Clinical Study On The Treatment Of Heart Failure With Preserved Ejection Fraction(Yang Deficiency And Blood Stasis Type) With Jiawei Linggui Zhugan Decoction

Objective:To observe the clinical efficacy and safety of Heart Failure with Preserved Ejection Fraction(HFPEF)(Yang Deficiency and Blood Stasis Type)with Jiawei Linggui Zhugan Decoction,and to provide a clinical reference basis for expanding the application of classical Chinese medicine formulas by summarizing and analyzing the results of clinical trial data and to lay the foundation for in-depth research on HFPEF in the future.Methods:Through the screening of diagnostic criteria,inclusion criteria and exclusion criteria,the 72 patients enrolled were divided equally into the treatment group and the control group according to the randomization principle.The control group was given basic western drug treatment according to the relevant HFPEF guidelines,and the treatment group was provided with Jiawei Linggui Zhugan Decoction on the basis of western drug treatment.Chinese medicine particles were taken: one packet once,three packets a day,by mouth half an hour after breakfast,lunch and dinner,100 ml of boiled water each time,and the course of treatment was 4 weeks.Changes in TCM symptoms,NYHA cardiac function classification,B-type natriuretic peptide(BNP),E/A ratio,tricuspid regurgitation peak velocity(TRPV),six-minute walk test(6MDW)and Minnesota quality of life score and safety indexes were observed before and after treatment in the two groups to determine the clinical effectiveness and safety of Jiawei Linggui Zhugan Decoction.Results:1.72 patients were included in this study,and 36 patients in each of the test and control groups were included according to the randomization principle.Four cases were shed in the treatment group and six cases were shed in the control group in the process of treatment,and the completion ratio of the two groups was 88.9% and 83.3%,respectively,and the total completion ratio was 86.1%,with no statistically significant difference between the two groups(P > 0.05).2.Comparison of general data: By analyzing the general data of the two groups,NYHA cardiac function grading and Chinese medicine syndromes scoring grading,we found that the differences were not statistically significant(P>0.05),and the two groups were comparable.3.Comparison of clinical efficacy.3.1 Efficacy of TCM syndromes: the statistics of Traditional Chinese Medicine syndromes of the two groups of patients were analyzed before the test,and the data were uniformly in comparison between the groups(P > 0.05).After the treatment,it was found that the efficacy of the Traditional Chinese Medicine syndromes of HFPEF patients in the treatment group was significantly superior to that of the control group(P < 0.05).Comparing the primary and secondary Traditional Chinese Medicine syndromes,we found that the treatment group was superior to the control group in improving the symptoms of "Yang deficiency",including shortness of breath,coldness in the limbs,swelling of the face and limbs,and weakness.(P < 0.01);while the differences between the treatment group and the control group were not statistically significant in the symptoms of chest pain,dullness of the face,little urination,and cough(P >0.05).3.2 The test group had better clinical outcomes than the control group in terms of improving B-type natriuretic peptide,NYHA cardiac function,6-minute walk test,and Minnesota quality of life score in the enrolled patients during the pilot study,with statistically significant differences(P < 0.05).3.3 Cardiac ultrasound index: E peak,A peak,E/A ratio and tricuspid regurgitation velocity(TRPV)were statistically significant(P < 0.05)in the treatment group and control groups between pre-treatment and post-treatment.However,the difference between the two groups showed no statistically significant difference in post treatment(P > 0.05).4.Observation of safety index: The safety indexes monitored in the two groups of patients were not obviously abnormal during the course of treatment.Conclusion:The present trial study showed that the efficacy of Jiawei Linggui Zhugan Decoction in relieving TCM-related syndromes,regulating exercise endurance,and improving survival quality of patients with Heart Failure with Preserved Ejection Fraction(HFPEF)after its application on them.It also has good clinical safety and is worthy of clinical application.However,cardiac ultrasound did not show good clinical efficacy in the trial group of this study,which may be related to the short duration of the trial and the insufficient base of the trial population,and is worthy of further study later.