益气方治疗慢性心力衰竭气虚证82例
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摘要
目的:观察益气方治疗慢性心力衰竭(Chronic heart failure,CHF)气虚证的临床疗效。方法:将166例CHF气虚证患者随机分为对照组84例和观察组82例。对照组采用西医规范化治疗,观察组在对照组的基础上加用益气方中药免煎颗粒剂。比较两组患者治疗后临床症状积分及心功能疗效,治疗前后左心室射血分数(left ventricular ejection fraction,LVEF)、脑钠肽(brain natriuretic peptide,BNP)水平及6分钟步行距离(six-minutes walking distance,6MWD)。结果:观察组治疗后临床症状积分低于对照组,差异具有统计学意义(P<0.05)。观察组神疲、少气懒言、头晕、目眩等症状消失率高于对照组,差异具有统计学意义(P<0.05)。对照组有效率为53.57%,观察组有效率为86.58%,两组患者心功能疗效比较,差异具有统计学意义(P<0.05)。两组患者治疗后LVEF、6MWD高于治疗前,观察组高于对照组(P<0.05);两组患者治疗后BNP低于治疗前,观察组治疗后低于对照组,差异均有统计学意义(P<0.05)。结论:益气方治疗CHF气虚证可有效改善患者心功能及超声心动图指标,显著降低血浆BNP水平,增加6MWD,改善CHF气虚证患者生存质量。
Objective:To observe the clinical curative effect of Qi-Tonifying Formula on chronic heart failure(CHF) with qi deficiency syndrome.Methods:A total of 166 patients with CHF with Qi deficiency syndrome were divided into the control group with 84 cases and the observation group with 82 cases.The control group was treated with standardized Western medicine,while the observation group was treated with decoction-free granules of Qi-Tonifying Formula on the basis of the control group.The clinical symptoms of JIFEN NYHA,left ventricular ejection fraction(LVEF) and brain natriuretic peptide(BNP) levels,and 6-minute walking distance(6 MWD).before and after the treatment were compared between the two groups.Results:The score of clinical symptoms in the observation group was lower than that in the control group after the treatment,and the difference was statistically significant(P<0.05).The disappearance rate of symptoms such as fatigue,lack of breath,reluctance to speak,dizziness in the observation group was higher than that in the control group,and the difference was statistically significant(P<0.05).The effective rate was 42.86% in the control group and 73.17% in the observation group.There was a significant difference between the two groups(P<0.05).After the treatment,the LVEF and 6 MWD of the two groups were higher than those before the treatment,and the observation group was higher than the control group.After the treatment,BNP of the two groups was lower than that before the treatment,and the observation group was lower than the control group,and all the differences were statistically significant(P<0.05).Conclusion:Qi-Tonifying Formula has a remarkable efficacy on CHF with qi deficiency syndrome,can effectively improve the cardiac function and echocardiographic parameters,significantly reduce the plasma BNP value,increase 6 MWD and improve the quality of life of patients.
Objective:To observe the clinical curative effect of Qi-Tonifying Formula on chronic heart failure(CHF) with qi deficiency syndrome.Methods:A total of 166 patients with CHF with Qi deficiency syndrome were divided into the control group with 84 cases and the observation group with 82 cases.The control group was treated with standardized Western medicine,while the observation group was treated with decoction-free granules of Qi-Tonifying Formula on the basis of the control group.The clinical symptoms of JIFEN NYHA,left ventricular ejection fraction(LVEF) and brain natriuretic peptide(BNP) levels,and 6-minute walking distance(6 MWD).before and after the treatment were compared between the two groups.Results:The score of clinical symptoms in the observation group was lower than that in the control group after the treatment,and the difference was statistically significant(P<0.05).The disappearance rate of symptoms such as fatigue,lack of breath,reluctance to speak,dizziness in the observation group was higher than that in the control group,and the difference was statistically significant(P<0.05).The effective rate was 42.86% in the control group and 73.17% in the observation group.There was a significant difference between the two groups(P<0.05).After the treatment,the LVEF and 6 MWD of the two groups were higher than those before the treatment,and the observation group was higher than the control group.After the treatment,BNP of the two groups was lower than that before the treatment,and the observation group was lower than the control group,and all the differences were statistically significant(P<0.05).Conclusion:Qi-Tonifying Formula has a remarkable efficacy on CHF with qi deficiency syndrome,can effectively improve the cardiac function and echocardiographic parameters,significantly reduce the plasma BNP value,increase 6 MWD and improve the quality of life of patients.
引文
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[5] 中华医学会心血管病分会.慢性心力衰竭诊断治疗指南.中华心血管病杂志,2007,35(12):1076-1095.
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[9] 周凤华.基于循证的中西医结合治疗冠心病室性早搏多中心随机对照临床试验研究[D].广州:南方医科大学,2013.
[10] 陈婵.基于数据挖掘的冠心病心力衰竭中医证候因素及生物学基础研究[D].北京:北京中医药大学,2010.
[11] 王娟.慢性心力衰竭中医证候生物学诊断模式及代谢组学研究[D].北京:北京中医药大学,2012.
[12] WANG R,LAGAKOS S W,WARE J H,et al.Statistics in medicine reporting of subgroup analyses in clinical trials[J].N Engl J Med,2007,357(21):2189-2194.
[13] KAY R.Statistical principles for clinical trials[J].Journal of International Medical Research,1998,26(2):57-65.
[14] BAKER S G,KRAMER B S,SARGENT D J,et al.Biomarkers,subgroup evaluation,and clinical trial design[J].Discovery Medicine,2012,13(70):187-192.
[15] CHOW S C,LIU J P.临床试验的设计与分析—概念与方法学[M].北京:北京大学医学出版社,2010:471.
