摘要
目的观察非诺贝特片联合双环醇片治疗非酒精性脂肪肝(NAFLD)的临床疗效及安全性。方法将156例NAFLD患者随机分为对照组70例和试验组86例。对照组予以双环醇每次50 mg,tid,口服12周,后改为每次25 mg,tid,口服24周;试验组在对照组治疗的基础上,予以非诺贝特每次0. 1 g,qd,口服12周。比较2组患者的临床疗效、肝功能和血脂,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为89. 53%(77例/86例)和71. 43%(50例/70例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的谷草转氨酶分别为(42. 47±5. 30)和(50. 35±5. 25) U·L-1,谷丙转氨酶分别为(29. 91±3. 79)和(39. 11±5. 03) U·L-1,总胆固醇分别为(1. 25±0. 17)和(1. 65±0. 29) mmol·L-1,三酰甘油分别为(2. 94±0. 40)和(4. 06±0. 54)mmol·L-1,差异均有统计学意义(均P <0. 05)。2组患者的药物不良反应均以乏力、失眠和食欲缺乏为主。试验组和对照组的总药物不良反应发生率分别为10. 47%和5. 71%,差异无统计学意义(P> 0. 05)。结论非诺贝特片联合双环醇片治疗NAFLD的临床疗效确切,其能显著地改善患者的肝功能及血脂水平,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of fenofibrate tablets combined with bicyclol tablets in the treatment of nonalcoholic fatty liver disease(NAFLD).Methods A total of 156 NAFLD patients were randomly divided into control group(n=70 cases)and treatment group(n=86 cases).Control group was given bicyclol 50 mg per time,tid,orally for 12 weeks,and then changed to 25 mg per time,tid,orally for 24 weeks.Treatment group received fenofibrate 0.1 g per time,qd,orally for 12 weeks,on the basis of control group.The clinical efficacy,liver function,blood lipid and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 89.53%(77 cases/86 cases)and 71.43%(50 cases/70 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and control groups were compared:glutamic-oxalacetic transaminase were(42.47±5.30)and(50.35±5.25)U·L-1,glutamic-pyruvic transaminase were(29.91±3.79)and(39.11±5.03)U·L-1,total cholesterol were(1.25±0.17)and(1.65±0.29)mmol·L-1,triacylglycerol were(2.94±0.40)and(4.06±0.54)mmol·L-1,the differences were statistically significant(all P<0.05).The adverse drug reactions of two groups were fatigue,insomnia and anorexia.The total incidences of adverse drug reactions in the treatment and control groups were 10.47%and 5.71%without significant difference(P>0.05).Conclusion Fenofibrate tablets combined with bicyclol tablets have a definite clinical efficacy in the treatment of NAFLD,which can significantly improve the liver function and blood lipid,without increasing the incidence of adverse drug reactions.
作者
庄瑛瑛
饶紫兰
房太勇
ZHUANG Ying-ying;RAO Zi-lan;FANG Tai-yong(Department of Gastroenterology,The Second Hospital Affiliated of Fujian Medical University,Quanzhou 362000,Fujian Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2019年第19期2225-2227,共3页
The Chinese Journal of Clinical Pharmacology
基金
福建省卫生计划生育委员会自然科学基金资助项目(2016J01443)
关键词
非诺贝特片
双环醇片
非酒精性脂肪肝
安全性评价
fenofibrate tablet
bicyclol tablet
non-alcoholic fatty liver disease
safety evaluation
