de Filippis Renato, Gaetano Raffaele, Schoretsanitis Georgios, Verde Giuseppe, Oliveti Cesare Anthony, Kane John M, Segura-Garcia Cristina, De Fazio Pasquale
Psychiatry Unit, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA.
Neuropsychiatr Dis Treat. 2021 Jul 1;17:2141-2150. doi: 10.2147/NDT.S312095. eCollection 2021.
Clozapine is well known for its efficacy and clinical superiority compared to other antipsychotics in treatment-resistant schizophrenia (TRS). However, it is frequently underutilized worldwide because of its acute adverse events, as well as for its long-term cardiometabolic and hematological consequences.
The aim of the study was to evaluate 5-year safety in chronic TRS inpatients with continuous clozapine use.
Patients with TRS and clozapine treatment were evaluated for 5 years. All participants were assessed using the Brief Psychiatric Rating Scale (BPRS), Glasgow Antipsychotic Side-effect Scale for Clozapine (GASS-C), Social Performance Scale (PSP) and Short Portable Mental Status Questionnaire (SPMSQ). Clinical, cardiometabolic and hematological data were collected periodically. General linear models (GLM) repeated measures controlling for CLZ dose were utilized to determine differences in variables across the time.
Overall, 189 inpatients were screened for study participation. The final sample included twenty-one TRS patients (16 males, 76%) with an average age of 57.6 years, all with 5-year continuous use of clozapine (mean dose 266 mg/day). There was not a significant effect of time on BPRS (=0.774), PSP (p=0.855) and SPMSQ (p=0.066); differences remained not significant after controlling for CLZ dose (p=0.585, p=0.467 and p=0.105, respectively). No changes were found in blood and clinical parameters except for red blood cell count, which decreased over time (=0.024; η= 0.952). Patients reported a significant BMI decrease (-8.98 kg, =0.008) between baseline and 5 years last observation.
The findings show how the application of a structured dietary, clinical and therapeutic monitoring program in psychiatric care facilities could allow the safe and effective long-term cardiometabolic and hematological management of clozapine. The unique role that clozapine plays in the current treatment of patients with TRS requires greater clinical awareness. Although its acute and chronic side effects are notorious, its safety management is feasible and broadens its potential practical application.
与其他抗精神病药物相比，氯氮平在难治性精神分裂症（TRS）治疗中的疗效和临床优势广为人知。然而，由于其急性不良事件以及长期的心脏代谢和血液学后果，它在全球范围内的使用常常不足。
本研究的目的是评估持续使用氯氮平的慢性TRS住院患者的5年安全性。
对接受氯氮平治疗的TRS患者进行了5年的评估。所有参与者均使用简明精神病评定量表（BPRS）、氯氮平的格拉斯哥抗精神病药物副作用量表（GASS-C）、社会功能量表（PSP）和简短便携式精神状态问卷（SPMSQ）进行评估。定期收集临床、心脏代谢和血液学数据。采用控制氯氮平剂量的一般线性模型（GLM）重复测量来确定不同时间变量的差异。
总体而言，对189名住院患者进行了研究参与筛查。最终样本包括21名TRS患者（16名男性，76%），平均年龄57.6岁，均连续使用氯氮平5年（平均剂量266毫克/天）。时间对BPRS（p = 0.774）、PSP（p = 0.855）和SPMSQ（p = 0.066）没有显著影响；在控制氯氮平剂量后差异仍不显著（分别为p = 0.585、p = 0.467和p = 0.105）。除红细胞计数随时间下降外（p = 0.024；η² = 0.952），血液和临床参数未发现变化。患者报告在基线和最后一次观察的5年之间BMI显著下降（-8.98千克，p = 0.008）。
研究结果表明，在精神科护理机构中应用结构化的饮食、临床和治疗监测计划如何能够实现氯氮平安全有效的长期心脏代谢和血液学管理。氯氮平在当前TRS患者治疗中所起的独特作用需要更高的临床认识。尽管其急性和慢性副作用声名狼藉，但其安全管理是可行的，并拓宽了其潜在的实际应用范围。
