摘要
目的评价安非他酮治疗抑郁症的疗效和安全性。方法采用随机、双盲双模拟、氟西汀平行对照、剂量固定的多中心研究。采用汉密尔顿抑郁量表(HAMD)17项总分减分值作为主要疗效指标,采用副反应量表(TESS)、实验室检查、心电图、生命体征和体格检查等观察药物的安全性。结果共收集意向性治疗(ITT)抑郁症患者228例,符合方案患者(PP)208例。根据PP样本,治疗6周后,安非他酮组和氟西汀组HAMD17总分减分值分别为(14.27±6.21)分及(14.86±6.09)分,与基线相比均具有显著性差异(P<0.01),但组间无显著性差异(P>0.05);安非他酮组在有效率、临床治愈率及CGI、HAMA评分上与氟西汀组比较均无显著性差异(P>0.05);ITT结果与PP相似。两组不良反应的症状和发生率也无统计学差异(P>0.05)。结论盐酸安非他酮缓释片治疗抑郁症的疗效、安全性以及治疗抑郁症伴焦虑的疗效均与盐酸氟西汀相似,是一种安全有效的抗抑郁药。
Objective To evaluate the efficacy and safety of bupropion hydrochloride tablet in the treatment of depression. Methods A randomized, double-blinded, double-dummy fluoxetine controlled, multicenter clinical trial was conducted. The primary efficacy indicator was the decreased score of Hamilton Depression （HAMD） Rating Scale 17; treatment emergent symptom scale, laboratory examinations, ECG, vital signs and physical examinations were used to evaluate safety of the medicine. Results Totally 228 treated patients were enrolled in this trial. Among them, the per protocol （PP） sample was 208 patients. Based on the PP sample, the HAMD 17 decreased score of bupropion group was （14.27± 6.21） six weeks after treatment, while fluoxetine group was （14.86 ± 6.09）, and there were no significant differences between the two groups （P〉0.05）. Besides, there were no significant differences in response rate （P〉0.05）, remission rate （P〉0.05）, CGI and HAMA. Safety analysis showed no significant differences found in symptoms and frequency of side effects between the two groups. Conclusion Bupropion SR tablet is an effective and safe antidepressant. It has a similar effect and safety compared with fluoxetine in treatment of depression.
出处
《西安交通大学学报（医学版）》
CAS
CSCD
北大核心
2007年第5期533-536,543,共5页
Journal of Xi’an Jiaotong University（Medical Sciences）
