Rudin Dan, Shah Sooraj M, Kiss Alexander, Wetz Robert V, Sottile Vincent M
Department of Internal Medicine, Staten Island University Hospital, Staten Island, NY 10305, USA.
Liver Int. 2007 Nov;27(9):1185-93. doi: 10.1111/j.1478-3231.2007.01580.x.
To compare interferon monotherapy with its combination with lamivudine for hepatitis B e antigen (HBeAg)-positive hepatitis B treatment.
Two independent researchers identified pertinent randomized controlled trials. The trials were evaluated for methodological quality and heterogeneity. Rates of sustained virological and biochemical responses, and HBeAg clearance and seroconversion were used as primary efficacy measures. Quantitative meta-analyses were conducted to assess differences between groups for conventional and pegylated interferon, and overall.
Greater sustained virological, biochemical and seroconversion rates were observed with addition of lamivudine to conventional [odds ratio (OR)=3.1, 95% confidence intervals (CI) (1.7-5.5), P<0.0001, OR=1.8, 95% CI (1.2-2.7), P=0.007 and OR=1.8, 95% CI (1.1-2.8), P=0.01 respectively], although not pegylated [OR=1.1, 95% CI (0.5-2.3), P=0.8, OR=1.0, 95% CI (0.7-1.3), P=0.94, and OR=0.9, 95% CI (0.6-1.2), P=0.34 respectively] interferon-alpha, with no significant affect on HBeAg clearance rates [OR=1.6, 95% CI (0.9-2.7), P=0.09, and OR=0.8, 95% CI (0.6-1.1), P=0.26 respectively]. Excluding virological response (P<0.001), pegylated interferon monotherapy and conventional interferon and lamivudine combination therapy were similarly efficacious (P>0.05), with the former studied in harder to treat patients, as evidenced by the superior virological response observed with conventional as compared with pegylated interferon monotherapy (P<0.0001).
In comparable populations, pegylated interferon monotherapy is likely to be equally or more efficacious than conventional interferon and lamivudine combination therapy, thus constituting the treatment of choice, with no added benefit with lamivudine addition. However, when conventional interferon is used, its combination with lamivudine should be considered.
比较干扰素单药治疗与干扰素联合拉米夫定治疗乙肝e抗原（HBeAg）阳性乙型肝炎的效果。
两名独立研究人员确定相关随机对照试验。对试验进行方法学质量和异质性评估。持续病毒学应答率、生化应答率、HBeAg清除率及血清学转换率用作主要疗效指标。进行定量荟萃分析以评估普通干扰素和聚乙二醇化干扰素组间及总体差异。
普通干扰素联合拉米夫定治疗的持续病毒学应答率、生化应答率及血清学转换率更高[比值比（OR）=3.1，95%置信区间（CI）（1.7 - 5.5），P<0.0001；OR = 1.8，95%CI（1.2 - 2.7），P = 0.007；OR = 1.8，95%CI（1.1 - 2.8），P = 0.01]，而聚乙二醇化干扰素联合拉米夫定治疗的上述指标无显著差异[OR = 1.1，95%CI（0.5 - 2.3），P = 0.8；OR = 1.0，95%CI（0.7 - 1.3），P = 0.94；OR = 0.9，95%CI（0.6 - 1.2），P = 0.34]。联合拉米夫定对HBeAg清除率无显著影响[OR = 1.6，95%CI（0.9 - 2.7），P = 0.09；OR = 0.8，95%CI（0.6 - 1.1），P = 0.26]。排除病毒学应答因素（P<0.001）后，聚乙二醇化干扰素单药治疗与普通干扰素联合拉米夫定治疗疗效相似（P>0.05），且前者治疗的患者病情更难，这从普通干扰素单药治疗的病毒学应答优于聚乙二醇化干扰素单药治疗可得到证明（P<0.0001）。
在可比人群中，聚乙二醇化干扰素单药治疗可能与普通干扰素联合拉米夫定治疗同样有效或更有效，因此是首选治疗方法，联合拉米夫定并无额外益处。然而，使用普通干扰素时，应考虑联合拉米夫定。
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