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轻度和中度复杂腹腔内感染的短程与常规抗菌疗程比较:一项随机对照试验。

Comparison of Short-Course and Conventional Antimicrobial Duration in Mild and Moderate Complicated Intra-Abdominal Infections: A randomised controlled trial.

机构信息

Departments of Surgery & Preventive.

Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.

出版信息

Sultan Qaboos Univ Med J. 2023 May;23(2):212-219. doi: 10.18295/squmj.1.2023.006. Epub 2023 May 31.

Abstract

OBJECTIVES

Studies have shown the feasibility of short-course antimicrobials in complicated intra-abdominal infection (CIAI) following source control procedure (SCP). This study aimed to compare postoperative complication rates in short-course (5 days) and conventional (7-10 days) duration groups after antimicrobial therapy.

METHODS

This was a single-centre, open-labelled, randomised controlled trial conducted in Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India, from July 2017 to December 2019 on patients with CIAI. Patients who were haemodynamically unstable, pregnant and had non-perforated, non-gangrenous appendicitis or cholecystitis were excluded. Primary endpoints were surgical site infection (SSI), recurrent intra-abdominal infection (IAI) and mortality. Secondary endpoints included time till occurrence of composite primary outcomes, duration of antimicrobial therapy, the length of hospital stays, antimicrobial-free interval, hospital-free days at 30 day intervals and the presence of extra-abdominal infections.

RESULTS

Overall, 140 patients were included whose demographic and clinico-pathological details were comparable in both groups. There was no difference in SSI (37% versus 35.6%) and recurrent IAI (5.7% versus 2.8%; = 0.76); no mortality was observed in either groups. The composite primary outcome (37% versus 35.7%) was also similar in both groups. Secondary outcomes included the duration of antimicrobial therapy (5 versus 8 days; <0.001) and length of hospitalisation (5 versus 7 days; = 0.014) were significant. Times till occurrence of SSI and recurrent IAI, incidence of extra-abdominal infection and resistant pathogens were comparable.

CONCLUSION

Short-course antimicrobial therapy for 5 days following SCP for mild and moderate CIAI was comparable to conventional duration antimicrobial therapy, indicating similar efficacy.

摘要

目的

研究表明,在进行源头控制程序(SCP)后,短疗程抗生素治疗复杂的腹腔内感染(CIAI)是可行的。本研究旨在比较抗生素治疗后短疗程(5 天)和常规疗程(7-10 天)的术后并发症发生率。

方法

这是一项在印度本地治里的贾瓦哈拉尔尼赫鲁医学研究所进行的单中心、开放标签、随机对照试验,时间为 2017 年 7 月至 2019 年 12 月,研究对象为 CIAI 患者。排除血流动力学不稳定、妊娠、非穿孔性、非坏疽性阑尾炎或胆囊炎的患者。主要终点为手术部位感染(SSI)、复发性腹腔内感染(IAI)和死亡率。次要终点包括复合主要结局的发生时间、抗生素治疗持续时间、住院时间、抗生素无间隔时间、30 天间隔的住院天数和腹部外感染的发生。

结果

共有 140 例患者入组,两组患者的人口统计学和临床病理特征相似。两组 SSI(37%比 35.6%)和复发性 IAI(5.7%比 2.8%; = 0.76)发生率无差异,两组均无死亡病例。复合主要结局(37%比 35.7%)也相似。次要结局包括抗生素治疗持续时间(5 天比 8 天; <0.001)和住院时间(5 天比 7 天; = 0.014)有显著差异。SSI 和复发性 IAI 的发生时间、腹部外感染和耐药病原体的发生率无差异。

结论

在 SCP 后对轻度和中度 CIAI 进行 5 天的短疗程抗生素治疗与常规疗程抗生素治疗效果相当,表明疗效相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ae8/10292598/bc17fcb87327/squmj2305-212-219f1.jpg

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