泻肺利水合剂联合西医常规方法治疗慢性缺血性心力衰竭气虚血瘀证疗效的真实世界、多中心、队列研究

Treatment of Chronic Ischemic Heart Failure with Qi Deficiency and Blood Stasis Pattern by Xiefei Lishui Mixture (泻肺利水合剂) Combined with Western Medicine Routine Therapy: A Real-world Multicenter Cohort Study

目的探讨泻肺利水合剂联合西医常规方法治疗慢性缺血性心力衰竭气虚血瘀证的临床疗效。方法纳入8家协作医院因慢性缺血性心力衰竭气虚血瘀证住院患者,依据患者意愿分为泻肺利水合剂组73例及辨证施治组72例。所有患者均给予西医规范化治疗,在此基础上泻肺利水合剂组给予泻肺利水合剂,辨证施治组由临床应诊医师根据个人经验依辨证施治原则处方。两组患者均每日1剂口服,疗程(14±3)天。治疗前后比较患者血清N端脑钠肽前体(NT-proBNP)水平、NT-proBNP下降幅度、临床症状积分(包括喘息、气短、神疲乏力、肢体浮肿、小便短少)、心功能[包括左室舒张末期内径(LVEDD)、左室射血分数(LVEF)]、6分钟步行距离,记录患者治疗期间不良反应;治疗结束30天及180天随访记录主要心血管不良事件(MACE)发生情况。结果两组治疗后NT-proBNP水平均较本组治疗前下降,治疗后泻肺利水合剂组NT-proBNP水平低于辨证施治组,泻肺利水合剂组NT-proBNP下降(1920±1115.49) pg/ml,大于辨证施治组的下降值(1273±120.81) pg/ml (P<0.05)。治疗后泻肺利水合剂组LVEDD水平较治疗前下降,LVEF水平较治疗前上升(P<0.05)。两组患者6分钟步行试验距离均较治疗前增加、各项临床症状积分均较治疗前下降,且泻肺利水合剂组6分钟步行距离大于辨证施治组,气短、肢体浮肿、小便短少症状积分低于辨证施治组(P<0.05)。治疗后结束30天及180天随访时两组MACE发生情况差异无统计学意义(P>0.05)。两组均未见明显不良反应。结论在联合西医常规疗法基础上,泻肺利水合剂较常规中药辨证治疗可以更好地降低慢性缺血性心力衰竭气虚血瘀证患者血清NT-proBNP水平、改善患者临床症状与心功能、延长6分钟步行距离,且安全性好。

Objective To analyze the clinical effect on chronic ischemic heart failure(CIHF)with qi deficiency and blood stasis pattern treated by Xiefei Lishui Mixture(泻肺利水合剂,XLM)combined with western medicine routine therapy.Methods hospitals were included,and they were divided into XLM group and control group according to the patients’willingness.All the patients received routine western medicine.Additionally,patients in XLM group were administered with XLM,while those in the control group received syndrome-differentiated prescriptions based on clinicians’experience.The prescriptions in both groups were orally administered,one dose daily,and the course was 14±3 days.The Nterminal pro-brain natriuretic peptide(NT-proBNP)level in serum,the decline of NT-proBNP,scores of clinical symptoms including wheezing,shortness of breath,fatigue,limb edema and shortness of urine,cardiac function indicators left ventricular end-diastolic diameter(LVEDD)and left ventricular ejection fraction(LVEF),and 6-minute walking distance(6 WMD)were assessed before and after treatment,and the adverse reactions were recorded.The occurrence of major adverse cardiovascular events(MACE)were recorded 30 days and 180 days after treatment.Results The NT-proBNP level in both groups decreased after treatment,and it was lower in XLM group as more decrease was found in XLM group(1920±1115.49 pg/ml)than in the control group(1273±120.81 pg/ml,P<0.05).The LVEDD level in XLM group decreased,while the LVEF level increased after treatment(P<0.05).The 6 MWD of the two groups were higher than those before treatment,and the clinical symptoms scores were lower.Moreover,more increase of 6 MWD,as well as more decreases of clinical symptoms scores regarding shortness of breath,limb edema,and shortness of urine were found in XLM group than in the control group(P<0.05).There was no significant difference between groups in the occurrence of MACE at follow-up of 30 days and 180 days after treatment(P>0.05).There were no obvious adverse reactions in both groups.Conclusion medicine can better reduce the NT-proBNP level,improve the clinical symptoms and cardiac function,and prolong the 6 MWD in CIHF patients with qi deficiency and blood stasis pattern when compared to the differentiated prescriptions combined with western medicine,and is safe.