| Objective: To evaluate the clinical effect of Zhenwu decoction combined with Wuling powder in the treatment of acute decompensated heart failure with Yang deficiency and water flooding syndrome.Methods: The prospective randomized controlled clinical trial was used in the study.96 patients with acute decompensated heart failure with Yang deficiency and water flooding syndrome who were hospitalized in Wuyi Hospital of traditional Chinese medicine of Jiangmen City from January2018 to October 2019 were included in the study.Randomly divided into control group and observation group,48 cases in each group.All patients were treated and managed according to China heart failure diagnosis and treatment guidelines 2014,and the observation group added Zhenwu Decoction and Wuling powder.Efficacy indicators: edema of lower limbs,visual analogue score of dyspnea(VAS),fasting weight in the morning,24 h in and out volume,BNP level,six minute walking distance(6MWD)after treatment in the first,third and seventh day after admission;Safety indicators: adverse reactions,dosage,etc.;Short-term prognosis indicators:including Minnesota quality of life Scale score,readmission and death within 30 days,color Doppler index of heart.Results:(1)Baseline data:In the control group,2 patients were removed due to cardiogenic shock,1 patient was automatically discharged from the hospital and dropped off,and 1 patient was removed by taking proprietary Chinese medicine;in the observation group,2 patients could not insist on taking traditional Chinese medicine and dropped off,and 1 patient died suddenly in hospital.There was no significant difference in gender,age,primary disease,comorbidity,NYHA grade,Forrester classification,and basic vital signs between the two groups(P > 0.05).(2)Efficacy index:(1)Calf circumference: On the third and seventh day after admission,the reduction of the circumference of the leg in the observation group was significantly greater than that in the control group(P < 0.05).(2)Body weight: there was no significant difference between the two groups on the day of admission and on the 7th day(P > 0.05).On the 3rd day of admission,the body weight of the observation group was significantly lower than that of the control group(P < 0.05).(3)Dyspnea and lung rales: There was no significant difference in the VAS score of dyspnea between the two groups on the day of admission and the seventh day(P > 0.05).While the VAS score of the observation group was significantly lower than that of the control group on the third day(P <0.05).The proportion of patients without rales in the observation group on the 3rd and 7th day was significantly higher than that in the control group(P< 0.05).(4)Negative balance body fluid: There was no significant difference in the negative balance between the two groups at 24 hours on the first day of admission(P > 0.05).On the third and seventh day of admission,the volume of negative balance body fluid in the observation group was significantly higher than that in the control group(P < 0.05).(5)BNP: There was no significant difference in BNP level between the two groups on the day of admission(P > 0.05).On the third and seventh day of admission,BNP level in the observation group was significantly lower than that in the control group(P < 0.05).(6)Overall recovery: The time for the patients in the observation group to reach the discharge standard was significantly shorter than that in the control group(P < 0.05).On the 7th day,the six minute walking distance of the observation group was significantly longer than that of the control group(P < 0.05).(3)Safety indicators:(1)Side effects: There was no significant difference between the two groups in the incidence of various adverse reactions(P > 0.05).(2)Drug used: In the control group and the observation group,6patients and 5 patients switched to or combined with torasemide tablets,and1 patient in the two groups respectively used torvaptan tablets.The averagetotal dose of all kinds of diuretics used in the observation group during hospitalization was significantly lower than that in the control group(P <0.05).There were 10 patients in the control group and 7 patients in the observation group using dopamine respectively.The use rate of the control group was 22.73%,which was higher than that of the observation group(15.56%),but the difference was not statistically significant(P > 0.05).The total dose and time of dopamine use in the control group were higher than that in the observation group,the difference was statistically significant(P< 0.05).(4)Short term prognosis:(1)Death and readmission: There was no significant difference between the two groups in the number of admission due to heart failure within 30days(P > 0.05).3 patients in the control group died within 30 days after treatment,the death rate was 6.82%.2 patients in the observation group died of sudden death within 30 days after treatment,the death rate was4.44%,the difference was not significant(P > 0.05).(2)Quality of life: There was no significant difference in Minnesota quality of life score between the two groups before and after treatment(P >0.05).(3)Echocardiography: There was no significant difference in LVDd and LVEF between the two groups before and after treatment(P > 0.05).Conclusion:(1)Compared with the standardized treatment of Western medicine alone,the combination of Zhenwu Decoction and Wuling powder can accelerate the relief of clinical symptoms and signs in patients with acute decompensated heart failure with Yang deficiency and water flooding syndrome.(2)Standardized treatment combined with Zhenwu Decoction and Wuling powder can further reduce the blood BNP level in patients with acute decompensated heart failure with Yang deficiency and water flooding syndrome.(3)Standardized treatment combined with Zhenwu Decoction and Wuling powder can reduce the use of diuretics and vasoactive drugs without increasing adverse reactions.(4)Standardized treatment combined with Zhenwu Decoction and Wuling powder can not improve the quality of life,the index of color Doppler echocardiography,the number of rehospitalization and death rate30 days after the treatment. |
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