Gurusamy Kurinchi Selvan, Tsochatzis Emmanuel, Xirouchakis Elias, Burroughs Andrew K, Davidson Brian R
University Department of Surgery, Royal Free Hospital and University College School of Medicine, 9th Floor, Royal Free Hospital, Pond Street, London, UK, NW3 2QG.
Cochrane Database Syst Rev. 2010 Jan 20(1):CD006803. doi: 10.1002/14651858.CD006803.pub3.
Antiviral therapy to treat recurrent hepatitis C infection after liver transplantation is controversial due to unresolved balance between benefits and harms.
To compare the therapeutic benefits and harms of different antiviral regimens in patients with hepatitis C re-infected grafts after liver transplantation.
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until March 2009.
Only randomised clinical trials (irrespective of language, blinding, or publication status) comparing various antiviral therapies (alone or in combination) in the treatment of hepatitis C virus recurrence in liver transplantation were considered for the review.
Two authors collected the data independently. We calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) using the fixed-effect and the random-effects models based on available case-analysis. In the presence of only trial for a dichotomous outcome, we performed the Fisher's exact test.
A total of 425 liver transplant recipients with proven hepatitis C recurrence were randomised in twelve trials to various interventions and controls. The mean proportion of genotype I was 79.9% in the nine trials that reported the genotype. All the trials were of high risk of bias. One to two trials were included under each comparison including single drug or multidrug regimens of interferon, ribavirin, and amantadine. There was no significant difference in the mortality, graft rejection, or in re-transplantation between intervention and control in any of the comparisons that reported these outcomes. None of the trials reported liver decompensation or quality of life. Life-threatening adverse effects were not reported in either group in any of the comparisons. Up to 87.5% of patients required reduction in dose and up to 42.9% of patients required cessation of treatment in the various comparisons because of adverse effects or because of patient's choice to stop treatment.
AUTHORS' CONCLUSIONS: Considering the lack of clinical benefit and the frequent adverse effects, there is currently no evidence to recommend antiviral treatment for recurrent liver graft infection with HCV. Further randomised clinical trials with adequate trial methodology and adequate duration of follow-up are necessary.
由于利弊平衡尚未明确,肝移植后复发性丙型肝炎感染的抗病毒治疗存在争议。
比较不同抗病毒方案对肝移植后丙型肝炎再感染患者的治疗益处和危害。
我们检索了Cochrane肝胆组对照试验注册库、Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE和科学引文索引扩展版,检索截至2009年3月。
纳入本综述的仅为比较各种抗病毒疗法(单独或联合使用)治疗肝移植中丙型肝炎病毒复发的随机临床试验(无论语言、盲法或发表状态如何)。
两位作者独立收集数据。我们根据可用的病例分析,使用固定效应模型和随机效应模型计算风险比(RR)或平均差(MD)以及95%置信区间(CI)。对于二分结局仅存在一项试验时,我们进行Fisher精确检验。
共有425例经证实丙型肝炎复发的肝移植受者在12项试验中被随机分配至各种干预措施和对照。在报告基因型的9项试验中,基因型I的平均比例为79.9%。所有试验均存在高偏倚风险。每项比较(包括干扰素、利巴韦林和金刚烷胺的单药或多药方案)纳入1至2项试验。在报告这些结局的任何比较中,干预组和对照组在死亡率、移植物排斥或再次移植方面均无显著差异。没有试验报告肝失代偿或生活质量情况。在任何比较中,两组均未报告危及生命的不良反应。在各种比较中,高达87.5%的患者需要减少剂量,高达42.9%的患者因不良反应或患者选择停止治疗而需要停止治疗。
考虑到缺乏临床益处且不良反应频繁,目前尚无证据推荐对复发性肝移植感染HCV进行抗病毒治疗。有必要开展具有充分试验方法和足够随访期的进一步随机临床试验。