The aim of this study was to perform a systematic review of the effects of 1-month paliperidone palmitate (PP1M) for the treatment of schizophrenia and related psychotic disorders in terms of outcomes reported in real-world evidence studies. A systematic review of real-world randomized and nonrandomized studies with PP1M was performed and is reported according to PRISMA guidelines. Comparative effectiveness data with oral antipsychotics indicate that PP1M has a lower likelihood of relapse-related events, including rehospitalization, and these differences are clinically relevant. A randomized, double-blind study showed that PP1M has no advantage over haloperidol decanoate in the time to treatment failure. Although there was a marked variability across studies, PP1M was not superior to other antipsychotics in terms of study completion rates. Pharmacoeconomic data show that, during a follow-up period of 12 months, the mean total healthcare cost was not significantly different in patients treated with PP1M compared with those receiving oral antipsychotics. The mean maximum prolactin levels were significantly higher with PP1M than with haloperidol decanoate; however, neither drug differs in the frequency of prolactin-related adverse events. Results on prolactin-related adverse events were inconsistent in two randomized comparisons with oral antipsychotics and were not reported in a randomized comparison with aripiprazole. There were no significant differences between haloperidol decanoate and PP1M in the severity of abnormal involuntary movements and parkinsonism, or in the incidence of tardive dyskinesia; however, patients treated with haloperidol decanoate showed greater worsening of akathisia and required treatment for parkinsonism and akathisia significantly more frequently than patients who received PP1M. In conclusion, real-world data that originate from both pragmatic randomized clinical trials and observational studies indicate that PP1M is superior to oral antipsychotics in delaying the time to relapse or treatment failure. Furthermore, the pharmacoeconomic data reviewed for this article suggest that the advantages of PP1M compared with oral antipsychotics are not associated with an increased total cost for healthcare providers.

中文翻译：

---

帕潘立酮棕榈酸酯治疗精神分裂症和其他精神病的真实世界数据：对随机和非随机研究的系统评价。

这项研究的目的是根据实际证据研究中报告的结果，对1个月帕潘立酮棕榈酸酯（PP1M）对精神分裂症和相关精神病的治疗效果进行系统评价。系统地审查了PP1M在现实世界中的随机和非随机研究，并根据PRISMA指南进行了报道。口服抗精神病药的有效性比较数据表明，PP1M与复发相关事件（包括重新住院）的可能性较低，并且这些差异在临床上具有相关性。一项随机，双盲研究表明，PP1M在治疗失败的时间上没有优于氟哌啶醇癸酸酯的优势。尽管各研究之间存在显着差异，但就研究完成率而言，PP1M并不优于其他抗精神病药。药物经济学数据显示，在12个月的随访期内，与接受口服抗精神病药的患者相比，接受PP1M治疗的患者的平均总医疗费用没有显着差异。PP1M的平均最大催乳素水平显着高于氟哌啶醇癸酸酯。但是，这两种药物在催乳激素相关不良事件发生频率上均没有差异。催乳素相关不良事件的结果在与口服抗精神病药的两次随机比较中不一致，在与阿立哌唑的随机比较中没有报道。氟哌啶醇癸酸酯和PP1M在异常不自主运动和帕金森病的严重程度或迟发性运动障碍的发生率方面无显着差异。然而，接受氟哌啶醇癸酸酯治疗的患者比接受PP1M的患者表现出更严重的静坐无力恶化，并且需要接受帕金森氏病和静坐无力治疗的频率更高。总之，来自实用随机临床试验和观察性研究的真实数据表明，PP1M在延迟复发或治疗失败方面优于口服抗精神病药。此外，本文所审查的药物经济学数据表明，与口服抗精神病药相比，PP1M的优势与医疗保健提供者的总成本增加无关。来自实用随机临床试验和观察性研究的真实数据表明，PP1M在延迟复发或治疗失败方面优于口服抗精神病药。此外，本文所审查的药物经济学数据表明，与口服抗精神病药相比，PP1M的优势与医疗保健提供者的总成本增加无关。来自实用随机临床试验和观察性研究的真实数据表明，PP1M在延迟复发或治疗失败方面优于口服抗精神病药。此外，本文所审查的药物经济学数据表明，与口服抗精神病药相比，PP1M的优势与医疗保健提供者的总成本增加无关。