头孢哌酮/舒巴坦联合阿米卡星与亚胺培南/西司他丁经验性治疗中性粒细胞缺乏发热患者的对照研究

Empirical Treatment for Patients with Neutropenia and Fever:A Controlled Clinical Trial of Cefoperazone/Sulbactam Combined with Amikacin vs Imipenem/Cilastatin

目的研究血液肿瘤患者粒细胞缺乏出现发热时,头孢哌酮/舒巴坦联合阿米卡星与亚胺培南/西司他丁治疗的临床疗效和安全性。方法一项随机、单盲、对照的多中心研究,共纳入216例确诊为血液系统肿瘤伴中性粒细胞缺乏发热的住院患者,随机分组接受头孢哌酮/舒巴坦联合阿米卡星与亚胺培南/西司他丁治疗,对比其临床疗效、细菌学疗效与不良反应。结果两组临床有效率分别为69.05%和74.44%,经统计学处理,两组间差异无统计学意义;治疗后体温明显降低,与基线相比具差异有统计学意义(P<0.01);每日体温的变化,头孢哌酮/舒巴坦联合阿米卡星组比亚胺培南/西司他丁组更明显,平均退热时间分别为(3.09±1.81)d和(3.67±1.99)d;头孢哌酮/舒巴坦联合阿米卡星组的细菌学疗效明显优于亚胺培南/西司他丁组,头孢哌酮/舒巴坦联合阿米卡星组不良反应的发生率更低(3.97%vs10.00%),两组病例均未观察到有明显的肝、肾功能损害,亦无严重不良反应发生。结论头孢哌酮/舒巴坦联合阿米卡星可作为经验性治疗中性粒细胞缺乏伴发热的血液系统肿瘤患者的理想治疗,不良反应轻,耐受性好。

OBJECTIVE To compare the clinical efficiency and safety either of cefoperazone/sulbactam combined with amikacin （CPZ/SUL＋AMK） or imipenem/cilastatin （IMP/CS） for the empirical treatment of blood tumor patients with fever during the period of neutropenia. METHODS In this randomized, single-blind, muhicenter controlled study,216 patients that had been hospitalized for febrile neutropenia and tumor of blood system were randomized divided into two groups and received either CPZ/SUL ＋ AMK or IMP/CS. The clinical and bacteriological efficiency as well as the side reaction of the two groups were compared. RESULTS There was no statistical significant difference in clinical efficiency between the two groups （69.05% in CPZ/SUL＋AMK group vs 74. 44% in IMP/CS group）. After treatment, the body temperature showed a significant fall compared to baseline （P〈0.01）. In CPZ/SUL＋AMK group,the change in everyday body temperature was more obviously than that in IMP/CS group. The bacteriological efficiency in CPZ/SUL＋AMK group was better than in IMP/CS group. The average time of abatement of fever was 3.09±1.81 days and 3. 67±1.99 days,respectively （P= 0. 083）. The rate of adverse event was lower in CPZ/SUL＋ AMK group than that of IMP/CS group（3.97 % vs 10%）. In the two groups, no visible hepatic and renal function damage was found, and no serious adverse event was reported. CONCLUSIONS Cefoperazone/sulbaetam combined with amikaein （CPZ/SUL＋ AMK） is an ideal alternative for empirical therapy of febrile neutropenic patients with tumor of blood system, with light adverse reaction and well tolerance.