【摘要】 目的:评价巴戟天寡糖胶囊治疗轻、中度抑郁症的疗效和安全性。方法:采用多中心、随机、双盲双模拟、盐酸氟西汀对照的研究方法。符合入选标准的受试者被随机分配到3个治疗组:巴戟天寡糖胶囊高剂量组(400 mg或800 mg.d-1),巴戟天寡糖胶囊低剂量组(300 mg或600 mg.d-1),盐酸氟西汀片对照组(20 mg或30 mg.d-1),疗程6周。结果:巴戟天寡糖胶囊高、低剂量组和盐酸氟西汀片对照组的有效率分别为:70.34%,66.38%,68.91%,治疗终点HAMD-17评分与基线减分差值分别为-11.6(4.6),-11.8(4.0)和-11.9(4.1),三组间比较差异无统计学意义(P=0.82),巴戟天寡糖胶囊高、低剂量组与盐酸氟西汀对照组的非劣效性检验合格(P<0.05)。不良事件发生率分别为:巴戟天寡糖胶囊高剂量组29.41%,低剂量组19.83%,对照组为24.17%,差异无统计学意义(P=0.22)。结论:巴戟天寡糖胶囊治疗轻、中度抑郁症患者的疗效与盐酸氟西汀片相当,不良反应轻微,可用于轻、中度抑郁症的治疗。更多还原

【Abstract】 Objectives: To evaluate the efficacy and safety of morinda officinalis oligose capsule in the treatment mild or moderate depressive disorder.Methods: In a randomized,double-blind,double-dummy,multicenter and fluoxetine controlled clinical trial,356 subjects were enrolled and randomly divided into 3 groups.The patients were treated with high-dose(n=119) and low-dose of morinda officinalis oligose capsule(n=119),or fluoxetine hydrochloride tablets(n=118,control).Results: The response rates were 70.34%(high-dose group),66.38%(low-dose group) and 68.91%(control group) respectively;no significant difference was found among 3 groups(F=0.197,P=0.82).At the end point,the scores of HAMD-17 decreased from baseline were 11.6(4.6),11.8(4.0) and 11.9(4.1),respectively.Non-inferiority test with the criterion of 15% was conducted on the efficacies of morinda officinalis oligose capsules and fluoxetine hydrochloride tablets,and the result showed non-inferiority of morinda officinalis oligose capsules(P<0.05).The incidences of adverse events were 29.41%(high-dose group),19.83%(low-dose group) and 24.17%(controlled group),respectively;there were no significant differences within groups(P=0.22).Conclusion: Morinda officinalis oligose capsule is effective,similar to fluoxetine hydrochloride tablets,and safe in the treatment of mild and moderate depressive episode.更多还原