Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas
Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas
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DOI：
10.1056/nejmoa050078
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发表时间：
2005-09-08
影响因子：
158.5
通讯作者：
Stanley, A
中科院分区：
文献类型：
--
作者：
Cullen, M;Steven, N;Stanley, A
背景：化疗后预防性抗菌药物的作用仍存在争议。 方法：我们对正在接受实体瘤或淋巴瘤循环化疗且有暂时性严重中性粒细胞减少症（每立方毫米中性粒细胞低于 500 个）风险的患者进行了一项随机、双盲、安慰剂对照试验。在预期的中性粒细胞减少期间，患者被随机分配接受 500 毫克左氧氟沙星，每日一次或匹配的安慰剂，为期 7 天。主要结局是临床记录的因感染引起的发热发作（体温超过 38 摄氏度）的发生率。次要结局包括所有可能感染、严重感染和住院治疗的发生率，但不包括抗菌素耐药性的系统评估。 结果：共有 1565 名患者接受了随机分组（784 名患者接受安慰剂，781 名患者接受左氧氟沙星）。这些肿瘤包括乳腺癌（35.4%）、肺癌（22.5%）、睾丸癌（14.4%）和淋巴瘤（12.8%）。在第一个化疗周期期间，左氧氟沙星组中有 3.5% 的患者至少出现过一次发热发作，而安慰剂组中这一比例为 7.9%（P
BACKGROUND:The role of prophylactic antibacterial agents after chemotherapy remains controversial.METHODS:We conducted a randomized, double-blind, placebo-controlled trial in patients who were receiving cyclic chemotherapy for solid tumors or lymphoma and who were at risk for temporary, severe neutropenia (fewer than 500 neutrophils per cubic millimeter). Patients were randomly assigned to receive either 500 mg of levofloxacin once daily or matching placebo for seven days during the expected neutropenic period. The primary outcome was the incidence of clinically documented febrile episodes (temperature of more than 38 degreesC) attributed to infection. Secondary outcomes included the incidence of all probable infections, severe infections, and hospitalization but did not include a systematic evaluation of antibacterial resistance.RESULTS:A total of 1565 patients underwent randomization (784 to placebo and 781 to levofloxacin). The tumors included breast cancer (35.4 percent), lung cancer (22.5 percent), testicular cancer (14.4 percent), and lymphoma (12.8 percent). During the first cycle of chemotherapy, 3.5 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 7.9 percent in the placebo group (P