帕利哌酮缓释片与奥氮平对于精神分裂症患者肝功能的影响  

The effects of paliperidone extended-release tablets and olanzapine on the liver function of patients with schizophrenia

作　　者：郭小兵[1] 王刚[1] 王智民[1] 王楠[1] 

机构地区：[1]首都医科大学附属北京安定医院,北京100088

出　　处：《中国新药杂志》2014年第16期1941-1945,共5页Chinese Journal of New Drugs

摘　　要：目的:探讨与奥氮平相比,帕利哌酮缓释片对于精神分裂症患者肝功能的影响,同时评估疗效及安全性。方法:将60例精神分裂症患者随机分为帕利哌酮缓释片组(30例)和奥氮平组(30例),两组进行为期8周的对照研究。以血清丙氨酸转氨酶(ALT)、血清天冬氨酸转氨酶(AST)、碱性磷酸酶(ALP)、总胆红素(TB)等评估肝功能指标,根据中华医学会消化病学分会肝胆疾病协作组对于肝损伤的定义,评估两组治疗中出现肝损伤患者的比例。用阳性和阴性症状量表(PANSS)评估疗效,用治疗时出现的症状量表(TESS)评估安全性。结果:在治疗第2周末、第4周末及第8周末,帕利哌酮缓释片组ALT,AST指标异常的比例低于奥氮平组,肝损伤的比例帕利哌酮缓释片组低于奥氮平组,PANSS总分较基线的减分帕利哌酮缓释片组优于奥氮平组,以上差异均具有统计学意义(P均<0.05)。帕利哌酮缓释片组在嗜睡、震颤、静坐不能、便秘、心动过速、体重增加方面比例较奥氮平组低,差异有统计学意义(P<0.05)。结论:与奥氮平相比,帕利哌酮缓释片对肝功能的影响更小,引起肝损伤的可能性更低,同时也能迅速、有效地控制阳性和阴性症状,不良反应更小。Objective： To compare the effects of paliperidone extended-release （ER） tablets and olanzapine on the liver function of patients with schizophrenia and evaluate the efficacy and safety of paliperidone ER for the treatment of schizophrenia. Methods： A randomized, controlled clinical trial was performed which lasted for 8 weeks. Sixty patients with schizophrenia were divided into two groups and treated with paliperidone ER and olanzapine respectively. The serum alanine aminotransferase （AET） , aspartate aminotransferase （AST） , alkaline phos- phatase （ALP） and total bilirubin （TB） were monitored to evaluate the percentage of patients with liver injury according to the criteria set by the hepatobiliary disease collaborative group of digestive disease branch of Chinese Medical Association. The positive and negative syndrome scale （PANSS） was used to evaluate the efficacy. The treatment emergent symptom scale （TESS） was used to assess the safety. Results： The percentage of patients with liver injury of paliperidone ER group was lower than olanzapine group, and the PANSS change of paliperidone ER group was less than olanzapine group at the end of 2, 4, and 8 week, all with statistically significant differences （P 〈 0.05）. The percentage of patients with drowsiness, tremor, akathisia, constipation, tachycardia and weight gain of paliperidone ER group was lower than olanzapine group, all with statistically significant differences （P 〈 0.05）. Conclusion： Compared with olanzapine, paliperidone ER has less impact on liver function, and causes less liver injury. Paliperidone ER can control the symptoms of schizophrenia rapidly and effectively with less adverse reactions.

关 键 词：帕利哌酮缓释片 奥氮平 肝损伤 疗效 安全性 

分 类 号：R971.4[医药卫生—药品]