Clinical observation of Huatan Huoxue Formula in treating coronary heart disease with hyperlipidemia

Dong Qiaozhi(董巧稚), Lin Qian(林谦), Zhang Liyuan(张历元), Wang Yu'nong(王羽侬), Wang Yao(王瑶), and Cai Lingling(蔡玲玲)

Clinical observation of Huatan Huoxue Formula in treating coronary heart disease with hyperlipidemia

Dong Qiaozhi(董巧稚), Lin Qian(林谦), Zhang Liyuan(张历元), Wang Yu'nong(王羽侬), Wang Yao(王瑶), and Cai Lingling(蔡玲玲)＊

Dongfang Hospital, the Second Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100078, China

OBJECTIVE:To explore the effect of the Huatan Huoxue Formula combined with atorvastatin calcium in the treatment of coronary heart disease with hyperlipidemia.

Coronary heart disease; Hyperlipidemia; Atorvastatin; Clinical ef f ects

Coronary heart disease is quite common in cardiovascular department1. 95% of coronary heart disease is caused by disordered lipid metabolism. The blood lipid deposited at the vessel wall, caused arterial lumen and finally led to cardiac ischemia. Lipid adjusting treatment has the important clinical value in preventing and controlling coronary heart disease. Statins is the most common clinical lipid-lowering drug, but it’s reported that the long-term use of statins can lead to liver damage, myositis, rhabdomyolysis and other side effects2. Traditional Chinese medicine believes that the main pathogenesis of hyperlipidemia is phlegm turbidity and blood stasis. This research investigates the effect of Huatan Huoxue Formula combine atorvastatin therapy on blood lipid of hyperlipidemia patients with coronary heart disease based on randomized controlled method.

MATERIALS AND METHODS

Materials

50 patients with coronary heart disease（CHD）combined hyperlipidemia from outpatient department of our hospital from March 2015 to April 2016 were selected as the research subjects, all patients provided written informed consent. The patients were divided into the experimental group and control group randomly. 25 cases were in the experimental group, 15 male, 10 female, aged 45～70 （50.5 + 8.7）, BMI=27.32±2.10 kg/cm2；25 cases were in the control group，16 male，9 female，aged 44～74（49.8 + 8.6）, BMI=27.82±2.50 kg/cm2； the experimental group and control group showed no statistical dif f erence in age, sex, body mass index, blood lipid levels before treatment（Supporting Information Fig. 1）.

Methods

All patients were given beta blockers, angiotensin receptor antagonist, nitrates, angiotensin converting enzyme inhibitors and antiplatelet drugs, atorvastatin and other conventional drug treatment. The experimental group received Huatan Huoxue Formula on the basis of this combined therapy. Ingredients: HuangQi (Radix astragali) 30g, GeGen (radix puerariae) 30g, DangShen (Codonopsispilosula) 10g, ChenPi(pericarpiumcitrireticulatae) 10g, ShanZha, (hawthorn), 10g, TianMa (gastrodiaelata) 10g, JueMingzi (cassia seeds) 10g, DanShen(salvia miltiorrhiza)10g, SanQi (notoginseng) 10g. The decoction was taken twice everyday and the treatment course was of 8 weeks.

Observation target

Comparing the fasting venous blood lipid four indicators of two groups before and after treatment:Total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDLC), low density lipoprotein cholesterol(LDL-C), recorded every adverse reactions in the process of treatment.

Criterion of Curative Effect: Reference to Guidelines Principles for Clinical Research of New Traditional Chinese Medicine3: ① Clinically controlled: Blood lipids recovers to normal level; ② Signif i cantly ef f ective: The decreasing of TC level≥20% or the decreasing of TG level≥40%;③Ef f ective: 10%≤the decreasing of TC level＜20%or 20%≤the decreasing of TC level＜40%; ④Inef f ective: Level of Blood lipids didn’t reach above standards. Total ef f ective rate= (the sum subtracts invalid case number) / the sum.

Statistical methods

Statistical analysis was carried out using SPSS19.0 software (SPSS, Chicago, IL, USA). All measurement data were expressed as mean±SD. Student’s t test was used for multi-group comparisons. Chi-squared tests were used for composition ratio of categorical data. P＜ 0.05 was considered to be statistically signif i cant.

RESULTS

Changes of FBG (Fasting blood-glucose) level between before and after treatment in two groups

There was no statistical signif i cance of lipid levels between both groups before treatment (P＞0.05). After treatment, levels of TG, TC and LDL-C have reduced and level of HDL-C have increased (P＜0.05). There were signif i cant dif f erences in intra-group and inter-group comparison(P＜0.05). See table 1.

Table 1. FBG levels between the two groups before and after treatmentmmol/L]

Table 1. FBG levels between the two groups before and after treatmentmmol/L]

Note: Compared with pre-treatment level,aP＜0.05; Compared with the control group after treatment,bP＜0.05.

