肝移植术后乙肝主动免疫重建受者停用HBIG和（或）核苷（酸）类似物的长期安全性和有效性

Long-term safety and effectiveness of withdrawal of HBIG and/or nucleos(t)ide analogues in recipients undergoing hepatitis B immune reconstitution after liver transplantation

    摘要
  • 摘要:
      目的   探讨乙型病毒性肝炎（乙肝）相关疾病肝移植受者接种乙肝疫苗成功后长期停用乙型肝炎免疫球蛋白（HBIG）和（或）核苷（酸）类似物（NAs）预防乙型肝炎病毒（HBV）再感染的安全性及有效性。
      方法   回顾性分析76例接种乙肝疫苗后成功重建乙肝主动免疫的肝移植受者的基本资料，分析疫苗接种及应答情况、应答者停用HBIG和（或）NAs的随访结果、停用HBIG和（或）NAs后HBV再感染情况。
      结果   肝移植术后至开始接种乙肝疫苗的时间间隔为26（20，40）个月。接种疫苗至应答时间为15（8，27）个月。初始76例受者全部停用HBIG，36例受者停用HBIG和NAs。随访期间，76例停用HBIG受者中12例恢复使用HBIG，36例停用HBIG和NAs者中16例恢复使用NAs。HBIG和NAs停用时间分别为135（98，150）个月与133（34，149）个月。16例应答者未接种过加强针，36例应答者定期接种加强针，第1次接种加强针的时间距离停用HBIG的间隔时间为44（11，87）个月，未接种加强针和接种加强针的应答者一般资料比较差异均无统计学意义（均为P>0.05）。截至随访日，9例受者失访，5例HBV再感染，3例受者死亡，1例受者移植物丢失并进行二次肝移植。5例HBV再感染受者中4例发生病毒变异。再感染者与未感染者是否停用过NAs、移植前乙型肝炎e抗原（HBeAg）是否为阳性差异有统计学意义（均为P<0.05）。
      结论   乙肝相关疾病肝移植术后乙肝主动免疫重建成功的受者长期停用HBIG是可行和安全的，但能否同时停用NAs还需要进一步研究。

     

    Abstract:
      Objective   To investigate the long-term safety and effectiveness of withdrawal of hepatitis B immuneglobulin (HBIG) and/or nucleos(t)ide analogues (NAs) to prevent hepatitis B virus (HBV) reinfection in liver transplant recipients with hepatitis B-related diseases after successful vaccination.
      Methods  Baseline data of 76 liver transplant recipients undergoing hepatitis B immune reconstitution after receiving hepatitis B vaccines were retrospectively analyzed. The vaccination and response, the follow-up results of respondents with HBIG and/or NAs withdrawal, and the reinfection of HBV after withdrawal of HBIG and/or NAs were analyzed.
      Results  The time interval from liver transplantation to hepatitis B vaccination was 26 (20, 40) months. The time interval from vaccination to response was 15 (8,27) months. Initially, 76 recipients withdrew HBIG, and 36 recipients withdrew HBIG and NAs. During the follow-up, 12 of 76 recipients who withdrew HBIG resumed use of HBIG, and 16 of 36 recipients who withdrew HBIG and NAs resumed use of NAs. The withdrawal time of HBIG and NAs was 135 (98,150) and 133 (34,149) months, respectively. Sixteen respondents did not receive booster, and 36 respondents received boosters on a regular basis. The time interval between the first booster and HBIG withdrawal was 44 (11,87) months. No significant differences were observed in baseline data between the respondents with and without boosters (all P>0.05). During the follow-up, 9 recipients were lost to follow-up, 5 were re-infected with HBV, 3 died, and 1 recipient developed graft loss and underwent secondary liver transplantation. Among 5 recipients re-infected with HBV, 4 cases had virus mutation. Significant differences were found between re-infected and uninfected patients regarding withdrawal of NAs and hepatitis B e antigen (HBeAg) positive before transplantation (both P<0.05).
      Conclusions  Long-term withdrawal of HBIG is feasible and safe for recipients with successful hepatitis B immune reconstitution after liver transplantation for hepatitis B-related diseases. Nevertheless, whether antiviral drugs can be simultaneously withdrawn remains to be validated.

     

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