Influence of combined intravenous and topical antibiotic prophylaxis on the incidence of infections, organ dysfunctions, and mortality in critically ill surgical patients - A prospective, stratified, randomized, double-blind, placebo-controlled clinical trial
Influence of combined intravenous and topical antibiotic prophylaxis on the incidence of infections, organ dysfunctions, and mortality in critically ill surgical patients - A prospective, stratified, randomized, double-blind, placebo-controlled clinical trial
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DOI：
10.1164/rccm.2105141
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发表时间：
2002-10-15
影响因子：
24.7
通讯作者：
Unertl, KE
中科院分区：
文献类型：
--
作者：
Krueger, WA;Lenhart, FP;Unertl, KE
我们前瞻性地研究了抗生素预防方案对以外科和创伤重症监护室（ICU）为主的人群的感染发生率、器官功能障碍和死亡率的影响。共入组546例患者，并根据急性生理学和慢性健康评价（APACHE）-II评分进行分层。然后，他们被随机分配接受2 x 400 mg环丙沙星静脉注射4天，以及在ICU期间将局部庆大霉素和多粘菌素混合物应用于鼻孔，口腔和胃部，或接受静脉注射和局部安慰剂。当接受预防时，获得感染的患者明显减少（p = 0.001，风险比[RR]，0.477; 95%置信区间[CI]，0.367-0.620），尤其是肺炎（6 vs 29，p = 0.007），其他下呼吸道感染（39与70，p = 0.007）、血液感染（14与36，p = 0.007）或尿路感染（36与60，p = 0.0412）。此外，获得严重器官功能障碍的患者显著较少（63例患者vs 96例患者，p = 0.0051; RR，0.636; 95% CI，0.463-0.874），尤其是肾功能障碍（17例患者vs 38例患者; p = 0.018）。入院后5天内，每组有24例患者死亡，而此后接受预防性治疗的28例患者和接受安慰剂的51例患者在ICU死亡（p = 0.0589; RR，0.640; 95%CI，0.402-1.017）。总体ICU死亡率无统计学差异（52例对75例死亡），但对于237例入院时APACHE-II评分为20-29的中等水平患者，死亡率显著降低（20例vs 38例死亡，p = 0.0147; RR，0.508; 95% CI，0.295-0.875）; 1年后仍有有利趋势（51例vs 60例死亡; p = 0.0844; RR，0.720; 95% CI，0.496-1.046）。气管支气管、口咽和胃分泌物以及直肠拭子的监测培养物未显示接受预防治疗的患者中选择耐药微生物的任何证据。
We prospectively studied the impact of an antibiotic prophylaxis regimen on the incidence of infections, organ dysfunctions, and mortality in a predominantly surgical and trauma intensive care unit (ICU) population. A total of 546 patients were enrolled and stratified according to Acute Physiology and Chronic Health Evaluation (APACHE)-II scores. They were then randomized to receive either 2 x 400 mg of intravenous ciprofloxacin for 4 days, together with a mixture of topical gentamicin and polymyxin applied to the nostrils, mouth, and stomach throughout their ICU stay or to receive intravenous and topical placebo. When receiving prophylaxis, significantly fewer patients acquired infections (p = 0.001, risk ratio [RR], 0.477; 95% confidence interval [CI], 0.367-0.620), especially pneumonias (6 versus 29, p = 0.007), other lower respiratory tract infections (39 versus 70, p = 0.007), bloodstream infections (14 versus 36, p = 0.007), or urinary tract infections (36 versus 60, p = 0.0412). Also, significantly fewer patients acquired severe organ dysfunctions (63 versus 96 patients, p = 0.0051; RR, 0.636; 95% CI, 0.463-0.874), especially renal dysfunctions (17 versus 38; p = 0.018). Within 5 days after admission, 24 patients died in each group, whereas 28 patients receiving prophylaxis and 51 receiving placebo died in the ICU thereafter (p = 0.0589; RR, 0.640; 95% CI, 0.402-1.017). The overall ICU mortality was not statistically different (52 versus 75 fatalities), but the mortality was significantly reduced for 237 patients of the midrange stratum with APACHE-II scores of 20-29 on admission (20 versus 38 fatalities, p = 0.0147; RR, 0.508; 95% CI, 0.295-0.875); there was still a favorable trend after 1 year (51 versus 60 fatalities; p = 0.0844; RR, 0.720; 95% CI, 0.496-1.046). Surveillance cultures from tracheobronchial, oropharyngeal, and gastric secretions and from rectal swabs did not show any evidence for the selection of resistant microorganisms in the patients receiving prophylaxis.