Division of Digestive Surgery, Amiens University Medical Center, Amiens, France2Jules Verne University of Picardie, Unit EA4294, Amiens, France3Clinical Research Center, Amiens University Medical Center, Amiens, France.
Division of Digestive Surgery, Amiens University Medical Center, Amiens, France.
JAMA. 2014 Jul;312(2):145-54. doi: 10.1001/jama.2014.7586.
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.
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.
After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days.
The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit.
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.
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.
clinicaltrials.gov Identifier: NCT01015417.
90%的急性结石性胆囊炎病例为轻度（I 级）或中度（II 级）严重程度。虽然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效果数据很少。
确定胆囊切除术后使用阿莫西林克拉维酸后的感染率。
设计、地点和患者：2010 年 5 月至 2012 年 8 月，在 17 家医疗中心治疗的 414 例 I 级或 II 级急性结石性胆囊炎患者，在住院期间和手术时每天接受 2 克阿莫西林克拉维酸 3 次，随机分为术后开放性、非劣效性、随机临床试验。
手术后，不使用抗生素或继续术前抗生素方案，每日 3 次，连用 5 天。
记录术前或术后 4 周随访时的术后手术部位或远处感染比例。
对 414 例患者进行意向治疗分析表明，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，1.93%；95%CI，-8.98%至 5.12%）。在包含 338 例患者的方案分析中，相应的感染率均为 13%（绝对差异，0.3%；95%CI，-5.0%至 6.3%）。基于 11%的非劣效性边界，术后不使用抗生素治疗与抗生素治疗相比，结局没有恶化。胆汁培养显示，60.9%无病原体。两组的 Clavien 并发症严重程度结果相似：未治疗组 195 例（94.2%）患者评分 0 至 I 级，2 例（0.97%）患者评分 III 至 V 级，抗生素组 182 例（87.8%）患者评分 0 至 I 级，4 例（1.93%）患者评分 III 至 V 级。
在接受术前和术中抗生素治疗的轻度或中度结石性胆囊炎患者中，术后不使用阿莫西林克拉维酸治疗并未导致术后感染发生率增加。
clinicaltrials.gov 标识符：NCT01015417。
