金香疏肝片治疗抑郁症(肝郁脾虚证)的随机双盲双模拟多中心平行对照研究  

Clinical trail of Jinxiang Shugan tablet in depression patients with the syndrome of liver-depression and spleen-defi ciency

作　　者：张培智 

机构地区：[1]上海双基药业有限公司,上海201319

出　　处：《世界临床药物》2014年第7期399-403,416,共6页World Clinical Drug

基　　金：国家科技重大专项重大新药创制项目(2014zx09101021-002)

摘　　要：目的评价金香疏肝片治疗抑郁症(肝郁脾虚证)的有效性和安全性。方法采用随机双盲双模拟多中心平行对照研究。入选455例抑郁症患者,随机分为试验组(金香疏肝片,一日3.6 g)和对照组(盐酸氟西汀,一日10 mg),开展为期6周的治疗。采用总有效率、疗效指数、17项汉密尔顿抑郁量表(HAMD-17)、汉密尔顿焦虑量表(HAMA)和中医证候等评价疗效,以实验室相关检查和不良反应量表(TESS)评价安全性。结果试验组和对照组的总有效率为80.95%和78.57%,两组差异无统计学意义。试验组和对照组疗效指数分别为(2.70±1.11)和(2.31±1.25),试验组显著高于对照组(P<0.01)。对两组治疗前后HAMD-17、HAMA及两者的症状体征分级进行评分比较,差异显著(P<0.01)。试验组和对照组的中医证候总有效率分别为83.33%和81.25%,两组差异无统计学意义。试验组不良反应发生率、严重程度和痛苦程度均较对照组轻,组间差异显示(P<0.01);试验组和对照组不良事件发生率分别为1.47%和9.65%,试验组显著低于对照组(P<0.01)。结论金香疏肝片治疗抑郁症(肝郁脾虚证)安全有效,适合临床应用。Objective To evaluate the efficacy and safety of Jinxiang Shugan tablet in the treatment of depression patients with syndrome of liver-depression and spleen-deficiency. Methods A randomized, double-blinded, double-dummy, positive drug parallel controlled clinical trail was used. 455 patients were treated in six weeks. The test group was given Jinxiang Shugan tablet and the control group was given fiuoxetine hydrochloride. Effects were evaluated through the total effective rate, therapy index, Hamilton depression scale 17 item （HAMD-17）, Hamilton anxiety scale （HAMA） and TCM Syndrome. The safety was evaluated with the laboratory examination and treatment emergem symptoms scale （TESS）. Results The total effective rates of test group and control group were 80.95% and 78.57% respectively. There was no significant difference between two groups. The therapy index of test group was significantly higher than that of control group （2.70±1.11 vs 2.31 ±1.25）. Before and after treatment the comparison of two groups with HAMD-17 score, HAMA score, signs and symptoms HAMD/HAMA classification score showed a significant difference （P〈0.01）. The total effective rate of TCM syndromes of test group and control group were 83.33% and 81.25% without significant difference. In the test group the rate of adverse reactions, severity and pain were lower than those in the control group, and the adverse event in test group was milder than control group （P〈0.01）. The adverse reaction rate in test group was 1.47%, which was lower than in control group （9.65%）. Conclusion Jinxiang Shugan tablet is safer and effective for depression patients for clinical application.

关 键 词：金香疏肝片 抑郁症 肝郁脾虚证 

分 类 号：R971.43[医药卫生—药品] R749.41[医药卫生—药学]