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400042 重庆,陆军特色医学中心放射科
[ 李雪,E-mail: lixue928136@163.com LI Xue, E-mail: lixue928136@163.com
收稿:2022-08-09,
修回:2022-09-20,
纸质出版:2023-02-15
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邱海燕, 王羚入, 李建洁, 等. 332 683例CT增强检查患者非离子碘对比剂急性不良反应情况及其影响因素分析[J]. 陆军军医大学学报, 2023,45(3):257-264.
Haiyan QIU, Lingru WANG, Jianjie LI, et al. Acute adverse reactions and influencing factors of non-ionic iodine contrast in 332 683 patients undergoing contrast-enhanced CT scanning[J]. Journal of Army Medical University, 2023, 45(3): 257-264.
邱海燕, 王羚入, 李建洁, 等. 332 683例CT增强检查患者非离子碘对比剂急性不良反应情况及其影响因素分析[J]. 陆军军医大学学报, 2023,45(3):257-264. DOI: 10.16016/j.2097-0927.202208068.
Haiyan QIU, Lingru WANG, Jianjie LI, et al. Acute adverse reactions and influencing factors of non-ionic iodine contrast in 332 683 patients undergoing contrast-enhanced CT scanning[J]. Journal of Army Medical University, 2023, 45(3): 257-264. DOI: 10.16016/j.2097-0927.202208068.
目的
2
分析真实世界中非离子碘对比剂(iodinated contrast medium,ICM)急性不良反应(acute adverse reactions,AARs)的发生情况及影响因素。
方法
2
采用回顾性病例对照研究,纳入2014-2020年在陆军特色医学中心使用ICM行CT增强检查的332 683例患者,其中男性184 498例,女性148 185例,年龄0~101(57.91±14.36)岁,根据是否发生AARs分为病例组和对照组。采用单因素和多因素Logistic回归分析筛出发生ICM-AARs的影响因素。
结果
2
病例组931例(发生ICM-AARs者),对照组331 752例(未发生ICM-AARs者)。ICM-AARs总发生率为0.28%,其中轻度、中度、重度AARs分别占93.88%、4.83%、1.29%。回归分析结果显示,既往有ICM不良反应发生史(
OR
=22.881
95%
CI
: 16.235~32.246)、其他过敏史(
OR
=4.406
95%
CI
: 2.338~8.303)、患有哮喘(
OR
=5.614
95%
CI
: 2.596~12.138)与ICM-AARs的关联强度较强(
P
<
0.05),性别、来源、药物过敏史、ICM类型和注射速度5个危险因素和高龄、ICM使用史、高血压病史3个保护因素(
OR
=0.396~1.674)与ICM-AARs的关联强度较弱(
P
<
0.05)。
结论
2
ICM-AARs发生率为0.28%,以轻度不良反应为主。既往有ICM不良反应发生史、其他过敏史、哮喘是ICM-AARs发生的主要影响因素。
Objective
2
To analyze the incidence and influencing factors of acute adverse reactions (AARs) of non-ionic iodine contrast medium (ICM) in the real world.
Methods
2
A retrospective case-control study was carried out on 332 683 patients receiving ICM-enhanced CT examination at our medical center from 2014 to 2020. They were 184 498 males and 148 185 females
at an age from 0 to 101 (57.91±14.36) years. According to experiencing AARs or not
the patients were divided into case group (ICM-AARs
n
=931) and control group (no ICM-AARs
n
=331 752). Single factor and multi factor logistic regression analyses were used to screen out the influencing factors of ICM-AARs.
Results
2
In the cohort
the incidence of ICM-AARs was 0.28% (931/332 683)
with mild
moderate and severe AARs accounted for 93.88%
4.83% and 1.29%
respectively. The results of regression analysis showed that history of ICM adverse reactions (
OR
=22.881
95%
CI
: 16.235~32.246)
history of other allergies (
OR
=4.406
95%
CI
: 2.338~8.303) and asthma (
OR
=5.614
95%
CI
: 2.596~12.138) were closely associated with the occurrence of ICM-AARs (
P
<
0.05). Gender
source
history of drug allergy
ICM type and injection speed were risk factors
while older age
history of ICM use and hypertension history were protective factors (
OR
=0.396~1.674
P
<
0.05)
but the strengths of above associations with the ICM-AARs were relatively weak (
P
<
0.05).
Conclusion
2
The incidence of ICM-AARs is 0.28%
mainly mild adverse reactions. Previous history of ICM adverse reactions
other allergies
and asthma are the main factors affecting the occurrence of ICM-AARs.
BÖHM I, MORELLI J, NAIRZ K, et al . Myths and misconceptions concerning contrast media-induced anaphylaxis: a narrative review[J ] . Postgrad Med, 2017, 129(2): 259-266. DOI: 10.1080/00325481.2017.1282296.
