Post-marketing safety evaluation of Guhong Injection: a multicenter, prospective real-world study of 30,000 cases in China.

Abstract

Objective: To evaluate the incidence, nature, and clinical manifestations of adverse events (AEs) and adverse drug reactions (ADRs) associated with Guhong Injection, and to provide evidence for the safe clinical use of this drug.

Methods: A prospective, multicenter, large-scale, registry-based hospital centralized monitoring system was employed to track eligible patients using Guhong Injection across 31 hospitals in China from October 2019 to December 2022.

Results: A total of 30,000 cases were included in the study, with 81 AEs reported, involving 67 patients, yielding an incidence rate of 2.23‰. Of these 67 patients, 60 were first-time users of Guhong Injection, accounting for 89.55% of the AEs. The most common ADR observed was hypersensitivity, with an incidence rate of 1.13‰, primarily presenting as skin itching (0.53‰) and rash (0.43‰). Multifactorial unconditional logistic regression analysis revealed that ethnicity, frequency of drug use, contraindications, and allergic history were significantly associated with the occurrence of AEs.

Conclusion: The overall AE rate of Guhong Injection was classified as uncommon according to CIOMS guidelines. Hypersensitivity reactions, particularly skin itching and rash, were the most frequently observed ADRs. Factors such as ethnicity, frequency of drug use, contraindications, and allergic history were identified as contributing to the occurrence of AEs, providing crucial insights for ensuring the safe clinical use of Guhong Injection.