Klinger Tatjana, Ibach Bernd, Schoenknecht Peter, Kamleiter Martin, Silver Gabrielle, Schroeder Johannes, Mielke Ruediger
Staedt. Klinikum St. Georg, Verbund Gemeindenahe Psychiatrie West/Suedwest, Leipzig, Germany.
Curr Med Res Opin. 2005 May;21(5):723-32. doi: 10.1185/030079905x43668.
This open-label, prospective, observational, Post-Marketing Surveillance (PMS) study assessed the efficacy and safety of donepezil in patients who had been switched from therapies currently used in Germany to treat Alzheimer's disease (AD), such as memantine and nootropics, due to insufficient efficacy or poor tolerability. A treatment-naive population was included as a comparator.
Patients with AD were treated with donepezil and observed for a period of approximately 3 months. A cognitive assessment was made using the Mini-Mental State Examination (MMSE). Quality of life (QoL) was assessed by the investigators who answered the question 'How did therapy with donepezil influence the QoL of the patient and/or his family over the observation period?' and was graded using three ratings: improved/unchanged/worsened. Adverse events (AEs) were also monitored.
A total of 913 patients entered the study (mean +/- SD MMSE score 18.03 +/- 5.34). Efficacy assessments were analyzed for three groups: an overall group of patients who had received any form of prior AD drug therapy (N+ group; n = 709); a subgroup of patients from the N+ group who had received prior memantine therapy only (M+ group; n = 111) and patients who were drug treatment naive (N- group; n = 204). In the evaluable population donepezil improved MMSE scores by 2.21 +/- 3.47 points on average, with similar improvements observed in all three groups. QoL was judged to be improved in at least 70% of patients, again with similar results obtained for all three groups. Donepezil was well tolerated, with 85 of 913 (9.3%) patients reporting AEs. The most common AEs were those typically seen with cholinergic therapies (i.e., diarrhoea, vomiting and nausea).
In this observational PMS study, donepezil was shown to be efficacious and well tolerated in patients who were being insufficiently treated with memantine or nootropic therapy. The magnitude of response was similar to that observed in patients who were previously treatment naive, suggesting prior medication does not effect donepezil's efficacy.
本开放标签、前瞻性、观察性上市后监测（PMS）研究评估了多奈哌齐对因疗效不足或耐受性差而从德国目前用于治疗阿尔茨海默病（AD）的疗法（如美金刚和益智药）转换过来的患者的疗效和安全性。将未接受过治疗的人群作为对照。
AD患者接受多奈哌齐治疗，并观察约3个月。使用简易精神状态检查表（MMSE）进行认知评估。生活质量（QoL）由回答“在观察期内，多奈哌齐治疗如何影响患者和/或其家人的生活质量？”这一问题的研究人员进行评估，并使用三个等级进行评分：改善/不变/恶化。还对不良事件（AE）进行了监测。
共有913名患者进入研究（平均±标准差MMSE评分18.03±5.34）。对三组进行了疗效评估：接受过任何形式的先前AD药物治疗的患者总体组（N+组；n = 709）；仅接受过先前美金刚治疗的N+组亚组患者（M+组；n = 111）以及未接受过药物治疗的患者（N-组；n = 204）。在可评估人群中，多奈哌齐使MMSE评分平均提高了2.21±3.47分，三组均观察到类似的改善。至少70%的患者的生活质量被判定为有所改善，三组再次获得类似结果。多奈哌齐耐受性良好，913名患者中有85名（9.3%）报告了不良事件。最常见的不良事件是胆碱能疗法中常见的那些（即腹泻、呕吐和恶心）。
在这项观察性PMS研究中，多奈哌齐在接受美金刚或益智药治疗效果不佳的患者中显示出疗效且耐受性良好。反应程度与先前未接受过治疗的患者中观察到的相似，表明先前用药不影响多奈哌齐的疗效。
