The 肾使用Lancet：肾病患者可安全使用某些心脏病药物

2011-06-13 13:10 · moon

摘要：过去通常认为肾病患者不宜使用心脏病药物，因为可能会有加重肾病的病患副作用。但英国医学期刊《柳叶刀》刊登一项最新研究说，可脏病肾病患者可以安全使用某些心脏病药物，安全这对具有较高心脏病风险的某心肾病患者是个好消息。 英国牛津大学等机构的药物研究人员对十多个国家的9000多名肾病患者进行了长

摘要：过去通常认为肾病患者不宜使用心脏病药物，因为可能会有加重肾病的肾使用副作用。但英国医学期刊《柳叶刀》刊登一项最新研究说，病患肾病患者可以安全使用某些心脏病药物，可脏病这对具有较高心脏病风险的安全肾病患者是个好消息。

英国牛津大学等机构的某心研究人员对十多个国家的9000多名肾病患者进行了长期跟踪调查，其中随机选出的药物约一半人被安排每天服用由辛伐他汀和依泽替米贝两种药物混合而成的药片。这是肾使用普通人常用来降低心脏病风险的药物，但对肾病患者来说，病患过去由于担心副作用而很少让他们服用这些药物。可脏病

结果显示，那些服药的肾病患者与其他人相比，心脏病风险明显下降，而更为关键的是，服药并没有产生太大的副作用，试验证明肾病患者服用这些药物是安全的。

领导这项研究的英国牛津大学教授科林·贝金特早在30年前就患有肾病，并因此接受了肾移植手术。他说，肾病常常会增大心脏病风险，在他早年的肾病病友中，有许多人没有死于肾病，而是最终死于了心脏病。本次研究证明肾病患者也可以安全服用某些心脏病药物，对于可能出现心脏病的肾病患者来说是个好消息。

生物探索推荐英文原文摘要：

The Lancet, Early Online Publication, 9 June 2011

doi:10.1016/S0140-6736(11)60739-3

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial

Background

Lowering LDL cholesterol with statin regimens reduces the risk of myocardial infarction, ischaemic stroke, and the need for coronary revascularisation in people without kidney disease, but its effects in people with moderate-to-severe kidney disease are uncertain. The SHARP trial aimed to assess the efficacy and safety of the combination of simvastatin plus ezetimibe in such patients.

Methods

This randomised double-blind trial included 9270 patients with chronic kidney disease (3023 on dialysis and 6247 not) with no known history of myocardial infarction or coronary revascularisation. Patients were randomly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo. The key prespecified outcome was first major atherosclerotic event (non-fatal myocardial infarction or coronary death, non-haemorrhagic stroke, or any arterial revascularisation procedure). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00125593, and ISRCTN54137607.

Findings

4650 patients were assigned to receive simvastatin plus ezetimibe and 4620 to placebo. Allocation to simvastatin plus ezetimibe yielded an average LDL cholesterol difference of 0·85 mmol/L (SE 0·02; with about two-thirds compliance) during a median follow-up of 4·9 years and produced a 17% proportional reduction in major atherosclerotic events (526 [11·3%] simvastatin plus ezetimibe vs 619 [13·4%] placebo; rate ratio [RR] 0·83, 95% CI 0·74—0·94; log-rank p=0·0021). Non-significantly fewer patients allocated to simvastatin plus ezetimibe had a non-fatal myocardial infarction or died from coronary heart disease (213 [4·6%] vs 230 [5·0%]; RR 0·92, 95% CI 0·76—1·11; p=0·37) and there were significant reductions in non-haemorrhagic stroke (131 [2·8%] vs 174 [3·8%]; RR 0·75, 95% CI 0·60—0·94; p=0·01) and arterial revascularisation procedures (284 [6·1%] vs 352 [7·6%]; RR 0·79, 95% CI 0·68—0·93; p=0·0036). After weighting for subgroup-specific reductions in LDL cholesterol, there was no good evidence that the proportional effects on major atherosclerotic events differed from the summary rate ratio in any subgroup examined, and, in particular, they were similar in patients on dialysis and those who were not. The excess risk of myopathy was only two per 10 000 patients per year of treatment with this combination (9 [0·2%] vs 5 [0·1%]). There was no evidence of excess risks of hepatitis (21 [0·5%] vs 18 [0·4%]), gallstones (106 [2·3%] vs 106 [2·3%]), or cancer (438 [9·4%] vs 439 [9·5%], p=0·89) and there was no significant excess of death from any non-vascular cause (668 [14·4%] vs 612 [13·2%], p=0·13).