盐酸奈法唑酮片治疗抑郁症的临床试验  

A randomized, double blind and positive control clinical trial of nefazodone for the treatment of depression

作　　者：陈晋东[1] 国效峰[1] 李乐华[1] 罗琼[1] 薛志敏[1] 赵靖平[1] 陈远光[1] 

机构地区：[1]中南大学湘雅二院精神卫生研究所,长沙410011

出　　处：《中国新药杂志》2006年第6期464-466,共3页Chinese Journal of New Drugs

摘　　要：目的:评价国产盐酸奈法唑酮片治疗抑郁症的有效性和安全性。方法:随机、双盲、双模拟、阳性药平行对照、剂量可调整研究。48例抑郁症患者随机分为奈法唑酮组24例与氟西汀组24例,分别口服盐酸奈法唑酮片200～500 mg·d-1或氟西汀10～40 mg·d-1,疗程42 d。结果:治疗14 d起两组汉密尔顿抑郁量表(HAMD)评分较基线均显菩减少(P<0．01);奈法唑酮组与氟西汀组有效率分别为85．7％与83．3％,差异无显著性(P>0．05)。奈法唑酮常见的不良反应为恶心呕吐、头昏、头痛,发生率与氟西汀相当。结论:盐酸奈法唑酮治疗抑郁症安全、有效。Objective：To evaluate the efficacy and safety of nefazodone 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 nefazodone 300 mg or fluoxetine 20 mg daily for 42 days. The efficacy of both treatment groups was evaluated based on HAMD, CGI and clinical general impression scale pre- and post-treatment. Results：Compared to the baseline scores, patients （P〈0. experienced significant improvements in the Hamilton Depression Scale at the end of the therapy 05）. The efficacy rate in both treatment groups was 85.7% and 83.3% , 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 （ P 〉 0. 05）. Conclusion ： made in China offers an effective and safe option in the treatment of depression.

关 键 词：奈法唑酮 氟西汀 抑郁症 汉密尔顿抑郁量表(HAMD) 

分 类 号：R969.4[医药卫生—药理学] R749.42[医药卫生—药学]