A controlled clinical study of Qishen granules in the treatment of heart failure with preserved ejection fraction
Sun Rui
Li Meng
Wu Zhuoran
Xiao Di
Guo Shuzhen
Zhang Lijing
Abstract：Objective To observe the efficacy,safety and anti-inflammatory effect of Qishen granules in the treatment of heart failure with preserved ejection fraction(HFpEF).Methods A total of 80 HFpEF patients admitted to Dongzhimen Hospital,Beijing University of Chinese Medicine from December 2023 to October 2024 were selected.The patients were divided into observation group and control group by block randomization,with 40 cases in each group.All patients were given standard heart failure treatment,and the control group and the observation group were treated with placebo and Qishen granules,respectively,for 12 weeks.The decline rate of N-terminal pro-brain natriuretic peptide(NT-proBNP),New York Heart Association(NYHA)functional class,Kansas City Cardiomyopathy Questionnaire(KCCQ-12)score,traditional Chinese medicine syndrome score,6 min walk test(6MWT)distance,echocardiographic indicators,inflammatory exploratory indicators and safety evaluation were compared between the two groups.Results There were no significant differences in general data between the two groups(all P＞0.05).After 12 weeks of treatment,the levels of NT-proBNP,high-sensitivity C-reactive protein,soluble tumor suppressor 2,and tumor necrosis factor-α in the observation group were lower than those in the control group[(921±212)ng/L vs(1 054±305)ng/L,(3.2±1.3)mg/L vs(4.1±2.0)mg/L,(19±4)ng/L vs(21±4)ng/L,(34±8)mg/L vs(40±10)mg/L],and the effective decline rate of NT-proBNP,the total effective rate of cardiac function improvement,and 6MWT distance were higher/longer than those in the control group[60.0％(24/40)vs 37.5％(15/40),67.5％(27/40)vs 35.0％(14/40),(348±62)m vs(315±51)m](all P＜0.05).After 8 and 12 weeks of treatment,the KCCQ-12 scores of the observation group were higher than those of the control group,and the traditional Chinese medicine syndrome scores were lower than those of the control group(all P＜0.05).There were no significant differences in the safety indicators between the two groups(all P＞0.05).Conclusion Qishen granules can improve the rate of NT-proBNP decline in patients with HFpEF,improve cardiac function,exercise tolerance and quality of life,reduce the levels of inflammatory factors,and has good safety.
Keywords：Heart failure with preserved ejection fractionQishen granulesInflammation
Publication Date：2025-12-18
Online Publishing Date：2026-09-14(First online date of this platform, not the publication date of the document)
Pages：6( 1846-1851 )