Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
J Clin Oncol. 2011 Oct 20;29(30):3977-83. doi: 10.1200/JCO.2011.35.0884. Epub 2011 Sep 19.
Febrile neutropenia commonly complicates cancer chemotherapy. Outpatient treatment may reduce costs and improve patient comfort but risk progression of undetected medical problems.
By using our validated algorithm, we identified medically stable inpatients admitted for febrile neutropenia (neutrophils < 500/μL) after chemotherapy and randomly assigned them to continued inpatient antibiotic therapy or early discharge to receive identical antibiotic treatment at home. Our primary outcome was the occurrence of any serious medical complication, defined as evidence of medical instability requiring urgent medical attention.
We enrolled 117 patients with 121 febrile neutropenia episodes before study termination for poor accrual. We excluded five episodes as ineligible and three because of inadequate documentation of the study outcome. Treatment groups were clinically similar, but sociodemographic imbalances occurred because of block randomization. The median presenting absolute neutrophil count was 100/μL. Hematopoietic growth factors were used in 38% of episodes. The median neutropenia duration was 4 days (range, 1 to 15 days). Five outpatients were readmitted to the hospital. Major medical complications occurred in five episodes (8%) in the hospital arm and four (9%) in the home arm (95% CI for the difference, -10% to 13%; P = .56). No study patient died. Patient-reported quality of life was similar on both arms.
We found no evidence of adverse medical consequences from home care, despite a protocol designed to detect evidence of clinical deterioration. These results should reassure clinicians who elect to treat rigorously characterized low-risk patients with febrile neutropenia in suitable outpatient settings with appropriate surveillance for unexpected clinical deterioration.
发热性中性粒细胞减少症常并发于癌症化疗。门诊治疗可降低成本并提高患者舒适度,但存在未检出医疗问题进展的风险。
我们使用经过验证的算法,确定了在接受化疗后因发热性中性粒细胞减少症(中性粒细胞 < 500/μL)而入院的医学稳定的住院患者,并将其随机分配到继续住院接受抗生素治疗或提前出院,在家中接受相同的抗生素治疗。我们的主要结局是发生任何严重的医疗并发症,定义为需要紧急医疗关注的医疗不稳定证据。
在因入组人数不足而终止研究之前,我们共纳入了 117 名患者的 121 例发热性中性粒细胞减少症发作。我们排除了 5 例因不符合条件和 3 例因研究结果记录不足而不合格的发作。治疗组在临床上相似,但由于分组随机化,存在社会人口统计学不平衡。就诊时的绝对中性粒细胞计数中位数为 100/μL。有 38%的发作使用了造血生长因子。中性粒细胞减少症的中位数持续时间为 4 天(范围 1 至 15 天)。有 5 名门诊患者再次入院。在住院组中,有 5 例(8%)和在家庭组中有 4 例(9%)(医院组与家庭组差异的 95%置信区间为-10%至 13%;P =.56)发生主要医疗并发症。没有研究患者死亡。两组患者的报告的生活质量相似。
尽管我们的方案旨在检测临床恶化的证据,但我们未发现家庭护理带来不良医疗后果的证据。这些结果应该使选择在适当的门诊环境中治疗具有严格特征的低风险发热性中性粒细胞减少症患者并对意外临床恶化进行适当监测的临床医生感到放心。