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

Jiayu Deng, Tianzi Lei, Xiangfeng Wang, Changxin Liu, Yanqing Song

Abstract readMulticenter Study

In one paragraph

Article in BMC complementary medicine and therapies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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5 · Who and what money

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5 authors.

Jiayu DengDepartment of Pharmacy, Lequn Branch, The First Hospital of Jilin University, Changchun, 130031, China.

Tianzi LeiDepartment of Pharmacy, Lequn Branch, The First Hospital of Jilin University, Changchun, 130031, China.

Xiangfeng WangDepartment of Pharmacy, Lequn Branch, The First Hospital of Jilin University, Changchun, 130031, China.

Changxin LiuSchool of Pharmaceutical Sciences, Jilin University, Changchun, 130021, China.

Yanqing SongDepartment of Pharmacy, Lequn Branch, The First Hospital of Jilin University, Changchun, 130031, China. songyanq@jlu.edu.cn.

Funding

the Jilin Province Department of Finance, China 20200401007MHthe Science and Technology Department of Jilin Province, China 20200401007MH

6 · The paper itself

Abstract

objectiveTo 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.

methodsA 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.

resultsA 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.

conclusionThe 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.

Indexed as

Drug-Related Side Effects and Adverse ReactionsDrugs, Chinese HerbalProduct Surveillance, PostmarketingAdolescentAdultAgedAged, 80 and overChildChinaFemaleHumansInjectionsMaleMiddle AgedProspective StudiesYoung AdultDrugs, Chinese HerbalAdverse drug reactionsAdverse eventsCentralized monitoringGuhong InjectionSafety

Identifiers

PMID41044700

DOI10.1186/s12906-025-05112-5

PMCPMC12495768

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LicenceCC BY-NC-ND

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.