Bauduer F, Cousin T, Boulat O, Rigal-Huguet F, Molina L, Fegueux N, Jourdan E, Boiron J M, Reiffers J
Hematology Department, CHI Bayonne, France.
Leuk Lymphoma. 2001 Jul;42(3):379-86. doi: 10.3109/10428190109064594.
Fever is frequently the only clinical sign of infection in patients with chemo-induced neutropenia. In this setting, empirical administration of broad spectrum antibiotics must be rapid. The aim of this work was to compare, for the first time, cefpirome (CPO) and piperacillin-tazobactam (PT) in a large randomized trial. Two hundred-eight febrile neutropenic episodes (FNE) (> or = 38.5 degrees C and ANC < or = 0.5 giga/l) were treated by randomization, as first line therapy, using either CPO 2 g x 2/day (105 cases) or PT 4 g x 3/day (103 cases), alone (CPO: 15/PT: 15), or plus aminoglycoside (165 cases, CPO: 82/PT: 83) or quinolone (CPO: 2/PT: 2). There were 131 men and 77 women aged between 17 and 83 years (median: 49) who received chemotherapy (n = 160) or allogeneic (n = 10) or autologous (n = 38) stem cell transplantations. Underlying diseases were: acute leukemia (n = 131), lymphoma (n = 33), myeloma (n = 16), solid tumor (n = 8), myeloproliferative disorder (n = 9), chronic lymphoid leukemia (n = 5), aplastic anemia (n = 3), myelodysplasia (n = 3). Distribution of age, neutropenia duration (median: 17 days), underlying disease, and protocol therapy duration (median: 11 days) was comparable in both arms. A microbiologically documented infection (MDI) was evidenced in 57 cases (27%). Bacteria were isolated from blood cultures in 54 cases (Gram positive: 32 cases). Their in vitro susceptibility rates to CPO and PT were not different. Two days after antibiotics initiation, clinical (fever disappearance) and microbiological (culture negativation) success rates (SR) were 62% for CPO versus 61% for PT and 50% versus 55% respectively in case of MDI (p = 0.89). Two deaths and 77 failures were registered. At the end of protocol, SR (no antibiotic change/absence of superinfection) was 59% with CPO versus 50% with PT (p = 0.27) and 53% versus 40% respectively in the 151 cases with neutropenia > or = 10 days (p = 0.17). The occurrence of side effects was similar in both arms. In our hands, the efficacy of CPO and PT was comparable for treating FNE.
发热常常是化疗所致中性粒细胞减少患者感染的唯一临床症状。在此情况下，必须迅速给予经验性广谱抗生素治疗。本研究首次在一项大型随机试验中比较头孢匹罗（CPO）和哌拉西林 - 他唑巴坦（PT）。280例发热性中性粒细胞减少发作（FNE）（体温≥38.5℃且中性粒细胞绝对值（ANC）≤0.5×10⁹/L）被随机分组，作为一线治疗，分别使用CPO 2g，每日2次（105例）或PT 4g，每日3次（103例），单独使用（CPO组15例/PT组15例），或加用氨基糖苷类（165例，CPO组82例/PT组83例）或喹诺酮类（CPO组2例/PT组2例）。共有131名男性和77名女性，年龄在17至83岁之间（中位数：49岁），接受了化疗（n = 160）或异基因（n = 10）或自体（n = 38）干细胞移植。基础疾病包括：急性白血病（n = 131）、淋巴瘤（n = 33）、骨髓瘤（n = 16）、实体瘤（n = 8）、骨髓增殖性疾病（n = 9）、慢性淋巴细胞白血病（n = 5）、再生障碍性贫血（n = 3）、骨髓发育异常（n = 3）。两组在年龄、中性粒细胞减少持续时间（中位数：17天）、基础疾病和方案治疗持续时间（中位数：11天）的分布上具有可比性。57例（27%）有微生物学证实的感染（MDI）。54例血培养分离出细菌（革兰阳性菌：32例）。它们对CPO和PT的体外药敏率无差异。抗生素开始使用两天后，临床（发热消失）和微生物学（培养转阴）成功率（SR），CPO组为62%，PT组为61%；MDI情况下分别为50%和55%（p = 0.89）。记录到2例死亡和77例治疗失败。方案结束时，SR（未更换抗生素/无二重感染），CPO组为59%，PT组为50%（p = 0.27）；在151例中性粒细胞减少≥10天的患者中分别为53%和40%（p = 0.17）。两组副作用的发生率相似。在我们的研究中，CPO和PT治疗FNE的疗效相当。
