【摘要翻译】 实体瘤和淋巴瘤化疗后预防性应用抗菌药有益

Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas

Cullen M, Steven N, Billingham L, Gaunt C, Hastings M,et,al.

N Engl J Med. 2005 Sep 8;353(10):988-98.
Comment in:
N Engl J Med. 2005 Sep 8;353(10):1052-4.
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 degrees C) 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<0.001). During the entire chemotherapy course, 10.8 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 15.2 percent of patients in the placebo group (P=0.01); the respective rates of probable infection were 34.2 percent and 41.5 percent (P=0.004). Hospitalization was required for the treatment of infection in 15.7 percent of patients in the levofloxacin group and 21.6 percent of patients in the placebo group (P=0.004). The respective rate of severe infection was 1.0 percent and 2.0 percent (P=0.15), with four infection-related deaths in each group. An organism was isolated in 9.2 percent of probable infections. CONCLUSIONS: Among patients receiving chemotherapy for solid tumors or lymphoma, the prophylactic use of levofloxacin reduces the incidence of fever, probable infection, and hospitalization. Copyright 2005 Massachusetts Medical Society.
PMID: 16148284

实体瘤和淋巴瘤化疗后预防性应用抗菌药有益

背景 化疗后是否需要预防性应用抗菌药一直存在争论。方法 我们的实验方案是随机双盲安慰剂对照实验。入选的受试者是接受周期性化疗的实体瘤或淋巴瘤的患者，并且他们有发生暂时性严重中性粒细胞减少症（每立方厘米少于500个中性粒细胞）的危险。在预计的中性粒细胞减少期，这些患者随机被指定连续七天，每天服用500 mg的左氧氟沙星或相配的安慰剂。首要的观察的是临床上报道的由感染导致的热发作（温度高于38摄氏度）的发生。
次要观察的是包括所有机会感染的发生、严重感染和住院治疗，但不包括抗菌药抵抗的系统评价。结果 对1565名患者进行了随机分组（784名服用安慰剂781名服用左氧氟沙星）。肿瘤的类型包括乳腺癌(35.4 %)、肺癌(22.5 %)、 睾丸癌(14.4 %)和淋巴瘤(12.8 %)。在第一个化疗周期中，左氧氟沙星组3.5%的患者发生了至少一次的热发作，而安慰剂组为7.9% (P<0.001)。在整个化疗过程中，左氧氟沙星组10.8%的患者发生了至少一次的热发作，而安慰剂组为15.2 % (P=0.001)，各组分别有34.2 %和 41.5%的患者发生机会感染(P=0.004)。15.7%的左氧氟沙星组患者发生的感染需要入院治疗，而安慰剂组为21.6 (P=0.004)。各组分别有1.0 % and 2.0 %的患者发生严重感染(P=0.15)，并且每组中均有四例感染相关的死亡病历。在9.2%的机会感染中分离出了致病微生物。结论 在接受化疗的实体瘤和淋巴瘤患者中，左氧氟沙星的预防性应用可以减少发热、机会感染的发生和入院治疗次数。