Oldfield E C, Garst P D, Hostettler C, White M, Samuelson D
Department of Internal Medicine, Naval Hospital, San Diego, California 92134-5000.
Antimicrob Agents Chemother. 1990 Jul;34(7):1402-6. doi: 10.1128/AAC.34.7.1402.
We conducted a randomized, double-blind trial of 1- versus 4-h infusions of amphotericin B to determine whether there was any difference in infusion-related toxicity. A total of 128 maintenance infusions in 12 patients were studied; 62 were randomized to 1-h infusions (group A) and 66 were randomized to 4-h infusions (group B). We found no significant differences between patients in groups A and B in mean temperature, pulse, or systolic or diastolic blood pressure measured during the infusions. At a significant level of 0.05, the power to detect a mean difference in temperature of 2 degrees C, a pulse difference of 20 beats per min, a decrease in diastolic blood pressure of 10 mm Hg, or a decrease in systolic blood pressure of 20 mm Hg was 0.95. Rigors and chills were noted in 15 of 62 (24.1%) infusions in group A patients and 12 of 66 (18.1%) infusions in group B patients (P = 0.40). Meperidine was required because of severe persistent rigors in 6 of 62 (9.6%) infusions in group A patients and 6 of 66 (8.9%) infusions in group B patients (P = 0.91). An increase in temperature was noted in five (8%) of the group A infusions and seven (10.6%) of the group B infusions (P = 0.63). The mean time to onset of rigors, an increase in temperature, and an increase in pulse occurred significantly earlier in group A than in group B patients (P = 0.02 for all comparisons). We conclude that there is no difference in the incidence or severity of the infusion-related toxicity of amphotericin B with a 1-h infusion rate compared with a 4-h infusion rate. However, the onset of infusion-related toxicity occurs significantly earlier with a 1-h infusion.
我们进行了一项关于两性霉素B 1小时输注与4小时输注的随机双盲试验，以确定输注相关毒性是否存在差异。共研究了12例患者的128次维持输注；62例随机接受1小时输注（A组），66例随机接受4小时输注（B组）。我们发现，在输注过程中测量的A组和B组患者的平均体温、脉搏、收缩压或舒张压之间无显著差异。在0.05的显著水平下，检测体温平均差异2℃、脉搏差异每分钟20次、舒张压下降10 mmHg或收缩压下降20 mmHg的检验效能为0.95。A组患者的62次输注中有15次（24.1%）出现寒战，B组患者的66次输注中有12次（18.1%）出现寒战（P = 0.40）。A组患者的62次输注中有6次（9.6%）因严重持续寒战需要使用哌替啶，B组患者的66次输注中有6次（8.9%）需要使用（P = 0.91）。A组输注中有5次（8%）出现体温升高，B组输注中有7次（10.6%）出现体温升高（P = 0.63）。寒战、体温升高和脉搏加快的平均发作时间在A组患者中比B组患者显著更早出现（所有比较P = 0.02）。我们得出结论，两性霉素B 1小时输注率与4小时输注率相比，输注相关毒性的发生率和严重程度没有差异。然而，1小时输注时输注相关毒性的发作明显更早。
