中国药物警戒 ›› 2026, Vol. 23 ›› Issue (7): 746-752.
DOI: 10.19803/j.1672-8629.20260440

• 脓毒症中医药机制与临床用药研究专栏 • 上一篇    下一篇

苏合香丸治疗脓毒症相关心肌损伤的探索性随机对照研究

杨玉媚1,3, 白颖璐1,2, 丁茂裕1,3, 徐霄龙1,2, 陈腾飞1, 杨思雯1,4#, 刘清泉1,*   

  1. 1首都医科大学附属北京中医医院急诊危重症诊疗中心,北京 100010;
    2北京市中医药研究所,北京 100010;
    3北京中医药大学临床医学院,北京 100029;
    4长治市中医研究所附属医院重症医学科,山西 长治 046000
  • 收稿日期:2026-06-01 出版日期:2026-07-15 发布日期:2026-07-16
  • 通讯作者: #为共同通信作者。*刘清泉,男,主任医师,教授·博导,中西医结合急诊与危重症。E-mail: liuqingquan2003@126.com
  • 作者简介:杨玉媚,女,在读硕士,中医内科学。
  • 基金资助:
    国家科技重大专项重大新药创制（2025ZD01903000）; 国家中医药多学科交叉创新团队（ZYYCXTD-D-202201）; 国家中医药管理局高水平中医药重点学科建设项目（ZYYZDXK-2023001）; 蒙西地区急性呼吸道感染性疾病中医病证特征研究及数据中心建设（2023YFSH0030）; 首都医科大学临床—基础联合实验室青年项目; 北京中医医院—长治市中医研究所附属医院重症医学科研合作项目

Exploratory randomized controlled trial of Suhexiang Pills in the treatment of sepsis-related myocardial injury

Yang Yumei1,3, Bai Yinglu1,2, Ding Maoyu1,3, Xu Xiaolong1,2, Chen Tengfei1, Yang Siwen1,4#, Liu Qingquan1,*   

  1. 1Emergency and Critical Care Center, Bejing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China;
    2Beijing Institute of Traditional Chinese Medicine, Beijing 100010, China;
    3School of Clinical Medicine, Beijing University of Chinese Medicine, Beijing 100029, China;
    4Department of Critical Care Medicine, Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine, Changzhi Shanxi, 046000, China
  • Received:2026-06-01 Online:2026-07-15 Published:2026-07-16

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摘要： 目的 探讨苏合香丸治疗脓毒症相关心肌损伤（SRMI）的临床疗效及安全性,为中西医结合救治SRMI提供参考。方法 纳入2024年8月1日至2025年12月31日期间首都医科大学附属北京中医医院ICU收治的SRMI患者,按1∶1随机分为对照组和试验组。对照组予以常规西医综合治疗,试验组在常规治疗基础上加用苏合香丸,疗程为7 d。在治疗前、治疗第3天及第7天,比较2组患者的心肌肌钙蛋白Ⅰ（cTnⅠ）、心功能指标[B型钠尿肽（BNP）、左心室射血分数（LVEF）、二尖瓣舒张早期与晚期血流速度比值（E/A）、左心室舒张末期内径（LVEDD）]、炎症指标[C反应蛋白（CRP）、降钙素原（PCT）、中性粒细胞（NEUT）、白细胞（WBC）]、凝血指标[血小板（PLT）、D-二聚体（D-D）、凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）]以及预后评分[序贯器官衰竭评分（SOFA）、急性生理学与慢性健康状况评价系统Ⅱ（APACHE-Ⅱ）、28 d病死率]的变化。结果 治疗第3天,试验组血清cTnⅠ与CRP水平显著低于对照组（P<0.05）。治疗第7天,试验组LVEF及E/A比值显著高于对照组,IL-6、TNF-α及APTT水平均显著低于对照组（P<0.05）。2组在治疗后的疾病严重程度评分及各项短期预后指标方面差异均无统计学意义（P>0.05）。结论 在西医常规治疗的基础上联合应用苏合香丸,能够有效减轻心肌细胞受损,提高心脏收缩能力,降低炎症相关指标,改善凝血功能,且对患者肝肾功能无影响。

关键词: 脓毒症相关心肌损伤, 苏合香丸, 解毒开窍, 随机对照研究, 临床疗效

Abstract: Objective To explore the clinical efficacy and safety of Suhexiang pills in the treatment of sepsis-related myocardial injury (SRMI), and provide references for the integrated Chinese and Western medicine treatment of SRMI. Methods Patients with SRMI admitted to the ICU of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between August 2024 and December 2025 were enrolled before being evenly and randomly assigned to the control group and experimental group. The control group received routine Western medicine treatment while the experimental group was additionally given Suhexiang pills. The course of treatment was 7 days. Cardiac troponinⅠ (cTnⅠ), cardiac function indicators (LVEF, E/A and LVEDD), inflammatory indicators (CRP, PCT, NEUT and WBC), coagulation indicators (PLT, D-D, PT and APTT), and prognostic scores (SOFA, APACHE-Ⅱand 28-day mortality) were compared between the two groups before treatment and on the 3rd and 7th days of treatment. Results On the 3rd day of treatment, the serum levels of cTn Ⅰand CRP in the experimental group were significantly lower than those of the control group (P<0.05). On the 7th day of treatment, the LVEF and E/A ratio of the experimental group were significantly higher than those of the control group, but the levels of IL-6, TNF-α and APTT were markedly decreased(P<0.05). There were no statistically significant differences in disease severity scores or short-term prognostic indicators between the two groups after treatment (P>0.05). Conclusion The administration of Suhexiang pills combined with routine Western medicine treatment can effectively alleviate cardiomyocyte damage, improve cardiac systolic function, reduce inflammatory levels and optimize coagulation function with a favorable safety profile.

Key words: Sepsis-Related Myocardial Injury, Suhexiang Pills, Detoxification and Orifice-Opening, Randomized Controlled Study, Clinical Efficacy

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