帕利哌酮缓释片与奥氮平治疗难治性精神分裂症的对照研究

A comparative study of paliperidone and olanzapine in the treatment of treatment-refractory schizophrenia

目的:比较帕利哌酮缓释片与奥氮平对难治性精神分裂症的疗效及安全性。方法:将30例难治性精神分裂症患者随机分为帕利哌酮组[15例,(10.1±2.6)mg.d-1]和奥氮平组[15例,(14.6±5.8)mg.d-1],疗程为12周。采用阳性和阴性症状量表(PANSS)和治疗中需处理的不良反应症状量表(TESS),在治疗前及治疗第1,2,4,8和12周末分别评定疗效和不良反应。结果:①帕利哌酮组PANSS总分、阳性症状分及一般病理分从治疗第1周末起,阴性症状分从第2周末起较治疗前下降(P<0.05);奥氮平组PANSS总分、阳性症状分、阴性症状分及一般病理分均从治疗第2周末起较治疗前下降(P<0.05);两组PANSS总分及各因子分自第2周末起差异无统计学意义。②治疗第12周末,帕利哌酮组和奥氮平组临床总有效率分别为73%(11/15)和67%(10/15),差异无统计学意义。③帕利哌酮组和奥氮平组的不良反应发生率分别为47%(7/15)和53%(8/15),差异无统计学意义。其中,帕利哌酮组异常泌乳和(或)闭经发生率高于奥氮平组(P<0.05),奥氮平组体质量增加及糖耐量异常发生率高于帕利哌酮组(P<0.01)。结论:帕利哌酮缓释片对难治性精神分裂症疗效良好且不良反应轻微。

Objective： To compare the efficacy and safety of paliperidone and olanzapine in the treatment of treatment-refractory schizophrenia. Methods： 30 patients with treatment-refractory schizophrenia were randomly assigned topaliperidone [15 cases, （10.1 ±2.6） mg.d^-1] and olanzapine [15 cases, （14.6±5.8） mg.d-^1] for 12 weeks treatment, and the Positive and Negative Symptom Scale （PANSS） and the Treatment Emergent Symptom Scale （TESS） were used to evaluate the effect and the side effect before and 1, 2, 4, 8, 12-week after treatment. Results： ① The PANSS score, positive symptom and general path-score of paliperidone group was decreased significantly （ P 〈 0.05 ） since the end of 1-week treatment. The negative symptom score was decreased significantly （P 〈0.05） since the end of 2-week treatment. The PANSS score, positive symptom, negative symptom and general path-score of olanzapine group was decreased significantly （ P 〈 0.05 ） since the end of 2-week treatment. There was no difference in The PANSS score, positive symptom, negative symptom and general path-score between the two groups since the end of 2-week treatment. ② After 12 weeks treatment, the total effective rates of paliperidone and olanzapine groups were 73% （11/15） and 67% （10/15） respectively, which showed no difference. ③ The side effect rates of paliperidone and olanzapine groups were 47% （7/15） and 53% （8/15） respectively, which showed no difference. The incidence rate of Abnormal lactation and menostasia of paliperidone group were higher than that of olanzapine groups （P 〈 0. 05） , while the incidence rate of increased weight and abnormal