Corrado M L, Struble W E, Hesney M
Merck Sharp and Dohme Research Laboratories, West Point, Pennsylvania.
Eur J Cancer Clin Oncol. 1988;24 Suppl 1:S29-33.
Norfloxacin has been compared to placebo (136 patients), sulfamethoxazole plus trimethoprim (SXT, 72 patients) and oral vancomycin plus colistin (V/C, 61 patients) for the prevention of alimentary tract-associated infections during and after induction chemotherapy. These patients were evaluated for the safety and tolerability of each regimen by clinical and laboratory means. Most neutropenics involved, regardless of the regimen, experienced at least one adverse experience. The majority were felt to be unrelated to prophylactic study drug therapy. Of 139 patients who received norfloxacin, only two had drug-related adverse experiences, compared to two of 35 receiving SXT, five of 28 for VC, and none of 67 receiving placebo. In evaluating adverse experiences considered possibly drug related, 19 occurred on norfloxacin compared to 13 for placebo. Among neurologic adverse experiences, only one possibly related to norfloxacin occurred (confusion), while three occurred on placebo (confusion, decreased auditory acuity and hallucinations). Generally, no significant differences were seen between any of the regimens except for a higher frequency of diarrhea in those receiving V/C.
在诱导化疗期间及之后，对诺氟沙星与安慰剂（136例患者）、磺胺甲恶唑加甲氧苄啶（复方新诺明，72例患者）以及口服万古霉素加黏菌素（V/C，61例患者）预防消化道相关感染的效果进行了比较。通过临床和实验室手段对这些患者每种治疗方案的安全性和耐受性进行了评估。无论采用何种治疗方案，大多数中性粒细胞减少症患者都至少经历了一次不良事件。多数不良事件被认为与预防性研究药物治疗无关。在139例接受诺氟沙星治疗的患者中，只有2例出现与药物相关的不良事件，相比之下，接受复方新诺明治疗的35例中有2例，接受V/C治疗的28例中有5例，接受安慰剂治疗的67例中无1例出现相关不良事件。在评估可能与药物相关的不良事件时，接受诺氟沙星治疗的患者出现19例，接受安慰剂治疗的患者出现13例。在神经系统不良事件中，只有1例可能与诺氟沙星有关（意识模糊），而接受安慰剂治疗的患者出现3例（意识模糊、听力减退和幻觉）。总体而言，除了接受V/C治疗的患者腹泻发生率较高外，各治疗方案之间未见显著差异。
