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一项来自日本全国数据库的关于氯氮平使用 10 年的描述性研究。

A descriptive study of 10-year clozapine use from the nationwide database in Japan.

机构信息

Department of Neuropsychiatry, Osaka Medical College, 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.

Department of Pharmacy, Osaka Medical College Hospital, 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan.

出版信息

Psychiatry Res. 2021 Mar;297:113764. doi: 10.1016/j.psychres.2021.113764. Epub 2021 Jan 27.

Abstract

This survey was conducted to identify the actual usage of clozapine and changes required to increase the number of patients with schizophrenia who would benefit from clozapine. We obtained Clozaril® Patient Monitoring Service (CPMS) data for 8,263 patients that received clozapine between July 2009 and January 2020. Patients were divided into the early (n=3,696 cases, which have been analyzed previously) and late groups (n=4,567 cases) according to the date of the treatment initiation. In total, 417 facilities offered the drug, with a surge in cases in the late group (40.0 hospitals/year, 568.6 cases/year vs. 39.3 hospitals/year, 1,141.8 cases/year). We found a significant between-group difference in the mean dosage during treatment (early group: 309.1 mg/day; late group: 247.9 mg/day). The treatment continuation rates at 1 and 4 years in all study participants were 77.2% and 65.1%, respectively. The incidences of granulocytopenia and agranulocytosis were 5.5% and 1.0%, respectively. The discontinuation rate because of granulocytopenia was significantly lower in the late group. There were no differences in the discontinuation rate because of glucose intolerance between the groups. An assessment of the current CPMS regulations may be required to further examine the clozapine use effectiveness.

摘要

本调查旨在确定氯氮平的实际使用情况,并确定需要做出哪些改变,以增加受益于氯氮平治疗的精神分裂症患者人数。我们获取了 2009 年 7 月至 2020 年 1 月期间使用氯氮平的 8263 名患者的 Clozaril®患者监测服务(CPMS)数据。根据治疗开始日期,患者被分为早期(n=3696 例,之前已进行分析)和晚期组(n=4567 例)。共有 417 家机构提供了该药物,晚期组的病例数明显增加(40.0 家/年,40.0 家/年,568.6 例/年,39.3 家/年,1141.8 例/年)。我们发现两组患者在治疗期间的平均剂量存在显著差异(早期组:309.1mg/天;晚期组:247.9mg/天)。所有研究参与者的 1 年和 4 年治疗延续率分别为 77.2%和 65.1%。粒细胞减少症和粒细胞缺乏症的发生率分别为 5.5%和 1.0%。晚期组因粒细胞减少症而停药的比例明显较低。两组间因葡萄糖耐受不良而停药的比例无差异。可能需要对当前 CPMS 规定进行评估,以进一步检查氯氮平的使用效果。

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