辛伐他汀调脂安全性分析  

Safety of Simvastatin in the Treatment of Patients with Dyslipidemia

作　　者：冯花[1] 冯江[1] 黄河浪[1] 

机构地区：[1]南昌大学医学院公共卫生学院,南昌市330006

出　　处：《中国药房》2010年第6期517-519,共3页China Pharmacy

摘　　要：目的:探讨血脂异常人群服用不同剂量辛伐他汀后的安全性。方法:269例原发性血脂异常患者,随机给予3种不同剂量辛伐他汀,即小剂量组(5mg·d-1)、一般剂量组(10mg·d-1)、大剂量组(40mg·d-1)治疗8周,比较各组疗效和不良反应(ADR)。结果:不同剂量的辛伐他汀,调节总胆固醇、甘油三酯、高密度脂蛋白胆固醇的总有效率差异有统计学意义(P<0.01),但3组之间低密度脂蛋白胆固醇总有效率差异无统计学意义(P>0.05)。治疗期间,总ADR发生率为14.87%,以胃肠道反应、肌痛为主,ADR发生率在不同剂量间差异有统计学意义(P=0.03),但在不同性别和不同年龄组间差异无统计学意义(P=0.46,P=0.07)。结论:辛伐他汀在临床应用过程中出现ADR应予肯定,但多数症状轻微;随剂量的增大,ADR发生率升高。根据病情适量使用,更安全。OBJECTIVE： To explore the safety of different dosages of simvastatin in patients with dyslipidemia. METHODS： 269 patients with essential dyslipidemia were randomly assigned to receive simvastatin （5, 10 or 40 mg.d^-1） for 8 weeks. The curative efficacy and the adverse reactions were compared among groups. RESULTS： There were significant differences across the 3 groups （5, 10 or 40 mg. d ^-1） with regard to the total effective rates on regulating total cholesterol, triglyceride, high-density lipo- protein cholesterol（P〈0.01 ）, but no significant difference was noted among the 3 groups with regard to the total effective rates on low-density lipoprotein cholesterol（P〉0.05）. The total incidence of ADRs was 14.87%, which appeared mainly as gastrointestinal reaction and myosalgia, and the differences across the 3 groups were significant （P=0.03）, but no significant difference was noted with regard to sex and age （P=0.46,P=0.07）. CONCLUSION： Simvastatin may induce ADRs, but in most cases the ADRs were mild, and the incidence of the ADRs increased as the dosage of simvastatin increased.Tailoring the dosage of simvastatin to patients＇ clinical characteristics is conducive to patients＇ medication safety.

关 键 词：血脂异常 辛伐他汀 不同剂量 不良反应 

分 类 号：R972.6[医药卫生—药品] R969.3[医药卫生—药学]