β-内酰胺类药物所致过敏反应的风险比较：越南药物警戒数据库中的治疗分层分析

Risk comparison of beta-lactam-induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database.

作者信息

Nguyen Khac-Dung, Vu Dinh-Hoa, Nguyen Hoang-Anh, Dao Van-Tu, Montastruc Jean-Louis, Bagheri Haleh

机构信息

The National Centre of Drug Information and Adverse Drug Reaction Monitoring, Hanoi University of Pharmacy, Hanoi, Vietnam.

Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine de l'Université Paul-Sabatier (Medical and Clinical Pharmacology Laboratory, Faculty of Medicine Paul-Sabatier University) and Centre de PharmacoVigilance, de Pharmacoépidémiologie et d'Information sur le Médicament de Toulouse (Centre for Pharmacovigilance, Pharmacoepidemiology and Drug Information), UMR INSERM 1027, Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Toulouse, France.

出版信息

J Clin Pharm Ther. 2021 Aug;46(4):950-956. doi: 10.1111/jcpt.13376. Epub 2021 Feb 10.

DOI:10.1111/jcpt.13376

PMID:33565097

Abstract

WHAT IS KNOWN AND OBJECTIVE

There is limited data on the specific risks of anaphylaxis induced by beta-lactam drugs. The aim of this study was to compare the risks of reporting beta-lactam-induced anaphylaxis using the national pharmacovigilance database of Vietnam (NPDV).

METHODS

The multivariate generalised linear regression model was applied for signal generation and comparison of beta-lactams.

RESULTS

Between 2010 and 2016, there were 2,921 reports of anaphylaxis (19.93%) from 14,655 spontaneous reports of beta-lactam use in the NDPV. Anaphylaxis signal generation was also found for the subgroup J01D (cephalosporins and carbapenems) (ROR = 1.27 [1.16-1.39]) and beta-lactamase-sensitive penicillins (ROR = 1.74 [1.27-2.35]). In the third generation cephalosporin subgroup, different risks were identified for the following combinations of beta-lactams: 1) cefotaxime with cefoperazone+sulbactam; 2) cefixime/cefpodoxime/cefdinir with cefoperazone+sulbactam or ceftizoxime/cefoperazone/ceftazidime/ceftriaxone/cefotaxime. For the second generation cephalosporin subgroup, different risks were found for cefotiam compared to cefmetazole, cefaclor, cefamandole and cefuroxime.

WHAT IS NEW AND CONCLUSION

These findings identified and highlighted the different anaphylactic risks caused by various beta-lactams in the main subgroups.

摘要

已知信息与研究目的

关于β-内酰胺类药物引起过敏反应的具体风险的数据有限。本研究的目的是利用越南国家药物警戒数据库（NPDV）比较报告β-内酰胺类药物引起过敏反应的风险。

方法

采用多变量广义线性回归模型进行信号生成及β-内酰胺类药物的比较。

结果

2010年至2016年期间，在NPDV中14655份β-内酰胺类药物使用的自发报告中有2921份过敏反应报告（19.93%）。还发现J01D亚组（头孢菌素类和碳青霉烯类）（报告比值比[ROR]=1.27[1.16 - 1.39]）和β-内酰胺酶敏感青霉素类（ROR = 1.74[1.27 - 2.35]）有过敏反应信号生成。在第三代头孢菌素亚组中，对于以下β-内酰胺类药物组合确定了不同风险：1）头孢噻肟与头孢哌酮+舒巴坦；2）头孢克肟/头孢泊肟酯/头孢地尼与头孢哌酮+舒巴坦或头孢唑肟/头孢哌酮/头孢他啶/头孢曲松/头孢噻肟。对于第二代头孢菌素亚组，发现头孢替安与头孢美唑、头孢克洛、头孢孟多和头孢呋辛相比有不同风险。