文拉法辛缓释剂治疗抑郁症伴发焦虑的临床疗效  

Clinical study of venlafaxine extended release capsule in treatment of depression associated with anxiety

作　　者：姚军[1] 吴文源[1] 

机构地区：[1]同济大学附属同济医院心身科,上海200065

出　　处：《内科理论与实践》2011年第3期192-195,共4页Journal of Internal Medicine Concepts & Practice

基　　金：文拉法辛缓释剂中国注册试验(方案号:PRC-VENXR001)

摘　　要：目的:评价文拉法辛缓释剂治疗抑郁症伴发焦虑的有效性及安全性。方法:采用随机、双盲、双模拟、平行对照、多中心临床研究的方法。入组汉密尔顿抑郁(HAMD)量表17项≥18分且汉密尔顿焦虑(HAMA)量表≥14分的抑郁症伴发焦虑患者共111例,分为试验组60例和对照组51例。试验组每天服用文拉法辛75 mg,对照组每天服氟西汀20 mg。治疗时间为6周,在基线及治疗1、2、4、6周时评定HAMA、HAMD量表。安全性评价应用治疗不良反应量表(TESS)、实验室检查及体检。结果:经过6周治疗,文拉法辛组抑郁症伴发焦虑的临床痊愈率为35%,有效率为82%。氟西汀组的临床痊愈率为31%,有效率为73%,P>0.05。文拉法辛组起效作用较快。文拉法辛组不良反应轻,安全性好;常见不良反应有恶心、呕吐、口干及出汗等。结论:文拉法辛缓释剂治疗抑郁症伴发焦虑的作用有一定的优势;患者对药物的耐受性好。Objective To evaluate the efficacy and safety of venlafaxine extended release capsule in the treatment of depression associated with anxiety.Methods A randomized,double-blind,and double-dummy clinical trial was performed to compare the efficacy and safety of venlafaxine extended release capsule with fluoxetine as the control.One hundred and eleven depression patients associated with anxiety [Hamilton rating scale for depression（HAMD） ≥18 and Hamilton anxiety scale（HAMA） ≥14] were enrolled,60 patients was randomized to study group and 51 patients to control group.Patients in study group were given venlafaxine extended release capsule 75 mg/d,and fluoxetine 20 mg/d was given to patients in control group.The treatment duration was 6 week.HAMA and HAMD were measured at baseline and week 1,2,4 and 6 of study.Safety was assayed by treatment emergent symptom scale（TESS） and laboratory and physical examinations.Results After 6 weeks treatment,the clinical cure rate of depression associated with anxiety in venlafaxine group was 35% and the response rate was 82%,and the clinical cure rate and response rate of fluoxetine group were 31% and 73%,respectively（P0.05）.However,venlafaxine had a more rapid onset of action.The adverse effect of venlafaxine was mild.Conclusions Venlafaxine extended release capsule is an effective and safe medicine for the treatment of depression associated with anxiety,and venlafaxine has a more rapid onset of action.

关 键 词：文拉法辛 氟西汀 抑郁症伴发焦虑 有效性 

分 类 号：R749.4[医药卫生—神经病学与精神病学] R749.7[医药卫生—临床医学]