108139
论文已发表
注册即可获取德孚的最新动态
IF 收录期刊
- 3.4 Breast Cancer (Dove Med Press)
- 3.2 Clin Epidemiol
- 2.6 Cancer Manag Res
- 2.9 Infect Drug Resist
- 3.7 Clin Interv Aging
- 5.1 Drug Des Dev Ther
- 3.1 Int J Chronic Obstr
- 6.6 Int J Nanomed
- 2.6 Int J Women's Health
- 2.9 Neuropsych Dis Treat
- 2.8 OncoTargets Ther
- 2.0 Patient Prefer Adher
- 2.2 Ther Clin Risk Manag
- 2.5 J Pain Res
- 3.0 Diabet Metab Synd Ob
- 3.2 Psychol Res Behav Ma
- 3.4 Nat Sci Sleep
- 1.8 Pharmgenomics Pers Med
- 2.0 Risk Manag Healthc Policy
- 4.1 J Inflamm Res
- 2.0 Int J Gen Med
- 3.4 J Hepatocell Carcinoma
- 3.0 J Asthma Allergy
- 2.2 Clin Cosmet Investig Dermatol
- 2.4 J Multidiscip Healthc
已发表论文
重新审视地氟醚的安全性：一项从 FAERS 数据中检测潜在安全信号的药物警戒研究
Received 31 May 2025
Accepted for publication 29 August 2025
Published 26 September 2025 Volume 2025:18 Pages 5069—5080
DOI https://doi.org/10.2147/JPR.S544011
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Robert B. Raffa
Wei Wei,1,* Liang Chen,2,* Xiaomei Ying3
1Department of Anesthesiology and Pain Research Center, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, People’s Republic of China; 2Department of Hepatobiliary and Pancreatic Surgery, Conversion Therapy Center for Hepatobiliary and Pancreatic Tumors, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, People’s Republic of China; 3Thyroid and Breast Department, Suzhou Hospital of Anhui Medical University, Suzhou, Anhui, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Xiaomei Ying, Thyroid and Breast Department, Suzhou Hospital of Anhui Medical University, Suzhou, Anhui, People’s Republic of China, Email m18156236886@163.com
Purpose: Desflurane is a widely used volatile anesthetic with multiple clinical advantages, but comprehensive pharmacovigilance analyses are needed to optimize its safety profile. This study aimed to analyze and classify adverse events(AEs) associated with desflurane in the Food and Drug Administration Adverse Event Reporting System(FAERS) database and evaluate potential safety signals.
Patients and Methods: We analyzed FAERS reports from 2004Q1 to 2025Q1 where desflurane was the primary suspect(PS) drug. Cases were classified using Medical Dictionary for Regulatory Activities (MedDRA27.1) terminology and processed following FDA-recommended deduplication strategy. Four disproportionality analyses were conducted: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
Results: Among 1,191 cases, bradycardia was most frequent (n = 39; ROR = 38.72, 95% CI 28.14– 53.28) with 79.4% classified as serious. Notable findings included anaphylactic shock (n = 23; 69.6% serious), bronchospasm (n = 22), and malignant hyperthermia(MH) (n = 20; 25% mortality). Acute respiratory distress syndrome (ARDS) (n = 2) and disseminated intravascular coagulation (DIC) (n = 2) were documented - a previously unreported association with desflurane exposure.
Conclusion: Our analysis reveals clinically significant safety signals associated with desflurane, including cardiovascular, anaphylactic, and respiratory complications that may require enhanced perioperative monitoring. The study underscores the critical importance of sustained post-marketing surveillance for detecting rare but serious safety signals, not typically evident in pre-approval clinical trials.
Keywords: desflurane, nociception, pharmacovigilance, FAERS, anaphylactic shock, DIC
1Department of Anesthesiology and Pain Research Center, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, People’s Republic of China; 2Department of Hepatobiliary and Pancreatic Surgery, Conversion Therapy Center for Hepatobiliary and Pancreatic Tumors, The Affiliated Hospital of Jiaxing University, Jiaxing, Zhejiang, People’s Republic of China; 3Thyroid and Breast Department, Suzhou Hospital of Anhui Medical University, Suzhou, Anhui, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Xiaomei Ying, Thyroid and Breast Department, Suzhou Hospital of Anhui Medical University, Suzhou, Anhui, People’s Republic of China, Email m18156236886@163.com
Purpose: Desflurane is a widely used volatile anesthetic with multiple clinical advantages, but comprehensive pharmacovigilance analyses are needed to optimize its safety profile. This study aimed to analyze and classify adverse events(AEs) associated with desflurane in the Food and Drug Administration Adverse Event Reporting System(FAERS) database and evaluate potential safety signals.
Patients and Methods: We analyzed FAERS reports from 2004Q1 to 2025Q1 where desflurane was the primary suspect(PS) drug. Cases were classified using Medical Dictionary for Regulatory Activities (MedDRA27.1) terminology and processed following FDA-recommended deduplication strategy. Four disproportionality analyses were conducted: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).
Results: Among 1,191 cases, bradycardia was most frequent (n = 39; ROR = 38.72, 95% CI 28.14– 53.28) with 79.4% classified as serious. Notable findings included anaphylactic shock (n = 23; 69.6% serious), bronchospasm (n = 22), and malignant hyperthermia(MH) (n = 20; 25% mortality). Acute respiratory distress syndrome (ARDS) (n = 2) and disseminated intravascular coagulation (DIC) (n = 2) were documented - a previously unreported association with desflurane exposure.
Conclusion: Our analysis reveals clinically significant safety signals associated with desflurane, including cardiovascular, anaphylactic, and respiratory complications that may require enhanced perioperative monitoring. The study underscores the critical importance of sustained post-marketing surveillance for detecting rare but serious safety signals, not typically evident in pre-approval clinical trials.
Keywords: desflurane, nociception, pharmacovigilance, FAERS, anaphylactic shock, DIC