Department of Psychiatry, Osaka University Graduate School of Medicine, Suita, Japan.
Osaka Psychiatric Medical Center, Osaka, Japan.
Neuropsychopharmacol Rep. 2021 Jun;41(2):179-184. doi: 10.1002/npr2.12166. Epub 2021 Feb 19.
As an emergency measure during the coronavirus disease pandemic, the monitoring interval for clozapine use was temporarily extended beyond the regulatory requirement in Japan, which is the safest monitoring interval worldwide. In this study, we aimed to explore the effect of this measure on patients undergoing clozapine treatment.
This retrospective chart review study included patients with treatment-resistant schizophrenia (TRS) who were undergoing clozapine treatment at four psychiatric institutions in Japan. Demographic characteristics and clinical information of these patients were collected on April 27, 2020, when Japanese psychiatrists were virtually allowed to prescribe clozapine beyond the regulatory requirement. Furthermore, information of adverse events related to the emergency measure was collected and analyzed.
Of the 41 patients with TRS included in this study, 19 patients underwent extended hematological monitoring during clozapine treatment. No psychiatric or hematological adverse events were observed in the patients during the extended monitoring interval.
This study suggested that there were few adverse events of clozapine-treated patients related to emergency measures in Japan. However, hematological monitoring intervals during clozapine treatment have been emergently extended worldwide; hence, it is necessary to verify the results of these measures.
在冠状病毒病大流行期间,作为一项紧急措施,日本暂时将氯氮平的监测间隔延长至超过监管要求的时间,而这是全球范围内最安全的监测间隔。本研究旨在探讨这一措施对接受氯氮平治疗的患者的影响。
本回顾性图表研究纳入了在日本四家精神病院接受氯氮平治疗的治疗抵抗性精神分裂症(TRS)患者。收集了这些患者的人口统计学特征和临床信息,时间为 2020 年 4 月 27 日,当时日本精神病医生被允许在监管要求之外远程开具氯氮平处方。此外,还收集并分析了与紧急措施相关的不良事件信息。
本研究共纳入 41 例 TRS 患者,其中 19 例患者在氯氮平治疗期间接受了延长的血液学监测。在延长的监测间隔期间,患者未出现精神或血液学不良事件。
本研究表明,日本的紧急措施很少引起氯氮平治疗患者的不良事件。然而,氯氮平治疗期间的血液学监测间隔已在全球范围内紧急延长;因此,有必要验证这些措施的结果。