Prati Daniele, Taioli Emanuela, Zanella Alberto, Della Torre Emanuela, Butelli Sonia, Del Vecchio Emanuela, Vianello Luciana, Zanuso Francesco, Mozzi Fulvio, Milani Silvano, Conte Dario, Colombo Massimo, Sirchia Girolamo
Centro Trasfusionale e di Immunologia dei Trapianti, Laboratorio di Epidemiologia, Divisione di Ematologia, Istituto di Statistica Medica e Biometria, Cattedra di Gastroenterologia, Milan, Italy.
Ann Intern Med. 2002 Jul 2;137(1):1-10. doi: 10.7326/0003-4819-137-1-200207020-00006.
Serum alanine aminotransferase (ALT) activity, the variable most commonly measured to assess hepatic disease, fails to identify many patients with hepatic injury. Current standards for "normal" ALT level were defined by using populations that included persons with subclinical liver disease.
To update definitions of healthy ranges for serum ALT level.
Retrospective cohort study.
A university hospital in Milan, Italy.
6835 persons who were first-time blood donors from 1995 through 1999, were negative for anti-hepatitis C virus (HCV), and had no contraindications to donation and 209 persons who attempted to donate blood from 1990 through 1999 but were found to have anti-HCV antibodies. Of the latter group, 131 had HCV viremia.
Univariate and multivariate analyses examined associations between clinical and laboratory factors and ALT levels. Healthy ranges for ALT were computed from the population at lowest risk for liver disease. Sensitivity and specificity of healthy ALT ranges were evaluated in the donors with HCV antibodies, of whom 133 had liver biopsy.
Serum ALT activity was independently related to body mass index and to laboratory indicators of abnormal lipid or carbohydrate metabolism. Updated upper limits (for men, 500 nkat/L [30 U/L]; for women, 317 nkat/L [19 U/L]) were lower than current limits (for men, 667 nkat/L [40 U/L]; for women, 500 nkat/L [30 U/L]) and, during 6-month follow-up, showed superior sensitivity in identifying participants with HCV viremia (sensitivity, 76.3% [95 % CI, 69.1% to 83.6%] vs. 55% [CI, 46.4% to 63.5%]). The related tradeoff in specificity was acceptable (88.5% [CI, 79.2% to 94.6%] vs. 97.4% [91% to 99.7%]). The increased sensitivity targeted patients with minimal to mild histologic lesions.
In patients with chronic HCV infection or nonalcoholic fatty liver disease, revision of normal limits for ALT level is advisable.
血清丙氨酸氨基转移酶(ALT)活性是评估肝脏疾病时最常检测的指标,但它无法识别许多肝脏损伤患者。“正常”ALT水平的现行标准是通过纳入包括亚临床肝病患者在内的人群来定义的。
更新血清ALT水平健康范围的定义。
回顾性队列研究。
意大利米兰的一家大学医院。
1995年至1999年首次献血的6835人,抗丙型肝炎病毒(HCV)检测为阴性,且无献血禁忌证;以及1990年至1999年试图献血但被发现有抗HCV抗体的209人。后一组中,131人有HCV病毒血症。
单因素和多因素分析检查临床和实验室因素与ALT水平之间的关联。根据肝病风险最低的人群计算ALT的健康范围。在有HCV抗体的献血者中评估健康ALT范围的敏感性和特异性,其中133人进行了肝活检。
血清ALT活性与体重指数以及脂质或碳水化合物代谢异常的实验室指标独立相关。更新后的上限(男性为500 nkat/L [30 U/L];女性为317 nkat/L [19 U/L])低于现行上限(男性为667 nkat/L [40 U/L];女性为500 nkat/L [30 U/L]),并且在6个月的随访期间,在识别有HCV病毒血症的参与者方面显示出更高的敏感性(敏感性为76.3% [95% CI,69.1%至83.6%],而现行上限为55% [CI,46.4%至63.5%])。特异性方面的相关权衡是可以接受的(88.5% [CI,79.2%至94.6%],而现行上限为97.4% [91%至99.7%])。提高的敏感性针对的是组织学病变轻微至轻度的患者。
对于慢性HCV感染或非酒精性脂肪性肝病患者,建议修订ALT水平的正常范围。