Hall J C, Christiansen K, Carter M J, Edwards M G, Hodge A J, Newman M A, Nicholls T T, Hall J
Division of Surgery, Royal Perth Hospital, Australia.
Ann Thorac Surg. 1993 Oct;56(4):916-22. doi: 10.1016/0003-4975(93)90355-l.
This clinical trial, which was composed of 1,031 adults undergoing cardiac operations, compared the efficacy of a single dose of 1 g of ceftriaxone with a 48-our regimen consisting of flucloxacillin and gentamicin. There was no significant difference (p = 0.89) in the overall incidence of major infections: 30 of 515 patients (5.8%; 95% confidence interval, 5.4% to 6.2%) taking ceftriaxone and 29 of 516 patients (5.6%; 95% confidence interval, 5.2% to 6.0%) taking flucloxacillin and gentamicin. Subgroup analyses, with a lower statistical power, failed to show a significant difference between patients who received ceftriaxone and those who received flucloxacillin/gentamicin: major sternal wound infections arose in 2.7% of the patients taking ceftriaxone versus 1.6% in those on the 48-hour regimen (p = 0.20) and major limb wound infections arose in 4.2% and 5.4%, respectively (p = 0.44). Single-dose prophylaxis was associated with fewer intravenous administrations (864 doses versus 9,570 doses) and cost less (A$17,248 versus A$78,510). Although the regimen that included gentamicin was associated with the greatest biochemical impairment of renal function, the overall toxicity for both groups was low. We conclude that a single dose of ceftriaxone provided cost-efficient prophylaxis for adults undergoing cardiac operations when compared with a 48-hour regimen of gentamicin and flucloxacillin. The general principle revealed by our data is that the short-term administration of an appropriate antibiotic regimen represents optimal prophylaxis for patients undergoing cardiac procedures.
这项临床试验纳入了1031名接受心脏手术的成年人,比较了单剂量1克头孢曲松与由氟氯西林和庆大霉素组成的48小时治疗方案的疗效。主要感染的总体发生率无显著差异(p = 0.89):服用头孢曲松的515名患者中有30名(5.8%;95%置信区间,5.4%至6.2%),服用氟氯西林和庆大霉素的516名患者中有29名(5.6%;95%置信区间,5.2%至6.0%)。亚组分析的统计效力较低,未显示接受头孢曲松的患者与接受氟氯西林/庆大霉素的患者之间存在显著差异:服用头孢曲松的患者中主要胸骨伤口感染发生率为2.7%,而接受48小时治疗方案的患者中为1.6%(p = 0.20),主要肢体伤口感染发生率分别为4.2%和5.4%(p = 0.44)。单剂量预防用药的静脉给药次数较少(864次与9570次),成本较低(17248澳元与78510澳元)。虽然包含庆大霉素的治疗方案与最大程度的肾功能生化损害相关,但两组的总体毒性都较低。我们得出结论,与庆大霉素和氟氯西林的48小时治疗方案相比,单剂量头孢曲松为接受心脏手术的成年人提供了具有成本效益的预防措施。我们的数据揭示的一般原则是,对接受心脏手术的患者而言,短期给予适当的抗生素治疗方案是最佳的预防措施。