帕利哌酮缓释片与利培酮片治疗精神分裂症对照研究

A clinical controlled study on schizophrenia treated with paliperidone-ER and risperidone

目的:比较帕利哌酮缓释片与利培酮片治疗精神分裂症的疗效和不良反应。方法:64例精神分裂症患者随机分为研究组和对照组各32例,分别给予帕利哌酮缓释片与利培酮治疗。疗程8周。分别于治疗前和治疗1、2、4和8周采用阳性与阴性症状量表(PANSS)评定疗效;以治疗中出现的症状量表(TESS)评定不良反应。结果:研究组显效率和有效率分别为59.4%和81.2%,对照组分别为57.1%和75.0%,两组比较,差异无统计学意义(P>0.05)。两组PANSS评分治疗后均较治疗前明显下降(P<0.05或P<0.01),以研究组阴性症状因子分在治疗4周和8周时[分别为(15.8±3.1)分和(11.9±2.1)分]显著低于对照组[分别为(20.2±3.2)分和(17.6±5.4)分],两组比较,差异有统计学意义(P<0.05或P<0.01)。结论:帕利哌酮缓释片是一种安全有效的抗精神病药,对阴性症状的改善更为显著。

Objective：To compare the efficacy and side effects of paliperidone-ER and risperidone in treating schizophrenia. Method：64 patients of schizophrenia were treated with paliperidone-ER（n=32） or risperidone（n=32）randomly,for 8 weeks.The efficacy was assessed with the positive and negative symptoms scale （PANSS）,and the safety was assessed with treatment emergent symptoms scale （TESS） before treatment and at the ends of week 1,2,4 and 8 treatment,respectively. Results：The significantly effective rate and effective rate of paliperidone-ER were 59.4% and 81.2%,and of risperidone were 57.1% and 75.0% respectively,and there were no significant differences between two groups（P0.05）,Paliperidone-ER group showed lower negative symptom score at week 4 （15.8±3.1 vs 20.2±3.2,P0.05） and at week 8 （11.9±2.1 vs 17.6±5.4,P0.01） than risperidone group,although the scores decreased after 4 and 8 weeks. Conclusion：Paliperidone-ER is an effective and safe antipsychotic drug with more showing significant improvement compared with risperidone in negative symptoms.