择期腹腔镜结直肠手术中口服及肠外联合与单纯肠外抗生素预防治疗（JMTO PREV 07 - 01）：一项3期、多中心、开放标签的随机试验

Oral and Parenteral Versus Parenteral Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery (JMTO PREV 07-01): A Phase 3, Multicenter, Open-label, Randomized Trial.

作者信息

Hata Hiroaki, Yamaguchi Takashi, Hasegawa Suguru, Nomura Akinari, Hida Koya, Nishitai Ryuta, Yamanokuchi Satoshi, Yamanaka Takeharu, Sakai Yoshiharu

机构信息

*Department of Surgery, National Hospital Organization, Kyoto Medical Centre, Kyoto, Japan†Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan‡Department of Surgery, Faculty of Medicine, Saga University, Saga, Japan§Department of Surgery, Digestive Disease Centre, Kyoto Katsura Hospital, Kyoto, Japan¶Department of Surgery, Osaka Red Cross Hospital, Osaka, Japan||Department of Biostatistics and Epidemiology, Graduate school of Medicine, Yokohama City University, Yokohama, Japan.

出版信息

Ann Surg. 2016 Jun;263(6):1085-91. doi: 10.1097/SLA.0000000000001581.

DOI:10.1097/SLA.0000000000001581

PMID:26756752

Abstract

OBJECTIVE

To confirm the efficacy of oral and parenteral antibiotic prophylaxis (ABX) in the elective laparoscopic colorectal surgery.

BACKGROUND

There is no evidence for the establishment of an optimal ABX regimen for laparoscopic colorectal surgery, which has become an important choice for the colorectal cancer patients.

METHODS

The colorectal cancer patients scheduled to undergo laparoscopic surgery were eligible for this multicenter, open-label, randomized trial. They were randomized to receive either oral and parenteral prophylaxis (1 g cefmetazole before and every 3 h during the surgery plus 1 g oral kanamycin and 750 mg metronidazole twice on the day before the surgery; Oral-IV group) or parenteral prophylaxis alone (the same IV regimen; IV group). The primary endpoint was the incidence of surgical site infections (SSIs). Secondary endpoints were the incidence rates of Clostridium difficile colitis, other infections, and postoperative noninfectious complications, as well as the frequency of isolating specific organisms.

RESULTS

Between November 2007 and December 2012, 579 patients (289 in the Oral-IV group and 290 in IV group) were evaluated for this study. The incidence of SSIs was 7.26% (21/289) in the Oral-IV group and 12.8% (37/290) in the IV group with an odds ratio of 0.536 (95% CI, 0.305-0.940; P = 0.028). The 2 groups had similar incidence rates of C difficile colitis (1/289 vs 3/290), other infections (6/289 vs 5/290), and postoperative noninfectious complications (11/289 vs 12/290).

CONCLUSIONS

Our oral-parenteral ABX regimen significantly reduced the risk of SSIs following elective laparoscopic colorectal surgery.

摘要

目的

确认口服和胃肠外抗生素预防措施（ABX）在择期腹腔镜结直肠手术中的疗效。

背景

尚无证据表明腹腔镜结直肠手术存在最佳ABX方案，而该手术已成为结直肠癌患者的重要选择。

方法

计划接受腹腔镜手术的结直肠癌患者符合本多中心、开放标签、随机试验的条件。他们被随机分为接受口服和胃肠外预防措施（手术前及手术期间每3小时静脉注射1克头孢美唑，术前一天口服1克卡那霉素及750毫克甲硝唑两次；口服-静脉联合组）或仅接受胃肠外预防措施（相同的静脉注射方案；静脉注射组）。主要终点是手术部位感染（SSIs）的发生率。次要终点是艰难梭菌结肠炎、其他感染及术后非感染性并发症的发生率，以及特定微生物分离频率。

结果

2007年11月至2012年12月期间，579例患者（口服-静脉联合组289例，静脉注射组290例）纳入本研究评估。口服-静脉联合组SSIs发生率为7.26%（21/289），静脉注射组为12.8%（37/290），比值比为0.536（95%CI，0.305 - 0.940；P = 0.028）。两组艰难梭菌结肠炎（1/289对3/290）、其他感染（6/289对5/290）及术后非感染性并发症（11/289对12/290）的发生率相似。