巴戟天寡糖胶囊治疗轻、中度抑郁症的疗效和安全性

Efficacy and safety of morinda officinalis oligose capsule in the treatment of mild or moderate depression

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。

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 eondueted on the efficacies of morinda officinalis oligose capsules and fluoxetine hydrochloride tablets, and the result showed non- inferiority of morinda officinalis oligose eapsules （P 〈 0.05 ）. The ineidenees 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 eapsule is effeetive, similar to fluoxetinc hydrochloride tablets, and safe in the treatment of mild and moderate depressive episode.