目的:确定更换钆基造影剂(GBCAs)对减少GBCA相关急性药物不良反应(ADRs)复发的预防作用。
方法:本回顾性研究,观察,2016年1月至2021年12月进行的单中心研究包括238743项连续GBCA增强MRI检查.我们专注于在任何这些检查中经历急性GBCA相关ADR的患者亚组,随后进行了随访GBCA增强MRI检查,直到2023年7月。与最初引起急性ADR的GBCA相比,随访检查涉及相同(无变化组)或不同(变化组)的GBCA。基线参与者特征,GBCA的通用配置文件,给药,碘化造影剂的既往不良反应史,并对GBCA相关急性ADRs的症状进行回顾性分析。使用具有广义估计方程和倾向得分匹配的多变量逻辑回归。
结果:共报告了1042例急性不良反应(0.44%;95%置信区间[CI]:0.41%-0.46%)。在研究期间内经历GBCA相关的急性ADR后,共有三百七十三例患者接受了GBCA增强MRI检查;在任何随访检查中,31.9%(119/373)再次经历了急性ADR。根据多变量逻辑回归(调整后比值比[OR]:0.35;95%CI:0.13-0.90;P=0.03)和倾向评分匹配分析(14.3%[6/42]vs.36.9%[31/84],分别为;OR:0.32,95%CI:0.11-0.94;P=0.04)。碘化造影剂的ADR病史(OR:1.14,95%CI:0.68-1.90;P=0.62)和术前用药(校正OR:2.09,95%CI:0.93-4.68;P=0.07)与GBCA相关的急性ADR复发没有显着相关。对复发性变态反应样超敏反应的单独分析显示了相似的结果(校正OR:0.20,95%CI:0.06-0.65;P<0.01)。
结论:改变GBCA可降低GBCA相关急性ADR复发的风险。
OBJECTIVE: To determine the preventive effect of changing
gadolinium-based contrast agents (GBCAs) to reduce the recurrence of GBCA-associated acute adverse drug reactions (ADRs).
METHODS: This retrospective, observational, single-center study-conducted between January 2016 and December 2021-included 238743 consecutive GBCA-enhanced MRI examinations. We focused on a subgroup of patients who experienced acute GBCA-associated ADRs during any of these examinations and subsequently underwent follow-up GBCA-enhanced MRI examinations up until July 2023. The follow-up examinations involved either the same (non-change group) or different (change group) GBCAs compared to the ones that initially caused the acute ADR. Baseline participant characteristics, generic profile of the GBCAs, administration of premedication, history of prior ADR to iodinated contrast media, and symptoms of GBCA-associated acute ADRs were retrospectively analyzed. Multivariable logistic regression with generalized estimating equations and propensity score matching were used.
RESULTS: A total of 1042 instances of acute ADRs (0.44%; 95% confidence interval [CI]: 0.41%-0.46%) were reported. Three-hundred and seventy-three patients underwent GBCA-enhanced MRI examinations after experiencing GBCA-associated acute ADRs within the study period; 31.9% (119/373) reexperienced acute ADRs at any of the follow-up examinations. The ADR recurrence was significantly lower in the GBCA change group than in the non-change group according to multivariable logistic regression (adjusted odds ratio [OR]: 0.35; 95% CI: 0.13-0.90; P = 0.03) and analysis with propensity score matching (14.3% [6/42] vs. 36.9% [31/84], respectively; OR: 0.32, 95% CI: 0.11-0.94; P = 0.04). A history of an ADR to iodinated contrast media (OR: 1.14, 95% CI: 0.68-1.90; P = 0.62) and premedication (adjusted OR: 2.09, 95% CI: 0.93-4.68; P = 0.07) were not significantly associated with GBCA-associated acute ADR recurrence. A separate analysis for recurrent allergic-like hypersensitivity reactions demonstrated similar results (adjusted OR: 0.20, 95% CI: 0.06-0.65; P < 0.01).
CONCLUSIONS: Changing GBCAs may reduce the risk of GBCA-associated acute ADR recurrence.