两种帕罗西汀(乐友与赛乐特)治疗抑郁症疗效及安全性

A comparative study of domestic and imported proucts of paroxetine on efficacy and safety in patients with major depression

目的比较国产帕罗西汀(乐友)与进口帕罗西汀(赛乐特)治疗抑郁症的临床疗效及安全性。方法研究采用随机、双盲、活性药物(赛乐特)对照的方法,多中心入组,治疗周期为8周。共完成临床观察210例(乐友组106例、赛乐特组104例)。采用汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)评定疗效,以生命体征、实验室检查、ECG的改变和不良事件的发生率评价安全性。结果两组HAMD、HAMA评分治疗后均有明显下降,乐友组有效率为81．1％,赛乐特组有效率为80． 7％,两组间疗效无显著差异。乐友组不良事件发生率为32．1％,赛乐特组为36．5％,两组无显著性差异。结论乐友治疗抑郁症安全有效,与赛乐特比较无显著性差异。

Objective： To compare the clinical efficacy and safety of domestic paroxetine（Leyou） in the treatment on major depression with seroxat . Methods： A 8 -week double -blind multicentre study compared Leyou（20mg/d, n = 106）with seroxat（20mg/d, n = 104） in 210 patients with major depression. To assess the efficacy and safety by using Hamilton rating scale for depression and anxiety （HAMD and HAMA ）, biochemical index, electrocardiogram and the rate of adverse events. Results： 1 ） The Leyou group ： the scroes of the HAMD and HAMA after treatment （5.9 ± 5.0; 4.9 ± 4.3 ） were significantly lower than the baseline （26. 4±6.8; 24.2±8.1） （P〈0.001）, the rate the HAMD of score decreasing that was over 50% was 81.1% ; the seroxat group： the scroes of HAMD and HAMA after treatment （5.7 ± 5.4; 5.0 ± 5.3 ） were significantly lower than the baseline （26.4 ± 6.3; 24.1 ± 8.2） （P 〈 0. 001 ）, the rate the HAMD of score decreasing that was over 50% was 80.7%. 2） After 8 - week treated, there was no significant difference on the rate of adverse events between the two groups （P 〉 0.05 ）. Conclusion：The Leyou would effectively improve the symptoms of the patients with major depression; moreover, there were no significant difference on efficacy and safety between the Leyou and seroxat.