文拉法辛缓释剂治疗抑郁症的双盲、随机、平行对照、多中心临床研究

目的 :比较文拉法辛缓释剂与氟西汀治疗抑郁症的疗效及安全性。方法 :文拉法辛缓释剂组(文拉法辛组 ) 6 4例 ,年龄为 4 1a±s 13a ,氟西汀组6 3例 ,年龄为 4 2a± 12a。按双盲双模拟法文拉法辛组用量 75m·d- 1,qd或氟西汀组用量 2 0mg·d- 1,qd。共 6wk。疗效评定采用HAMD ,HAMA及CGI。安全性评价应用TESS、实验室检查及体检。结果 :经过 6wk治疗 ,文拉法辛组痊愈率 6 9% ,有效率为 83%。氟西汀组的痊愈率 5 9% ,有效率为 71% ,P >0 .0 5。另外 ,文拉法辛组的抗抑郁作用起效较快 ,对伴随的焦虑症状也有较好疗效。文拉法辛组不良反应轻 ,安全性好 ;常见不良反应有 :恶心、呕吐、口干及出汗等。结论 :文拉法辛缓释剂是一种安全而有效的抗抑郁药 ,病人对药物的耐受性及依从性好

Extended release venlafaxine in treatment of major depression: a double-blind, randomized, and controlled multicentre study

AIM:To compare the efficacy and adverse reaction of venlafaxine extended release(XR) versus fluoxetine in the treatment of major depression METHODS: Sixty four patients(age 41 a± s 13 a) were enrolled in venlafaxine group and 63 patients(age 42 a±12 a) in fluoxetine group. Patients randomized to venlafaxine group received 75 mg·d -1 ,qd and those to fluoxetine group 20 mg·d -1 ,qd respectively. The duration of treatment was 6 wk. HAMD, HAMA and CGI were adopted to evaluate the efficacy. Safety was evaluated by TESS, laboratory and physical examination. RESULTS: After 6 wk treatment, the results based on the reduction rate of HAMD showed venlafaxine group was effective on depression, the remission rate was 69 %, the response rate was 83 %. The remission rate and the response rate of fluoxetine group was 59 % and 71 % respectively. There were no significant differences between the two groups( P > 0.05 ). On the other hand, venlafaxine group had effect on anxiety symptom. The adverse reactions of venlafaxine were mild. CONCLUSION: Venlafaxine XR is an effective and safe antidepressant. The tolerance and compliance are good.