艾司西酞普兰治疗抑郁症的疗效和安全性

Efficacy and safety of escitalopram in treatment of depressive disorder

目的评价国产艾司西酞普兰治疗抑郁症的疗效和安全性。方法本研究为多中心、开放性研究,共入组符合CCMD-3诊断标准的抑郁症患者238例,服用国产艾司西酞普兰片10～20 mg·d^(-1),疗程为6 wk。使用汉密尔顿抑郁量表17项(HAMD-17)、临床疗效总评量表(CGI,包括病情严重程度CGI-S、疗效总评CGI-I)分别在治疗wk 1、2、4、6末进行疗效评价,使用不良事件记录表并根据症状、体征、实验室和心电图检查结果评价药物安全性。结果共计232例完成研究,在各时点HAMD-17(P<0.01)、CGI-S(P<0.05)、CGI-I(P<0.01)的总分与治疗前比较,均有显著差异。总体有效率为82.8%,痊愈率为58.6%。不良反应发生率为11.2%,整体耐受性较好。结论国产艾司西酞普兰是一种安全、有效的抗抑郁药物。

AIM To evaluate the clinical efficacy and safety of domestic escitalopram in the treatment of depression. METHODS Two hundred and thirty-eight patients met with CCMD-3 criteria of depressive disorder were included into the open, multicenter, six-week research with flexible dosages 10 - 20 mg. d-1 of escitalopram. The HAMD-17, CGI, adverse event rating scale and related laboratory examinations were used to assess the efficacy and safety of the treatment by the end of 1, 2, 4, 6 wk. RESULTS Two hundred and thirty-two patients completed the study. Results indicated a significant reduction in scores of HAMD-17 （P 〈 0.01 ）, CGI- S （P 〈 0.05） and CGI-I （P 〈 0.01） in every treatment time points compared with those in baseline. The effective rate and cure rate was 82.8% and 58.6%, respectively. The adverse reaction rate was 11.2%, and all adverse reactions were well tolerated. CONCLUSION Generic escitalopram is an effective and safe antidepressant.