摘要
目的:
观察以化瘀浊益肝肾法为法则组方的“降压1号”颗粒对老年性高血压病左心室肥厚及左心室舒张功能的影响,为中医药防治高血压病提供一个思路或方法。方法:
1、纳入2006年8月～2008年2月就诊于泉州市中医院心血管专科的老年性高血压病患者60例。按数字表法随机分为两组,即治疗组和对照组各30例。两组均服用依那普利10mg,2次/d作为基础用药;2周后若舒张压仍大于95mmHg,则加用倍他乐克25mg,2次/d;治疗组在对照组用药的基础上,加服“降压1号”颗粒1包,3次/d。
2、疗程12周。所有病例在进入随机后和治疗结束时,各进行一次临床疗效评估和不良反应分析,分析治疗前后血压、左心室结构参数、左心室舒张功能及临床疗效的变化。
结果:
1、两组治疗前平均收缩压、平均舒张压差异无统计学意义(P＞0.05);两组治疗后与治疗前比较显著性降低(P＜0.05或P＜0.01),而且治疗后两组问比较有显著差异(P＜0.05)。
2、两组在第二周末血压均较前有明显下降,两组间比较无显著差异(P＞0.05);但在第四周末两组间降压比较显著性差异(P＜0.05),尤其是收缩压降低与对照组有明显差异(P＜0.05)。
3、两组治疗前左室肥厚参数无显著差异(P＞0.05);两组治疗后与治疗前比较显著性降低(P＜0.05或P＜0.01),治疗后两组间比较亦有显著差异(P＜0.01)。
4、两组治疗前后E峰与A峰比值显著性升高(P＜0.05或P＜0.01),治疗后两组间比较亦有显著差异(P＜0.01)。
5、两组治疗前平均心率水平差异无统计学意义(P＞0.05);两组治疗后与治疗前无明显降低(P＞0.05),治疗后两组间比较无显著差异(P＞0.05)。
6、两组的临床症状较治疗前均有明显改善,特别是治疗组在单项症状改善情况优于对照组(P＜0.05或P＜0.01)。
7、两组患者服药前后证候积分比较有显著性差异(P＜0.01),治疗后两组间比较亦有显著差异(P＜0.05),
结论:
1、“降压1号”颗粒能够显著改善患者临床症状,并且在单项症状改善与依那普利相比有明显优势。
2、“降压1号”颗粒与西药常规配合使用,综合疗效优于单用西药治疗。
3、“降压1号”颗粒可有效降压,具有更好的改善老年性高血压左室肥厚的作用。
4、“降压1号”颗粒没有明显副作用,临床应用本方安全。
5、“降压1号"颗粒治疗上围绕高血压发生的核心病机,以化瘀浊益肝肾法组方,从根本上抓住了治疗原发性高血压病的关键,疗效显著,体现了中医整体观念、辨证论治的优势,为临床上开发高血压病的主要新药做了很好的基础工作。
6、12周的临床随访已能监测出高血压合并左室肥厚以及左室舒张功能的改善,然而,鉴于高血压病是一个终身性疾病,肯定的结论有待更长期的随访结果。
OBJECTIVE:
It is to observe the influence of "NO.1 Granule "with functions of removing blood stasis-turbid and tonifying the liver and kidney on left ventricular hypertrophy and left ventricular diastolic function in the aged patient of hypertension grade II. And so as to give a new idea and method in evaluating the Curative effect of traditional Chinese medicine.
MATERIALS AND METHODS:
Totally 60 elderly patients with EH which treated in the Quanzhou Hospital of Tradional Chinese Medicine among August 2006 to February 2008 were adopted. The patients were randomly divided into two groups by numerical form. There were 30 in each group, which were the treatment group and the control group. Captopril was taken antihypertensive therapy to the control group, on the basis of using captopril the treatment group add "NO.1 Granule" treatment. The blood pressure and left ventricular mass index (LVMI) of the patients in each group were calculated and also the side effects were analyzed before entered the random experiment and after experiment. After one treatment course of 12 weeks, all the patients were evaluated in clinical effects and LVMI, and the efficacy of lowering pressure and symptom improvement . To analysis the changes of influence of left ventricular mass index, clinical effects and the side effects before and after treatment.
RESULTS:
(1) Two groups have the effect of lower the blood pressure after treatment. The scope of lower blood pressure of treatment group were greatest(P<0.05 or P<0.01).But there was a significant difference in DBP and SBP between two groups after treatment(P<0.05).
