短期强化他汀治疗的临床疗效及安全性分析

短期强化他汀在急性冠脉综合征患者治疗中的临床疗效及安全性分析

孙丽娜王宁夫康兰李虹来蕾潘浩徐海鹰杨俊周占林徐鹏凌峰叶显华许轶洲黄进宇于忠徐坚周亮王振东朱钢杰沈芸童晓珊童国新杨建敏郭士遵高微鲁明谢剑昶任雅琦李佩璋马辉吴欣侯绪伟高炎钟益刚高贝贝汪莉莉金建芬王咏梅

[摘要]目的探讨短期大剂量他汀强化在急性冠脉综合征患者治疗中的临床疗效及安全性。方法入组2013年3月至7月于杭州市第一人民医院就诊的冠心病急性冠脉综合征患者共209例，按单双号随机入组法分为强化组与常规组，强化组入院及住院期间均予阿托伐他汀80mg/晚，出院后予阿托伐他汀40mg/晚；常规组入院及住院期间均予阿托伐他汀20mg/晚，出院后予阿托伐他汀20mg/晚。入院时及出院后1个月检测两组生化指标。结果强化组治疗一个月后，其血脂、胆固醇等均较前显著下降（分别为134.95±77.64vs66.86±12.79，P＜0.05、176.12±43.51vs85.39±30.31，P＜0.05、86.34±29.87vs68.04±12.14，P＜0.05），而高密度脂蛋白胆固醇升高明显（44.35±13.16vs58.68±15.72，P＜0.05）；与常规组相比，强化组一个月后其肝酶及肌酸激酶等无显著增加，其肌酐水平较治疗前有所下降（82.53±23.85vs57.81±15.27，P＜0.05），有一定的肾功能保护作用，同时患者的血同型半胱氨酸及超敏C-反应蛋白水平较前下降（30.70±18.82vs10.52±4.66，P＜0.05、19.75±11.91vs8.06±2.68，P＜0.05）。结论短期强化他汀治疗在保证用药安全的前提下，能快速有效的降低患者的血脂、胆固醇水平及同型半胱氨酸水平，提高高密度脂蛋白胆固醇，并有一定的抗炎、肾功能保护作用，临床获益大。

[关键词] 大剂量他汀；急性冠脉综合征；经皮冠脉介入术；临床疗效；安全性

The clinical efficacy and safety analysis of short-term intensive statin therapy in patients with acute coronary syndrome

SUN Li-na*, WANG Ning-fu

Affiliated Hangzhou Hospital of Nanjing Medical University, Hangzhou First People’s Hospital, Hangzhou 310006, China

Corresponding author: WANG Ning-fu, Email: wangningfu@

【Abstract】Objective To investigate t he clinical efficacy and safety analysis of short-term intensive statin therapy in patients with acute coronary syndrome.Methods A total of 209 ACS patients who were treated in Hangzhou First People’s Hospital from March 2013 to July 2013 were enrolled into this study. They were randomly divided into the intensive group and conventional group according to odd and even numbers . The intensive group patients were given 80mg atorvastatin on hospitalization., and after discharged get atorvastatin 40mg/night for one month ;The general group patients were given 20mg from they came to our hospital.,and after discharged get atorvastatin 20mg/night for one month. All the patients were given the biochemical indexes detection both on the first day and after one month’s treatment.. Results After one month’s treatment,the total cholesterol, triglycerides and LDL cholesterol of intensive group were significantly lower than baseline(respectively 134.95

±77.64vs66.86±12.79,P＜0.05,176.12±43.51vs85.39±30.31,P＜0.05,86.34±29.87vs68.04±12.14,P＜0.05),and the high density lipoprotein cholesterol was higher (44.35±13.16vs58.68±15.72,P＜0.05);compared with the conventional group,the intensive group’s liver enzymes creatine kinase was no significant increase,but the creatinine levels decreased than before(82.53±23.85vs57.81±15.27,P＜0.05),there is a certain protective effect of renal function,and the patient’s blood homocysteine and ultra-sensitivity C-reactive protein levels decreased compared with the previous(30.70±18.82vs10.52±4.66,P＜0.05,19.75±11.91vs8.06±2.68,P＜0.05).Conclusion Short-term intensive statin therapy can quickly and effectively reduce blood lipid,cholesterol levels and homocysteine levels,raise HDL cholesterol,and have some anti-inflammatory,renal protective effect under the premise of drug safety,and provide more clinical benefit in patients with ACS.

【Key words】high doses of atorvastatin;acute coronary syndrome;percutaneous coronary intervention;efficacy;safety

2013年美国心脏病学学会基金会/美国心脏协会更新的ST段抬高心肌梗死管理指南中再次强调ACS患者的强化他汀治疗,指南指出对没有禁忌症的所有ST 段抬高型心肌梗死患者，一入院即开始或持续进行高强度的他汀治疗；他汀类药物通过调整和降低血脂水平不但能降低冠心病的发病率并且能改变冠心病的病程，使病变进展延缓，甚至逆转[1]。众多研究表明，大剂量强化他汀治疗将带来更多临床获益，安全性高，但国人ACS患者大剂量阿托伐他汀使用经验尚不足，缺少大样本的临床研究。本研究的目的在于探讨国内ACS患者短期大剂量强化他汀治疗的临床疗效及安全性，为冠心病急性冠脉综合征患者的强化他汀治疗提供更加充分的临床依据。

一、资料与方法：

1、对象

本研究为前瞻性、随机、临床队列研究，入选2013年3月至7月于杭州市第一人民医院就诊并住院的冠心病急性冠脉综合征（ACS）患者。

1)入选标准：（1）年龄大于18岁；（2）入院后诊断为ACS的患者,即不稳定性心绞痛（UA），ST段抬高型心肌梗死(STEMI)和非ST段抬高型心肌梗死(NSTEMI)。

2)排除标准：有以下情况之一者排除：（1）年龄大于等于90岁者；（2）同时患有恶性肿瘤、严重呼吸系统、血液系统或自身免疫性疾病等；（3）冠心病介入治疗禁忌症的患者，如严重肾功能不全患者等；（4）有严重肝损害的患者（如肝酶大于正常3倍以上者）。

2、方法

1）、强化组：随机入组的患者无论有无他汀类药物口服史、基线血脂如何，一入院即予80mg阿托伐他汀（立普妥，辉瑞公司）口服，入院后根据病情决定是否保守治疗或择日或急诊行冠脉造影或PCI手术，术后及住院期间均予80mg/晚口服，出院后予40mg阿托伐他汀每晚一次，入院当时及出院一个月后予生化检查，记录结果。

2）、常规组：随机入组的患者无论有无他汀类药物口服史、基线血脂如何，