A multicenter, randomized, double blind placebo-controlled trial of amoxicillin/clavulanate for the prophylaxis of fever and infection in neutropenic children with cancer
A multicenter, randomized, double blind placebo-controlled trial of amoxicillin/clavulanate for the prophylaxis of fever and infection in neutropenic children with cancer
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阿莫西林/克拉维酸预防中性粒细胞减少癌症儿童发烧和感染的多中心、随机、双盲安慰剂对照试验
DOI：
10.1097/01.inf.0000061014.97037.a8
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发表时间：
2003
期刊：
影响因子：
--
通讯作者：
C. Viscoli
中科院分区：
文献类型：
--
作者：
E. Castagnola;L. Boni;M. Giacchino;S. Cesaro;L. de Sio;A. Garaventa;Pierfrancesco Biddau;M. Rossi;F. Schettini;P. Bruzzi;C. Viscoli
研究的目的。评价口服阿莫西林/克拉维酸（25 mg/kg，每12 h一次）预防贫血癌症儿童发热和/或感染的有效性。方法.多中心、前瞻性、随机、双盲安慰剂对照试验。结果在意向性治疗分析中，阿莫西林/克拉维汀在降低发热或感染事件发生率方面的获益比安慰剂增加了12%[83例患者中的44例（53%）vs. 84例患者中的55例（65%）; 95%置信区间，−28%至+3%;P = 0.101]。这一获益还与第15天无失败生存概率增加30%相关（P = 0.138）。Logistic回归分析显示，预防的效果是相关的，特别是在白血病或淋巴瘤患者和未接受造血生长因子的患者中，绝对获益增加17%和15%（logistic P = 0.014和0.034，分别）。口服药物的依从性良好，药物相关不良事件很少且不严重。结论.在这项研究中，阿莫西林/克拉维酸在减少患有癌症的贫血儿童的发热和感染方面具有可检测的临床效果，特别是那些患有急性白血病且未接受生长因子的儿童;该研究没有把握度证明在总体患者人群中具有统计学显著性效果。
Aim of the study. To evaluate the effectiveness of oral amoxicillin/clavulanate (25 mg/kg every 12 h) for prevention of fever and/or infection in neutropenic children with cancer. Methods. Multicenter, prospective, randomized, double blind placebo-controlled trial. Results. In the intention-to-treat analysis, amoxicillin/clavulanate had a 12% benefit increase in terms of reduction in the incidence of febrile or infectious episodes, compared with placebo [44 of 83 (53%) vs. 55 of 84 (65%); 95% confidence interval, −28% to +3%;P = 0.101]. This benefit was also associated with a 30% increase in the probability of failure-free survival at Day 15 (P = 0.138). A logistic regression analysis showed the effect of prophylaxis to be relevant, especially in patients with leukemia or lymphoma and in those not receiving hematopoietic growth factors, with 17 and 15% absolute benefit increases (logistic P = 0.014 and 0.034, respectively). Compliance with oral drugs was good, with very few and nonsevere drug-related adverse events. Conclusions. In this study amoxicillin/clavulanate was associated with a detectable clinical effect in the reduction of fever and infection in neutropenic children with cancer, especially those with acute leukemia and not receiving growth factors; the study was not powered to demonstrate a statistically significant effect in the overall patient population.
影响因子：
158.5
作者：
Gold, DR;Wang, XB;Dockery, DW
通讯作者：
Dockery, DW
诺氟沙星用于预防粒细胞减少症患者的细菌感染。
DOI：
10.1016/0002-9343(87)90617-6
发表时间：
1987
期刊：
The American journal of medicine
影响因子：
--
作者：
Winston,DJ;Ho,WG;Champlin,RE;Karp,J;Bartlett,J;Finley,RS;Joshi,JH;Talbot,G;Levitt,L;Deresinski,S
通讯作者：
Deresinski,S