• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

宏基因组二代测序对脓毒症抗菌药物优化、临床预后及成本-效果的影响

通讯作者: 赵勇, yfy153678@fy.ahmu.edu.cn
DOI:10.12201/bmr.202603.00021
声明:预印本系统所发表的论文仅用于最新科研成果的交流与共享,未经同行评议,因此不建议直接应用于指导临床实践。

Impact of Metagenomic Next-Generation Sequencing on Antimicrobial Optimization, Clinical Prognosis, and Cost-Effectiveness in Sepsis

Corresponding author: Zhao Yong, yfy153678@fy.ahmu.edu.cn
  • 摘要:目的 针对宏基因组二代测序(mNGS)在脓毒症诊疗中面临的“高成本-低获益”争议,本研究旨在基于真实世界数据评价其临床决策价值与卫生经济学效益。方法 回顾性分析2023年1月至12月安徽医科大学第一附属医院收治的316例脓毒症患者临床资料,根据是否进行mNGS检测分为mNGS组(n=177)和非mNGS组(n=139)。采用广义线性模型(GLM)及多因素Logistic回归校正混杂因素,分析mNGS对治疗决策、28天病死率及医疗费用的影响。结果 mNGS组基线病情更为危重,ICU入住率(67.2%)及SOFA评分高于非mNGS组(P<0.001)。mNGS检出率达81.9%,指导62.7%的阳性匹配患者进行了抗菌药物优化,其中86.5%为治疗升级。然而,校正病情严重程度后,mNGS未改善28天生存率(调整后OR=1.974,P=0.077);GLM模型证实ICU及机械通气是费用主要驱动因子,mNGS组校正后人均医疗费用增加7057元。结论在当前晚期抢救性使用模式下,mNGS策略成本更高且无生存获益,属于卫生经济学上的“绝对劣势”方案。若通过早期介入提高生存率,有望改善其成本-效果比。

    关键词: 宏基因组二代测序;脓毒症;抗菌药物优化;成本-效果分析;适应症偏倚

     

    Abstract: Objective To evaluate the clinical decision-making value and health economic benefits of metagenomic next-generation sequencing (mNGS) in the diagnosis and treatment of sepsis, addressing the controversy of its high cost and low benefit based on real-world data. Methods The clinical data of 316 patients with sepsis admitted to The First Affiliated Hospital of Anhui Medical University from January to December 2023 were retrospectively analyzed. Patients were divided into an mNGS group (n=177) and a non-mNGS group (n=139) based on whether mNGS testing was performed. Generalized linear models (GLM) and multivariate logistic regression were used to adjust for confounding factors to analyze the impact of mNGS on treatment decisions, 28-day mortality, and medical costs. Results The baseline condition of the mNGS group was more critical; the intensive care unit (ICU) admission rate (67.2%) and sequential organ failure assessment (SOFA) scores were higher than those of the non-mNGS group, with the differences being statistically significant (P < 0.001). The positive detection rate of mNGS was 81.9%, which guided the optimization of antimicrobial agents in 62.7% of positive-matched patients, of which 86.5% were treatment escalations. However, after adjusting for disease severity, mNGS did not improve the 28-day survival rate (adjusted OR = 1.974, P = 0.077). The GLM model confirmed that ICU admission and mechanical ventilation were the main drivers of costs, and the adjusted per capita medical cost in the mNGS group increased by 7 057 RMB. Conclusion Under the current salvage use mode in late stages, the mNGS strategy incurs higher costs without survival benefits, making it an economically dominated scheme. Improving survival rates through early intervention is expected to improve its cost-effectiveness ratio.

    Key words: Metagenomic next-generation sequencing / Sepsis / Antimicrobial optimization / Cost-effectiveness analysis / Indication bias

    提交时间:2026-03-09

    版权声明:作者本人独立拥有该论文的版权,预印本系统仅拥有论文的永久保存权利。任何人未经允许不得重复使用。
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  • 序号 提交日期 编号 操作
    1 2026-02-23

    10.12201/bmr.202603.00021V1

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谢远航, 赵勇, 吴红磊. 宏基因组二代测序对脓毒症抗菌药物优化、临床预后及成本-效果的影响. 2026. biomedRxiv.202603.00021

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