南方医科大学学报

南方医科大学学报 ›› 2019, Vol. 39 ›› Issue (02): 150-.doi: 10.12122/j.issn.1673-4254.2019.02.04

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慢性乙型肝炎患者的基线丙氨酸氨基转移酶水平与抗病毒疗效的关系

肖芷琪，周福元，周彬，杨洁   

  • 出版日期:2019-02-20 发布日期:2019-02-20

Association of baseline alanine aminotransferase levels with therapeutic effects of entecavir and interferon-α in patients with chronic hepatitis B

  • Online:2019-02-20 Published:2019-02-20

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摘要： 目的分析恩替卡韦与α干扰素在不同基线丙氨酸氨基转移酶（ALT）水平治疗48周后的疗效，为临床慢性乙型肝炎（CHB） 抗病毒治疗提供参考依据。方法回顾性分析369例CHB患者的资料，根据治疗方案及基线ALT水平分组，分析治疗48周后不 同治疗方案、不同基线ALT水平的病毒学应答率、HBeAg转阴率、HBsAg下降情况，评估治疗效果。结果①病毒学应答情况： 治疗48周后恩替卡韦组在基线ALT≤5倍正常值上限（ULN）（组1）、5~10×ULN（组2）、>10×ULN（组3）的病毒学应答率分别为 83.3%、91.4%、95.5%，α干扰素组则分别为19.7%，40%，42.9%，不同治疗方案之间及不同ALT水平组之间对比差异均有统计学 意义（P<0.05）。②HBeAg转阴情况：恩替卡韦组的组1、组2、组3在治疗48周后的HBeAg转阴率分别为8.3%、16.7%、35.5%， 而α干扰素组分别为1.8%、41.9%、38.1%，对比同一治疗方案不同ALT分组，差异具有统计学意义（P<0.05），而分析同一ALT分 组不同治疗方案，仅在组2中两种治疗方案的HBeAg转阴率差异有统计学意义（P<0.05）。③HBsAg下降情况：恩替卡韦组在 基线ALT≤5×ULN组和>5×ULN组的HBsAg小于200 U/mL率分别为2.5%、13.8%，两者差异无统计学意义，α干扰素组则分别 为30.6%、33.3%，差异无统计学意义（P>0.05），而同一ALT分组两种治疗方案的HBsAg小于200 U/mL率的差异均具有统计学 意义（P<0.05）。结论治疗48周后，恩替卡韦组在各个ALT组均较α干扰素组有更高的病毒学应答率。在基线ALT5~10×ULN 组中，α干扰素组的HBeAg转阴率高于恩替卡韦组。对于HBsAg下降情况，α干扰素组在各个ALT组均较恩替卡韦组有更好的效 果，而同一治疗方案不同ALT组中，基线高ALT水平（ALT>5×ULN）组的疗效均优于基线低ALT水平（ALT≤5×ULN）组。因此， 建议基线ALT水平在5~10×ULN的患者优先选择α干扰素治疗，而基线ALT水平≤5×ULN、>10×ULN的患者选用恩替卡韦治疗。

Abstract: Objective To evaluate the therapeutic effects of entecavir (ETV) and interferon-α (IFN-α) treatments for 48 weeks for chronic hepatitis B (CHB) in patients with different baseline alanine aminotransferase (ALT) levels. Methods We retrospectively analyzed the data of 369 CHB patients receiving ETV and IFN-α treatments for 48 weeks. We compared the virological response rates, HBsAg clearance, and HBsAg reduction between the patients receiving ETV and IFN-α treatments with different baseline ALT levels [≤5×upper limits of normal (ULN) level (subgroup 1), 5-10×ULN (subgroup 2), and >10× ULN (subgroup 3)]. Results In patients receiving ETV treatment, the virological response rate was 83.3% in subgroup 1, 91.4% in subgroup 2, and 95.5% in subgroup 3, as compared with 19.7%, 40%, and 42.9% in the 3 subgroups with IFN-α treatment, respectively, showing significantly differences both among different subgroups with the same treatment and between the same subgroup with different treatments (P<0.05). HBeAg clearance rates in the 3 subgroups were 8.3%, 16.7% and 35.5% in patients with ETV treatment and were 1.8%, 41.9%, and 38.1% in patients with IFN-α treatment, respectively, showing significant differences among the 3 subgroups with the same treatment (P<0.05); in the same subgroups with different treatments, the rates differed significantly only between subgroups 2 (P<0.05). In ETV group, the rate of HBsAg reduction to below 200 IU/ml was 2.5% in subgroup 1 and 13.8% in subgroup 2, showing no significant difference between the two subgroups; in IFN-α group, the rates were also similar between subgroups 1 and 2 (30.6% vs 33.3%, P>0.05); but the rates differed significantly between the same subgroups with different treatments (P<0.05). Conclusion In all the subgroups with different baseline ALT levels, ETV treatment for 48 weeks results in significantly higher virological response rates than IFN-α treatment in patients with CHB. In patients with a baseline ALT of 5-10 ×ULN, IFN-α can result in a higher HBeAg clearance rate than ETV. In patients with comparable baseline ALT level, IFN-α more effectively reduces HBsAg level than ETV. The patients with a relatively high baseline ALT level (>5 × ULN) show better responses to both ETV and IFN-α treatment than those with ALT level below 5×ULN. We thus recommend IFN-α for patients with a baseline ALT of 5-10×ULN and ETV for patients with a baseline ALT either below 5 × ULN or beyond 10×ULN.