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前瞻性比较高危人群 ERCP 术后胆管炎患者中静脉注射莫西沙星和头孢曲松的预防用抗生素效果。

Prospective comparison of prophylactic antibiotic use between intravenous moxifloxacin and ceftriaxone for high-risk patients with post-ERCP cholangitis.

机构信息

Department of Internal Medicine, Sungkyunkwan University Kangbuk Samsung Hospital, Seoul 03181, Korea.

Department of Internal Medicine, Sungkyunkwan University Kangbuk Samsung Hospital, Seoul 03181, Korea.

出版信息

Hepatobiliary Pancreat Dis Int. 2017 Oct 15;16(5):512-518. doi: 10.1016/S1499-3872(17)60056-0.

Abstract

BACKGROUND

The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography (ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an obstructed biliary system. This study compared the occurrence rate of post-procedural complications, including cholangitis and septicemia, between prophylactic intravenous moxifloxacin and ceftriaxone in patients with bile duct obstruction scheduled for therapeutic ERCP.

METHODS

From November 2013 to July 2015, 86 consecutive patients with biliary obstruction with one or more factors predicting benefits of antibiotic prophylaxis prior to ERCP were included in the current randomized open-label non-inferiority trial (ClinicalTrial.gov identifier NCT02098486). Intravenous moxifloxacin (400 mg/day) or ceftriaxone (2 g/day) were given 90 minutes before ERCP, and were administered for more than 3 days if the patient developed symptoms and signs of cholangitis or septicemia. Recalcitrant cholangitis was defined as persistence of cholangitis for more than 5 days after ERCP or recurrence of cholangitis within 30 days after ERCP.

RESULTS

Recalcitrant cholangitis occurred in 1 (2.3%) and 2 (4.8%) patients receiving intravenous moxifloxacin and ceftriaxone group, respectively (P=0.612). Septicemia was noted in 1 (2.3%) and 1 (2.4%) patient in intravenous moxifloxacin and ceftriaxone group, respectively (P=1.0). The mean hospital stay was also not significantly different between the moxifloxacin and ceftriaxone groups (8.8±7.2 vs 9.1±9.4 days, P=0.867). Antibiotic resistance of the isolated pathogens by in vitro activity assay was noted in 1 (2.3%) and 2 (4.8%) patients in the moxifloxacin and ceftriaxone group, respectively (P=0.612).

CONCLUSION

Intravenous moxifloxacin is not inferior to intravenous ceftriaxone for the prophylactic treatment of post-ERCP cholangitis and cholangitis-associated morbidity.

摘要

背景

所有主要的国际胃肠病学协会都建议在进行内镜逆行胰胆管造影术(ERCP)前使用预防性抗生素,尤其是在存在胆道阻塞的情况下。本研究比较了在接受治疗性 ERCP 的胆管阻塞患者中,预防性静脉使用莫西沙星和头孢曲松后,术后并发症(包括胆管炎和败血症)的发生率,这些患者存在一个或多个预测 ERCP 前抗生素预防益处的因素。

方法

2013 年 11 月至 2015 年 7 月,连续纳入 86 例存在一个或多个预测 ERCP 前抗生素预防益处的因素的胆道阻塞患者,进行了当前的随机、开放标签、非劣效性试验(ClinicalTrials.gov 标识符:NCT02098486)。莫西沙星(400mg/天)或头孢曲松(2g/天)在 ERCP 前 90 分钟静脉给药,如果患者出现胆管炎或败血症的症状和体征,则给予超过 3 天的治疗。难治性胆管炎定义为 ERCP 后胆管炎持续超过 5 天或 ERCP 后 30 天内胆管炎复发。

结果

莫西沙星组和头孢曲松组分别有 1(2.3%)和 2(4.8%)例患者发生难治性胆管炎(P=0.612)。莫西沙星组和头孢曲松组分别有 1(2.3%)和 1(2.4%)例患者发生败血症(P=1.0)。莫西沙星组和头孢曲松组的平均住院时间也无显著差异(8.8±7.2 天 vs 9.1±9.4 天,P=0.867)。体外活性试验检测到分离病原体的抗生素耐药性分别在莫西沙星组和头孢曲松组各有 1 例(2.3%)和 2 例(4.8%)(P=0.612)。

结论

静脉使用莫西沙星与静脉使用头孢曲松预防 ERCP 后胆管炎和胆管炎相关发病率无差异。

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