慢性HBV感染者肝移植术后乙型肝炎免疫球蛋白用药方法的合理性分析

魏宪义; 魏红

doi:10.3969/j.issn.1001-5256.2014.01.01-007

慢性HBV感染者肝移植术后乙型肝炎免疫球蛋白用药方法的合理性分析

DOI: 10.3969/j.issn.1001-5256.2014.01.01-007

魏宪义,
魏红

1. 四川远大蜀阳药业股份有限公司
2. 四川大学华西医院眼科

详细信息

中图分类号: R657.3
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出版历程
- 收稿日期: 2013-04-10
- 出版日期: 2014-01-20

Rationality analysis of delivery method for hepatitis B immune globulin in patients with chronic HBV infection after liver transplantation

Sichuan Yuanda Shuyang Pharmaceutical Co. , Ltd

摘要

摘要:
目的分析慢性HBV感染者肝移植术后乙型肝炎免疫球蛋白（HBIG）用药方法的合理性,探讨用药指导原则。方法对2008年8月至2010年12月,参加静脉注射HBIGⅣ期临床研究的44例乙型肝炎相关肝移植患者,按重症肝病、肝癌、肝硬化分为3组,采用卡方检验比较各组病例HBV DNA及HBeAg的阳性率,采用方差分析比较HBV DNA水平,采用Pearson分析不同给药剂量与间隔时间的血药浓度与药物半衰期的相关性;采用t检验比较HBeAg阴性、阳性组,HBV DNA高、低量值组,术后1周的抗-HBs滴度;观察有无再感染病例出现。结果重症肝病、肝癌、肝硬化3组HBV DNA水平及HBeAg的阳性率差异无统计学意义（χ2=4.871、1.079,P=0.088、0.583）;各组HBV DNA水平均值差异无统计学意义（F=0.895,P=0.418）;血药浓度与药物半衰期的Pearson分析显示存在明显的负相关（r=0.988,P=0.012）;HBeAg阴性、阳性组,HBV DNA高、低量值组,术后1周的抗-HBs滴度量值差异无统计学意义（t=1.757,P=0.087）,观察期内没有HBV再感...
- 肝移植 /
- 肝炎,乙型,慢性 /
- 免疫球蛋白类,静脉内 /
- 临床试验,Ⅳ期
Abstract:
Objective To analyze the rationality of delivery method for hepatitis B immune globulin ( HBIG) in patients with chronic hepatitis B virus ( HBV) infection after liver transplantation and to investigate the guiding principle for medication. Methods Forty- four cases of hepatitis B- related liver transplantation who participated in the phase IV clinical trial of HBIG for intravenous injection from August 2008 to December 2010 were analyzed. These patients were divided into severe liver disease group, liver cancer group, and liver cirrhosis group. The positive rates of HBV DNA and HBeAg were compared between groups by chi- square test. The HBV DNA level was compared by analysis of variance. The correlation between blood concentration and half- life of HBIG at different doses and dosing intervals was analyzed by Pearson's correlation test. The titer of anti- HBs at one week after operation was compared between HBeAg- negative group and HBeAg-positive group and between high- HBV DNA group and low- HBV DNA group by t test. Cases of reinfection were also monitored. Results There were no significant differences in the positive rates of HBV DNA and HBeAg between the severe liver disease group, liver cancer group, and liver cirrhosis group ( χ2= 4. 871, P = 0. 088; χ2= 1. 079, P = 0. 583) . No significant differences in mean HBV DNA level were found between these groups ( F = 0. 895, P = 0. 418) . The Pearson's correlation analysis revealed a significant negative correlation between the blood concentration and half- life of HBIG ( r = 0. 988, P = 0. 012) . The tier of anti- HBs showed no significant differences between HBeAg- negative group and HBeAg- positive group and between high- HBV DNA group and low- HBV DNA group one week after operation ( t = 1. 757, P = 0. 087) . No cases of reinfection were found during the observation period. Conclusion It is necessary to give HBIG 4000 IU during operation and 2000 IU daily for 6 days after operation, and the dose should be increased appropriately when the patients have relatively high viral load in serum. For the patients whose serological markers of hepatitis B become negative, the antibody level can be maintained at about 100 IU / L until the next administration if 600 IU of HBIG is given once a month by intramuscular injection.
- liver transplantation /
- hepatitis B, chronic /
- immunoglobulins, intravenaus /
- clinical trial, phase Ⅳ

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参考文献(10)

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