帕利哌酮缓释片与氯氮平治疗难治性精神分裂症对照研究

A comparative study on efficacy and safety of paliperidone extended-release tablets and clozapine in treatment of resistant schizophrenia

目的:比较帕利哌酮缓释片与氯氮平治疗难治性精神分裂症的疗效及安全性。方法:50例难治性精神分裂症患者随机分为研究组(n=25)与对照组(n=25),分别给予帕利哌酮缓释片和氯氮平单药治疗,观察时间为12周。采用阳性和阴性症状量表(PANSS)及药物不良反应评定量表(TESS)评价临床疗效及安全性。结果:研究组有效率为72%,对照组有效率为68%,组间比较差异无统计学意义。至研究终点,两组患者PANSS总分及分量表分均较治疗前显著下降(P<0.01);治疗后仅在第2周组间比较PANSS总分及阳性症状分差异有统计学意义(P<0.05)。对照组嗜睡、过度镇静、头晕/头痛、心电图异常及性功能障碍发生率显著高于研究组(P<0.05);治疗12周末研究组TESS评分显著低于对照组(P<0.05);对照组总不良反应发生率为56%,研究组为28%,组间比较差异有统计学意义(P<0.05)。结论:帕利哌酮缓释片治疗难治性精神分裂症疗效与氯氮平相当,但起效更快,安全性高,有利于提高患者的依从性。

Objective：To compare the efficacy and safety of paliperid＇one extended-release tablets （ER） and clozapine for treating treatment resistant schizophrenia （TRS）. Methods：Totally 50 TRS patients were ran- domly divided into study group （ n = 25 ） and control group （ n = 25） and treated with paliperidone EI/and elozapine correspondingly for 12 weeks. Positive and Negative Syndrome Scale （PANSS） and Treatment Emergent Symptom Scale （TESS） were used to evaluate the efficacy and safety. Results： The effective rate in the two groups （72% and 68% ） had no statistically significant difference. At the end of the study, the total scores and sub-scores of PANSS were significantly reduced in the two groups （P 〈0.01 ）. There were significant differences in total scores and positive symptom scores of PANSS between the two groups only at the second week after the treatment （P 〈 0.05）. The incidences of sleepiness, over-sedation, headache/dizziness, abnormal electrocardiogram and sexual dysfunction in the control group were much higher than that in study group （P 〈 0.05）. The scores of TESS in the study group were much lower than that in the control group at the 12th week after the treatment （P 〈 0.05 ）. The incidence of adverse reaction in the study group （28%） was much lower than that in the control group （56% , P 〈 0.05）. Conclusion： Paliperidone ER is as effective as clozapine, however, it has rapid onset and is safer with fewer side effects compared with elozapine, which is helpful in improving treatment compliance.