,质量不高,且未提及长期随访,故其分析结果仍需通过多中心、大样本、高质量的RCT进一步验证。

The clinical randomized controlled trials of Bushen Qiangdu Recipe combined with sulfasalazine(trial group)vs sulfasalazine alone(control group)for the treatment of ankylosing spondylitis in the main domestic and oversea databases of CNKI,VIP,CBM,Wanfang Data,PubMed,CENTRAL,EMbase,and Cochrane Library were reviewed.Revman 5.3 was adopted for the systematic evaluation of the clinical efficacy and safety of the combined therapy.The outcomes covered Bath ankylosing spondylitis function index(BASFI),Bath ankylosing spondylitis disease activity index(BASDAI),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rachialgia,and adverse events.The results showed that 4 clinical randomized controlled trials which met the included and excluded criteria were obtained,involving 1165 cases.The results of Meta-analysis showed that the effects on improving BASFI(WMD=-0.23,95%CI[-0.38,-0.08],P=0.002)and on relieving rachialgia(WMD=-0.33,95%CI[-0.64,-0.03],P=0.03)in the trial group were superior to those in the control group.The trial group probably had some advantages on improving BASDAI(WMD=-0.44,95%CI[-1.3,0.41],P=0.08),ESR(WMD=-7.21,95%CI[-18.04,3.62],P<0.00001),and CRP(WMD=-13.93,95%CI[-32.18,4.32],P<0.00001)in paticular on ESR and CRP.But for the sensitivity analysis still presented significant heterogeneity,the improvement effect had insufficient evidence.The adverse reaction of the two groups mainly manifested as the gastrointestinal reaction.The results indicated that Bushen Qiangdu Recipe combined with sulfasalazine has certain advantages of improving BASFI and rachialgia than sulfasalazine alone for the treatment of ankylosing spondylitis.But for the less amount and low quality of the included studies as well as the absence of long-term follow-up,the conclusion still needs further verification with multi-center,large-sample,and highquality randomized controlled trials.