注射用利培酮微球对精神分裂症患者维持治疗的疗效和安全性研究

摘要

Objective To evaluate the efficacy and safety of risperidone long-acting injection (RLAI) in the maintenance treatment for schizophrenia.Methods This was an open label, single arm and multi-center study.Two hundred schizophrenic patients switching from other antipsychotics accepted the treatment of two-week interval injections of RLAI for nine months.The dosages were 25.0 mg, 37.5 mg or 50.0 mg every two weeks.The patients were assessed with the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) rating scale, etc.Safety was assessed with adverse event report, the Extrapyramidal Symptom Rating Scale (ESRS), laboratory test and ECG examination.Results The intend-to-treat (ITT) analysis was included 192 cases and per-protocol (PP) analysis was 169 cases.The PANSS total score were(68.05±22.79), (61.10±21.91), (55.08± 21.29 ), (51.26 ±20.62)and (48.88±19.92)at baseline, 4th, 12th, 24th and 36th week respectively.The reduction of PANSS total score was (19.17±21.50) from baseline to the endpoint.There were significant differences on the scores between at baseline and each of visits after treatment (P<0.01).The improvement and remission rates were 65.6% and 58.9% respectively.According to the CGI-S score, the total patient number of normal,borderline and mild was 135 (70.3%).There were 106 patients (55.2%) reported AE, and the common adverse event were EPS (28.5%), sleep disorder (10.1%), akathisia (7.2%), ECG change (6.3%),weight gain (5.8%) and upper respiratory tract infection (5.3%), etc.Conclusion RLAI is effective and safe in the maintenance treatment of schizophrenia.%目的 评价注射用利培酮微球(RLAI)用于精神分裂症维持治疗的疗效和安全性.方法 为开放、单组的多中心研究.200例精神分裂症患者原使用的抗精神病药换用RLAI维持治疗9个月,治疗期间每2周注射RLAI 25.0 mg、37.5 mg或50.0 mg;在基线及第4,12,24,36周末评定阳性和阴性症状量表(PANSS)、临床总体印象量表等量表评分;以基线与研究终点PANSS总分的变化为主要疗效指标.安全性指标包括不良事件、锥体外系不良反应量表、实验室检查和心电图检查等.结果 200例中意向性治疗集192例,符合方案集169例;患者PANSS总分在基线和治疗第4,12,24和36周末分别为(68.05±22.79)分、(61.10±21.91)分、(55.08±21.29)分、(51.26±20.62)分和(48.88±19.92)分,治疗第36周末总分下降(19.17±21.50)分;治疗后各随访时点评分与基线的差异均有统计学意义(秩和检验,P均<0.01).根据PANSS评分,治疗改善率和临床痊愈率分别为65.6%和58.9%.在治疗第36周末,临床总体印象量表-严重程度评分中正常、边缘性有病及轻度有病者共135例(70.3%).192例中106例(55.2%)报告有不良事件,常见的有锥体外系不良反应(EPS,28.5%),睡眠障碍(10.1%),静坐不能(7.2%),心电图改变(6.3%)、体质量增加(5.8%)和上呼吸道感染(5.3%)等.结论 RLAI用于精神分裂症维持治疗有效而安全.