文拉法辛缓释片与缓释胶囊治疗抑郁症的随机、双盲、对照研究

A randomized double-blind controlled clinical trail of venlafaxine sustained release tablets vs.sustained-release capsules in treatment of major depression disorder

目的比较文拉法辛缓释片和缓释胶囊治疗抑郁症的有效性和安全性。方法以文拉法辛缓释胶囊为阳性对照,采用随机、双盲双模拟、对照研究。抑郁症患者74例随机分成缓释片组(n=38)和缓释胶囊组(n=36),所有患者入组后的前4 d每日早餐后顿服1片(粒)文拉法辛(75 mg)和模拟药,第5日开始顿服2片(粒)文拉法辛(150 mg)和模拟药。分别在基线期和治疗第1、2、3、4、6、8周末对患者进行汉密尔顿抑郁量表17项(HAMD-17)、疼痛视觉模拟评分自评量表评估。以首次出现HAMD-17减分率大于50%为观察终点绘制生存曲线,比较两组在首次起效时间上的差异。结果文拉法辛缓释片组和缓释胶囊组各有27例和26例完成8周随访。缓释片组的有效率为71%,痊愈率为66%;缓释胶囊组有效率为67%,痊愈率为61%,两组间无显著差异(P>0.05)。两组间首次起效时间、对疼痛的有效率均无显著差异(P>0.05)。缓释片组不良事件发生率为29%,缓释胶囊组为39%,组间无显著差异(P>0.05)。结论文拉法辛缓释片对抑郁症状及伴发疼痛的总体疗效及安全性均与缓释胶囊相当。

AIM To compare the efficiency and safety of venlafaxine sustained- release tablets with sustained- release capsules in treatment of major depression disorder. METHODS The study was a double- blinded randomized controlled trial using venlafaxine sustained-release capsules as a positive control. Totally 74 depression patients were enrolled and divided into sustained- release tablets group （n = 38） and sustainedrelease capsules group （n = 36）. All patients were given one tablet （capsule） of venlafaxine （75 mg） or placebo after breakfast in the first 4 days. From the 5 th day, the dosage were increased to 2 tablets （capsules） in both groups and lasted until the end of 8 th week. Hamilton＇ s depression scale- 17 （HAMD- 17） and pain visual analogue scale self-rating scale were tested at baseline time and week 1, 2, 3, 4, 6, 8 of the treatment. The initial appearance of reduction rate of HAMD- 17 〉 50% was taken as end point to make survival curves, then the differences of acting times between the two groups were analyzed. RESULTS There were 27 and 26 patients finished the 8- week treatment in venlafaxine ustained- release tablets group and sustained- release capsules group, respectively. The response rate and cure rate of the ustained-release tablets group was 71% and 66% respectively, and that of the sustained-release capsules group was 67% and 61% respectively, with no significant differences between the two groups （P 〉 0.05）. There were no significant differences in the acting time and the response rate of pain between the two groups （P 〉 0.05）. The adverse event rate in the venlafaxine sustained- release tablets group and sustained- release capsules group was 29% and 39% respectively, with no significant difference between the two groups （P 〉 0.05）. CONCLUSION The general effectiveness on depression symptoms and accompanied pain symptoms of venlafaxine sustained-release tablets were equal to those of venlafaxine sustained-release capsules, and the same as their safety.