目的:非选择性β受体阻滞剂(NSBBs)和内镜下静脉曲张结扎术(EVL)预防首次静脉曲张出血的疗效相似。代偿和失代偿期肝硬化是明显不同的阶段,这可能会影响治疗结果。我们的目的是评估NSBBs与EVL对无既往出血的高危静脉曲张患者生存的疗效。根据肝硬化代偿/失代偿期进行风险分层。
方法:通过系统评价,我们确定了比较NSBB和EVL的RCT,在单一疗法或联合疗法中,用于预防原发性出血。我们承担了竞争风险,事件发生时间荟萃分析,使用从RCTs的主要研究者获得的个体患者数据(IPD)。根据先前的肝硬化代偿失调进行分层分析。
结果:在25个符合条件的RCT中,14个未能提供IPD,11个被包括在内,包括1400名患者(656名代偿,744失代偿),用NSBB处理(N=625),EVL(N=546)或NSBB+EVL(N=229)。组间基线特征相似。总的来说,EVL与EVL的死亡风险相似。NSBB(亚分布危险比(sHR)=1.05,95%CI=0.75-1.49)和EVLNSBB与单药治疗,异质性低(I2=28.7%)。在补偿患者中,EVL与NSBBs的死亡风险更高(sHR=1.76,95%CI=1.11-2.77),而NSBBsEVL与NSBBs的死亡风险并没有显着降低,无异质性(I2=0%)。在失代偿患者中,EVL与EVL的死亡风险相似。NSBB和NSBB+EVL与要么是单一疗法。
结论:在初级预防的代偿性肝硬化和高危静脉曲张患者中,与EVL相比,NSBB显着提高了生存率,没有注意到将EVL添加到NSBB的额外好处。在失代偿患者中,两种疗法的生存率相似.研究表明,在代偿患者中建议预防性治疗时,NSBB是优选的。
Non-selective β-blockers (NSBBs) and endoscopic variceal-ligation (EVL) have similar efficacy preventing first variceal bleeding. Compensated and decompensated cirrhosis are markedly different stages, which may impact treatment outcomes. We aimed to assess the efficacy of NSBBs vs EVL on survival in patients with high-risk varices without previous bleeding, stratifying risk according to compensated/decompensated stage of cirrhosis.
By systematic review, we identified RCTs comparing NSBBs vs EVL, in monotherapy or combined, for primary bleeding prevention. We performed a competing-risk, time-to-event meta-analysis, using individual patient data (IPD) obtained from principal investigators of RCTs. Analyses were stratified according to previous decompensation of cirrhosis.
Of 25 RCTs eligible, 14 failed to provide IPD and 11 were included, comprising 1400 patients (656 compensated, 744 decompensated), treated with NSBBs (N = 625), EVL (N = 546) or NSBB+EVL (N = 229). Baseline characteristics were similar between groups. Overall, mortality risk was similar with EVL vs. NSBBs (subdistribution hazard-ratio (sHR) = 1.05, 95% CI = 0.75-1.49) and with EVL + NSBBs vs either monotherapy, with low heterogeneity (I2 = 28.7%). In compensated patients, mortality risk was higher with EVL vs NSBBs (sHR = 1.76, 95% CI = 1.11-2.77) and not significantly lower with NSBBs+EVL vs NSBBs, without heterogeneity (I2 = 0%). In decompensated patients, mortality risk was similar with EVL vs. NSBBs and with NSBBs+EVL vs. either monotherapy.
In patients with compensated cirrhosis and high-risk varices on primary prophylaxis, NSBBs significantly improved survival vs EVL, with no additional benefit noted adding EVL to NSBBs. In decompensated patients, survival was similar with both therapies. The study suggests that NSBBs are preferable when advising preventive therapy in compensated patients.