评价烟酸缓释片治疗混合性高脂血症的疗效及安全性

Study of the efficacy and safety of extended-release niacin in patients with combined hyperlipidemia

目的探讨烟酸缓释片治疗混合性高脂血症的临床疗效及安全性。方法85例高脂血症患者,随机分为阿伐他汀组(n=42,10 mg·d-1)和烟酸缓释片组(n=43,500 mg·d-1),疗程均为4 wk,观察治疗前后主要血脂参数(TC、TC、LDL-C、HDL- C、α-脂蛋白)的变化率、达标率及不良反应。结果在降低TG、α-脂蛋白,升高HDL-C方面,烟酸缓释片优于他汀类药物。在不良反应和安全性方面,烟酸缓释片组有较高比例患者出现皮肤潮红和瘙痒,但对肝、肾功能影响无统计学意义。结论烟酸缓释片(500 mg·d-1)可以更全面地改善混合性高脂血症患者的血脂异常,尤其是升高HDL-C、降低TG和α-脂蛋白方面,安全性好,但其耐受性和依从性方面较阿伐他汀差。

AIM To investigate the effects and the safety of extended-release niacin, METHODS Eighty-five patients with hyperlipidemia were randomly assigned into atorvastatin group （n = 42）and extended-release niacin group （n = 43）. They were treated with atorvastatin and extended-release niacin, 10 mg·d^-1 and 500 mg·d^-1,respectively for 4 wk. Lipid profile and physical laboratory investigations for adverse drug reactions were also assessed. Serum levels of total cholesterol （TC）,triglyceride （TG）,low density lipoprotein cholesterol （ LDL-C ） , high density lipoprotein cholesterol （ HDL-C ） and a-lipoprotein were measured at the end of 4 wk of the trial period. RESULTS Extended-release niacin treatment was more effective than atorvastatin in reducing serum levels ofTC, TG, LDL-C and a-lipopretein and in raising HDL-C. Extended-release niacin group had more adverse drug reactions than atorvastatin group during the period of treatment, while most of patient＇s tolerance was good in both groups. CONCLUSION ①Extended-release niacin has full-seale lipid-regulating effects , especially in reducing serum levels of TG and α-lipoprotein and raising HDL-C. ② Extended-release niacin has more flushing and gastrointestinal symptoms than atorvastatin ,but it is also safe.