(2) The blood pressure levels of the patients of the two groups were all cut down significantly, but the two groups exist an obvious difference compared with that in control group at the end of the fourth week(P<0.05),especially SBP lowered down more significantly (P<0.05).
(3) The differences were extremely significant in the LVH of two groups before and after treatment(P<0.05 or P<0.01); The parameters of LVH such as LVDd,LVPW,IVS,and LVMI in treatment group were obviously lower than those in control group(P<0.05).
(4) The ratio of E/A between the two groups was markedly increased before and after treatment(P<0.05).;
(5) Heart rate between the two groups had no significant difference before and after treatment. (P>0.05);
(6) Both of the groups had extremely significant differences in the physical symptoms, energy, and abilityof everyday life. In addition, Monomial symptoms score in treatment group were improved more obviously than that in control group(P<0.05 or P<0.01);
(7) The differences of syndrome scores of two groups before and after treatment were extremely significant (P<0.01); There were significant differences between two groups after treatment in syndrome scores (P<0.05); the symptom curative effect between two groups had significant differences (P<0.01).
CONCLUSIONS:
(1) The "NO.1 Granule "could directly relsted to the improvement of clinical symptoms. In addition, there has an obvious advantage in monomial symptoms.
(2) The comprehensive effects of "NO.1 Granule "combined with western medicine group were better that of group using the western medicine only.
(3) The "NO.1 Granule" could significantly effectively lower down LVMI and could achieve the objective of lowering down the blood pressure and reversing the LVH.
(4) The "NO.1 Granule"was no obvious toxicity, and it was safe for the clinical application.
(5) It is a significant influence of "NO.1 Granule"with functions of removing blood stasis-turbid and tonifying the liver and kidney on left ventricular hypertrophy and left ventricular diastolic function in the aged patient of hypertension grade II. The "NO.1 Granule"could directly grasp the key pathogenesis of essential hypertension, embody the advantage in TCM treatment based on syndrome differentiation and integer concept, and it is to do basic clinical work well for the development of new Chinese drugs in essential hypertension.
(6) the left ventricular hypertrophy and left ventricular diastolic function in the aged patient of hypertension were improved after 12 weeks clinical follow-up. But it is to need a long-term results of follow-up to ascertain the conclusion because EH is a common, lifelong disease, which serious damages people's health.
引文
[1]陈志君,罗明高血压左心室肥厚研究的进展[J]同济大学报2001,22(1):81-83
[2]MESSERLI FH,KETELHUR.Left ventricular hypertrophy:apressuredependent cardiovaular risk fador[J],Cardiovascular Pharmacology,1993,22(1):7-13
[3]中华人民共和国卫生部,卫生部心血管防治研究中心,中国高血压联盟.中国高血压防治指南(2005年修订版)(M).北京:中国高血压防治指南修订委员会.2005:7-8
[4]DEVEREUX RB,Reichek N.Echocardiographic determination of left yen2 tricular massin man:anatomic validation of the method[J].Circulation,1987,(55):631
[5]PalmieriV,Bella JN,Arnett DK,et al.Effect of type2 diabetes mellitus on left Ventricular geometry and systolic function in hypertensive subject[J].Circulation ,2001,103:102-107
[6]郑筱萸主编.中药新药临床研究指导原则.中药新药治疗高血压病的临床研究指导原则[M].北京:中国医药科技出版社,2002.73-75
[7]余振球,赵连友高血压诊断与治疗手册[M].北京:科学出版社.2001,508
[8]边平达 季秀央 老年人左室肥厚影响因素研究[J].医学研究杂志,2007,7:29-32
[9]刘德桓主编.高血压病中西医结合诊治研究[M].第一版.福建:厦门大学出版社.2003,12:149-154
[10]胡英,蔡乃绳.高血压左室肥厚的组织重构.中华内科杂志.1999.36(6):424-426
[11]McLenachan JM.Hendeson E,Norris KI.et al.A possible mechanism of sudden death in hypertensive left ventricular hypertrophy.Hypertension 1987.5(suppl 5):620-621
[12]McLenachan JM,Hendeson E.Morris KI.et al.Ventricular arrhy:hmia in patients with hypertensive left ventricular hypertrophy.N Engljmed.1987,31 7(13):787
[13]LevyD,AndcrsonKM,Savaged D,et al,Risk of Ventricular arhythmiain left ventricular hypertrophy.The Framinghall heart study.J Am Cardiol,1987;60:560
[14]Vasan RS,Larson MG,Benjamin EJ,Evans JC,Reiss OK,kvy D.Congestive heart failure in subjects witll normal versus reduced left ventricular ejection fraction:prevalence and mortality in a population-based cohort.J Am Coll Cardiol.1999:33:1948-1955.
