Clinical study of Yiqi Liangxue Shengji prescription (益气凉血生肌方) for improving cardiac function after myocardial ischemia reperfusion injury in patients with acute myocardial infarction: a randomized, double-blind, placebo-controlled trial

doi:10.19852/j.cnki.jtcm.2025.04.012

Abstract

Abstract:

OBJECTIVE: To evaluate the effect of Yiqi Liangxue Shengji prescription (益气凉血生肌方, YQLXSJ) on cardiac function and outcomes in acute myocardial infarction (AMI) patients with myocardial ischemia-reperfusion injury (MIRI) and to determine its clinical efficacy.

METHODS: This prospective, randomized, double-blind, placebo-controlled trial enrolled hospitalized patients with AMI who underwent percutaneous coronary intervention and experienced MIRI either intraoperatively or postoperatively. Participants were randomly allocated to the treatment group, which received YQLXSJ, or the control group, which received a placebo, concurrent with standard Western Medicine therapy. The intervention period lasted 8 weeks. The primary outcome measure was left ventricular ejection fraction (LVEF), determined by echocardiography. Secondary outcomes included N-terminal pro brain natriuretic peptide (NT-proBNP) and cardiac troponin I (cTnI) levels, left ventricular internal diameter, major adverse cardiovascular events (MACE), angina pectoris scores, and Chinese medicine evidence scores.

RESULTS: Following 8 weeks of intervention, the treatment group demonstrated a significant increase in LVEF and a marked reduction in NT-proBNP when compared to the control group. There was also a significant decrease in peak cTnI levels, Chinese medicine evidence scores, and angina pectoris scores. The control group’s left ventricular end-systolic diameter (LVESD) significantly increased compared to baseline after 8 weeks (P < 0.05), whereas the treatment group's LVESD showed no significant change from baseline (P > 0.05). Although the treatment group showed a downward trend in MACE incidence compared to the control group, this difference was not statistically significant (P > 0.05).

CONCLUSIONS: This study demonstrated that the addition of YQLXSJ to standard therapy can improve cardiac function and alleviate clinical symptoms in AMI patients with MIRI, and also showed a potential to mitigate the incidence of MACE. Furthermore, YQLXSJ displayed a favorable safety profile in clinical application.

Key words: myocardial reperfusion injury, stroke volume, natriuretic peptide, brain, troponin I, randomized controlled trial, blind, Yiqi Liangxue Shengji prescription

LI Yuxuan, LI Yan, WANG Wujiao, CUI Xiaoyun, WAN Jie, ZHOU Kun, LU Jinjin, LIU Jing, LIN Qian, LI Dong. Clinical study of Yiqi Liangxue Shengji prescription (益气凉血生肌方) for improving cardiac function after myocardial ischemia reperfusion injury in patients with acute myocardial infarction: a randomized, double-blind, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2025, 45(4): 836-844.

Figures/Tables 4

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Item	Control (n = 36)	Treatment (n = 35)	P value
Baseline characteristic
Age [years, median (IQR)]	63 (55.75, 70.50)	59 (55.00, 63.00)	0.081
Sex [n (%)]
Female	11 (30.56)	9 (25.71)	0.650
Male	25 (69.44)	26 (74.29)
Risk factor [n (%)]
Hypertension	25 (69.44)	17 (48.57)	0.074
Diabetes	15 (41.67)	8 (22.86)	0.090
Dyslipidemia	16 (44.44)	19 (54.29)	0.407
Smoking history	15 (41.67)	21 (60.00)	0.122
Drinking history	5 (13.89)	11 (31.43)	0.077
Family history of coronary	7 (19.44)	8 (22.86)	0.725
Medical history [n (%)]
Myocardial infarction	4 (11.11)	4 (11.43)	1.000
Percutaneous coronary intervention	4 (11.11)	5 (14.29)	0.964
Presentation feature ($\bar{x} \pm s$)
Systolic blood pressure (mm Hg)	130.22±19.24	121.49±19.81	0.064
Diastolic blood pressure (mm Hg)	78.67±12.53	72.86±12.80	0.057
Heart rate (beats/min)	78.89±14.79	76.43±13.22	0.463
Culprit lesion [n (%)]
Left anterior descending branch	21 (58.33)	17 (48.57)	0.278
Left circumflex branch	8 (22.22)	14 (40.00)
Right coronary artery	6 (16.67)	4 (11.43)
Left main coronary artery	1 (2.78)	0 (0.00)
Type of vascular lesion [n (%)]
Single-vessel lesion	12 (33.33)	11 (31.43)	0.945
Double vessel lesion	13 (36.11)	14 (40.00)
Three-vessel disease	11 (30.56)	10 (28.57)
Characteristic of myocardial infarction
STEMI [n (%)]	25 (69.44)	24 (68.6)	0.937
NSTEMI [n (%)]	11 (30.56)	11 (31.43)
Infarctional Q wave [n (%)]	18 (50.00)	13 (37.14)	0.275
Non-infarctional Q wave [n (%)]	18 (50.00)	22 (62.86)
With arrhythmia [n (%)]	5 (13.88)	9 (25.71)	0.211
No arrhythmia [n (%)]	31 (86.11)	26 (74.29)
Number of cardiac stents [median (IQR)]	1.00 (1.00, 2.00)	1.00 (1.00, 2.00)	0.325
Number of drug balloons [median (IQR)]	0.00 (0.00, 1.00)	0.00 (0.00, 1.00)	0.669

