Treatment of candidemia and invasive candidiasis in the intensive care unit: post hoc analysis of a randomized, controlled trial comparing micafungin and liposomal amphotericin B.
Treatment of candidemia and invasive candidiasis in the intensive care unit: post hoc analysis of a randomized, controlled trial comparing micafungin and liposomal amphotericin B.
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DOI：
10.1186/cc8117
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发表时间：
2009
期刊：
影响因子：
--
通讯作者：
Yeldandi V
中科院分区：
文献类型：
--
作者：
Dupont BF;Lortholary O;Ostrosky-Zeichner L;Stucker F;Yeldandi V
侵袭性念珠菌病和念珠菌血症是重症监护病人中危及生命的医院感染。一项评估米卡芬净(受试者为100毫克/天；受试者为40公斤；受试者为2毫克/公斤/天)与脂质体两性霉素B(3毫克/公斤/天)的3期试验的事后分析。根据治疗第一天的病房类型确定亚组：重症监护病房(ICU)或非ICU。采用多因素回归分析确定与治疗结束时的治疗成功率和治疗第8天和第30天的全因死亡率相关的因素。在非ICU受试者中，米卡芬金组的治疗成功率显著高于两性霉素B脂质体(85%)和72.1%(P=0.0113)。然而，对于ICU受试者，米卡芬金组和两性霉素B脂质体的治疗成功率相似(62.5%(n=75)和66.4%(n=73/110)；P=0.5828)。总体而言，ICU患者的治疗成功率显著低于非ICU患者(64.3%和78.3%，P=0.0006)。多变量回归分析显示：ICU与非ICU受试者相比，治疗成功的可能性较低；持续性中性粒细胞减少；以及急性生理学和慢性健康评估(APACHE)II评分高与低。然而，当潜在解释因素之间的交互作用被包括在分析模型中时，ICU状态不再作为显著的关联变量出现，但APACHE II评分和治疗结果之间的关联仍然存在。进一步的分析表明，APACHE II评分较低的受试者在第8天和第30天死亡的可能性较低。在非重症监护室和重症监护室受试者中，米卡芬金组肾小球滤过率(ml/分钟/1.73m2)的平均峰值变化(ml/min/1.73m2)分别为-18.2%(P<；0.0001)和-17.7%(P=0.0124)。总体而言，ICU患者的两性霉素B和米卡芬金脂质体的治疗成功率均低于非ICU患者。控制潜在混杂因素后的多变量回归表明，APACHE II评分仍然是与治疗成功、第8天的死亡率和第30天的死亡率相关的潜在解释因素。专案分析-临床试验.gov试验NCT00106288。
Invasive candidiasis and candidemia are life-threatening nosocomial infections in intensive care patients. A post hoc analysis of a phase 3 trial assessing micafungin (100 mg/day for subjects > 40 kg; 2 mg/kg/day for subjects ≤ 40 kg) versus liposomal amphotericin B (3 mg/kg/day). Subgroups were defined according to the type of ward on the first day of treatment: intensive care unit (ICU) or non-ICU. Multivariate regression was performed to identify factors associated with treatment success at end of therapy and all-cause mortality at days 8 and 30. In non-ICU subjects, treatment success was significantly higher for micafungin versus liposomal amphotericin B (85% (n = 108/127) versus 72.1% (n = 98/136); P = 0.0113). However, for ICU subjects, treatment success rates for micafungin versus liposomal amphotericin B were similar (62.5% (n = 75/120) versus 66.4% (n = 73/110); P = 0.5828). Overall, treatment success was significantly lower in ICU subjects compared with non-ICU subjects (64.3% (n = 148/230) versus 78.3% (n = 206/263); P = 0.0006). Multivariate regression analysis revealed a lower likelihood of treatment success for: ICU versus non-ICU subjects; persistent neutropenia; and high versus low Acute Physiology and Chronic Health Evaluation (APACHE) II scores. However, when interactions between potential explanatory factors were included in the analysis model, ICU status no longer emerged as a significant associated variable but the association between APACHE II score and treatment outcome remained. Further analyses indicated that the likelihood of mortality at day 8 and day 30 was lower for subjects with lower APACHE II scores. Renal function was significantly better in micafungin versus liposomal amphotericin B subjects: a difference (liposomal amphotericin B - micafungin in mean peak change in estimated glomerular filtration rate (ml/minute/1.73 m2) of -18.2 (P < 0.0001) and -17.7 (P = 0.0124) in non-ICU and ICU subjects, respectively. Overall, ICU subjects had lower treatment success rates than non-ICU subjects for both liposomal amphotericin B and micafungin. Multivariate regression after controlling for potential confounding factors suggested the APACHE II score remained a potential explanatory factor associated with treatment success, mortality at day 8, and mortality at day 30. Post hoc analysis - clinicaltrials.gov trial NCT00106288.
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作者：
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