Mathews Maju, Gopal Srihari, Nuamah Isaac, Hargarter Ludger, Savitz Adam J, Kim Edward, Tan Wilson, Soares Bernardo, Correll Christoph U
Department of Neuroscience, Janssen Research & Development, LLC, Raritan, NJ, USA.
Department of Neuroscience, Janssen-Cilag EMEA, Neuss, Deutschland.
Neuropsychiatr Dis Treat. 2019 May 21;15:1365-1379. doi: 10.2147/NDT.S197225. eCollection 2019.
Antipsychotics are the mainstay in schizophrenia management, and long-acting injectable (LAI) antipsychotics contribute to the successful maintenance of treatment by improving non-adherence and preventing relapses. Paliperidone palmitate 3-monthly (PP3M) formulation is the only available LAI antipsychotic that offers an extended 3-month window of stable plasma drug concentration, enabling only four injections per year. This paper summarizes clinically relevant endpoints from available evidence for PP3M to bridge translational research gaps and provide measurable outcomes that can be interpreted in clinical practice. Low number-needed-to-treat (NNT) for relapse prevention (NNT [95% CI] 6-month estimate: 4.8 [3.2; 10.0]; 12-month estimate: 3.4 [2.2; 7.0]), and high number-needed-to-harm (NNH [95% CI] akathisia, 27.1 [12.3; -667.1]; tremor, 80.0 [22.5; 67.3]; dyskinesia, -132.6 [44.5; -23.2]; parkinsonism, 160.0 [28.9; -49.8]) quantify the relative benefits and low propensity for adverse events with PP3M. Symptom remission and reductions in positive and negative symptoms indicate treatment stability. Additionally, meaningful functional remission, reduced dosing frequency, and freedom from daily negotiations favorably impact patient preference and attenuate burdensome aspects of caregiving, representing important healthcare determinants that enhance prospects of treatment continuity in schizophrenia. This information can potentially improve clinicians' judgment of treatment choices, clinical response, and patient selection in routine care. Taken together, PP3M is a valuable antipsychotic treatment option, meriting consideration for a broader role in the long-term management of schizophrenia; its utility should not be limited to patients with poor adherence or when oral antipsychotics have failed.
抗精神病药物是精神分裂症治疗的主要手段，长效注射（LAI）抗精神病药物通过改善依从性和预防复发，有助于成功维持治疗。棕榈酸帕利哌酮3个月剂型（PP3M）是唯一一种可提供长达3个月稳定血浆药物浓度窗口的LAI抗精神病药物，每年只需注射4次。本文总结了PP3M现有证据中的临床相关终点，以弥合转化研究差距，并提供可在临床实践中解读的可测量结果。预防复发的低治疗所需人数（NNT [95% CI] 6个月估计值：4.8 [3.2；10.0]；12个月估计值：3.4 [2.2；7.0]），以及高伤害所需人数（NNH [95% CI] 静坐不能，27.1 [12.3；-667.1]；震颤，80.0 [22.5；67.3]；运动障碍，-132.6 [44.5；-23.2]；帕金森症，160.0 [28.9；-49.8]）量化了PP3M的相对益处和不良事件的低发生率。症状缓解以及阳性和阴性症状的减轻表明治疗稳定。此外，有意义的功能缓解、给药频率降低以及无需每日服药，对患者偏好产生有利影响，并减轻了护理的繁重方面，代表了重要的医疗保健决定因素，可增强精神分裂症治疗连续性的前景。这些信息可能会改善临床医生在常规护理中对治疗选择、临床反应和患者选择的判断。综上所述，PP3M是一种有价值的抗精神病治疗选择，值得在精神分裂症的长期管理中发挥更广泛的作用；其效用不应仅限于依从性差的患者或口服抗精神病药物治疗失败的情况。
