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首页> 外文期刊>The Canadian journal of hospital pharmacy. >Efficacy and Safety of Infliximab in Pediatric Crohn Disease: A Systematic Review and Meta-Analysis
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Efficacy and Safety of Infliximab in Pediatric Crohn Disease: A Systematic Review and Meta-Analysis

机译：英夫利昔单抗在儿科克罗恩病中的疗效和安全性：系统评价和荟萃分析

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Background: Crohn disease is an inflammatory bowel disease with intermittent symptoms relating to damage to the gastrointestinal tract. Compared with adult-onset Crohn disease, the childhood-onset form is more likely to be severe. Infliximab has shown efficacy in adult patients. Objective To examine the efficacy and safety of infliximab in pediatric Crohn disease, by means of a systematic review. Data Sources: Three databases (MEDLINE, Embase, and Cochrane Central Register of Controlled Trials) and regulatory documents were searched from inception to December 2017. Clinical trial registries, conference abstracts, and reference lists were searched to March 2018. Study Selection and Data Extraction: Randomized controlled trials (RCTs) and prospective cohort studies that compared infliximab with active control were included in the analysis. Two reviewers independendy performed screening, extracted data, and assessed risk of bias. The primary outcomes were induction and maintenance of endoscopic remission and severe adverse effects. Data Synthesis: Three eligible RCTs comparing different dose regimens, 16 prospective cohort studies comparing infliximab with other therapies (adalimumab, exclusive enteral nutrition, or standard of care), and 3 prospective cohort studies comparing different infliximab regimens were identified. Meta-analysis of the RCTs showed no significant difference between infliximab every 8 weeks compared with longer intervals for maintenance of clinical remission (risk ratio [RR] 1.76, 95% confidence interval [CI] 0.98—3.19). Meta-analyses of the prospective cohort studies showed no significant differences between infliximab and adalimumab for maintenance of endoscopic remission (RR 1.07,95% CI 0.60-1.92), between infliximab and exclusive enteral nutrition for induction of clinical remission (RR 1.09, 95% CI 0.82-1.45), or between infliximab and standard of care for maintenance of clinical remission at 6 and 12 months (RR 1.12, 95% CI 0.58-2.17, and RR 1.24, 95% CI 0.84-1.84, respectively). Conclusions: Current evidence suggested comparable efficacy for infliximab and other therapies; however, the available literature was limited by risk of bias and small sample size. Further prospective studies are needed to confirm the efficacy and safety of this drug in pediatric Crohn disease.
机译：背景：克罗恩病是一种炎症性肠病，具有与胃肠道损伤有关的间歇性症状。与成人发病克罗恩病相比，儿童期发病形式更可能是严重的。英夫利昔单抗表明了成年患者的疗效。目的探讨英夫利昔单抗在儿科克罗恩病的疗效和安全性，通过系统审查。数据来源：从2007年12月开始搜查了三个数据库（受控试验的Cochrane中央登记册）和监管文件。临床试验登记处，会议摘要和参考列表被检测到2018年3月。学习选择和数据提取：随机对照试验（RCT）和预期队列研究，将英夫利昔单抗与活性对照相比，分析中包括在分析中。两位审稿人独立执行筛选，提取数据和评估偏倚风险。主要结果是诱导和维持内镜缓解和严重不良反应。数据合成：三个符合不同剂量方案的符合条件的RCT，鉴定了16种前瞻性队列与其他疗法（Adalimalab，独家肠内营养或护理标准）进行比较的前瞻性队列研究和3种预期队列研究。 RCT的荟萃分析显示，与临床缓解的较长间隔（风险比[RR] 1.76,95％置信区间隔[CI] 0.98-3.19）相比，RCT在每8周之间没有显着差异。前瞻性队列研究的荟萃分析显示，英夫利昔单抗和阿达木单抗之间没有显着差异，以维持内镜缓解（RR 1.07,95％CI 0.60-1.92），incriximab和专有肠内营养之间的临床缓解（RR 1.09,95％ CI 0.82-1.45），或在6和12个月维持临床缓解的英夫利昔单抗和护理标准（RR 1.12,95％CI 0.58-2.17和RR 1.24,95％CI 0.84-1.84）。结论：目前的证据表明英夫利昔单抗和其他疗法的可比疗效;然而，可用文献受到偏差风险和小样本大小的限制。需要进一步的前瞻性研究来证实该药物在儿科克罗恩病中该药物的疗效和安全性。

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