Title:Lamivudine plus low-dose hepatitis B immunoglobulin to prevent recurrent hepatitis B following liver transplantation.
Author: Gane EJ, Angus PW, Strasser S, Crawford DH, Ring J, Jeffrey GP, McCaughan GW; Australasian Liver Transplant Study Group.
Sourse: Gastroenterology. 2007 Mar;132(3):931-7. Epub 2007 Jan 5.
BACKGROUND AND AIMS: High-dose intravenous hepatitis B immunoglobulin (HBIG) may prevent recurrent hepatitis B virus (HBV) infection, but the cost has limited its widespread use in countries with endemic HBV infection. We report on long-term safety and efficacy of an alternative strategy of very low doses (400-800 IU/month) of intramuscular (IM) HBIG plus lamivudine. METHODS: Australian and New Zealand patients who received low-dose HBIG plus lamivudine following liver transplantation for HBV-related end-stage liver disease were studied. Prior to transplantation, patients with detectable serum HBV DNA received lamivudine 100 mg daily. Posttransplantation, all patients received lamivudine 100 mg daily plus IM HBIG 400 or 800 IU daily for 1 week then monthly thereafter. Serum HBV DNA levels were measured prior to lamivudine, at transplantation, and at 12 months posttransplantation. Serum titers of antibody to HBV surface antigen were measured at 1, 3, and 12 months posttransplantation. RESULTS: Between February 1996 and October 2004, 147 patients received low-dose HBIG plus lamivudine. Thirty-one percent were hepatitis B e antigen positive, and 85% were HBV DNA+ prior to transplantation. The median duration of pretransplantation lamivudine was 92 days (range, 1-1775). Median follow-up posttransplantation was 1860 days. Kaplan-Meier patient survival was 92% at 1 year and 88% at 5 years. The actuarial risk of HBV recurrence was 1% at 1 year and 4% at 5 years. Baseline HBV DNA titer was associated with HBV recurrence. CONCLUSION: Low-dose IM HBIG plus lamivudine provides safe and effective long-term prophylaxis against recurrent HBV at <10% the cost of the high-dose regimen.
Publication Types:
Multicenter Study
PMID: 17383422
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Title:Lamivudine plus low-dose hepatitis B immunoglobulin to prevent recurrent hepatitis B following liver transplantation.
拉米夫定与低剂量乙肝免疫球蛋白合用以预防肝移植后乙肝复发的临床研究
Author: Gane EJ, Angus PW, Strasser S, Crawford DH, Ring J, Jeffrey GP, McCaughan GW; Australasian Liver Transplant Study Group.
作者：Gane EJ, Angus PW, Strasser S, Crawford DH, Ring J, Jeffrey GP, McCaughan GW;澳洲肝移植研究小组
Source: Gastroenterology. 2007 Mar;132(3):931-7. Epub 2007 Jan 5.
来源：胃肠病学，2007年3月号：132(3):931-7，网络发表：07年1月5日
BACKGROUND AND AIMS:研究现状与目标
High-dose intravenous hepatitis B immunoglobulin (HBIG) may prevent recurrent hepatitis B virus (HBV) infection, but the cost has limited its widespread use in countries with endemic HBV infection.
静脉高剂量的输注乙肝病毒免疫球蛋白(HBIG)可避免乙型肝炎(HBV)的感染的复发，但鉴于成本太高（免疫球蛋白价格昂贵）限制了该方法在HBV感染流行国家或地区的广泛应用
We report on long-term safety and efficacy of an alternative strategy of very low doses (400-800 IU/month) of intramuscular (IM) HBIG plus lamivudine.
我们研究小组现提供一项可选择性方案即低剂量(400-800 IU/month)肌注乙肝病毒免疫球蛋白和拉咪夫定。
METHODS: Australian and New Zealand patients who received low-dose HBIG plus lamivudine following liver transplantation for HBV-related end-stage liver disease were studied.
方法：选择澳洲和新西兰曾接受乙型肝炎免疫球蛋白联合拉米夫定的患者，对这类患者行肝移植后发生的与乙型肝炎病毒相关的末期肝脏疾病进行研究。
Prior to transplantation, patients with detectable serum HBV DNA received lamivudine 100 mg daily. Posttransplantation, all patients received lamivudine 100 mg daily plus IM HBIG 400 or 800 IU daily for 1 wee k then monthly thereafter.
