拉米夫定和恩替卡韦治疗急性乙型肝炎：系统评价和荟萃分析。

BACKGROUND: Acute hepatitis B infection is associated with severe liver disease and chronic sequelae in some cases. The purpose of this review was to determine the efficacy of nucleoside analogues (NA) (lamivudine versus entecavir) compared to placebo or no intervention for treating acute primary HBV infection. METHODS: A meta-analysis for drug intervention was performed, following a fixed-effect model. Randomized controlled trials (RCTs) and quasi-randomized studies that evaluated the outcomes of NA in acute hepatitis B infection were included. The following outcomes were considered: virological cure (PCR negative), elimination of acute infection (seroconversion of HBsAg), mortality, and serious adverse events. RESULTS: Five trials with 627 adult participants with severe acute hepatitis B defined by biochemical and serologic parameters were included. Virological cure did not favor any intervention: OR 0.96, 95% CI 0.54 to 1.7 ( = 0.90), I2 = 58%. Seroconversion of HBsAg to negative favored placebo/standard-of-care compared to lamivudine: OR 0.54, 95% CI 0.33 to 0.9 ( = 0.02), I2 = 31%. The only trial that compared entecavir and lamivudine favored entecavir over lamivudine (OR: 3.64, 95% CI 1.31-10.13; 90 participants). Adverse events were mild. CONCLUSION: There is insufficient evidence that NA obtain superior efficacy compared with placebo/standard-of-care in patients with acute viral hepatitis, based on low quality evidence.

背景：急性乙型肝炎感染在某些情况下会导致严重的肝脏疾病和慢性后遗症。本综述的目的是确定核苷类似物（NA）（拉米夫定与恩替卡韦）与安慰剂或不干预相比，治疗急性原发性 HBV 感染的疗效。

方法：采用固定效应模型进行药物干预的荟萃分析。纳入评估 NA 在急性乙型肝炎感染中的疗效的随机对照试验（RCT）和准随机研究。考虑了以下结局：病毒学治愈（PCR 阴性）、急性感染消除（HBsAg 血清学转换）、死亡率和严重不良事件。

结果：纳入了 5 项试验，共 627 名成人严重急性乙型肝炎患者，根据生化和血清学参数定义。病毒学治愈不支持任何干预：OR 0.96，95%CI 0.54 至 1.7（=0.90），I2 = 58%。与拉米夫定相比，HBsAg 血清学转换为阴性更有利于安慰剂/标准治疗：OR 0.54，95%CI 0.33 至 0.9（=0.02），I2 = 31%。唯一比较恩替卡韦和拉米夫定的试验中，恩替卡韦优于拉米夫定（OR：3.64，95%CI 1.31-10.13；90 名参与者）。不良事件为轻度。

结论：根据低质量证据，尚无充分证据表明 NA 在急性病毒性肝炎患者中比安慰剂/标准治疗更有效。