艾司西酞普兰与西酞普兰治疗抑郁症的随机、双盲、双模拟、多中心平行对照研究
摘要
AIM To evaluate the efficacy and safety of domestic manufactured escitalopram in treating unipolar depressioon. METHODS Two hundred and forty patients met with CCMD-3 criteria of depressive episode were randomized into escitalopram group (n = 120) and citalopram group (n = 120) for a six-week double-blind, double-dummy controlled study with flexible dosages for each respectively. The HAMD-17, CGI, adverse event rating scale and related laboratory examinations were employed to assess the effectiveness and safety of the treatment by the ends of 1, 2, 4, 6 wk. RESULTS Two hundred and three patients completed the study, 101 in escitalopram group and 102 in citalopram group; with total clinical effective rates of 81.2% and 83.3% respectively, and no significant difference between the two groups (P=0.6891). The clinical curing rate was significantly higher in escitalopram group than that in citalopram group (45.5% vs 29.4%, P = 0.0176). The adverse reactions such as nausea and other gastrointestinal discomfort were well tolerated, with no significant difference in the prevalence between the two groups (28.7% vs 29.9%, P = 0.8384). CONCLUSION Domestic manufactured escitalopram is an effective and safe antidepressant.