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高危穿透性中空脏器损伤围手术期抗生素的使用:一项24小时与5天的前瞻性随机双盲安慰剂对照试验

Perioperative antibiotic use in high-risk penetrating hollow viscus injury: a prospective randomized, double-blind, placebo-control trial of 24 hours versus 5 days.

作者信息

Kirton O C, O'Neill P A, Kestner M, Tortella B J

机构信息

University of Miami, Jackson Memorial Medical Center, Florida, USA.

出版信息

J Trauma. 2000 Nov;49(5):822-32. doi: 10.1097/00005373-200011000-00006.

DOI:10.1097/00005373-200011000-00006
PMID:11086771
Abstract

BACKGROUND

The purpose of this study was to compare the safety and therapeutic efficacy of a 24-hour versus 5-day course of ampicillin/sulbactam for the prevention of postoperative infections in high-risk patients sustaining hollow viscus injury from penetrating abdominal trauma.

METHODS

A total of 317 patients from four Level I trauma centers with penetrating abdominal injuries and at least one hollow viscus perforation each received one preoperative and three postoperative doses of ampicillin/sulbactam 3 g intravenously. After receiving 24 hours of unblinded ampicillin/sulbactam, patients were then randomized into one of two groups. Group 1 received 4 additional days of blinded ampicillin/sulbactam (5 days total of antibiotic), and Group 2 received 4 days of placebo (24 hours of antibiotic). Patients were assessed postoperatively for occurrence of deep surgical-site infections (intra-abdominal abscess, fasciitis, and peritonitis) and superficial (wound) surgical-site infections. Development of nonsurgical-site infections (e.g., pneumonia, urinary tract infection, phlebitis, and cellulitis) was also recorded. Continuous variables were analyzed by analysis of variance and discrete variables by the Cochran-Mantel-Haenszel chi2 test. Multivariate logistic regression analyses were also performed to identify independent risk factors for postoperative infection.

RESULTS

A total of 159 patients were randomized into Group 1, and 158 patients were randomized into Group 2. The Injury Severity Score and penetrating abdominal trauma index were 18+/-8 and 21+/-13, respectively, for Group 1 and 18+/-9 and 20+/-15, respectively, for Group 2. A total of 162 (51%) patients sustained one or more colon injuries (82 in Group 1 and 80 in Group 2). There were 16 (10%) surgical-site infections in Group 1 and 13 (8%) surgical-site infections in Group 2 (p = 0.74). Group 1 patients experienced 17 (11%) nonsurgical-site infections, whereas Group 2 had 32 (20%) nonsurgical-site infections. This difference, however, was not statistically significant (p = 0.16). Only the total number of blood units transfused and the presence of a PATI score greater than or equal to 25 were found to be independently associated with the development of a postoperative surgical- and nonsurgical-site infections (p = 0.001 and p = 0.003, respectively). Of note, the presence of a colon injury was not found to be an independent risk factor (p = 0.11) for either surgical or nonsurgical site postoperative infection in our study.

CONCLUSION

High-risk patients with colon or other hollow viscus injuries from penetrating abdominal trauma are at no greater risk for surgical-site or nonsurgical-site infection when treated with only a 24-hour course of a broad-spectrum antibiotic.

摘要

背景

本研究旨在比较24小时疗程与5天疗程的氨苄西林/舒巴坦预防腹部穿透性创伤致中空脏器损伤的高危患者术后感染的安全性和治疗效果。

方法

来自四个一级创伤中心的317例腹部穿透伤且至少有一处中空脏器穿孔的患者,均接受术前及术后三次静脉注射3g氨苄西林/舒巴坦。在接受24小时非盲法氨苄西林/舒巴坦治疗后,患者被随机分为两组。第1组额外接受4天盲法氨苄西林/舒巴坦治疗(抗生素总疗程5天),第2组接受4天安慰剂治疗(抗生素疗程24小时)。术后评估患者深部手术部位感染(腹腔内脓肿、筋膜炎和腹膜炎)及浅表(伤口)手术部位感染的发生情况。同时记录非手术部位感染(如肺炎、尿路感染、静脉炎和蜂窝织炎)的发生情况。连续变量采用方差分析,离散变量采用Cochran-Mantel-Haenszel卡方检验进行分析。还进行了多因素逻辑回归分析以确定术后感染的独立危险因素。

结果

共159例患者被随机分为第1组,158例患者被随机分为第2组。第1组的损伤严重程度评分和腹部穿透伤指数分别为18±8和21±13,第2组分别为18±9和20±15。共有162例(51%)患者发生一处或多处结肠损伤(第1组82例,第2组80例)。第1组有16例(10%)手术部位感染,第2组有13例(8%)手术部位感染(p = 0.74)。第1组患者发生17例(11%)非手术部位感染,而第2组有32例(20%)非手术部位感染。然而,这种差异无统计学意义(p = 0.16)。仅发现输注的血液单位总数以及PATI评分大于或等于25与术后手术部位和非手术部位感染的发生独立相关(分别为p = 0.001和p = 0.003)。值得注意的是,在我们的研究中,结肠损伤的存在并非手术或非手术部位术后感染的独立危险因素(p = 0.11)。

结论

腹部穿透性创伤致结肠或其他中空脏器损伤的高危患者,仅接受24小时疗程的广谱抗生素治疗时,发生手术部位或非手术部位感染的风险不会更高。

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