维多珠单抗治疗活动性炎症性肠病疗效和安全性的评价

Evaluation of Efficacy and Safety of Vedolizumab in Treatment of Active Inflammatory Bowel Disease

背景:炎症性肠病(IBD)是一种反复复发的胃肠道非特异性炎症性疾病。选择性阻断白细胞与肠道血管内皮细胞黏附的维多珠单抗(VDZ)对活动性IBD有较好疗效。目的:系统评价VDZ对活动性IBD的疗效和安全性。方法:计算机检索PubMed、Embase、Cochrane Library、Google Scholar 2018年8月前发表的VDZ治疗IBD的随机安慰剂对照试验,检索语言仅限英文。应用RevMan 5.30软件进行meta分析。结果: 8项涉及3 159例活动性IBD患者的随机对照试验纳入研究。Meta分析显示,对于活动期UC,VDZ组临床反应率、临床缓解率、内镜缓解率均优于安慰剂组(RR=1.62, 95% CI: 1.33~1.97, P <0.000 01;RR=2.45, 95% CI: 1.56~3.83, P <0.000 1;RR= 1.75 , 95% CI: 1.29~2.37, P =0.000 3),缓解期临床缓解率亦优于安慰剂组(RR=2.43, 95% CI: 1.73~3.41, P < 0.000 01)。对于活动期CD,VDZ组临床反应率、临床缓解率同样优于安慰剂组(RR=1.47, 95% CI: 1.21~ 1.79, P =0.000 1;RR=1.87, 95% CI: 1.37~2.56, P <0.000 1),但亚组分析显示VDZ仅在未经抗肿瘤坏死因子-α(TNF-α)治疗者中具有诱导缓解作用。仅1篇文献描述了VDZ对缓解期CD的维持缓解情况,结果显示VDZ疗效优于安慰剂。除鼻咽炎外,VDZ引发的不良事件并不多于安慰剂。结论: VDZ用于活动性IBD的诱导和维持缓解安全、有效,但对抗TNF-α治疗失败的CD患者可能无效。

Background: Inflammatory bowel disease (IBD) is a non-specific inflammatory disease of the gastrointestinal tract with a course of repeated episodes and remissions. Vedolizumab (VDZ), a selective blocker of interaction between leukocytes and vascular endothelium of the gut, has been demonstrated effective in treatment of active IBD. Aims: To systematically evaluate the efficacy and safety of VDZ for active IBD. Methods: PubMed, Embase, Cochrane Library and Google Scholar were retrieved to collect randomized controlled trials (RCTs) comparing VDZ and placebo in patients with IBD published in English before Aug. 2018. Meta-analysis was conducted by using RevMan 5.30 software. Results: Eight RCTs involving 3 159 active IBD patients were included. Meta-analysis showed that VDZ was superior to placebo in inducing clinical response, clinical remission and endoscopic remission in active UC (RR=1.62, 95% CI: 1.33-1.97, P < 0.000 01;RR=2.45, 95% CI: 1.56-3.83, P <0.000 1;RR=1.75, 95% CI: 1.29-2.37, P =0.000 3, respectively) and in maintenance of clinical remission in inactive UC (RR=2.43, 95% CI: 1.73-3.41, P <0.000 01). Also, VDZ was superior to placebo in inducing clinical response and clinical remission in active CD (RR=1.47, 95% CI: 1.21- 1.79, P =0.000 1;RR=1.87, 95% CI: 1.37-2.56, P <0.000 1, respectively). Subgroup analysis revealed that clinical remission was only achieved in CD patients naive to anti-tumor necrosis factor-α(TNF-α) therapy. Only one trial described the clinical remission in inactive CD, the results showed that VDZ was superior to placebo. Except for nasopharyngitis, adverse events were similar between VDZ group and placebo group. Conclusions: VDZ is safe and effective for induction and maintenance of remission in active IBD, but may be not more effective than placebo in CD patients failure to anti-TNF-α therapy.