Analysis for risk factors of adverse drug reactions related to iodinated contrast medium
10.3760/cma.j.issn.1008-5734.2015.01.006
- VernacularTitle:碘造影剂相关不良反应危险因素分析
- Author:
Ruya GAO
1
;
Liwei JI
;
Kongcai ZHU
;
Xin HU
;
Guoying CAO
Author Information
1. 100730 北京医院药学部;北京大学医学部药事管理与临床药学系
- Publication Type:Journal Article
- Keywords:
Contrast media;
Iodine;
Drug-related side effects and adverse reactions;
Risk factors
- From:
Adverse Drug Reactions Journal
2015;17(1):27-35
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze the risk factors of adverse drug reactions related to iodinated contrast medium.Methods All the hospitalized patients,who underwent coronary angiography (CAG) or percutaneous coronary intervention (PCI) from April 20th 2013 to July 20th 2013 in Beijing Hospital,were investigated using a questionnaire on usage of iodinated contrast medium designed by the research group.The investigation included patients' basic information,main discharge diagnosis,information on surgery,combined drugs,the results of laboratory tests before and after using iodinated contrast medium,and information on adverse drug reactions and adverse events.The questionnaire was filled in by the research group according to the patient's subjective feelings one day after surgery and on discharge and the medical records.Using the patient's sex,age,body mass index (BMI),CAG or PCI,usage of iodinated contrast medium,allergic history,history of drinking,coexisting diseases,kinds of iodinated contrast medium used this time,and combined drugs as independent variables,the whole iodinated contrast medium-related adverse reactions and adverse reactions of single system were studied by the single-factor analysis.The significant statistical variables were selected and the logistic regression analysis including odds ratio (OR) and 95％ confidence interval (CI) was performed.Results Totally 581 patients were enrolled into this study; 364 were men (62.7％) and 217 women (38.3％) with an average age of (65 ± 12) years (29-90).The patients' levels of BMI were 15.8-41.0 kg/m2 with an average level of (25.5 ± 3.4) kg/m2.Of them,338 patients (58.2％) underwent CAG and 243 patients (41.8％) underwent PCI.The number of patients receiving iohexol injection (Shuangbei),iohexol injection (Omnipaque),iodixanol injection (Visipaque),and iopromide injection (Ultravist) were 173 (29.8％),160 (27.5％),164 (28.2％),and 84 (14.5％),respectively.And the dosage of iodinated contrast medium was 23-500 ml with an average dose of (136 ± 77) ml.Of the 581 patients,69 patients (11.9％) developed iodinated contrast medium-related adverse reactions.The incidences of Shuangbei,Omnipaque,Visipaque,and Ultravist were respectively 12.7％ (22/173),7.5％ (12/160),18.3％ (30/164),and 6.0％ (5/84)and there were no statistically significant differences among the different kinds (P ＜ 0.05,P ＜ 0.01).The 69 patients experienced 88 adverse reactions in total including 60 mild reactions and 28 moderate reactions.These reactions involved skin and accessories (23 reactions,26.1％),central and peripheral nervous system (17 reactions,19.4％),gastro-intestinal system (14 reactions,15.9％),autonomic nervous system (12 reactions,13.6％),urinary system (12 reactions,13.6％),systemic disorders (8 reactions,9.1％),and musculoskeletal system (2 reactions,2.3％).The logistic regression analysis showed that the risk factors of skin and accessories disorders were duration of hospital stay (OR =1.083,95％ CI:1.024-1.146,P =0.005),history of liver disease (OR =4.483,95％ CI:1.815-11.072,P =0.001),and allergic history (OR =5.686,95％ CI:2.136-15.135,P =0.001) ; the risk factors of gastro-intestinal system disorders were history of liver disease (OR =3.879,95％ CI:1.110-13.552,P =0.034) and insulin use (OR =3.764,95％ CI:1.087-12.027,P =0.036) ; the risk factors of central and peripheral nervous system disorders was allergic history (OR =6.778,95％ CI:1.187-38.685,P =0.031) ; the risk factors of urinary system disorders was anti-infective drug use (OR =6.918,95％ CI:1.425-33.589,P =0.016) ; the risk factors of musculoskeletal system disorders was BMI (OR =0.608,95％ CI:0.376-0.984,P =0.043); the risk factors of the systemic reactions were history of liver disease (OR =2.925,95％ CI:1.412-6.061,P =0.004),having PCI (OR =2.546,95 ％ CI:1.071-6.054,P =0.034),underweight (OR =10.743,95％ CI:2.040-56.572,P =0.005),and allergic history (OR =2.925,95％ CI:1.191-7.183,P =0.019).Conclusions The main risk factors of adverse drug reactions related to iodinated contrast medium to different system were different.The main systemic risk factors of the iodinated contrast medium-related adverse reactions were history of liver disease,underweight,and allergic history.
