zhang hewei

and 3 more

Abstract Aim: We aim to compare nephrotoxic spectrum of IOCM and that of LOCM in a more intensive and comprehensive perspective using the real-world database. Methos: This is an observational, retrospective, pharmacovigilance study based on Vigibase. 7 products (iodixanol, iohexol, iopamidol, iopromide, iobitridol, ioversol and iomeprol) of ICM were included. Variable matching method was used for deduplication procedure. Two data mining method, reporting odds ratio (ROR) and bayesian confidence propagation neural networks of information components (IC) were used to detect signals for the full database, gender stratums (male and female), age stratum (0 to 64 years, 65 to 74 years and 75 or more years) and pooled analysis of total renal adverse events (AEs). Package ‘base’, ‘utils’ and ‘pheatmap’ of R language (version 4.1.2) were used to perform analysis and plot figures. Results: We got 2703 ICSRs and 3155 renal AE reports. The five most frequently reported were acute kidney injury, renal failure, renal impairment azotaemia and anuria. All ICM had highest signal value detected in age ≥75 years. Iodaxinal and iohexol had most signals detected. In pooled analysis of renal AEs, no signals detected for iopamidol, iomeprol and iopromide in the full database stratum. Conclusion: No evidence approved IOCM has safer nephrotoxicity than LOCM. CIN spectrum varies a lot within LOCM. Regarding to the whole population, not all products of ICM, such as iopamidol, iomeprol and iopromide, is likely to cause CIN.

Qiang Lyu

and 8 more

Aim: Residual neuromuscular blockade is a common complication after general anaesthesia. Sugammadex can reverse the action of aminosteroid neuromuscular blockers. Our study aimed to explore sugammadex safety issues in the real world and determine the spectrum of adverse reactions. Methods: All sugammadex-related adverse events reported in VigiBase between 2010 and 2019 were classified by group queries according to the Medical Dictionary for Regulatory Activities. A disproportionality analysis of data was performed using the information component (IC); positive IC values were deemed significant. Results: Overall, 16,219,410 adverse events were reported, and 2032 were associated with sugammadex. The most frequent reactions were recurrence of neuromuscular blockade (n = 54, IC: 6.74, 95% credibility interval [CI]: 6.33–7.10), laryngospasm (n = 53, IC: 6.05, IC025:5.64), bronchospasm (n = 119, IC: 5.63 , IC025:5.36), and bradycardia (n = 169, IC: 5.13, IC025:4.90). Fatal cases were more likely with cardiac disorders, especially in patients over 65 years. In addition, the common adverse drug reactions (ADRs) differed between different age groups (P < 0.01). The ADRs were higher between 0–17 years than in other age groups. The onset time of common ADRs was typically within one day, and 68.9% occurred within half an hour after sugammadex administration. Conclusions: Anaesthesiologists should carefully monitor the anaesthesia recovery period to correct the adverse drug reactions caused by sugammadex and recommend monitoring neuromuscular function throughout the anaesthesia process. Sugammadex should be used carefully in patients with cardiovascular diseases, and ECG and hemodynamic changes monitored after medication.