Smith C Christopher, Bernstein Lana I, Davis Roger B, Rind David M, Shmerling Robert H
Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.
Arch Intern Med. 2003 Mar 24;163(6):688-92. doi: 10.1001/archinte.163.6.688.
Recommendations for monitoring levels of transaminases (alanine aminotransferase and aspartate aminotransferase) and of creatine kinase (CK) in patients taking 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) vary and are not based on data from clinical practice. We performed a study to determine the yield of routine screening of aminotransferase and CK levels among patients taking statins.
We performed a retrospective review of a primary care practice's computerized medical record. A computerized search identified all patients with a statin on their medication list and gave their alanine aminotransferase, aspartate aminotransferase, and CK values for 1998. We reviewed the records of all patients for whom these values were significantly or moderately abnormal to determine the values' relationship to statin therapy and outcomes.
During the year of the study, 1014 (85%) of the 1194 patients who had a statin on their medication list had at least 1 monitoring test performed. Of these 1014 patients, 10 (1.0%) had a significant elevation and 5 (0.5%) a moderate elevation of transaminase levels, but none of these abnormalities appeared to be related to statin use. Moreover, 6 (0.9%) patients had at least 1 significantly abnormal CK value but it did not appear to be attributable to a statin; and of the 14 (2.1%) patients who had a moderate CK elevation, it was potentially due to a statin in only 2. There were no documented adverse sequelae associated with these abnormal results.
In this study of statin use in a primary care practice, routine monitoring revealed no cases of significantly or moderately abnormal transaminase values attributable to statins. No significantly abnormal and only 2 moderately abnormal CK values were potentially attributable to statin use. This study questions the usefulness of routine measurement of transaminase and CK levels in all patients taking statins.
对于服用3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂（他汀类药物）的患者，监测转氨酶（丙氨酸转氨酶和天冬氨酸转氨酶）及肌酸激酶（CK）水平的建议各不相同，且并非基于临床实践数据。我们开展了一项研究，以确定对服用他汀类药物的患者进行转氨酶和CK水平常规筛查的收益情况。
我们对一家初级保健机构的计算机化病历进行了回顾性分析。通过计算机检索，确定了所有在用药清单上有他汀类药物的患者，并给出了他们1998年的丙氨酸转氨酶、天冬氨酸转氨酶和CK值。我们查阅了所有这些值显著或中度异常的患者的病历，以确定这些值与他汀类药物治疗及结果之间的关系。
在研究当年，1194名用药清单上有他汀类药物的患者中，1014名（85%）至少进行了1次监测检查。在这1014名患者中，10名（1.0%）转氨酶水平显著升高，5名（0.5%）中度升高，但这些异常似乎均与他汀类药物的使用无关。此外，6名（0.9%）患者至少有1次CK值显著异常，但似乎并非由他汀类药物所致；在14名（2.1%）CK中度升高的患者中，只有2名可能是由他汀类药物引起的。这些异常结果均未记录到相关不良后果。
在这项针对初级保健机构中他汀类药物使用情况的研究中，常规监测未发现因他汀类药物导致的显著或中度异常转氨酶值病例。仅有2例中度异常CK值可能归因于他汀类药物的使用，未发现显著异常的情况。本研究对所有服用他汀类药物的患者常规测量转氨酶和CK水平的实用性提出了质疑。
