Academic Journal
Pharmacovigilance and toxicological studies on safety signals associated with the combined use of propofol and midazolam.
| Τίτλος: | Pharmacovigilance and toxicological studies on safety signals associated with the combined use of propofol and midazolam. |
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| Συγγραφείς: | Wei W; Department of Anesthesiology and Pain Research Center, The Affiliated Hospital of Jiaxing University & The First Hospital of Jiaxing, Jiaxing, Zhejiang, China., Wang L; Department of Anesthesiology and Pain Research Center, The Affiliated Hospital of Jiaxing University & The First Hospital of Jiaxing, Jiaxing, Zhejiang, China., Chen L; Department of Hepatobiliary and Pancreatic Surgery, Conversion therapy center for Hepatobiliary and Pancreatic Tumors, The Affiliated Hospital of Jiaxing University & The First Hospital of Jiaxing, Jiaxing, Zhejiang, China., Ying X; Suzhou Hospital of Anhui Medical University, Anhui, Suzhou, China., Xu S; Department of Anesthesiology and Pain Research Center, The Affiliated Hospital of Jiaxing University & The First Hospital of Jiaxing, Jiaxing, Zhejiang, China. 1813110760@qq.com. |
| Πηγή: | BMC anesthesiology [BMC Anesthesiol] 2026 Apr 21; Vol. 26 (1). Date of Electronic Publication: 2026 Apr 21. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968535 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2253 (Electronic) Linking ISSN: 14712253 NLM ISO Abbreviation: BMC Anesthesiol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2001- |
| Ιατρικοί όροι (MeSH): | Midazolam*/adverse effects , Midazolam*/administration & dosage , Propofol*/adverse effects , Propofol*/administration & dosage , Hypnotics and Sedatives*/adverse effects , Hypnotics and Sedatives*/administration & dosage , Anesthetics, Intravenous*/adverse effects , Anesthetics, Intravenous*/administration & dosage , Anesthetics, Combined*/adverse effects , Anesthetics, Combined*/administration & dosage , Pharmacovigilance*, Propofol Infusion Syndrome/epidemiology ; Anaphylaxis/chemically induced ; Anaphylaxis/epidemiology ; Humans ; Databases, Factual |
| Περίληψη: | BACKGROUND: Propofol and midazolam are widely used in sedation and general anesthesia, but there has been a lack of systematic research on safety signals caused by the combination medication. METHODS: We collected data on drug safety signals related to propofol and midazolam from the FAERS database (2004Q1-2025Q1). Disproportionality analysis, Time-to-event, and Weibull distribution are performed for signal monitoring and risk assessment. We further analyze the potential mechanism of allergic reactions caused by the combination medication. RESULTS: A strong signal for Propofol Infusion Syndrome (PRIS) was detected with propofol alone (ROR: 4514.44, 95% CI: 3851.09–5292.06), whereas no risk reduction was observed with combination medication (ROR: 2219.2, 95% CI: 1753.85–2808.03). Anaphylactic Shock (ROR: 39.45, 95% CI: 30.49–51.04) had high signal values. Time-to-event onset analysis in the combination therapy group showed that the most common onset time for safety signals was 3–7 days (46.3%). The Scale Parameter α was the smallest in the combination medication group (6.37, 95% CI: 5.48–7.26). Further research is needed to determine whether the PI3K-Akt signaling pathway represents a potential mechanism underlying anaphylactic reactions induced by the combination medication. CONCLUSIONS: Early monitoring should be performed when propofol and midazolam are used in combination. At the same time, the occurrence of anaphylactic reactions should be taken seriously when combining medications. |
| Competing Interests: | Declarations. Ethics approval and consent to participate: was not considered necessary because this study used publicly available FAERS data. Consent for publication: Not Applicable. Competing interests: The authors declare no competing interests. |
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| Contributed Indexing: | Keywords: Anaphylactic shock; FAERS; Midazolam; Pharmacovigilance; Propofol |
| Substance Nomenclature: | R60L0SM5BC (Midazolam) YI7VU623SF (Propofol) 0 (Hypnotics and Sedatives) 0 (Anesthetics, Intravenous) 0 (Anesthetics, Combined) |
| Entry Date(s): | Date Created: 20260422 Date Completed: 20260628 Latest Revision: 20260813 |
| Update Code: | 20260813 |
| PubMed Central ID: | PMC13235193 |
| DOI: | 10.1186/s12871-026-03833-9 |
| PMID: | 42014971 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1471-2253 |
|---|---|
| DOI: | 10.1186/s12871-026-03833-9 |