Njei Basile, Gupta Neil, Ewelukwa Oforbuike, Ditah Ivo, Foma Munoh, Lim Joseph K
Section of Digestive Diseases and Yale Liver Center, Yale University School of Medicine, New Haven, CT, USA.
Investigative Medicine Program, Yale Center of Clinical Investigation, New Haven, CT, USA.
Liver Int. 2016 May;36(5):634-41. doi: 10.1111/liv.12959. Epub 2015 Oct 1.
BACKGROUND & AIMS: Antiviral drugs are safe and effective in the third trimester to prevent intrauterine transmission of hepatitis B virus, and are recommended for hepatitis B virus (HBV) infected gravid mothers (between weeks 28 and 32) with high viral load, followed by postnatal hepatitis B immunization in the newborn. We estimated the comparative efficacy of antiviral drugs for prevention of vertical transmission of HBV, through a network meta-analysis of clinical trials.
We conducted a comprehensive search of MEDLINE, EMBASE and published proceedings from major liver meetings from January 1980 to November 2014. We conducted pair-wise meta-analyses and Bayesian framework using Markov chain Monte Carlo methods, combining direct and indirect evidence for any given pair of treatments.
Seventeen clinical trials involving 2764 newborns of hepatitis B surface antigen seropositive mothers were eligible for analysis. There were no clinical trials involving tenofovir or entecavir. On pair-wise meta-analyses, telbivudine (hazard ratio, HR 0.12, 95% confidence interval (CI) 0.04-0.37; I(2) = 0%), and Lamivudine (HR 0.40, 95% CI 0.24-0.65; I(2) = 0%), were more effective than placebo in reducing vertical transmission of HBV in high viremic hepatitis B e antigen (HBeAg)-positive chronic Hepatitis B Chinese patients. Sensitivity analyses limited to studies with HBeAg seropositive mothers revealed similar results.
Based on a Bayesian network meta-analysis of clinical trials, combining direct and indirect treatment comparisons, telbivudine appears to be more effective than Lamivudine for preventing vertical transmission of HBV infection. Trials assessing the efficacy of tenofovir or entecavir compared to placebo or other antiviral drugs are lacking.
抗病毒药物在孕晚期预防乙型肝炎病毒宫内传播方面安全有效,推荐用于病毒载量高的乙型肝炎病毒(HBV)感染孕妇(28至32周),随后对新生儿进行出生后乙型肝炎免疫接种。我们通过对临床试验的网状Meta分析,评估了抗病毒药物预防HBV垂直传播的相对疗效。
我们全面检索了1980年1月至2014年11月的MEDLINE、EMBASE以及主要肝脏会议的发表论文。我们使用马尔可夫链蒙特卡罗方法进行成对Meta分析和贝叶斯框架分析,结合任何给定治疗对的直接和间接证据。
17项涉及2764名乙型肝炎表面抗原血清阳性母亲新生儿的临床试验符合分析条件。没有涉及替诺福韦或恩替卡韦的临床试验。在成对Meta分析中,替比夫定(风险比,HR 0.12,95%置信区间(CI)0.04 - 0.37;I(2) = 0%)和拉米夫定(HR 0.40,95% CI 0.24 - 0.65;I(2) = 0%)在降低高病毒血症乙型肝炎e抗原(HBeAg)阳性慢性乙型肝炎中国患者的HBV垂直传播方面比安慰剂更有效。限于HBeAg血清阳性母亲的研究的敏感性分析显示了类似结果。
基于对临床试验的贝叶斯网状Meta分析,结合直接和间接治疗比较,替比夫定在预防HBV感染垂直传播方面似乎比拉米夫定更有效。缺乏评估替诺福韦或恩替卡韦与安慰剂或其他抗病毒药物疗效比较的试验。