Zaske D E, Bootman J L, Solem L B, Strate R G
Surgery. 1982 Feb;91(2):142-9.
The clinical effect of measuring serum gentamicin concentrations and individualizing each patient's dosage regimen was determined 105 burn patients with severe gram-negative sepsis. Thirty-nine patients (conventionally dosed group) received the recommended dosage regimen of 3 to 5 mg/kg/day from 1972 to 1974. From 1974 to 1976, serum concentrations were measured in 66 patients (individually dosed group), and each patient's dose was individually calculated to obtain therapeutic serum concentrations. All patients had normal renal function prior to initiation of gentamicin therapy. For each group, 16 independent variables were compared that may have influenced treatment response. The patients in the individually dosed group required an average dose of 7.4 mg/kg/day to achieve therapeutic concentrations, compared to the average dose of 4.4 mg/kg/day for the patients receiving conventional doses (P less than 0.001). An abrupt increase in patient survival occurred with the implementation of individualized regimens. Patient survival rates for the entire hospital course were 33% and 64% for the conventionally dosed and individually dosed groups, respectively (P less than 0.005). Survival rates for the first septic episode were 51.3% and 86.4%, respectively (P less than 0.001). Individualized gentamicin regimens, age, percent burn, and sex were the statistically significant variables related to patient survival for the first episode of sepsis. Age, percent burn, individualized dosing, complications during hospitalization, and a positive blood culture were significant factors related to patient survival for the entire hospital course. These data confirm the need for measuring serum gentamicin concentrations and adjusting dosages to ensure therapeutic levels and maximal efficacy of gentamicin in burn patients.
对105例患有严重革兰氏阴性菌败血症的烧伤患者测定血清庆大霉素浓度并为每位患者个体化制定给药方案的临床效果进行了研究。39例患者(传统给药组)在1972年至1974年期间接受了推荐的3至5mg/kg/天的给药方案。1974年至1976年,对66例患者(个体化给药组)测定了血清浓度,并分别计算每位患者的剂量以获得治疗性血清浓度。所有患者在开始庆大霉素治疗前肾功能均正常。对每组比较了16个可能影响治疗反应的独立变量。个体化给药组的患者平均需要7.4mg/kg/天的剂量才能达到治疗浓度,而接受传统剂量的患者平均剂量为4.4mg/kg/天(P<0.001)。实施个体化方案后患者生存率突然上升。传统给药组和个体化给药组整个住院过程的患者生存率分别为33%和64%(P<0.005)。首次败血症发作的生存率分别为51.3%和86.4%(P<0.001)。个体化庆大霉素方案、年龄、烧伤百分比和性别是与败血症首次发作患者生存相关的统计学显著变量。年龄、烧伤百分比、个体化给药、住院期间的并发症和血培养阳性是与整个住院过程患者生存相关的重要因素。这些数据证实了测定血清庆大霉素浓度并调整剂量以确保烧伤患者中庆大霉素达到治疗水平和最大疗效的必要性。