太子神悦胶囊治疗轻中度抑郁症的疗效和安全性  

Efficacy and safety of Taizi Shenyue Capsules in the treatment of mild to moderate depression

作　　者：徐保彦[1,2] 刘远新 殷晓莉[4] 赵靖平[1] 伍海姗[1] 张克让[5] 肖卫东[6] 侯冬芬[7] 刘盈[8] 李成功 李乐华[1] XU Bao-yann;LIU Yuan-xin;YIN Xiao-li;ZHAO Jing-ping;WU Hai-shan;ZHANC Ke-rang;XIAO Wei-dong;HOU Dong-fen;LIU Ying;LI Cheng-gong;LI Le-hua(Mental Heath Institute,The Second Xiangya Hospital,Central South University,Changsha 410011,China;Hebei Provincial Mental Health Center,Baoding 071000,China;Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine,Urumqi 830000,China;The Second Hospital Affiliated to Liaoning University of Traditional Chinese Medicine,Shenyang 110034,China;The First Affiliated Hospital of Shanxi Medical University,Taiyuan 030000,China;People's Hospital of Wuhan University,Wuhan 430060,China;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300150,China;The First Hospital of China Medical University,Shenyang 110000,China;Xinjiang Huachun Biopharmaceutical Co.,Ltd.,Urumqi 830000,China)

机构地区：[1]中南大学湘雅二医院精神卫生研究所,长沙410011 [2]河北省精神卫生中心,保定071000 [3]新疆维吾尔自治区中医医院,乌鲁木齐830000 [4]辽宁中医药大学附属第二医院,沈阳110034 [5]山西医科大学第一医院,太原030000 [6]武汉大学人民医院,武汉430060 [7]天津中医药大学第二附属医院,天津300150 [8]中国医科大学附属第一医院,沈阳110000 [9]新疆华春生物药业股份有限公司,乌鲁木齐830000

出　　处：《中国新药杂志》2024年第8期792-797,共6页Chinese Journal of New Drugs

摘　　要：目的:评价太子神悦胶囊治疗轻中度抑郁症的疗效和安全性。方法:将研究对象随机分为试验组、阳性药组和安慰剂组,疗程为8周。以治疗终点的汉密尔顿抑郁17项(Hamilton Depression Scale-17 items,HAMD-17)量表减分值作为主要疗效评价指标,在基线、给药后1,2,4,8周末进行评价;安全性评价指标包括实验室检查、心电图检查、生命体征及不良事件发生率。结果:纳入符合标准的抑郁症患者601例。治疗终点3组间减分值比较差异有统计学意义(P<0.0001),试验组优于安慰剂组(P<0.0001),试验组非劣于阳性药组(P=0.7354>0.05),尚不能认为试验组优于阳性药组。治疗期不良事件发生率分别为9.27%,15.97%,10.83%,组间差异无统计学意义(P>0.05)。结论:太子神悦胶囊治疗轻中度抑郁症安全有效。Objective:To evaluate the efficacy and safety of Taizi Shenyue Capsules in the treatment of mild to moderate depression.Methods:The study subjects were randomly divided into experimental group,positive drug group,and placebo group,with a treatment period of 8 weeks.Evaluation was conducted after 0,1,2,4,8 weeks of treatment with the Hamilton Depression Scale-17 items(HAMD-17)scale score reduction as the main efficacy evaluation indicators,and the safety evaluation indicators included laboratory examination,electrocardiogram examination,vital signs,and incidence of adverse events.Results:Totally 601 depression patients met the inclusion criteria.At the treatment endpoint,there was a statistically significant difference in the reduction score between the three groups(P<0.0001).The experimental group was superior to the placebo group(P<0.0001),while the experimental group was not inferior to the positive drug group(P=0.7354>0.05).It cannot be considered that the experimental group was superior to the positive drug group.The incidences of adverse events during the treatment period were 9.27%,15.97%,and 10.83%,respectively(P>0.05).Conclusion:Taizi Shenyue Capsules is safe and effective in treating mild to moderate depression.

关 键 词：轻中度抑郁症 太子神悦胶囊 中医药疗法 安全性 

分 类 号：R971.4[医药卫生—药品] R969.3[医药卫生—药学]