盐酸胍法辛缓释片治疗儿童注意缺陷多动障碍快速卫生技术评估

Rapid Health Technology Assessment of Guanfacine Hydrochloride Extended Release Tablets in the Treatment of Attention Deficit Hyperactivity Disorder in Children

目的快速评估盐酸胍法辛缓释片(简称胍法辛)治疗儿童注意缺陷多动障碍(ADHD)的有效性、安全性和经济性。方法检索中国知网、万方、维普、PubMed、ScienceDirect、EBSCO、Web of Science、Springer、SciFinder数据库及卫生技术评估(HTA)相关网站,纳入以胍法辛为干预药物的系统评价/Meta分析、HTA报告及药物经济学研究。采用HTA清单(Checklist)评估HTA报告的质量;采用系统评价方法学质量评价工具(AMSTAR)评估系统评价/Meta分析的质量;采用卫生经济学评价报告标准共识(CHEERS)评估药物经济学研究的质量。结果共纳入HTA报告1篇(质量较高),Meta分析/网络Meta分析6篇(质量均较高),药物经济学研究4篇(无法评价质量)。有效性方面,与安慰剂比较,胍法辛单药及联合用药均可有效改善患儿临床总体印象(CGI)量表和ADHD评定量表Ⅳ评分(P<0.05)。安全性方面,与安慰剂比较,胍法辛的不良反应停药率、睡眠障碍发生率均更高(P<0.05),体质量降低更显著(P<0.05);与托莫西汀比较,使用胍法辛患儿食欲降低发生率显著降低(P<0.05)。经济性方面,与托莫西汀比较,胍法辛具有明显的成本-效果优势。结论胍法辛治疗ADHD具有良好的有效性和安全性,并在同类药物中具有一定的经济性,有待国内经济学评价进一步验证。

Objective To quickly evaluate the effectiveness,safety and economy of Guanfacine Hydrochloride Extended Release Tablets(hereinafter referred to as guanfacine)in the treatment of attention deficit hyperactivity disorder(ADHD)in children.Methods Systematic reviews/Meta-analyses,HTA reports and pharmacoeconomic studies with guanfacine as the intervention drug were searched from the CNKI,WanFang,VIP,PubMed,ScienceDirect,EBSCO,Web of Science,Springer,SciFinder and health technology assessment(HTA)-related websites.The quality of HTA reports was evaluated by the HTA Checklist,the quality of systematic reviews/Meta-analyses was evaluated by a measurement tool to assess systematic reviews(AMSTAR),and the quality of pharmacoeconomic studies was evaluated by the consolidated health economic evaluation reporting standards(CHEERS).Results One HTA report(with high quality),six Meta-analyses/network Meta-analyses(all with high quality)and four pharmacoeconomic studies(unable to evaluate quality)were included.For effectiveness,guanfacine monotherapy and combination therapy with other drugs can more effectively improve the Clinical Global Impression(CGI)Scale and ADHD Rating ScaleⅣscores in children than placebo(P<0.05).For safety,guanfacine had higher incidence of drug withdrawal due to adverse reaction and sleep disorders and more obvious decrease of body mass than placebo(P<0.05),and it had lower incidence of appetite decrease than atomoxetine(P<0.05).For economy,guanfacine had a more obvious cost-effectiveness advantage than atomoxetine.Conclusion Guanfacine is effective and safe in the treatment of ADHD,and is economical among similar drugs,which needs further verification by domestic economic studies.