固定剂量阿戈美拉汀短期治疗广泛性焦虑障碍的临床对照试验

Controlled clinical trial of fixed-dose agomelatine in short-term treatment of generalized anxiety disorder

目的比较不同剂量组阿戈美拉汀治疗广泛性焦虑障碍的短期疗效和安全性。方法广泛性焦虑障碍患者86例随机分为阿戈美拉汀25mg组（n=30）、50mg组（n=28）和丁螺环酮组（n=28．30～45mg·d-1），开放治疗6周。在治疗前及治疗后2、4、6周末采用汉密尔顿焦虑量表（HAMA）、临床疗效总评量表病情严重程度（CGI—SI）评定临床疗效，副反应量表（TESS）评定药物不良反应。结果三组治疗后HAMA总分和因子分、CGI-SI评分均显著下降（P〈0．05，P〈0．01）。阿戈美拉汀25mg组有效率77％、临床治愈率33％，50mg组有效率79％、临床治愈率54％，丁螺环酮组有效率75％、临床治愈率32％，三组有效率（χ2=0．100，P=0．951）、临床治愈率（χ2=3．430，P=0．180）比较无显著差异。HAMA、CGI评分显示阿戈美拉汀治疗2周起效（P〈0．05），且25mg组与50mg组比较无显著差异（P〉0．05）。TESS评分丁螺环酮组高于阿戈美拉汀两个剂量组（P〈0．01）。结论阿戈美拉汀25、50mg·d-1短期治疗广泛性焦虑障碍均安全、有效。

AIM To evaluate the efficacy and safety of two fixed- dose agomelatine in short- termtreatment of generalized anxiety disorder （GAD）. METHODS Eighty- six patients with GAD were randomly assigned to 3 groups received agomelatine 25 mg.d-1 （n = 30）, 50 mg.d-1 （n = 28） and buspiron （n = 28, 30 - 45 mg.d-1） for 6 weeks. All the patients were assessed with the Hamilton Rating Scale for Anxiety （HAMA）, and the Severity Index of the Clinical Global Impression Scale （CGI- SI） before the treatment and after 2, 4 and 6 weeks treatment. The Treatment Emergent Symptom Scale （TESS） was used to assess safety. RESULTS At the end of the treatment, the mean scores of HAMA and CGI-SI had dropped significantly in all groups （P 〈 0.05, P 〈 0.01） . The total effective rate was 77% in the agomelatine 25 mg group, 79% in the agomelatine 50 mg group, and 75% in the buspiron group, with no statistically significant difference （χ2 = 0.100, P = 0.951）. The remission rate was 33% in the agomelatine 25 mg group, 54% in the agomelatine 50 mg group, and 32% in the buspiron group, with no statistically significant difference （χ2 = 3.430, P = 0.180）. The CGI and HAMA scores of the two agomelatine groups were both significantly decreased （P 〈 0.05） at the second week of treatment, with no significantly difference between the two doses （P 〉 0.05） . CONCLUSION Agomelatine 25 and 50 mg.d-1 are effective and safe in short-term treatment of GAD.