Somberg John C, Timar Sandor, Bailin Steven J, Lakatos Ferenc, Haffajee Charles I, Tarjan Jeno, Paladino Walter P, Sarosi Istvan, Kerin Nicholas Z, Borbola Jozsef, Bridges Duane E, Molnar Janos
Rush University, Chicago, Illinois, USA.
Am J Cardiol. 2004 Mar 1;93(5):576-81. doi: 10.1016/j.amjcard.2003.11.021.
Hypotension is the most frequent adverse event reported with intravenous amiodarone. Hypotension has been attributed to the vasoactive solvents of the standard formulation (Cordarone IV) and is not dose related, but related to the rate of infusion. Drug labeling calls for intravenous amiodarone to be administered over 10 minutes. A new aqueous formulation of amiodarone (Amio-Aqueous) does not contain vasoactive excipients and may be administered safely by rapid administration without hypotension. This hypothesis was tested using combined data of 4 clinical trials; each assessed the development of hypotension prospectively. Hypotension was defined as a 25% decrease in systolic blood pressure (BP), with the development of a systolic BP of <90 mm Hg or a systolic BP that decreased to <80 mm Hg. In all, 358 Amio-Aqueous and 225 lidocaine boluses were administered to 278 patients; 246 had ventricular tachycardia (VT) during drug administration. Hypotension developed in 11% of patients on Amio-Aqueous versus 19% on lidocaine (p = NS), all during VT; most resolved spontaneously with VT termination. With both drugs, hypotension persisted after VT termination in 1% of patients; the incidence of drug-related hypotension occurred in 2% of patients (1% had hypotension requiring treatment). The Amio-Aqueous was discontinued in 1% of patients, and lidocaine was discontinued in 2% of patients because of hypotension. We conclude that Amio-Aqueous is at least as safe as lidocaine in terms of causing hypotension when administered rapidly. This is a significant advantage over the standard amiodarone formulation, because Cordarone cannot be administered by rapid bolus owing to excipient-related hypotension.
低血压是静脉注射胺碘酮最常见的不良事件。低血压被认为与标准制剂（可达龙静脉注射剂）中的血管活性溶剂有关，与剂量无关，而与输注速度有关。药品标签要求静脉注射胺碘酮的时间超过10分钟。一种新的胺碘酮水性制剂（胺碘酮水剂）不含血管活性辅料，可安全地快速给药而不会引起低血压。使用4项临床试验的合并数据对这一假设进行了验证；每项试验均前瞻性地评估了低血压的发生情况。低血压定义为收缩压（BP）下降25%，收缩压降至<90 mmHg或收缩压降至<80 mmHg。总共对278例患者给予了358次胺碘酮水剂和225次利多卡因推注；246例患者在给药期间发生室性心动过速（VT）。胺碘酮水剂组11%的患者出现低血压，利多卡因组为19%（p=无显著性差异），均发生在VT期间；大多数在VT终止后自发缓解。使用这两种药物时，VT终止后1%的患者低血压持续存在；药物相关性低血压的发生率为2%（1%的患者低血压需要治疗）。1%的患者因低血压停用胺碘酮水剂，2%的患者停用利多卡因。我们得出结论，快速给药时，胺碘酮水剂在引起低血压方面至少与利多卡因一样安全。这是相对于标准胺碘酮制剂的一个显著优势，因为由于辅料相关的低血压，可达龙不能快速推注给药。