Item	Control (n = 36)	Treatment (n = 35)	P value
Baseline characteristic
Age [years, median (IQR)]	63 (55.75, 70.50)	59 (55.00, 63.00)	0.081
Sex [n (%)]
Female	11 (30.56)	9 (25.71)	0.650
Male	25 (69.44)	26 (74.29)
Risk factor [n (%)]
Hypertension	25 (69.44)	17 (48.57)	0.074
Diabetes	15 (41.67)	8 (22.86)	0.090
Dyslipidemia	16 (44.44)	19 (54.29)	0.407
Smoking history	15 (41.67)	21 (60.00)	0.122
Drinking history	5 (13.89)	11 (31.43)	0.077
Family history of coronary	7 (19.44)	8 (22.86)	0.725
Medical history [n (%)]
Myocardial infarction	4 (11.11)	4 (11.43)	1.000
Percutaneous coronary intervention	4 (11.11)	5 (14.29)	0.964
Presentation feature ($\bar{x} \pm s$)
Systolic blood pressure (mm Hg)	130.22±19.24	121.49±19.81	0.064
Diastolic blood pressure (mm Hg)	78.67±12.53	72.86±12.80	0.057
Heart rate (beats/min)	78.89±14.79	76.43±13.22	0.463
Culprit lesion [n (%)]
Left anterior descending branch	21 (58.33)	17 (48.57)	0.278
Left circumflex branch	8 (22.22)	14 (40.00)
Right coronary artery	6 (16.67)	4 (11.43)
Left main coronary artery	1 (2.78)	0 (0.00)
Type of vascular lesion [n (%)]
Single-vessel lesion	12 (33.33)	11 (31.43)	0.945
Double vessel lesion	13 (36.11)	14 (40.00)
Three-vessel disease	11 (30.56)	10 (28.57)
Characteristic of myocardial infarction
STEMI [n (%)]	25 (69.44)	24 (68.6)	0.937
NSTEMI [n (%)]	11 (30.56)	11 (31.43)
Infarctional Q wave [n (%)]	18 (50.00)	13 (37.14)	0.275
Non-infarctional Q wave [n (%)]	18 (50.00)	22 (62.86)
With arrhythmia [n (%)]	5 (13.88)	9 (25.71)	0.211
No arrhythmia [n (%)]	31 (86.11)	26 (74.29)
Number of cardiac stents [median (IQR)]	1.00 (1.00, 2.00)	1.00 (1.00, 2.00)	0.325
Number of drug balloons [median (IQR)]	0.00 (0.00, 1.00)	0.00 (0.00, 1.00)	0.669

Drug	Treatment	Control	χ ² value	P value
Dual antiplatelet drugs	34 (97.14)	35 (97.22)	0.000	1.00
Lipid-lowering drugs	34 (97.14)	35 (97.22)	0.000	1.00
Nitrates	10 (28.57)	13 (36.11)	0.461	0.497
β-blockers	21 (60)	26 (72.22)	1.185	0.276
Calcium antagonists	3 (8.57)	5 (13.89)	0.111	0.739
ACEI/ARB	19 (54.29)	27 (75.00)	3.338	0.068
Low-molecular heparin, diuretics	33 (94.29)	35 (97.22)	0.001	0.980
Diuretics	5 (14.29)	6 (16.67)	0.077	0.782
Cardiotonic agents	3 (8.57)	1 (2.78)	0.296	0.587

Drug	Treatment	Control	χ ² value	P value
Dual antiplatelet drugs	34 (97.14)	35 (97.22)	0.000	1.00
Lipid-lowering drugs	34 (97.14)	35 (97.22)	0.000	1.00
Nitrates	10 (28.57)	13 (36.11)	0.461	0.497
β-blockers	21 (60)	26 (72.22)	1.185	0.276
Calcium antagonists	3 (8.57)	5 (13.89)	0.111	0.739
ACEI/ARB	19 (54.29)	27 (75.00)	3.338	0.068
Low-molecular heparin, diuretics	33 (94.29)	35 (97.22)	0.001	0.980
Diuretics	5 (14.29)	6 (16.67)	0.077	0.782
Cardiotonic agents	3 (8.57)	1 (2.78)	0.296	0.587

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