参元丹胶囊干预气虚血瘀证缺血性心力衰竭的随机、对照临床研究  

Clinical Study on Intervention of Shenyuandan Capsule on Ischemic Heart Failure with Qi Deficiency and Blood Stasis Syndrome:A Randomized,Controlled Trial

作　　者：李享[1] 何刚[2] 刘红旭[1] 娄妍 张赫怡 LI Xiang;HE Gang;LIU Hong-xu;LOU Yan;ZHANG He-yi(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010;Beijing University of Chinese Medicine,Beijing 100029)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]北京中医药大学,北京100029

出　　处：《世界中西医结合杂志》2021年第8期1481-1485,共5页World Journal of Integrated Traditional and Western Medicine

基　　金：北京市医院管理局重点医学专业发展计划(ZYLX201817);北京市医管局“青苗计划”人才培养对象(QML20181002)。

摘　　要：目的评价参元丹胶囊干预气虚血瘀证缺血性心力衰竭(IHF)的临床疗效。方法选取2020年2月—2020年12月期间于首都医科大学附属北京中医医院心血管科就诊的气虚血瘀证IHF患者66例(研究过程中有5例患者脱落)。采用随机、双盲、安慰剂对照的研究方法,随机分为参元丹组29例和安慰剂组32例,两组患者在规范化治疗基础上分别加用参元丹或安慰剂,两组患者均连续服药30 d。观察记录两组患者治疗前后中医证候积分及疗效指数、血清脑钠肽(B-type Natriureticeptide,BNP)水平及治疗前后BNP下降幅度、超声心动参数[左室射血分数(Left Ventricular Ejection Fraction,LVEF)、左室舒张末径(Left Ventricular End-diastolic Ddiameter,LVEDD)]以及治疗30 d后药物应用不良反应及心血管事件(Major Adverse Cardiovascular Events,MACE)发生情况。结果治疗后两组患者BNP水平较治疗前下降,差异有统计学意义(P<0.05);且参元丹组治疗后BNP水平明显低于安慰剂组,参元丹组BNP下降幅度明显大于安慰剂组,两组比较,差异有统计学意义(P<0.05)。治疗后两组患者LVEF水平较治疗前提升,LVEDD水平较治疗前下降,差异有统计学意义(P<0.05)。两组患者治疗后LVEF、LVEDD水平及其LVEF上升幅度、LVEDD下降幅度比较,差异无统计学意义(P>0.05)。参元丹组及安慰剂组患者在治疗30 d后,均无患者死亡情况发生。安慰剂组有2例患者出现心衰加重再住院,两组患者MACE事件发生率比较,差异无统计学意义(P>0.05)。治疗后两组患者中医证候积分水平较治疗前明显下降,差异有统计学意义(P<0.05);且参元丹组治疗后中医证候积分明显低于安慰剂组,疗效指数明显高于安慰剂组,两组比较,差异有统计学意义(P<0.05)。结论参元丹具有改善气虚血瘀证IHF患者心功能的潜在作用。Objective To evaluate the clinical effect of Shenyuandan Capsule on ischemic heart failure(IHF)with Qi deficiency and blood stasis syndrome.Methods A total of 66 patients with IHF with Qi deficiency and blood stasis syndrome were selected from the Department of Cardiology,Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from February 2020 to December 2020(5 patients dropped out during the study).Using a randomized,double-blind,placebo-controlled research method,they were randomly divided into 29 patients in the Shenyuandan group and 32 patients in the placebo group.Patients in the two groups were treated with Shenyuandan or placebo on the basis of standardized treatment.The patients took the medicine for 30 consecutive days.Serum BNP levels,echocardiographic parameters[left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD)],major cardiac adverse events(MACE)30 days after treatment and TCM syndrome score and curative effect index before and after treatment were recorded.Results After treatment,the BNP level of the two groups of patients decreased compared with before treatment,and the difference was statistically significant(P<0.05).The BNP level of the Shenyuandan group after treatment was significantly lower than that of the placebo group.And the decrease of BNP in the Shenyuandan group was significantly greater than that of the placebo group.In the treatment group,the difference between the two groups was statistically significant(P<0.05).After treatment,the LVEF level of the two groups of patients increased compared with thatbefore the treatment,and the LVEDD level decreased compared with that before the treatment,and the difference was statistically significant(P<0.05).There was no statistically significant difference between the two groups of patients in the levels of LVEF,LVEDD,the increase in LVEF,and the decrease in LVEDD after treatment(P>0.05).No patients died in the Shenyuandan group and placebo group after 30 days of treatment.I

关 键 词：益气逐瘀法 参元丹 缺血性心力衰竭 

分 类 号：R541.6[医药卫生—心血管疾病]