接受第二代抗精神病药物治疗的精神分裂症患者停药和缓解率及社会功能：JUMPs 的 52 周随机、开放标签研究。
Discontinuation and remission rates and social functioning in patients with schizophrenia receiving second-generation antipsychotics: 52-week evaluation of JUMPs, a randomized, open-label study.
机构信息
Department of Psychiatry, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.
Department of Psychiatry, National Center of Neurology and Psychiatry, Tokyo, Japan.
出版信息
Psychiatry Clin Neurosci. 2022 Jan;76(1):22-31. doi: 10.1111/pcn.13304. Epub 2021 Nov 17.
AIM
Globally, evidence from short-term studies is insufficient for the guidelines to uniformly recommend a particular antipsychotic(s) for the maintenance treatment of schizophrenia. Therefore, long-term comprehensive evaluation of antipsychotics is required from a social rehabilitation perspective, especially for drugs that have not yet been studied. The Japan Useful Medication Program for Schizophrenia (JUMPs) is a large-scale, long-term naturalistic study to present pivotal 52-week data on the continuity of second-generation antipsychotics (SGA: aripiprazole, blonanserin, and paliperidone).
METHODS
JUMPs was an open-label, three-arm, randomized, parallel-group, 52-week study. Enrolled patients had schizophrenia, were ≥20 years old, and required antipsychotic treatment or switched from previous therapy. The primary endpoint was treatment discontinuation rate over 52 weeks. Secondary outcomes included remission rate, social functioning, and quality-of-life scores [Personal and Social Performance Scale (PSP) and EuroQol-5 dimensions], and safety.
RESULTS
In total, 251 patients received aripiprazole (n = 82), blonanserin (n = 85), or paliperidone (n = 84). The discontinuation rate (P = 0.9771) and remission rates (P > 0.05) over 52 weeks did not differ significantly between the three treatment groups. The discontinuation rates were 68.3%, 68.2%, and 65.5% in the aripiprazole, blonanserin, and paliperidone groups, respectively. Significant improvements (all P < 0.05) from baseline in PSP scores were observed at start of monotherapy, week 26, and week 52 in the overall cohort and blonanserin group and at week 26 in the aripiprazole group. The adverse event profile favored blonanserin.
CONCLUSION
All three SGAs evaluated in this study showed similar treatment discontinuation rates in patients with chronic schizophrenia in Japan.
目的
从短期研究来看，全球证据尚不足以让指南统一推荐某种特定的抗精神病药物用于精神分裂症的维持治疗。因此，需要从社会康复的角度对各种抗精神病药物进行长期综合评估，尤其是对尚未进行研究的药物。日本精神分裂症有效药物项目（JUMPs）是一项大规模、长期的自然主义研究，旨在提供 52 周第二代抗精神病药物（SGA：阿立哌唑、布南色林和帕利哌酮）连续性的关键数据。
方法
JUMPs 是一项开放标签、三臂、随机、平行组、52 周研究。入组患者患有精神分裂症，年龄≥20 岁，需要抗精神病药物治疗或从之前的治疗中转换。主要终点是 52 周时的停药率。次要结局包括缓解率、社会功能和生活质量评分[个人和社会表现量表（PSP）和欧洲五维健康量表（EQ-5D）]，以及安全性。
结果
共有 251 名患者接受了阿立哌唑（n=82）、布南色林（n=85）或帕利哌酮（n=84）治疗。三组治疗 52 周时的停药率（P=0.9771）和缓解率（P＞0.05）无显著差异。阿立哌唑、布南色林和帕利哌酮组的停药率分别为 68.3%、68.2%和 65.5%。整体队列和布南色林组从基线开始，PSP 评分在单药治疗开始时、第 26 周和第 52 周时均有显著改善（均 P＜0.05），阿立哌唑组在第 26 周时也有显著改善。不良事件谱有利于布南色林。
结论
在日本慢性精神分裂症患者中，本研究评估的三种 SGA 药物的停药率相似。
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