利培酮口服液与利培酮片剂治疗老年期精神分裂症疗效与安全性的对照研究

A comparatire study of risperidone oral solution and risperidone tablets in the treatment of elderly schizophrenia

目的比较利培酮口服液与利培酮片剂治疗老年期精神分裂症的疗效和安全性。方法将68例老年期精神分裂症患者随机分为利培酮口服液组和利培酮片剂组。疗程8周,使用阳性与阴性症状量表评定临床疗效,使用副反应量表评定药物不良反应。结果两组在治疗后的第2周均起效,PANSS分数在两组治疗后的2、4、8周降低与治疗前比较其差异均有显著性(P<0.01);利培酮口服液组有效率85.7%,利培酮片剂组有效率87.9%;8周末利培酮口服液与片剂的不良反应主要为肌强直、震颤,约20%～25%,其次为失眠、便秘与食欲差等,约9%～11%,但上述症状发生均较轻,未经特殊处理。两组不良反应发生率比较其差异无显著性(P>0.01)。结论利培酮口服液与利培酮片剂治疗老年期精神分裂症有相同的疗效,安全性高、耐受性好。与利培酮片剂相比口服液给药途径方便,更适合老年患者使用。

Objective To compare the efficacy and safety of risperidone oral solution and risperidone tablets in the treatment of elderly schizophrenia. Methods A total of 68 aged patients with schizophrenia were randomly divided into risperidone oral solution group and risperidone tablets group respectively for 8 weeks of treatment. The efficacy was evaluated by Positive and Negative Symptom Scale （PANSS）,and the side effects by Treatment Emergent Symptom Scale （TESS）. Results Efficacy of two groups started in the 2nd weekend after treatment. Significant differences were found in the reduction of PANSS score between each stage （respectively in the 2nd,4th ,8th week after treatment）and baseline in both groups（P〈0.01）. The effective rate in risperidone oral solution group was 85.7% ,and in risperidone tablets group was 87.9%. The efficacy and side effects of two groups at the end of 8th week were mainly myotonia and tremor（20%-25%）, then insomnia, constipation and bad appetite（9%-11%） and there were no significant differences between two groups. Conclusion Risperidone oral solution has high safety , good tolerability and similar curative effects to risperidone tablets, and more convenient administration route which is more suitable for elderly patients .