Guelfi J D, Dulcire C, Le Moine P, Tafani A
CMME, Service du Pr. Samuel-Lajeunesse, Paris, France.
Neuropsychobiology. 1992;25(3):140-8. doi: 10.1159/000118824.
1,927 outpatients were included by 392 general practitioners in an open study in order to evaluate the safety of tianeptine in the ambulatory treatment of depression. The results of 1,858 depressed patients without melancholia and psychotic features, fulfilling DSM III criteria of Major Depressive Episode or Dysthymic Disorder, could be analysed. 1,458 patients completed the 3-month treatment period. The group treated with 37.5 mg/day of tianeptine showed improvement on the Montgomery-Asberg Depression Rating Scale. With regard to the clinical tolerance of tianeptine, somatic complaints were rarely reported and adverse events necessitating premature termination of treatment (4.8% of included patients) were without clinical severity. Cardiovascular, haematologic, hepatic and biochemical safety were verified. No signs of dependence and no specific withdrawal symptoms were found after discontinuation of treatment.
392名全科医生在一项开放性研究中纳入了1927名门诊患者，以评估噻奈普汀在抑郁症门诊治疗中的安全性。对1858名无忧郁症和精神病特征、符合《精神疾病诊断与统计手册》第三版中重度抑郁发作或恶劣心境障碍标准的抑郁症患者的结果进行了分析。1458名患者完成了3个月的治疗期。接受每日37.5毫克噻奈普汀治疗的组在蒙哥马利-阿斯伯格抑郁评定量表上有改善。关于噻奈普汀的临床耐受性，很少有躯体不适的报告，需要提前终止治疗的不良事件（占纳入患者的4.8%）不具有临床严重性。心血管、血液学、肝脏和生化安全性得到了验证。停药后未发现依赖迹象和特定的戒断症状。
