参附注射液治疗感染性休克患者的疗效与安全性：一项随机对照开放标签试验及基于网络药理学的机制探讨

HUANG Po; HE Sha-sha; FENG Shuo; DENG Wen-jie; LIU Qing-quan; LI Bo

doi:10.1007/s11655-026-4158-0

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参附注射液治疗感染性休克患者的疗效与安全性：一项随机对照开放标签试验及基于网络药理学的机制探讨

Original Article | Updated：2026-08-04

- 参附注射液治疗感染性休克患者的疗效与安全性：一项随机对照开放标签试验及基于网络药理学的机制探讨
- Efficacy and Safety of Shenfu Injection in Patients with Septic Shock: A Randomized Controlled Open-Label Trial with Network Pharmacology-Based Mechanistic Insights
- 中国结合医学杂志（英文版） 2026年32卷第7期页码：579-587
- Affiliations：
  
  1.Emergency Department, Beijing Dongfang Hospital, Beijing University of Traditional Chinese Medicine, Beijing (100078), China
  2.Key Laboratory of Infectious Diseases of Traditional Chinese Medicine, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing (100078), China
  3.Research Department, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China
  4.Second Clinical Medical College, Beijing University of Chinese Medicine, Beijing (100029), China
  5.Beijing Institute of Traditional Chinese Medicine, Beijing (100010), China
  6.Beijing Evidence-Based Chinese Medicine Center, Beijing (100010), China
  7.Big Data and Evidence-Based Medicine Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing (100010), China
- Author bio：
  
  Prof. LI Bo, E-mail: libo@bjzhongyi.com
- Funds：
  
  the National Natural Science Foundation of China(82205070);the National Administration of Traditional Chinese Medicine High-Level Key Discipline Construction Project of Traditional Chinese Medicine(zyyzdxk-2023001);the Beijing Union Medical Fund—Rui E (Ruiyi) Emergency Medical Research Fund(2021-Rui E 10);Beijing Nova Program(20250484815)
- DOI：10.1007/s11655-026-4158-0
  中图分类号：
- 录用：2026-01-20，
  
  网络首发：2026-03-23，
  
  纸质出版：2026-07
- Accepted：
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HUANG Po, HE Sha-sha, FENG Shuo, 等. 参附注射液治疗感染性休克患者的疗效与安全性：一项随机对照开放标签试验及基于网络药理学的机制探讨[J]. 中国结合医学杂志（英文版）, 2026,32(7):579-587.

HUANG Po, HE Sha-sha, FENG Shuo, et al. Efficacy and Safety of Shenfu Injection in Patients with Septic Shock: A Randomized Controlled Open-Label Trial with Network Pharmacology-Based Mechanistic Insights[J]. Chinese Journal of Integrative Medicine, 2026, 32(7): 579-587.
HUANG Po, HE Sha-sha, FENG Shuo, 等. 参附注射液治疗感染性休克患者的疗效与安全性：一项随机对照开放标签试验及基于网络药理学的机制探讨[J]. 中国结合医学杂志（英文版）, 2026,32(7):579-587. DOI： 10.1007/s11655-026-4158-0.

HUANG Po, HE Sha-sha, FENG Shuo, et al. Efficacy and Safety of Shenfu Injection in Patients with Septic Shock: A Randomized Controlled Open-Label Trial with Network Pharmacology-Based Mechanistic Insights[J]. Chinese Journal of Integrative Medicine, 2026, 32(7): 579-587. DOI： 10.1007/s11655-026-4158-0.

摘要

目的：

通过随机对照试验评价参附注射液（SFI）治疗感染性休克患者的临床疗效，并利用网络药理学探讨其潜在作用机制。

方法：

于2022年11月3日至2025年5月4日期间，开展了一项前瞻性、单中心、随机、开放标签、平行对照临床试验，评估参附注射液对122例动脉血乳酸水平为4.5–7.0 mmol/L的感染性休克患者的有效性和安全性。采用分层区组随机化方法将受试者按1：1比例随机分为试验组或对照组。在指南推荐的标准化治疗基础上，治疗组给予参附注射液（100 mL）联合0.9%生理盐水（100 mL），对照组给予0.9%生理盐水（200 mL），两组均通过静脉输注给药，每次输注60分钟，每日1次，连续7天，并随访至第28天。主要结局指标为28天全因死亡率。次要结局指标包括住院及重症监护病房（ICU）停留时间、机械通气持续时间、动脉血乳酸水平、去甲肾上腺素用量、平均动脉压（MAP）、乳酸清除率、第7天的左心室射血分数（LVEF）、肌酸激酶同工酶（CK-MB）和肌钙蛋白I（TnI）水平。记录并比较两组的不良事件。此外，通过基因本体论（GO）和京都基因与基因组百科全书（KEGG）通路富集分析以阐明潜在作用机制。

结果：

参附注射液组28天全因死亡率为41.0%（25/61），对照组为50.8%（31/61），组间差异无统计学意义（

=0.271）。参附注射液组的7天全因死亡率显著低于对照组[4.9%（3/61）

. 16.4%（10/61），

=0.046

]

。入组后第7天，参附注射液组的去甲肾上腺素用量显著低于对照组[1.48（1.12

1.82）

. 2.37（1.68

2.80） µg·kg

-1

·min

-1

，

0.01

]

。同样，第7天参附注射液组的乳酸水平显著低于对照组[3.02（2.50

3.33）

. 4.37（3.78

4.90） mmol/L，

0.01

]

。此外，与对照组相比，参附注射液组在第7天的乳酸清除率、平均动脉压和左心室射血分数均显著升高，而CK-MB和TnI水平显著降低（所有比较

0.01）。两组间不良事件发生率无显著差异（5/59

. 3/61，

0.05）。网络药理学分析确定了102个参附注射液与感染性休克的交集靶基因，这些基因富集于多个脓毒症相关通路，如IL-17、TNF和PI3K-Akt信号通路。

结论：

对于乳酸水平为4.5–7.0 mmol/L的感染性休克患者，加用参附注射液未能显著降低28天全因死亡率。然而，参附注射液与7天死亡率显著降低、以及第7天血流动力学、代谢和心脏参数的改善相关，且安全性良好。网络药理学分析提示其潜在机制可能涉及调节炎症和细胞信号通路。（临床试验注册号：ChiCTR2200065122）

Abstract

Objective:

To evaluate the clinical efficacy of Shenfu Injection (SFI) in treating patients with septic shock through a randomized controlled trial

and explore the underling mechanisms by network pharmacology.

Methods:

A prospective

single-center

randomized

open-label

parallel-controlled clinical trial was conducted between November 3

2022 and May 4

2025 to assess the effectiveness safety of SFI in 122 patients with septic shock (arterial blood lactate 4.5–7.0 mmol/L). Participants were randomly assigned (1:1) to the experimental or control group using stratified block randomization. In addition to the standard care recommended by guidelines

the treatment group received SFI (100 mL) combined with 0.9% saline (100 mL)

while the control group received 0.9% saline (200 mL)

both via intravenous infusion over 60 min once daily for 7 consecutive days and followed by a 28-d follow-up period. Primary outcomes included 28-d all-cause mortality. Secondary outcomes comprised duration of hospital and intensive care unit (ICU) stays

duration of mechanical ventilation

arterial blood lactate levels

norepinephrine dose

mean arterial pressure (MAP)

lactate clearance

left ventricular ejection fraction (LVEF)

creatine kinase-MB (CK-MB)

and troponin I (TnI) levels on day 7. Aderverse events were recorded and compared between groups. Furthermore

Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analyses were performed to elucidate the underlying mechanisms.

Results:

The 28-d all-cause mortality was 41.0% (25/61) in the SFI group compared with 50.8% (31/61) in the control group (

=0.271). The 7-d all-cause mortality was significantly lower in the SFI group (4.9%

3/61) compared with the control group (16.4%

10/61;

=0.046). On day 7 post-enrollment

the norepinephrine dose in the SFI group was significantly lower than that in the control group [1.48 (1.12

1.82)

. 2.37 (1.68

2.80) μg•kg

-1

•min

-1

0.01

]

. Similarly

lactate levels in the SFI group were significantly lower than those in the control group [3.02 (2.50

3.33)

. 4.37 (3.78

4.90) mmol/L

]

on day 7 (

0.01). In addition

the SFI group demonstrated significantly higher lactate clearance

MAP

and LVEF

alongside significantly lower CK-MB and TnI levels compared with the control group on day 7 (all

0.01). No significant differences in adverse events were observed between two groups(5/59

. 3/61

0.05). Network pharmacology analysis identified 102 intersection target genes between SFI- and septic shock-related targets

which were significantly enriched in several sepsis-related pathways

such as the IL-17

TNF

and PI3K-Akt signaling pathways.

Conclusion:

In patients with septic shock and lactate levels of 4.5–7.0 mmol/L

adjunctive SFI did not significantly reduce 28-d all-cause mortality. However

it was associated with a significant reduction in 7-d mortality and improved hemodynamic

metabolic

and cardiac parameters by day 7

with a favorable safety profile. Network pharmacology analysis suggests its potential mechanisms may involve modulation of inflammatory and cellular signaling pathways. (Trial registration No. ChiCTR2200065122)

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