A multicenter, double-blind, placebo-controlled trial comparing piperacillin-tazobactam with and without amikacin as empiric therapy for febrile neutropenia
A multicenter, double-blind, placebo-controlled trial comparing piperacillin-tazobactam with and without amikacin as empiric therapy for febrile neutropenia
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DOI：
10.1086/322646
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发表时间：
2001-10-15
影响因子：
11.8
通讯作者：
Mandelli, F
中科院分区：
文献类型：
--
作者：
Del Favero, A;Menichetti, F;Mandelli, F
在一项前瞻性、多中心、双盲、随机临床试验中，我们比较了哌拉西林-他唑巴坦（4.5 g，每日 3 次，静脉注射）加安慰剂与哌拉西林-他唑巴坦加阿米卡星（7.5 mg/kg，每日两次，静脉注射）治疗 760 名患有化疗引起的严重（10 天）中性粒细胞减少症的发热成年癌症患者的疗效。共有 733 名患者接受了药物治疗方案的疗效评估，接受单一治疗的患者中有 49%（364 名患者中的 179 名）报告总体成功结果，而接受联合治疗的患者中这一比例为 53%（369 名中的 196 名）（P = .2）。两种方案的缓解率相似，菌血症的发生率、临床记录的感染和可能的感染也相似。在我们的流行病学环境中，与最初的单一疗法相比，最初的经验性联合疗法与改善结果无关。
In a prospective, multicenter, double-blind, randomized clinical trial, we compared the efficacy of piperacillin-tazobactam (4.5 g 3 times daily intravenously) plus placebo versus piperacillin-tazobactam plus amikacin (7.5 mg/kg twice daily intravenously) for the treatment of 760 febrile, adult patients with cancer with chemotherapy-induced profound (10 days) neutropenia. A total of 733 patients were assessable for efficacy of the drug regimens, and an overall successful outcome was reported in 49% (179 of 364) of the patients who received monotherapy, compared with 53% (196 of 369) of patients who received combination therapy (P = .2). Response rates were similar with both regimens, as were incidences of bacteremia and clinically documented and possible infections. In our epidemiological setting, the initial empiric combination therapy was not associated with improved outcomes when compared with initial monotherapy.