摘要
目的:评价解郁胶囊治疗轻、中度抑郁症的疗效和安全性,探索适宜治疗剂量。方法:采用多中心、随机、双盲双模拟、阳性药和安慰剂平行对照的研究方法。共入组轻、中度抑郁症患者433例,高剂量组108例,低剂量组109例,安慰剂对照组107例,阳性药对照组109例,疗程均为6周。用汉密尔顿抑郁量表17项(HAMD17)、中医症候量化评分作为疗效评价指标。结果:治疗6周后,4组患者HAMD17项总分的减分值分别为(8.95±4.97),(8.06±4.78),(6.09±6.02)和(7.38±4.58)(P=0.000 7)。基于中医症候量化评分,高剂量组疗效最好(P=0.036)。4组不良事件发生率无显著性差异。结论:解郁胶囊治疗轻中度抑郁症安全有效。
Objective: To evaluate the efficacy and safety of Jieyu capsule in the treatment of mild and moderate depression,and explore the suitable dose. Methods: In a randomized,double-blind,double simulationcontrolled and multicenter trial,433 patients with mild or moderate depression were recruited. They were treated with Jieyu capsules in high dose group( n = 108) and low dose group( n = 109),placebo group( n = 107),or positive drug control group( n = 109) for 6 weeks. The efficacy was evaluated by Hamilton Depression Scale 17item( HAMD17) and symptom of traditional Chinese medicine( STCM). Results: Compared with baseline,the decreases of HAMD 17 were 8. 95 ± 4. 97( high dose of Jieyu capsule),8. 06 ± 4. 78( low dose of Jieyu capsule),6. 09 ± 6. 02( placebo capsules) and 7. 38 ± 4. 58( positive drug control group),respectively( P = 0. 000 7). The efficacy of high dose Jieyu capsule was the best based on STCM( P = 0. 036). The incidences of adverse events were not significantly different among the 4 groups. Conclusion: Jieyu capsule is an effective and safe antidepressant.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第14期1622-1625,共4页
Chinese Journal of New Drugs
关键词
解郁胶囊
抑郁症
中医症候
疗效
安全性
Jieyu capsule
depression
syndrome of traditional Chinese medicine
efficacy
safety