帕利哌酮与利培酮治疗酒精所致精神障碍疗效及安全性对照研究

Control study of efficacy and safety of Paliperidone and Risperidone in treatment of alcohol-induced mental disorder

目的:探讨帕利哌酮缓释片与利培酮片治疗酒精所致精神障碍的临床疗效及安全性。方法:共纳入40例酒精所致精神障碍患者进行6周的研究。将患者分为帕利哌酮缓释片组(研究组)和利培酮组(对照组)各20例。在患者治疗前及治疗第1、2、4、6周末采用阳性和阴性症状量表(PANSS)评定临床疗效;治疗中需处理的不良反应量表(TESS)评定不良反应;两组患者均入院即使用相同护肝药物,定期检测肝功能,监测肝功能各项指标变化。结果:两药对酒精所致精神障碍的疗效无显著性差异(P>0.05);在不良反应方面,帕利哌酮缓释片组患者低于利培酮组,两组患者比较有显著差异(P<0.05);研究组患者治疗2周后较对照组肝功能改善明显,差异有统计学意义(P<0.05)。结论:帕利哌酮缓释片治疗酒精所致精神障碍疗效显著,不良反应较利培酮轻微,且有助于肝功能改善,值得临床进一步推广运用。

Objective：To investigate the clinical efficacy and safety of Paliperidone ER and Risperidone in treatment of alcohol-induced mental disorder. Methods：40 patients diagnosed with alcohol-induced mental disorder were randomly assigned to study group （20 cases, treated with Paliperidone ER for six weeks） and control group （20 cases, treated with Risperidone for six weeks）. The positive and negative syndrome scale （ PANSS） and the treatment emergent symptom scale （ TESS） were used to assess the clinical efficacy and safety at baseline, 1, 2, 4, and 6 weeks after the treatment, respectively. The same liver aid drugs and periodic liver function tests were used to treat the two groups since hospitalization, while various indicators of liver function were monitored. Results：Both Paliperidone ER and Risperidone had equal efficacy in the treatment of alcohol-induced mental disorder, and there was no signifi-cant difference （P〉0. 05）. The study group had significant less side effects than control group, and the difference was significant （P〈0. 05）. The study group had more significant improvement in liver function compared to control group 2 weeks after the treatment, and the difference was significant （P〈0. 05）. Conclusions： Paliperidone ER has good efficacy in the treatment of alcohol-induced mental disorder. It has less side effects than Risperidone and helps the improvement of liver function. Paliperidone ER is worth further clinical application.