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氨苄西林-舒巴坦与莫西沙星单药治疗社区获得性复杂性腹腔内感染的前瞻性、随机研究。

Prospective, randomized, study of ampicillin-sulbactam versus moxifloxacin monotherapy for the treatment of community-acquired complicated intra-abdominal infections.

机构信息

Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807, Taiwan.

出版信息

Surg Infect (Larchmt). 2013 Aug;14(4):389-96. doi: 10.1089/sur.2012.017. Epub 2013 Jul 16.

DOI:10.1089/sur.2012.017
PMID:23859673
Abstract

BACKGROUND

The ideal antimicrobial treatment for intra-abdominal infections (IAIs) in the setting of fast-paced emergency departments (EDs) should be effective, convenient, and of limited resource utilization. Antibiotic monotherapy is a feasible option for this. We conducted a study in which we compared two regimens for antibiotic monotherapy recommended by published guidelines in ED patients with community-acquired, complicated IAIs (cIAIs).

METHODS

The study was a prospective, randomized, study of ampicillin-sulbactam versus moxifloxacin for cIAIs. After the diagnosis of cIAI was established, patients were assigned randomly to receive either moxifloxacin 400 mg intravenously (IV) qd followed by moxifloxacin 400 mg orally (PO) qd, or ampicillin-sulbactam 1.5 g IV qid followed by ampicillin-sulbactam 750 mg PO q12h. Source control procedures were used for all patients and all had complete follow-up. The primary efficacy variable for the study was the clinical response at the test-of-cure visit.

RESULTS

A total of 116 patients were enrolled for prospective evaluation and randomized assignment to treatment with ampicillin-sulbactam (n=55) or moxifloxacin (n=61). At the test-of-cure evaluation, the overall clinical failure rate was 13.8%. The clinical failure rates in the ampicillin-sulbactam and moxifloxacin groups were 16.4% (9/55) and 11.5% (7/61), respectively (p=0.446). With regard to infection site, the clinical failure rate in cIAIs consisting of lower gastrointestinal (GI) tract infection was significantly lower in the moxifloxacin than in the ampicillin-sulbactam group (4.3% vs. 19.6%; p=0.024). According to multivariable analysis, independent risk factors for treatment failure were the time to ED presentation >24 h (odds ratio [OR] 6.8; 95% CI 1.3-36.2; p=0.024) and ampicillin-sulbactam therapy (OR 9.5; 95% CI 1.1-76.6; p=0.033).

CONCLUSIONS

A significant difference existed in the clinical responses of the two groups. As compared with ampicillin-sulbactam, moxifloxacin was more effective for the treatment of community-acquired cIAIs of the lower GI tract. A higher risk of treatment failure for antibiotic therapy was found for patients presenting to the ED with symptoms of cIAIs lasting >24 h. Alternative antimicrobial agents should be considered for treating these patients.

摘要

背景

在快节奏的急诊科(ED)中,治疗腹腔内感染(IAI)的理想抗菌治疗方法应该是有效、方便且对资源的利用有限。抗生素单药治疗是一种可行的选择。我们进行了一项研究,比较了两种在社区获得性复杂 IAI(cIAI)的 ED 患者中推荐的发表指南的抗生素单药治疗方案。

方法

这项研究是一项前瞻性、随机研究,比较了 ampicillin-sulbactam 与 moxifloxacin 治疗 cIAI。在确定 cIAI 诊断后,患者被随机分配接受莫西沙星 400mg 静脉注射(IV)qd 随后莫西沙星 400mg 口服(PO)qd,或 ampicillin-sulbactam 1.5g IV qid 随后 ampicillin-sulbactam 750mg PO q12h。所有患者均采用源控制程序,并进行了完整的随访。研究的主要疗效变量是治愈随访时的临床反应。

结果

共有 116 名患者接受前瞻性评估并随机分配接受 ampicillin-sulbactam(n=55)或 moxifloxacin(n=61)治疗。在治愈评估时,整体临床失败率为 13.8%。ampicillin-sulbactam 和 moxifloxacin 组的临床失败率分别为 16.4%(9/55)和 11.5%(7/61)(p=0.446)。关于感染部位,由下消化道(GI)感染引起的 cIAI 的临床失败率在 moxifloxacin 组明显低于 ampicillin-sulbactam 组(4.3%比 19.6%;p=0.024)。多变量分析显示,治疗失败的独立危险因素是就诊至 ED 的时间>24 小时(优势比[OR]6.8;95%CI 1.3-36.2;p=0.024)和 ampicillin-sulbactam 治疗(OR 9.5;95%CI 1.1-76.6;p=0.033)。

结论

两组的临床反应存在显著差异。与 ampicillin-sulbactam 相比,莫西沙星治疗社区获得性下消化道 cIAI 更有效。对于就诊至 ED 的 cIAI 症状持续>24 小时的患者,抗生素治疗失败的风险更高。对于这些患者,应考虑使用替代的抗菌药物。

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