泻肺利水合剂治疗慢性心力衰竭患者的临床疗效评价

Clinical effect evaluation on the treatment of chronic heart failure using Xiefei Lishui Mixture

目的观察泻肺利水合剂治疗气虚血瘀兼阳虚水泛型慢性心力衰竭(CHF)的临床疗效。方法选择2020年1月—2022年6月在首都医科大学附属北京中医医院和北京中医医院顺义医院心内科病房收治的CHF患者99例,按随机数字表法分成观察组49例与对照组50例。对照组给予西医常规治疗,加口服中药安慰剂治疗,每次100 mL,2次/d,早晚餐后服用;观察组给予西医常规治疗,加首都医科大学附属北京中医医院的院内制剂泻肺利水合剂口服治疗,每次100 mL,2次/d,温服。2组疗程均为6周。对比2组治疗前后血清N端脑钠肽前体(NT-proBNP)水平、心脏输出量(CO)、左室射血分数(LVEF)、每搏输出量(SV)、左室舒张末期容积(LVEDV),左心室收缩末期容积(LVESV),二尖瓣口舒张早期流速峰值与舒张晚期流速峰值比值(E/A),再次住院频次及不良事件、疗效。结果治疗2、6周,2组血清NT-proBNP水平均较治疗前降低(P<0.05),且观察组低于对照组(P<0.05)。治疗2、6周,观察组LVEDV、LVESV、LVEF、E/A、SV与对照组比较,差异有统计学意义(P<0.05)。治疗6周,观察组CO低于对照组,差异有统计学意义(P<0.05)。观察组总有效率高于对照组(P<0.05)。治疗后半年随访,观察组2例(4.3%)患者再次住院,对照组8例(17.0%)患者再次住院,2组间差异有统计学意义(P<0.05)。观察组和对照组发生室性心律失常分别为1、2例,发生低血压分别为4、6例,差异无统计学意义(P>0.05)。2组均无药物性猝死、尿便常规异常、药物性肝肾损害、血糖异常发生。结论西医常规治疗联合泻肺利水合剂4号可降低气虚血瘀兼阳虚水泛型CHF患者的血清NT-proBNP,改善心功能,降低住院频次,效果优于单纯西医常规治疗,且未增加不良事件。

Objective To evaluate the clinical effect of Xiefei Lishui Mixture in the treatment of chronic heart failure of qi and blood deficiency,blood stagnation and yang deficiency and water overflowing.Methods 99 patients,who were admitted to the Cardiology Ward,Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University and the Cardiology Ward of Shunyi Hospital of Beijing Hospital of Traditional Chinese Medicine from January 2020 to June 2022,were divided into control group(50)and observation group(49)by the random number method.The control group was routinely treated with western medicine according to the guidelines combined with oral Chinese medicine placebo,100 mL each time,twice a day after breakfast and dinner;and the observation group was routinely treated with western medicine according to the guidelines combined with hospital preparations of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University number 4,100 mL each time,twice a day with warm temperature.and the course of both groups was 6 weeks.Serum Serum n-terminal pro-brain natriuretic peptide(NT-proBNP)levels and cardiac function before and after treatment[Cardiac output(Cardiac output,CO),left ventricular ejection fraction(Left Ventricular Eject Fraction,LVEF),stroke output(Stroke volume,SV),left ventricular end-diastolic volume(Left ventricular end diastolic volume,LVEDV),Left ventricular end-systolic volume(left ventricular end-systolic volume,LVESV),Ratio of peak flow rate(E/A)],frequency of re-hospitalization,adverse events and efficacy were compared between the two groups before and after the treatment.Results After 2 and 6 weeks of treatment,the serum NT-proBNP levels in both groups were lower than before treatment(P<0.05),and the observation group was lower than the control group(P<0.05).After 2 and 6 weeks of treatment,there were significant differences in LVEDV,LVEV,LVEF,E/A and SV between the observation group and the control group(P<0.05).After 6 weeks of treatment,the CO in the observation group was lower than that in the control group,and the difference was statistically significant(P<0.05).The total effective rate of the observation group was higher than that of the control group(P<0.05).Six months after treatment through follow-up,two patients(4.3%)in the observation group were hospitalized again,which was less than that in the control group(8 cases(17.0%)),and the difference was statistically significant(P<0.05).There were 1 and 2 cases of ventricular arrhythmia and 4 and 6 cases of hypotension in the observation group and the control group,respectively,with no statistical significance(P>0.05).There were no drug-induced sudden death,abnormal urine and stool routine,drug-induced liver and kidney damage and abnormal glucose in both groups.Conclusion Conventional treatment of western medicine combined with Xiefei Lishui Mixture no.4 could reduce the serum NT-proBNP in patients with qi deficiency,blood stasis with Yang deficiency and water overflowing in chronic heart failure,improve cardiac function,reduce the frequency of hospitalization with better effect than the simple routine treatment of western medicine,and there is no increase in adverse events.