长、短疗程口服抗病毒药预防急性髓系白血病患者乙型肝炎病毒再激活的观察研究

庄　衍; 唐　勇; 俞夜花

doi:10.19401/j.cnki.1007-3639.2017.12.008

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长、短疗程口服抗病毒药预防急性髓系白血病患者乙型肝炎病毒再激活的观察研究

更新时间：2025-12-31

- 长、短疗程口服抗病毒药预防急性髓系白血病患者乙型肝炎病毒再激活的观察研究
- Observational studies on prophylaxis of hepatitis B virus reactivation with long or short course oral antiviral agents among patients with acute myeloid leukemia
- 中国癌症杂志 2017年27卷第12期页码：964-969
- 作者机构：
  
  上海交通大学医学院附属第九人民医院血液内科,上海,200011
- 作者简介：
- 基金信息：
  
  上海交通大学医学院附属第九人民医院科室融合基金(九院融合2017)。
- DOI：10.19401/j.cnki.1007-3639.2017.12.008
  中图分类号：
- 网络出版：2018-01-11，
  
  纸质出版：2017-01-11
- 稿件说明：
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庄　衍,唐　勇,俞夜花,等. 长、短疗程口服抗病毒药预防急性髓系白血病患者乙型肝炎病毒再激活的观察研究[J]. 中国癌症杂志, 2017, 27(12): 964-969.

庄　衍, 唐　勇, 俞夜花. Observational studies on prophylaxis of hepatitis B virus reactivation with long or short course oral antiviral agents among patients with acute myeloid leukemia[J]. China Oncology, 2017, 27(12): 964-969.
庄　衍,唐　勇,俞夜花,等. 长、短疗程口服抗病毒药预防急性髓系白血病患者乙型肝炎病毒再激活的观察研究[J]. 中国癌症杂志, 2017, 27(12): 964-969. DOI： 10.19401/j.cnki.1007-3639.2017.12.008.

庄　衍, 唐　勇, 俞夜花. Observational studies on prophylaxis of hepatitis B virus reactivation with long or short course oral antiviral agents among patients with acute myeloid leukemia[J]. China Oncology, 2017, 27(12): 964-969. DOI： 10.19401/j.cnki.1007-3639.2017.12.008.

摘要

背景与目的：乙型肝炎病毒(hepatitis B virus，HBV)再激活是急性髓系白血病(acute myeloid leukemia，AML)合并HBV感染的患者接受诱导和巩固化疗期间严重并发症之一，核苷类抗HBV药物(包括拉米夫定和恩替卡韦等)已成为预防和抢先治疗HBV再激活主要抗病毒药物。该研究观察并探究AML合并HBV感染患者化疗前后长疗程和短疗程口服核苷类抗HBV药物预防病毒再激活的临床疗效和安全性。方法：回顾性分析29例AML合并HBV感染并接受至少4个疗程化疗患者的临床资料。根据患者口服核苷类抗HBV药物预防治疗前HBV表面抗原(hepatitis B surface antigen，HBsAg)含量以及抗HBV药物持续服用时间分为4个亚组，系统分析和比较不同亚组患者HBV再激活情况和药物不良反应。结果：长疗程预防(long course prophylaxis group，LCP)组，即口服抗HBV药物持续至化疗结束后6个月以上，该组患者的HBV再激活率和HBV相关性肝炎发生率分别为5.56%(1/18)和0%(0/18)，明显低于短疗程预防(short course prophylaxis group，SCP)组患者(即口服抗HBV药物持续至化疗结束后1个月以内)的45.45%(5/11)和36.36%(4/11)，差异有统计学意义(P=0.018和P=0.014)，而LCP和SCP组患者的HBV原发耐药率分别为11.11%(2/18)和9.09%(1/11)，差异无统计学意义(P0.05)。进一步亚组分析显示，预防治疗前HBsAg阳性患者(HBsAg大于等于0.05 IU/mL)经长疗程预防，其HBV再激活率和HBV相关性肝炎发生率分别为8.33%(1/12)和0%(0/12)，明显低于SCP组，66.67%(4/6)和66.67%(4/6)，差异有统计学意义(P=0.022和P=0.005)；同时，LCP和SCP组中HBsAg(+)患者的HBV原发耐药率分别为8.33%(1/12)和16.67%(1/6)，差异无统计学意义(P0.05)。此外，LCP组中HBsAg阴性患者(HBsAg小于0.05 IU/mL)的HBV再激活率、肝炎发生率和原发耐药率与SCP组中HBsAg(-)患者比较，差异无统计学意义(P0.05)。LCP和SCP组患者均未发生3级以上药物毒性反应。结论：长疗程口服核苷类抗HBV药物是降低AML合并HBsAg(+)感染患者化疗后病毒再激活以及病毒相关事件发生率有效而且安全性良好的预防治疗方案。

Abstract

Background and purpose: Hepatitis B virus (HBV) reactivation is one of the serious complications among patients with acute myeloid leukemia (AML) following cytotoxic induction and consolidation chemotherapy. Nucleoside analogs including lamivudine and entecavir have been widely used as prophylactic or preemptive treatment for HBV reactivation. This study was to investigate clinical efficacy and safety of long or short course oral anti- HBV agents for preventing HBV reactivation in AML patients with HBV infection during chemotherapy. Methods: The medical records of 29 AML patients with HBV infection receiving at least 4 courses of chemotherapy were retrospectively identified and systematically analyzed. These patients were further divided into four groups according to their hepatitis B surface antigen (HBsAg) status prior to initiation of chemotherapy and duration of prophylactic therapy. Reactivation of HBV and toxicity profiles of oral antiviral agents were systematically analyzed and compared among different groups. Results: HBV reactivation and documented HBV-related hepatitis were significantly lower in AML patients under long course antiviral prophylaxis (i.e. continuing oral antiviral therapy for at least 6 months after cessation of chemotherapy

LCP group) than in the patients with short course antiviral prophylaxis (i.e. continuing oral antiviral therapy for one month after cessation of chemotherapy

SCP group)

which was 5.56% (1/18) and 0% (0/18) compared with 45.45% (5/11) and 36.36% (4/11) (P=0.018 and P=0.014). There was little difference in the incidence of antiviral resistance between LCP and SCP groups ［11.11% (2/18) vs 9.09% (1/11)

P0.05］. Furthermore

the rates of HBV reactivation and HBV-related hepatitis were significantly lower in AML patients with positive HBsAg (HBsAg≥0.05 IU/mL) under long course antiviral prophylaxis than in HBsAg positive patients who received short course antiviral agents ［8.33% (1/12) and 0% (0/12) vs 66.67% (4/6) and 66.67% (4/6)

P=0.022 and P=0.005］. Meanwhile

there was little difference in the rates of antiviral resistance between LCP and SCP groups among HBsAg positive patients ［8.33% (1/12) vs 16.67% (1/6)

P0.05］. In addition

the rates of HBV reactivation and HBV-related hepatitis as well as antiviral resistance were shown to have little difference in AML patients with negative HBsAg (HBsAg0.05 IU/mL) between LCP and SCP groups. Concerning antiviral agent toxicity

no grade 3-4 toxicity occurred in patients from LCP or SCP group. Conclusion: Long course prophylaxis with oral antiviral agent appears to be an effective and well tolerated preventative approach for reducing risks of HBV reactivation and associated events in AML patients with positive HBsAg during chemotherapy

which serves as a platform for the design of prospective clinical trials.

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