Fainstein V, Elting L, Pitlik S, Hortobagyi G, Keating M, Bodey G P
Am J Med. 1985 Nov 29;79(5B):62-6.
Since the combination of ticarcillin with clavulanic acid is active against many otherwise resistant organisms that commonly affect patients with cancer, a therapeutic trial with ticarcillin disodium plus clavulanate potassium for treating infections in cancer patients was conducted. A total of 127 evaluable patients were treated with this antibiotic. Of these, 63 percent were women with breast carcinoma, 28 percent were patients with leukemia, and the remainder were patients with sarcomas and lung cancer. The median duration of therapy was 7.7 days. There were 63 documented infections, with bacteriologic documentation in 39 episodes. Because of the high incidence of gram-positive infections and after the failure of ticarcillin plus clavulanate potassium in two of these episodes, vancomycin was added to the regimen. The overall response rate was 75 percent. In microbiologically proved infections, the response rate was 79 percent. Thirteen of 17 gram-negative infections responded (76 percent), including four of four episodes caused by Pseudomonas aeruginosa. The only failures in this group were two episodes with Klebsiella species, one episode with Escherichia coli, and one episode with Enterobacter species. Of the gram-positive infections treated without vancomycin, five of eight (63 percent) responded and only two episodes due to Staphylococcus aureus and one due to JK diphtheroid bacteria failed. All episodes treated with the combination of ticarcillin plus clavulanate potassium and vancomycin responded. Seven of eight (88 percent) polymicrobial infections and 73 percent of those infections without identified organisms responded as well. The overall response rates for septicemia, pneumonia, soft tissue infections, and urinary tract infections were 71, 50, 71, and 83 percent, respectively. Of five microbiologically proved superinfections, three were fungal, and one each was due to Klebsiella species and S. aureus. No toxicity was observed. For 12 organisms, the minimal inhibitory concentration was lower for ticarcillin plus clavulanate potassium than for ticarcillin alone; in six it was identical. Five organisms were resistant to both, and three that were resistant to ticarcillin were sensitive to ticarcillin plus clavulanate potassium. Ticarcillin plus clavulanate potassium is a safe drug with an expanded spectrum of activity. More therapeutic trials need to be conducted to better define its role in the therapy of serious infections in cancer patients.
由于替卡西林与克拉维酸联合使用对许多通常感染癌症患者的耐药菌具有活性，因此开展了一项用替卡西林二钠加克拉维酸钾治疗癌症患者感染的治疗性试验。共有127例可评估患者接受了这种抗生素治疗。其中，63%为乳腺癌女性患者，28%为白血病患者，其余为肉瘤和肺癌患者。治疗的中位持续时间为7.7天。有63例记录在案的感染，其中39例有细菌学记录。由于革兰氏阳性菌感染发生率高，且在其中两例中替卡西林加克拉维酸钾治疗失败，因此在治疗方案中加用了万古霉素。总体有效率为75%。在微生物学证实的感染中，有效率为79%。17例革兰氏阴性菌感染中有13例有效（76%），包括4例由铜绿假单胞菌引起的感染。该组中仅有的治疗失败病例为2例克雷伯菌属感染、1例大肠杆菌感染和1例肠杆菌属感染。在未使用万古霉素治疗的革兰氏阳性菌感染中，8例中有5例有效（63%），仅2例金黄色葡萄球菌感染和1例JK类白喉杆菌感染治疗失败。所有使用替卡西林加克拉维酸钾与万古霉素联合治疗的病例均有效。8例混合菌感染中有7例（88%）有效，73%的未明确病原体的感染也有效。败血症、肺炎、软组织感染和尿路感染的总体有效率分别为71%、50%、71%和83%。在5例微生物学证实的二重感染中，3例为真菌性感染，1例由克雷伯菌属引起，1例由金黄色葡萄球菌引起。未观察到毒性反应。对于12种微生物，替卡西林加克拉维酸钾的最低抑菌浓度低于单独使用替卡西林；6种微生物二者相同。5种微生物对二者均耐药，3种对替卡西林耐药的微生物对替卡西林加克拉维酸钾敏感。替卡西林加克拉维酸钾是一种安全的药物，抗菌谱有所扩大。需要开展更多治疗性试验以更好地明确其在癌症患者严重感染治疗中的作用。
