Chen Qin-Lan, Zhao Xiao-Ying, Wang Xiao-Mi, Lv Na, Zhu Ling-Ling, Xu Hui-Min, Zhou Quan
Radiology Nursing Unit, Division of Nursing.
Department of Quality Management.
Ther Clin Risk Manag. 2017 Apr 26;13:565-573. doi: 10.2147/TCRM.S134265. eCollection 2017.
The authors retrospectively analyzed the pattern and characteristics of non-laboratory-based adverse drug reactions (ADRs) induced by intravenous radiocontrast agents in a large-scale hospital in China during 2014-2015. There were 314 ADR cases among 118,208 patients receiving enhanced CT or MRI examinations. The frequency of moderate/severe ADRs defined by Chinese Society of Radiology (ie, severe vomiting, systematic urticaria, facial swelling, dyspnea, vasovagal reaction, laryngeal edema, seizure, trembling, convulsions, unconsciousness, shock, death, and other unexpected adverse reactions) was rare (0.0431%), whereas the mild ADRs were uncommon (0.2225%) and accounted for 83.76% of ADRs. Frequency of ADRs induced by iodinated contrast agents was related with examination site, sex, and type of patient settings (<0.01) and was higher compared with gadolinium contrast agents (0.3676% vs 0.0504%, <0.01). From 2014 to 2015, frequencies of total and moderate/severe ADRs induced by iodinated contrast agents decreased significantly (0.4410% vs 0.2947%, <0.01; 0.0960% vs 0.0282%, <0.01, respectively). Frequency of ADRs differed among different iodinated contrast and gadolinium contrast (<0.05) agents. Iopromide's ADR frequency in 2014 was significantly higher compared with iopamidol, ioversol, or iohexol (<0.01). Frequency of moderate/severe ADRs induced by iodixanol was 4.1-5.4 times that of iohexol, iopromide, or iopamidol. Rash was the predominant ADR subtype (84.39%) and occurred more frequently with iodixanol compared with iohexol, iopamidol, or ioversol (<0.01). Overall, 21.97% of ADR cases had allergy history or atopy traits, and these cases experienced ADRs earlier than the negative ones (17.19 min vs 85.34 min, <0.01). The mean time to onset of ADRs was increased in patients receiving iodixanol compared with other iodinated contrast agents (323.77 min vs 42.36 min, <0.01). Overall, 37.26% of ADRs occurred within 5 min and 84.08% of ADRs occurred within 30 min. Efficient quality improvement in decreasing ADRs induced by radiocontrast agents has been achieved by multidisciplinary collaboration.
作者回顾性分析了2014 - 2015年期间中国一家大型医院中静脉注射造影剂引起的非实验室检测的药物不良反应（ADR）的模式和特征。在118208例接受增强CT或MRI检查的患者中，有314例ADR病例。中华放射学会定义的中度/重度ADR（即严重呕吐、全身性荨麻疹、面部肿胀、呼吸困难、血管迷走神经反应、喉头水肿、癫痫发作、颤抖、惊厥、昏迷、休克、死亡及其他意外不良反应）的发生率较低（0.0431%），而轻度ADR并不常见（0.2225%），占ADR的83.76%。碘化造影剂引起的ADR发生率与检查部位、性别及患者类型有关（<0.01），且高于钆造影剂（0.3676%对0.0504%，<0.01）。2014年至2015年，碘化造影剂引起的总ADR及中度/重度ADR发生率显著下降（分别为0.4410%对0.2947%，<0.01；0.0960%对0.0282%，<0.01）。不同碘化造影剂和钆造影剂引起的ADR发生率不同（<0.05）。2014年碘普罗胺的ADR发生率显著高于碘帕醇、碘海醇或碘克沙醇（<0.01）。碘克沙醇引起的中度/重度ADR发生率是碘海醇、碘普罗胺或碘帕醇的4.1 - 5.4倍。皮疹是主要的ADR亚型（84.39%），与碘海醇、碘帕醇或碘海醇相比（<0.01），碘克沙醇引起皮疹的频率更高。总体而言，21.97%的ADR病例有过敏史或特应性特征，这些病例发生ADR的时间早于无相关特征者（17.19分钟对85.34分钟，<0.01）。与其他碘化造影剂相比，接受碘克沙醇的患者发生ADR的平均起病时间增加（323.77分钟对42.36分钟，<0.01）。总体而言，37.26%的ADR在5分钟内发生，84.08%的ADR在30分钟内发生。通过多学科协作，在降低造影剂引起的ADR方面已实现了有效的质量改进。
