Lau D T, Everhart J, Kleiner D E, Park Y, Vergalla J, Schmid P, Hoofnagle J H
Digestive Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892, USA.
Gastroenterology. 1997 Nov;113(5):1660-7. doi: 10.1053/gast.1997.v113.pm9352870.
BACKGROUND & AIMS: Therapy with interferon alfa (IFN-alpha) leads to remission of disease in one third of patients with chronic hepatitis B. The aim of this study was to better define the long-term prognosis of this outcome.
One hundred three patients with chronic hepatitis B who underwent IFN-alpha therapy in three clinical trials between 1984 and 1991 were followed up for serological status, biochemical evidence of liver disease, and liver complications or mortality through 1994.
Among 103 patients, 31 (30%) responded to therapy with loss of hepatitis B e antigen and viral DNA from serum. Responders were more likely than nonresponders to be women, black, and to have more severe liver disease including cirrhosis (P < 0.05). Up to 11 years (mean, 6.2 years) after therapy, a higher percentage of responders than nonresponders were still negative for hepatitis B e antigen (94% vs. 40%; P < 0.001) and hepatitis B surface antigen (71% vs 8.3%; P < 0.001). Overall, the rate of liver-related complications and death did not differ by IFN-alpha response, but with adjustment for cirrhosis, nonresponders had higher rates of liver-related complications and mortality (hazard ratio, 13.7; 95% confidence interval, 3.0-63.5).
The response to IFN-alpha therapy in chronic hepatitis B is usually a sustained improvement in disease markers and, when cirrhosis is considered, patient outcome.
干扰素α（IFN-α）治疗可使三分之一的慢性乙型肝炎患者病情缓解。本研究旨在更好地明确这一结果的长期预后。
对1984年至1991年间在三项临床试验中接受IFN-α治疗的103例慢性乙型肝炎患者进行随访，直至1994年，观察其血清学状态、肝病的生化证据以及肝脏并发症或死亡率。
103例患者中，31例（30%）治疗有效，血清中乙肝e抗原和病毒DNA消失。与未应答者相比，应答者更可能为女性、黑人，且肝病更严重，包括肝硬化（P < 0.05）。治疗后长达11年（平均6.2年），应答者中乙肝e抗原仍为阴性的比例高于未应答者（94%对40%；P < 0.001），乙肝表面抗原仍为阴性的比例亦高于未应答者（71%对8.3%；P < 0.001）。总体而言，IFN-α应答与否与肝脏相关并发症和死亡率无关，但校正肝硬化因素后，未应答者的肝脏相关并发症和死亡率更高（风险比，13.7；95%置信区间，3.0 - 63.5）。
慢性乙型肝炎患者对IFN-α治疗的应答通常表现为疾病标志物的持续改善，若考虑肝硬化因素，则患者预后也会改善。
