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聚乙二醇化干扰素α-2b与利巴韦林用于肝移植后复发性丙型肝炎的初步研究。

Pilot study of pegylated interferon alfa-2b and ribavirin for recurrent hepatitis C after liver transplantation.

作者信息

Mukherjee S, Rogge J, Weaver L, Schafer D F

机构信息

Section of Gastroenterology and Hepatology, University of Nebraska Medical Center, 983285 Nebraska Medical Center, Omaha, NE 68198, USA.

出版信息

Transplant Proc. 2003 Dec;35(8):3042-4. doi: 10.1016/j.transproceed.2003.10.083.

DOI:10.1016/j.transproceed.2003.10.083
PMID:14697974
Abstract

UNLABELLED

Recurrent hepatitis C is often treated with an interferon and ribavirin combination therapy, but the results have been disappointing. Given the promising results reported with pegylated interferon and ribavirin for hepatitis C, we were interested in evaluating the effectiveness of this treatment in liver transplant recipients with recurrent hepatitis C (HCV).

METHODS

Between November 2001 and September 2002, patients with recurrent HCV were screened to determine if they were eligible for treatment. Liver function tests, HCV-RNA, and liver biopsies were performed on all patients prior to treatment. HCV-RNA was repeated at 3 months, the end of treatment (EOT), and 6 months after EOT for patients who were HCV-RNA negative at EOT. Patients were prospectively followed after starting weekly pegylated interferon alfa-2b 1.5 mcg/kg per week and ribavirin 800 mg per day (Schering-Plough, Kenilworth, NJ, USA) with folic acid 1 mg per day.

RESULTS

Thirty-nine patients eligible for treatment displayed a median age of 50.4 years. Eighteen patients completed treatment, 4 remain on treatment, and 17 were intolerant. Sustained HCV-RNA eradication occurred in 66.7% of patients who completed treatment. Side effects led to treatment withdrawal in 17 patients (43.6%) In an intention-to treat analysis, sustained HCV-RNA eradication occurred in 30.8% of patients.

CONCLUSION

Side effects are an important limiting factor in the treatment of recurrent HCV with pegylated interferon and ribavirin. However, these results are encouraging as sustained HCV eradication occurred in at least 66.7% of patients who completed treatment. Prospective randomized trials are required to assess the effectiveness of this treatment and its impact on quality of life and histology.

摘要

未标注

复发性丙型肝炎通常采用干扰素和利巴韦林联合治疗,但结果令人失望。鉴于聚乙二醇化干扰素和利巴韦林治疗丙型肝炎已报道有令人鼓舞的结果,我们有兴趣评估这种治疗方法对肝移植受者复发性丙型肝炎(HCV)的有效性。

方法

在2001年11月至2002年9月期间,对复发性HCV患者进行筛查以确定他们是否适合治疗。在治疗前对所有患者进行肝功能检查、HCV-RNA检测和肝活检。对于治疗结束时HCV-RNA阴性的患者,在治疗3个月、治疗结束时(EOT)以及EOT后6个月重复检测HCV-RNA。患者开始接受每周一次的聚乙二醇化干扰素α-2b 1.5 mcg/kg和每天800 mg利巴韦林(美国新泽西州肯尼沃斯的先灵葆雅公司生产)治疗,并每日服用1 mg叶酸,之后进行前瞻性随访。

结果

39名适合治疗的患者中位年龄为50.4岁。18名患者完成治疗,4名仍在接受治疗,17名不耐受。完成治疗的患者中66.7%实现了HCV-RNA的持续清除。副作用导致17名患者(43.6%)停止治疗。在意向性分析中,30.8%的患者实现了HCV-RNA的持续清除。

结论

副作用是聚乙二醇化干扰素和利巴韦林治疗复发性HCV的一个重要限制因素。然而,这些结果令人鼓舞,因为至少66.7%完成治疗的患者实现了HCV的持续清除。需要进行前瞻性随机试验来评估这种治疗方法的有效性及其对生活质量和组织学的影响。

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