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环丙沙星预防急性坏死性胰腺炎患者的双盲、安慰剂对照试验。

A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotizing pancreatitis.

作者信息

García-Barrasa A, Borobia F G, Pallares R, Jorba R, Poves I, Busquets J, Fabregat J

机构信息

Department of General Surgery and Digestive Tract, Bellvitge Hospital, Idibell, University of Barcelona, Barcelona, Spain.

出版信息

J Gastrointest Surg. 2009 Apr;13(4):768-74. doi: 10.1007/s11605-008-0773-7. Epub 2008 Dec 11.

DOI:10.1007/s11605-008-0773-7
PMID:19082671
Abstract

BACKGROUND

The use of prophylactic antibiotics in acute severe necrotizing pancreatitis is controversial.

METHODS

Prospective, randomized, placebo-controlled, double-blind study was carried out at Bellvitge Hospital, in Barcelona, Spain. Among 229 diagnosed with severe acute pancreatitis, 80 had evidence of necrotizing pancreatitis (34/80 patients were excluded of the protocol). Forty-six patients without previous antibiotic treatment with pancreatic necrosis in a contrast-enhanced CT scan were randomly assigned to receive either intravenous ciprofloxacin or placebo. Five patients were secondarily excluded, and the remaining 41 patients were finally included in the study (22 patients received intravenous ciprofloxacin and 19 patients placebo).

RESULTS

Comparing the 22 with intravenous ciprofloxacin and 19 with placebo, infected pancreatic necrosis was detected in 36% and 42% respectively (p = 0.7). The mortality rate was 18% and 11%, respectively (p = 0.6). No significant differences between both treatment groups were observed with respect to variables such as: non-pancreatic infections, surgical treatment, timing and the re-operation rate, organ failure, length of hospital and ICU stays.

CONCLUSION

The prophylactic use of ciprofloxacin in patients with severe necrotizing pancreatitis did not significantly reduce the risk of developing pancreatic infection or decrease the mortality rate. The small number of patients included in this study should be considered.

摘要

背景

急性重症坏死性胰腺炎预防性使用抗生素存在争议。

方法

在西班牙巴塞罗那的贝尔维特奇医院进行了一项前瞻性、随机、安慰剂对照、双盲研究。在229例被诊断为重症急性胰腺炎的患者中,80例有坏死性胰腺炎的证据(34/80例患者被排除在研究方案之外)。46例在增强CT扫描中显示有胰腺坏死且未接受过抗生素治疗的患者被随机分配接受静脉注射环丙沙星或安慰剂。5例患者被二次排除,其余41例患者最终纳入研究(22例患者接受静脉注射环丙沙星,19例患者接受安慰剂)。

结果

比较接受静脉注射环丙沙星的22例患者和接受安慰剂的19例患者,分别有36%和42%检测到感染性胰腺坏死(p = 0.7)。死亡率分别为18%和11%(p = 0.6)。在以下变量方面,两个治疗组之间未观察到显著差异:非胰腺感染、手术治疗、时间和再次手术率、器官衰竭、住院时间和ICU住院时间。

结论

环丙沙星预防性用于重症坏死性胰腺炎患者并未显著降低发生胰腺感染的风险或降低死亡率。应考虑本研究纳入的患者数量较少这一情况。

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Ann Surg. 2007 May;245(5):674-83. doi: 10.1097/01.sla.0000250414.09255.84.
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Meta-analysis of prophylactic antibiotic use in acute necrotizing pancreatitis.急性坏死性胰腺炎预防性使用抗生素的荟萃分析。
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