Lok A S, Ghany M G, Watson G, Ayola B
Division of Gastroenterology, University of Michigan, Ann Arbor, USA.
J Viral Hepat. 1998 May;5(3):171-8. doi: 10.1046/j.1365-2893.1998.00098.x.
In a previously reported randomized controlled trial of interferon-alpha (IFN-alpha) for chronic hepatitis B, we found a significant difference in response between Chinese adults with elevated vs normal pretreatment aminotransferase (ALT) levels. The aim of this study was to determine the correlation between serum hepatitis B virus (HBV) DNA levels and response to IFN therapy. HBV DNA levels in residual stored sera from patients who participated in the above trial were quantified by a branched DNA (bDNA) assay. Nominal logistic regression was used to estimate the probability of response to IFN treatment as a function of pretreatment ALT and/or HBV DNA levels. We found a significant (P < 0.01) correlation between the HBV DNA levels at midtreatment and response to IFN therapy. Response was achieved in 53% of patients who had undetectable HBV DNA levels at midtreatment but in only 17% of those who remained HBV DNA positive (P < 0.01). In contrast, the probabilities of response for patients with baseline HBV DNA levels over the range 10 to 10000 million equivalents (MEq) ml-1 were almost identical. We also found a significant correlation between the pretreatment ALT levels and response to IFN therapy. The probabilities of response for patients with pretreatment ALT levels of 500 and 100 IU l-1 were higher than for patients with normal ALT levels by two and onefold, respectively. Our findings may help to improve the cost-effectiveness of IFN therapy for chronic hepatitis B by guiding the selection of patients for therapy and in optimizing the duration of treatment for the individual patient.
在先前报道的一项关于干扰素-α（IFN-α）治疗慢性乙型肝炎的随机对照试验中，我们发现，治疗前丙氨酸氨基转移酶（ALT）水平升高的中国成年人与ALT水平正常的成年人在治疗反应上存在显著差异。本研究的目的是确定血清乙型肝炎病毒（HBV）DNA水平与IFN治疗反应之间的相关性。采用分支DNA（bDNA）分析法对参与上述试验患者留存的血清中的HBV DNA水平进行定量分析。使用名义逻辑回归来估计IFN治疗反应的概率，将其作为治疗前ALT和/或HBV DNA水平的函数。我们发现治疗中期的HBV DNA水平与IFN治疗反应之间存在显著相关性（P < 0.01）。治疗中期HBV DNA水平检测不到的患者中，53%获得了治疗反应，而HBV DNA仍呈阳性的患者中只有17%获得了治疗反应（P < 0.01）。相比之下，基线HBV DNA水平在10至10000百万当量（MEq）/ml范围内的患者的治疗反应概率几乎相同。我们还发现治疗前ALT水平与IFN治疗反应之间存在显著相关性。治疗前ALT水平为500和100 IU/L的患者的治疗反应概率分别比ALT水平正常的患者高出两倍和一倍。我们的研究结果可能有助于通过指导患者的治疗选择和优化个体患者的治疗疗程来提高IFN治疗慢性乙型肝炎的成本效益。
