瑞波西汀治疗抑郁症的随机、双盲、平行对照、多中心临床试验  

A randomized,double blind,and parallel controlled multicenter clinical trial of reboxetine in treatment of depression

作　　者：毛佩贤[1] 蔡焯基[1] 张鸿艳[2] 李静[3] 谢世平[4] 许秀峰[5] 熊鹏[5] 周新腾[6] 姜斯博 石晓东[6] 

机构地区：[1]首都医科大学附属北京安定医院,北京100088 [2]北京大学精神卫生研究所,北京100083 [3]四川大学华西医院,四川成都610041 [4]南京脑科医院,江苏南京210029 [5]昆明医学院第一附属医院,云南昆明650032 [6]北京红林制药有限公司,北京100025

出　　处：《中国新药与临床杂志》2010年第7期490-494,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的评价瑞波西汀治疗成人抑郁症的疗效和安全性。方法采用随机、双盲、阳性药对照的多中心临床研究,240例抑郁症患者按照1:1的比例分为瑞波西汀组和氟西汀组。受试者d 1～3分别口服瑞波西汀4 mg·d^(-1)和氟西汀10 mg·d^(-1),从d 4开始2组每日剂量分别固定为8 mg和20 mg,直至试验结束,疗程共6 wk。在治疗1、2、4和6 wk末回访,分别以汉密尔顿抑郁量表17项(HAMD 17)、汉密尔顿焦虑量表(HAMA)、临床疗效总评量表-疗效总评(CGI-I)和临床疗效总评量表-严重程度(CGI-S)评价疗效;以不良反应观察以及试验结束时体格、生命体征、心电图检查和临床实验室检测进行安全性评价。结果本试验意向性分析集(ITT)235例:瑞波西汀组118例,氟西汀组117例;符合方案集(PP)218例:瑞波西汀组110例,氟西汀组108例;安全性分析集(SS)237例:瑞波西汀组120例,氟西汀组117例。在治疗1、2、4、6 wk末,2组HAMD 17评分减分和减分率均无显著差异(P>0.05);2组HAMA减分率在wk 1末有非常显著差异(P<0.01),在其他各时间点均无显著差异(P>0.05)。治疗6 wk末,2组以HAMD 17定义的有效率(减分率≥50%)和痊愈率(总分≤7)均无显著差异(P>0.05)。2组间不良反应发生率无显著差异(P>0.05),瑞波西汀组主要为头晕、口干、便秘和排尿困难,均在服药早期出现,且为轻度、一过性,停药后可缓解。结论瑞波西汀治疗抑郁症的疗效和安全性与氟西汀相当,在改善焦虑方面比氟西汀起效更快。AIM To evaluate the efficacy and safety of reboxetine in adult patients with depression. METHODS In this randomized, double blind, fluoxetine parallel controlled, muhicenter clinical trial, 240 patients were randomly divided into reboxetine group and iluoxetine group at the ratio of 1 ： 1. The daily dose of reboxetine and fluoxetine was 4 mg and 10 mg respectively in the first 3 days, and then from the 4th day the daily dose was 8 mg and 20 mg respectively. The treatment period was 6 weeks. At the end of wk 1, 2, 4, and 6, HAMD17, HAMA, CGI-I, and CGI-S were used to assess the therapeutic efficacy. Safety evaluation indicators included the adverse reactions, as well as physical, vital signs, electrocardiograph examination, and clinical laboratory tests at the baseline and the end of the trial or the premature cessation. RESULTS The patients of the reboxetine group and the fluoxetine group were 118 and 117 in the intent-to-treat set, 110 and 108 in the per-protocol set, and 120 and 117 in the safety analysis set. At the end ofwk 1, 2, 4, and 6, the HAMD17 scores and reduction rates had no significant difference between the two groups （P 〉 0.05）. The reduction rates of HAMA scores at the end of wk 1 had very significant difference between the two groups （P 〈 0.01）, with no difference at the other time points （P 〉 0.05）. At the end of wk 6, there was no significant difference in the effective （reduction rate of HAMD ≥ 50%） rates and cure （total HAMD score ≤ 7） rates between the two groups. The adverse reaction rates between the two groups had no significant difference （P 〉 0.05）. The main adverse reactions of reboxetine contained dizziness, dry mouth, constipation, and dysuria, but they all emerged in the early stage and were mild, transient, and could be alleviated when no drug administration. CONCLUSION Reboxetine have the same efficacy and safety as fluoxetine in treating depression, and reboxetine has a much more rapid onset than fluoxetine especially in improving anxiety.

关 键 词：瑞波西汀 氟西汀 抑郁症 多中心研究 随机对照试验 

分 类 号：R749.4[医药卫生—神经病学与精神病学] R969[医药卫生—临床医学]