Re-evaluation of serum alanine aminotransferase upper normal limit and its modulating factors in a large-scale population study
Re-evaluation of serum alanine aminotransferase upper normal limit and its modulating factors in a large-scale population study
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DOI：
10.1111/j.1478-3231.2006.01197.x
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发表时间：
2006-05-01
影响因子：
6.7
通讯作者：
Halpern, Z
中科院分区：
文献类型：
--
作者：
Kariv, R;Leshno, M;Halpern, Z
背景资料：血清丙氨酸氨基转移酶（ALT）正常范围的正常上限（ULN）最近受到挑战，因为诊断为肝病的患者可能具有“正常”或接近“正常”的ALT水平，并且因为在确定正常范围时通常忽略可能的调节剂。目的：估计ULN血清ALT. Subjects和方法：我们回顾了15-90岁的受试者的病历，他们接受了标准的实验室检查，包括血清ALT，超过6个月，在中心实验室。定义了三组：第1组，包括总研究人群（N=272 273）。第2组（N=87 020）包括总研究人群，不包括接受潜在肝毒性药物、或诊断为肝病、或除甘油三酯、胆固醇、葡萄糖或HbA 1c外有任何异常实验室检查结果的患者。第3组（N=17 496）为“健康”人群，根据其ALT值确定新的ULN，包括第2组甘油三酯、胆固醇、葡萄糖和HbA 1c水平正常的受试者。结果：第1、2和3组中对应于ULN的第95百分位数ALT值分别为50.1、40和37.5 U/l。6.2%（16 943/273 273）的ALT低于检测试剂制造商列出的ULN（52 U/l）的受试者的ALT水平高于我们的新ULN。线性和逻辑回归分析表明，ALT水平显着修改性别，年龄，血糖，胆固醇，甘油三酯，超重/肥胖诊断。性别、血糖和胆固醇水平之间存在显著的相互作用。结论：在这第一个大规模的研究“健康”人群中，血清ALT ULN远低于目前公认的值。在确定ALT ULN时，可考虑年龄和性别。
Background: The upper normal limit (ULN) of serum alanine-aminotrasferase (ALT) normal range was recently challenged, because patients diagnosed with liver diseases may have 'normal' or near-'normal' ALT levels, and because possible modulators are often ignored in determining normal range. Aim: To estimate the ULN for serum ALT and to identify factors modulating it. Subjects and methods: We reviewed medical records of subjects aged 15-90, who underwent standard panels of laboratory tests, including serum ALT, over 6 months at a central laboratory. Three groups were defined: Group 1, comprised total study population (N=272 273). Group 2 (N=87 020) comprised total study population, excluding those receiving potentially hepatotoxic drugs, or diagnosed with liver disease, or had any abnormal laboratory test results other than for triglycerides, cholesterol, glucose, or HbA1c. Group 3 (N=17 496) the 'healthy' population, from whose ALT values we established the new ULN, comprised Group 2 subjects with normal triglycerides, cholesterol, glucose, and HbA1c levels. Results: The 95th percentile ALT values, corresponding to the ULN, in groups 1, 2, and 3 were 50.1, 40, and 37.5 U/l, respectively. 6.2% (16 943/273 273) of subjects whose ALT was below ULN listed by the test manufacturer (52 U/l), had ALT level above our new ULN. Linear and logistic-regression analyses showed that ALT levels were significantly modified by gender, age, glucose, cholesterol, triglycerides, and overweight/obesity diagnosis. Significant interaction was found between gender, glucose and cholesterol levels. Conclusion: In this first large-scale study of 'healthy' population, serum ALT ULN was far lower than currently accepted value. Age and gender may be considered when determining the ULN for ALT.