ABSTRACT

[Objective]: 80 patients with hyperlipidemia were randomly divided into group of Xuezhikang and ZOCOR. TC and TG decreased similarly in both groups, but the effect on LDL-c lowering in ZOCOR group is better than that of Xuezhikang group; the effect of increasing HDL-c in ZOCOR group is better than that of Xuezhikang group, but the increased ratio of two groups has no notable difference. During this trial all the patients in both groups had no obvious side effects observed.
[Key Words]: Xuezhikang, ZOCOR , Hyperlipidemia

INTRODUCTION

Xuezhikang, the initial domestically produced medicine in adjusting lipids, which contains chiefly HMG-CoA reductase inhibitor. This paper intends to further study the adjusting lipids action of Xuezhikang, and compares with that of ZOCOR.

CASES AND METHOD

Standard of Diagnosis: TC=5.70mmol/L, and/or TG=2.36mmol/L, or LDL-C=3.36mmol/L, and/or HDL-C=1.57mmol/L in male, =1.82mmol/L in female.

Case's Standard: The adult patients with hyperlipidemia, in outpatient clinic (OPD) or on admission, with primary diagnosed of hyperlipidemia and never received any treatment before, who were compatible with the standard being selected randomly in two groups of Xuezhikang and ZOCOR. The general conduction and level of lipid are basically similar in two groups (as shown in Table I.)

Standard of Exclusion:
During the last 6 months, Patients had suffered from myocardial infarction, stroke, severe trauma or major surgery, gravida and women in lactation;

Patients suffered from nephrotic syndrome, hypothyroidism, acute or chronic hepatobiliary disorders, diabetes mellitus (DM) or gout;

Patients has hyperlipemia induced by drugs (Such as phenothiazine, beta-blocking agent, adrenocortical steroid, some kinds of contraceptive and etc.);

Complicated with other sever or metal diseases;

Patients with irritability physique or did not obey the rule of medication, therefore influenced its effect, or the clinical materials are insufficient to judge its safety.


Method
The patients took Xuezhikang 0.6g each time, twice a day in Xuezhikang group, and Zocor 10mg once in the evening. Before and 4 weeks after the treatment, took samples of venous blood on an empty stomach respectively in the morning, and checked blood lipid, hepatic and renal function and blood sugar. During medication the patients were asked to maintain their dietary habits and living styles as before. Drugs that are not interfering with blood lipid metabolism for hypertension or CHD may be continued.

Criteria of Assay: take the enzyme reagent and method to assay directly the level of serum TC, TG, HDL-C and LDL-C, or hepatic and renal function and blood sugar.

Statistical Processing: paired t test, cpd analysis and chi-square test.

Standard of Judgement of Curative Effect: According to the "Clinical Research Guidance Principle on Drug" by the Ministry of Health July in 1993. (1) Evident Effects: Achieved the following arbitrary items: TC decreased by =20%; TG decreased by=40%; HDL-C increased by=0.26mmol/L respectively. (2) Effective: TC decreased by =10%-29%; TG decreased by=20%-39%; HDL-C increased by=0.104-0.25mmol/L. (3) Invalid: did not reach the above-mentioned standard. (4) Worsen, achieved the following arbitrary items: TC increased by=10%; HDL-C decreased by=0.104mmol/L.

RESULTS

After 4-week treatment, there are valuable reducing TC,TG and increasing HDL-c in both groups, but the total effect in increasing HDL-C with Xuezhikang is lower than that of ZOCOR(P<0.05) (as shown in Table II).

After 4-week treatment, from the aspect of range of lowering, there are no notable differences in reducing TC and TG in both groups, except LDL-C decreased by Xuezhikang is better than that of ZOCOR (P<0.01). There is no notable difference in the range of increasing HDL-C in both groups (as shown in Table III.).

For any level of TG and HDL-C, the curing effect is the most significant when it is >2.27mmol/L and =0.91mmol/L respectively (Table IV).

All patients had no evident side effects after 4-week treatment, and no significant difference of blood sugar before and after treatment observed (P>0.05).

DISCUSSION

The lipid infiltration theory has a close relationship with the development of atherosclerosis (AS). Hyperlipidemia is one of the major risk factors for coronary heart disease (CHD). TC, TG and LDL-C decrease, HDL-C increases, and lipid level maintains on normal level well benefit to inhibit AS and lowing the morbidity and mortality associated with CHD. For the treatment of hyperlipemia, is stressed upon comprehensive therapy, supplement with drugs on the basis of dietary adjustment and proper exercises is very important. At present, most of the medicines in adjusting lipid for clinical treatment are imported, and the medicines of domestic production are rather less satisfied in its effect. But Xuezhikang capsule, used in this experiment is produced and refined from red yeast rice provided by the WBL Peking University Biotech Co.Ltd., and the chief components is the HMG-CoA reductase inhibitor, multiple kinds of essential amino acids and unsaturated fatty acids and polysaccharides and etc. that the human body needs. It reduces biosynthesis of TC, through feedback adjustment, and increased activity of receptor of LDL on the surface of liver cell and accelerated the removal of LDL[3]. The evident effect and ideal safety with ZOCOR have been confirmed by extensive clinical staffs. The chief effective composition of ZOCOR is also due to contains HMG-COA reductase inhibitor [4,5].

The results in this trial indicated that, after taking Xuezhikang for 4 weeks, actions in reducing TC, TG, LDL-C and increasing HDL-c were remarkable and no side effects occurred, and the similar results were seen in treatment with Zocor. The effective rate in increasing HDL-C, Zocor was better than Xuezhikang(P<0.05), but no significant difference on the range of increasing its level of content. It seemed that the level of TG reduced, Xuezhikang was little better than Zocor, but there was no significant difference in both groups. It is probably that owing to Xuezhikang included multiple kinds of essential amino acid and unsaturated fatty acids.

At same time, the results indicated that the higher level of TG and the lower level of HDL-C were, the more significant effective by Xuezhikang, which is identical with the result observed by Wang Junxian et al [1].

It was reported: after 8-week treated with Xuezhikang the TG decreased by 28.1-36.4% and HDL-C increased by 19.6%[1,2], while in this trial, TG decreased by 13.28% and HDL-C increased by 6.38%, and total effects in adjusting lipids in both groups are significant different as compared with relevant reports. Through analysis of the result we obtained, considered that possibly it related with the short-term treatment, and without restrict dietary control and lack of physical exercises. Whether any other reason influenced its effect, still requires further observation.

In summary, we suggest that Xuezhikang is an effective and well-tolerated lipid-adjusting medicine of domestic production, which possess the function to regulating the disorder of lipid metabolism.

REFERENCES