恩替卡韦或富马酸替诺福韦二氧吡酯治疗慢性乙型肝炎患者丙氨酸转氨酶反应的评价

Ufuk Sonmez, Özge Kaya, Derya Çağlayan, Alpay Arı
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Methods: This retrospective cohort study collected data from treatment-naive and treatment-experienced patients with elevated ALT levels who received either ETV (0.5 or 1 mg per day) or TDF (245 mg per day) treatment between 2008 and 2018. Pregnant women and patients under 18 were excluded from the study. Elevated ALT levels were defined as greater than 35 IU/L for men and 25 IU/L for women. All patients underwent examinations for ALT, HBV DNA levels, HBeAg, and antiHBe at baseline and every 3–6 months. ALT levels of the patients were monitored for 60 months, and the presence of fatty liver was also documented. Results: Our study comprised 192 patients with a mean age of 53.7 (13.42) years. The majority of patients, 130 (67.7%), were male. Of these, 97 (50.5%) started ETV treatment, while 95 (49.5%) began TDF treatment. The median baseline ALT levels of the patients were 68 (44–133.5) IU/L, and the median ALT levels at the 60th month were 24 (18–32) IU/L. The median initial HBV DNA level was 114,282 (267.5–5,029,875) IU/mL, and the median HBV DNA levels from the 6th month onwards were 0 (0–0). ALT normalization was observed in 44.8% of men and 28.1% of women at 3 months, which was statistically significant (P=0.034). Normalization rates by gender remained consistent in all other months. No significant differences were noted in this regard. ALT normalization rates were 58.5% at the 6th month and 74.7% at the 24th month in the ETV group, significantly higher than in the TDF group (P=0.01, P=0.02, respectively). In patients with fatty liver, ALT normalization rates were significantly lower at 6, 12, 24, and 48 months than those without fatty liver (P=0.01, P=0.01, P=0.009, P=0.002, respectively). Conclusion: Although ALT responses to ETV treatment were more pronounced in specific months, both drugs demonstrated overall efficacy. ALT levels in patients with fatty liver remained elevated despite antiviral treatment. 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引用次数: 0

摘要

背景/目的:全世界估计有3亿人感染乙型肝炎病毒(HBV)。谷丙转氨酶(ALT)水平是慢性乙型肝炎患者随访中经常监测的关键实验室参数之一,当ALT水平升高时表明肝损害。抗病毒治疗的主要目的是通过抑制HBV复制来减少肝脏炎症和预防肝细胞癌或肝硬化的发展。本研究评估了开始恩替卡韦(ETV)或富马酸替诺福韦(TDF)治疗后患者的ALT反应,并确定了影响患者反应的因素。方法:本回顾性队列研究收集了2008年至2018年期间接受ETV(0.5或1mg /天)或TDF (245mg /天)治疗的未接受治疗和有治疗经验的ALT水平升高患者的数据。孕妇和18岁以下的患者被排除在研究之外。ALT水平升高的定义是男性大于35 IU/L,女性大于25 IU/L。所有患者在基线和每3-6个月检查一次ALT、HBV DNA水平、HBeAg和抗hbe。监测患者的ALT水平60个月,并记录脂肪肝的存在。结果:我们的研究纳入192例患者,平均年龄53.7(13.42)岁。130例(67.7%)为男性。其中97例(50.5%)开始ETV治疗,95例(49.5%)开始TDF治疗。患者基线ALT水平中位数为68 (44-133.5)IU/L,第60个月ALT水平中位数为24 (18-32)IU/L。初始HBV DNA水平中位数为114,282 (267.5-5,029,875)IU/mL, 6个月后HBV DNA水平中位数为0(0 - 0)。3个月时,男性44.8% ALT恢复正常,女性28.1% ALT恢复正常,差异有统计学意义(P=0.034)。按性别划分的正常化比率在所有其他月份保持一致。在这方面没有注意到重大差异。ETV组第6个月ALT正常化率58.5%,第24个月ALT正常化率74.7%,显著高于TDF组(P=0.01, P=0.02)。脂肪肝患者ALT正常化率在6、12、24、48个月明显低于非脂肪肝患者(P=0.01、P=0.01、P=0.009、P=0.002)。结论:虽然ETV治疗的ALT反应在特定月份更为明显,但两种药物均显示出总体疗效。尽管抗病毒治疗,脂肪肝患者的ALT水平仍然升高。因此,慢性乙型肝炎和脂肪肝患者可能需要抗病毒治疗之外的额外支持,包括代谢、营养和生活方式建议。
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Evaluation of alanine aminotransferase responses in chronic hepatitis B patients using entecavir or tenofovir disoproxil fumarate
Background/Aim: An estimated 300 million individuals worldwide live with hepatitis B virus (HBV) infection. Alanine aminotransferase (ALT) levels, which indicate liver damage when elevated, are among the crucial laboratory parameters frequently monitored in the follow-up of chronic hepatitis B patients. The primary objectives of antiviral treatment are to reduce liver inflammation and prevent the development of hepatocellular carcinoma or cirrhosis by inhibiting HBV replication. This study evaluated ALT responses and identified factors influencing patient responses following initiating entecavir (ETV) or tenofovir disoproxil fumarate (TDF) treatment. Methods: This retrospective cohort study collected data from treatment-naive and treatment-experienced patients with elevated ALT levels who received either ETV (0.5 or 1 mg per day) or TDF (245 mg per day) treatment between 2008 and 2018. Pregnant women and patients under 18 were excluded from the study. Elevated ALT levels were defined as greater than 35 IU/L for men and 25 IU/L for women. All patients underwent examinations for ALT, HBV DNA levels, HBeAg, and antiHBe at baseline and every 3–6 months. ALT levels of the patients were monitored for 60 months, and the presence of fatty liver was also documented. Results: Our study comprised 192 patients with a mean age of 53.7 (13.42) years. The majority of patients, 130 (67.7%), were male. Of these, 97 (50.5%) started ETV treatment, while 95 (49.5%) began TDF treatment. The median baseline ALT levels of the patients were 68 (44–133.5) IU/L, and the median ALT levels at the 60th month were 24 (18–32) IU/L. The median initial HBV DNA level was 114,282 (267.5–5,029,875) IU/mL, and the median HBV DNA levels from the 6th month onwards were 0 (0–0). ALT normalization was observed in 44.8% of men and 28.1% of women at 3 months, which was statistically significant (P=0.034). Normalization rates by gender remained consistent in all other months. No significant differences were noted in this regard. ALT normalization rates were 58.5% at the 6th month and 74.7% at the 24th month in the ETV group, significantly higher than in the TDF group (P=0.01, P=0.02, respectively). In patients with fatty liver, ALT normalization rates were significantly lower at 6, 12, 24, and 48 months than those without fatty liver (P=0.01, P=0.01, P=0.009, P=0.002, respectively). Conclusion: Although ALT responses to ETV treatment were more pronounced in specific months, both drugs demonstrated overall efficacy. ALT levels in patients with fatty liver remained elevated despite antiviral treatment. Therefore, patients with chronic hepatitis B and fatty liver may require additional support beyond antiviral therapy, including metabolic, nutritional, and lifestyle recommendations.
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