METHODS: In this prospective observational study, a total number of 106 patients presenting to the ED in a 3-month period with nausea and vomiting treated with IV ondansetron were enrolled. QT and QTc intervals were measured at baseline (QT0 and QTc0), and 60 min (QT60 and QTc60) following a single-dose administration of ondansetron at 4 or 8 mg doses. To evaluate the predictive ability of these variables, we employed receiver operating characteristic (ROC) curve analyses.
RESULTS: The predictive models for QTc prolongation 1-hour post-ondansetron administration showed the following: at baseline, the area under curve of 0.70 for QT, 0.71 for QTc, and 0.64 for dosage. Conversely, a QTc0 = 375 msec indicated a QTc60 > 480 msec with a specificity of 97%. Additionally, a QTc0 of 400 msec had a sensitivity of 100% in predicting a QTc60 < 480 msec, while a QTc0 > 460 msec predicted a QTc60 > 480 msec with a specificity of 98%. Moreover, 8 mg doses were associated with higher rates of QTc60 prolongation, while 4 mg doses favored maintaining QTc60 within normal limits.
CONCLUSIONS: Our study demonstrates the predictive capacity of QT0, QTc0, and ondansetron dosage in forecasting QTc60 prolongation (> 480 msec) post-ondansetron administration. These findings advocate for their incorporation into clinical protocols to enhance safety monitoring in adult ED patients.
方法:在这项前瞻性观察研究中,共纳入106例ED患者,这些患者在3个月内出现恶心和呕吐,并接受了昂丹司琼静脉注射治疗.在基线测量QT和QTc间隔(QT0和QTc0),单剂量给予4或8mg剂量的昂丹司琼60分钟(QT60和QTc60)。为了评估这些变量的预测能力,我们采用接收器工作特性(ROC)曲线分析。
结果:恩丹西酮给药后1小时QTc延长的预测模型显示:在基线,QT的曲线下面积为0.70,QTc为0.71,和0.64的剂量。相反,aQTc0=375毫秒表示QTc60>480毫秒,特异性为97%。此外,400毫秒的QTc0在预测QTc60<480毫秒时具有100%的灵敏度,而QTc0>460毫秒预测QTc60>480毫秒,特异性为98%。此外,8mg剂量与较高的QTc60延长率相关,而4毫克剂量有利于将QTc60维持在正常范围内。
结论:我们的研究证明了QT0,QTc0和昂丹司琼剂量在预测昂丹司琼给药后QTc60延长(>480毫秒)方面的预测能力。这些发现主张将其纳入临床方案,以增强成年ED患者的安全性监测。