Saracco G, Rosina F, Abate M L, Chiandussi L, Gallo V, Cerutti E, Di Napoli A, Solinas A, Deplano A, Tocco A
Dipartimento di Gastroenterologia, Ospedale Molinette, Torino, Italy.
Hepatology. 1993 Dec;18(6):1300-5.
Eighty patients with chronic hepatitis C who completed a previously reported randomized controlled trial on the efficacy of interferon-alpha 2b were followed up for at least 36 mo after therapy discontinuation. Seventeen patients (21.2%) maintained normal ALT values throughout the follow-up; 63 (78.8%) either did not normalize the levels of ALT or relapsed during the follow-up. A significantly greater proportion of patients treated with 3 million units of interferon three times a week subcutaneously for 48 wk were long-term responders compared with patients treated for 24 wk. Sex, age, hepatitis C virus antibody status, source of infection and pretreatment levels of ALT were not predictive of long-term response. Cirrhosis was found to be an unfavorable predictive factor. After 3 yr of follow-up, clearance of viremia was observed in 58.9% of the 17 long-term responders but in none of the non-responders (p = 0.002). E2-NS1 antibody tested negative in 88.2% of long-term responders and in 14.3% of nonresponders (p = 0.001). Fifty-nine percent of long-term responders tested negative for C100-NS4 antibody compared with 14.3% of nonresponders (p = 0.031). No significant change was observed in other antibodies. Four long-term responders underwent liver biopsy 2 yr after discontinuation of therapy. All four patients had normal liver histology compared with baseline assessment of chronic active hepatitis in three and chronic persistent hepatitis in the other. Three of the four were negative for serum hepatitis C virus RNA.
80例完成了先前报道的关于α-干扰素2b疗效的随机对照试验的慢性丙型肝炎患者在治疗中断后接受了至少36个月的随访。17例患者（21.2%）在整个随访期间ALT值维持正常；63例（78.8%）在随访期间ALT水平未恢复正常或复发。与接受24周治疗的患者相比，每周皮下注射300万单位干扰素共48周的患者中，长期缓解者的比例显著更高。性别、年龄、丙型肝炎病毒抗体状态、感染源和ALT的治疗前水平均不能预测长期缓解情况。发现肝硬化是一个不利的预测因素。随访3年后，17例长期缓解者中有58.9%出现病毒血症清除，而非缓解者中无一例出现（p = 0.002）。88.2%的长期缓解者E2-NS1抗体检测为阴性，非缓解者中这一比例为14.3%（p = 0.001）。59%的长期缓解者C100-NS4抗体检测为阴性，而非缓解者中这一比例为14.3%（p = 0.031）。其他抗体未观察到显著变化。4例长期缓解者在治疗中断2年后接受了肝活检。与基线评估相比，4例患者中有3例为慢性活动性肝炎，另1例为慢性持续性肝炎，所有4例患者的肝脏组织学均正常。4例中有3例血清丙型肝炎病毒RNA检测为阴性。
