Böhme A, Shah P M, Stille W, Hoelzer D
Department of Hematology/Oncology, Johann Wolfgang Goethe- University Frankfurt/Germany.
Eur J Med Res. 1998 Jul 20;3(7):324-30.
The objective of the presented prospective, randomized study was to compare the efficacy of empirical antimicrobial monotherapy with piperacillin/tazobactam (PIP/TAZ) to cefepime (CEFP) for treatment of infections in neutropenic patients. From a total of 102 febrile episodes 100 were evaluable. The most frequent microorganisms were gram-negative, documented in 22% vs. 24% of the febrile episodes (gram-positives 18% vs. 16%, fungi 2% vs. 4%). The response rate was similar with 22/51 (43%) of episodes treated with PIP/TAZ vs. 19/49 (39%) with CEFP. Of the different infection types classified at the end of the febrile episodes, patients with fever of unknown origin (FUO) and primary bacteremias showed the best initial responses with 25/44 (57%) and 11/22 (50%). Lower initial response rates were found in pneumonias with totally 3/13 (23%) and other clinically documented infections with 2/21 (10%), without any difference between both groups. Gram positive infections showed a higher response with PIP/TAZ than with CEFP (4/9 vs. 0/8), gram negative responded less frequently (3/11 vs. 7/13). The median time until persistent defervescence was equal in both groups (2.5 vs. 2 days), likewise the response rates after the different steps of therapy modifications (change to imipenem or ceftazidim, or addition of gentamycin, vancomycin or amphotericin B). Totally, 96% of febrile episodes responded in both therapy arms. Overall, we found no significant differences in efficacy between the two therapeutic regimens. In conclusion, PIP/TAZ as well as CEFP might be a sufficient initial therapy for febrile neutropenia, but further randomized trials with larger patient numbers are necessary.
本前瞻性随机研究的目的是比较经验性抗菌单药治疗哌拉西林/他唑巴坦（PIP/TAZ）与头孢吡肟（CEFP）治疗中性粒细胞减少患者感染的疗效。在总共102次发热发作中，100次可评估。最常见的微生物是革兰氏阴性菌，在发热发作中分别占22%和24%（革兰氏阳性菌分别占18%和16%，真菌分别占2%和4%）。PIP/TAZ治疗的发作中有22/51（43%），CEFP治疗的发作中有19/49（39%），缓解率相似。在发热发作结束时分类的不同感染类型中，不明原因发热（FUO）患者和原发性菌血症患者的初始缓解效果最佳，分别为25/44（57%）和11/22（50%）。肺炎患者的初始缓解率较低，共3/13（23%），其他临床记录的感染患者为2/21（10%），两组之间无差异。革兰氏阳性菌感染使用PIP/TAZ的缓解率高于CEFP（4/9对0/8），革兰氏阴性菌感染的缓解率较低（3/11对7/13）。两组持续退热的中位时间相等（2.5天对2天），治疗调整不同步骤后的缓解率（改为亚胺培南或头孢他啶，或加用庆大霉素、万古霉素或两性霉素B）也是如此。两个治疗组中96%的发热发作有反应。总体而言，我们发现两种治疗方案在疗效上无显著差异。总之，PIP/TAZ以及CEFP可能是发热性中性粒细胞减少症的充分初始治疗方法，但需要进一步进行更大样本量的随机试验。
