Li Sophia, Reynaert Christopher, Su Annie Ling, Sawh Sonja
, PharmD, RPh, was, at the time this study was initiated, with the Pharmacy Department, London Health Sciences Centre, London, Ontario. She is now is a Clinical Pharmacist with the Pharmacy Department, Providence Healthcare, Vancouver, British Columbia.
, BScPhm, RPh, is a Pharmacist with the Pharmacy Department, London Health Sciences Centre, London, Ontario.
Can J Hosp Pharm. 2019 May-Jun;72(3):227-238. Epub 2018 Jun 30.
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.
To examine the efficacy and safety of infliximab in pediatric Crohn disease, by means of a systematic review.
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.
Randomized controlled trials (RCTs) and prospective cohort studies that compared infliximab with active control were included in the analysis. Two reviewers independently performed screening, extracted data, and assessed risk of bias. The primary outcomes were induction and maintenance of endoscopic remission and severe adverse effects.
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).
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.
克罗恩病是一种炎症性肠病，其症状间歇性发作，与胃肠道损伤有关。与成人发病的克罗恩病相比，儿童发病型更可能较为严重。英夫利昔单抗已在成年患者中显示出疗效。
通过系统评价来研究英夫利昔单抗治疗儿童克罗恩病的疗效和安全性。
检索了三个数据库（MEDLINE、Embase和Cochrane对照试验中央注册库）以及监管文件，检索时间从建库至2017年12月。检索临床试验注册库、会议摘要和参考文献列表至2018年3月。
分析纳入了比较英夫利昔单抗与活性对照的随机对照试验（RCT）和前瞻性队列研究。两名评价员独立进行筛选、提取数据并评估偏倚风险。主要结局为内镜缓解的诱导和维持以及严重不良反应。
确定了三项比较不同剂量方案的合格RCT、16项比较英夫利昔单抗与其他疗法（阿达木单抗、全肠内营养或标准治疗）的前瞻性队列研究以及3项比较不同英夫利昔单抗方案的前瞻性队列研究。RCT的荟萃分析显示，每8周使用英夫利昔单抗与更长间隔使用英夫利昔单抗在维持临床缓解方面无显著差异（风险比[RR]1.76，95%置信区间[CI]0.98 - 3.19）。前瞻性队列研究的荟萃分析显示，英夫利昔单抗与阿达木单抗在维持内镜缓解方面无显著差异（RR 1.07，95% CI 0.60 - 1.92），英夫利昔单抗与全肠内营养在诱导临床缓解方面无显著差异（RR 1.09，95% CI 0.82 - 1.45），英夫利昔单抗与标准治疗在6个月和12个月维持临床缓解方面无显著差异（RR分别为1.12，95% CI 0.58 - 2.17和RR 1.24，95% CI 0.84 - 1.84）。
当前证据表明英夫利昔单抗与其他疗法疗效相当；然而，现有文献存在偏倚风险和样本量小的局限性。需要进一步的前瞻性研究来证实该药物在儿童克罗恩病中的疗效和安全性。
