| Objective:To objectively evaluate the clinical efficacy and safety of Lishui Qiangxin Decoction based on the method of "Regulating Sanjiaon" in the treatment of chronic heart failure(CHF).Besides,preliminary exploration of the "time-effect relationship" and the characteristic advantages in the treatment of CHF.The study also explored the academic thinking and pharmacological characteristics of Professor Ling Feng’s method of "Regulating Sanjiao" in the treatment of CHF.Methods:The study was designed as a prospective,single-arm,self-controlled,observational case series.Patients who were treated by Professor Ling Feng in Guang’anmen Hospital of Chinese Academy of traditional Chinese medicine between May 2022 and February 2023 and met the diagnostic criteria for chronic heart failure with "Qi deficiency and water stoppage,congestion of Sanjiao" were selected for the study.A total of 70 patients were included as observation subjects according to the criteria of nadir,and all patients were treated with the Chinese medicine prescription "Lishui Qiangxin Decoction",which has the effect of"Regulating Sanjiao".The main therapeutic indexes of the study were NT-proBNP and TCM syndrome score.Secondary efficacy indicators included cardiac function classification(N YHA),LVEF,LVEDd,Minnesota Living with Heart Failure Questionnaire,and the reduction of western medicine;The safety observation indexes included blood pressure,liver and kidney function and other adverse events.The general clinical data(Gender,age,course of disease,previous disease history,personal life history,family genetic history and current use of western medicine),primary and secondary efficacy indicators and safety observation indicators of patients were collected and recorded on the day of admission and the 8 week after medication.Meanwhile,at the fourth week,the patients’ TCM syndrome scores and secondary efficacy indicators(excluding LVEF and LVEDd)were followed up.The data related to the study were statistically processed and analyzed using SPSS 26.0 software.All statistical tests were performed using a two-sided test with a test level of α=0.05,and differences were considered statistically significant at P<0.05.Results:1.Main efficacy indicators(1)NT-proBNP:After 8 weeks of treatment,NT-proBNP was reduced by 715.00(153.75,1226.50)pg/mL compared with before treatment.Among them,the NT-proBNP of patients with LVEF<50%was reduced by 716.00(153.00,1124.00)pg/mL compared with before treatment,and that of patients with preserved ejection fraction was reduced by 601.00(196.00,1580.00)pg/mL compared with before treatment.The differences were statistically significant(P<0.01).(2)TCM syndrome scoring:the total effective rate of patients’ TCM symptom improvement was 61.43%after 4 weeks of treatment,of which the apparent rate was 10.00%;after 8 weeks of treatment,the total effective rate was further increased to 88.57%,of which the apparent rate was increased to 32.86%,and the difference before and after was statistically significant(P<0.01).In terms of symptom improvement in Shangjiao,Zhongjiao and Xiajiao,the total effective rate of improvement in Shangjiao was significantly lower than that in Zhongjiao and Xiajiao,however,the difference between the improvement of the three was not statistically significant(P>0.05).As for the improvement of individual symptoms,the total effective rate of improvement of the main symptoms after 4 weeks of treatment was,in descending order,lower limb edema(86.89%)>fatigue(77.14%)>shortness of breath and cough(70.00%),and after 8 weeks of treatment,fatigue(94.29%)>lower limb edema(93.44%)>shortness of breath and cough(87.14%),and the total effective rate of improvement of the main symptoms after 8 weeks of treatment was,in descending order,lower limb edema(93.44%)>shortness of breath and cough(87.14%).Compared with 4 weeks of treatment,the total effective rate of improvement of the three main symptoms of fatigue,lower extremity edema and shortness of breath and cough was further increased and statistically different(P<0.05).As for the improvement of other symptoms,the top three symptoms in terms of total effective rate after 4 weeks of treatment were abnormal stool(80.43%),abnormal diet(80.36%),and low urine output(74.14%),and after 8 weeks of treatment,they were abnormal diet(98.21%),low urine output(93.10%),and thirsty(91.84%),in descending order.At the same time,the total effective rate of improvement of all other symptoms was further increased after 8 weeks of treatment compared with 4 weeks of treatment,and all symptoms were statistically different except palpitations and abnormal stool(P<0.05).2.Secondary efficacy indicators(1)Cardiac function classification:The total effective rate of grading improvement of cardiac function was 82.86%after 4 weeks of treatment,and 84.29%after 8 weeks of treatment,the difference was statistically significant(P<0.05).At the same time,after 8 weeks of treatment,the apparent improvement rate of cardiac function classification was 38.57%,which was significantly improved compared with 18.57%after 4 weeks of treatment.