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学科主题: 临床医学
题名:
Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study
作者: Leng, Xi-sheng1; Zhao, Yong-jie2; Qiu, Hui-zhong3; Cao, Yong-kuan4; Zhu, Wei-hua1; Shen, Ju-fang5; Paschke, Amanda6; Dai, Wei-min7; Caldwell, Nicole6; Wang, Jue5
关键词: beta-lactams ; ceftriaxone ; metronidazole
刊名: JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
发表日期: 2014-12-01
DOI: 10.1093/jac/dku302
卷: 69, 期:12, 页:3379-3386
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Infectious Diseases ; Microbiology ; Pharmacology & Pharmacy
研究领域[WOS]: Infectious Diseases ; Microbiology ; Pharmacology & Pharmacy
关键词[WOS]: ANTIBIOTIC-PROPHYLAXIS ; CEFOTETAN PROPHYLAXIS ; METRONIDAZOLE ; CEFTRIAXONE ; TRIALS ; RATES
英文摘要:

Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgical site infections (SSIs) following elective colorectal surgery in Chinese adult patients.

Eligible Chinese adults aged 18-80 years scheduled to undergo elective colorectal surgery by laparotomy were randomized to receive a 30 min infusion of 1 g of ertapenem/metronidazole placebo or 2 g of ceftriaxone/500 mg of metronidazole within 2 h before initial incision. The study endpoint was the proportion of patients with successful prophylaxis at 4 weeks after treatment. The primary analysis was based on the evaluable population (PP population) and the pre-specified non-inferiority margin was set at -15%. ClinicalTrials.gov: NCT01254344.

Of 599 patients randomized, 499 (251 ertapenem and 248 ceftriaxone) were eligible for inclusion in the PP population. The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxone groups were 90.4% (227/251) and 90.3% (224/248), respectively. The difference in the proportion of successful outcomes was 0.1% (95% CI -5.2%, 5.5%). Unexplained antibiotic use was the most frequent reason for prophylaxis failure in both groups [ertapenem 4.8% (12/251), ceftriaxone 4.4% (11/248); difference 0.3%; 95% CI -3.6, 4.3]. Pathogen species isolated from SSI sources were consistent with previously conducted studies and the product package insert. The incidence of adverse events (AEs) was similar between the groups, with the most common AE being pyrexia [ertapenem 7.6% (22/290), ceftriaxone 5.7% (17/297)].

Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoing elective colorectal surgery, and is well tolerated.

语种: 英语
项目资助者: Merck Co., Inc. ; Merck Sharp &amp ; Dohme Corp., China
WOS记录号: WOS:000345767300029
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/54758
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Peking Univ, Peoples Hosp, Dept Surg, Beijing 100871, Peoples R China
2.Tianjin Peoples Hosp, Dept Surg, Tianjin, Peoples R China
3.Beijing Union Med Coll Hosp, Dept Gen Surg, Beijing, Peoples R China
4.Chengdu Mil Gen Hosp, Dept Gen Surg, Chengdu, Peoples R China
5.MSD China, Shanghai, Peoples R China
6.Merck & Co Inc, Whitehouse Stn, NJ USA
7.PAREXEL Int, Shanghai, Peoples R China

Recommended Citation:
Leng, Xi-sheng,Zhao, Yong-jie,Qiu, Hui-zhong,et al. Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study[J]. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY,2014,69(12):3379-3386.
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