盐酸文拉法辛缓释胶囊治疗青少年抑郁症对照研究

目的 评价盐酸文拉法辛缓释胶囊治疗抑郁症的疗效与安全性。方法 采用随机、双盲、双模拟、氟西汀平行对照研究。60 例青少年抑郁症患者随机分为盐酸文拉法辛缓释胶囊组30 例与氟西汀组30 例, 分别口服盐酸文拉法辛缓释胶囊150 mg d 或氟西汀20 mg d, 疗程8 周。以汉密尔顿抑郁量表(HAMD) 和临床疗效总评量表(CGI)为评估临床疗效的工具。结果 两组HAMD 评分在治疗结束时较基线均显著减少(P<0.01) ;盐酸文拉法辛缓释胶囊组与氟西汀组有效率分别为70.0 %与65.5 %, 差异无统计学意义(P >0.05)。取Λ=0.1, α=0.05 进行等效性检验, u =1.97, P<0.05。盐酸文拉法辛缓释胶囊组常见的不良反应为恶心、头痛、失眠和食欲减退, 发生率与氟西汀组差异无统计学意义(P >0.05)。结论 两组药物不良反应发生率无统计学差异, 盐酸文拉法辛缓释胶囊治疗青少年抑郁症和氟西汀一样有效。

A randomized and double-blind clinical trial of venlafaxine hydrochloride sustained release capsules for treating juvenile depression

AIM: To evaluate the efficacy and safety of venlafaxine hydrochloride (HCl) sustained release capsules in treating juvenile with depressive disorder. METHODS: A randomized, double blind and double dummy clinical trial enrolled 60 adolescent patients with depression, who were randomizedly designed to administer venlafaxine HCl sustained release capsules 150 mg or fluoxetine 20 mg daily for 8 weeks. The efficacies of both treatment groups was evaluated based on the Hamilton Depression Scale and Clinical General Impression Scale pre and post-treatment. RESULTS: The scores of Hamilton Depression Scale at the end of therapy were significantly reduced compared with the baseline in both groups(P<0.01). The effective rate of venlafaxine HCl sustained release capsules versus fluoxetine treatment was 70.0 % and 65.5 %, respectively, the P value showed no statistical difference(P >0.05). The common adverse reactions included dry mouth, insomnia, dizziness, and loss of appetite. CONCLUSION: Venlafaxine HCl sustained release capsules is an effective agent for juvenile with major depression.