Effect of Postoperative Antibiotic Administration on Postoperative Infection Following Cholecystectomy for Acute Calculous Cholecystitis A Randomized Clinical Trial
Effect of Postoperative Antibiotic Administration on Postoperative Infection Following Cholecystectomy for Acute Calculous Cholecystitis A Randomized Clinical Trial
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DOI：
10.1001/jama.2014.7586
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发表时间：
2014-07-09
影响因子：
120.7
通讯作者：
Pocard, Marc
中科院分区：
文献类型：
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作者：
Regimbeau, Jean Marc;Fuks, David;Pocard, Marc
重要性90%的急性结石性胆囊炎病例的严重程度为轻度（I级）或中度（II级）。尽管急性结石性胆囊炎的术前和术中抗生素管理已经标准化，但术后抗生素治疗的实用性数据很少。目的确定术后阿莫西林联合克拉维酸对胆囊切除术后感染率的影响。在17个医疗中心治疗的I级或II级急性结石性胆囊炎患者共414例，接受2 g阿莫西林加克拉维酸3次在2010年5月至2012年8月期间，在手术前住院一天和手术时一次，在手术后随机分配至开放标签、非劣效性、随机临床试验。干预手术后，主要结果和指标：术前或术后1个月内记录的手术部位或远处感染的比例4周随访。结果：对414例患者进行的插补意向治疗分析显示，未治疗组的术后感染率为17%（35/207），抗生素组为15%（31/207）（绝对差异为1.93%; 95%CI为-8.98%至5.12%）。在涉及338例患者的符合方案分析中，相应的发生率均为13%（绝对差异，0.3%; 95% CI，-5.0%至6.3%）。基于11%的非劣效性界值，术后缺乏抗生素治疗与抗生素治疗相比结局更差无关。胆汁培养显示60.9%无病原体。两组的Clavien并发症严重程度结局相似：195例患者未治疗组94.2%的患者评分为0 ~ 1分，（0.97%）的评分为III至V，182例患者抗生素组0 ~ 1分者占87.8%，（1.93%）的评分为III至V。结论和相关性在术前和术中接受抗生素治疗的轻度或中度结石性胆囊炎患者中，缺乏阿莫西林加克拉维酸的术后治疗并没有导致术后感染的发生率增加。
IMPORTANCE Ninety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment.OBJECTIVE To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy.DESIGN, SETTING, AND PATIENTS A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012.INTERVENTIONS After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days.MAIN OUTCOMES AND MEASURES The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit. RESULTS An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17%(35 of 207) in the nontreatment group and 15%(31 of 207) in the antibiotic group (absolute difference, 1.93%; 95% CI, -8.98% to 5.12%). In the per-protocol analysis, which involved 338 patients, the corresponding rates were both 13%(absolute difference, 0.3%; 95% CI, -5.0% to 6.3%). Based on a noninferiority margin of 11%, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment. Bile cultures showed that 60.9% were pathogen free. Both groups had similar Clavien complication severity outcomes: 195 patients (94.2%) in the nontreatment group had a score of 0 to I and 2 patients (0.97%) had a score of III to V, and 182 patients (87.8%) in the antibiotic group had a score of 0 to I and 4 patients (1.93%) had a score of III to V.CONCLUSIONS AND RELEVANCE Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections.