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

doi:10.19803/j.1672-8629.20260440

Abstract

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

CLC Number:

Yang Yumei, Bai Yinglu, Ding Maoyu, Xu Xiaolong, Chen Tengfei, Yang Siwen, Liu Qingquan. Exploratory randomized controlled trial of Suhexiang Pills in the treatment of sepsis-related myocardial injury[J]. Chinese Journal of Pharmacovigilance, 2026, 23(7): 746-752.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20260440

https://zgywjj.magtechjournal.com/EN/Y2026/V23/I7/746

References

[1] Aissaoui N, Boissier F, Chew M, et al.Sepsis-induced cardiomyopathy[J]. European Heart Journal, 2025, 46(34): 3339-3353.
[2] Yang W, Cao Y, Li J, et al.Pathogenesis and treatment strategies of sepsis-induced myocardial injury: modern and traditional medical perspectives[J]. International Journal of Biological Sciences, 2025, 21(8): 3478-3504.
[3] Kong Li, Lu Xiaohui, Jiang Tao.Fundamental pathogenesis of systemic inflammatory response syndrome is qi movement disorder[J]. Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care(中国中西医结合急救杂志), 2005(2): 68-70.
[4] Xu Z, Lu D, Yuan J, et al.Storax attenuates cardiac fibrosis following acute myocardial infarction in rats via suppression of AT1R-Ankrd1-P53 signaling pathway[J]. International Journal of Molecular Sciences, 2022, 23(21): 13161.
[5] Zhou Min, Zhao Pei, Zhu Jinqiang, et al.Preliminary study on the effect of storax on acute focal cerebral ischemic injury in rats[J]. Tianjin Journal of Traditional Chinese Medicine(天津中医药), 2015, 32(8): 496-500.
[6] Ehrman R R, Sullivan A N, Favot M J, et al.Pathophysiology, echocar-diographic evaluation, biomarker findings, and prognostic implications of septic cardiomyopathy: a review of the literature[J]. Critical Care (London, England), 2018, 22(1): 112.
[7] Singer M, Deutschman C S, Seymour C W, et al.The third international consensus definitions for sepsis and septic shock (sepsis-3)[J]. JAMA, 2016, 315(8): 801-810.
[8] Gonzalez F A, Bacariza J, Varudo A R, et al.Sepsis-induced myocardial dysfunction diagnosed with strain versus non-strain echocardiography parameters: incidence, evolution and association with prognosis[J]. Annals of Intensive Care, 2025, 15(1): 141.
[9] Jin Y, Fleishman J, Ma Y, et al.NLRP3 inflammasome targeting offers a novel therapeutic paradigm for sepsis-induced myocardial injury[J]. Drug Design, Development and Therapy, 2025, 19: 1025-1041.
[10] Singam A.Myocardial injury as a harbinger of multi-organ failure in septic shock: a comprehensive review[J]. Cureus, 2024, 16(2): e55021.
[11] Lin Y, Xu Y, Zhang Z.Sepsis-induced myocardial dysfunction (SIMD): the pathophysiological mechanisms and therapeutic strategies targeting mitochondria[J]. Inflammation, 2020, 43(4): 1184-1200.
[12] Zhang Yuliang, Xu Sheng, Hao Rui, et al.Pathogenesis and treatment progress of sepsis-induced cardiomyopathy in traditional Chinese and western medicine[J]. China Medical Herald(中国医药导报), 2025, 22(36): 181-185.
[13] Rao Wenjuan.Observation on the therapeutic effect of Suhexiang pill combined with bisoprolol in the treatment of coronary heart disease with angina pectoris[J]. Journal of Medical Theory and Practice(医学理论与实践), 2020, 33(11): 1759-1760.
[14] Li Shibao, Bo Jinhong, Liao Xin, et al. Clinical observation of Suhexiang pill combined with acetylcysteine aerosol inhalation in the treatment of pulmonary infection after cerebral hemorrhage[J/OL]. Chinese Archives of Traditional Chinese Medicine(中华中医药学刊),2025-09-12. https://link.cnki.net/urlid/21.1546.r.20250912.1344.032.
[15] Liu Ping, Yu Shaoshuai, He Xinrong.Research progress of traditional Chinese medicine storax[J]. Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2010, 7(5): 315-317.
[16] Lei Zhiqiang, Wang Chaoping, Abid Naeem, et al.Exploring the mechanism of volatile oil of“Chuanxiong-Suhexiang-Bingpian”formulation in the treatment of angina pectoris and its protective effect on rats with myocardial injury based on network pharmacology[J]. Digital Chinese Medicine, 2021, 4(3): 202-213.
[17] Zhang Hui, Wen Jin, Zhang Jianwu, et al. Effects of borneol on apoptosis in hypoxia/reoxygenation H9C2 rat cardiomyocytes[J/OL]. Authorea, 2022, https://www.researchgate.net/publication/365495898.
[18] Zhang Jinfeng, Bao Shasha, Zhang Chenxing, et al.Effect of Suhexiang pill on neuroinflammation and neuronal apoptosis in rats with acute cerebral infarction by regulating cAMP-PKA signaling pathway[J]. Progress in Modern Biomedicine(现代生物医学进展), 2024, 24(12): 2237-2243.
[19] Molero-Calafell J, Burón A, Castells X, et al.Intention to treat and per protocol analyses: differences and similarities[J]. Journal of Clinical Epidemiology, 2024, 173: 111457.
[20] Zhang Caixia, Zhou Yi, Tan Lu, et al.Pharmaceutical care of a patient with sepsis secondary to pulmonary Aspergillus infection[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2024, 21(9): 1064-1067.