ABSTRACT
Objective To explore the potential adverse reactions of acalabrutinib by mining and analyzing the pharmacovigilance signal of acalabrutinib, to provide a reference for clinically safe and rational drug use. Methods Data related to acalabrutinib in the FAERS database were searched, and pharmacovigilance signals were obtained using the disproportionality measurement. Results A total of 3, 155 reports of adverse events with acalabrutinib as the primary suspected drug were extracted, and 73 warning signals were detected involving 15 system organ classifications, 36 of which were not included in the drug instructions of acalabrutinib. The strong signals of acalabrutinib were mainly concentrated in various inflammatory and bleeding, anemia, contusion, atrial fibrillation, and so on. The largest number of system organ classification signals were focused on the blood and lymphatic system disorders, investigations, infections, and so on. In addition, the drug may cause tachycardia, brittle nails, and other warning signs. Through further analysis of gender-related adverse events, there were a total of 49 high-risk signals with gender differences found. Herein, male patients should pay attention to adverse reactions in bleeding, heart, urinary system, hypertension, and so on; meanwhile, female patients should be alert to adverse reactions in liver function, skin inflammation, and so on. Conclusion A total of 36 drug warning signs that are not mentioned in the instructions for acalabrutinib are mined using FAERS, and blood, infection, and cardiac toxicity require special attention. Thus, these signals should be detected promptly for effective prevention in clinical medication to reduce the risk of medication use for patients.
ABSTRACT
Objective To perform a network meta-analysis (NMA) for the efficacy of 11 drugs in preventing chronic peripheral neuropathy induced by platinum and taxane (PTIPN). Methods PubMed, Cochrane library, Embase, CNKI, WanFang database and VIP database were searched up to February 2021 for relevant randomized controlled trials (RCTs) addressing the drugs to prevent PTIPN. After extracting relevant data, Stata 14.0 and ADDIS 1.16.6 softwares were used for statistical analysis. Results A total of 70 studies involving 6201 patients were included. The results of network Meta-analysis showed that amifostine, ganglioside, Huangqi Guizhi Wuwu decoction (HQGZT), vitamin E, calcium and magnesium infusion and omega-3 fatty acids were superior to placebo or blank groups in reducing the incidence of overall or severe PTIPN. The rank probability plot and the SUCRA calculation results suggested that amifostine, HQGZT and omega-3 fatty acids were in first order. The differences between the 11 drugs and placebo or blank groups were not statistically significant, except for amifostine which was reported to aggravate the adverse reactions of nausea and vomiting and hypotension in patients. Conclusion HQGZT, Ganglioside, Vitamin E, omega-3 fatty acids, calcium and magnesium infusion and glutathione can reduce the occurrence of PTIPN, and HQGZT has the highest efficiency.