(2)LVEF and LVEDd:After 8 weeks of treatment,the LVEF of patients with heart failure with reduced ejection fraction(LVEF<50%)was increased by 8.00 ± 7.98,the LVEDd of these patients was reduced by 3.65 ± 4.35mm compared with that before treatment,and both differences were statistically significant(P<0.01).(4)Minnesota Living with Heart Failure Questionnaire:After 4 weeks of treatment,The Minnesota Living with Heart Failure Questionnaire score of patients was decreased by 12.00(8.00,17.00)compared to pre-treatment,and after 8 weeks of treatment,it was reduced by 24.00±10.08 compared to before treatment.The decrease score after 8 weeks of treatment was significantly greater than that after 4 weeks of treatment,with statistically significant differences(P<0.01).(5)The reduction of western medicine:53 patients took the diuretics or aldosterone receptor antagonists before the treatment,and 3 8 patients stopped taking that after the treatment,the withdrawal rate was 28.30%,which was statistically significant.(P<0.05).The number of those taking β-blockers,ARNI/ACEI/ARB,digoxin,and ivabradine was reduced after the treatment compared with before,and the difference was not statistically significant(P>0.05).3.Safety evaluation(1)Blood pressure:Before the treatment,there were 9 patients with low blood pressure(systolic blood pressure<90mmHg and/or diastolic blood pressure<60mmHg),7 patients with high blood pressure(systolic blood pressure≥140mmHg and/or diastolic blood pressure ≥90mmHg),and 54 patients with normal blood pressure.After the treatment,there were 2 patients with low blood pressure,1 patient with high blood pressure,and a total of 67 patients with normal blood pressure.The number of patients with abnormal blood pressure after the treatment was lower than that before,and the difference was statistically significant(P<0.05).(2)Hepatic and kidney function:10 patients had abnormal hepatic function and 19 patients had abnormal renal function before the treatment.After the treatment of 8 weeks,6 patients had abnormal liver function and 17 patients had abnormal renal function.There was no significant difference in liver and renal function before and after the treatment(P>0.05).Among the patients with abnormal hepatic function,no patient experienced deterioration of hepatic function after 8 weeks of the treatment,and the values of abnormal liver function indexes in 4 patients were decreased compared with the previous values.Among the patients with abnormal renal function,renal function was not changed obviously in 2 patients after 8 weeks of treatment,and the values of renal dysfunction indexes in 17 patients were lower than before.Among them,serum creatinine of the patients was lower than before,and the differences were statistically significant(P<0.05).Serum urea nitrogen was decreased significantly without statistical difference(P>0.05).As for adverse events,no patient experienced any obvious allergic reactions or gastrointestinal reactions during the treatment.Conclusions:1.Lishui Qiangxin Decoction based on the method of "Regulating Sanjiao" reduces plasma NT-proBNP levels in patients with CHF.At the same time,LVEF is increased and LVEDd is decreased in patients with LVEF<50%.It has some effects on improving ventricular remodeling.2.Lishui Qiangxin Decoction based on the method of "Regulating Sanjiao"obviously relieves the clinical symptoms of patients with CHF,especially for fatigue,edema of lower limbs and abnormal diet,which can significantly improve the cardiac function and quality of life of patients with CHF.Moreover,the improvement after 8 weeks is more obvious than that after 4 weeks.3.Lishui Qiangxin Decoction based on the method of "Regulating Sanjiao" reduces the use of diuretics in patients with CHF.4.Lishui Qiangxin Decoction based on the method of "Regulating Sanjiao" has no obvious damage to blood pressure and hepatic and renal function of patients with CHF.It is safe and may have a certain trend of regulating abnormal blood pressure and improving abnormal hepatic and renal function. |