[15]Bonow RO,Udelson JE.Left ventricular diastolic dysfunction as a cause of congestive heart failure:mechanisms and management[J].Ann Intern Med,1992,11 7:502-510
[16]Cohn JH,Johnson G.Heart failure with normalejection fraction:theV Heft study [J].Circulation,1990.80(Suppl 3):48-53
[17]Mathew J,Sleight P,Lonn E,et al.Reduction of cardiovascular risk by regression of electrocardiographic markers of left ventricular hypertrophy by the angiotensin converting enzyme inhibitor ramipril[J].Circulation,2001,104:1615-1621
[18]Saupe KW,Limc C,Ingvill JS,et al.Cornparison of hearts with 2 types of pressure overload left ventricular hypertrophy[J].Hypertension,2000,35:1167-1172
[19]Fischer M,Baessler A,Hense HW,et al.Prevalence of left ventricular diastolic dysfunction in the community results from a Doppler echocardiographic based survey of a population sample[J].Eurhcart J,2003,24:320-328.
[20]Sugaya,Hw Lju,TX Cui,et al.Important role of nitric oxide in the effect of angiotensin converting enzyme inhibitor imi dapril on Vascular injury.Hypertension,2003,42:542-547.
[21]Pacea SR,De Azevedo AP,De Oliveira CF,et al.Attenuation of hypertension,cardiomyocyte hypertrophy,and myocardial fibrosis by beta-adrenoceptor blockers in rats under long-term blockade of nitric oxide synthesis[J].Cardiovasc Pharmacol,2002,39:201-207.
[22]Terpstra WF,May JF,Smith AJ,et al.Long-term effects of Binled ipine and lisinopril on left ventricular ulabs and diastolic function in elderly,previously un treated hypertensive patients:the ELVERA trial.[J].Hypertension,2001,19:303-309
[23]刘劲松,张榴修,周宜轩 高血压左室肥厚的中医病机学说[J].中国中医基础医学杂志,2004,10(2):71
[24]杨传华,韩玉水,刘政中医药逆转高血压左心室肥厚的理论探讨[J].河北中医,1994,16(5):18-21
[25]李燕钰 心肌肥厚之“痰瘀相关”理论探讨[J].陕西中医,2004,25(7):619-620
[26]严灿,张新春,邓中炎 心肌康对高血压病性左室肥厚逆转的临床作用观察及机理探[J].中国中医药科技,1995,2(5):17-18
[27]严季澜.高血压病中医治疗[M].北京:中国医药科技出版社,1992:8.
[28]刘德桓 中医辨证治疗对高血压病左心室肥厚伴心肌缺雪28例临床观察[J].山东中医杂志,1999,40(6):345-347
[29]刘德桓 辨证治疗对高血压病左心室肥厚逆转作用和改善左室功能的影响[J].山东中医杂志,1999,18(5):199-201
[30]刘泽银,罗英 灯盏花素片对高血压左室肥厚的逆转作用研究[J].实用中医内科杂志,2003,17(5):363-365
[31]赵玉霞 补阳还五汤对高血压病患者左室舒张功能的影响[J].辽宁中医杂志,2000,27(10):452-453
[32]刘德桓主编.高血压病中西医结合诊治研究[M].第一版.福建:厦门大学出版社.2003,12:136-140
[1]陈志君,罗明 高血压左心室肥厚研究的进展[J].同济大学报2001,22(1):81-83
