高龄老年心绞痛患者长期应用辛伐他汀的临床安全性研究  

Studies on clinical safety following long-term use of simvastatin in very elderly patients with angina pectoris

作　　者：骆雷鸣[1] 范利[1] 张灵[1] 薛浩[1] 史军[1] 刘煜[1] 朱启伟[1] 刘国树[1] 

机构地区：[1]解放军总医院南楼心血管二科,北京100853

出　　处：《药物不良反应杂志》2006年第2期97-100,共4页Adverse Drug Reactions Journal

摘　　要：目的:评价辛伐他汀常规剂量长期用于高龄老年患者的安全性。方法:160例75岁以上的高龄老年心绞痛患者入选研究,根据《血脂异常防治建议》中冠心病二级预防标准,分为辛伐他汀组(简称他汀组)和对照组。他汀组入选89例,除接受抗心肌缺血治疗外,应用辛伐他汀10～20mg/d。对照组71例,仅接受抗心肌缺血治疗。疗程12个月。用药前及用药第1、3、6、12个月末,检查血脂、血糖、肝、肾功能及血清CK水平,并进行表格式问卷与电话问答相结合的随访调查。结果:他汀组10例失访,1例死亡;对照组8例失访,3例死亡。他汀组与对照组各种不良反应发生率,肝脏氨基转移酶升高分别为5.1%、5.0%,血清CK升高为3.8%、5.0%,睡眠障碍为10.3%、10.0%,痴呆为5.1%、5.0%,胃肠道症状为12.8%、11.7%,肾功能恶化为6.4%、5.0%,差异均无统计学意义(均为P>0.05)。结论:高龄老年心绞痛患者长期接受常规剂量辛伐他汀治疗,不良反应发生率较低,安全性较好。Objective： To evaluate the clinical safety following long-term use of simvastatin with usual dose in very elderly patients with angina pectoris. Methods： One hundred and sixty patients with angina pectoris over age 75 were selected for the research. The patients were assigned into simvastation group （in short： statin groups） and the control group, according to the second degree prevention criterion of comary heart disease from Guideline in Prevention and Cure of Lipid Abnormality. Eighty-nine patients in statin group were administered simvastation 10-20 mg daily, besides anti-ischemia therapy, 71 patients in the control group received anti-isehemia therapy only. The treatment course was 12 months. Blood-lipid, blood-glucose, liver function, renal function and serum CK level were measured before treatment and druing the end of the first, third, sixth and twelfth month of the treatment, and a follow-up investigation with questionnaire and telephone interview was performed. Results： In statin group, the follow-up to ten patients were lose and one patient died. In the control group, the follow-up to eight patients were lose and 3 patients died. The comparison of adverse reaction incidence between statin group and the control group was as follows： elevated hepatic transaminase （5.1%, 5.0%, P 〉0.05）, elevated creatine （3,8%, 5.0%, P 〉0.05）, sleep disorder （10.3%, 10.0%, P〉0.05）, dementia （5.1%, 5.0%, P〉 0.05）, gastrointestinal tract disorder （12.8%, 11.7%, P 〉0.05）, and aggravated renal function （6.4%, 5.0%, P 〉0.05）, there was no significant deference statistically between the two groups. Conclusion： Long-term use of simvastatin in an usual dose is safe for very elderly patients withangina pectoris.

关 键 词：高龄老年 辛伐他汀 不良反应 

分 类 号：R541.4[医药卫生—心血管疾病]