Flaherty J P, Waitley D, Edlin B, George D, Arnow P, O'Keefe P, Weinstein R A
Department of Medicine, University of Chicago Medical Center, Illinois 60637.
Am J Med. 1989 Nov 30;87(5A):278S-282S. doi: 10.1016/0002-9343(89)90080-6.
In a multicenter, randomized clinical trial, the efficacy of ciprofloxacin plus azlocillin was compared with that of a standard regimen of ceftazidime plus amikacin for the initial empiric treatment of fever in neutropenic cancer patients. In addition, the efficacy of early conversion from intravenous therapy to orally administered ciprofloxacin was compared with that of continued ceftazidime plus amikacin. Seventy-one oncology patients with 79 episodes of fever and neutropenia were randomly assigned to receive initial empiric antibiotic therapy with either intravenously administered ciprofloxacin and azlocillin followed by orally administered ciprofloxacin (regimen 1, 25 episodes); ceftazidime and amikacin (regimen 2, 30 episodes); or ceftazidime and amikacin followed by oral ciprofloxacin (regimen 3, 24 episodes). Microbiologically documented infections were the cause of fever in 10 (40 percent), seven (23 percent), and nine (38 percent) episodes in regimens 1, 2, and 3, respectively, including six, five, and four episodes of bacteremia. Patient survival was 90 to 92 percent in each regimen; however, some modification of antimicrobial therapy occurred in 65, 44, and 41 percent of surviving patients in regimens 1, 2, and 3, respectively. The rate of clearance of initial bacteremia was 67 percent (four of six) in regimen 1, 100 percent (five of five) in regimen 2 and 50 percent (two of four) in regimen 3. Patients in regimens 1 and 3 were able to convert to orally administered ciprofloxacin in 32 (65 percent) of 49 episodes after a mean of six days of intravenous therapy. Superinfections occurred in 24, 10, and 12 percent of patients receiving regimens 1, 2, and 3, respectively, and occurred similarly for patients receiving orally administered ciprofloxacin, 12 percent (four of 32), and intravenous therapy, 17 percent (eight of 47). Parenteral ciprofloxacin was generally well tolerated. One (4 percent) of 25 patients receiving regimen 1 experienced oto- or nephrotoxicity, compared with eight (15 percent) of 54 patients receiving regimens 1, 2, and 3 (p = 0.15), including three patients who required premature termination of aminoglycoside therapy. Our data suggest that the combination of ciprofloxacin and azlocillin is an effective alternative to ceftazidime and amikacin for the initial empiric therapy of febrile neutropenic patients, is generally well tolerated, and avoids the oto- and nephrotoxicity associated with aminoglycoside use. In addition, a majority of patients could change to orally administered ciprofloxacin alone after six days of parenteral therapy.
在一项多中心随机临床试验中，将环丙沙星加阿洛西林的疗效与头孢他啶加阿米卡星的标准方案用于中性粒细胞减少癌症患者发热的初始经验性治疗进行比较。此外，还比较了从静脉治疗早期转换为口服环丙沙星与持续使用头孢他啶加阿米卡星的疗效。71例肿瘤患者发生79次发热和中性粒细胞减少发作，被随机分配接受初始经验性抗生素治疗，分别为静脉注射环丙沙星和阿洛西林后口服环丙沙星（方案1，25次发作）；头孢他啶和阿米卡星（方案2，30次发作）；或头孢他啶和阿米卡星后口服环丙沙星（方案3，24次发作）。微生物学确诊的感染分别是方案1、2和3中10次（40%）、7次（23%）和9次（38%）发作的发热原因，包括6次、5次和4次菌血症发作。每个方案的患者生存率为90%至92%；然而，方案1、2和3中分别有65%、44%和41%的存活患者对抗菌治疗进行了一些调整。方案1中初始菌血症的清除率为67%（6例中的4例），方案2中为100%（5例中的5例），方案3中为50%（4例中的2例）。方案1和3中的患者在平均6天的静脉治疗后，49次发作中有32次（65%）能够转换为口服环丙沙星。接受方案1、2和3的患者中分别有24%、10%和12%发生了二重感染，接受口服环丙沙星的患者中为12%（32例中的4例），接受静脉治疗的患者中为17%（47例中的8例）。胃肠外环丙沙星一般耐受性良好。接受方案1的25例患者中有1例（4%）出现耳毒性或肾毒性，而接受方案1、2和3的54例患者中有8例（15%）出现（p = 0.15），包括3例需要提前终止氨基糖苷类治疗的患者。我们的数据表明，环丙沙星和阿洛西林联合使用是头孢他啶和阿米卡星用于发热性中性粒细胞减少患者初始经验性治疗的有效替代方案，一般耐受性良好，且避免了与使用氨基糖苷类药物相关的耳毒性和肾毒性。此外，大多数患者在胃肠外治疗6天后可单独转换为口服环丙沙星。
