This study aims to evaluate the efficacy and safety of Fuzheng Yangxin Formula (FZYXF) in the treatment of qi-yin deficiency syndrome after coronary artery bypass grafting (CABG), formulate an integrated Chinese and Western medicine rehabilitation protocol, develop special proprietary Chinese medicines for postoperative patients, establish a postoperative rehabilitation database, and promote the standardized application and achievement transformation of integrated Chinese and Western medicine therapy in cardiac surgery.
This study adopts a randomized controlled trial design. A total of 230 patients presenting with qi-yin deficiency syndrome after coronary artery bypass grafting (CABG) will be enrolled and randomly assigned to the Fuzheng Yangxin Formula (FZYXF) experimental group (115 patients) and the control group (115 patients). The primary outcome is the Seattle Angina Questionnaire (SAQ) score at 7 days after medication. Secondary outcomes include perioperative safety and follow-up health assessments to comprehensively evaluate the therapeutic efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
230
Intervention: Fuzheng Yangxin Formula granules combined with routine postoperative management. The formula consists of Radix Ginseng 20 g, processed Radix Aconiti Lateralis Preparata 10 g (pre-decocted), Radix Astragali 30 g, Radix Ophiopogonis 20 g, Radix Angelicae Sinensis 15 g, Radix Rehmanniae 15 g, Radix Rhodiolae 30 g, Radix Notoginseng powder 6 g (mixed with warm water for oral use). Participants take the granules orally for 7 consecutive days after CABG.
Peking University 3rd hospital
Beijing, China
Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication
Measured using the Seattle Angina Questionnaire
Time frame: 7 days after operation
Length of Stay
The postoperative length of hospital stay
Time frame: Perioperative
Follow-up Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
The incidence of MACCE, which includes all-cause mortality, repeat bypass surgery or stenting, acute myocardial infarction, and stroke.
Time frame: up to 12 months
Seattle Angina Questionnaire (SAQ) Scores
Evaluation of the patient's health and angina status, including the total score and scores across 5 dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception.
Time frame: up to 12 months
Incidence of poor wound healing.
Assessed by routine postoperative clinical physical examination. A positive event is defined as the presence of any of the following: local wound dehiscence (splitting open), abnormal wound exudate (purulent or serous drainage), or the need for secondary surgical suturing/re-suturing. Number and percentage of participants with poor wound healing (number of events / total participants in group × 100%).
Time frame: up to 30 days
Perioperative MACCE
Composite endpoint before discharge, including death, myocardial infarction, stroke, and revascularization
Time frame: Perioperative
Graft patency
graft patency rate (assessed by angiography)，Using the Fitz-Gibbon grading system, grade A and grade B are considered patent.
Time frame: perioperative
atrial fibrillation incidence
Monitor patients for atrial fibrillation during hospitalization; if it occurs, it is considered positive.
Time frame: perioperative
Renal failure
Patients who develop new-onset renal failure after surgery and require dialysis
Time frame: Perioperative
reintubation
Reintubation and mechanical ventilation are required during the postoperative hospital stay
Time frame: Perioperative
length of ICU stay.
length of Intensive Care Unit (ICU) stay.
Time frame: perioperative
Peking University 3rd Hospital cardiac surgery
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