Pharmaceutical Sciences Postgraduate Program, Universidade Federal do Paraná, Curitiba, Brazil.
Department of Medical and Pharmaceutical Sciences, Universidade Estadual do Oeste do Paraná, Cascavel, Brazil.
Eur Child Adolesc Psychiatry. 2018 Oct;27(10):1335-1345. doi: 10.1007/s00787-018-1125-0. Epub 2018 Feb 19.
The aim of this study is to gather evidence of head-to-head double-blind randomized-controlled trials on the efficacy and safety of available treatments for attention deficit hyperactivity disorder (ADHD) in children and adolescents. A systematic review was conducted by two independent reviewers in ten electronic databases (PROSPERO register CRD42016043239). Methodological quality of included studies was evaluated according to the Jadad scale. Network meta-analyses were performed including double-blinded head-to-head trials comparing active allopathic drugs in patients (0-18 years old) diagnosed with ADHD. The results of efficacy and safety of atomoxetine (ATX), bupropion, buspirone (BSP), dexamphetamine, edivoxetine (EDX), guanfacine (GXR), lisdexamfetamine (LDX), methylphenidate (MPH), mixed amphetamine salts, modafinil, pindolol (PDL), reboxetine (RBX), selegiline, and venlafaxine were analyzed using ADDIS software v.1.16.5. Forty-eight trials were identified (n = 4169 participants), of which 12 were used for efficacy analysis and 33 for safety analysis. On the CGI-I scale, the analysis revealed that MPH was more effective than ATX and GXR. For the safety outcomes, according to drug ranks, LDX was more likely to cause sleep disorders (39%) as well as loss of appetite (65%) and behavior problems such as irritability (60%). BSP (71%) and EDX (44%) caused less appetite decrease. For behavioral effects, PDL was considered safest (50%). For any adverse events, RBX (89%) was the safest alternative. The lack of head-to-head trials properly reporting outcomes of interest limited some comparisons. Network meta-analysis offered a broader overview on the available treatments for ADHD, especially for safety issues, and contributes towards evidence gathering and clinical practice decisions. A core outcome set for ADHD should be designed to guide the conduction and report of clinical trials.
本研究旨在收集针对儿童和青少年注意缺陷多动障碍（ADHD）现有治疗方法的疗效和安全性的头对头双盲随机对照试验证据。两位独立审查员在十个电子数据库（PROSPERO 注册 CRD42016043239）中进行了系统评价。根据 Jadad 量表评估纳入研究的方法学质量。进行了网络荟萃分析，包括比较诊断为 ADHD 的患者（0-18 岁）使用的活性同种药物的双盲头对头试验。使用 ADDIS 软件 v.1.16.5 分析了阿托西汀（ATX）、安非他酮、丁螺环酮（BSP）、右旋苯丙胺、依度沙班（EDX）、胍法辛（GXR）、右苯丙胺、哌醋甲酯（MPH）、混合安非他命盐、莫达非尼、普萘洛尔（PDL）、瑞波西汀（RBX）、司来吉兰和文拉法辛的疗效和安全性结果。确定了 48 项试验（n=4169 名参与者），其中 12 项用于疗效分析，33 项用于安全性分析。在 CGI-I 量表上，分析表明 MPH 比 ATX 和 GXR 更有效。对于安全性结果，根据药物等级，LDX 更有可能引起睡眠障碍（39%）、食欲不振（65%）以及易怒等行为问题（60%）。BSP（71%）和 EDX（44%）导致食欲下降较少。对于行为影响，PDL 被认为是最安全的（50%）。对于任何不良事件，RBX（89%）是最安全的替代药物。缺乏对头对头试验的恰当报告限制了一些比较。网络荟萃分析提供了 ADHD 现有治疗方法的更广泛概述，特别是关于安全性问题，并有助于证据收集和临床实践决策。应设计 ADHD 的核心结局集，以指导临床试验的进行和报告。
