Ballarè M, Campanini M, Airoldi G, Zaccala G, Bertoncelli M C, Cornaglia G, Porzio M, Monteverde A
Divisione di Medicina Generale II, Ospedale Maggiore di Novara.
Minerva Gastroenterol Dietol. 1992 Jan-Mar;38(1):41-4.
The first clinical studies on hydroxy-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors reported a low incidence of liver toxicity. The personal observation of a case of simvastatin-induced acute cholestatic hepatitis prompted us to evaluate the true incidence of hepatic side effects of these drugs in a large Italian population. One hundred patients taking simvastatin and ninety patients treated with pravastatin were followed-up six months with periodical evaluation of serum lipid levels and liver function test. In 5% of simvastatin-treated patients and 4.5% of pravastatin-treated patients significant liver toxicity was observed, which required drug discontinuation. The mechanism of liver damage was direct, idiosyncratic, but immunological features of drug toxicity could be hypothesized in one patient.
关于羟甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂的首批临床研究报告称，肝毒性发生率较低。对一例辛伐他汀诱发的急性胆汁淤积性肝炎病例的个人观察促使我们在一大群意大利人群中评估这些药物肝脏副作用的真实发生率。对100例服用辛伐他汀的患者和90例服用普伐他汀的患者进行了为期6个月的随访，定期评估血脂水平和肝功能测试。在5%服用辛伐他汀的患者和4.5%服用普伐他汀的患者中观察到了显著的肝毒性，这需要停药。肝损伤机制是直接的、特异质性的，但在一名患者中可以推测存在药物毒性的免疫特征。
