国产与进口帕罗西汀治疗抑郁症的疗效及安全性

目的评价国产与进口帕罗西汀治疗抑郁症的临床疗效及安全性。方法随机选择门诊、住院抑郁症病人138例，分为试验组69例，男性28例，女性41例，年龄（42.50±12.43）岁（21-66岁），病程0.04-3.5a。对照组69例，男性30例，女性39例，病程0.04-4a。年龄（42.25±11.38）岁（17-63岁）。2组分别口服国产及进口帕罗西汀20-40mg／d，治疗12周。疗效评定采用汉米斯顿抑郁量表（HAMD）和临床总体印象量表（CGI），安全性评价应用不良反应量表（TESS）。结果试验组痊愈率为70％，有效率为86％，对照组痊愈率为74％，有效率为90％，2组间疗效差异无统计学意义（P〉0.05）。试验组和对照组不良反应发生率分别为32％和28％，2组的不良反应轻微，安全性好，常见的有恶心、头痛、出汗、失眠，嗜睡。结论国产帕罗西汀的抗抑郁作用疗效肯定.使用安wg ,与进口帕罗西汀疗效相似。

Effect and Safety of Domestic and Imported Paroxetine in Treatment of Depression

[Objective] To evaluate clinical effect and safety of domestic and imported Paroxetine [Methods] 138 patients with depression were randomly divided into test group with 69 cases （ Male 28, Female 41, age 42.50±12.43 years and 21-66 years）, and controlled group with 69 cases （Male 30, Female 39, age 42.25±11.38 years and 17-63 years, course 0.04-4 years ）. The 2 groups were administered domestic and imported Paroxetine orally and respectively with the course for 12 weeks. HAMD and CGI were adopted to evaluate the efficacy, safety was evaluated by TESS. [Results] The cure rates and effective rates of test and controlled group were 70% and 86%, 74% and 90% respectively, the clinical effect of the two groups showed no significant difference （ P 〉 0. 05 ）. The adverse reaction rates in the test and controlled were 32% and 28% respectively. No severe adverse reaction were found. The most common adverse reactions with Paroxetine were nausea, headache, sweating, insomnia, and somnolence. [Conclusion] Domesticparoxetine is as effective and safe as imported one in the treatment of depression.