CAJ | 학술논문

目的：探讨对比剂碘克沙醇在常规临床应用中的迟发药物不良反应及危险因素。 　　方法：在全国95个医学中心连续入组20185例使用碘克沙醇的患者，记录危险因素（如高血压、哮喘、既往对比剂反应史等）、对比剂资料（如给药剂量、碘浓度等）、给药过程资料（给药途径、注射方式、注射流速、给药前碘克沙醇是否加热等）及人口学资料。使用碘克沙醇后，观察记录1小时内的急性不良反应及1小时后至7天内的延迟不良反应。使用单因素分析及Logistic回归分析迟发不良反应的危险因素。 　　结果：碘克沙醇总体不良反应发生率为1.52%，其中急性不良反应发生率0.58%，延迟不良反应发生率0.97%。迟发不良反应以轻度为主，以皮肤系统反应最常见，发生率0.68%，包括皮疹、荨麻疹和瘙痒等。多因素Logistic回归分析显示，男性（OR=0.71，P=0.036）、年龄（OR=0.82，P=0.001)、动脉给药途径（OR=0.21，P<0.001）、使用前加热（OR=1.44， P=0.036）、注射流速（OR=1.28，P=0.001）、既往对比剂反应史（OR=16.04，P<0.001）是迟发不良反应的独立危险因素。 　　结论：中国人群使用碘克沙醇迟发不良反应发生率较低。男性、年龄、动脉给药途径、使用前加热、注射流速、既往对比剂反应史是碘克沙醇迟发不良反应的独立危险因素。
목적：탐토대비제전극사순재상규림상응용중적지발약물불량반응급위험인소。 　　방법：재전국95개의학중심련속입조20185례사용전극사순적환자，기록위험인소（여고혈압、효천、기왕대비제반응사등）、대비제자료（여급약제량、전농도등）、급약과정자료（급약도경、주사방식、주사류속、급약전전극사순시부가열등）급인구학자료。사용전극사순후，관찰기록1소시내적급성불량반응급1소시후지7천내적연지불량반응。사용단인소분석급Logistic회귀분석지발불량반응적위험인소。 　　결과：전극사순총체불량반응발생솔위1.52%，기중급성불량반응발생솔0.58%，연지불량반응발생솔0.97%。지발불량반응이경도위주，이피부계통반응최상견，발생솔0.68%，포괄피진、담마진화소양등。다인소Logistic회귀분석현시，남성（OR=0.71，P=0.036）、년령（OR=0.82，P=0.001)、동맥급약도경（OR=0.21，P<0.001）、사용전가열（OR=1.44， P=0.036）、주사류속（OR=1.28，P=0.001）、기왕대비제반응사（OR=16.04，P<0.001）시지발불량반응적독립위험인소。 　　결론：중국인군사용전극사순지발불량반응발생솔교저。남성、년령、동맥급약도경、사용전가열、주사류속、기왕대비제반응사시전극사순지발불량반응적독립위험인소。
Objective: To investigate the incidence of coutrast media iodixanol-induced delayed adverse reaction with the risk factors in general clinical practice. Methods: A total of 20,185 patients with contrast iodixanol were recruited from 95 medical centers in China. The risk factors for adverse drug reaction as hypertension, asthma, previous contrast reaction were assessed;the administrative processes as route, injection manner, lfow rate of injection, prior heating of iodixanol were monitored and the demographic information was documented. The immediate adverse reaction within 1 hour of media administration and the delayed adverse reaction from 1 hour to 7 days after administration were recorded. The risk factors for iodixanol-induced delayed adverse reaction were studied by singlevariate and multivariate logistic regression analysis. Results: The overall iodixanol-induced adverse reaction rate was 1.52%, of which the immediate reaction was 0.58%and delayed reaction was 0.97%. The major delayed reaction was mild and it mostly happened in skin (0.68%) including rash, pruritus and urticaria. Multivariate logistic regression analysis revealed that male gender (OR=0.71, P=0.036), age (OR=0.82, P=0.001), route of administration (OR=0.21, P<0.001), prior heating of iodixanol (OR=1.44, P=0.036), lfow rate of injection (OR=1.28, P=0.001) and previous contrast reaction (OR=16.04, P<0.001) were the independent risk factors for delayed adverse reactions.