Menichetti F, Martino P, Bucaneve G, Gentile G, D'Antonio D, Liso V, Ricci P, Nosari A M, Buelli M, Carotenuto M
Istituto di Malattie Infettive, Università di Perugia, Ospedale Policlinico Monteluce, Italy.
Antimicrob Agents Chemother. 1994 Sep;38(9):2041-6. doi: 10.1128/AAC.38.9.2041.
The efficacy and toxicity of teicoplanin and vancomycin in the initial empirical antibiotic regimen in febrile, neutropenic patients with hematologic malignancies were compared in a prospective, randomized, unblinded, multicenter trial in the setting of 29 hematologic units in tertiary-care or university hospitals. A total of 635 consecutive febrile patients with hematologic malignancies and chemotherapy-induced neutropenia were randomly assigned to receive intravenously amikacin plus ceftazidime plus either teicoplanin at 6 mg/kg of body weight once daily or vancomycin at 1 g twice daily. An efficacy analysis was done for 527 evaluable patients: 275 treated with teicoplanin and 252 treated with vancomycin. Overall, successful outcomes were recorded for 78% of patients who received teicoplanin and 75% of those who were randomized to vancomycin (difference, 3%; 95% confidence interval [CI], -10 to 4%; P = 0.33). A total of 102 patients presented with primary, single-agent, gram-positive bacteremia. Coagulase-negative staphylococci accounted for 42%, Staphylococcus aureus accounted for 27%, and streptococci accounted for 21% of all gram-positive blood isolates. The overall responses to therapy of gram-positive bacteremias were 92 and 87% for teicoplanin and vancomycin, respectively (difference, 5%; CI, -17 to 6%; P = 0.22). Side effects, mainly represented by skin rash, occurred in 3.2 and 8% of teicoplanin- and vancomycin-treated patients, respectively (difference, -4.8%; CI, 0.7 to 8%; P = 0.03); the rate of nephrotoxicity was 1.4 and 0.8% for the teicoplanin and vancomycin groups, respectively (difference, 0.6%; CI, -2 to 1%; P = 0.68). Further infections were caused by gram-positive organisms in two patients (0.7%) treated with teicoplanin and one patient (0.4%) who received vancomycin (difference, 0.3%; CI, -0.9 to 1.0%; P = 0.53). Overall mortalities were 8.5 and 11% for teicoplanin- and vancomycin-treated patients, respectively (difference, -2.5%; CI, - 2 to 7%; P = 0.43); death was caused by primary gram-positive infections in three patients (1%) in each treatment group. When used for initial empirical antibiotic therapy in febrile, neutropenic patients, teicoplanin was at least as efficacious as vancomycin, but it was associated with fewer side effects.
在一项前瞻性、随机、非盲、多中心试验中，在29家三级医疗或大学医院的血液科病房，对替考拉宁和万古霉素在发热性、中性粒细胞减少的血液系统恶性肿瘤患者初始经验性抗生素治疗方案中的疗效和毒性进行了比较。共有635例连续的发热性血液系统恶性肿瘤和化疗引起的中性粒细胞减少患者被随机分配接受静脉注射阿米卡星加头孢他啶，再加上每日一次6mg/kg体重的替考拉宁或每日两次1g的万古霉素。对527例可评估患者进行了疗效分析：275例接受替考拉宁治疗，252例接受万古霉素治疗。总体而言，接受替考拉宁治疗的患者中有78%记录了成功的治疗结果，随机接受万古霉素治疗的患者中有75%记录了成功的治疗结果（差异为3%；95%置信区间[CI]，-10%至4%；P=0.33）。共有102例患者出现原发性、单一病原体的革兰氏阳性菌血症。凝固酶阴性葡萄球菌占所有革兰氏阳性血培养分离菌的42%，金黄色葡萄球菌占27%，链球菌占21%。替考拉宁和万古霉素对革兰氏阳性菌血症治疗的总体有效率分别为92%和87%（差异为5%；CI，-17%至6%；P=0.22）。副作用主要表现为皮疹，分别发生在接受替考拉宁和万古霉素治疗患者中的3.2%和8%（差异为-4.8%；CI，0.7%至8%；P=0.03）；替考拉宁组和万古霉素组的肾毒性发生率分别为1.4%和0.8%（差异为0.6%；CI，-2%至1%；P=0.68）。接受替考拉宁治疗的2例患者（0.7%）和接受万古霉素治疗的1例患者（0.4%）由革兰氏阳性菌引起了进一步感染（差异为0.3%；CI，-0.9%至1.0%；P=0.53）。替考拉宁和万古霉素治疗患者的总体死亡率分别为8.5%和11%（差异为-2.5%；CI，-2%至7%；P=0.43）；每个治疗组中各有3例患者（1%）因原发性革兰氏阳性感染死亡。在发热性、中性粒细胞减少的患者中用于初始经验性抗生素治疗时，替考拉宁至少与万古霉素一样有效，但副作用更少。
