European journal of pharmacology · 2025
The risk of propofol infusion syndrome on epilepsy patients:Insights from FAERS data and published case reports.
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Zhang Yongyi, Qian Mengying, Zheng Aili, Chen Yan, Li Bing, Tang Jinbao, Guo Jinmin
Аннотация
OBJECTIVE: PRIS has been documented in epilepsy patients treated with propofol. But the clinical features associated with the occurrence of PRIS in patients with epilepsy remain incompletely elucidated. This study aimed to investigate the relationship between epilepsy, antiepileptic drugs, and PRIS and draw conclusions about its clinical features.
METHODS: Extracted PRIS reports documented in the FAERS (January 2013 to December 2023). Epilepsy patients and non-epilepsy patients were distinguished based on the indication information. We performed multivariate analyses for demography, epilepsy status, and the use of antiepileptic drugs between these two populations. Additionally, we collected all published reports on propofol usage that resulted in PRIS. We focused on the differences in clinical manifestations of PRIS between epilepsy patients and non-epilepsy patients and analyzed them retrospectively.
RESULTS: For 349 PRIS cases in the FAERS database, 94 cases involved epilepsy. Epilepsy was a significant risk factor for PRIS development (ROR = 3.89) and death outcomes (ROR = 1.997). Further analysis of antiepileptic drug regimens revealed that valproic acid was associated with an increased risk of PRIS (ROR = 3.264) and adverse outcomes (ROR = 2.518). For 185 PRIS cases in this review, 49 demonstrated a history of epilepsy. Patients with epilepsy displayed a lower median infusion rate of propofol than those without but a higher median cumulative dose.
CONCLUSION: When using propofol, epilepsy patients are at high risk of PRIS and are vulnerable to death. Therefore, patients with epilepsy must be closely monitored for safety during treatment, especially when they using valproic acid.
METHODS: Extracted PRIS reports documented in the FAERS (January 2013 to December 2023). Epilepsy patients and non-epilepsy patients were distinguished based on the indication information. We performed multivariate analyses for demography, epilepsy status, and the use of antiepileptic drugs between these two populations. Additionally, we collected all published reports on propofol usage that resulted in PRIS. We focused on the differences in clinical manifestations of PRIS between epilepsy patients and non-epilepsy patients and analyzed them retrospectively.
RESULTS: For 349 PRIS cases in the FAERS database, 94 cases involved epilepsy. Epilepsy was a significant risk factor for PRIS development (ROR = 3.89) and death outcomes (ROR = 1.997). Further analysis of antiepileptic drug regimens revealed that valproic acid was associated with an increased risk of PRIS (ROR = 3.264) and adverse outcomes (ROR = 2.518). For 185 PRIS cases in this review, 49 demonstrated a history of epilepsy. Patients with epilepsy displayed a lower median infusion rate of propofol than those without but a higher median cumulative dose.
CONCLUSION: When using propofol, epilepsy patients are at high risk of PRIS and are vulnerable to death. Therefore, patients with epilepsy must be closely monitored for safety during treatment, especially when they using valproic acid.