Camp M J, Wingard J R, Gilmore C E, Lin L S, Dix S P, Davidson T G, Geller R B
Department of Pharmaceutical Services, Emory University Hospital, Emory University, Atlanta, Georgia 30322, USA.
Antimicrob Agents Chemother. 1998 Dec;42(12):3103-6. doi: 10.1128/AAC.42.12.3103.
This study evaluated the efficacy of low-dose dopamine for prevention of amphotericin B-induced nephrotoxicity in autologous bone marrow transplant and leukemia patients. Seventy-one patients undergoing cytoreductive therapy who required amphotericin B were randomly assigned in an unblinded fashion to a group receiving continuous-infusion low-dose dopamine (3 microgram/kg/min) or a group receiving no dopamine. Amphotericin B was dosed at 0.5 or 1.0 mg/kg/day based on computerized tomography scan results or presence of positive blood cultures. No patient received saline boluses. The rate of nephrotoxicity, severity as graded by Southwest Oncology Group toxicity criteria, and time to each grade of nephrotoxicity were compared between the two groups. Eighty percent of the no-dopamine group and 66.7% of the dopamine group developed nephrotoxicity, defined as a 1.5-fold or greater increase in baseline serum creatinine level (P = 0.20). No statistical difference was noted at any grade of nephrotoxicity between the two groups. Thirty-four percent of patients in the no-dopamine group versus 17.6% in the dopamine group had a 2.5-fold or greater increase in serum creatinine level, which was not statistically significant (P = 0.0888). Ten patients developed grade IV nephrotoxicity and were withdrawn from the study, 7 in the no-dopamine group and 3 in the dopamine group (P = 0.19). The time to each grade of nephrotoxicity was also not significantly different for the two groups. Eleven adverse drug reactions were reported in the dopamine group in comparison to one in the no-dopamine group. Thus, dopamine offers little in the way of prevention of nephrotoxicity associated with amphotericin B therapy. Although the significance of drug reactions in the dopamine group is not clearly established due to lack of cardiac monitoring in the no-dopamine group, dopamine therapy is not without complications.
本研究评估了低剂量多巴胺对自体骨髓移植和白血病患者中两性霉素B所致肾毒性的预防效果。71例接受细胞减灭治疗且需要使用两性霉素B的患者,以非盲法随机分为两组,一组接受持续静脉输注低剂量多巴胺(3微克/千克/分钟),另一组不接受多巴胺治疗。根据计算机断层扫描结果或血培养阳性情况,两性霉素B的剂量为0.5或1.0毫克/千克/天。所有患者均未接受生理盐水推注。比较两组的肾毒性发生率、按照西南肿瘤协作组毒性标准分级的严重程度以及达到各等级肾毒性的时间。未接受多巴胺治疗组80%的患者和接受多巴胺治疗组66.7%的患者发生了肾毒性,定义为基线血清肌酐水平升高1.5倍或更多(P = 0.20)。两组在任何等级的肾毒性方面均未发现统计学差异。未接受多巴胺治疗组34%的患者与接受多巴胺治疗组17.6%的患者血清肌酐水平升高2.5倍或更多,差异无统计学意义(P = 0.0888)。10例患者发生IV级肾毒性并退出研究,未接受多巴胺治疗组7例,接受多巴胺治疗组3例(P = 0.19)。两组达到各等级肾毒性的时间也无显著差异。接受多巴胺治疗组报告了11例药物不良反应,而未接受多巴胺治疗组仅报告了1例。因此,多巴胺对预防两性霉素B治疗相关的肾毒性作用不大。尽管由于未接受多巴胺治疗组未进行心脏监测,多巴胺治疗组药物反应的意义尚未明确,但多巴胺治疗并非没有并发症。