Leweke F M, Gerth C W, Koethe D, Nolden B M, Klosterkötter J
Klinik für Psychiatrie und Psychotherapie, Universität zu Köln.
Fortschr Neurol Psychiatr. 2007 Apr;75(4):211-9. doi: 10.1055/s-2006-954962. Epub 2007 Jan 17.
We performed a post marketing surveillance study (PMS study) to reveal the efficacy and tolerability of orally administered quetiapine in the treatment of acute psychosis over a period of up to three weeks. 398 respective inpatients were assessed in 88 psychiatric departments in Germany by use of the Clinical Global Impression Scale (CGI) and the Brief Psychiatric Rating Scale (BPRS) as well as the clinical impression of psychiatric raters. Safety and tolerability were assessed by vital parameters such as blood pressure, hearth rate and weight as well as the clinical impression of the psychiatric raters. In addition, dosing, concomitant and/or previous pharmacotherapies as well as certain aspects of psychiatric and medical history were documented. A significant reduction of psychopathology was found during three weeks of drug treatment. Daily dosages of quetiapine between 400 and 1200 mg were well tolerated with a limited number of adverse and no serious adverse events. Noteworthy, more than 35 % of all patients received and tolerated excellently more than 800 mg of quetiapine per day under naturalistic treatment conditions, well above the approved maximum daily dosage. This study reflects the clinical efficacy and good tolerability of quetiapine under real world treatment conditions and is in line with the results of the controlled clinical trials of phase II and III.
我们开展了一项上市后监测研究(PMS研究),以揭示口服喹硫平在长达三周的时间内治疗急性精神病的疗效和耐受性。德国88个精神科的398名住院患者分别使用临床总体印象量表(CGI)、简明精神病评定量表(BPRS)以及精神科评估者的临床印象进行评估。通过血压、心率和体重等生命体征参数以及精神科评估者的临床印象来评估安全性和耐受性。此外,记录了给药剂量、合并用药和/或既往药物治疗以及精神病史和病史的某些方面。在药物治疗的三周内发现精神病理学有显著减轻。喹硫平每日剂量在400至1200毫克之间耐受性良好,不良事件数量有限,无严重不良事件。值得注意的是,在自然治疗条件下,超过35%的患者每天接受并耐受超过800毫克的喹硫平,远高于批准的最大日剂量。这项研究反映了喹硫平在现实世界治疗条件下的临床疗效和良好耐受性,与II期和III期对照临床试验的结果一致。