度洛西汀的药理机制和临床疗效.pptVIP

* Key Points: 在一项为期一年的开放性抑郁症研究中，接受度洛西汀80或者120mg/day治疗的患者(汇总)，在前8周急性治疗期体重减少0.15kg，治疗一年后体重平均增加2.14kg(MMRM统计方式)，体重平均增加1.12kg(LOCF统计方式)。 总共有1282位抑郁患者入选本研究，其中1274位有基线后的体重数据。总共520位患者接受了52周的度洛西汀治疗。 Background： 这是一项度洛西汀的开放性研究，评估剂量达到80或120mg/day(半量 BID)时的长期(52周)安全性。入选标准是18岁以上的门诊患者，符合DSM-IV抑郁症诊断标准，基线HAM-D17评分≥15，并且CGI-S评分≥4(意味着至少中等程度疾病)。 Key Points: In a 1-year, open-label MDD study, patients treated with duloxetine 80 or 120 mg/day (pooled) showed a decrease of –0.15 kg (-0.33 lbs) after 8-weeks of acute therapy and a weight increase of 2.14 kg (4.71 lbs) after 1-year of treatment with duloxetine by mixed model repeated measures (MMRM) analysis. In mean change from baseline to endpoint showed a 1.12 kg (2.46 lbs) weight increase by last observation carried forward (LOCF) analysis. A total of 1282 patients with major depression enrolled in the study and 1274 had post-baseline weight data. A total of 520 patients completed 52-weeks of treatment with duloxetine. Raskin 2003 manuscript reports the LOCF end-point but not MMRM by week, which is presented in the Mallickrodt 2003 poster. Background: This was an open label study of duloxetine at doses of 80 or 120 mg/day (given as a twice-daily divided dose) for the evaluation of long-term (52-weeks) safety in patients with major depression. Entry criteria included a DSM-IV diagnosis of major depression with a severity specified by a Clinical Global Impression of Severity (CGI-S) score of 3 (indicating at least mildly ill) at baseline for out-patients at least 18 years of age. Reference: Raskin J, Goldstein DJ, Mallinckrodt CH, Ferguson MB. Duloxetine in the long-term treatment of major depressive disorder. J Clin Psychiatry 2003;64:1237-1244. Mallinckrodt C.H., Detke M.J., Raskin J., et al. Weight Changes During Long-term Treatment With Duloxetine and Paroxetine. Presented at the 16th Annual US Psychiatric Conference. November 6-9, 2003. Orlando, Florida. Study: F1J-MC-HMAU * Key Points: 基线没有性功能障碍的女性患者，在急性期研究中，度洛西汀治疗组(