噻奈普汀与阿米替林治疗抑郁症的对照研究  

A controlled trial of tianeptine versus amitriptyline in the treatment of major depression.

作　　者：王立伟 顾牛范 施慎逊 李华芳 陆峥[1] 

机构地区：[1]上海铁道大学医学院附属甘泉医院

出　　处：《上海精神医学》1999年第4期215-219,共5页Shanghai Archives of Psychiatry

摘　　要：目的 验证噻奈普汀(Tianeptine)治疗抑郁症的临床疗效和安全性。方法研究对象符合CCMD-2-R中抑郁发作的诊断标准,经安慰剂清洗3-7天后,被随机分入噻奈普汀治疗组和阿米替林治疗组,治疗剂量分别为37.5mg/日和/150mg/日,疗程为6周。疗效评价采用汉密尔顿抑郁量表(HAMD,17项),蒙哥马利抑郁量表(MADRS),汉密尔顿焦虑量表(HAMA)和临床疗效总评量表(CGI),安全性评价采用不良反应清单(AMDP-5),于治疗前、治疗后第1、2、4、6周各评定一次。实验室检查包括血液常规、肝肾功能和ECG等。结果 共入组26例,噻奈普汀和阿米替林组各15例。根据HAMD减分率评价(减分率>25％为有效),6周末达噻奈普汀组的有效率为90.9％,显著高于阿米替林组的69.2％(P<0.05)。6周末噻奈普汀组的HAND总分平均下降73％,而阿米替林组为48％,差别有显著意义(P=0.029)。两药的起效时间均在第2周。噻奈普汀的抗焦虑作用在第一周末即有显著效果,6周末的HAMA总分平均下降68％,显著高于阿米替林组的33％(P=0.0196)。噻奈普汀的不良反应较阿米替林少而轻。结论 噻奈普汀具有肯定的抗抑郁和抗焦虑作用,6周末的临床疗效优于阿米替林,安全性高。Objective: To determine the efficacy and safety of tianeptine in the treatment of Chinese patients with major depression. Methods: Subjects met the CCMD-2-R criteria for depressive episode and assigned randomly into the groups of tianeptine or amitriptyline treatment for 6 weeks. The efficacy was evaluated by using HAMD, MADRS, HAMA and CGI scales, and the safety was measured with AMDP-5 and laboratory tests. Results: The overall response rate of tianeptine was 90.9% and was significantly higher than that of amitriptyine (P< 0.05). The total HAMD scores were decreased by 73% in tianeptine-treated patients, but only 48% of the scores were reduced in the amitriptyline group (P = 0.029). The anti-anxiety effect of tianeptine occurred in the first week and the total HAMA scores were reduced by 68%. Adverse side effects were less and mild in patients taking tianeptine. Conclusion: Tianeptine was effective and safe in the treatment of major depression and co-existing anxiety.

关 键 词：噻奈普汀 阿米替林 抑郁症 药物治疗 

分 类 号：R749.41[医药卫生—神经病学与精神病学]