Perrillo R, Tamburro C, Regenstein F, Balart L, Bodenheimer H, Silva M, Schiff E, Bodicky C, Miller B, Denham C
Gastroenterology Section, Veterans Affairs Medical Center, St. Louis, Missouri, USA.
Gastroenterology. 1995 Sep;109(3):908-16. doi: 10.1016/0016-5085(95)90401-8.
BACKGROUND & AIMS: Interferon therapy has been associated with a number of severe side effects when administered to patients with decompensated cirrhosis caused by chronic hepatitis B. The safety and potential efficacy of a low-dose, titratable regimen of interferon alfa-2b in patients with decompensated liver disease caused by chronic hepatitis B virus infection were studied.
Twenty-six patients were treated at five medical centers. Five patients had Child's class A status, 15 had Child's B status, and 6 had Child's C status. Treatment was continued for 24 weeks whenever possible. Dose adjustments were made according to predefined safety criteria.
All patients with Child's A status responded with a sustained loss of serum hepatitis B virus DNA, reduction in aminotransferase activity, and clinical stabilization. Only 5 patients with Child's B (33%) and no patients with Child's C status reached similar end points. The probability of survival was greater in responders than in nonresponders (P = 0.017). Three patients each developed serious infections or greater than twofold increases in serum aminotransferase levels during therapy.
Low-dose, titratable interferon therapy is safer than previously reported regimens. Nonetheless, serious infections were observed relatively frequently, and this therapy should be reserved for individuals with mild to moderate hepatic decompensation, preferably patients with Child's A status.
对于慢性乙型肝炎所致失代偿期肝硬化患者，干扰素治疗一直与多种严重副作用相关。本研究旨在探讨低剂量、可滴定的α-2b干扰素方案治疗慢性乙型肝炎病毒感染所致失代偿期肝病患者的安全性和潜在疗效。
26例患者在5个医学中心接受治疗。其中5例为Child A级，15例为Child B级，6例为Child C级。尽可能持续治疗24周。根据预定义的安全标准进行剂量调整。
所有Child A级患者均出现血清乙型肝炎病毒DNA持续下降、转氨酶活性降低及临床病情稳定。只有5例Child B级患者（33%）达到类似终点，Child C级患者无一人达到。应答者的生存概率高于无应答者（P = 0.017）。治疗期间，3例患者分别发生严重感染或血清转氨酶水平升高超过两倍。
低剂量、可滴定的干扰素治疗比先前报道的方案更安全。尽管如此，严重感染相对频繁发生，该治疗应仅限于轻度至中度肝失代偿患者，最好是Child A级患者。
