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慢性肾脏病患者丙型肝炎的抗病毒治疗:对照临床试验的荟萃分析。

Antiviral therapy of hepatitis C in chronic kidney diseases: meta-analysis of controlled clinical trials.

机构信息

Division of Nephrology and Dialysis, Maggiore Hospital, IRCCS Foundation, Milano, Italy.

出版信息

J Viral Hepat. 2008 Aug;15(8):600-6. doi: 10.1111/j.1365-2893.2008.00990.x. Epub 2008 Apr 28.

Abstract

Hepatitis C virus (HCV) infection remains frequent in patients with chronic kidney disease and the detrimental role of HCV on survival is well-established in this population. Several authors have reported on efficacy and safety of antiviral therapy for hepatitis C in this polulation but there is no clear consensus on management. To evaluate efficacy and safety of antiviral therapy for hepatitis C in patients with chronic kidney disease, we performed a systematic review of the published medical literature and completed a meta-analysis of controlled clinical trials. The primary outcome was sustained virological response (as a measure of efficacy); the secondary outcome was drop-out rate (as a measure of tolerability). We used the random effects model of Der Simonian and Laird, with heterogeneity and sensitivity analyses. We identified 13 studies including 539 unique patients; 10 (76.9%) concerned patients on maintenance dialysis. Only prospective, controlled clinical trials were included. Pooling of study results showed a significant increase of viral response in study (patients treated with antiviral therapy) than control patients (patients who did not receive therapy), the pooled odds ratio (OR) of failure to obtain a sustained viral response was 0.081 [95% confidence intervals (CI), 0.029-0.230], P = 0.0001. The pooled OR of drop-out rate was significantly increased in study vs control patients, OR = 0.389 (95% CI, 0.155-0.957), P = 0.04. The studies were heterogeneous with regard to viral response and drop-out rate. In the subset of clinical trials (n = 6) involving only dialysis patients receiving interferon (IFN) monotherapy for chronic HCV, there was a significant difference in the risk of failure to obtain a sustained viral response (study vs control patients), OR = 0.054 (95% CI, 0.019; 0.150), P = 0.0001 (random-effects model). No significant (NS) heterogeneity was found (Q = 14.604, P = 1.0). No difference in the drop-out rate between study and control patients was shown, OR = 0.920 (95% CI, 0.367; 2.311), NS. This result being homogeneous (Q = 3.639, P = 0.388). Our meta-analysis showed that the viral response was greater in patients with chronic kidney disease who received antiviral therapy than controls. No difference in the drop-out rate between study and control patients occurred in the subgroup of dialysis patients on IFN monotherapy. These results support IFN-based therapy for hepatitis C in patients on maintenance dialysis.

摘要

丙型肝炎病毒(HCV)感染在慢性肾脏病患者中仍然很常见,并且 HCV 对该人群的生存有不良影响已得到充分证实。许多作者已经报道了在该人群中治疗 HCV 的抗病毒治疗的疗效和安全性,但在管理方面尚无明确共识。为了评估慢性肾脏病患者的 HCV 抗病毒治疗的疗效和安全性,我们对已发表的医学文献进行了系统评价,并对对照临床试验进行了荟萃分析。主要结局是持续病毒学应答(作为疗效的衡量指标);次要结局是退出率(作为耐受性的衡量指标)。我们使用了 Der Simonian 和 Laird 的随机效应模型,并进行了异质性和敏感性分析。我们确定了 13 项研究,共纳入 539 名患者;其中 10 项(76.9%)涉及维持性透析患者。仅纳入前瞻性对照临床试验。汇总研究结果显示,治疗组(接受抗病毒治疗的患者)与对照组(未接受治疗的患者)相比,病毒应答显著增加,失败获得持续病毒应答的汇总比值比(OR)为 0.081[95%置信区间(CI),0.029-0.230],P = 0.0001。与对照组相比,治疗组的退出率显著增加,OR=0.389[95%CI,0.155-0.957],P=0.04。研究结果在病毒应答和退出率方面存在异质性。在仅涉及接受干扰素(IFN)单药治疗慢性 HCV 的透析患者的临床试验亚组(n=6)中,治疗组与对照组之间失败获得持续病毒应答的风险存在显著差异,OR=0.054[95%CI,0.019-0.150],P=0.0001(随机效应模型)。未发现显著异质性(Q=14.604,P=1.0)。未显示治疗组和对照组之间的退出率存在差异,OR=0.920[95%CI,0.367-2.311],NS。该结果是同质的(Q=3.639,P=0.388)。我们的荟萃分析显示,接受抗病毒治疗的慢性肾脏病患者的病毒应答大于对照组。在接受 IFN 单药治疗的透析患者亚组中,治疗组和对照组之间的退出率没有差异。这些结果支持维持性透析患者的 IFN 为基础的 HCV 治疗。

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