A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections.
A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections.
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胃肠道手术后，一项预防侵入性念珠菌病的预先抗真菌治疗的随机，安慰剂对照试验。
DOI：
10.1093/cid/civ707
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发表时间：
2015-12-01
期刊：
影响因子：
--
通讯作者：
Cornely OA
中科院分区：
文献类型：
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作者：
Knitsch W;Vincent JL;Utzolino S;François B;Dinya T;Dimopoulos G;Özgüneş İ;Valía JC;Eggimann P;León C;Montravers P;Phillips S;Tweddle L;Karas A;Brown M;Cornely OA
因腹腔内感染而接受紧急胃肠手术的患者是侵袭性念珠菌病的高危人群。这项探索性临床试验不能提供证据表明先发制人的抗真菌治疗策略对该患者组有效。背景。因腹腔内感染而接受紧急胃肠手术的患者有侵袭性念珠菌病（IC）的风险，需要先发制人的抗真菌治疗。方法。这项探索性、随机、双盲、安慰剂对照试验评估了米卡芬净（100mg /d）先发制人抗真菌治疗需要手术治疗腹部感染的重症监护病房患者的方法。主要疗效变量为全分析组中IC的发生率和从基线到第一次IC的时间；独立数据审查委员会确认了IC。使用逻辑回归进行探索性生物标志物分析。结果。完整的分析集包括124名安慰剂组和117名米卡芬治疗组的患者。安慰剂组IC发生率为8.9%，米卡芬净组为11.1%（差异为2.24%；[95%可信区间，−5.52至10.20]）。两组之间发生IC的中位时间没有差异。估计比值比显示，(1,3)-β-d-葡聚糖（ßDG）阳性的患者确诊IC的可能性是阴性患者的3.66倍（95%可信区间，1.01-13.29）。结论。本研究无法提供证据表明，在高危外科重症监护病房腹腔感染患者中，先发制人地给予棘白菌素对预防IC有效。这可能是因为给药太晚，无法预防IC，加上IC事件的总体数量较少。它确实为使用ßDG识别IC高风险患者提供了一些支持。临床试验注册号NCT01122368。
Patients undergoing emergency gastrointestinal surgery for intra-abdominal infection are at high risk for invasive candidiasis. This exploratory clinical trial could not provide evidence that a preemptive antifungal treatment strategy was effective in this patient group. Background. Patients undergoing emergency gastrointestinal surgery for intra-abdominal infection are at risk of invasive candidiasis (IC) and candidates for preemptive antifungal therapy. Methods. This exploratory, randomized, double-blind, placebo-controlled trial assessed a preemptive antifungal approach with micafungin (100 mg/d) in intensive care unit patients requiring surgery for intra-abdominal infection. Coprimary efficacy variables were the incidence of IC and the time from baseline to first IC in the full analysis set; an independent data review board confirmed IC. An exploratory biomarker analysis was performed using logistic regression. Results. The full analysis set comprised 124 placebo- and 117 micafungin-treated patients. The incidence of IC was 8.9% for placebo and 11.1% for micafungin (difference, 2.24%; [95% confidence interval, −5.52 to 10.20]). There was no difference between the arms in median time to IC. The estimated odds ratio showed that patients with a positive (1,3)-β-d-glucan (ßDG) result were 3.66 (95% confidence interval, 1.01–13.29) times more likely to have confirmed IC than those with a negative result. Conclusions. This study was unable to provide evidence that preemptive administration of an echinocandin was effective in preventing IC in high-risk surgical intensive care unit patients with intra-abdominal infections. This may have been because the drug was administered too late to prevent IC coupled with an overall low number of IC events. It does provide some support for using ßDG to identify patients at high risk of IC. Clinical Trials Registration. NCT01122368.