Lin Zhi-qing, Fang Feng, Guo Zhi-feng, Chen Qi
Department of Pediatrics, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
Zhonghua Er Ke Za Zhi. 2007 Aug;45(8):592-8.
To assess the efficacy and safety of interferon-alpha (IFN-alpha) in children with Hepatitis B e antigen-positive chronic hepatitis B virus infection.
PubMed and Chinese Biomedical Database were searched from the beginning of operation of the databases to April 2006, and the references of eligible studies were manually screened. Randomized controlled trials (RCTs) published in the English and Chinese literature comparing interferon-alpha with non-antiviral interventions (placebo or no treatment) in children with hepatitis B e antigen-positive chronic hepatitis B virus infection were eligible for inclusion. Studies were included if patients were treated for at least 3 months and followed-up for at least 6 months after cessation of therapy. Two investigators independently assessed the quality and extracted the data. The methodological quality of trails was assessed by the Jadad-scale plus allocation concealment. Heterogeneity was examined by Chi-square test. Fixed effects model or random effects model were used to pool the data. Sensitivity analyses were used for the treatment course.
Ten randomized controlled studies with a total of 542 children chronic HBV carriers who were positive for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) were identified. It was found by the meta-analysis that, compared with the control, at the end of the follow-up period, IFN-alpha could still significantly clear HBeAg [31.1% vs. 12.4%, odds ratio (OR): 3.17, 95% CI (2.00, 5.02), P < 0.000 01], clear HBV-DNA [33.9% vs. 16.2%, OR: 2.59, 95% CI (1.70, 3.96), P < 0.0001], clear HBsAg [5.5% vs. 1.2%, OR: 3.44, 95% CI (1.20, 9.89), P = 0.02], normalize ALT [43.0% vs. 27.7%, OR: 1.99, 95% CI (1.16, 3.42), P = 0.01], and achieve HBeAg seroconversion [30.4% vs. 12.8%, OR: 2.90, 95% CI (1.56, 5.39), P = 0.0008], but was not effective in HBsAg seroconversion [1.9% vs. 0, 95% CI (0.42, 18.13), P = 0.29].
Interferon-alpha might be efficacious in clearance of HBeAg, HBV-DNA and HBsAg, normalization of ALT, and achievement of HBeAg seroconversion in children with chronic hepatitis B. Little evidence is available on HBsAg seroconversion. Further RCTs of high-quality and sufficient number of cases are needed for confirmation of the clinical efficacy of IFN-alpha in chronic hepatitis B in children.
评估α干扰素（IFN-α）治疗乙肝e抗原阳性慢性乙型肝炎病毒感染儿童的疗效和安全性。
检索PubMed和中国生物医学数据库自建库起至2006年4月的数据，并人工筛选符合条件研究的参考文献。纳入比较α干扰素与非抗病毒干预措施（安慰剂或不治疗）用于乙肝e抗原阳性慢性乙型肝炎病毒感染儿童的英文和中文文献中发表的随机对照试验（RCT）。若患者接受至少3个月治疗且治疗停止后至少随访6个月，则纳入研究。两名研究者独立评估质量并提取数据。采用Jadad量表加分配隐藏评估试验的方法学质量。通过卡方检验检查异质性。使用固定效应模型或随机效应模型汇总数据。对疗程进行敏感性分析。
共纳入10项随机对照研究，总计542例乙肝表面抗原（HBsAg）和乙肝e抗原（HBeAg）阳性的慢性HBV携带者儿童。荟萃分析发现，与对照组相比，随访期末，IFN-α仍能显著清除HBeAg[31.1%对12.4%，比值比（OR）：3.17，95%置信区间（CI）（2.00，5.02），P<0.00001]，清除HBV-DNA[33.9%对16.2%，OR：2.59，95%CI（1.70，3.96），P<0.0001]，清除HBsAg[5.5%对1.2%，OR：3.44，95%CI（1.20，9.89），P = 0.02]，使ALT正常化[43.0%对27.7%，OR：?1.99，95%CI（1.16，3.42），P = 0.01]，并实现HBeAg血清学转换[30.4%对12.8%，OR：2.90，95%CI（1.56，5.39），P = 0.0008]，但对HBsAg血清学转换无效[1.9%对0，95%CI（0.42，18.13），P = 0.29]。
α干扰素可能对慢性乙型肝炎儿童清除HBeAg、HBV-DNA和HBsAg、使ALT正常化以及实现HBeAg血清学转换有效。关于HBsAg血清学转换的证据不足。需要进一步开展高质量、足够病例数的RCT来证实IFN-α对儿童慢性乙型肝炎的临床疗效。
