Analysis of adverse drug reactions induced by tacrolimus combined with mycophenolic acid
10.13699/j.cnki.1001-6821.2024.19.027
- VernacularTitle:他克莫司与霉酚酸联用的药物不良反应分析
- Author:
Hong-Sheng CHEN
1
;
Shuang LIU
;
Rong-Sheng ZHAO
Author Information
1. 北京大学第三医院药学部,北京 100191;北京大学医学部药物评价中心,北京 100191;北京大学药学院药事管理与临床药学系,北京 100191
- Keywords:
tacrolimus;
mycophenolic acid;
adverse drug reaction;
signal mining
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(19):2896-2900
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine and analyze the adverse drug reaction(ADR)signals caused by tacrolimus(Tac)combined with mycophenolic acid(MPA)based on Food and Drug Administration(FDA)adverse event reporting system(FAERS)database,so as to provide reference for clinical drug combination.Methods Open Vigil 2.1 platform was used to collect adverse events reports related to Tac and MPA between the first quarter of 2004 and the first quarter of 2023.Disproportionality analysis methods were used to mine the ADR risk signals.Characteristics of the population reporting adverse events were analyzed.ADR that arose from the combination of the two drugs were compared with those specified in the instructions of the two drugs in order to screen out new ADR.Results A total of 32 866 ADR reports of Tac and MPA used in combination were retrieved,in which 17 455 cases(53.11％)were males,11 445 cases(34.82％)were females.Cases were major in age from 40 to 65 years old(13 174 cases,40.08％).ADR with high frequency mainly included pyrexia,infections and renal impairment;ADR with strong signal strength mainly included infections and skin toxicity;new ADR mainly included blood parathyroid hormone increased,heart valve incompetence and acute psychosis.Conclusion When using Tac and MPA in combination,attention and care should be paid to the high frequency,strong signal strength and new signal of ADR.
