INTRODUCTION

Since March to September in 1996, we used Xuezhikang to cure 50 cases of NIDDM, and the effects were evident. Report is as follows.

In this trial, 50 cases of diabetes mellitus (DM) are compatible with the diagnosis standard of DM, which provided by the DM Specialist Committee of WHO, in type belonging to NIDDM.
In order to exclude hyperlipidemia caused by blood sugar increased, through control blood sugar (blood sugar on an empty stomach is less than 6.7mmol/L and 2-hr postprandial is less than 8.9mmol/L) three months later, recheck blood lipid, that fitted one or more criteria as follows: (1)TC=5.98mmol/L;(2)TG=22.2mmol/L; (3) HDL-C male=1.04mmol/L, female =1.16mmol/L,(4)LDL-C=3.36mmol/L, and cases in the last half a year had suffered from myocardial infarction, cerebral vascular strock, severe trauma, major surgery, nephrotic syndrome, hypothyroidism, acute or chronic hepatobiliary disorders, gout, homozygote familial hypercholesterolemia and drug induced hyperlipidemia. 50 patients were all selected from DM special outpatient clinic and on admission, 21 are male and 29 female, age is from 40 to 72 years old and average 60 years old. 37 patients complicate with hypertension and 8 coronary heart disease (CHD). 14 cases are obese (body weight index =24). 28 TC, 22 TG and 42 LDL-C increased respectively, 26 HDL-C is below the lower limit of normal range.

METHODS OF TREATMENT
50 patients were asked to keep the habit of living and diet as before, and maintained the drugs in curing diabetes mellitus, hypertension and coronary heart disease identical with that before treatment. Adopted the Xuezhikang capsule, production of the WBL Peking University Biotech Co.,Ltd. (Batch number 951107), which possesses major composition of hydroxy-methyl-glutaryl coenzyme A (HMG-COA)reductase inhibitors and multiple kinds of unsaturated fatty acids and amino acids that human body needs. Each tablet contains 0.3g, take orally 0.6g each time, twice a day for 4 weeks. Before and after the treatment measure and record BP, cardiac rhythm and heart rate, ECG, blood lipid, BUN, creatinine, SGPT, creatine phosphokinase and routine of blood and urine. Statistical processing with t test for auto-comparison before and after the treatment.

RESULT
Standard of Determination of Curative Effect: According to "The Guidance Principle of the Clinic Study on the Cardiovascular Drug" adopted by the Ministry of Health in 1988. The result indicated that the total efficiency , in lowering TC,TG, TCHDLC / HDL-C and increasing HDL-C, is 26 (92.95),19 (86.4%),45 (90%) and 15 (57.7%) respectively. After the treatment the average of TC, TG, LDL-C, TC-HDL-C/HDL-C are decreased and HDL-c increased by 25.7%, 48.4%, 33.0%, 32.0% and 21.4% respectively,there are significant difference compared with that before the treatment(P<0.01-0.001).

DISCUSSION
Xuezhikang, used in this experiment, is produced and refined from red yeast rice of TCM. Through the animal experiments confirmed that it can significantly reduces the level of blood lipid, and also can inhibit the formation of atherosclerotic plaque and the deposition of lipid in the liver in hyperlipidemia rabbit. The clinical observation of this trial further confirmed that lipid-adjusting effect of Xuezhikang is evident. In addition, through competitive inhibition for HMG-CoA, which reduces TC synthesis and its level in serum, and through feedback adjustment, to increased activity of LDL receptor on cell surface, and accelerate the elimination LDL, at same time significantly reduces TG and increased HDL-C. The differential diagnosis of TCM recognized that the occurrence of hyperlipidemia is concerned with the factor of spleen-asthenia, phlegm damp, dyspepsia, blood stasis and etc. Red yeast rice is sweet taste and warm in nature, and Ben Cao Gang Mu noted that it can "promoting digestion and blood flow, invigorating the spleen for eliminating dampness". It is thus clear that Xuezhikang through strengthening spleen and stomach, invigorating, promote digestion and removing blood stasis, to improve transport of body fluid, achieve adjusting metabolism disorder of blood lipid in vivo. Thus, Xuezhikang capsule is a kind of curing hyperlipidemia medicine of TCM, effective and easy to be tolerated. Because of the benefit are appeared quicker and definite, without side effects, Xuezhikang is worthwhile to spread its clinical application.