巴戟天寡糖胶囊治疗抑郁症的临床疗效与安全性  

Efficacy and safety of Morinda officinalis oligose capsule in the treatment of depression

作　　者：孔庆梅[1] 舒良[1] 张鸿燕[1] 焦富英[2] 韩祖成[3] 王健[4] 杜波[5] 师建国[6] 王晓萍[7] 艾长山[8] 高成阁[9] 李玲芝[1] 黄兰[1] 

机构地区：[1]北京大学第六医院,北京100191 [2]辽宁中医药大学附属第二医院,沈阳110034 [3]陕西省中医药研究院附属医院,西安710003 [4]辽宁中医药大学附属医院,沈阳110032 [5]河北省精神卫生中心,河北保定071000 [6]西安市精神卫生中心,西安710061 [7]武汉大学人民医院,武汉430060 [8]吉林省中西医结合医院,长春130021 [9]西安交通大学附属第一医院,西安710061

出　　处：《中国临床药理学杂志》2011年第3期170-173,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价巴戟天寡糖胶囊(抗抑郁症中药)治疗抑郁症的疗效与安全性。方法用区组随机、双盲双模拟、安慰剂与阳性药平行对照、多中心临床试验方法,受试者被随机分到3组:巴戟天寡糖胶囊试验组(300 or 600 mg.d-1)、盐酸氟西汀片对照组(20 or 30 mg.d-1)及安慰剂组,疗程6周。结果用药6周末,HAMD-17评分与基线差值,巴戟天寡糖胶囊试验组、盐酸氟西汀片对照组、安慰剂组分别为-(13.03±5.43),-(13.86±5.24),-(8.27±4.76),差异有统计学意义(P=0.0000);HAMA与基线差值,3组分别为-(8.87±5.29),-(11.10±5.90),-(6.31±6.07),差异有统计学意义(P=0.0000)。3组有效率分别为71.23%,72.65%,36.97%,差异有统计学意义(P<0.01)。试验组与对照组率差统计学意义(P<0.05)。中医证候疗效,3组有效率分别为72.93%,59.83%,37.82%,试验组与对照组均优于安慰剂组,差异有显著统计学意义(P<0.01)。不良反应发生率3组分别为17.49%,22.76%,21.14%,差异无统计学意义(P>0.05)。结论巴戟天寡糖胶囊治疗抑郁症的疗效优于氟西汀;对抑郁伴发的焦虑也有效;不良反应轻微,安全性好。Objective To evaluate the efficacy and safety of Morinda officinalis oligose capsule in the treatment of depressive disorder.Methods In a randomized,double blind,double-dummy,multicenter clinical trial,subjects were enrolled and randomly divided into 3 groups.The patients were treated with Morinda officinalis oligose capsule,or fluoxetine hydrochloride tablets or placebol for six weeks.Results At the end point,the scores of HAMD-17 decreased in three groups（trial,control,placebo） from baseline were-（13.03±5.43）,-（13.86±5.24）,-（8.27±4.76） respectively（P=0.0000）.The response rates in three groups were 71.23%,72.65%,36.97% respectively（P0.01）.Non-inferiority test with the criterion of 15% was conducted on the efficacy of Morinda officinalis oligose capsules and fluoxetine hydrochloride tablets,and non-inferiority of Morinda officinalis oligose capsules was showed（P0.05）.The response rates evaluated by traditional Chinese medical scale in three groups were 72.93%,59.83%,37.82% respectively（P0.01）.The incidences of adverse events in three groups were 17.49%,22.76%,21.14% respectively（P=0.3699）.Conclusion Morinda officinalis oligose capsule is effective,similar to fluoxetine hydrochloride tablets on depressive disorder,and is superior than the latter on treatment of traditional Chinese medical symptoms.The drug is safe.

关 键 词：巴戟天寡糖胶囊 盐酸氟西汀 抑郁症 

分 类 号：R749.41[医药卫生—神经病学与精神病学] R971.43[医药卫生—临床医学]