移植行使之前，患者在血清HBV DNA检测的情况下每天给予100 mg的拉米夫定。移植后，所有的患者均接受拉米夫定100 mg同时每天给予联合应用400或800国际单位的HBIG肌注一周，之后改为每月同样进行。
Serum HBV DNA levels were measured prior to lamivudine, at transplantation, and at 12 months posttransplantation. Serum titers of antibody to HBV surface antigen were measured at 1, 3, and 12 months posttransplantation.
移植时的血清HBV DNA含量的测定在给予拉米夫定之前以及移植后的12个月后进行。血清的HBV表面抗原的抗体滴度的测定则分别在移植后的1，3，12 月之后进行。
RESULTS: Between February 1996 and October 2004, 147 patients received low-dose HBIG plus lamivudine. Thirty-one percent were hepatitis B e antigen positive, and 85% were HBV DNA+ prior to transplantation. The median duration of pretransplantation lamivudine was 92 days (range, 1-1775).
结果：在1996年2月至2004年的10月间，147名患者接受了低剂量乙型肝炎免疫球蛋白联合拉米夫定的治疗方案。移植前，31%的患者e抗原阳性，85%的患者血清HBV DNA+。移植前的拉米夫定持续使用的中位数时间为92天（范围介于：1—1775）
Median follow-up posttransplantation was 1860 days. Kaplan-Meier patient survival was 92% at 1 year and 88% at 5 years. The actuarial risk of HBV recurrence was 1% at 1 year and 4% at 5 years. Baseline HBV DNA titer was associated with HBV recurrence.
移植后的中位随访时间是1860天，卡普兰-迈耶曲线（生存率曲线）的结果显示患者一年生存率为92%，5年生存率为88%。HBV复发的精确风险评估是1年1%和4年5%. HBV DNA 滴度基线与HBV的复发率相关联。
CONCLUSION: Low-dose IM HBIG plus lamivudine provides safe and effective long-term prophylaxis against recurrent HBV at <10% the cost of the high-dose regimen.
结论：低剂量肌注乙型肝炎免疫球蛋白联合拉米夫定的使用为长时间的预防HBV复发提供了安全有效的方案并且可使花费小于大剂量用药方案费用的10%。
Publication Types:
发布形式：
Multicenter Study
多中心研究
编译后：（693字)
拉米夫定与低剂量乙肝免疫球蛋白合用以预防肝移植后乙肝复发的临床研究
作者：Gane EJ, Angus PW, Strasser S, Crawford DH, Ring J, Jeffrey GP, McCaughan GW;澳洲肝移植研究小组
来源：胃肠病学，2007年3月号：132(3):931-7，网络发表：07年1月5日
研究现状与目标;
静脉高剂量的输注乙肝病毒免疫球蛋白(HBIG)可避免乙型肝炎(HBV)的感染的复发，但鉴于成本太高（免疫球蛋白价格昂贵）限制了该方法在HBV感染流行国家或地区的广泛应用。我们研究小组现提供一项可选择性方案即低剂量(400-800 IU/month)肌注乙肝病毒免疫球蛋白和拉咪夫定。
方法：选择澳洲和新西兰曾接受乙型肝炎免疫球蛋白联合拉米夫定的患者，对这类患者行肝移植后发生的与乙型肝炎病毒相关的末期肝脏疾病进行研究。移植行使之前，患者在血清HBV DNA检测的情况下每天给予100 mg的拉米夫定。移植后，所有的患者均接受拉米夫定100 mg同时每天给予联合应用400或800国际单位的HBIG肌注一周，之后改为每月同样进行。移植时的血清HBV DNA含量的测定在给予拉米夫定之前以及移植后的12个月后进行。血清的HBV表面抗原的抗体滴度的测定则分别在移植后的1，3，12 月之后进行。
结果：在1996年2月至2004年的10月间，147名患者接受了低剂量乙型肝炎免疫球蛋白联合拉米夫定的治疗方案。移植前，31%的患者e抗原阳性，85%的患者血清HBV DNA+。移植前的拉米夫定持续使用的中位数时间为92天（范围介于：1—1775）.移植后的中位随访时间是1860天，卡普兰-迈耶曲线（生存率曲线）的结果显示患者一年生存率为92%，5年生存率为88%。HBV复发的精确风险评估是1年1%和4年5%. HBV DNA 滴度基线与HBV的复发率相关联。结论：低剂量肌注乙型肝炎免疫球蛋白联合拉米夫定的使用为长时间的预防HBV复发提供了安全有效的方案并且可使花费小于大剂量用药方案费用的10%。
发布形式：
多中心研究
请按文摘编译格式进行编译，谢谢