[2]PalmieriV,Bella JN,Arnett DK,et al.Effect of type2 diabetes mellitus on left ventricular geometry and systolic function in hypertensive subject[J].Circulation,2001,103:102-107
[3]吴之理 实用医学大词典[M].北京:人民军医出版社,1990.1011
[4]DEVEREUX RB,Reichek N1Echocardiographic determination of left ven2 tricular massin man:anatomic validation of the method[J].Circulation,1987,(55):631
[5]刘劲松,张榴修,周宜轩高血压左室肥厚的中医病机学说[J]中国中医基础医学杂志,2004,10(2):71
[6]杨传华,韩玉水,刘政中医药逆转高血压左心室肥厚的理论探讨[J]河北中医,1994,16(5):1-2
[7]李燕钰 心肌肥厚之“痰瘀相关”理论探讨[J].陕西中医,2004,25(7):619-620
[8]严灿,张新春,邓中炎心肌康对高血压病性左室肥厚逆转的临床作用观察及机理探[J].中国中医药科技,1995,2(5):17-18
[9]严季澜.高血压病中医治疗[M].北京:中国医药科技出版社,1992:8
[10]翁伟强 探索中西医结合治疗高血压病的最佳结合点[J].中国中医基础医学杂志,1995,1(3):34-35
[11]郭伟星,周次清补益肾气法治疗老年人高血压的研究[J].山东中医学院学报,1994,18(5):304-310
[12]刘德桓 辨证治疗对高血压病左心室肥厚逆转作用和改善左室功能的影响[J].山东中医杂志,1999,18(5):199-201
[13]刘德桓 中医辨证治疗对高血压病左心室肥厚伴心肌缺血28例临床观察[J].山东中医杂志,1999,40(6):345-347
[14]王显,程永杰,袁丽荣高血压病左心室肥厚的阴阳属性及其治疗[J].吉林中医药,1997,(6):4-5
[15]赵玉霞 补阳还五汤对高血压病患者左室舒张功能的影响[J].辽宁中医杂志,2000,27(10):452-453
[16]杨宁,胡勤辉,程廉 调压益心胶囊治疗老年收缩期高血压50例疗效观察[J].中国中西医结合急救杂志,2002,9
[17]黄惠萍,卢焰山,郭小梅松龄血脉康对高血压病患者心脏结构及功能的影响[J].湖北中医杂志,2002,24(9):27
[18]陆曙 降防保心片对高血压左室肥厚影响的临床研究[N],南京中医药大学报,1998,14(1):79
[19]符德玉,罗海明,黄蔚活血潜阳方治疗血瘀、阳亢证高血压病患者左心室肥厚的临床研[J].上海中医药杂志,2003,37(2):6-9
[20]李雪山,缪灿铭,林凯旋,等1黄蛭口服液对高血压病血液流变学及左室肥厚影响的临床研究[J].新中医,2004,36(7):23-24
[21]李勇 白花前胡浸膏对臀型高血压左室肥厚大鼠的血压、左室肥厚的形成及血流动力学的影响[J],中国中西医结合杂志,1996,16(11):676
[22]刘泽银,罗英灯盏花素片对高血压左室肥厚的逆转作用研究[J].实用中医内科杂志,2003,17(5):363-365
[23]郁晓群 银杏叶片与开搏通治疗高血压左心室肥厚疗效观察[J].实用中医药杂志,1999,15(5):37
[24]于兆安.鲜鬼针草对逆转高血压病左室肥厚及心功能影响的研究[J].基层中药杂志,2001,15(3):59
[25]潘毅,邓中炎,严灿心肌康逆转高血压左室肥厚的临床研究[J].中国中医药科技,2001,8(4):213-214
[26]唐成玉,王剑,严灿 活血祛痰法对高血压左心室肥厚大鼠心肌ras原癌基因表达的影响 [J].中医研究,2001,14(1):14
[27]饶曼人,孙兰,张晓文前胡香豆素对肾型高血压大鼠左室肥厚及心肌胞内钙、钠,K—ATP酶和Ca~(2),Mg~(2+)一ATP酶活性的影响[J].药学学报,2002,37(6):401
[28]陆曙,龚少愚,吴新欲养血活血中药对高血压左室肥厚心肌血管紧素Ⅱ及肌浆网钙泵的影响[J].中华实用中西医杂志,2005,18(13):205-206
[29]刘建斌,任江华钩藤对自发性高血压大鼠心肌重构及原癌基因c—fos表达的影响[J].中国中医基础医学杂志,2000,6(5):40
[30]郑智,韩少杰,任大宏丹参对白发性高血压大鼠左室肥厚及心脏局部醛固酮的作用[J].中华急诊医学杂志,2002,11(1):22
[31]柳锋,郑智丹参预防自发性高血压大鼠左室肥厚及对转移生长因子B1的影响[J].中国急救医学,2003,23(2):71
[32]龚丽娅,郑智,黄俊丹参酮ⅡA对心肌肥厚的作用及其机制研究[J].中国急救医学,2004,24(2):116-118
[33]郭自强,王硕仁,朱陵群丹参素和川芎嗪对血管紧张素Ⅱ致心肌肥大相关基因的影响[J].中国中西医结合杂志,2005,4(25):342-344