116例未成年精神分裂症患者应用利培酮的开放性试验

Open-label trial of risperidone in treatment of schizophrenia in 116 cases of children or adolescent

目的:了解利培酮治疗未成年精神分裂症的疗效与安全性。方法:收集未成年精神分裂症患者,停用其他抗精神病药,以可变剂量利培酮治疗,以简明精神疾病量表(BPRS)、临床疗效评定、看护者疗效评定、临床总体印象量表(CGI)评定疗效,以TESS、合并用药情况、实验室监测评价安全性。于基线时、试验第1,2,4,8,12和16周末进行各项评定和检查。结果:共收集年龄10～17岁的有效病例116例。研究结束时,BPRS减分率≥50％者为88.8％;医生临床评定为“痊愈”或“显著好转”者为83.6％;看护者评定为“很有效”者为67.2％;以3种方法评定为“无效或恶化”者均<7％。根据利培酮最高日剂量分为高剂量组(>4mg·d^(-1))与低剂量组(≤4mg·d^(-1)),试验结束时低剂量组的BPRS减分率大于高剂量组,差异显著。CGI-Ⅰ中位数从6分变为2分;CGI-Ⅱ中位数从4分变为1分。主要不良反应为静坐不能5例(4.5％)、震颤4例(3.6％)、体重增加4例(3.6％)、失眠3例(2.7％)、心动过速3例(2.7％)、视物模糊2例(1.8％)。患者的依从性高,达95％以上,没有因不良反应提前退出试验者,亦未发现严重不良事件。CGI-Ⅲ中位数在治疗16周末时为4。结论:利培酮治疗未成年精神分裂症安全、有效。

Objective:To study the efficacy and safety of resperidone in treatment of schizophrenia in children or adolescent. Methods: Children or adolescent patients with schizophrenia were enrolled into the study. They were treated with flexible doses of resperidone after stop other antipsychotic drugs. The effectiveness was evaluated with BPRS,clinical records, nurses rating,and CGI and the safety was evaluated with TESS and laboratory data. Results:At the end of the study,67%-89% patient were significantly improved or recovered while less than 7 % were no response or worsened. The BPRS reduction in resperidone high dose ( >4mg·d-1 ) group was significantly lower than those in resperidone low dose (≤4mg·d-1) group at the end point. CGI-1 and CGI-Ⅱ scores were changed from 6 to 2 and 4 to 1 respectively. The side effects observed were akathisia, tremor, weight gain, insomnia, and techycardia and no severe side effect was observed. Conclusion: Resperidone is safe and effective in treatment of children or adolescent with schizophrenia.