Safety of the Xuesaitong injection in China: results from a large-scale multicentre post-marketing surveillance study in a real-world setting
| Autor: | Xue-Jun Hong, Bang-Hua Huang, Wei Liu, Xiao-Jun Wu, Lei Li, Xiao-Guang Liu, Hong-Lian Yang, Yan He, Xue-Min Gao, Ming-Hui Xue, Jun-Feng Liu |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Male
China Surveillance study Drug-Related Side Effects and Adverse Reactions Scale (ratio) Databases Pharmaceutical Postmarketing surveillance Traditional Chinese medicine 030204 cardiovascular system & hematology Logistic regression Injections 03 medical and health sciences 0302 clinical medicine Product Surveillance Postmarketing Humans Medicine Operations management 030212 general & internal medicine Aged business.industry Incidence General Medicine Middle Aged Saponins Safety profile Female business Drugs Chinese Herbal |
| DOI: | 10.6084/m9.figshare.13049701.v1 |
| Popis: | The safety profile of traditional Chinese medicine injections has emerged as the greatest challenge to their clinical application. The authors aimed to perform a post-marketing surveillance study in a real-world setting to evaluate the safety of the Xuesaitong (XST) injection in China. This multi-centre, post-marketing, observational study enrolled patients who received XST injections in 42 centres in China between March 2015 and November 2017. Adverse drug reactions (ADRs) and adverse drug events (ADEs) were collected and evaluated in a post-marketing database. Logistic regression analysis was performed to analyse the risk factors for ADRs. A total of 30,008 consecutive patients with a mean age of 62.29 ± 14.58 years were included in this post-marketing study. The incidences of ADEs and ADRs were 0.5% and 0.33%, respectively. The most common clinical manifestations were damage to skin and appendages (47.66%). There were four new kinds of ADEs found in the present monitoring study. The majority of ADRs were type B (62.62%) and occurred within 24 h after XST injection treatment. No severe ADRs were reported in this analysis. Multivariate logistic regression analysis showed that the hospital level (OR = 0.607; 95% CI = 0.407–0.906; p = .0144), hypertension (OR = 1.979; 95% CI, 1.323–2.959; p = .0009) and solvent type (OR = 2.951; 95% CI, 1.608–5.417; p = .0005) were risk factors for ADR occurrence. XST injection is well tolerated and has a favourable safety profile for patients in a real-world setting. This post-marketing study provided further evidence of the safety of XST injections for clinical applications. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|