利培酮片剂与微球制剂治疗精神分裂症的对照研究

Comparison of effects between risperidone microballoons and risperidone tablets on schizophrenia

目的探讨利培酮片剂与微球制剂用于治疗精神分裂症的疗效及不良反应。方法45例精神分裂症患者随机分为利培酮片剂组(n=23)和微球制剂组(n=22),根据患者治疗前及治疗第8、16周末的阳性和阴性症状量表(PANSS)评分,以PANSS减分率为疗效评定依据。治疗第8、16周末采用不良反应量表(TESS)评定不良反应。结果与治疗前相比,治疗第8、16周末片剂组及微球制剂组PANSS评分均显著降低,且差异有统计学意义;组间相比,治疗第8周末微球制剂组PANSS评分低于片剂组,且差异有统计学意义(P<0.05),治疗第8、16周末两组TESS评分差异无统计学意义(P>0.05)。结论治疗早期利培酮微球制剂较片剂疗效更显著,治疗结束时两种剂型疗效及不良反应无显著差异。

Objective To investigate the difference of efficacy and adverse reactions between risperidone tablets and risperidone microballoons in the treatment of schizophrenia. Methods Forty-five patients with schizophrenia were randomly divided into risperidone tablets group （n = 23） and risperidone microballoons group （n = 22）. All the patients enrolled were performed positive and negative syndrome scale （PANSS）score before and after 8 as well as 16 weeks of treatment. The rate of decreased PANSS score was used to evaluate the curative effect. Treatment emergent symptom scale （TESS）was used to evaluate the adverse reactions and patients should perform TESS score after 8 and 16 weeks of treatment. Results Compared with pretherapy, PANSS score of both groups decreased significantly after treatment. The effective rate of microballoons group was higher than tablets group （P 〈 0.05） after 8 weeks of treatment. There was no difference in the curative effect between two groups after 16 weeks of treatment （P 〉 0.05）. There were no differences in TESS score between two groups after 8 and 16 weeks of treatment. Conclusion Risperidone can be used effectively and safely in the treatment of schizophrenia. Compared with risperidone tablets, the effect of risperidone microballoons in the earlier period of treatment is more significantly.