参蛤散治疗心肾阳虚型射血分数保留心力衰竭合并心房颤动的随机对照试验OA

Objective To observe the efficacy and safety of Shen'ge San in treating patients with heart failure with preserved ejection fraction(HFpEF)complicated by atrial fibrillation(AF)and presenting with heart-kidney yang deficiency syndrome.Methods Eighty patients with HFpEF complicated by AF and heart-kidney yang deficiency syndrome who attended the Department of Cardiology,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from June 2024 to July 2025 were randomly assigned to a treatment group and a control group using a random number table,with 40 cases in each group.The control group received guideline-directed standardized treatment,while the treatment group received Shen'ge San granules in addition to the treatment given to the control group.The treatment course for both groups was 12 weeks.The changes in serum N-terminal pro-B-type natriuretic peptide(NT-proBNP),left ventricular ejection fraction(LVEF),oxygen uptake at anaerobic threshold(VO2 AT),peak oxygen uptake(VO2 peak),Minnesota Living with Heart Failure Questionnaire(MLHFQ)score,and 6-minute walk test(6MWT)distance were observed before and after treatment in both groups.The traditional Chinese medicine(TCM)syndrome efficacy and medication safety were evaluated in both groups.Results(1)Regarding efficacy,after 12 weeks of treatment,the total effective rate was 95.00%(38/40)in the treatment group and 77.50%(31/40)in the control group;intergroup comparison(by chi-square test)showed that the TCM syndrome efficacy in the treatment group was significantly superior to that in the control group(P＜0.05).(2)Regarding serum NT-proBNP level and LVEF,after treatment,serum NT-proBNP levels in both groups decreased compared with those before treatment(P＜0.01),and LVEF values increased compared with those before treatment(P＜0.01).The treatment group showed significantly greater reductions in serum NT-proBNP level and increases in LVEF value compared with the control group(P＜0.01).(3)Regarding cardiopulmonary exercise testing,after treatment,VO2 AT and VO2 peak levels in both groups increased compared with those before treatment(P＜0.01),and the treatment group showed significantly greater increases in both VO2 AT and VO2 peak levels compared with the control group(P＜0.01).(4)Regarding quality of life and exercise tolerance,after treatment,MLHFQ scores in both groups decreased compared with those before treatment(P＜0.01),and 6MWT distances increased compared with those before treatment(P＜0.01).The treatment group showed significantly greater reductions in MLHFQ score and increases in 6MWT distance compared with the control group(P＜0.01).(5)Regarding safety,during the treatment period,no adverse drug reactions such as nausea,vomiting,or allergy occurred in either group,and no abnormal changes were observed in safety indicators including blood and urine routine tests and liver and kidney function before and after treatment in both groups.Conclusion Shen'ge San demonstrates good efficacy and safety in treating patients with HFpEF complicated by AF and heart-kidney yang deficiency syndrome.It is effective on decreasing serum NT-proBNP levels,improving LVEF,enhancing cardiac function,and increasing quality of life in these patients.