Gurusamy Kurinchi Selvan, Tsochatzis Emmanuel, Davidson Brian R, Burroughs Andrew K
Department of Surgery, Royal Free Campus, UCL Medical School, 9th Floor, Royal Free Hospital, Pond Street, London, UK, NW3 2QG.
Cochrane Database Syst Rev. 2010 Dec 8(12):CD006573. doi: 10.1002/14651858.CD006573.pub2.
It is not clear whether prophylactic antiviral therapy is indicated in patients undergoing liver transplantation for chronic decompensated hepatitis C virus (HCV) infection.
To compare the benefits and harms of different prophylactic anti-viral therapies for patients undergoing liver transplantation for chronic HCV infection.
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 August 2010.
Only randomised clinical trials irrespective of language, blinding, or publication status and comparing various prophylactic antiviral therapies (alone or in combination) in the prophylactic treatment of patients undergoing liver transplantation for chronic HCV infection.
Two authors collected the data independently. We calculated the risk ratio (RR) or mean difference (MD) or hazard ratio (HR) with 95% confidence intervals (CI) using the fixed-effect and the random-effects models based on available case analysis.
A total of 477 liver transplant recipients undergoing liver transplantation for chronic HCV infection were randomised in eleven trials to various interventions and controls. The proportion of genotype I varied between 49% to 88% in the five trials that reported the genotype. Only one or two trials were included under each comparison. All the trials were of high risk of bias. There was no significant differences in the patient survival, graft rejection, re-transplantation, or HCV recurrence between intervention and control groups in any of the comparisons that reported these outcomes. None of the trials reported liver decompensation, primary graft non-function, intensive therapy unit stay, hospital stay, or quality of life. Life-threatening adverse events were not reported in either group in any of the comparisons. Up to 91% of patients required reduction in dose and up to 36% of patients required cessation of treatment in the various comparisons because of adverse events or because of patient's choice to stop treatment.
AUTHORS' CONCLUSIONS: There is currently no evidence to recommend prophylactic antiviral treatment to prevent recurrence of HCV infection either in primary liver transplantation or re-transplantation. Further randomised clinical trials with adequate trial methodology and adequate duration of follow-up are necessary.
对于因慢性丙型肝炎病毒(HCV)感染而接受肝移植的患者,是否应进行预防性抗病毒治疗尚不清楚。
比较不同预防性抗病毒治疗对因慢性HCV感染而接受肝移植患者的利弊。
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2010年8月。
仅纳入随机临床试验,不考虑语言、盲法或发表状态,且比较各种预防性抗病毒治疗(单独或联合)对因慢性HCV感染而接受肝移植患者的预防性治疗。
两名作者独立收集数据。我们根据可用病例分析,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)或风险比(HR)及其95%置信区间(CI)。
共有477例因慢性HCV感染而接受肝移植的患者在11项试验中被随机分配至各种干预措施和对照组。在报告基因型的5项试验中,基因型I的比例在49%至88%之间。每次比较下仅纳入一两项试验。所有试验均存在高偏倚风险。在报告这些结果的任何比较中,干预组和对照组在患者生存率、移植物排斥反应、再次移植或HCV复发方面均无显著差异。没有试验报告肝失代偿、原发性移植物无功能、重症监护病房停留时间、住院时间或生活质量情况。在任何比较中,两组均未报告危及生命的不良事件。在各种比较中,高达91%的患者需要减少剂量,高达36%的患者因不良事件或患者选择停止治疗而需要停止治疗。
目前没有证据推荐在初次肝移植或再次移植中进行预防性抗病毒治疗以预防HCV感染复发。有必要进行进一步的随机临床试验,采用适当的试验方法并进行足够长的随访。