de la Cámara R, Figuera A, Sureda A, Hermida G, Verge G, Olalla I, Fernández Rañada J M, Domingo Albos A
Hospital de la Princesa, Madrid, Spain.
Haematologica. 1997 Nov-Dec;82(6):668-75.
Meropenem is the first of a new class of carbapenems which may be administered without cilastatin. This study was performed to assess the clinical efficacy and tolerability of meropenem monotherapy (1 g/8 h) compared with the standard combination of ceftazidime (2 g/8 h) plus amikacin (15 mg/kg/day) for the empirical treatment of infective febrile episodes in neutropenic cancer patients.
This was a three-center, randomized, non-blind parallel group trial. The primary objective was to compare the clinical efficacy of meropenem monotherapy with that of ceftazidime plus amikacin in the empirical treatment of febrile infective episodes in neutropenic patients. This was evaluated by the number of patients surviving on unmodified therapy at 72 h (primary end point) and by the clinical response at the end of therapy (secondary end point).
A total of 93 febrile episodes (46 meropenem, 47 ceftazidime/amikacin) were evaluable. Bone marrow transplant patients accounted for 49.5% of all cases. There was a high incidence of Gram-positive infections but no pseudomonal infections. Microbiologically documented infections, clinically documented infections and unexplained fever accounted for 45%, 10% and 45% of episodes, respectively. There was a similar proportion of patients in the meropenem and ceftazidime/amikacin groups on unmodified empiric therapy at 72 h (80.4% vs 76.6%, p = 0.65,) and cured at the end of therapy (37% vs 36.2%, p = 0.9). No significant difference in tolerability was observed between the groups. Meropenem was well tolerated; of note, there were no cases of nausea/vomiting or seizure related to its use.
Meropenem monotherapy was well tolerated and produced response rates similar to those obtained with ceftazidime/amikacin. The low overall success rates with both treatments concur with those of other recent studies and are probably due to a combination of several factors, including the adoption of strict assessment criteria.
美罗培南是新型碳青霉烯类药物中的首个品种，可不加西司他丁使用。本研究旨在评估美罗培南单药治疗（1克/8小时）与头孢他啶（2克/8小时）加阿米卡星（15毫克/千克/天）的标准联合用药方案相比，对中性粒细胞减少的癌症患者感染性发热发作进行经验性治疗的临床疗效和耐受性。
这是一项三中心、随机、非盲平行组试验。主要目的是比较美罗培南单药治疗与头孢他啶加阿米卡星对中性粒细胞减少患者发热性感染发作进行经验性治疗的临床疗效。通过72小时未调整治疗的存活患者数量（主要终点）和治疗结束时的临床反应（次要终点）进行评估。
总共93例发热发作（46例使用美罗培南，47例使用头孢他啶/阿米卡星）可进行评估。骨髓移植患者占所有病例的49.5%。革兰氏阳性菌感染发生率高，但无假单胞菌感染。微生物学确诊感染、临床确诊感染和不明原因发热分别占发作病例的45%、10%和45%。美罗培南组和头孢他啶/阿米卡星组在72小时接受未调整经验性治疗的患者比例相似（80.4%对76.6%，p = 0.65），治疗结束时治愈的患者比例也相似（37%对36.2%，p = 0.9）。两组之间在耐受性方面未观察到显著差异。美罗培南耐受性良好；值得注意的是，未出现与其使用相关的恶心/呕吐或癫痫病例。
美罗培南单药治疗耐受性良好，产生的反应率与头孢他啶/阿米卡星相似。两种治疗的总体成功率较低，与近期其他研究结果一致，可能是多种因素共同作用的结果，包括采用了严格的评估标准。
