A double-blind comparison of galantamine hydrogen bromide and placebo in adults with attention-deficit/hyperactivity disorder - A pilot study
A double-blind comparison of galantamine hydrogen bromide and placebo in adults with attention-deficit/hyperactivity disorder - A pilot study
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DOI：
10.1097/01.jcp.0000204139.20417.8a
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发表时间：
2006-04-01
影响因子：
2.9
通讯作者：
Spencer, T
中科院分区：
文献类型：
--
作者：
Biederman, J;Mick, E;Spencer, T
背景：加兰他敏氢溴酸盐（HBr）是一种竞争性、可逆性乙酰胆碱酯酶抑制剂。由于其胆碱能烟碱作用机制，加兰他敏HBr被假设为具有治疗注意力缺陷/多动障碍（ADHD）的治疗活性。我们进行了一项为期12周的双盲、安慰剂对照、随机临床试验，使用日剂量高达24 mg/d的加兰他敏HBr治疗符合完整的《诊断和统计手册》的成人，第四版ADHD儿童期发作和持续成人症状的标准。所有的分析都打算与最后一次观察结转的受试者谁没有完成完整的study schedule.Results：平均每日剂量在第12周为19.8 - 6.4毫克的加兰他宁HBr和21.8 +/- 4.6毫克的安慰剂（P = 0.3）。与接受安慰剂的受试者相比，接受加兰他敏HBr治疗的受试者的ADHD症状没有统计学或临床显著性更大的减少（P = 0.5）。采用末次观察值结转法，18例接受加兰他敏HBr治疗的患者中有4例（22%）被视为应答者（在临床总体印象改善量表上有很大或非常大的改善，并且在ADHD调查者症状报告量表上至少减少30%，而安慰剂组为11% [2/18]; P = 0.4）。这些结果不支持加兰他敏HBr在本初步研究中使用的剂量下治疗ADHD的临床效用。
Background: Galantamine hydrogen bromide (HBr) is a competitive and reversible inhibitor of acetylcholinesterase. Because of its cholinergic nicotinic mechanism of action, galantamine HBr was hypothesized to have therapeutic activity in the treatment of attention-deficit/hyperactivity disorder (ADHD).Method: We conducted a 12-week, double-blind, placebo-controlled, randomized clinical trial using daily doses of up to 24mg/d of galantamine HBr in the treatment of adults who met full Diagnostic and Statistical Manual of Alental Disorders, Fourth Edition criteria for ADHD with childhood-onset and persistent adult symptoms. All analyses were intention to treat with the last observation carried forward for subjects who did not complete the full study schedule.Results: The mean daily doses at week 12 were 19.8 6.4 mg for galantarnine HBr and 21.8 +/- 4.6 mg for placebo (P = 0.3). There was no statistically or clinically significant greater reduction in ADHD symptoms in subjects treated with galantamine HBr relative to those receiving placebo (P = 0.5). Using last observation carried forward, 4 (22%), of 18 patients receiving galantamine HBr were considered responders (much or very much improved on the Clinical Global Impression Improvement Scale and at least a 30% reduction on the ADHD Investigator Symptom Report Scale compared with 11% [2/18] on placebo; P = 0.4).Conclusion: These results do not support the clinical utility of galantamine HBr in the treatment of ADHD at the doses used in this pilot study.