Xuezhikang, a newly developed lipid-regulating medicine in China,
has been used in clinical observations after more than two years
fundamental studies. This paper studied 45 cases of type II diabetic
patients associated with hyperlipoidemia in terms of changes of
serum lipid, blood sugar and insulin levels and further explored
the influence of Xuezhikang on lipid metabolism and islet b cell
Patients were selected from diabetes department according
to Recommended Clinical Standard of Diabetes Patients stipulated
by WHO in 1985. They should have a minimum stable symptom period
of 2 months after proper diet, physical exercise and/or blood sugar
regulating medicine treatment. Two or more consecutive tests with
1 ~ 2 weeks intermittence showed their FBG ³ 7.8 mmol/L, 2h-PG
³ 11.1 mmol/L. These above patients were chosen as clinical
targets. And those patients with serum TC ³ 5.72 mmol/L(220
mg/dl), TG > 1.7 mmol/L (150 mg/dl) tested at least one month
after low cholesterol diet were regarded as type II diabetes patients
coupled with hyperlipoidemia. Meanwhile, those with HDL-C < 0.91
mmol/L were classified as low lipid patients.
with syndromes, within 6 months, such as acute myocardial infarction,
cerebrovascular accidents, renal disease resulting from diabetes,
protein urea quality analysis higher than (++), IV type or higher
retinosis caused by diabetes and/or large scale fundus oculi bleeding,
diabetes hyperosmolar coma, ketoacidosis, or serious injury caused
by major surgery had been excluded. In addition, hyperlipoidemia
resulting from family genes, or diseases of liver, gallbladder,
kidney and thyroid or from drug were also excluded. Those patients
satisfying the above standards and not taking lipid regulating agents
in the past two months were finally selected totaling 45 cases with
20 males and 25 females, age from 35.1 to 71.5 years old, the average
57.78 ± 8.22. These patients had a medical history of 1 week
to 11.5 years averaging 3.51 years. There were 7 male patients with
body weight measuring index [BMI(kg/m2)] > 25 and 15 female patients
with BMI > 24. And 23 cases had lower BMI index. At the same
time, 30 type II diabetic patients without hyperlipoidemia, 12 male,
20 female, age from 34.2 ~ 72.5, the average of 58.12 ± 3.42
were chosen as control group. They had 1 week to 10 years medical
history averaging 3.11 years. Among them, there were 5 male with
BMI> 25 and 10 female BMI > 24.
observation was employed in the study. Every one in the treatment
group took two capsules of Xuezhikang (manufactured by WBL Peking
University Biotech Limited Company) twice a day, one after breakfast
and one after dinner for 8 weeks. During treatment, the lifestyle
and diet habit as well as other pharmaceutical treatment kept the
and after the treatment, patients were tested on their height and
body weight (after relieving bowels and urine) to calculate their
BMI. They were also required to test blood pressure, heart rate,
blood sugar, serum lipid, serum insulin, glutamic-pyruvic transaminase,
BUN and blood creatinine. High cholesterol diet and alcohol were
prohibited one day before blood sampling and venous blood samples
were taken from 12h-fasting patients to identify the concentrations
of blood sugar, lipid and insulin. Two hours after a standard meal,
venous blood samples were taken again to determine the levels of
blood sugar and insulin. Blood sugar and lipid were determined by
oxidase method and insulin by radioimmunoassay method.
Criteria for Effects
of Xuezhikang refers to Guiding Standards on Clinical Study of Medicines
(Draft) stipulated by Ministry of Public Health P. R. China in July
TC reduction ³ 20%, or TG decrease ³ 40%, or HDL-C increase
³ 0.26 mmol/L, FBG < 7.2 mmol/L then 2h-PG < 8.3 mmol/L.
TC reduction 10% ~ 20%, or TG decrease 20% ~ 40%, or HDL-C increase
by 0.1 ~ 0.25 mmol/L(4 - 10 mg/dl), FBG < 8.3 mmol/L and then
2h-PG < 10 mmol/L.
not reaching any one of the above criteria.
TC increase ³ 10%, or TG elevation ³ 10%, or HDL-C decrease
³ 0.1mmol/L (4mg/dl).
lipid, blood sugar, insulin and Sensitivity analysis of insulin
employed t-test with all parameters expressed in the form of average
value ± standard deviation (X ± S).
on Type II Diabetic Patients Associated with Hyperlipoidemia
results showed that at 4 and 8 weeks after treatment, TC decreased
by 20.8% and 27.06% respectively; TG decreased by 19.27% and 42.3%
respectively; HDL-C elevated by 24.32% and 54.95% and AS index decreased
by 32.35% and 49.13% respectively.
on Islet b Cell Functions of Type II Diabetic Patients with Hyperlipoidemia
findings illustrated that levels of FBG, FBI, 2h-PG and 2h-PI decreased
significantly at the end of both 4 weeks and 8 weeks treatment with
P < 0.05 ~ 0.001.
