盐酸安非他酮缓释片治疗抑郁症的临床试验

A randomized and double blind positive control clinical trial of bupropion SR for the treatment of depression

目的:评价国产盐酸安非他酮缓释片治疗抑郁症的有效性和安全性。方法:采用随机、双盲、双模拟、阳性药平行对照研究。48例抑郁症患者随机分为试验组24例与对照组24例,分别口服盐酸安非他酮缓释片300mg·d^(-1)或氟西汀20mg·d^(-1),疗程42d,观察汉密尔顿抑郁量表与临床总体印象量表总分变化及药物不良反应等。结果:两组汉密尔顿抑郁量表评分在治疗结束时较基线均显著减少(P＜0．01);试验组与对照组有效率分别为86．4%与73．9%,差异无显著性(P＞0．05)。试验组常见的不良反应为:恶心呕吐、头昏、口干、食欲减退。结论:盐酸安非他酮缓释片治疗抑郁症安全而有效。

Objective：To evaluate the efficacy and safety of bupropion SR made in China in the treatment of depression. Methods： A randomized, double blind positive control clinical trial enrolled forth-eight patients with depression, who were randomized 1：1 to administer bupropion SR 300 mg or fluoxetine 20 mg daily for 42 days. The efficacy of both treatment groups was evaluated based on the Hamilton Depression Scale and Clinical General Impression Scale pre- and post-treatment. Results：Compared to the baseline scores, patients experienced significant improvements in the Hamilton Depression Scale at the end of the therapy （P 〈 0.05）. The efficacy rate in both treatment groups was 86.4% and 73.9% , respectively ; the p value showed no significant difference （ P 〉 0.05 ）. Both therapies demonstrated common adverse events including nausea, dizziness, dry mouth, and poor appetite. Conelusion：Bupropion SR made in China offers an effective and safe option in the treatment of depression.