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β-内酰胺类/β-内酰胺酶抑制剂联合用药在多重耐药菌感染中的作用:一项全面的荟萃分析。

The role of β-lactam/β-lactamase inhibitor combinations in multidrug-resistant bacterial infections: a comprehensive meta-analysis.

作者信息

Wu Fei, Liu Qiaoli, Hu Piao, Wu Changcai

机构信息

Department of Infectious Diseases, The First People's Hospital of Xiaoshan District, Xiaoshan Affiliated Hospital of Wenzhou Medical University Hangzhou 311200, Zhejiang, China.

Department of General Practice, The First People's Hospital of Xiaoshan District, Xiaoshan Affiliated Hospital of Wenzhou Medical University Hangzhou 311200, Zhejiang, China.

出版信息

Am J Transl Res. 2025 Aug 15;17(8):6488-6503. doi: 10.62347/JVJW7760. eCollection 2025.

Abstract

BACKGROUND

Multidrug-resistant (MDR) bacterial infections pose a global public health challenge. β-Lactam/β-lactamase inhibitor combinations (BLIs) are essential for treating MDR infections, although their efficacy varies across studies. This meta-analysis aims to evaluate their clinical value.

METHODS

A systematic search of PubMed, Embase, and Cochrane Library was conducted for randomized controlled trials (RCTs) on BLIs for MDR bacterial infections published from January 2000 to December 2024. Study quality was assessed using the Cochrane Risk of Bias tool, and meta-analysis was performed using RevMan 5.4. Primary outcomes included clinical efficacy rate, bacterial clearance rate, and incidence of adverse reactions.

RESULTS

Eighteen high-quality RCTs involving 2,356 patients were included. BLIs showed a significantly higher clinical efficacy rate (76.23%) than controls (62.45%) (RR=1.59, 95% CI: 1.44-1.73, P<0.001) and bacterial clearance rate (71.58% vs. 58.67%, RR=1.21, 95% CI: 1.16-1.26, P<0.001). Subgroup analysis revealed clinical efficacy rates of 73.45% for carbapenem-resistant Enterobacteriaceae (CRE) and 78.32% for ESBL-producing Enterobacteriaceae, with bacterial clearance rates of 68.72% and 74.11%, respectively. The adverse reaction rate in the BLI group was 15.68% (mainly diarrhea, nausea, rash), which was not significantly different from the control group (17.89%, RR=0.96, 95% CI: 0.85-1.07, P=0.977).

CONCLUSION

BLIs demonstrate high efficacy, bacterial clearance, and safety in treating MDR infections, particularly CRE and ESBL infections. Larger multicenter RCTs are needed for further validation.

摘要

背景

多重耐药(MDR)细菌感染构成了全球公共卫生挑战。β-内酰胺/β-内酰胺酶抑制剂联合制剂(BLIs)对于治疗MDR感染至关重要,尽管其疗效在各项研究中有所不同。本荟萃分析旨在评估其临床价值。

方法

对PubMed、Embase和Cochrane图书馆进行系统检索,以查找2000年1月至2024年12月发表的关于BLIs治疗MDR细菌感染的随机对照试验(RCTs)。使用Cochrane偏倚风险工具评估研究质量,并使用RevMan 5.4进行荟萃分析。主要结局包括临床有效率、细菌清除率和不良反应发生率。

结果

纳入了18项涉及2356例患者的高质量RCTs。BLIs的临床有效率(76.23%)显著高于对照组(62.45%)(RR=1.59,95%CI:1.44-1.73,P<0.001)和细菌清除率(71.58%对58.67%,RR=1.21,95%CI:1.16-1.26,P<0.001)。亚组分析显示,耐碳青霉烯类肠杆菌科细菌(CRE)的临床有效率为73.45%,产超广谱β-内酰胺酶(ESBL)的肠杆菌科细菌的临床有效率为78.32%,细菌清除率分别为68.72%和74.11%。BLIs组的不良反应发生率为15.68%(主要为腹泻、恶心、皮疹),与对照组(17.89%,RR=0.96,95%CI:0.85-1.07,P=0.977)无显著差异。

结论

BLIs在治疗MDR感染,特别是CRE和ESBL感染方面显示出高效、细菌清除效果及安全性。需要开展更大规模的多中心RCTs进行进一步验证。

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