Shiffman Mitchell L, Diago Moisés, Tran Albert, Pockros Paul, Reindollar Robert, Prati Daniele, Rodríguez-Torres Maribel, Lardelli Pilar, Blotner Steven, Zeuzem Stefan
Virginia Commonwealth University Medical Center, Richmond, Virginia 23298, USA, and Hospital General de Valencia, Spain.
Clin Gastroenterol Hepatol. 2006 May;4(5):645-52. doi: 10.1016/j.cgh.2006.02.002.
BACKGROUND & AIMS: Many patients with chronic hepatitis C virus (HCV) have persistently normal serum alanine transaminase (ALT) levels. We compared characteristics of chronic hepatitis C patients with patients with normal and elevated ALT levels using data from 3 randomized phase III trials of peginterferon alfa-2a (40 kDa).
The characteristics of 480 patients with normal ALT values (on >or=3 occasions without any increases in ALT level over a 6- to 18-month period) and 1993 patients with elevated ALT levels were compared. Sixty-eight of the 480 patients with normal ALT levels were randomized to no treatment and monitored for 72 weeks.
More patients with normal ALT levels than patients with elevated ALT levels were women (59% vs 32%; P<.01). The serum HCV RNA titer was significantly lower in patients with normal ALT levels (P<.01 vs in patients with elevated ALT levels). Patients with normal ALT levels had significantly lower inflammation and fibrosis scores on liver biopsy examination than patients with elevated ALT levels, but almost two-thirds had portal fibrosis and 10% had bridging fibrosis. No correlation between baseline ALT activity, HCV RNA level, and liver histology was observed in patients with normal ALT levels. During the 72-week follow-up period, ALT activity elevated above the upper limit of normal in 53% of the untreated patients with normal levels of ALT. None became HCV RNA undetectable.
Chronic hepatitis C patients with normal ALT levels should be evaluated in a similar manner as patients with elevated ALT levels because they are at risk for developing significant liver disease. The decision to treat with peginterferon alfa and ribavirin should be based on multiple factors, rather than on ALT levels alone.
许多慢性丙型肝炎病毒（HCV）感染者的血清丙氨酸转氨酶（ALT）水平持续正常。我们利用聚乙二醇化干扰素α-2a（40 kDa）的3项随机III期试验数据，比较了慢性丙型肝炎患者与ALT水平正常及升高患者的特征。
比较了480例ALT值正常（在6至18个月期间≥3次，ALT水平无任何升高）患者和1993例ALT水平升高患者的特征。480例ALT水平正常的患者中有68例被随机分配至不治疗组，并进行72周的监测。
ALT水平正常的女性患者多于ALT水平升高的女性患者（59%对32%；P<0.01）。ALT水平正常患者的血清HCV RNA滴度显著较低（与ALT水平升高患者相比，P<0.01）。ALT水平正常患者肝活检检查的炎症和纤维化评分显著低于ALT水平升高患者，但近三分之二有门脉纤维化，10%有桥接纤维化。ALT水平正常患者的基线ALT活性、HCV RNA水平与肝组织学之间未观察到相关性。在72周的随访期内，53%的未治疗ALT水平正常患者的ALT活性升高至正常上限以上。无一例患者的HCV RNA检测不到。
ALT水平正常的慢性丙型肝炎患者应与ALT水平升高的患者一样进行评估，因为他们有发生严重肝病的风险。使用聚乙二醇化干扰素α和利巴韦林治疗的决定应基于多种因素，而不是仅基于ALT水平。
