氟伏沙明与阿米替林治疗抑郁症的临床对照研究

The efficacy and tolerability of Fluvoxamine and Amitriptyline in treatment of patients with first-episode depression

目的:探讨氟伏沙明治疗抑郁症患者的有效性及安全性。方法:采用随机对照法将76例年龄18～49岁的抑郁症首发患者分为氟伏沙明组和阿米替林组,疗程均为6周,治疗第2、4、6周以汉密尔顿抑郁量表(HAMD,17项)评估疗效;记录不良反应及实验情况。结果:实际完成观察73例,其中氟伏沙明组39例,阿米替林组34例。治疗第2、4、6周末,氟伏沙明组有效率分别为17.94%、56.41%、79.48%,阿米替林组分别为14.70%、61.76%、76.47%,两组比较差异无显著性。治疗第2、4、6周末,氟伏沙明组、阿米替林组的HAMD总分较治疗前均明显下降(P<0.01),组间差异无显著性。氟伏沙明组患者出现药物不良反应16例(41.02%),阿米替林组26(76.47%),差异有统计学意义(χ2=9.3403,P<0.01)。结论:氟伏沙明治疗抑郁症临床疗效同阿米替林相似,但不良反应发生率明显低于阿米替林。

Objective： To study the efficacy and tolerability of Fluvoxamine in treating the patients with depression.Methods： A random study was conducted in 76 depressive patients aged from 18 to 49 years old. The patients were assigned to receive Fluvoxamine or Amitriptyline treatment for 6 weeks. The efficacy was evaluated with the Hamilton Rating Scale for depression （HAMD）, and the side - effects and laboratory test data were recorded as well. Results： 73 cases finished the study, 39 cases were in Fluvoxamine group and 34 cases were in Amitriptyline group. At the end of week2,4 and 6, the effective rate in Fluvoxamine group were 17.94%, 56.41%, 79.48% respectively, and the effective rate in Amitriptyline group were 14.70% ,61.76% ,76.47% respectively, there were not significant differences between two group. At the end of week 2,4 and 6, HAMD score were significantly reduced in Fluvoxamine group and in Amitriptyhne group. But there were not significant differences between two groups. Adverse drug reaction cases in Fluvoxamine group were 16, and that in Amitriptyline group were 26. There was significant difference between two groups（x^2 = 9. 3403, P 〈 0.01 ）. Conclusion： The efficacy of Fluvoxamine in treating the patients with depression was similar with that of Amitriptyline, but the ineidenee rate of adverse drug reaction in Fluvoxamine group was significant lower than that in Amitriptyline group.