Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial.

PURPOSE: The risk of thromboembolic events is elevated in patients with nephrotic syndrome, and warfarin use has been associated with an increased risk of bleeding. Indobufen, a selective cyclooxygenase-1 inhibitor, is currently being evaluated for the prevention of thromboembolic events in nephrotic syndrome. This study aimed to compare the efficacy and safety of indobufen with that of warfarin in patients with nephrotic syndrome. MATERIALS AND METHODS: This multicenter, randomized, three-arm, open-label, parallel controlled trial involved a total of 180 adult patients with nephrotic syndrome from four centers in China. Patients were randomly assigned to receive 100 mg indobufen (bid), 200 mg indobufen (bid), and 3 mg warfarin (qd) daily for 12 weeks. The primary endpoints included thromboembolic and bleeding events, while laboratory results and adverse events constituted secondary endpoints. RESULTS: No thromboembolic events occurred in the high-/low-dose indobufen and warfarin groups. Moreover, the use of a low dose of indobufen significantly reduced the risk of minor bleeding events compared with warfarin use (2% versus 18%, p < .05). Finally, adverse events were more frequent in warfarin-treated patients. CONCLUSIONS: This study found that indobufen therapy provided equivalent effects in preventing thromboembolic events compared with warfarin therapy, while low dose of indobufen was associated with a reduced risk of bleeding events, thus it should be recommended for the prevention of thromboembolic events in clinical practice in patients with nephrotic syndrome. TRIAL REGISTRATION NUMBER: ChiCTR-IPR-17013428.

Peripheral Nervous System Adverse Events after the Administration of mRNA Vaccines: A Systematic Review and Meta-Analysis of Large-Scale Studies.

Although neurological complications after the administration of vaccines against coronavirus disease 2019 (COVID-19) are rare, they might result in long-term morbidity. This study was designed to determine the risk of peripheral nervous system (PNS) adverse events after the administration of mRNA vaccines against COVID-19. Large-scale randomized controlled trials (RCTs) and cohort studies were systematically searched in databases, and 15 cohort studies were included in the synthesis. Among all PNS adverse events, only Bell's palsy and Guillain-Barré syndrome (GBS) had sufficient data and were included for further analysis. Individuals who received mRNA vaccines had a higher risk of Bell's palsy than the unvaccinated group, and the risk of Bell's palsy after BNT162b2 was significantly higher than after mRNA-1273. Regarding GBS, no significant difference in the risk was observed between BNT162b2 and the unvaccinated group, but BNT126b2 introduced a higher risk of post-vaccinated GBS than mRNA-1273. In conclusion, PNS adverse events, especially Bell's palsy, should be carefully observed after mRNA vaccination against COVID-19. With the opportunity of vaccination campaigns on such a large scale, further investigation and surveillance of post-vaccination neurological adverse events should also be established.