Clinical effect of nucleos (t) ide analogues in treatment of acute exacerbation of chronic hepatitis B
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摘要: 目的探讨核苷(酸)类似物(NAs)治疗慢性乙型肝炎(CHB)急性发作48周的临床效果。方法选取2014年10月-2018年7月中南大学湘雅医学院附属海口医院诊治的HBeAg阳性CHB和HBeAg阴性CHB患者。其中ALT> 10倍正常值上限的CHB急性发作患者48例,为试验组; ALT <10×ULN且TBil <5×ULN的CHB患者51例,为对照组。2组患者均接受恩替卡韦和替诺福韦酯治疗。分析比较试验组和对照组经NAs治疗的临床过程和效果,观察指标包括基线时肝功能、HBV DNA、HBsAg、抗-HBs、HBeAg、抗-HBe和肝脏超声检查,并在治疗第12、24、48周进行随访评估。符合正态分布的计量资料2组间比较采用t检验,非正态分布的计量资料2组间比较采用Mann-Whitney U检验。计数资料2组间比较采用χ2检验或Fisher精确检验。结果试验组患者在12、24、48周的ALT复常率分别为89. 58%、93. 75%、93. 75%,与对照组患者的49. 02%、72. 55%、76. 47%相比,差异均有统计学意义(χ...Abstract: Objective To investigate the clinical effect of nucleos (t) ide analogues (NAs) in the treatment of acute exacerbation of chronic hepatitis B (CHB) for 48 weeks. Methods The CHB patients with positive or negative HBeAg who were diagnosed and treated in Haikou Hospital Affiliated to Xiangya School of Medicine, Central South University, from October 2014 to July 2018 were enrolled. Among these patients, 48 with an acute exacerbation of CHB and an alanine aminotransferase (ALT) level of > 10 × upper limit of normal (ULN) were enrolled as experimental group, and 51 with an ALT level of < 10 × ULN and a total bilirubin level of < 5 × ULN were enrolled as control group. Both groups were treated with entecavir and tenofovir disoproxil fumarate. The two groups were compared in terms of the clinical process and outcome of NA treatment, including baseline liver function, HBV DNA, HBsAg, anti-HBs, HBeAg, anti-HBe, and liver ultrasound findings, and follow-up was performed at weeks 12, 24, and 48 of treatment. The t-test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups. The chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups.Results There was a significant difference in ALT normalization rate at weeks 12, 24, and 48 of treatment between the experimental group and the control group (89. 58%/93. 75%/93. 75% vs 49. 02%/72. 55%/76. 47%, χ2= 18. 917, 7. 814, and 5. 743, all P < 0. 05) .There was a significant difference in the undetectable rate of HBV DNA at week 12 of treatment between the experimental group and the control group (83. 33% vs 60. 78%, χ2= 6. 198, P = 0. 013) , while there was no significant difference between the two groups at weeks 24 and48 of treatment (95. 83%/95. 83% vs 84. 31%/86. 27%, P > 0. 05) . There was a significant difference in HBeAg seroconversion rate between the experimental group and the control group at weeks 12, 24, and 48 of treatment (23. 26%/25. 58%/27. 91% vs 2. 22%/2. 22%/8. 89%, χ2= 8. 894, 10. 188, and 5. 346, all P < 0. 05) . Clearance or seroconversion of HBsAg was not observed in the experimental group or the control group. Conclusion NAs can achieve high ALT normalization rate, HBV DNA undetectable rate, and HBeAg seroconversion rate in the treatment of patients with acute exacerbation of CHB.
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Key words:
- hepatitis B, chronic /
- nucleosides /
- nucleotides /
- treatment outcome /
- retrospective studies
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