Rudin Dan
Department of Internal Medicine, Staten Island University Hospital, Staten Island, New York 10305, USA.
Adv Ther. 2007 Jul-Aug;24(4):784-95. doi: 10.1007/BF02849971.
The suboptimal outcomes of current chronic hepatitis B treatments have prompted the notion of combination therapy as a means of augmenting the therapeutic response. In this study, investigators compared lamivudine monotherapy versus its combination with conventional or pegylated interferon-alpha, pooling data from all pertinent randomized controlled studies into the meta-analysis. The studies were evaluated for methodologic quality and heterogeneity. Rates of sustained virologic and biochemical responses and of hepatitis B e antigen clearance and seroconversion were used as primary efficacy measures. Quantitative metaanalyses were conducted to assess differences between groups for conventional and pegylated interferon, and overall. Analysis yielded greater sustained virologic, biochemical, and seroconversion rates with the addition of conventional (odds ratio [OR]=4.5, 95% confidence interval [CI]=2.2-9.4, P<.001; OR=2.1, 95% CI=1.3-3.2, P=.002; and OR=2.6, 95% CI=1.4-4.8, P=.001, respectively) and pegylated (OR=2.0, 95% CI=1.1-3.6, P=.02; OR=1.8, 95% CI=1.3-2.6, P<.001; and OR=1.6, 95% CI=1.1-2.3, P=.03, respectively) interferon-alpha to lamivudine, with the former also yielding greater hepatitis B e antigen clearance rates (OR=2.6, 95% CI=1.3-5.2, P=.008). As previous studies suggested that pegylated interferon monotherapy and its combination with lamivudine were comparable, the use of this combination is not justified. In contrast, when conventional interferon-a is used, its combination with lamivudine should be considered.
目前慢性乙型肝炎治疗效果欠佳,促使人们提出联合治疗的概念,将其作为增强治疗反应的一种手段。在本研究中,研究人员比较了拉米夫定单药治疗及其与传统或聚乙二醇化α干扰素联合治疗的效果,将所有相关随机对照研究的数据汇总到荟萃分析中。对这些研究的方法学质量和异质性进行了评估。持续病毒学应答率、生化应答率、乙肝e抗原清除率和血清学转换率被用作主要疗效指标。进行了定量荟萃分析,以评估传统干扰素和聚乙二醇化干扰素组之间以及总体上的差异。分析结果显示,添加传统干扰素(比值比[OR]=4.5,95%置信区间[CI]=2.2-9.4,P<.001;OR=2.1,95%CI=1.3-3.2,P=.002;OR=2.6,95%CI=1.4-4.8,P=.001)和聚乙二醇化干扰素(OR=2.0,95%CI=1.1-3.6,P=.02;OR=1.8,95%CI=1.3-2.6,P<.001;OR=1.6,95%CI=1.1-2.3,P=.03)后,拉米夫定的持续病毒学应答率、生化应答率和血清学转换率更高,前者的乙肝e抗原清除率也更高(OR=2.6,95%CI=1.3-5.2,P=.008)。由于先前的研究表明聚乙二醇化干扰素单药治疗及其与拉米夫定联合治疗效果相当,因此这种联合治疗的使用不合理。相比之下,当使用传统α干扰素时,应考虑将其与拉米夫定联合使用。