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目的随机对比观察不稳定型心绞痛发生后48 h内使用两种剂量辛伐他汀的疗效与安全性及对近中期心血管事件的影响。方法所有临床确定的不稳定型心绞痛患者,入院后48 h内抽空腹静脉血查血脂等生化指标,如总胆固醇(TC)≥4.68 mmol/L和低密度脂蛋白胆固醇(LDL-C)≥2.6 mmol/L则依随机原则分别入选辛伐他汀10 mg组和20 mg组,分别于服药后3、6、12个月时复查血脂,并对临床事件随访登记,同时观察用药安全性。结果辛伐他汀10 mg组和20 mg组均能有效降低不稳定型心绞痛患者血清TC及LDL-C水平,其中20 mg剂量组降TC及LDL-C疗效均明显优于10 mg组,两组之间各时间段的达标率差异均有统计学意义(3个月时间TC为26%比16.5%,LDL-C为29.9%比19.6%,P均<0.05;6个月时间TC为29.9%比24%,LDL-C为29.9%比19.6%,P均<0.05;12个月时间TC为36.5%比26.3%,LDL-C为40.3%比28.5%,P<0.05,P<0.01);随访期间辛伐他汀20 mg组在心肌梗死发生率及因心绞痛而需再入院方面明显低于10 mg组。结论两种剂量辛伐他汀应用于不稳定型心绞痛患者早期均能安全有效地降低不稳定型心绞痛患者血清TC及LDL-C水平。辛伐他汀20 mg组的疗效明显优于辛伐他汀10 mg组。
Objective To compare the effects and safety of two doses of simvastatin within 48 h after unstable angina pectoris and its effect on near-mid-term cardiovascular events. Methods All patients with unstable angina pectoris who were diagnosed as unstable angina pectoris had fasting blood samples such as total cholesterol (TC) ≥4.68 mmol / L and low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol / L were selected according to the principle of random simvastatin 10 mg group and 20 mg group, respectively, at 3,6,12 months after taking blood lipid, and clinical follow-up registration, and observe the safety of medication. Results Simvastatin 10 mg group and 20 mg group were able to effectively reduce the serum TC and LDL-C levels in patients with unstable angina, 20 mg dose of TC and LDL-C reduction were significantly better than the 10 mg group, two groups (TC was 26% vs. 16.5% at 3 months, 29.9% vs 19.6% at LDL-C, P <0.05; TC at 6 months was 29.9% LDL-C was 29.9% vs 19.6%, P <0.05; TC was 36.5% vs. 26.3% at 12 months, 40.3% vs 28.5%, P <0.05, P <0.01) Simvastatin 20 mg group was significantly lower than the 10 mg group in the incidence of myocardial infarction and the need for re-admission due to angina pectoris during follow-up. Conclusion Both simvastatin used in the treatment of unstable angina pectoris patients can safely and effectively reduce serum TC and LDL-C levels in patients with unstable angina pectoris. Simvastatin 20 mg group was significantly better than simvastatin 10 mg group.