Department of Internal Medicine, Mount Sinai Medical Center, 4300 Alton Rd, Miami Beach, FL 33140, USA.
Mayo Clin Proc. 2010 Apr;85(4):349-56. doi: 10.4065/mcp.2009.0365.
The beneficial role of statins in primary and secondary prevention of coronary heart disease has resulted in their frequent use in clinical practice. However, safety concerns, especially regarding hepatotoxicity, have driven multiple trials, which have demonstrated the low incidence of statin-related hepatic adverse effects. The most commonly reported hepatic adverse effect is the phenomenon known as transaminitis, in which liver enzyme levels are elevated in the absence of proven hepatotoxicity. This class effect is usually asymptomatic, reversible, and dose-related. However, the increasing incidence of chronic liver diseases, including nonalcoholic fatty liver disease and hepatitis C, has created a new challenge when initiating statin treatment in patients with high cardiovascular risk. These diseases result in abnormally high liver biochemistry values, discouraging statin use by clinicians, fostering treatment discontinuation, and leaving a large number of at-risk patients untreated. A PubMed/MEDLINE search of the literature regarding statin safety (January 1, 1994-December 31, 2008) was performed, using the following search terms: statin safety, statin-related hepatotoxicity, and chronic liver disease and statin use, as well as the specific names of different statins and different liver diseases. Relevant clinical trials, review articles, panel discussions, and guideline recommendations were selected. This review supports the use of statin treatment in patients with high cardiovascular risk whose elevated aminotransferase levels have no clinical relevance or are attributable to known stable chronic liver conditions. For each patient, the decision should be based on an individual assessment of risks and benefits.
他汀类药物在冠心病的一级和二级预防中的有益作用使其在临床实践中得到广泛应用。然而，由于安全性方面的担忧，特别是与肝毒性相关的问题，促使人们开展了多项临床试验，这些试验均证实他汀类药物相关肝不良反应发生率较低。最常报告的肝不良反应是所谓的转氨基酶升高现象，即肝酶水平升高而无明确的肝毒性。这种类效应通常是无症状的、可逆转的、与剂量相关的。然而，随着非酒精性脂肪性肝病和丙型肝炎等慢性肝病发病率的上升，在心血管风险较高的患者中开始他汀类药物治疗时，又带来了新的挑战。这些疾病导致肝生化值异常升高，从而使临床医生不愿使用他汀类药物，导致治疗中断，使大量高危患者得不到治疗。检索了 1994 年 1 月 1 日至 2008 年 12 月 31 日PubMed/MEDLINE 文献，使用的检索词包括他汀类药物安全性、他汀类药物相关肝毒性、慢性肝病与他汀类药物应用，以及不同他汀类药物和不同肝病的具体名称。选择了相关的临床试验、综述文章、专家组讨论和指南建议。本综述支持对心血管风险较高且氨基转移酶升高无临床意义或归因于已知稳定慢性肝病的患者使用他汀类药物治疗。应根据患者的个体风险和获益情况做出决策。
