Marra C A, Frighetto L, Quaia C B, de Lemos M L, Warkentin D I, Marra F, Jewesson P J
CSU Pharmaceutical Sciences, Vancouver Hospital and Health Sciences Centre, British Columbia, Canada.
Pharmacotherapy. 2000 Aug;20(8):931-40. doi: 10.1592/phco.20.11.931.35258.
To determine treatment outcomes and economic impact of a ciprofloxacin stepdown program for high-risk febrile neutropenic adults from the hospital's perspective.
Unblinded, two-phase, single-center study.
Adult leukemia and stem cell transplant unit.
High-risk adults with febrile neutropenia.
Two conditions were analyzed: a multidisciplinary ciprofloxacin stepdown program involving a reduction in parenteral ciprofloxacin dose from 400 to 200 mg (i.v.-i.v.) and conversion to oral ciprofloxacin (i.v.-p.o.) when criteria were met; and no i.v.-i.v. stepdown program.
Forty-six sequential treatment courses were compared with 42 treatment course from 6-month periods in preintervention (P1) and postintervention (P2) phases. Assessed parameters were clinical and microbiologic outcomes, adverse drug reactions (ADRs), and direct medical resource use and costs (1998 $Canadian) for the episode of febrile neutropenia. A decision analytic model was used to map probabilities and costs and to conduct sensitivity analyses. To supplement standard statistical testing, 1,000 bootstrap samples were created, and the mean cost difference was calculated between phases for each sample. Patient demographics, percentage i.v.-p.o. stepdown, and duration of therapy were similar between phases. Clinical success (83% P1, 81% P2), microbiologic eradication (15% P1, 24% P2), and possible ADRs (6% P1, 9% P2) did not differ. Intravenous-to-intravenous dose stepdown occurred in 33% of P2 and no P1 treatment courses (p<0.001). Resource use and costs were similar between phases, although a reduction was seen in the drug's mean total cost/day ($58 P1, $52 P2, p=0.04). There was also a trend toward a decrease in mean total treatment costs ($4,843 P1, $3,493 P2, p=0.08). In 1,000 bootstrap samples, 99.8% showed a cost advantage for P2. The model was robust to sensitivity analyses.
This intervention influenced administration of ciprofloxacin without apparent compromise of patient outcomes and resulted in a reduction in total costs of treating febrile neutropenia.
从医院角度确定环丙沙星降阶梯方案对高危发热性中性粒细胞减少症成人患者的治疗效果和经济影响。
非盲法、两阶段、单中心研究。
成人白血病和干细胞移植科。
高危发热性中性粒细胞减少症成人患者。
分析了两种情况：一种是多学科环丙沙星降阶梯方案，包括将静脉注射环丙沙星剂量从400毫克降至200毫克（静脉-静脉），并在符合标准时转换为口服环丙沙星（静脉-口服）；另一种是无静脉-静脉降阶梯方案。
将46个连续治疗疗程与干预前（P1）和干预后（P2）阶段6个月期间的42个治疗疗程进行比较。评估参数包括临床和微生物学结果、药物不良反应（ADR）以及发热性中性粒细胞减少症发作的直接医疗资源使用和成本（1998加元）。使用决策分析模型绘制概率和成本，并进行敏感性分析。为补充标准统计测试，创建了1000个自抽样样本，并计算每个样本各阶段之间的平均成本差异。各阶段患者人口统计学、静脉-口服降阶梯百分比和治疗持续时间相似。临床成功率（P1为83%，P2为81%）、微生物清除率（P1为15%，P2为24%）和可能的ADR（P1为6%，P2为9%）无差异。P2阶段33%的治疗疗程发生了静脉-静脉剂量降阶梯，P1阶段无此情况（p<0.001）。各阶段资源使用和成本相似，尽管药物平均每日总成本有所降低（P1为58加元，P2为52加元，p=0.04）。平均总治疗成本也有下降趋势（P1为4843加元，P2为3493加元，p=0.08）。在1000个自抽样样本中，99.8%显示P2具有成本优势。该模型对敏感性分析具有稳健性。
该干预措施影响了环丙沙星的给药方式，且未明显损害患者治疗效果，同时降低了发热性中性粒细胞减少症的治疗总成本。
