炎症性肠病包括两种慢性炎症性疾病,溃疡性结肠炎和克罗恩病。全世界的疾病负担正在增加。已经发表了一些评估儿科使用肿瘤坏死因子(TNF)拮抗剂的评论,尽管这些主要包括观察性研究,不考虑经济评估。本系统综述评估了有关疗效的现有证据,安全,和TNF拮抗剂治疗小儿炎症性肠病的成本效益。我们搜索了PubMed/MEDLINE,Embase,和CochraneCentral(截至2022年5月)。9项随机临床试验和4项经济评估检查了任何抗TNF药物(例如,英夫利昔单抗,阿达木单抗,戈利木单抗,包括针对不同替代品的certolizumab)。在评估抗TNF药物对克罗恩病的疗效的研究中,大多数人评估了先前对诱导有反应的患者的维持方案的疗效(反应=28%-63%,临床缓解=17%-83%,取决于剂量,药物,和后续行动)。在溃疡性结肠炎中,抗TNF药物维持治疗的临床缓解率在17%至44%之间.9项研究报告了有关不良事件的信息。没有发现比较不同抗TNF药物的临床试验。这篇综述的结果表明,用抗TNF药物(如英夫利昔单抗和阿达木单抗)维持治疗小儿炎症性肠病可能是有效和安全的。然而,经济评估报告的成本效益比结果相互矛盾。协议注册:开放科学框架:https://osf.io/wjmvf。
Inflammatory bowel disease includes two chronic inflammatory diseases, ulcerative colitis and Crohn\'s disease. The burden of disease is increasing worldwide. A few reviews evaluating the paediatric use of tumour necrosis factor (TNF) antagonists have been published, although these mostly include observational studies and do not consider economic evaluations. This systematic
review evaluated the available evidence regarding the efficacy, safety, and cost-effectiveness of TNF antagonist therapy for paediatric inflammatory bowel disease. We searched PubMed/MEDLINE, Embase, and Cochrane Central (up to May 2022). Nine randomized clinical trials and four economic evaluations that examined any anti-TNF drugs (e.g., infliximab, adalimumab, golimumab, and certolizumab) against different alternatives were included. In studies evaluating the efficacy of anti-TNF drugs in Crohn\'s disease, most assessed the efficacy of maintenance regimen in patients who had previously responded to induction (response=28%-63%, and clinical remission=17%-83% depending on dose, drug, and follow-up). In ulcerative colitis, maintenance treatment with anti-TNF drugs reported clinical remission rates between 17% and 44%. Nine studies reported information on adverse events. No clinical trials comparing different anti-TNF drugs were found. The findings from this
review suggest that maintenance treatment with anti-TNF drugs (such as infliximab and adalimumab) in paediatric inflammatory bowel disease is probably effective and safe. However, the economic evaluations reported contradictory results of the cost-effectiveness ratios. Protocol registry: Open Science Framework: https://osf.io/wjmvf.