Departamento de Salud Pública, Universidad Icesi, Cali, Colombia.
Unidad Clínica de Leishmaniasis, Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia.
PLoS Negl Trop Dis. 2018 Dec 14;12(12):e0006986. doi: 10.1371/journal.pntd.0006986. eCollection 2018 Dec.
BACKGROUND: Case management in children with cutaneous leishmaniasis (CL) is mainly based on studies performed in adults. We aimed to determine the efficacy and harms of interventions to treat CL in children. METHODS: We conducted a systematic review of clinical trials and cohort studies, assessing treatments of CL in children (≤12 years old). We performed structured searches in PubMed, CENTRAL, LILACS, SciELO, Scopus, the International Clinical Trials Registry Platform (ICTRP), clinicaltrials.gov and Google Scholar. No restrictions regarding ethnicity, country, sex or year of publication were applied. Languages were limited to English, Spanish and Portuguese. Two reviewers screened articles, completed the data extraction and assessment of risk of bias. A qualitative summary of the included studies was performed. RESULTS: We identified 1092 records, and included 8 manuscripts (6 Randomized Clinical Trials [RCT] and 2 non-randomized studies). Most of the articles excluded in full-text review did not report outcomes separately for children. In American CL (ACL), 5 studies evaluated miltefosine and/or meglumine antimoniate (MA). Their efficacy varied from 68-83% and 17-69%, respectively. In Old-World CL (OWCL), two studies evaluated systemic therapies: rifampicin and MA; and one study assessed efficacy of cryotherapy (42%, Per Protocol [PP]) vs intralesional MA (72%, PP). Few studies (4) provided information on adverse events (AEs) for children, and no serious AEs were reported in participants. Risk of bias was generally low to unclear in ACL studies, and unclear to high in OWCL studies. CONCLUSION: Information on efficacy of treatment for CL in children is scarce. There is an unmet need to develop specific formulations, surveillance of AEs, and guidelines both for the management of CL and clinical trials involving the pediatric population. REGISTRATION: The protocol of this review was registered in the PROSPERO International register of systematic reviews, number CRD42017062164.
背景:儿童皮肤利什曼病(CL)的病例管理主要基于对成人进行的研究。我们旨在确定治疗儿童 CL 的干预措施的疗效和危害。
方法:我们对评估儿童(≤12 岁)CL 治疗的临床试验和队列研究进行了系统评价。我们在 PubMed、CENTRAL、LILACS、SciELO、Scopus、国际临床试验注册平台(ICTRP)、clinicaltrials.gov 和 Google Scholar 中进行了结构化检索。未对种族、国家、性别或发表年份施加限制。语言仅限于英语、西班牙语和葡萄牙语。两位审查员筛选文章、完成数据提取和偏倚风险评估。对纳入的研究进行定性总结。
结果:我们确定了 1092 条记录,并纳入了 8 篇文献(6 项随机临床试验 [RCT] 和 2 项非随机研究)。在全文审查中排除的大多数文章没有分别报告儿童的结局。在美洲利什曼病(ACL)中,5 项研究评估了米替福新和/或葡甲胺锑(MA)。它们的疗效分别为 68-83%和 17-69%。在旧世界利什曼病(OWCL)中,两项研究评估了系统治疗:利福平加 MA;一项研究评估了冷冻疗法(42%,按方案 [PP])与皮内 MA(72%,PP)的疗效。少数研究(4 项)提供了儿童不良事件(AE)的信息,参与者未报告严重 AE。ACL 研究的偏倚风险通常较低至不清楚,OWCL 研究的偏倚风险则不清楚至高。
结论:关于儿童 CL 治疗疗效的信息很少。迫切需要开发针对儿童的特定制剂、AE 监测以及 CL 管理和涉及儿科人群的临床试验指南。
登记:本综述的方案在 PROSPERO 国际系统评价注册中心进行了登记,编号为 CRD42017062164。
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