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
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