文拉法辛缓释片与阿米替林治疗难治性抑郁症的临床研究

Comparison of venlafaxine and amitriptyline in the treatment of patients with refractory depression

目的观察文拉法辛缓释片和阿米替林对难治性抑郁症的综合疗效和不良反应。方法将符合入组标准的103例患者随机分成文拉法辛组51例和阿米替林组52例。于治疗前和治疗第1、2、4、8周末采用汉密尔顿抑郁量表(HAMD)17项评定疾病严重程度和疗效,采用不良反应量表(TESS)评定药物不良反应,采用生活质量综合评定问卷(WHOQOL-100)评定生活质量。结果 (1)文拉法辛组痊愈16例,有效18例,无效17例,有效率65.48%;阿米替林组痊愈14例,有效19例,无效19例,有效率63.46%;两组间有效率比较差异无统计学意义(P>0.05)。(2)治疗1周时,文拉法辛组与阿米替林组之间HAMD总分的差异有统计学意义(P<0.01),但是在治疗8周末差异无统计学意义。(3)治疗8周末,文拉法辛组WHOQOL生活领域、心理领域、社会关系、环境因素因子分均高于阿米替林组,差异有统计学意义(P<0.01)。(4)在不良反应方面,睡眠障碍(文拉法辛组嗜睡4例,阿米替林组失眠、早醒8例)的发生率组间差异有统计学意义,但是均较轻微。结论与阿米替林相比,文拉法辛缓释片治疗难治性抑郁症起效快,疗效好,安全性好,且能显著改善患者的生存质量。

Objective To explore the efficacy and safety of venlafaxine sustained release tablets （venlafaxine -SR） and amitriptyline in the treatment of patients with refractory depression. Methods A total of 103 patients with refractory depression were randomly divided into venlafaxine- SR group （51 cases） and amitriptyline group （52 cases） for 8 - week treatment. Disease severity and efficacy was assessed with Hamilton Depression Scale （HAMD） , adverse effects with Treatment Emergent Symptom Scale （TESS） and quality of life with the WHO Quality of Life （WHOQOL） at the baseline, 1 st weekend, 2nd weekend, 4th weekend and 8th weekend. Results （ 1 ） Effective rate in venlafaxine - SR group was 65.48% （recovery： 16 cases; effectiveness： 18 cases; inefficiency： 17 cases）, in amitriptyline group was 63.46% （recovery： 14 cases; effectiveness： 19 cases; inefficiency： 19 cases）. There was no significant difference in effective rate between the two groups （ P 〉 0.05 ）. （ 2 ） There was significant difference in soere of HAMD between venlafaxine -SR group and amitriptyline group at the 1 st weekend （P 〈 0.01 ） , but the difference was not significant at the 8th weekend （P 〉 0.05）. （3） At the 8th weekend, scores of the WHOQOL living domain, psychological domain, social relationship and environmental factor in venlafaxine - SR group were significantly higher than those in amitriptyline group （P 〈0.01 ）. （4） There were significant differences in the incidence of insomnia between venlafaxine -SR group and amitriptyline group. But all the side effects were mild. Conclusion Compared with amitriptyline, Venlafaxine - SR is more effective and takes effect more quickly in the treatment of refractory depression with better tolerability. Furthermore, venlafaxine has advantage in improving quality of life of patients with refractory depression.