Division of Nephrology and Dialysis, Maggiore Hospital, IRCCS Foundation, Milano, Italy.
J Viral Hepat. 2011 Jul;18(7):e263-9. doi: 10.1111/j.1365-2893.2010.01405.x. Epub 2010 Nov 25.
The efficacy and safety of combined interferon (IFN) plus ribavirin in patients on long-term dialysis and chronic hepatitis C remains unclear, although a number of small clinical trials have addressed this issue. We evaluated the efficacy and safety of combination antiviral therapy (conventional or pegylated interferon plus ribavirin) in dialysis patients with chronic hepatitis C by performing a systematic review of the literature with a meta-analysis of clinical trials. The primary outcome was sustained virological response (SVR) (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 10 clinical studies (151 unique patients), one (10%) of which was a controlled clinical trial. Most (97.4%) patients were on long-term haemodialysis. The summary estimate for SVR and drop-out rate was 56% [95% Confidence Intervals (95% CI) 28-84] and 25% (95% CI, 10-40), respectively. The most frequent side effects requiring interruption of treatment were anaemia (26%) and heart failure (9%). These results occurred irrespective of type of interferon (conventional or peg-IFN, peg-IFNalfa-2a or alfa-2b), trial design (controlled or cohort study), or clinical characteristics of patients (naïve, nonresponders or relapsers). The studies were heterogeneous with regard to SVR and drop-out rate. Combination antiviral therapy (interferon plus ribavirin) gives encouraging results in terms of efficacy and safety among dialysis patients even if the limited number of patients enrolled in our meta-analysis hampers definitive conclusions.
联合干扰素(IFN)加利巴韦林治疗长期透析和慢性丙型肝炎患者的疗效和安全性尚不清楚,尽管一些小型临床试验已经解决了这个问题。我们通过对临床试验进行系统评价和荟萃分析,评估了联合抗病毒治疗(常规或聚乙二醇干扰素加利巴韦林)在透析慢性丙型肝炎患者中的疗效和安全性。主要结局是持续病毒学应答(SVR)(作为疗效的衡量标准);次要结局是脱落率(作为耐受性的衡量标准)。我们使用德西蒙和莱尔德的随机效应模型,进行异质性和敏感性分析。我们确定了 10 项临床研究(151 名独特患者),其中 1 项(10%)为对照临床试验。大多数(97.4%)患者接受长期血液透析。SVR 和脱落率的汇总估计值分别为 56%[95%置信区间(95%CI)28-84]和 25%(95%CI,10-40)。最常见需要中断治疗的副作用是贫血(26%)和心力衰竭(9%)。这些结果与干扰素类型(常规或聚乙二醇干扰素、聚乙二醇干扰素 alfa-2a 或 alfa-2b)、试验设计(对照或队列研究)或患者的临床特征(初治、无应答或复发)无关。这些研究在 SVR 和脱落率方面存在异质性。联合抗病毒治疗(干扰素加利巴韦林)在透析患者中的疗效和安全性方面给出了令人鼓舞的结果,尽管我们荟萃分析中纳入的患者数量有限,难以得出明确的结论。