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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 long-term safety of simvastatin at elderly patients. Methods: A total of 160 elderly angina patients over the age of 75 were enrolled in the study. According to the secondary prevention criteria of prevention and treatment of dyslipidemia, they were divided into simvastatin group (control group) and control group. Statin group was enrolled in 89 cases, except for anti-myocardial ischemia treatment, the application of simvastatin 10 ~ 20mg / d. Control group, 71 cases, only anti-myocardial ischemia treatment. Treatment for 12 months. At the end of the 1st, 3rd, 6th and 12th months after treatment, the blood lipids, blood glucose, liver and renal function and serum CK levels were examined. The follow-up investigation was conducted by combining the questionnaire with the telephone. Results: 10 patients were lost in the statin group and 1 died. In the control group, 8 patients were lost to follow-up and 3 patients died. The incidences of adverse reactions and hepatic aminotransferases in the statin group and the control group were 5.1% and 5.0%, 3.8% and 5.0% respectively, with sleep disorders of 10.3% and 10.0%, and dementia of 5.1% , 5.0%, gastrointestinal symptoms were 12.8%, 11.7%, renal dysfunction was 6.4%, 5.0%, the difference was not statistically significant (all P> 0.05). Conclusion: The senile patients with senile angina receive routine dose of simvastatin for a long time, the incidence of adverse reactions is lower and the safety is better.