盐酸安非他酮片与氟西汀治疗抑郁症多中心临床研究

Study of Bupropion Hydrochloride Tablet and Fluoxetine in Treatment of Depression Multicenter Clinical Trial

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。受试者分别口服安非他酮普通片300mg/d或氟西汀片20mg/d,共观察6周。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,以汉密尔顿焦虑量表(HAMA)和临床疗效总评量表(CGI)评分作为次要疗效指标,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208例,安非他酮组和氟西汀组各104例。符合方案患者(PP)201例,安非他酮组100例,氟西汀组101例。根据PP样本,治疗6周后,安非他酮组和氟西汀组HAMD17总分减分值为(17.7±8.5)分,与基线相比均存在显著性差异(P<0.01),但组间无统计学差异(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统计学差异(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, muhicenter clinical trial was conducted. Patients were assigned to two groups （bupropion 300 mg/d or fluoxetine 20 mg/d） and received six weeks treatment. The primary efficacy indicator was the decreased score of Hamilton depression （HAMD） rating scale 17, and the secondary efficacy indicators were the Hamilton anxiety （HAMA） rating scale and clinical global impression. Treatment emergent symptom scale, laboratory examinations, ECG , vital signs and physical examinations were used to evaluate safety of the medicine. Results Two hundred and eight intent-to-treat patients were enrolled in this trial, with 104 in the bupropion group and 104 in the fluoxetine group. Among them, the per protocol （PP） sample was 201 patients （bupropion group, 100 vs fluoxetine group, 101）. Based on the PP sample, the HAMD 17 decreased score of bupropion group was 17.7 ±8.5 six weeks after treatment, while fluoxetine group was 17.9 ±8.2 , 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 suggested that no significant differences were found in symptoms and frequency of side effects between the two groups. Conclusion Bupropion hydrochloride tablet is an effective and safe antidepressant. It has similar effect and safety compared with fluoxetine in the treatment of depression.