Ibor Juan José Lopez, Carrasco Jose Luis, Prieto Rita, García-Calvo Carmen
Psychiatry Department, San Carlos Clinic Hospital, Profesor Martín Lagos s/n, 28040 Madrid, Spain.
Arch Gerontol Geriatr. 2008 May-Jun;46(3):317-26. doi: 10.1016/j.archger.2007.05.005. Epub 2007 Jul 6.
The main objectives of this multicenter, naturalistic, open-label study is to evaluate the effectiveness, tolerability and safety of venlafaxine extended release (VXR) in a sample of 59 patients older than 60 years of age diagnosed of depressive disorders in the primary care setting. VXR was administered for 24 weeks at daily doses ranging from 75 mg to 225 mg. Effectiveness measurements included the 17 items Hamilton Depression Rating Scale (HAM-D(17)), the Clinical Global Impression Scales for Severity (CGI-S) and Improvement (CGI-I), the Visual Analogical Scale for Pain (P-VAS), and the Mini-Mental State Examination (MMSE) scale. At the endpoint, VXR achieved response and remission rates of 81.6% and 59.2%, respectively. Treatment was associated with a significant improvement of the patient's condition (89.8% of patients were rated by physicians as "much/very much improved"). Painful physical symptoms (p<0.0001) and cognitive state (p=0.0017) scores decreased along the study. A total of 83% of patients completed the study. Seven adverse events were recorded for four patients (6.8% overall). Data of this study suggest that VXR could be an effective and safe therapeutic option in the treatment of geriatric depression, reducing also the associated painful physical symptoms.
这项多中心、自然主义、开放标签研究的主要目的是评估文拉法辛缓释剂(VXR)在59例60岁以上、在初级保健机构中被诊断为抑郁症的患者样本中的有效性、耐受性和安全性。VXR以75毫克至225毫克的日剂量给药24周。有效性测量包括17项汉密尔顿抑郁量表(HAM-D(17))、临床总体印象严重程度量表(CGI-S)和改善量表(CGI-I)、视觉模拟疼痛量表(P-VAS)以及简易精神状态检查表(MMSE)量表。在研究终点,VXR的缓解率和治愈率分别达到81.6%和59.2%。治疗与患者病情的显著改善相关(89.8%的患者被医生评为“有很大/非常大的改善”)。在整个研究过程中,疼痛的身体症状(p<0.0001)和认知状态(p=0.0017)评分下降。共有83%的患者完成了研究。4名患者记录了7起不良事件(总体发生率为6.8%)。这项研究的数据表明,VXR可能是治疗老年抑郁症的一种有效且安全的治疗选择,同时还能减轻相关的疼痛身体症状。