Group n Time TC TG LDL-C HDL-C The experimental group 25 Pre-treatment 7.46±2.16 2.53±1.25 4.53±2.26 1.11±0.28 Post-treatment 4.44±1.41ab 1.35±0.86ab 2.54±1.73ab 1.48±0.26abPre-treatment 7.53±2.21 2.43±1.28 4.59±2.30 1.16±0.27 Post-treatment 5.74±2.04a 1.78±1.25a 3.22±2.31a 1.34±0.32aControl group 25

Comparison of therapeutic ef f ect of blood lipid in two groups

Curative ef f ects of lipid-lowering in the experimental group was significantly higher than that in the control group (P＜0.05). See table 2.

Table 2. Comparison of lipid-lowering ef f ect in two groups

DISCUSSION

According to the 2003 WHO statistics, almost 7,200,000 people in the world die from CHD each year, and the incidence and mortality rate of CHD are rising year after year in China4. Related studies have shown that dyslipidemiais the main pathogenic factor of CHD, therefore, the lipidlowering therapy is essential in the prevention and treatment of CHD.

Nowadays, statins is the most commonly prescribed medications used to lower blood lipids in the treatment of CHD, but there are still some problems in the clinical application of stains such as statins have certain adverse ef f ects on the liver and renal functions, some patients developed symptoms of dizziness, headache and muscle pain after taking the drug, and the Lipid-lowering effect is not ideal5. TCM holds that the hyperlipidemia in CHD belongs to the categories of “dizziness”, “obesity”, “phlegm-turbid”, “blood stasis”. In this prescription, Huangqi (Radix astragali) and Dangshen (Codonopsispilosula) can supplement Qi to activate blood circulation and anti-oxidation, they can also effectively reduce the total cholesteroland LDL6; Danshen (salvia miltiorrhiza)and Shanqi (notoginseng) could antagonize myocardial ischemia, promote vascular endothelial regeneration, resist blood vessels lipid deposition and improve microcirculation.7

Total flavone of Gegen (radix puerariae) and Shanzha (hawthorn) could improve myocardial oxidative metabolism, dilate blood vessels and activate blood circulation; Chenpi (pericarpiumcitrireticulatae), Tianma (gastrodiaelata) and Juemingzi (cassia seeds) have the functions of clearing away the liver-f i re, expelling turbid and regulating Qi, reinforcing kidney and improving eyesight, promoting digestion and removing stagnancy, promoting blood circulation and resolving phlegm.8 The combination of the above multiple Chinese herbs could have signif i cant ef f ects of resolving phlegm and removing blood stasis.

The research showed that the Blood-lipid indexes including TC, TG, LDL-C and HDL-C of Experiment Group had been obviously improved after treatment compared with the control group. The experiment group also presented significant advantage in antihypertensive efficacy. Thus it is safe to say that the Huatan Huoxue Formula combined with atorvastatin could signif i cantly improve blood lipid levels of patients with CHD and Hyperlipidemia.

REFERENCES

1 Su Lihua. An analysis of related risk factors between various types of hyperlipidemia and coronary heart disease. Guangzhou Medical Journal,2016,37(1):27-29.

2 Zeng Tingting. Analysis of 190 Reports of Adverse Drug Reaction Induced by Statins. Chinese Journal of Pharmacovigilance,2013,10(2): 96-100.

3 Zheng Xiaoyu. Guiding principles of clinical research on TCM medicine (Trial). Beijing: China Medical Science Press,2002:85-89.

4 Lee SH，Cho KI，Kim JY，et al. Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk Asian patients with mixed hyperlipidemia. Atherosclerosis，2012，221（1）：169-175.

5 Li Bo, Xiao Yin, Yan Meijuan, et al. Clinical observation on atorvastatin among 198 patients with hyperlipidemia. Modern Medical Journal,2011,39(11):57-59.

6 Rao Hong. Clinical study on treating hyperlipidemia with the Huangqi Yiyuan decoction. Journal of Traditional Chinese Medicine,2012,27(17):1642-1643.

7 Ma Xifan. Clinical observation on treating 60 cases of ischemic cardiomyopathy with Danshen Chuanxiongqin. Journal of Clinical Medicine,2015,1(12):72-73.

8 Yang Hua, Yang Zhigui, Li Xiaohui. Effects of total flavonoids of Shanzha leaves on blood lipid and hemorheology in hyperlipidemic rats. Chinese Journal of Experimental Traditional Medical Formulae,2012,18(12):257.

（Accepted: August 29, 2016）

Email: lingling89159166@126.com

METHODS:50 patients with coronary heart disease and hyperlipidemia were randomly divided into the experimental group and the control group, with 25 cases in each group, who were treated in the East Hospital of Beijing University of Chinese Medicine. From March 2015 to April 2016. Patients in the experimental group were given the Huatan Huoxue Formula combined with atorvastatin with 8 weeks; while the control group was just treated with atorvastatin. Blood Lipid changes were compared between the two groups.

RESULTS:Blood Lipid levels were significantly improved in the two groups after treatment. Compared with the control group, the levels of TG, TC and LDL-C in the experimental group were decreased, while the HDL-C was increased more significantly. The dif f erence was statistically signif i cant (P＜0.05).

CONCLUSIONS:The effect of the Huatan Huoxue Formula combined with atorvastatin on coronary heart disease and hyperlipidemia patients is more signif i cant.