Ethics Committee of University Hospital of Girona Dr. Josep Trueta, Girona, Spain.
Girona Biomedical Research Institute (IdIBGi), Girona, Spain.
Psychopharmacology (Berl). 2017 Sep;234(17):2657-2671. doi: 10.1007/s00213-017-4662-1. Epub 2017 Jun 19.
The risk-benefit balance of pharmacological treatment for children and adolescents with ADHD and the factors that moderate this relationship are unclear.
A systematic review and meta-analysis of randomised, placebo-controlled clinical trials (RPCCTs) investigating the efficacy of pharmacological treatment in children or adolescents with ADHD was carried out. Meta-analysis of treatment discontinuation, clinician-, parent- and teacher-rated efficacy and adverse events was performed. The effect of covariates was studied.
Sixty-three studies were included. Ten drugs were investigated, with atomoxetine and methylphenidate the most frequently studied. RPCCTs had mostly a short duration (7.9 weeks). All-cause treatment discontinuation was lower with pharmacological treatment than placebo (OR = 0.68). Pharmacological treatment was more efficacious than placebo independently of the rater (clinician, standardised mean difference (SMD) 0.74; parent, SMD = 0.63; or teacher, SMD = 0.75). Evidence of publication bias was found for clinician-rated efficacy, especially in industry-sponsored RPCCT. Psychostimulants showed a higher efficacy and were associated with a better outcome on treatment discontinuation than non-stimulant drugs. Efficacy was smaller in RPCCTs for which a psychiatric comorbid disorder was an inclusion criterion, was larger in studies with a commercial sponsorship and showed a negative association with treatment length.
In the short term, pharmacological treatment provides moderate-high symptom relief, is safe and shows lower treatment discontinuation than placebo, suggesting a suitable risk-benefit balance, particularly with psychostimulants. The efficacy is lower in patients with a comorbid psychiatric disorder and should be assessed periodically, as it appears to reduce over time. Publication bias of clinician-rated efficacy in studies with a commercial sponsor is suggested.
对于患有 ADHD 的儿童和青少年进行药物治疗的风险效益平衡以及调节这种关系的因素尚不清楚。
对评估药物治疗 ADHD 儿童或青少年疗效的随机、安慰剂对照临床试验（RPCCT）进行了系统评价和荟萃分析。对治疗中断、临床医生、家长和教师评定的疗效和不良事件进行了荟萃分析。研究了协变量的影响。
共纳入 63 项研究。研究了 10 种药物，其中阿托莫西汀和哌甲酯研究最多。RPCCT 的持续时间大多较短（7.9 周）。与安慰剂相比，药物治疗的全因治疗中断率较低（OR=0.68）。药物治疗比安慰剂更有效，而与评定者无关（临床医生，标准化均数差（SMD）0.74；家长，SMD=0.63；或教师，SMD=0.75）。发现了临床医生评定疗效的发表偏倚证据，尤其是在工业赞助的 RPCCT 中。与非兴奋剂药物相比，兴奋剂药物显示出更高的疗效，并且与治疗中断的更好结局相关。在将精神科合并症作为纳入标准的 RPCCT 中，疗效较小，在具有商业赞助的研究中，疗效较大，并且与治疗时间呈负相关。
在短期内，药物治疗可提供中度至高度症状缓解，安全且与安慰剂相比治疗中断率较低，表明具有适当的风险效益平衡，尤其是对于兴奋剂药物。在患有精神科合并症的患者中，疗效较低，应定期评估，因为它似乎随着时间的推移而降低。建议对具有商业赞助商的研究中临床医生评定疗效的发表偏倚进行研究。
