Reevaluation of the post-marketing safety of Xuebijing injection based on real-world and evidence-based evaluations - 09/12/18
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Graphical abstract |
Highlights |
• | Novel drug safety assessment protocol developed using meta-analysis, NCCS, and PSA. |
• | Can be applied in cost-effective clinical pre-marketing drug safety testing. |
• | Correlates ADR development risk with the most significantly influential factors. |
• | Xuebijing TCM has high efficacy against sepsis and MOF but may induce ADR. |
• | Glucose vehicle, drug combinations and age increase ADR risk. |
Abstract |
Aims |
To determine the causes of adverse reactions associated with Xuebijing injection and provide medical evidence for its safe and rational post-marketing use in clinical practice.
Materials and methods |
We used prospective nested case-control and prescription sequence analysis designs. Using data from the Hospital Information System, patients exhibiting trigger signals after receiving Xuebijing injection were classified as suspected allergic patients. Logistic regression analysis was performed on the risk factors associated with Xuebijing-induced allergic reactions. Randomized controlled and cohort studies on adverse drug reactions to Xuebijing injection were screened from databases and the results were subjected to meta-analysis.
Results |
The overall incidence of allergic reactions or anaphylaxis tended to increase with dosage and patient’s age. Moreover, compared with Xuebijing alone, co-administration of Xuebijing with other drugs or agents (including Ringer’s sodium acetate solution, reduced glutathione, aspirin-DL-lysine, and torasemide) increased the risk of adverse reactions. The use of glucose as a vehicle also provoked a greater incidence of allergic reactions than that by the use of 0.9% w/v sodium chloride as a vehicle. Adverse reactions occurred more frequently in patients receiving indicated dosages than in those receiving off-label dosages.
Conclusions |
Adverse reactions to Xuebijing injections were correlated with vehicle type, dosage, age, and drug combination. There was no clear association between patient’s condition at admission and suspected adverse reactions to Xuebijing injection. Factors influencing the adverse reactions to Xuebijing injection must be fully considered in clinical practice.
El texto completo de este artículo está disponible en PDF.Keywords : Real-world study, Evidence-based evaluation, Xuebijing injection, Post-marketing safety re-evaluation, Logistic regression analysis
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Vol 109
P. 1523-1531 - janvier 2019 Regresar al númeroBienvenido a EM-consulte, la referencia de los profesionales de la salud.
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