PARK H K, KANG M G, YANG M S, et al . Epidemiology of drug-induced anaphylaxis in a tertiary hospital in Korea[J ] . Allergol Int, 2017, 66(4): 557-562. DOI: 10.1016/j.alit.2017.02.008.
BAE K, LEE S M, HA J Y, et al . Adverse drug reactions to CT contrast media in south Korea: incidence and risk factors[J ] . J Korean Soc Radiol, 2016, 75(1): 41. DOI: 10.3348/jksr.2016.75.1.41.
LI X, CHEN J, ZHANG L, et al . Clinical observation of the adverse drug reactions caused by non-ionic iodinated contrast media: results from 109, 255 cases who underwent enhanced CT examination in Chongqing, China[J ] . Br J Radiol, 2015, 88(1047): 20140491. DOI: 10.1259/bjr.20140491.
SODAGARI F, MOZAFFARY A, WOOD C G 3rd, et al . Reactions to both nonionic iodinated and gadolinium-based contrast media: incidence and clinical characteristics[J ] . AJR Am J Roentgenol, 2018, 210(4): 715-719. DOI: 10.2214/AJR.17.18655.
WYSOWSKI D K, NOURJAH P. Deaths attributed to X-ray contrast media on US death certificates[J]. AJR Am J Roentgenol, 2006, 186(3): 613-615. DOI: 10.2214/AJR.04.1790.
KAITO D, HOMMA K, SASAKI J. Rapid collapse of the inferior vena cava in a patient with cardiac arrest induced by anaphylactic shock after iodinated contrast medium injection[J]. J Am Coll Emerg Physicians Open, 2020, 1(4): 379-382. DOI: 10.1002/emp2.12166.
常春兰, 彭繁. 证据: 从随机对照试验回归真实世界: 从新冠疫情中最佳证据缺失谈起[J]. 山东社会科学, 2022(6): 101-107. DOI: 10.14112/j.cnki.37-1053/c.2022.06.023.
CHANG C L, PENG F. The evidence: From randomized controlled trials to the real world: The best evidence is missing from the COVID-19 pandemic[J]. Shandong Soc Sci, 2022(6): 101-107. DOI: 10.14112/j.cnki.37-1053/c.2022.06.023.
[European Society of Urogenital Radiology. ESUR guidelines on contrast agents[E B/OL ] . [2022-08-30 ] . http://www.esur.org/fileadmin/content/2019/ESUR_Guidelines_10.0_Final_Version.pdf http://www.esur.org/fileadmin/content/2019/ESUR_Guidelines_10.0_Final_Version.pdf .
[ACR Committee on Drugs and Contrast Media (2017). ACR manual on contrast media, v10.3. American College of Radiology[EB/OL ] . [2022-09-20 ] . https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf , 2017.
中华医学会放射学分会放射护理专业委员会放射诊断护理学组. 影像科碘对比剂输注安全专家共识[J]. 介入放射学杂志, 2018, 27(8): 707-712. DOI: 10.3969/j.issn.1008-794X.2018.08.001.
Radiological Diagnostic Nursing Group, Professional Committee on Radiological Nursing Care, Radiology Branch of Chinese Medical Association. Expert consensus on the safety of iodine contrast agent infusion in imaging department[J]. J Interv Radiol, 2018, 27(8): 707-712. DOI: 10.3969/j.issn.1008-794X.2018.08.001.
张辉. 碘对比剂急性不良反应危险因素分析及与IgE, 嗜酸性粒细胞, 血糖等相关性研究[D]. 郑州: 郑州大学, 2021.
ZHANG H. Analysis of risk factors of acute adverse reaction to iodinated contrast media and investigating the correlation with IgE, eosinophils andblood glucose[D]. Zhengzhou: Zhengzhou University, 2021.
PALKOWITSCH P K, BOSTELMANN S, LENGSFELD P. Safety and tolerability of iopromide intravascular use: a pooled analysis of three non-interventional studies in 132, 012 patients[J]. Acta Radiol, 2014, 55(6): 707-714. DOI: 10.1177/0284185113504753.
NARITA S, GOLDBLUM R M, WATSON C S, et al . Environmental estrogens induce mast cell degranulation and enhance IgE-mediated release of allergic mediators[J ] . Environ Health Perspect, 2007, 115(1): 48-52. DOI: 10.1289/ehp.9378.
甘淼, 刘畅, 赵丽, 等. CT对比剂急性不良反应的相关因素分析[J]. 中国医科大学学报, 2020, 49(5): 458-462. DOI: 10.12007/j.issn.0258-4646.2020.05.016.
