噻奈普汀治疗抑郁症的临床疗效研究

A comparative study of tianeptine and amitriptyline for depressive patients

目的 验证噻奈普汀治疗抑郁症的疗效及安全性。方法 对 6 1例抑郁症患者进行噻奈普汀和阿米替林的多中心开放、对照治疗 ,其中噻奈普汀组 33例 (37 5mg/d) ,阿米替林组 2 8例(15 0mg/d) ;共治疗 6周。采用汉密尔顿抑郁量表 (HAMD)、汉密尔顿焦虑量表 (HAMA)、临床总体评定量表 (CGI)评定临床疗效 ,采用不良反应清单 (AMDP 5 )评定副反应。结果 噻奈普汀组的治疗总有效率为 85 % ,显效率为 6 7% ,阿米替林组分别为 86 %和 6 8% ,起效时间均在治疗第 2周末 ;两组间差异无显著性 (χ2 分别 =0 0 2 3和 0 0 11)。噻奈普汀组与阿米替林组治疗前后HAMD、HAMA评分及减分率的差异均无显著性 (P >0 0 5 )。噻奈普汀组的不良反应较阿米替林组少而轻 ,常见的有头晕、口干、胃肠不适等。结论 噻奈普汀治疗抑郁症有效 。

Objective The aim of this study was to determine the efficacy and safety of tianeptine to the patients with major depression and bipolar disorder, depressed episode Methods A multicenter open controlled study was carried out 65 patients who met the CCMD 2 R criteria of major depression or bipolar disorder, depressed episode, with a total score ≥18 of 17 items of Hamilton Depression Rating Scale (HAMD) were entered the study The 34 of total patients were treated with tianeptine (37 5 mg/day) and the others were treated with amitriptyline for 42 days The efficacy were assessed by Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Scale (HAMA), Clinical Global Impression (CGI) and the safety was assessed by AMDP 5 Results The improvement rate of tianeptine was 85% and significant improvement rate was 67% after 6 weeks treatment The efficacy started after 14 days tianeptine treatment The adverse events in both groups were dry mouth, dizziness, falling sleep difficulty and gastric internal discomfort However, there were significant lower side effects in tianeptine group than in amitriptyline group Conclusions Tianeptine is an effective antidepressants, with less side effects and better safety compared with amitriptyline