使用长效注射剂的安全性:从相反的角度看——长效注射剂是否更好?

Yutaro Suzuki
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摘要

当长效注射剂(LAI)作为第二代抗精神病药物进入日本时,用于症状稳定期的LAI治疗正在引起人们的关注,与帕利哌酮(PAL) -LAI相关的死亡被耸人听闻地报道,引起了人们对长效注射剂安全性的关注。在撰写本报告时,提供了一个反对LAI使用的机会,因此我们提出以下三个关于在症状稳定阶段使用第二代抗精神病药物LAI的问题。1)特别值得注意的不良反应是急性发展的,在某些情况下是致命的,包括恶性综合征、糖尿病酮症酸中毒、心电图QT间期延长引起的点扭转和白细胞减少。所有抗精神病药物都有这种不良反应的风险,由于不良反应的发生在服用前无法预测,一旦不良反应发生,应立即减少或停药,以将药物从体内清除;然而,由于这一过程不能与lai一起进行,这种致命的不良反应可能会延长。此外,在美国,注射后谵妄/镇静综合征(PDSS)的不良反应已被报道与奥氮平(OLZ) -LAI有关。这是一种疾病状态,在肌肉给药LAI后,药物快速流入血液,同时血液水平急剧升高,导致明显的镇静(某些情况下嗜睡)和/或严重症状伴谵妄;因此,为了最大限度地降低这些风险,美国FDA已强制要求使用称为REMS(风险评估和缓解策略)的OLZ-LAI监测系统。这种现象是否只发生在OLZ-LAI中还有待观察,因此必须仔细注意。2)在日本的精神科临床站点,目前的情况是对抗精神病药物的不良反应监测,特别是对门诊患者的不良反应监测不够充分。在这种情况下,在症状稳定阶段是否提倡用LAI替代口服药物仍然存在疑问。3)症状稳定期用LAI替代口服药物显著增加了治疗费用和就诊次数。这种治疗费用和就诊次数的增加可能对患者对药物的依从性产生很大影响。
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[The Safety of Using Long-acting Injections : From an Opposing Position-Is It Better to Administer Long-acting Injections?].

While long-acting injections (LAI) have arrived in Japan as a second-generation antipsy- chotic drug and LAI therapy for the symptom-stabilization phase is garnering attention, deaths associated with paliperidone (PAL) -LAI were sensationally reported, attracting interest regarding the safety of LAIs. In writing this report, an opportunity to oppose LAI usage was provided, so we raise the following three issues concerning the usage of the second-generation antipsychotic LAI for the symptom-stabilization phase. 1) Particularly notable adverse reactions of LAI are those acutely developed and in some cases fatal, including malignant syndrome, diabetic ketoacidosis, torsade de pointes due to pro- longed electrocardiogram QT, and leukopenia. All antipsychotic drugs come with the risk of such adverse reactions, and since the occurrence of adverse reactions cannot be predicted prior to administration, once they have developed, the offending drugs should be immediately reduced or discontinued to remove the drug from the body ; however, since this process can- not be followed with LAIs, such fatal adverse reactions may be protracted. Moreover, in the US, adverse reactions from post injection delirium/sedation syndrome (PDSS) have been reported in relation with olanzapine (OLZ) -LAI. This is a disease state in which the drug rap- idly flows into the blood following LAI intramuscular administration along with an acute increase in blood level, leading to significant sedation (lethargy in some cases) and/or serious symptoms accompanied by delirium ; therefore, in order to minimize these risks, the US FDA has made it mandatory to use a monitoring system referred to as REMS (Risk Evaluation and Mitigation Strategy)for OLZ-LAI. Whether or not the phenomenon occurs only with OLZ-LAI remains to be seen, so careful attention must be paid. 2) In Japanese psychiatric clinical sites, the current situation is that monitoring of adverse reactions for antipsychotic drugs, particularly with outpatients, is not sufficiently carried out Under such circumstances, there remain doubts when it comes to advocating -looking to replace oral drugs with LAI in the symptom-stabilization phase. 3) Replacing oral drugs with LAI in the symptom-stabilization phase significantly increases treatment costs as well as increasing the number of hospital visits. This increase in treatment cost and number of visits may have a large impact on the adherence of the patients to the drugs.

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