| Objective: To observe the clinical efficacy and safety of Sishen decoction in the treatment of chronic heart failure(qi-yin deficiency and blood stasis type),to provide the basis for clinical treatment of chronic heart failure,and to observe the effect of Sishen decoction on thyroid hormone level in patients with chronic heart failure(qi-yin deficiency and blood stasis type),so as to further explore the correlation between thyroid hormone level and chronic heart failure,and to provide a new idea for further treatment of chronic heart failure from the endocrine point of view.Methods: Patients visit to Yun Nan TCM Hospital from december 2018 to december2019,73 patients who met the diagnostic criteria of traditional chinese medicine and western medicine were divided into control group 37 cases and treatment group 36 cases according to the principle of random control.the control group was given routine western medicine treatment of chronic heart failure.The treatment group was treated with Sishen decoction on the basis of it,and the course of treatment in both groups was 28 days.TCM main and secondary symptoms,TCM syndrome score,TCM syndrome score efficacy,BNP level,NYHA heart function grade,Lee heart failure score and efficacy,6-minute walking experiment and efficacy,LVEF were studied in two groups,thyroid hormone levels(TSH?T3?FT3?T4?FT4)and so on before and after the treatment of intra-group,inter-group comparative analysis.Result:1.Factors such as rejecting,shedding and discontinuing,In this clinical study,there were 68 cases,34 cases in control group and 34 cases in treatment group.The general clinical data(sex,age,course of disease),single integral of main and secondary symptoms,TCM syndrome score,BNP?NYHA heart function grade,Lee heart failure score,thyroid hormone level(TSH?T3?FT3?T4?FT4)and safety index(ALT?AST?Cr?UREA?Na?K?Cl)of the two groups were recorded before the use of drugs in this clinical study.2.In terms of TCM efficacy:(1)Comparison between the two groups of patients before andafter the treatment of the main symptoms of TCM,secondary symptoms single points and TCM syndrome points showed: P<0.05,indicating: the two groups of patients with two different treatment plans of TCM main symptoms,secondary symptoms can be significantly improved,and both Sishen decoction and conventional western medicine can significantly reduce the TCM syndrome score of patients.(2)After treatment,the main and secondary symptoms were compared between the two groups,except for palpitation,dry pharynx and fever of the hand and foot hand and foot.P<0.05,indicating: in improving the main symptoms(shortness of breath,wheezing,fatigue),secondary symptoms(thirst,self-sweating,night sweats,facial color/lip purple dark),the treatment group plus Sishen decoction was better than the control group,but the two groups in improving the main symptoms(palpitations),secondary symptoms(pharynx,hand and foot heat)no significant difference,the effect.(3)For this clinical study,the two groups of patients after two different treatment options,according to the clinical data,the TCM syndrome score and its efficacy were compared between groups.The results showed: P<0.05,indicating: in reducing TCM syndrome score and improving the efficacy of TCM syndrome score,the treatment group with TCM Sishen decoction has more advantages than the control group.3.Indicators of western medicine:(1)The BNP?Lee heart failure score,6-minute walking distance and left ventricular ejection fraction(LVEF)were compared between the two groups before and after treatment.The results showed that P<0.05 showed that both groups(conventional western medicine group and four-shen decoction group)could significantly reduce the BNP level and Lee heart failure score,increase the 6-minute walking distance and LVEF;(2)The results of BNP ? NYHA cardiac function,Lee heart failure,6-minute walking experiment and LVEF were compared,All showed: P<0.05,Indicates:The two groups(routine western medicine group and sishen decoction group)were treated with sishen decoction group.The effect of the treatment group with sishen decoction was more obvious than that of the control group in reducing the BNP level,improving the curative effect of NYHA heart function,improving the integral effect of Lee heart failure,improving the curative effect of 6 minutes walking experiment and increasing LVEF.4.Thyroid hormone levels:(1)thyroid stimulating hormone(TSH),thyroxine(T4)and free thyroxine(FT4)were compared in the two groups before and after treatment,showing P>0.05,indicating that the drugs used in the treatment group and the control group did not affect the TSH?T4?FT4.(2)Triiodothyronine(T3)and free triiodothyronine(FT3)were compared in the group before and after treatment,and the T3?FT3 of the two groups after treatment showed P<0.05,indicating that both groups could increase significantly T3?FT3,indicating that the treatment group with Sishen decoction increased T3?FT3 the effect was more obvious than the control group.5.Safety indicators:No obvious adverse reactions occurred during treatment;Before and after treatment,two groups of patients,safety index(ALT?AST?Cr?UREA?Na?K?Cl)according to the type of data selected matching test method to compare,the results showed: P>0.05,indicating both the treatment group and the control group have no significant effect on the above safety indicators,but also indicated that the drug used in the study is safe.Conclusion:Sishen decoction has the function of improving the clinical symptoms and improving the quality of life of patients with chronic heart failure(qi and yin deficiency and blood stasis type).which can effectively reduce the BNP level of patients,increase the walking distance of 6 minutes,improve the curative effect of 6 minutes walking experiment,increase LVEF,improve cardiac function,reduce Lee heart failure integral,improve the curative effect of heart failure integral,and finally improve the overall symptoms of patients.can participate in the metabolic process of thyroid hormone levels in patients,and has the effect of raising T3?FT3 levels.There was no obvious effect on the safety indexes of vital signs,liver function,kidney function,electrolyte,urine routine,blood routine,stool routine and so on.and have good safety. |
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