[16] HJALMARSON A,FAGERBERG B.MERIT-HF mortality and morbidity data[J].Basic Research in Cardiology,2000,95(1):198-203.
[17] 张鹏.冠心病慢性心力衰竭常见证候、证候要素分布规律的研究[D].北京:北京中医药大学,2011.
[18] MANT D,HOBBS F R,GLASZIOU P,et al.Identification and guided treatment of ventricular dysfunction in general practice using blood B-type natriuretic peptide[J].Br J Gen Pract,2008,58(551):393-399.
[19] TROUGHTON R W,FRAMPTON C M,YANDLE T G,et al.Plasma Amino-Terminal B-Type Natriuretic Peptide Measured by Elecsys 2010 Assay in a Trial of Hormone-guided Treatment for Heart Failure[J].Clinical Chemistry,2003,49(7):1212-1215.
[20] LEMOS J A,MORROW D A.Brain natriuretic peptide measurement in acute coronary syndromes:ready for clinical application[J].Circulation,2002,106(23):2868-2870.
[21] ISHIL J,NOMURA M,NAKAMURA Y,et al.Risk stratification using a combination of cardiac troponin T and brain natriuretic peptide after optimized treatment in patients with advanced heart failure[J].American Journal of Cardiology,2002,89(6):691-695.
[22] 赵金龙,李大锋,管益国,等.慢性心力衰竭中医证型与相关客观指标关系的对照研究[J].中华中医药学刊,2013,31(10):2159-2162.
[23] 那开宪,余平.6分钟步行试验在慢性心力衰竭中的应用价值[J].中国临床医生杂志,2007,35(12):3-5.
[24] 张国林,郭兰,李河,等.同步实时测峰值摄氧量与6min步行试验[J].中国康复医学杂志,2007,22(7):596-598.
[2] 陈婵,王娟,张鹏,等.冠心病心力衰竭中医证候相关因素研究[J].中华中医药杂志,2012,27(11):2925-2928.
[3] 郭畅,刘文娴.心力衰竭的流行病学与防治现状[J].中国健康教育,2010,26(2):139-141.
[4] 国际心脏病学会和协会及世界卫生组织临床命名标准化联合专题组.缺血性心脏病的命名和诊断标准[J].国外医学·心血管疾病分册,1979,18(6):365-366.
[5] 中华医学会心血管病分会.慢性心力衰竭诊断治疗指南.中华心血管病杂志,2007,35(12):1076-1095.
[6] 陈灏珠.Braunwald心脏病学[M].5版.北京:人民卫生出版社,1999:407.
[7] 郑筱萸.中药新药临床研究指导原则 (试用)[M].北京:中国医药科技出版社,2002:77-85.
[8] CHRISTIAN GLUUD,武燕萍,高国福,等.循证医学的临床实践[J].中国医学科学院学报,2002,24(6):541-547.
[9] 周凤华.基于循证的中西医结合治疗冠心病室性早搏多中心随机对照临床试验研究[D].广州:南方医科大学,2013.
[10] 陈婵.基于数据挖掘的冠心病心力衰竭中医证候因素及生物学基础研究[D].北京:北京中医药大学,2010.
[11] 王娟.慢性心力衰竭中医证候生物学诊断模式及代谢组学研究[D].北京:北京中医药大学,2012.
[12] WANG R,LAGAKOS S W,WARE J H,et al.Statistics in medicine reporting of subgroup analyses in clinical trials[J].N Engl J Med,2007,357(21):2189-2194.
[13] KAY R.Statistical principles for clinical trials[J].Journal of International Medical Research,1998,26(2):57-65.
[14] BAKER S G,KRAMER B S,SARGENT D J,et al.Biomarkers,subgroup evaluation,and clinical trial design[J].Discovery Medicine,2012,13(70):187-192.
[15] CHOW S C,LIU J P.临床试验的设计与分析—概念与方法学[M].北京:北京大学医学出版社,2010:471.
[16] HJALMARSON A,FAGERBERG B.MERIT-HF mortality and morbidity data[J].Basic Research in Cardiology,2000,95(1):198-203.
[17] 张鹏.冠心病慢性心力衰竭常见证候、证候要素分布规律的研究[D].北京:北京中医药大学,2011.
[18] MANT D,HOBBS F R,GLASZIOU P,et al.Identification and guided treatment of ventricular dysfunction in general practice using blood B-type natriuretic peptide[J].Br J Gen Pract,2008,58(551):393-399.
[19] TROUGHTON R W,FRAMPTON C M,YANDLE T G,et al.Plasma Amino-Terminal B-Type Natriuretic Peptide Measured by Elecsys 2010 Assay in a Trial of Hormone-guided Treatment for Heart Failure[J].Clinical Chemistry,2003,49(7):1212-1215.
[20] LEMOS J A,MORROW D A.Brain natriuretic peptide measurement in acute coronary syndromes:ready for clinical application[J].Circulation,2002,106(23):2868-2870.
[21] ISHIL J,NOMURA M,NAKAMURA Y,et al.Risk stratification using a combination of cardiac troponin T and brain natriuretic peptide after optimized treatment in patients with advanced heart failure[J].American Journal of Cardiology,2002,89(6):691-695.
[22] 赵金龙,李大锋,管益国,等.慢性心力衰竭中医证型与相关客观指标关系的对照研究[J].中华中医药学刊,2013,31(10):2159-2162.
[23] 那开宪,余平.6分钟步行试验在慢性心力衰竭中的应用价值[J].中国临床医生杂志,2007,35(12):3-5.
[24] 张国林,郭兰,李河,等.同步实时测峰值摄氧量与6min步行试验[J].中国康复医学杂志,2007,22(7):596-598.