噻奈普汀与氟西汀治疗抑郁症疗效与安全性的多中心开放研究

A multi-center open comparative study on tianeptine versus Fluoxetine for treatment depression

目的 验证噻奈普汀治疗抑郁症的疗效和安全性。方法 对 2 6 4例患者进行噻奈普汀和氟西汀的多中心开放、对照治疗 ,其中噻奈普汀组 14 4例 (37 5mg/d) ,氟西汀组 12 0例 (2 0mg/d) ,治疗 6周。采用汉密尔顿抑郁量表 (HAMD)、汉密尔顿焦虑量表 (HAMA)、临床总体评价量表 (CGI)评定临床疗效 ,采用需要处理的不良反应量表 (TESS)评定安全性。结果 噻奈普汀组治疗和氟西汀组总有效率分别为 79 9%和 71 5 % ,两组无显著差异 (χ2 =2 4 1,P≥ 0 0 5 )。起效时间均在两周末。噻奈普汀在治疗 2、4、6周时的HAMD、HAMA减分率均高于氟西汀组 ,并有显著性差异 (P <0 0 1)。噻奈普汀组不良反应主要有口干、入睡困难、胃肠道不适、头痛、便秘等 ,不良反应较氟西汀少而轻。结论 噻奈普汀对抑郁症具有良好的疗效和安全性 ,且其安全性优于氟西汀。

Objective To investigate the clinical efficacy and safety of tianeptine used for major depression as compared with fluoxetine.Methods A multicenter open-controlled study was carried out. 264 patients who met DSM-IV or ICD-10 criteria of major depression with total scare≥18 of Hamilton Depression Rating Scale (HD) were enrolled in the study. Of them,144 patients were treated with tianeptine 37.5 mg/d and 120 treated with Fluoxetine for 42 days. The efficacy was assessed by Hamilton Depression Rating Scale (HAMD),Hamilton Anxiety Rating Scale (HAMA),Clinical Global Impression (CGI) and the safety was assessed by Treatment Emergent Symptoms Scale (TESS).Results The improvement rate was 79.9% and 71.5% after 6 weeks treatment with tianeptine and fluoxetine,respectively. There is no difference between two drugs in term of the improvement rate (χ 2 =2.41,P ≥0.05).The adverse events of tianeptine were dry mouth,falling sleep difficult,gastric-internal discomfort,headache and constipation. There were significantly lower side events in tianeptine than in fluoxetine.Conclusion Tianeptine has good efficacy and compliance in treating major depression,and has less adverse events than fluoxetine.