度洛西汀用于65岁及以上患者重度抑郁症的长期治疗：一项开放标签研究。
Duloxetine for the long-term treatment of major depressive disorder in patients aged 65 and older: an open-label study.
作者信息
Wohlreich Madelaine M, Mallinckrodt Craig H, Watkin John G, Hay Donald P
机构信息
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
出版信息
BMC Geriatr. 2004 Dec 7;4:11. doi: 10.1186/1471-2318-4-11.
BACKGROUND
Late-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age > or = 65 years; n = 101) who participated in a large, multinational, open-label study.
METHODS
Patients meeting DSM-IV criteria for MDD received duloxetine 80 mg/d (40 mg twice daily (BID)) to 120 mg/d (60 mg BID) for up to 52 weeks. Efficacy measures included the Clinical Global Impression of Severity (CGI-S) scale, the 17-item Hamilton Rating Scale for Depression (HAMD17), the Beck Depression Inventory-II (BDI-II), the Patient Global Impression of Improvement (PGI-I) scale, and the Sheehan Disability Scale (SDS). Safety and tolerability were evaluated using discontinuation rates, spontaneously reported adverse events, and changes in vital signs, ECG, and laboratory analytes.
RESULTS
Mean changes in HAMD17 total score at Weeks 6, 28, and 52 were -13.0, -17.4 and -17.5 (all p-values <.001). Significant improvement (p < .001) in both clinician- (CGI-S) and patient-rated (PGI-I) measures of improvement were observed at Week 1 and sustained throughout the study. Observed case response rates at Weeks 6, 28, and 52 were 62.9%, 84.9%, and 89.4%, respectively, while the corresponding rates of remission were 41.4%, 69.8%, and 72.3%. Adverse events led to discontinuation in 27 (26.7%) patients. Treatment-emergent adverse events reported by >10% of patients included dizziness, nausea, constipation, somnolence, insomnia, dry mouth, and diarrhea. Most events occurred early in the study. Mean changes at endpoint in blood pressure and body weight were less than 2.0 mm Hg, and -0.1 kg, respectively.
CONCLUSIONS
In this open-label study, duloxetine was effective, safe, and well tolerated in the long-term treatment of MDD in patients aged 65 and older.
背景
老年期抑郁症是一种常见、慢性且易复发的疾病，相关指南推荐进行长期治疗。使用来自参与一项大型、多国、开放标签研究的老年患者（年龄≥65岁；n = 101）的数据，评估了度洛西汀治疗重度抑郁症（MDD）的安全性和有效性。
方法
符合DSM-IV标准的MDD患者接受度洛西汀80mg/d（40mg每日两次）至120mg/d（60mg每日两次）治疗，最长52周。疗效指标包括临床总体印象严重程度（CGI-S）量表、17项汉密尔顿抑郁评定量表（HAMD17）、贝克抑郁量表第二版（BDI-II）、患者总体印象改善（PGI-I）量表以及希恩残疾量表（SDS）。使用停药率、自发报告的不良事件以及生命体征、心电图和实验室分析物的变化评估安全性和耐受性。
结果
第6周、28周和52周时HAMD17总分的平均变化分别为-13.0、-17.4和-17.5（所有p值<.001）。在第1周时，临床医生评定（CGI-S）和患者评定（PGI-I）的改善指标均有显著改善（p <.001），且在整个研究过程中持续存在。第6周、28周和52周时观察到的病例有效率分别为62.9%、84.9%和89.4%，而相应的缓解率分别为41.4%、69.8%和72.3%。不良事件导致27例（26.7%）患者停药。超过10%的患者报告的治疗中出现的不良事件包括头晕、恶心、便秘、嗜睡、失眠、口干和腹泻。大多数事件发生在研究早期。终点时血压和体重的平均变化分别小于2.0mmHg和-0.1kg。
结论
在这项开放标签研究中，度洛西汀在65岁及以上患者的MDD长期治疗中有效、安全且耐受性良好。
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