GAN M, LIU C, ZHAO L, et al . Analysis of related factors of acute adverse reaction caused by contrast agents used in computed tomography[J ] . J China Med Univ, 2020, 49(5): 458-462. DOI: 10.12007/j.issn.0258-4646.2020.05.016.
朱春燕, 郭晴, 田庆丰, 等. 河南省老年人综合能力失能现况及影响因素研究[J]. 中国全科医学, 2021, 24(12): 1500-1505. DOI: 10.12114/j.issn.1007-9572.2021.00.169.
ZHU C Y, GUO Q, TIAN Q F, et al . Prevalence and influencing factors of comprehensive disability in the elderly in Henan Province[J ] . Chin Gen Pract, 2021, 24(12): 1500-1505. DOI: 10.12114/j.issn.1007-9572.2021.00.169.
WOO S D, YOON J, DOO G E, et al . Common causes and characteristics of adverse drug reactions in older adults: a retrospective study[J ] . BMC Pharmacol Toxicol, 2020, 21(1): 87. DOI: 10.1186/s40360-020-00464-9.
MORTELÉ K J, OLIVA M R, ONDATEGUI S, et al . Universal use of nonionic iodinated contrast medium for CT: evaluation of safety in a large urban teaching hospital[J ] . AJR Am J Roentgenol, 2005, 184(1): 31-34. DOI: 10.2214/ajr.184.1.01840031.
CHA M J, KANG D Y, LEE W, et al . Hypersensitivity reactions toiodinated contrast media: a multicenter study of 196 081 patients[J ] . Radiology, 2019, 293(1): 117-124. DOI: 10.1148/radiol.2019190485.
ZHAI L Q, GUO X J, ZHANG H Y, et al . Non-ionic iodinated contrast media related immediate reactions: a mechanism study of 27 patients[J ] . Leg Med (Tokyo), 2017, 24: 56-62. DOI: 10.1016/j.legalmed.2016.11.006.
BOEHM I. Contrast medium and patients at risk: asthma[J]. Acta Radiol, 2009, 50(3): 348. DOI: 10.1080/02841850902729885.
BÖHM I, SPECK U, SCHILD H. Cell-dependent influence on the phagocytosis induced by non-ionic contrast medium injection[J]. Br J Radiol, 2008, 81(963): 199-203. DOI: 10.1259/bjr/13906058.
BERGSTRA A, VAN DIJK R B, BREKKE O, et al . Hemodynamic effects of iodixanol and iohexol during ventriculography in patients with compromised left ventricular function[J ] . Catheter Cardiovasc Interv, 2000, 50(3): 314-321. DOI: 10.1002/1522-726x(200007)50:3314:aid-ccd9 > 3.0.co;2-d.
樊明, 潘静. CT增强扫描注射碘对比剂后血流动力学指标的动态变化[J]. 临床放射学杂志, 2018, 37(12): 2096-2099. DOI: 10.13437/j.cnki.jcr.2018.12.041.
FAN M, PAN J. Dynamic changes of hemodynamic indexes in patients injecting iodine contrast media for CT examination[J]. J Clin Radiol, 2018, 37(12): 2096-2099. DOI: 10.13437/j.cnki.jcr.2018.12.041.
WIDMANN G, BALE R, ULMER H, et al . Systemic hypotension following intravenous administration of nonionic contrast medium during computed tomography: iopromide versus iodixanol[J ] . Anesth Analg, 2018, 126(3): 769-775. DOI: 10.1213/ANE.0000000000002346.
MORCOS S K, DAWSON P, PEARSON J D, et al . The haemodynamic effects of iodinated water soluble radiographic contrast media: a review[J ] . Eur J Radiol, 1998, 29(1): 31-46 . DOI: 10.1016/s0720-048x(98)00018-7.
[国家药品监督管理局药品审评中心. 国家药监局药审中心关于发布《用于产生真实世界证据的真实世界数据指导原则(试行)》的通告(2021年第27号)[EB/OL ] . (2021-04-13)[2021-07-20 ] . https://www.cde.org.cn/main/news/viewInfoCommon/2a1c437ed54e7b838a7e86f4ac21c539 https://www.cde.org.cn/main/news/viewInfoCommon/2a1c437ed54e7b838a7e86f4ac21c539 .
[Center for Drug Evaluation of National Medical Products Administration. Administration on the Release of "Guidelines for Real-World Data Used to Generate Real-World Evidence (Trial)" (No. 27, 2021)[EB/OL ] . (2021-04-13)[2021-07-20 ] . https://www.cde.org.cn/main/news/viewInfoCommon/2a1c437ed54e7b838a7e86f4ac21c539 https://www.cde.org.cn/main/news/viewInfoCommon/2a1c437ed54e7b838a7e86f4ac21c539 .
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