氟西汀肠溶片与氟西汀片对抑郁症巩固期患者疗效的双盲对照研究

Fluoxetine enteric tablet versus fluoxetine in continuation treatment of major depressive disorder:a multicentre randomized double-blind controlled study

目的评价氟西汀肠溶片对抑郁症缓解期患者的疗效及安全性。方法采用随机、双盲、活性药对照、多中心临床研究方法。按1:1将232例受试者随机分配到氟西汀肠溶片组(116例)或氟西汀片组(116例)。氟西汀肠溶片组药物剂量为90 mg/周,氟西汀片组20 mg/d,观察疗程均为12周。疗效评价工具为汉密尔顿抑郁量表和临床疗效总评量表。结果治疗第12周末,氟西汀肠溶片组与氟西汀片组的疗效相当。氟西汀肠溶片组(115例)和氟西汀片组(116例)的复燃率均为0.9%;稳定率分别为90.4%和89.7%;总不良事件发生率分别为20.9%和20.7%,相关不良事件的发生率分别为8.7%和12.1%;差异均无统计学意义(P>0.05)。较常见的不良反应均为口干、恶心、焦虑及嗜睡。结论氟西汀肠溶片对抑郁症缓解期患者有效,其疗效及安全性与氟西汀片相当。

Objective To evaluate the efficacy and safety of fluoxetine enteric tablet in the continuation treatment of major depressive disorder. Methods A randomized, double-blind, controlled multicentre clinical trial was conducted. All subjects （ n = 232） were randomized to receive either fluoxetine enteric tablet （n = 116） or fluoxetine （n = 116） for 12 weeks. The dosages were 90 mg weekly and 20 mg daily respectively. Results The fluoxetine enteric tablet showed equivalent therapeutic effect compared to fluoxetine. Only one patient in each group had symptom fluctuation. The relapse rate （0. 9% ） was same in both groups, and the stable rates were similar （90. 4% vs. 89.7% , P〉0. 05）. The total rates of adverse events were 20. 9% and 20.7% in both groups （ P 〉 0. 05 ）. The common adverse events included dry mouth, nausea, anxiety and somnolence. Conclusion The results show that fluoxetine enteric tablet have similar therapeutic effect and safety to fluoxetine in continuation treatment of major depressive disorder, with more convenient usage.