替诺福韦不同产后停药时间对乙型肝炎病毒标志物、病毒学以及生化学指标的影响

doi:10.12092/j.issn.1009-2501.2021.10.006

中国临床药理学与治疗学 ›› 2021, Vol. 26 ›› Issue (10): 1146-1152.doi: 10.12092/j.issn.1009-2501.2021.10.006

替诺福韦不同产后停药时间对乙型肝炎病毒标志物、病毒学以及生化学指标的影响

陶承静¹，刘寿荣²，程晓仙⁴，胡健女¹，白秀丽¹，张素英¹，赵春²，左中宝³

1浙江中医药大学附属杭州市西溪医院妇产科，
2内一科，
3检验科，杭州 310023，浙江；
4浙江省杭州市桐庐县妇幼保健院妇产科，杭州 311500，浙江

收稿日期:2020-07-26 修回日期:2021-07-21 出版日期:2021-10-26 发布日期:2021-11-02
通讯作者: 刘寿荣，通信作者，男，硕士，教授，博导，研究方向：感染性疾病的诊治。Tel: 18072980585 E-mail: lsr85463990@126.com E-mail:Lsr85463998@163.com
作者简介:陶承静，女，硕士，副主任医生，研究方向：妊娠合并感染性疾病的诊治。Tel: 13588029494 E-mail: taochengjing74@163.com
基金资助:
杭州市社会发展科研主动设计项目（20172016A03）；浙江省医药卫生科研面上项目（2018KY628）；杭州市卫生科技计划（一般）项目（201870354）

Effects of different postpartum withdrawal time of tenofovir on hepatitis B virus markers, virology and biochemical indexes

TAO Chengjing¹, LIU Shourong², CHENG Xiaoxian⁴, HU Jiannv¹, BAI Xiuli¹, ZHANG Suying¹, ZHAO Chun², ZUO Zhongbao³

1Department of Obstetrics and Gynecology, Hangzhou Xixi Hospital, Zhejiang Chinese Medical University, Hangzhou 310023, Zhejiang, China

Received:2020-07-26 Revised:2021-07-21 Online:2021-10-26 Published:2021-11-02

摘要/Abstract

摘要： 目的：评估不同停药时间对富马酸替诺福韦酯（tenofovir disoproxil fumarate, TDF）母婴阻断孕产妇的乙型肝炎病毒（HBV）标志物、病毒学指标及ALT变化的影响。方法：采用前瞻性、随机对照研究。选择孕24～28周开始服用TDF抗病毒治疗的HBV携带孕妇共120名为研究对象，随机分成A组（分娩时停药组）和B组（分娩后4周停药组），检测两组孕妇服药后不同时间段以及不同停药时间点HBV DNA定量、乙肝表面抗原（HBsAg）、乙肝e抗原（HBeAg）及血清中ALT水平变化，并采用Wilcoxon秩和检验、χ2检验进行差异性比较分析。结果：106名孕产妇完成检测和随访，A组56人和B组50人。两组孕妇HBsAg水平与各自基线相比以及两组间差异均无统计学意义（P>0.05）。B组患者的HBeAg（M=2.920Log10S/CO）和HBV DNA水平（M=1.477Log10拷贝/mL）在停药时明显低于A组（M=3.045Log10S/CO，M=2.647Log10拷贝/mL），差异有统计学意义（Z=3.126，P=0.002；Z=－2.940、P＜0.001）。B组孕产妇在停药时出现HBeAg血清学转换率22.00%（11/50），相比A组8.93%（5/56）略高，差异无统计学意义（P>0.05）。各组停药后ALT异常发生率（A组41.07%，B组40.00%）明显高于孕期异常率（A组19.64%，B组16.00%），差异有统计学意义（A组：χ2=6.081，P=0.014；B组：χ2=7.143，P=0.008）；两组停药后ALT异常率相比差别较小，差异无统计学意义（χ2=0.238，P=0.625）。对于孕期ALT异常孕产妇，A组出现停药后ALT异常率明显高于B组（A组100%，B组62.50%），差异有统计学意义（Z=0.696，P=0.048）。结论：分娩时停药和分娩后4周停药对孕产妇停药后的HBsAg、HBeAg、HBV DNA、ALT水平的影响没有较大差别。对于孕期出现ALT异常孕妇，在分娩时停药比分娩后4周停药更容易出现停药后ALT异常。建议对孕期出现ALT异常的孕妇，加强产后监测，必要时适当延迟停药时间。

