The secondary endpoints were adverse events related to treatment and death from any cause. All adverse events occurred during the study period were recorded. Based on the esophageal variceal bleeding rate of 20% in patients treated with beta blockers3 and 5% in patients receiving EVL plus nadolol,9 with a two-tailed test to achieve a statistical power of 80% and allowing a type I error of 5%, a sample size of 70 cases in each Napabucasin group were required. A total of 461 patients were screened. In all, 321 patients were excluded due to: hepatocellular carcinoma (184 patients), greater than 75 years old (61 patients), history of variceal bleeding
(27 patients), other malignancy (eight patients), chronic renal insufficiency (13 patients), heart disease (seven patients), refractory ascites (three patients), deep jaundice (three patients), asthma (two patients), refused to participate (13 patients). Finally, 140 consecutive patients
were enrolled in the trial, 70 patients in the Combined group and 70 Ibrutinib research buy patients in the Nadolol group (Fig. 1). Both groups were comparable in etiologies of portal hypertension, Child-Pugh’s class, and variceal sizes (Table 1). The median follow-up was 26.0 months in the Combined group and 26.4 months in the Nadolol group. Variceal obliteration was achieved in 50 patients (71%) of the Combined group. The mean sessions required to achieve variceal obliteration and rubber bands used in the Combined group were 2.1 ± 1.1 and 8.1 ± 4.3, respectively. Seven patients in the Combined group received only one session of EVL but refused to receive regular EVL to achieve variceal obliteration. Among patients achieving variceal obliteration, 46 patients received follow-up endoscopy and recurrent varices were noted in 18 patients (39%). These patients received a mean of 1.2 ± 0.5 sessions to achieve variceal obliteration once again. The mean dose of nadolol
was 52 ± 16 mg in the Combined group and 56 ± 19 mg in the Nadolol group. The mean interval between start of nadolol medication and ligation of varices was 10 ± 5 days in the Combined group. No patients bled during this period. Three patients in the Combined group and four patients in the Nadolol group did not take drugs regularly. Three patients in each group refused MycoClean Mycoplasma Removal Kit follow-up at outpatient visits. The results are shown in Table 2. Upper gastrointestinal hemorrhage occurred in 18 patients (26%) in the Combined group and 13 patients (18%) in the Nadolol group (Fig. 2; P = 0.42). Esophageal variceal bleeding occurred in 10 patients (14%) in the Combined group and nine patients in the Nadolol group (13%) (Fig. 3; P = 0.60). In the Combined group, seven patients had esophageal variceal bleeding before variceal obliteration and three patients bled after variceal obliteration. Among the seven patients who bled from esophageal varices before variceal obliteration, one was uncooperative to receive scheduled EVL treatment sessions.