中国循证医学杂志

中国循证医学杂志

干扰素治疗儿童乙型病毒性肝炎有效性和安全性的 Meta 分析

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目的 系统评价干扰素治疗儿童乙型病毒性肝炎患者的有效性与安全性。 方法 计算机检索 PubMed、EMbase、The Cochrane Library、WanFang Data 和 CNKI 数据库,搜集干扰素治疗儿童乙型病毒性肝炎疗效与安全性的随机对照试验(RCT),检索时限均从建库至 2016 年 12 月。由 2 名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行 Meta 分析。 结果 共纳入 12 个研究,包括 723 例患儿。Meta 分析结果显示:在随访早期(<12 个月),干扰素组显著改善了病毒学应答率[RR=2.82,95%CI(1.98,4.02),P<0.000 01]、HBeAg 清除率[RR=3.02,95%CI(1.95,4.67),P<0.000 01]和谷丙转氨酶复常率[RR=1.42,95%CI(1.19,1.70),P=0.000 1]。一年以上随访结果发现干扰素组在病毒学反应率[RR=1.75,95%CI(1.18,2.60),P=0.006]和 HBeAg 清除率[RR=2.17,95%CI(1.28,3.65),P=0.004]方面也显著优于对照组,差异均有统计学意义。目前结果显示干扰素治疗儿童乙型病毒性肝炎的不良反应尚可耐受,未发现严重不良反应。 结论 基于干扰素的抗病毒疗法是治疗儿童乙型病毒性肝炎的有效疗法,且安全性良好。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of interferon based antiviral therapy for children with hepatitis B. Methods PubMed, EMbase, The Cochrane Library, WanFang Data and CNKI databases were searched to collect randomized controlled trials (RCTs) of interferon based antiviral therapy for children with hepatitis B from inception to December 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 12 studies involving 723 patients were included. The results of meta-analysis showed that: follow-up <12 months, the virological response rate (RR=2.82, 95%CI 1.98 to 4.02, P<0.000 01), serum HBeAg clearance rate (RR=3.02, 95%CI 1.95 to 4.67,P<0.000 01) and ALT normalization rate (RR=1.42, 95%CI 1.19 to 1.70,P=0.000 1) were significantly higher in the interferon group than the control group. Follow-up >12 months, the virological response rate (RR=1.75, 95%CI 1.18 to 2.60, P=0.006) and serum HBeAg clearance rate (RR=2.17, 95%CI 1.28 to 3.65, P=0.004) were also significantly higher in the interferon group. Severe adverse effects were not reported in included studies. Conclusion Current evidence shows that higher virological response is found in HBV infected children with interferon treatment. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 儿童; 乙型病毒性肝炎; 疗效; 安全性; 系统评价; Meta 分析; 随机对照试验

Key words: Children; Hepatitis B; Efficacy; Safety; Systematic review; Meta-analysis; Randomized controlled trial

引用本文: 成大欣, 刘懿, 徐丽然, 于清清, 赵四海. 干扰素治疗儿童乙型病毒性肝炎有效性和安全性的 Meta 分析. 中国循证医学杂志, 2017, 17(11): 1298-1304. doi: 10.7507/1672-2531.201704051 复制

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