Talbot G H, Cassileth P A, Paradiso L, Correa-Coronas R, Bond L
Infectious Diseases Section, University of Pennsylvania Medical Center, Philadelphia, USA.
Antimicrob Agents Chemother. 1993 Mar;37(3):474-82. doi: 10.1128/AAC.37.3.474.
A randomized, double-blind, placebo-controlled trial was conducted in eight hematologic units to determine the efficacy and safety of oral enoxacin for infection prevention in adult patients with acute nonlymphocytic leukemia. One hundred nineteen patients undergoing remission induction or consolidation chemotherapy were enrolled; 62 of them received enoxacin (400 mg orally every 12 h). Patients received antifungal prophylaxis with oral mycostatin (1,000,000 U four times daily) or clotrimazole (1 troche five times daily). Analysis was performed on an intent-to-treat basis. There was no significant difference between groups in race, age, or type and stage of leukemia, but there were more males in the placebo group (P = 0.073 [Fisher's exact test]). Fewer enoxacin patients had gram-negative bacteremia (1 versus 14 [P < 0.001]), gram-negative infection at any site (2 versus 19 [P < 0.001]), or bacterial and/or fungal infection (17 versus 26 [P = 0.056]). There was no significant difference in the number of patients with gram-positive infection at any site (12 versus 16), gram-positive bacteremia (9 versus 10), deep fungal infection (6 versus 2), death (2 versus 3), other antimicrobial therapy required (48 versus 48), therapy with amphotericin B (15 versus 7 [P = 0.105]), any adverse event (45 versus 36), or any study drug-associated adverse events (13 versus 6). Logistic regression confirmed (odds ratios and 95% confidence intervals are given in parentheses) that enoxacin reduced the risk of gram-negative infection (0.07; 0.01 to 0.30), especially gram-negative bacillary bacteremia (0.05; 0.01 to 0.37), without altering the risk of gram-positive bacterial (0.63; 0.26 to 1.5), deep fungal (2.57; 0.47 to 13.9), or Clostridium difficile (1.16; 0.3 to 4.56) infection. The median time to the onset of fever of more than or equal 102.8 F (39.3 degree C) was 32 days for the enoxacin group versus 15 days for patients receiving placebo (P=0.0007 [Wilcoxon test]). In patients with acute nonlymphocytic leukemia, oral enoxacin prevents gram-negative infections, delays the onset of fever, does not alter the incidence of gram-positive or proven deep fungal infections, and is well tolerated.
在八个血液科单位进行了一项随机、双盲、安慰剂对照试验，以确定口服依诺沙星对预防成人急性非淋巴细胞白血病患者感染的疗效和安全性。119例接受缓解诱导或巩固化疗的患者入组；其中62例接受依诺沙星治疗（每12小时口服400mg）。患者接受了口服制霉菌素（每日4次，每次1000000U）或克霉唑（每日5次，每次1片）的抗真菌预防。分析采用意向性治疗原则。两组在种族、年龄、白血病类型和分期方面无显著差异，但安慰剂组男性更多（P = 0.073[Fisher精确检验]）。接受依诺沙星治疗的患者中，革兰阴性菌血症患者较少（1例对14例[P < 0.001]），任何部位的革兰阴性感染患者较少（2例对19例[P < 0.001]），细菌和/或真菌感染患者较少（17例对26例[P = 0.056]）。任何部位革兰阳性感染患者数量（12例对16例）、革兰阳性菌血症患者数量（9例对10例）、深部真菌感染患者数量（6例对2例）、死亡患者数量（2例对3例）、需要其他抗菌治疗的患者数量（48例对48例）、接受两性霉素B治疗的患者数量（15例对7例[P = 0.105]）、任何不良事件患者数量（45例对36例）或任何与研究药物相关的不良事件患者数量（13例对6例）均无显著差异。逻辑回归证实（括号内给出比值比和95%置信区间），依诺沙星降低了革兰阴性感染的风险（0.07；0.01至0.30），尤其是革兰阴性杆菌菌血症的风险（0.05；0.01至0.37），而未改变革兰阳性菌感染（0.63；0.26至1.5）、深部真菌感染（2.57；0.47至13.9）或艰难梭菌感染（1.16；0.3至4.56）的风险。依诺沙星组体温达到或超过102.8°F（39.3°C）的发热中位时间为32天，而接受安慰剂治疗的患者为15天（P = 0.0007[Wilcoxon检验]）。在急性非淋巴细胞白血病患者中，口服依诺沙星可预防革兰阴性感染，延迟发热的发生，不改变革兰阳性或已证实的深部真菌感染的发生率，且耐受性良好。
