注射用利培酮微球治疗精神分裂症的疗效和安全性研究

The efficacy and safety of risperidone long-acting injectable for the treatment of schizophrenia

目的 评估注射用利培酮微球（LAIR）对中国人群治疗精神分裂症的疗效和安全性.方法 采用前瞻性、开放、多中心研究方法,对251例符合美国精神障碍诊断与统计手册第4版诊断标准的精神分裂症患者进行LAIR治疗,每2周注射1次,观察期为12周.分别在基线和治疗第4,6,8,12周末进行阳性和阴性症状量表（PANSS）评分、临床总体印象量表评分等,并记录治疗中的不良事件.结果 治疗4周后,PANSS评分均较治疗前持续下降（P〈0.01） 而病程≤2年患者的PANSS总分[（28.01±24.74）分]降低程度显著优于病程〉2年者[（22.34±20.46）分] P〈0.01.治疗第4周末,临床总体印象量表-严重程度（CGI-S）评分较基线显著降低（P〈0.01）.总体不良事件发生率为12.4%,多为轻、中度不良事件.结论 LAIR治疗精神分裂症安全、有效,对病程较短者疗效更好.

Objective To evaluate the efficacy and safety of risperidone long-acting injectable （LAIR） for the treatment of schizophrenia in a large sample size in Chinese population.Methods This was an open-label, multi-center and prospective study in naturalistic treatment.Patients suffering from schizophrenia and schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders-IV diagnostic criteria were treated with LAIR for 12 weeks, every two weeks a time.The PANSS total score, positive and negative symptom scores, Clinical Global Impressions-Severity and Clinical Global Impressions-Improvement were evaluated at baseline, and the 4th, 6th, 8th, 12th week treatment respectively.The adverse events were recorded.Results Altogether 251 patients from 17 hospitals across China were enrolled in the study.From the end of 4th week to the end of 12th week, the PANSS total score,positive and negative symptom scores, general psychopathology score significantly decreased compared with the baseline score （P〈0.01）.The effective rate, improvement rate and the percentage of patients who met the criteria of clinical relief were 57.4%, 79.9% and 76.6%, respectively.At the end of 4th week, the better decline level on PANSS score were in patients with illness duration of 2 years or shorter than that in ones with duration of longer than 2 year, and this trend persisted into the end of treatment.The total adverse events rate was 12.4%, and most were mild and moderate.Conclusions LAIR is effective and safe for treatment of schizophrenia and schizoaffective disorder, with better effect in patients with shorter illness duration.