Department of Pharmacy, Jackson Health System, Miami, Florida.
Department of Pharmacy Practice and Science, University of Maryland School of Pharmacy, Baltimore, Maryland.
Pharmacotherapy. 2020 May;40(5):398-407. doi: 10.1002/phar.2393. Epub 2020 Apr 21.
Data on the impact of combination therapy (intravenous metronidazole [IV MTZ] plus oral vancomycin [PO VAN]) on clinical outcomes in intensive care unit (ICU) patients with severe non-fulminant Clostridioides difficile infection (CDI), including NAP1-positive samples, are lacking.
Retrospective observational cohort of adult patients who developed CDI in the ICU diagnosed with severe non-fulminant CDI who received PO VAN. Patients with an order for IV MTZ started within 72 hours of PO VAN and who received at least 72 hours of combined therapy composed the combination therapy group. A subset of patients had stool samples collected for NAP1 testing. An additional subset was matched by Acute Physiology and Chronic Health Evaluation (APACHE) II scores. The primary outcome was inpatient all-cause mortality within 30 days of CDI diagnosis.
A total of 138 patients were included with 60 (43.5%) patients in the combination group. Compared with the PO VAN group, those in the combination group had higher white blood cell counts at diagnosis (15.9 [interquartile range (IQR) 10.2-21.1] vs 20.9 [IQR 16.2-29] cells/mm , p<0.001), respectively. Overall inpatient mortality was higher in the combination group, but 30-day mortality was not significantly different between groups (12.8% monotherapy vs 18.3% combination, p=0.371). This finding was the same for the 96 patients in the APACHE II-matched subgroup, 14.6% monotherapy versus 18.8% combination, p=0.785. NAP1 testing was completed in 42 patients; 11 were positive (26.2%). Patients who were NAP1 positive were more likely to receive IV MTZ (54.5% vs 19.4%, p=0.026).
Compared with PO VAN, combination therapy with IV MTZ was not associated with better clinical outcomes in severe non-fulminant CDI in ICU patients.
关于联合治疗（静脉甲硝唑 [IV MTZ] 加口服万古霉素 [PO VAN]）对重症非暴发性艰难梭菌感染（CDI），包括 NAP1 阳性样本的 ICU 患者的临床结局的影响的数据尚缺乏。
对 ICU 中诊断为重症非暴发性 CDI 且接受 PO VAN 治疗的成年患者进行回顾性观察队列研究。患者在接受 PO VAN 后 72 小时内开始接受 IV MTZ 治疗，且接受至少 72 小时联合治疗的患者纳入联合治疗组。部分患者采集粪便样本进行 NAP1 检测。另一部分患者按照急性生理学和慢性健康评估（APACHE）II 评分进行匹配。主要结局为 CDI 诊断后 30 天内的住院全因死亡率。
共纳入 138 例患者，其中 60 例（43.5%）患者接受联合治疗。与 PO VAN 组相比，联合治疗组患者的诊断时白细胞计数更高（15.9 [四分位距 10.2-21.1] 与 20.9 [四分位距 16.2-29] 细胞/mm 3 ，p<0.001）。联合治疗组的总体住院死亡率较高，但 30 天死亡率在两组之间无显著差异（单药治疗组 12.8%，联合治疗组 18.3%，p=0.371）。在 APACHE II 匹配亚组的 96 例患者中也观察到了相同的结果，单药治疗组 14.6%，联合治疗组 18.8%，p=0.785。42 例患者完成了 NAP1 检测；其中 11 例为阳性（26.2%）。NAP1 阳性患者更有可能接受 IV MTZ 治疗（54.5% vs 19.4%，p=0.026）。
与 PO VAN 相比，重症非暴发性 CDI 的 ICU 患者接受 IV MTZ 联合治疗并未改善临床结局。
