Background and aims We aim to assess the safety and immunogenicity of inactivated whole-virion SARS-CoV-2 vaccines in patients with chronic liver diseases (CLD) in this study. Methods This was a prospective, multi-center, open-label study. Participants aged over 18 years with confirmed CLD and healthy volunteers were enrolled. All participants received 2 doses of inactivated whole-virion SARS-CoV-2 vaccines. Adverse reactions were recorded within 14 days after any dose of SARS-CoV-2 vaccine, laboratory testing results were collected after the second dose, and serum samples of enrolled subjects were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. Results A total of 581 participants (437 patients with CLD and 144 healthy volunteers) were enrolled from 15 sites in China. Most adverse reactions were mild and transient, and injection site pain (36 [8.2%]) was the most frequently reported adverse event. Three participants had Grade 3 aminopherase elevation (defined as alanine aminopherase>5 upper limits of normal) after the second dose of inactivated whole-virion SARS-CoV-2 vaccination, and only one of them was judged as severe adverse event potentially related to SARS-CoV-2 vaccination. The positive rates of SARS-CoV-2 neutralizing antibodies were 76.8% in non-cirrhotic CLD group, 78.9% in compensated cirrhotic group, 76.7% in decompensated cirrhotic group (P=0.894 among CLD subgroups) and 90.3% in healthy controls (P=0.008 versus CLD group). Conclusion Inactivated whole-virion SARS-CoV-2 vaccines are safe in patients with CLD. Patients with CLD had lower immunological response to SARS-CoV-2 vaccines than healthy population. The immunogenicity is similarly low in non-cirrhotic CLD, compensated cirrhosis and decompensated cirrhosis.
Background Data on safety and immunogenicity of coronavirus disease 2019 (COVID-19) vaccination in patients with compensated (C-cirrhosis) and decompensated cirrhosis (D-cirrhosis) are limited. Methods In this prospective multicenter study, adult participants with C-cirrhosis and D-cirrhosis were enrolled and received two doses of inactivated whole-virion COVID-19 vaccines. Adverse events were recorded within 14 days after any dose of vaccination, and serum samples of enrolled patients were collected and tested for SARS-CoV-2 neutralizing antibodies at least 14 days after the second dose. Risk factors for negative neutralizing antibody were analyzed. Results In total, 553 patients were enrolled from 15 centers in China, including 388 and 165 patients with C-cirrhosis and D-cirrhosis. The vaccines were well tolerated, most adverse reactions were mild and transient, and injection site pain (23/388 [5.9%] vs 9/165 [5.5%]) and fatigue (5/388 [1.3%] vs 3/165 [1.8%]) were the most frequently local and systemic adverse events in both the C-cirrhosis and D-cirrhosis groups. Overall, 4.4% (16/363) and 0.3% (1/363) of patients were reported Grades 2 and 3 alanine aminotransferase (ALT) elevations (defined as ALT > 2 upper limit of normal [ULN] but ≤ 5 ULN, and ALT > 5 ULN, respectively). The positive rates of COVID-19 neutralizing antibodies were 71.6% (278/388) and 66.1% (109/165) in C-cirrhosis and D-cirrhosis groups. Notably, Child–Pugh score of B and C levels was an independent risk factor of negative neutralizing antibody. Conclusions Inactivated COVID-19 vaccinations are safe with acceptable immunogenicity in cirrhotic patients, and Child–Pugh score of B and C levels is associated with hyporesponsive to COVID-19 vaccination.
Rationale: Owing to the anatomical characteristics of the duodenum, gastroduodenal artery (GDA) pseudoaneurysms can be caused by duodenal ulcers, which may rupture and lead to massive or repeated bleeding. Pseudoaneurysms are usually diagnosed using enhanced computerized tomography or angiography, whereas endoscopic signs have rarely been reported. Patient concerns: Three patients aged 18 to 83 years with bleeding duodenal ulcers and GDA pseudoaneurysms were treated. Diagnosis: All patients had symptoms of gastrointestinal bleeding, and endoscopy revealed duodenal ulcers with visible vessels or adherent clot pulsations. Angiography confirmed the presence of a GDA pseudoaneurysm, which had an adjacent relationship with the duodenum. Interventions: The GDA pseudoaneurysm was embolized in each patient. Outcomes: Through transcatheter arterial embolization, endoscopic treatment, and traditional treatment, hematemesis or melena was gradually stopped and all patients were discharged. Lessons: The pulsation of visible vessels or adherent clots observed during endoscopy in patients with duodenal ulcer may indicate the formation of a gastroduodenal artery pseudoaneurysm. Therefore, we suggest that such patients receive enhanced computerized tomography or angiography to assess whether they need timely endovascular intervention treatment to avoid bleeding caused by a pseudoaneurysm.
Aim To determine the tolerance and acceptance of hepatic venous pressure gradient (HVPG) measurements in patients with liver cirrhosis. Methods This prospective international multicenter study included 271 patients with cirrhosis who were scheduled to undergo HVPG measurement between October 2019 and June 2020. Data related to the tolerance and acceptance of HVPG measurements were collected using descriptive questionnaires. Results HVPG measurements were technically successful in all 271 patients, with 141 (52.0%) undergoing HVPG measurement alone. The complication rate was 0.4%. Postoperative pain was significantly lower than preoperative expected pain (p < 0.001) and intraoperative pain (p < 0.001), and intraoperative pain was also significantly lower than preoperative expected pain (p = 0.036). No, mild, moderate, severe, and intolerable discomfort scores were reported by 36.9%, 44.6%, 11.1%, 6.3%, and 0.4% of these patients, respectively, during HVPG measurement and by 54.6% 32.5%, 11.4%, 1.5%, and 0%, respectively, after HVPG measurement. Of these patients, 39.5% had little understanding and 10% had no understanding of the value of HVPG measurement, with 35.1% and 4.1% regarding HVPG measurements as being of little or no help, respectively. Most patients reported that they would definitely (15.5%), probably (46.9%), or possibly (29.9%) choose to undergo additional HVPG measurements again, and 62.7% regarded the cost of the procedure as acceptable. Conclusion HVPG measurement was safe and well‐tolerated in patients with cirrhosis, but patient education and communication are warranted to improve the acceptance of this procedure.
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