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试验目的是评价哌拉西林和他佐巴坦复方对控制粒细胞减少症患者发热的作用。在这个单中心的研究中,共入选病人247例,被随机分为两组,分别接受以下标准治疗方案:哌拉西林12g/d+他佐巴坦1.5g/d(4.5g tid)和妥布霉素3mg/(kg·d)(1.5mg/kg bid)或头孢他啶3g/d(1g tid)和妥布霉素3mg/(kg·d)(1.5mg/kg bid)。在头孢他啶组中,持续性发热的所有病例都加用万古霉素,而在哌拉西林/他佐巴坦组,只有当证实致病菌对哌拉西林/他佐巴坦耐药时,才加用万古霉素。对247例的疗效进行评价分析。这两组患者在年龄、性别、基础疾病、所接受的化疗方案、粒细胞减少的严重程度及持续时间、临床及细菌检查结果、是否口服脱污染剂等方面,均无明显的差异。结果显示:(1)在不更换抗生素的情况下,哌拉西林/他佐巴坦组72小时体温恢复正常患者的比率(54.4％)高于头孢他啶组(37.6％),P=0.008。(2)尽管哌拉西林/他佐巴坦组加用万古霉素的例次少于头孢他啶组(分别为54.4％和77.4％),但严重感染事件(由于感染引起死亡或延迟基础疾病治疗)的发生率,哌拉西林/他佐巴坦组(2.6％)低于头孢他啶组(11.3％),P=0.02。本试验证实,在严重粒细胞减少患者发热的经验性治疗中,哌拉西林与他佐巴坦复方有良好疗效,且可使糖肽类抗生素的使用明显减少。
The purpose of the trial was to evaluate the effects of piperacillin and tazobactam on the control of fever in patients with neutropenia. In this single-center study, a total of 247 patients were enrolled and were randomized to receive either of the following standard treatment regimens: piperacillin 12 g / d plus tazobactam 1.5 g / d (4.5 g tid) 3 mg / (kg.d) ofmycin (1.5 mg / kg bid) or ceftazidime 3 g / d (1 g tid) and tobramycin 3 mg / (kg.d) (1.5 mg / kg bid). In the ceftazidime group, vancomycin was added to all cases of persistent fever, whereas in the piperacillin / tazobactam group only when causative agents were confirmed to be resistant to piperacillin / tazobactam Add vancomycin. Evaluation of the efficacy of 247 cases. There were no significant differences in age, gender, underlying disease, chemotherapy regimen, severity and duration of neutropenia, clinical and bacterial test results, oral decontamination, and both. The results showed that: (1) The rate of body temperature recovery in patients receiving piperacillin / tazobactam at 72 hours was 54.4% higher than that of ceftazidime (37.6%) without antibiotics replacement (P = 0.008). (2) Although the cases of piperacillin / tazobactam plus vancomycin were less frequent than those of ceftazidime (54.4% and 77.4%, respectively), serious infections (death due to infection or delayed treatment of underlying disease) The incidence of piperacillin / tazobactam (2.6%) was lower than that of ceftazidime (11.3%), P = 0.02. This trial confirms that piperacillin and tazobactam have good efficacy in the empirical treatment of fever in patients with severe granulocytopenia and significantly reduce the use of glycopeptide antibiotics.