IL-12/IL-23拮抗剂治疗炎症性肠病有效性及安全性的Meta分析

目的评价IL-12/IL-23拮抗剂治疗炎症性肠病(inflammatory bowel disease,IBD)的有效性及安全性。方法利用PubMed、EmBase、Cochrane Library、中国知网、万方、维普等数据库检索自建库至2019年6月的相关文献,并对Gastroenterology and Hepatology、United European Gastroenterology Week和AGA Abstracts(2016-2018年)的会议记录进行回顾,制定严格的纳入、排除标准,进行筛选,并对相关研究指标进行数据提取,采用RevMan 5.3软件进行统计学处理。结果11项随机双盲安慰剂对照试验研究符合纳入标准,共计活动性IBD患者4181例,包括试验组2837例,安慰剂组1344例。Meta分析结果显示,试验组临床缓解率高于安慰剂组,差异有统计学意义(RR=3.02,95%CI:1.94~4.76,P<0.00001);临床反应率高于安慰剂组,差异有统计学意义(RR=1.57,95%CI:1.37~1.81,P<0.00001);不良反应发生率与安慰剂组比较,差异无统计学意义(RR=0.96,95%CI:0.91~1.02,P=0.16)。结论IL-12/IL-23拮抗剂可有效治疗中-重度活动性IBD,且安全性较好。

Efficacy and safety of IL-12/IL-23 antagonists in the treatment of inflammatory bowel disease:a Meta-analysis

Objective To evaluate the efficacy and safety of IL-12/IL-23 antagonists in the treatment of inflammatory bowel disease(IBD).Methods PubMed, EmBase, Cochrane Library, CNKI, WanFang, VIP and other databases were used retrieve relevant literatures from the establishment of the database to Jun. 2019, and the meeting minutes of Gastroenterology and Hepatology, United European Gastroenterology Week and AGA Abstracts(2016-2018) were reviewed, strict inclusion and exclusion criteria were formulated and screened. Data were extracted from relevant research indicators, and RevMan 5.3 software was used for statistical processing.Results 11 randomized double-blind placebo-controlled trials met the inclusion criteria, with a total of 4 181 cases of active IBD, including 2 837 cases in the experimental group and 1 344 cases in the placebo group. The results of Meta-analysis showed that the clinical remission rate in the experimental group was higher than that in the placebo group, with statistically significant difference(RR=3.02, 95% CI: 1.94-4.76, P<0.00001), and the clinical response rate was higher than that in the placebo group, with statistically significant difference(RR=1.57, 95% CI: 1.37-1.81, P<0.00001), and there was no significant difference of the incidence of adverse reactions than that in the placebo group(RR=0.96, 95% CI: 0.91-1.02, P=0.16).Conclusion IL-12/IL-23 antagonists can effectively treat moderate to severe active IBD with good safety.