通讯作者: 张婷婷, 984884918@qq.com

DOI：10.12201/bmr.202611.00005

Efficacy and Mechanism of Suhexiang Wan in Post-Stroke Patients with Pulmonary Infection: A Retrospective Cohort Study

• 摘要：摘要目的 基于真实世界数据，评估苏合香丸治疗脑卒中合并肺部感染的临床疗效，并探索其作用机制及疗效影响因素。方法 纳入2025年1月至2026年1月福建中医药大学附属康复医院脑病康复一科脑卒中合并肺部感染住院患者120例，根据是否使用苏合香丸分为实验组（n=60）和对照组（n=60）。主要结局为临床肺部感染评分（clinical pulmonary infection score，CPIS）变化值（ΔCPIS）；次要结局包括白细胞计数（white blood cell count，WBC）、C反应蛋白（C-reactive protein，CRP）、改良Barthel指数（modified Barthel index，MBI）、功能评估量表（Functional Assessment Measure，FAM）、白蛋白等。采用独立样本t检验/Mann-Whitney U检验、多因素线性回归、亚组分析、中介效应分析。结果 两组基线资料具有可比性（P>0.05）。实验组ΔCPIS显著高于对照组（β=0.526，95%CI：0.204~0.849，P=0.002）；实验组ΔWBC、ΔMBI、Δ白蛋白及体温恢复正常时间均显著优于对照组（P<0.05）。亚组分析显示女性（β=1.323，95%CI：0.507~2.139，P=0.030）及高血压患者（β=0.648，95%CI：0.017~1.279，P=0.047）获益显著。多因素回归显示基线CPIS（β=0.541，95%CI：0.444~0.638，P<0.001）及分组（β=0.526，95%CI：0.204~0.849，P=0.002）是ΔCPIS的独立预测因子。中介效应分析提示ΔWBC非CPIS改善的中介变量（间接效应-0.052，95%CI：-0.169~0.027，P=0.304）。敏感性分析结果与主要分析一致。两组均未报告不良事件。结论 苏合香丸联合常规抗感染治疗可显著改善脑卒中合并肺部感染患者的CPIS，其疗效独立于常规治疗；女性及高血压患者获益更大；其作用机制可能涉及多靶点综合调节。

  关键词： 脑卒中；肺部感染；苏合香丸；临床肺部感染评分；回顾性队列研究; ; ; ; 

   

  Abstract: 【Abstract】 Objective To evaluate the clinical efficacy of Suhexiang Wan as adjunctive therapy in post-stroke patients with pulmonary infection using real-world data, and to explore its mechanisms and factors influencing treatment response. Methods A total of 120 patients with post-stroke pulmonary infection admitted to the Department of Neurological Rehabilitation at the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine between January 2025 and January 2026 were enrolled and divided into experimental group (n=60) and control group (n=60) based on Suhexiang Wan use. The primary outcome was the change in Clinical Pulmonary Infection Score (CPIS) from baseline to post-treatment (ΔCPIS). Secondary outcomes included white blood cell count (WBC), C-reactive protein (CRP), modified Barthel index (MBI), Functional Assessment Measure (FAM), albumin, and time to defervescence. Statistical analyses comprised independent samples t-test/Mann-Whitney U test, multivariable linear regression, subgroup analysis, and mediation analysis. Results Baseline characteristics were comparable between the two groups (P>0.05). The experimental group showed significantly greater ΔCPIS than the control group (β=0.526, 95% CI: 0.204 to 0.849, P=0.002). Improvements in ΔWBC, ΔMBI, Δalbumin, and time to defervescence were also significantly superior in the experimental group (P<0.05). Subgroup analyses revealed greater benefits in female patients (β=1.323, 95% CI: 0.507 to 2.139, P=0.030) and those with hypertension (β=0.648, 95% CI: 0.017 to 1.279, P=0.047). Multivariable regression identified baseline CPIS (β=0.541, 95% CI: 0.444 to 0.638, P<0.001) and group allocation (β=0.526, 95% CI: 0.204 to 0.849, P=0.002) as independent predictors of ΔCPIS. Mediation analysis indicated that ΔWBC did not mediate the improvement in CPIS (indirect effect: -0.052, 95% CI: -0.169 to 0.027, P=0.304). Sensitivity analyses yielded results consistent with the primary analysis. No adverse events were reported in either group. Conclusion Suhexiang Wan as adjunctive therapy significantly improves CPIS in post-stroke patients with pulmonary infection, with effects independent of conventional treatment. Female patients and those with hypertension may derive greater benefits. The mechanism may involve multi-target regulation rather than a single anti-inflammatory pathway.

  Key words: Stroke; Pulmonary infection; Suhexiang Wan; Clinical Pulmonary Infection Score; Retrospective cohort study

  提交时间：2026-11-04

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• 序号	提交日期	编号	操作
  1	2026-07-07	10.12201/bmr.202611.00005V1	下载

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