舒郁胶囊治疗血管性抑郁患者随机双盲对照临床研究

A Clinical Study on A Randomized,Double-blind Controlled of ShuYu Capsule in Patients with Vascular Depresion

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(P<0.05);同时也能降低治疗组治疗8 周后NDS评分及血LDL-C水平(P<0.05),但对对照组NDS评分及血LDL-C水平改善不明显(P>0.05)。对两组治疗总有效率比较差异无统计学意义(P>0.05)。 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。

Abstract:

Objective: To evaluate the effectiveness of ShuYu Capsule in patients with vascular depresion (VD). Method: 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 (P<0.05) between two groups; Can reduce the NDS grading and blood LDL-C level (P<0.05) after 8 w in treatment group,But NDS grade and the blood LDL-C level can not be improved obviously (P>0.05) in control group. Have not statistics significantly (P>0.05) in the always efficient comparative difference between two groups of treatment. Conclusion: ShuYu Capsule has better clinical effect in vascular depresion,equal effect to Fluoxetine capsule.