安非他酮缓释片戒除尼古丁依赖的多中心随机双盲对照试验

目的:评价国产安非他酮缓释片戒除尼古丁依赖的有效性及安全性。方法:多中心、随机、双盲、安慰剂平行对照研究。共入组自愿戒烟者143例,安非他酮组72例与安慰剂组71例。受试者分别口服安非他酮缓释片150～300 mg·d-1或安慰剂,疗程4 wk,观察12 wk。结果:治疗后4,12 wk安非他酮组戒烟率分别为39％,31％,高于安慰剂组(13％,9％),差异有非常显著意义(P<0．01);治疗后1 wk起安非他酮组吸烟量的减少值均大于安慰剂组,差异有非常显著意义(P<0．01)。安非他酮常见不良反应为注意力不集中、乏力、腹部不适等,其发生率高于安慰剂组,差异有显著意义(P<0．05),2组均未发生严重不良反应。结论:国产安非他酮缓释片是一种安全、有一定疗效的戒除尼古丁依赖(烟瘾)的药物。

A multicenter, randomized and double-blind controlled clinical trial of bupropion-sustained release for smoking cessation

AIM:To evaluate the efficacy and safety of bupropion-sustained releases (SR) for smoking cessation. METHODS: A multicenter, randomized and double-blind controlled clinical trial was conducted for smoking cessation. The experimental group (n = 72) was treated with bupropion SR 150 - 300 mg·d-1 and the control group (n = 71) was treated with placebo for 28 d respectively and then all of them were undertaken closely observation for 12 wk. RESULTS: The efficacy rates in the 4 and 12 wk of experimental group were 39 % and 31 % respectively, showing significant difference with the control group (P < 0.01). The decrement of cigarettes per day was more in bupropion group than in control group (P < 0.01). The common adverse reactions of experimental group were impaired concentration, hypodynamia and abdominal discomfort. CONCLUSION: Bupropion SR is an effective and safe agent for smoking cessation.