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目的通过研究HBeAg阳性慢性乙型肝炎初治患者接受聚乙二醇干扰素-α(Peg-IFN-α)24周,根据RGT策略给予不同的治疗方案,分析比较其疗效及预测因素。方法收集87例初治选用足量Peg-IFN-α的HBeAg阳性慢性乙型肝炎患者,24周时根据应答情况接受不同序贯单药或联合治疗,分别为a:有早期应答者继续Peg-IFN-α治疗至48周(n=20);而对于无早期应答者采用3种治疗方案,即b:继续单药Peg-IFN-α治疗至48周(n=17);c:Peg-IFN-α单药延长治疗至96周(n=25);d:在Peg-IFN-α基础上联合恩替卡韦并延长治疗至96周(n=25)。比较分析各组之间的疗效及应答的预测因素。结果治疗结束时,a组较b组,d组较c组HBsAg、HBV DNA下降均有明显增加(P值分别为0.0194、0.041以及0.0008、0.0035)。96周治疗患者(无论单药还是联合)在治疗结束时达到HBsAg≤1000 IU/mL且HBeAg(-)的患者均较b组增加(P=0.0384);治疗结束时d组较c组HBeAg下降增加,对HBeAg消失及血清学转换有一定的作用,但差异无统计学意义;基线HBsAg≥1500 IU/mL的患者,治疗结束后d组较c组DNA转阴率、以及获得HBsAg下降≥2lg IU/mL且HBV DNA转阴的患者都明显增加(P分别为0.0228和0.0237)。结论对于无早期应答患者,延长干扰素疗程并同时加用核苷类药物可以提高HBsAg及HBV DNA载量下降的幅度。基线HBsAg≥1500IU/mL的患者,仍可选择联合核苷类药物并延长的治疗方案。
Objective To study the efficacy and predictive factors of peginterferon-α (Peg-IFN-α) in patients with primary HBeAg-positive chronic hepatitis B after 24 weeks according to the RGT strategy. Methods Eighty-seven patients with HBeAg-positive chronic hepatitis B who were initially treated with adequate Peg-IFN-α were enrolled. Patients were randomized to receive either sequential single-agent or combination therapy at 24 weeks according to response: a, with early responders continuing with Peg- (N = 20) for IFN-α therapy and 48 weeks (n = 20) for no response to the early responder, ie b: continuation of monotherapy with Peg-IFN-α until 48 weeks IFN-α monotherapy prolonged to 96 weeks (n = 25); d: entecavir combined with Peg-IFN-α and extended treatment to 96 weeks (n = 25). Comparative analysis of the efficacy of each group and predictors of response. Results At the end of treatment, the decrease of HBsAg and HBV DNA in group a were significantly higher than those in group b and group d (P = 0.0194, 0.041, 0.0008, 0.0035, respectively). Patients in 96 weeks (single or combined) achieved HBsAg ≤1000 IU / mL at the end of treatment and patients with HBeAg (-) had an increase compared to group b (p = 0.0384); HBeAg decreased in group d at 4 weeks after treatment Increase, HBeAg disappearance and seroconversion have a certain effect, but the difference was not statistically significant; baseline HBsAg ≥ 1500 IU / mL of patients after treatment, d group than c group DNA negative rate, and to obtain HBsAg decreased ≥ 21g IU / mL and HBV DNA negative patients were significantly increased (P 0.0228 and 0.0237, respectively). Conclusions For patients without early response, prolonging the duration of interferon treatment and adding nucleosides at the same time can increase the decrease of HBsAg and HBV DNA load. Patients with baseline HBsAg ≥ 1500 IU / mL may still be eligible for combination nucleosides and extended treatment regimens.