Zhao Jingping, Li Lehua, Shi Jianguo, Li Yi, Xu Xiufeng, Li Keqing, Zhang Lili, Cai Shangli, Feng Yu, Zhuo Jianmin, Liu Weihong, Lu Huafei
Department of Psychiatry, The Mental Health Institute, The Second Xiangya Hospital of Central South University.
Department of Psychiatry, Mental Health Center of Xi'an City.
Neuropsychiatr Dis Treat. 2017 Aug 2;13:2045-2056. doi: 10.2147/NDT.S131224. eCollection 2017.
Long-acting injectable (LAI) paliperidone palmitate 1-month formulation (PP1M) has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.
The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.
In this 25-week, open-label, Phase IV study, patients (18-65 years) diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS) total score of 60-120 (inclusive) were enrolled. All patients received injections of PP1M 150 mg eq. (day 1) and 100 mg eq. (day 8), followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq.).
Of the 353 patients, 234 (66.3%) completed the study treatment (mean age, 31.1 years; 52.7% men). The PANSS total score (primary end point) improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30]; <0.0001). The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points) also improved significantly (<0.0001). At 6 months, PP1M had a positive impact on medication satisfaction, adherence, and increased preference for LAIs. Treatment-emergent adverse events (TEAEs) were reported by 181 (51.3%) patients (TEAEs ≥5%: extrapyramidal disorder [15.3%], akathisia [10.5%], blood prolactin increase [8.8%], insomnia [5.4%]). A total of 8 deaths were reported, including 4 completed suicides.
Long-term treatment with PP1M was efficacious, and no new safety concerns were identified in Chinese patients with schizophrenia. Overall, the results were comparable with observations from previous studies.
长效注射用帕利哌酮棕榈酸酯1个月剂型（PP1M）在西方和亚洲精神分裂症患者中已显示出可接受的耐受性和良好的临床疗效。因此，专门分析PP1M在中国患者中的长期治疗结果具有重要意义。
本研究旨在评估PP1M治疗中国精神分裂症患者的长期安全性和有效性。
在这项为期25周的开放标签IV期研究中，纳入了年龄在18至65岁之间、诊断为精神分裂症且基线阳性和阴性症状量表（PANSS）总分在60至120（含）之间的患者。所有患者接受150 mg当量的PP1M注射（第1天）和100 mg当量的注射（第8天），随后进行灵活的每月一次维持给药（75、100或150 mg当量）。
353例患者中，234例（66.3%）完成了研究治疗（平均年龄31.1岁；52.7%为男性）。在6个月的治疗期内，PANSS总分（主要终点）显著改善（从基线到治疗结束的平均[标准差]变化为-27.2 [18.30]；<0.0001）。临床总体印象-严重程度以及个人和社会功能量表评分（次要终点）也显著改善（<0.0001）。在6个月时，PP1M对药物满意度、依从性以及对长效注射剂的偏好增加有积极影响。181例（51.3%）患者报告了治疗中出现的不良事件（TEAEs≥5%：锥体外系疾病[15.3%]、静坐不能[10.5%]、血催乳素升高[8.8%]、失眠[5.4%]）。共报告8例死亡，包括4例完全自杀。
PP1M长期治疗有效，在中国精神分裂症患者中未发现新的安全问题。总体而言，结果与先前研究的观察结果相当。
