Chen Keliang, Lu Pei, Song Rijin, Zhang Jiexiu, Tao Rongzhen, Wang Zijie, Zhang Wei, Gu Min
Department of Urology, First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
Medicine (Baltimore). 2017 Jul;96(30):e7568. doi: 10.1097/MD.0000000000007568.
The efficacy and safety of direct-acting antivirals (DAAs) for treating hepatitis C virus (HCV)-infected renal transplant recipients (RTRs) has not been determined.
We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials and assessed the quality of eligible studies using the Joanna Briggs Institute scale. DAA efficacy and safety were assessed using standard mean difference (SMD) with 95% confidence intervals (95%CIs).
Six studies (360 RTRs) were included. Two hundred thirty six RTRs (98.3%) achieved sustained virological response within 12 weeks; HCV infection was cleared in 239 RTRs after 24-week treatment. Liver function differed significantly pre- and posttreatment (alanine aminotransferase, SMD: 0.96, 95%CIs: 0.65, 1.26; aspartate aminotransferase, SMD: 0.89, 95%CIs: 0.60, 1.18); allograft function pre- and posttreatment was not statistically different (serum creatinine, SMD: -0.13, 95%CIs: -0.38, 0.12; estimated glomerular filtration rate, SMD: 0.20, 95%CIs: -0.11, 0.51). General symptoms (fatigue nausea dizziness or headache) were the most common adverse events (AEs) (39.3%). Severe AEs, that is, anemia, portal vein thrombosis, and streptococcus bacteraemia and pneumonia, were present in 1.1%, 0.6%, and 1.1% of RTRs, respectively.
Our findings suggest that DAAs are highly efficacious and safe for treating HCV-infected RTRs and without significant AE.
直接抗病毒药物(DAA)治疗丙型肝炎病毒(HCV)感染的肾移植受者(RTR)的疗效和安全性尚未确定。
我们检索了PubMed、Embase和Cochrane对照试验中央注册库,并使用乔安娜·布里格斯研究所的量表评估符合条件的研究的质量。使用具有95%置信区间(95%CI)的标准平均差(SMD)评估DAA的疗效和安全性。
纳入了6项研究(360名RTR)。236名RTR(98.3%)在12周内实现了持续病毒学应答;24周治疗后,239名RTR的HCV感染得到清除。治疗前后肝功能有显著差异(丙氨酸转氨酶,SMD:0.96,95%CI:0.65,1.26;天冬氨酸转氨酶,SMD:0.89,95%CI:0.60,1.18);治疗前后移植肾功能无统计学差异(血清肌酐,SMD:-0.13,95%CI:-0.38,0.12;估计肾小球滤过率,SMD:0.20,95%CI:-0.11,0.51)。一般症状(疲劳、恶心、头晕或头痛)是最常见的不良事件(AE)(39.3%)。严重AE,即贫血、门静脉血栓形成、B族链球菌血症和肺炎,分别出现在1.1%、0.6%和1.1%的RTR中。
我们的研究结果表明,DAA治疗HCV感染的RTR疗效高且安全,且无显著不良事件。