利培酮治疗精神分裂症2484例临床研究

Open clinical trial of risperidone in the treatment of 2482 schizophrenics

目的 了解利培酮在中国的应用概况。方法 在 2 484名使用利培酮的精神分裂症病人中 ,采用《临床总体印象量表》(CGI)、《阳性与阴性综合征量表》(PANSS)及不良反应量表 ,在利培酮治疗 8周前后进行评定分析。结果 在治疗第 8周末继续服用利培酮者占 97.0 2 % ,其中 96 .6 0 %服用剂量≤ 6mg·d-1,各项精神症状均较治疗前明显减轻 ,总体疗效达显著改善以上者占 6 3.2 % ,不良反应均较利培酮治疗前减轻。停用利培酮者占 2 .98%。结论 利培酮是有效。

Objective To study the efficacy and safety of risperidone in the treatment of schizophrenics in Chinese population. Methods The subjects were 2 484 schizophrenic outpatients or inpatients who were treated with risperidone for 8 weeks in 20 cities. They were assessed with Global Clinical Impression (CGI), brief Positive and Negative Syndrome Scale (PANSS) and a self compiled side effects scale before and after the risperidone trial. Results (1) At the end of 8 week trial 97.02% of the patients continued risperidone therapy and 96.60% of them took risperidone at a dose of 6 mg/day or less. All the psychiatric symptoms were significantly less severe after the trial than before the trial. 63.2% of these patients improved significantly or very significantly. All the side effects were lessened after the trial but only tardive dyskinesia had statistically significant decrease. (2) At the end of the trial 2.98 % of patients discontinued risperidone. The risk factors of discompliance included female, outpatient and first onset. Conclusion Risperidone is effective and safe in treating psychotics in China. Its side effects, especially EPS, are less frequent and milder than those of traditional antipsychotics.