摘要
目的评价艾司西酞普兰治疗抑郁症的疗效和安全性。方法采用随机、双盲双模拟、西酞普兰平行对照、多中心研究。受试者随机分成2组,分别口服草酸艾司西酞普兰10～20 mg·d^(-1)或氢溴酸西酞普兰片20～40 mg·d^(-1)。采用17项汉密尔顿抑郁量表(HAMD-17)总分减分值作为主要疗效指标,以临床疗效总评量表(CGI)和汉密尔顿焦虑量表(HAMA)评分作为次要疗效指标;采用不良事件观察、实验室检查、生命体征观察等评价药物安全性。结果共收集全分析集(FAS)抑郁症患者235例,艾司西酞普兰组119例,西酞普兰组116例。符合方案集(PPS)患者218例,艾司西酞普兰组110例,西酞普兰组108例。2组治疗1、2、4、6 wk末HAMD-17、HAMA总分与基线相比均有非常显著差异(P<0.01),组间无显著差异(P>0.05)。治疗6 wk后FAS分析,艾司西酞普兰组HAMD-17总分减分值为(13.28±4.30),西酞普兰组为(13.67±5.29)。2组治疗有效率分别为79.8%和81.9%,临床痊愈率分别为66.4%和62.9%,组间均无显著差异(P>0.05);2组CGI、HAMA评分亦无组间差异(P>0.05)。2组不良反应的症状和发生率均无显著差异(P>0.05)。结论艾司西酞普兰治疗抑郁症与西酞普兰疗效相当,安全性相似。
AIM To evaluate the efficacy and safety of escitalopram in treating depression.METHODS In this randomized,double-blind,double-mimicry,citalopram parallel controlled multicenter study,the patients were randomized in two groups who were treated with escitalopram oxalate tablet 10-20 mg·d^（-1） or citalopram hydrobromide tablet 20 - 40 mg ？ d^（-1） respectively.The primary efficacy variable was Hamilton Depression Scale 17-item（HAMD-17） while Clinical Global Impression（CGI） and Hamilton Anxiety Scale （HAMA） were used as secondary variables.Adverse events observation,lab examination and vital signs check were taken to assess the safety.RESULTS In FAS（235 patients）,the amount of patients belonged to escitalopram group or citalopram group was 119 vs.116;in PPS（218 patients）,110 vs.108.At the end of wk 1,2,4 and 6 in treatment,there were statistically significant reductions in HAMD-17 or HAMA total scores in both groups compared with their baseline（P0.01）,however,there was no significant difference between the two groups（P0.05）.After 6 weeks treatment,the reduction in HAMD-17 total score of escitalopram group was（13.28±4.30）,while the reduction of citalopram group was（13.67±5.29） by FAS analysis. For escitalopram group and citalopram group,the response rate was 79.8%and 81.9%,the remission rate was 66.4%and 62.9%,respectively,with no significant difference between the two groups（both P0.05）. Similar findings were found in CGI and HAMA（P0.05）.Safety assessment showed there was no statistically significant difference between the symptoms and incidence of adverse reactions（P0.05）. CONCLUSION Escitalopram is effective,safe and comparable to citalopram in treatment of patients with depression.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2011年第12期901-906,共6页
Chinese Journal of New Drugs and Clinical Remedies
基金
"重大新药创制"科技重大专项--精神药物新药临床评价研究技术平台(2008ZX09312-003)
关键词
艾司西酞普兰
西酞普兰
抑郁
治疗结果
安全
随机对照试验
多中心研究
escitalopram
citalopram
depression
treatment outcome
safety
randomized controlled trials
multicenter study