Comparison on Blood Sugar and Serum Lipid Reduction of Type II Diabetic
Patients with Hyperlipoidemia
study showed that after the treatment, serum TC and TG of diabetes
II patients with hyperlipoidemia reduced dramatically with total
efficacy of 88.9% and 90.3% respectively. HDL-C level elevates with
total efficacy of 97.8%. Whereas reduction occurred for both FBG
and PBG with total efficacy rate of 100% and 95.9% respectively.
of Xuezhikang on Islet b Cell Functions of Type II Diabetic Patients
blood sugar and insulin levels of type II diabetic patients without
hyperlipoidemia dropped obviously after 8 weeks treatment with P
< 0.05 ~ 0.001 compared with that of post treatment.
of the 45 cases had reported any discomfort or malaise after Xuezhikang
treatment, and liver and renal functions lay in normal range.
It is reported
that about 50% diabetic patients accompanying with hyperlipoidemia.
 And high concentrations of blood sugar, serum lipid, insulinemia
or high insulin sensitive index are pathological causes of diabetes
syndrome and usually lead to cardiocerebrovascular disease. Xuezhikang
contains HMG-CoA reductase inhibitor Lovastatin and various kinds
of unsaturated fatty acids and many effective ingredients like essential
amino acids. HMG-GoA reductase inhibitor is the speed limited enzyme
of cholesterol synthesis. The product of HMG-CoA reductase catalysis
reaction ¾mevalonic acid is the necessity of DNA synthesis
and cell proliferation. Xuezhikang competes to suppress the activity
of this enzyme, reduce the synthesis of cholesterol in liver. Meanwhile,
HMG-CoA reductase inhibitor stimulates the activity of LDL-C receptor
on liver cell surface and facilitates the elimination of serum LDL-C,
affects metabolism of cholesterol and TG in human body therefore
reduces the concentration of serum TC, TG and LDL-C. In this study,
45 diabetes patients with hyperlipoidemia had been treated with
Xuezhikang. Total efficacy rate of TC reduction reached 88.1% 4
weeks after and 88.9% 8 weeks after the treatment. Total efficacy
rate of TG reduction went to 77.4% 4 weeks after treatment and 90.3%
8 weeks after. Whereas total efficacy rate of HDL-C reached 84.2%
4 weeks after and 94.7% 8 weeks after the treatment. Compared with
the level before treatment, TC decreased by 27.06%, TG by 42.3%
and HDL-C increased by 54.94%..
- HDL-C/HDL-C ratio is one of the most sensitive variables which
is called as arteriosclerosis index (AS index). This study showed
a remarkable decrease of AS index after Xuezhikang treatment, P
< 0.001 or 0.01. It has been illustrated by some study that Xuezhikang
can protect the functions of neointimal cells of high diet fed rabbit.
 It can also inhibit the proliferation and migration of vessel
SMC of rabbit. This is essential to prevent the formation of
atherosclerosis. The research findings showed that, keeping the
same lifestyle and blood sugar regulating agents, type II diabetic
patients associated with hyperlipoidemia could lower their concentrations
of blood sugar and lipid and elevate insulin sensitive index by
way of lipid regulation. It is also true for type II diabetic patients
without hyperlipoidemia in the control group. It is assumed that
diabetes and hyperlipoidemia may possess the same pathological causes¾
insulin resistance. Because Xuezhikang contains various unsaturated
fatty acids, it inhibits the synthesis of TG and fatty acids, and
accelerates their metabolism, thus enhancing the secretion of insulin
from islet b cells and improving the sensitivity of surrounding
tissues. The observations in this study showed a slight reduction
of blood sugar and insulin after 4 weeks treatment, but a distinct
decrease 8 weeks after. This may have something to do with the above
mechanism. As for the effects of Xuezhikang on improving vascular
complications of diabetes, it is still open to further study.
Dong Yanhu, Qian Rongli. Modern treatment for diabetes and their
complications, First edition, Shandong Science & Technology
Publishing House, 1994, pp121-128.
Zheng Xiaowei, Zeng Dingyi, Wang Xiaojing, et al. Protection
on vessel endothelial cell functions of high diet rabbit by
Xuezhikang, China Journal of Internal Medicine, 1998, Vol.6:367-370.
Zeng Dingyi, Yu Bo, Zheng Xiaowei, et al. Suppression of Xuezhikang
on the proliferation and migration of vessel SMC, China Journal
of Internal Medicine, 1998, Vol.6:400.