Shi Chuan, Yao Shu Qiao, Xu Yi Feng, Shi Jian Guo, Xu Xiu Feng, Zhang Cong Pei, Jin Hua, Yu Xin
Clinical Research Center, Peking University Sixth Hospital; Clinical Research Center, Peking University Institute of Mental Health; Key Laboratory of Mental Health, Ministry of Health (Peking University); National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing.
Clinical Center of Psychology, The Second Xiangya Hospital, Central South University, Changsha, Hunan Province.
Neuropsychiatr Dis Treat. 2016 Aug 24;12:2095-104. doi: 10.2147/NDT.S112542. eCollection 2016.
This single-arm, open-label study aimed to explore the effects of extended-release paliperidone on social and cognitive function in patients with schizophrenia.
Paliperidone extended-release (flexible dose ranging from 3 to 12 mg/day orally) was administered for 24 weeks in patients with schizophrenia. Patient function was assessed using the personal and social performance scale, measurement and treatment research to improve cognition in schizophrenia initiative-consensus cognitive battery, positive and negative syndrome scale, and clinical global impression-severity.
Ninety patients were included in the full analysis set, while 72 patients were included in the per protocol set. The personal and social performance score was 54.3±14.3 at baseline, and significantly increased to 73.4±12.6 at week 24 (P<0.001). For the measurement and treatment research to improve cognition in schizophrenia initiative-consensus cognitive battery assessment, six of the nine individual subtests, six of the seven cognitive domains, and total cognitive scores improved significantly (P<0.05) between baseline and endpoint. positive and negative syndrome scale total scores and clinical global impression-severity scores decreased gradually (P<0.001) from week 4 to the conclusion of the study.
Paliperidone extended-release treatment significantly improves social and neurocognitive function as well as symptoms in Chinese patients with schizophrenia.
本单臂、开放标签研究旨在探讨缓释帕利哌酮对精神分裂症患者社交和认知功能的影响。
对精神分裂症患者口服缓释帕利哌酮（灵活剂量范围为3至12毫克/天），持续给药24周。使用个人和社会表现量表、改善精神分裂症认知的测量与治疗研究共识认知成套测验、阳性和阴性症状量表以及临床总体印象严重程度来评估患者功能。
完整分析集纳入90例患者，符合方案集纳入72例患者。个人和社会表现评分在基线时为54.3±14.3，在第24周时显著提高至73.4±12.6（P<0.001）。在改善精神分裂症认知的测量与治疗研究共识认知成套测验评估中，九个单项子测验中的六个、七个认知领域中的六个以及总认知评分在基线和终点之间显著改善（P<0.05）。从第4周直至研究结束，阳性和阴性症状量表总分以及临床总体印象严重程度评分逐渐下降（P<0.001）。
缓释帕利哌酮治疗可显著改善中国精神分裂症患者的社交和神经认知功能以及症状。
