舒郁胶囊治疗血管性抑郁患者随机双盲对照临床研究.doc

PAGE PAGE 3 基金项目:江苏省中医药局科技专项资助项目(No.HZ07031)； 江苏省连云港市科教兴卫125工程基金资助项目(No. ZC111.) 作者简介：李乐军，男，医学博士，副主任中医师，主要研究方向：中西医结合防治脑血管病。 联系电话：（0 邮箱： lilejjun999@163.com,传真：0518 舒郁胶囊治疗血管性抑郁患者随机双盲对照临床研究 李乐军1,2 邵凤扬1,2 肖辉1,2 刘晓丽1,2 周永媛1,2 许运堂1,2 1 江苏省连云港市中医院，江苏 连云港 222004 2 南京中医药大学连云港附属医院，江苏 连云港 222004 摘要：目的:观察舒郁胶囊对血管性抑郁(vascular depresion，VD）患者的临床疗效。方法: 对各组试验药进行盲法要求包装,采用随机、双盲、阳性平行对照法共观察60例VD患者。治疗组30例，服用舒郁胶囊，每次3粒，每日3次，同时服氟西汀胶囊安慰剂每次1粒，每日1次；对照组30例，服用氟西汀胶囊每次1粒，每日1次，同时服舒郁胶囊安慰剂每次3粒，每日3次, 连续治疗，两组总疗程均为8 周。于服药前、服药4 周、8 周后分别进行神经心理学量表评价和血脂检测分析。结果: 采用舒郁胶囊能降低治疗前后HAMD、MMSE、CGI评分，两组间比较HAMD、MMSE、CGI的评分差异有统计学意义(P0.05)；同时也能降低治疗组治疗8 周后NDS评分及血LDL-C水平(P0.05)，但对对照组NDS评分及血LDL-C水平改善不明显(P0.05)。对两组治疗总有效率比较差异无统计学意义(P0.05)。结论: 舒郁胶囊治疗血管性抑郁有较好临床疗效,与氟西汀胶囊治疗效果相当。 关键词:中草药制剂；血管性抑郁；随机对照试验；双盲法；中医药疗法 A clinical study on a randomized, double-blind controlled of ShuYu Capsule in patients with vascular depresion LI Le-jun, SHAO Fen-yang, XIAO Hui, et al. Department of cerebral vascular disease, Lianyungang Hospital of traditional Chinese medicine，lianyungang 222004, China Objective : To evaluate the effectiveness of ShuYu Capsule in patients with vascular depresion (VD). Methods: The investigational drugs were packed by blind method. A randomized , double-blind and controlled trial was conducted on sixty patients with VD. The sixty patients were randomly divided into treatment group (n =30), orally ShuYu Capsule 3# tid and Fluoxetine capsule placebo 20mg qd, for 8 wk.and control group ( n =30) , orally Fluoxetine capsule 20mg qd ,and ShuYu Capsule placebo 3# tid, for 8 wk. All subjects were assessed by HAMD, MMSE, CGI , NDS and Blood lipids. Result: ShuYu Capsule can be reduced the scores of HAMD, MMSE, CGI of Before and after treatment, The difference has statistics meaning (P0.05) between two groups ; Can reduce the NDS grading and blood LDL-C level (P0.05) after 8 w in treatment group,But NDS grade and the blood LDL-C level can not be improved obviously (P0.05) in control group