Clinical Pharmacology Unit, Luigi Sacco University Hospital, Milan, Italy.
J Clin Psychopharmacol. 2022;42(1):23-30. doi: 10.1097/JCP.0000000000001484.
PURPOSE/BACKGROUND: The aim of the study was a preliminary evaluation of the maintenance of clinical efficacy and tolerability of paliperidone palmitate in patients with schizophrenia during the transition phase from 1-monthly paliperidone palmitate formulation (PP1M) to PP3M, with the evaluation of plasma levels of the drug.
METHODS/PROCEDURES: A prospective observational study was conducted for 13 months involving 22 outpatients, aged 18 to 66 years and clinically stabilized. Patients were affected by schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria. For each patient, clinical assessment, safety and tolerability, and drug plasma level determination were performed. Clinical efficacy was assessed by Brief Psychiatric Rating Scale, Positive and Negative Symptom Scale, and Hamilton Rating Scale for Depression. During the first 4 months of the study, once-monthly paliperidone palmitate was administered, and then during the following 9 months, the 3-monthly formulation was administered.
FINDINGS/RESULTS: The time course of the Brief Psychiatric Rating Scale total scores showed a statistically significant (P = 0.006) improvement from T0 to T8; Positive and Negative Symptom Scale scores showed a similar time course, with a statistically significant (P = 0.0016) reduction of the mean total score; Hamilton Rating Scale for Depression mean scores showed a statistically significant (P = 0.003) reduction with substantial maintenance of clinical stabilization of the patients. Only 1 patient dropped out after the first PP3M injection.
IMPLICATIONS/CONCLUSIONS: Our preliminary data currently confirm the maintenance of clinical stability shifting from PP1M to PP3M.
目的/背景：本研究的目的是初步评估棕榈酸帕利哌酮从 1 月制剂（PP1M）转换为 3 月制剂（PP3M）期间，精神分裂症患者的临床疗效和耐受性的维持情况，并评估药物的血浆水平。
方法/程序：进行了一项为期 13 个月的前瞻性观察研究，涉及 22 名年龄在 18 至 66 岁之间、临床稳定的门诊患者。根据《精神障碍诊断与统计手册》第五版的标准，所有患者均被诊断为精神分裂症。对每位患者进行临床评估、安全性和耐受性以及药物血浆水平测定。临床疗效通过简明精神病评定量表、阳性和阴性症状量表以及汉密尔顿抑郁评定量表进行评估。在研究的前 4 个月，每月给予棕榈酸帕利哌酮 1 次，然后在接下来的 9 个月给予 3 月制剂。
结果/发现：简明精神病评定量表总分的时间过程显示，从 T0 到 T8 有统计学意义的（P = 0.006）改善；阳性和阴性症状量表评分也呈现出类似的时间过程，平均总分有统计学意义的（P = 0.0016）降低；汉密尔顿抑郁评定量表平均评分显示有统计学意义的（P = 0.003）降低，同时患者的临床稳定状态得到了实质性的维持。只有 1 名患者在首次接受 PP3M 注射后退出。
我们的初步数据目前证实了从 PP1M 转换为 PP3M 后临床稳定性的维持。
