A Single-case Randomized Controlled Trial Of Jiawei Yiqi Huoxue Lishui Recipe In The Treatment Of Patients With Chronic Heart Failure

Objective:To observe the clinical efficacy of Modified Yiqi Huoxue Lishui Decoction in patients with chronic heart failure with qi deficiency,blood stasis and water withdrawal syndrome through a series of N-of-1 trials,and compare the difference between the effects of Radix Hedysari and Astragalus.Efficacy evaluation and development of personalized treatment plans that are most suitable for this patient,and explore new ideas for the treatment of chronic heart failure by integrating traditional Chinese and western medicine.Methods:This trial is a series of N-of-1 trials,collected from September 2018 to August 2019 in patients with chronic heart failure with qi deficiency,blood stasis and stasis treated in the Department of Cardiology,Dongzhimen Hospital,Beijing University of Chinese Medicine,or ward.A randomized,single-blind,controlled trial was used to evaluate the effectiveness of Modified Yiqi Huoxue Lishui Decoction.Patients meeting the criteria will receive 2 or 3 pairs treatments for a total of 11 or 17 weeks.1 Modified Yiqi Huoxue Lishui Decoction(Radix Hedysari 20g,Codonopsis 15g,Salvia miltiorrhiza 30g,Safflower 10g,Mulberry peel 12g,Gardenia 15g,Psyllium seed 20g,Poria cocos 15g,Poria cocos 15g,Zelan 15g.)period and a control drug(Modified Yiqi Huoxue Lishui Decoction add Raw Astragalus without Radix Hedysari)period constitute a pair,the order of the two periods is random.According to the pre-test results,the treatment time for each stage is set to 2 weeks,and there is a 1-week washout period between each period to minimize the residual effect.Observe and record the patient's MLHFQ,symptom score,and 6MWT before the start of the trial and on the last day of each stage of treatment.Criteria for individualized curative effect:Criteria for the method of Yiqi Huoxue Lishui Method:(1)The total MLHFQ score at the treatment period was reduced by ?19 points or the mean change in symptom score was reduced by?0.5 points.(2)The result of the 6MWT test at the treatment period is?45m higher than the baseline value.Effective:greater than or equal to 50%of the treatment periods meet the above two conditions,invalid:less than 50%of the treatment periods meet the above two conditions.Based on the effectiveness of the method of nourishing qi and activating blood,the efficacy of Modified Yiqi Huoxue Lishui Decoction was judged as follows:(1)The total MLHFQ score of Modified Yiqi Huoxue Lishui Decoction and the control group was reduced by ? 19 points or the average change in symptoms score was reduced by?0.5 points.(2)The 6MWT test results of Modified Yiqi Huoxue Lishui Decoction and the control side increased by?45m.Valid:At least 2 pairs meet both of the above 2 items;Possibly valid:Only 1 pair meets the above 2 items at the same time;Invalid:No pair satisfies both of the above 2 items.The overall efficacy was evaluated by considering each subject's paired trials as separate trials combined.Truthfully record any adverse events during the trial.Results:A series of N-of-1 trials were used to evaluate the effectiveness of Yiqi Huoxue Lishui Method and the clinical efficacy of Modified Yiqi Huoxue Lishui Decoction for 6 CHF patients.The results show that Yiqi Huoxue Lishui method is effective for 3 subjects Among them,the effect of Modified Yiqi Huoxue Lishui Decoction on one subject was significantly better than that of the control drug,and Yiqi Huoxue Lishui method was not effective on the other 3 subjects.The paired trials of each subject were considered as independent trials.The results showed that MLHFQ,symptom score,and 6MWT were significantly improved after the treatment of Modified Yiqi Huoxue Lishui Decoction and the control drugs(P<0.05).The overall efficacy of Modified Yiqi Huoxue Lishui Decoction in MLHFQ,symptom score and 6MWT was not significantly different from that of the control(P>0.05).Conclusion:This test uses a series of N-of-1 trials to objectively and systematically evaluate the effectiveness of Yiqi Huoxue Lishui Method and the clinical efficacy of Modified Yiqi Huoxue Lishui Decoction on 6 CHF patients.The effects of Radix Hedysari and Astragalus were compared.The test method is close to the clinic and fully cooperates with the patient during the test.Finally,according to the test results,personalized treatment recommendations are given to patients to help patients find a treatment that suits them.At the same time,carry forward the characteristics of syndrome differentiation and treatment of traditional Chinese medicine,and use scientific methods to apply the clinical experience of famous old Chinese medicine to clinical treatment,and further explore new methods of combined traditional Chinese and western medicine to treat CHF.