ObjectiveTo systematically review the efficacy and safety of Molnupiravir in the treatment of COVID-19. MethodsThe CNKI, VIP, WanFang Data, PubMed, Web of Science, Cochrane Library, and Epistemonikos COVID-19 L·OVE databases were electronically searched to collect randomized controlled trials (RCTs) related to Molnupiravir therapy for COVID-19 from inception to July, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4 software. ResultsA total of 9 RCTs involving 32 086 patients were included. The meta-analysis results revealed that no significant differences were observed in the 28-29 day hospitalization rate, the 28-29 day mortality rate, 14-15 day PCR test conversion rate, or adverse event incidence between the two groups. However, there was a significant increase in adverse events related to four types of systemic organ diseases in the Monolaurin group. Conclusion Current evidence shows that the safety profile of Monolaurin and its potential benefits for COVID-19 patients with a high risk of progressing to severe illness is unclear. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
ObjectiveTo conduct a comprehensive analysis of hematologic and lymphatic adverse events associated with Axicabtagene ciloleucel using the FDA adverse event reporting system (FAERS) database, providing valuable references for clinical safety in medication. MethodsWe retrieved reports of adverse reactions related to Axicabtagene ciloleucel from the FAERS database covering the period from October 2017 to December 2023. A disproportionality analysis was performed using the reporting odds ratio (ROR) and information component (IC) to identify hematologic and lymphatic adverse events associated with Axicabtagene ciloleucel. ResultsA total of 790 reports of hematologic and lymphatic adverse events related to Axicabtagene ciloleucel were identified, leading to the detection of 16 signals. Six of these adverse events were not included in the product labeling. Neutropenia was the most frequently reported hematologic adverse event associated with Axicabtagene ciloleucel. The strongest signal identified was cytopenia. Notably, 13.9% of cases resulted in death, with pancytopenia being the most common adverse event among the fatal outcomes. ConclusionAdverse events such as disseminated intravascular coagulation, coagulopathy, and bone marrow dysfunction are rarely reported in clinical practice and are not included in the product labeling, yet they are highly associated with mortality.