Sabini E, Sisti E, Coco B, Leo M, Ionni I, Menconi F, Profilo M A, Mazzi B, Rocchi R, Latrofa F, Vitti P, Brunetto M, Marcocci C, Marinò M
Endocrinology Unit I, Department of Clinical and Experimental Medicine, University of Pisa and University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
Hepatology Unit, University Hospital of Pisa, Via Paradisa 2, 56124, Pisa, Italy.
J Endocrinol Invest. 2016 Nov;39(11):1323-1327. doi: 10.1007/s40618-016-0518-5. Epub 2016 Jul 27.
Acute liver damage (ALD) is associated with high-dose intravenous (iv) glucocorticoid (GC) (ivGC) pulse therapy in ~1 % of patients for Graves' orbitopathy (GO). It has been proposed that statins may increase the risk of ALD. Here we investigated the frequency of ALD according to the assumption of statins in a large retrospective cohort study.
We studied 1076 consecutive patients with GO given ivGC. ALD was defined as an increase in alanine aminotransferase ≥300 U/l.
At the time of ivGC, 62 patients were taking statins and 1014 were not. The frequency of ALD has been reported to be 1.2 cases/100,000 statins users and 1300/100,000 in GO patients given ivGC. Thus, the expected frequency of ALD in patients given both statins and ivGC is 1560/100,000. Transferring these data to our series, one would have expected at least 0.96 cases of ALD (~one case), in the 62 patients given both ivGC and statins. However, no cases of ALD were observed in patients given statins, and the previously reported 14 cases of ALD in this series were seen in patients who were not taking statins.
The lack of observation of cases of ALD in patients given ivGC and statins is quite reassuring. Although caution should be applied to any patient candidate to ivGC treatment and this should be particularly accurate in patients given statins, our findings somehow justify the use of ivGC in patients under statins, although further studies in larger cohorts are needed to confirm our conclusions.
在约1%的格雷夫斯眼病（GO）患者中，急性肝损伤（ALD）与大剂量静脉注射（iv）糖皮质激素（GC）脉冲疗法相关。有人提出他汀类药物可能会增加ALD的风险。在此，我们在一项大型回顾性队列研究中，根据他汀类药物的使用情况调查了ALD的发生率。
我们研究了1076例连续接受ivGC治疗的GO患者。ALD定义为丙氨酸转氨酶升高≥300 U/l。
在接受ivGC治疗时，62例患者正在服用他汀类药物，1014例未服用。据报道，他汀类药物使用者中ALD的发生率为1.2例/10万，接受ivGC治疗的GO患者中为1300/10万。因此，同时服用他汀类药物和ivGC的患者中ALD的预期发生率为1560/10万。将这些数据应用到我们的研究系列中，在62例同时接受ivGC和他汀类药物治疗的患者中，预计至少会有0.96例ALD（约1例）。然而，服用他汀类药物的患者中未观察到ALD病例，该系列中先前报道的14例ALD病例见于未服用他汀类药物的患者。
在接受ivGC和他汀类药物治疗的患者中未观察到ALD病例，这相当令人安心。尽管对于任何接受ivGC治疗的患者都应谨慎，对于服用他汀类药物的患者尤其应如此，但我们的研究结果在一定程度上证明了在服用他汀类药物的患者中使用ivGC的合理性，不过需要在更大的队列中进行进一步研究以证实我们的结论。