关键词: 乙型肝炎病毒, 替诺福韦, 停药时间

Abstract: AIM: To evaluate the effect of TDF withdrawal time on changes of serum HBV-M, HBV DNA and ALT level in the mother-to-child blocking of the maternal population. METHODS: A prospective, randomized and controlled study was conducted. The 120 pregnant women with HBV who took TDF during 24 to 28 weeks of gestation were randomly divided into group A (withdrawal at delivery) and group B (withdrawal at 4 weeks postpartum), levels of HBV-M,HBV DNA, and ALT at different times were detected. The results were statistically analyzed by Wilcoxon Rank-sum test and χ2 test. RESULTS: In total, 106 pregnant women have completed testing and follow-up, including 56 in group A and 50 in group B. The levels of HBsAg showed no significant difference in both groups and between the two groups (P>0.05). The levels of HBeAg (M=2.920Log10S/CO) and HBV DNA (M=1.477Log10copies/mL) of group B at withdrawal were significantly lower than group A (M=3.045Log10S/CO, M=2.647Log10 copies/mL). The difference were statistically significant (Z=3.126, P=0.002; Z=－2.940, P＜0.001). The HBeAg serological conversional rate of group B was 22.00%(11/50), which was higher than group A ［8.93% (5/56)］, but it was not statistically significant (P>0.05). The ALT abnormal incidence rate after withdrawal (41.07% in group A and 40.00% in group B) were significantly higher than during pregnancy (19.64% in group A, 16.00% in group B). The difference were statistically significant (group A: χ2=6.081, P=0.014; group B: χ2=7.143, P=0.008); The result of group A and group B compared each was no statistics significant (χ2=0.238, P=0.625). About women with abnormal ALT during pregnancy, the abnormal incidence rate of ALT in group A after withdrawal (100%) was significantly higher than in group B (62.50%) , and the difference was statistically significant (Z=0.696, P=0.048). CONCLUSION: The levels of HBsAg, HBeAg, HBV DNA and ALT have no difference between group A (withdrawal at delivery) and group B(withdrawal at 4 weeks after delivery). About women with abnormal ALT during pregnancy, people in group A show more incurrence than group B after drug withdrawal. Pregnant women with abnormal ALT during pregnancy should enhance postpartum monitoring and delay the drug time when necessary.

Key words: hepatitis B virus, tenofovir, drug withdrawal time

中图分类号:

R512.6+2

陶承静, 刘寿荣, 程晓仙, 胡健女, 白秀丽, 张素英, 赵春, 左中宝. 替诺福韦不同产后停药时间对乙型肝炎病毒标志物、病毒学以及生化学指标的影响[J]. 中国临床药理学与治疗学, 2021, 26(10): 1146-1152.

TAO Chengjing, LIU Shourong, CHENG Xiaoxian, HU Jiannv, BAI Xiuli, ZHANG Suying, ZHAO Chun, ZUO Zhongbao. Effects of different postpartum withdrawal time of tenofovir on hepatitis B virus markers, virology and biochemical indexes[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2021, 26(10): 1146-1152.

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替诺福韦不同产后停药时间对乙型肝炎病毒标志物、病毒学以及生化学指标的影响

Effects of different postpartum withdrawal time of tenofovir on hepatitis B virus markers, virology and biochemical indexes

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