【摘要】 目的:评价金玉康胶囊治疗轻中度抑郁症的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、活性药物平行对照设计。入选293例轻中度抑郁症患者,随机分为试验组145例和对照组148例,分别口服金玉康胶囊600 mg·d-1或盐酸氟西汀片20 mg·d-1,疗程均为6周。疗效观察指标包括基线以及治疗不同阶段的17项汉密尔顿抑郁量表(Hamilton rating scale for depression,HAMD17)、汉密尔顿焦虑量表(Hamilton rating scale for anxiety,HAMA)、临床总体印象量表(Clinical Global Impression scale,CGI)评分,以HAMD17作为主要疗效指标。结果:治疗结束时,两组的HAMD17总分与基线相比均明显降低,但两组间差异无显著性;两组的HAMD减分率接近,分别为55．77％和59．95％;以HAMD17减分率判断有效率,两组间差异也无显著性。两组的不良反应发生频率相当;体重在治疗结束时金玉康组较基线有所增加而氟西汀组没有明显变化,组间比较差异有统计学意义(F=5．014,P=0．026)。结论:金玉康胶囊治疗轻中度抑郁症安全、有效。更多还原

【Abstract】 Objective: To assess the efficacy and safety of Jinyukang capsules versus fluoxetine in patients with mild and moderate major depression. Methods: A multicenter, randomized double blind, double dummy, positive-control clinical study recruited 293 subjects with mild and moderate depression. Subjects were randomized to receive 600 mg·d-1 Jinyukang capsules made from Hypericum extract (n = 145) or 20 mg fluoxetine (n = 148) for six weeks. The primary endpoint was to measure improvements of Hamilton rating scale for depression (HAMD17). The secondary endpoints included Hamilton rating scale for anxiety (HAMA) and clinical global impression scale (CGI). Results: At the end of therapy, subjects treated with Hypericum extract and fluoxetine all experienced significant decreases of HAMD 17 from the baseline, scoring 55. 77% and 59. 95% , respectively (P > 0. 05). The major adverse event for Hypericum-treated subjects was weight gain; the P value for such weight gain showed statistical difference (P = 0. 026). Conclusion: The Jinyukang capsules provided a therapeutic option for subjects with mild and moderate depression.更多还原