Li Qinyuan, Zhou Qi, Fan Jiangbo, Huang Siyuan, Chen Yaolong, Song Fujian, Fu Zhou, Liu Enmei, Tang Daolin, Zeng Ling, Luo Zhengxiu
Department of Respiratory Medicine Children's Hospital of Chongqing Medical University, National Clinical Research Centre for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Key Laboratory of Children's Vital Organ Development and Diseases of Chongqing Health Commission, Chongqing, China.
Evidence-Based Medicine Centre, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China; Lanzhou University, an Affiliate of the Cochrane China Network, Lanzhou, China; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Clin Microbiol Infect. 2025 Apr;31(4):551-559. doi: 10.1016/j.cmi.2024.11.035. Epub 2024 Dec 4.
Bacteraemia and sepsis have traditionally required continued intravenous (IV) antibiotics.
This study aims to evaluate if early transition to oral antibiotics is non-inferior to continued IV antibiotic therapy in treating patients with bacteraemia and sepsis.
Data sources include MEDLINE, Embase, Web of Science, the Cochrane Library, and Wanfang databases from inception to 13 July 2024, along with clinical trial registries and Google.com.
Study eligibility criteria include randomized controlled trials (RCTs) and cohort studies.
Participants include patients with bacteraemia and sepsis.
Interventions include early transition to oral antibiotics vs. continued IV antibiotics. Early oral switch was defined as 5-9 days for uncomplicated Staphylococcus aureus bacteraemia, <4 weeks for complicated S. aureus bacteraemia, 3-7 days for uncomplicated Streptococcus bacteraemia, and 3-5 days for uncomplicated Enterobacterales bacteraemia.
Assessment of risk of bias includes Cochrane risk of bias tool and Newcastle-Ottawa Scale.
Random-effect models were used to pool the data. The primary outcome was treatment failure. The non-inferiority margin for treatment failure was 10%. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to rate the certainty of the evidence.
In total, 38 studies (6 RCTs, 10 adjusted cohorts, and 22 unadjusted cohorts) involving 11 566 patients were included. A primary analysis of 6 RCTs and 10 adjusted cohorts comprised 7102 patients. High-certainty evidence from six RCTs showed that early transition to oral antibiotics was non-inferior to continued IV therapy for treatment failure (n = 529; OR 0.89; 95% CI: 0.54-1.48). Low-certainty evidence from five adjusted cohorts also found no significant difference in treatment failure between the two groups (n = 929; OR 0.60; 95% CI: 0.29-1.72). Moderate-certainty evidence showed that oral switch therapy significantly reduced hospital stay (n = 2041; mean difference: -5.19 days; 95% CI: -8.16 to -2.22).
Early transition to oral antibiotics was non-inferior to continued IV antibiotic treatment for bacteraemia and sepsis.
传统上，菌血症和脓毒症患者需要持续静脉注射抗生素。
本研究旨在评估在治疗菌血症和脓毒症患者时，早期转换为口服抗生素是否不劣于持续静脉注射抗生素治疗。
数据来源包括MEDLINE、Embase、科学网、考克兰图书馆以及万方数据库，检索时间从建库至2024年7月13日，同时检索了临床试验注册库和谷歌网站。
研究纳入标准包括随机对照试验（RCT）和队列研究。
参与者包括菌血症和脓毒症患者。
干预措施包括早期转换为口服抗生素与持续静脉注射抗生素。早期口服转换的定义为：单纯性金黄色葡萄球菌菌血症为5 - 9天，复杂性金黄色葡萄球菌菌血症为<4周，单纯性链球菌菌血症为3 - 7天，单纯性肠杆菌科菌血症为3 - 5天。
偏倚风险评估包括考克兰偏倚风险工具和纽卡斯尔 - 渥太华量表。
采用随机效应模型汇总数据。主要结局为治疗失败。治疗失败的非劣效界值为10%。采用推荐分级的评估、制定与评价方法对证据的确定性进行评级。
共纳入38项研究（6项RCT、10项校正队列研究和22项未校正队列研究），涉及11566例患者。对6项RCT和10项校正队列研究（共7102例患者）的初步分析。6项RCT的高确定性证据表明，早期转换为口服抗生素在治疗失败方面不劣于持续静脉注射治疗（n = 529；OR 0.89；95% CI：0.54 - 1.48）。5项校正队列研究的低确定性证据也发现两组在治疗失败方面无显著差异（n = 929；OR 0.60；95% CI：0.29 - 1.72）。中度确定性证据表明，口服转换治疗显著缩短了住院时间（n = 2041；平均差值：-5.19天；95% CI：-8.16至-2.22）。
在菌血症和脓毒症治疗中，早期转换为口服抗生素不劣于持续静脉注射抗生素治疗。
