This randomized controlled trial enrolled patients with virologically suppressed HBV-compensated cirrhosis and small/medium EV. The participants were randomly assigned to receive nucleos(t)ide analog (NUC) or carvedilol 12.5 mg plus NUC (1:1 allocation ratio). The primary end point was the progression rate of EV at 2 years of follow-up.
A total of 238 patients (small EV, 77.3%) were randomized into 119 NUC and 119 carvedilol plus NUC (carvedilol [CARV] combination group). Among them, 205 patients (86.1%) completed paired endoscopies. EV progression rate was 15.5% (16/103) in the NUC group and 12.7% (13/102) in the CARV combination group (relative risk = 0.79, 95% confidence interval 0.36-1.75, P = 0.567). Subgroup analysis on medium EV showed the CARV combination group had a more favorable effect in promoting EV regression (43.5% vs 13.1%, P = 0.022) than NUC alone, but not in small cases ( P = 0.534). The incidence of liver-related events (decompensation, hepatocellular carcinoma, or death/liver transplantation) within 2 years was similar between the 2 groups (11.2% vs 10.4%, P = 0.881).
The overall results did not show statistically significant differences between the added carvedilol strategy and NUC monotherapy in preventing EV progression in patients with virologically suppressed HBV-compensated cirrhosis. However, the carvedilol-added approach might offer improved outcomes specifically for patients with medium EV (NCT03736265).
方法:这项随机对照试验招募了病毒学抑制的HBV代偿性肝硬化和小/中EV患者。参与者被随机分配接受核苷(t)ide类似物(NUC)或卡维地洛12.5mg加NUC(分配比1:1)。主要终点是随访2年的EV进展率。
结果:共238例患者(小EV,77.3%)被随机分为119个NUC和119个卡维地洛+NUC(卡维地洛[CARV]组合组)。其中,205例患者(86.1%)完成了配对内窥镜检查。NUC组EV进展率为15.5%(16/103),CARV组合组为12.7%(13/102)(相对危险度=0.79,95%置信区间为0.36-1.75,P=0.567)。对中EV的亚组分析显示,CARV组合组在促进EV消退方面具有更有利的作用(43.5%vs13.1%,P=0.022)比单独的NUC,但不是在小的情况下(P=0.534)。肝脏相关事件的发生率(失代偿,肝细胞癌,或死亡/肝移植)在2年内两组之间相似(11.2%vs10.4%,P=0.881)。
结论:总体结果未显示添加卡维地洛策略和NUC单一疗法在预防病毒学抑制的HBV代偿性肝硬化患者的EV进展方面的统计学差异。然而,添加卡维地洛的方法可能会改善中等EV患者的结局(NCT03736265).