Invasive candidiasis treated in the intensive care unit: Observations from a randomized clinical trial

Invasive candidiasis treated in the intensive care unit: Observations from a randomized clinical trial
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DOI:
10.1016/j.jcrc.2006.11.004
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发表时间:
2007-09-01
影响因子:
3.7
通讯作者:
Kartsonis, Nicholas A.
Kartsonis, Nicholas A.
中科院分区:
医学3区
文献类型:
--
作者:
DiNubile, Mark J.;Lupinacci, Robert J.;Kartsonis, Nicholas A.

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目的:本研究的目的是比较在重症监护病房 (ICU) 治疗的侵袭性念珠菌病患者与在 ICU 外治疗的侵袭性念珠菌病患者的危险因素、微生物学和结果,并描述卡泊芬净对 ICU 患者的治疗结果。 材料和方法:作为双盲随机试验的一部分,我们回顾性地确定了在 ICU 接受第一剂研究药物的有记录的侵袭性念珠菌病患者。参与者在进入时并未根据其 ICU 状态进行分层。患者接受卡泊方净(70 mg负荷剂量后50 mg/d)或传统两性霉素B(每天0.6-1.0 mg/kg)治疗10至14天。良好的反应需要消除体征和症状以及根除念珠菌病原体。结果:在 224 名患者中,97 名 (43%) 在 ICU 中接受了第一剂研究药物。大多数患者具有众所周知的侵袭性念珠菌病危险因素,包括广谱抗生素、中心静脉导管和营养过剩。与非 ICU 患者相比,ICU 患者近期手术更为常见,而恶性肿瘤、中性粒细胞减少症和免疫抑制则较少见。 81% 的 ICU 患者和 84% 的非 ICU 患者出现念珠菌血症。 ICU 患者与非 ICU 患者的良好缓解率分别为:卡泊芬净 68%(95% 置信区间 [CI] = 53%、82%) vs 77%(95% CI = 67%、87%);两性霉素为 56%(95% CI = 43%、69%) vs 67%(95% CI = 55%、79%) B. 在考虑了 APACHE(急性生理学和慢性健康评估)II 评分、中性粒细胞减少症状态和地理区域的差异后,我们发现在 ICU 内开始研究治疗的患者仍然比在 ICU 外开始研究治疗的患者更有可能死亡。对于 ICU 患者,卡泊芬净接受者的全因死亡率为 45%(95% CI = 30%、60%),两性霉素 B 接受者为 40%(95% CI = 28%、53%),而卡泊芬净接受者的全因死亡率为 5%(95% CI = 0%、12%)和 11%。 (95% CI = 3%, 19%) 对于两性霉素 B 接受者。总体而言,与非 ICU 患者相比,ICU 患者报告的药物相关不良事件较少。结论:在接受抗真菌治疗的 ICU 患者中,侵袭性念珠菌病与大量死亡率相关,但大多数死亡不能直接归因于这种感染。 (C) 2007 年,爱思唯尔公司出版。
Objectives: The objectives of this study were to contrast risk factors, microbiology, and outcomes in patients with invasive candidiasis treated in an intensive care unit (ICU) with those in patients with invasive candidiasis treated outside an ICU and to describe therapeutic results with caspofungin in ICU patients.Materials and Methods: We retrospectively identified patients with documented invasive candidiasis who received their first dose of the study drug in the ICU as part of a double-blind randomized trial. Participants were not stratified at entry by their ICU status. Patients received caspofangin (50 mg/d after a 70-mg loading dose) or conventional amphotericin B (0.6-1.0 mg/kg per day) for 10 to 14 days. A favorable response required resolution of signs and symptoms as well as eradication of Candida pathogens.Results: Of the 224 patients, 97 (43%) received their first dose of the study drug in the ICU. Most patients had well-recognized risk factors for invasive candidiasis, including broad-spectrum antibiotics, central venous catheters, and hyperalimentation. Recent surgery was more common whereas malignancy, neutropenia, and immunosuppression were less common among ICU patients than among non-ICU patients. Candidemia was demonstrated in 81% of ICU patients and in 84% of non-ICU patients. Favorable response rates in the ICU patients vs the non-ICU patients were 68% (95% confidence interval [CI] = 53%, 82%) vs 77% (95% CI = 67%, 87%) for caspofungin and 56% (95% CI = 43%, 69%) vs 67% (95% CI = 55%, 79%) for amphotericin B. After accounting for differences in APACHE (Acute Physiology and Chronic Health Evaluation) II score, neutropenia status, and geographic region, we found that patients initiating the study therapy in an ICU were still more likely to die than patients initiating study therapy outside an ICU. For ICU patients, all-cause mortality rates were 45% (95% CI = 30%, 60%) for caspofangin recipients and 40% (95% CI = 28%, 53%) for amphotericin B recipients, whereas candidiasis-attributable mortality rates were 5% (95% CI = 0%, 12%) for caspofungin recipients and 11% (95% CI = 3%, 19%) for amphotericin B recipients. Overall, drug-related adverse events were reported less often among the ICU patients than among the non-ICU patients.Conclusions: In ICU patients treated with antifungal therapy, invasive candidiasis is associated with substantial mortality, but most deaths cannot be directly attributed to this infection. (C) 2007 Published by Elsevier Inc.