ABSTRACT
Objective
To confirm the effect of Xuezhikang on sugar and lipid metabolism
in type II diabetes mellitus (DM).
Methods: 100 cases of type II DM patients were divided into four
groups based on previous measures for lowering blood sugar. This
trial was carried out on 30 cases without (group A) and with (group
B) hyperlipidemia respectively, took 2 capsules of Xuezhikang twice
a day for two months. 40 cases compatible with group A and B serving
as control groups (group C and group D), while no Xuezhikang was
taken.
Results: Fasting blood glucose decreased by 7.6%±7.7% and
10.8%±9.6%, 2-hour
post-prandial blood sugar by 14.1%±9.0% and 12.2%±10.5%,
HbAlc by 11.0%±5.4% and 6.3%±7.8%, serum total cholesterol
by 9.0%±9.0% and 15.0%±9.0%, triglyceride by 4.0%±13.0%
and 21.0%±26.0% in group A and B respectively. The parameters
after treatment were significantly different from that before treatment
(P<0.05 and <0.01 respectively). In group C and D there were
no change of the parameters before and after the observation. No
side effects were observed in those cases treated by Xuezhikang.
Conclusion: Xuezhikang not only can adjust disorders of lipidemia,
but also have some effects on ameliorating hyperglycemia in type
II DM.
Key Words
Diabetes mellitus; non-insulin-dependent; Xuezhikang
INTRODUCTION
Lipid metabolic disorders, hemorrheological abnormality and microcirculation
disturbance have become one of the major reasons for the development
of cardio-cerebrovascular diseases such as atherosclerosis, myocardial
infarction and cerebrovascular accidents. In this study, we used
Xuezhikang to treat 70 hyperlipoidemia patients to investigate its
curative effects on lipid level, hemorrheology and nailbed microcirculation.
Here is the detail.
PATIENTS
AND METHODS
Patients
In out-patient-clinic (OPD) or on admission, patients were
selected for clinical observation according to the diagnostic standard
advocated by WHO (1985), after dietary adjustment and/or took drugs
lowering blood sugar and condition stable for more than two months,
whose 2-hour post-prandial blood sugar (2-hr BS) were measured successively
twice (2-4 weeks interval) 10.6 mmol/L, or fasting blood sugar =8.3
mmol/L in type II DM.
Among
those cases complicating abnormal blood lipid, after taking low
fat and low cholesterol diet for one month, measured blood total
cholesterol (TC) =5.9 mmol/L or triglyceride (TG)=2.3 mmol/L twice
successively, belonging to the hyperlipidemic group, blood sugar
(HDL-C) male <1.0 mmol/L or female <1.2 mmol/L belonging to
low HDL-C group. In all cases excluded those with diabetic retinopathy
over stage or massive fresh bleeding on foundus of eye; diabetic
renopathy; proteinuria over (++) quantitatively or serum BUN >10.7
mmol/L and creatinine (Cr)>176.8µmol/L; episode of diabetic
ketosis accompanied with ketotic acidosis, hypertonic coma syndrome
or lactic acidosis and serious infection with acute complication
within three months; suffered from acute myocardial infarction;
frequent attacks of angina pectoris; cerebral accidents; serious
wound within half a year, and drugs induced abnormal lipid metabolism,
etc.
Administration
Method
Xuezhikang capsule, [(1995) approval code Z-94 by the Ministry of
Public Health], developed by Beijing WBL Peking University Biotech
Co., Ltd., was administrated by target patients with 0.6 g each
time, twice a day. Each capsule contains 0.3 g Xuezhikang. The treatment
lasted for 2 months.
Observation
Methods
Open contrast study. Patients compatible with the requirements are
divided into four groups. 30 case with (group A) and without (group
B) hyperlipidemia respectively were selected. Another 20 cases,
correspondent in sex, age, level of blood sugar, course of illness
and not (group C) complicating with hyperlipidemia and with hyperlipidemia
(group D) serving as contrast groups. The common clinical materials
are shown in Table I.Open contrast study. Patients compatible with
the requirements are divided into four groups. 30 case with (group
A) and without (group B) hyperlipidemia respectively were selected.
Another 20 cases, correspondent in sex, age, level of blood sugar,
course of illness and not (group C) complicating with hyperlipidemia
and with hyperlipidemia (group D) serving as contrast groups. The
common clinical materials are shown in Table I.
Table
I. Common clinical Material of Diabetes Mellitus Patient |
Case
|
Age
(y)
|
Course
(y)
|
Body
mass index
|
Main
complication
incidence rate %
|
Group
|
Sex
|
x±S
|
Range
|
Mean
|
Range
|
>
25
|
<=
25
|
Rretina
nephritic lesion
|
Rretina
nephritic syndrome
|
PN
|
HD
|
CHD
|
CD
|
Lower
limb angiopathy
|
M |
F |
Xuezhikang
|
A
|
17
|
13
|
55.0±9.1
|
35~70
|
7.97±6.16
|
2.00~16
|
2
|
28
|
36.7
|
30.0
|
70.0
|
43.3
|
26.7
|
20.0
|
13.3
|
B
|
18
|
12
|
54.7±9.2
|
35~70
|
6.14±4.22
|
0.17~15
|
5
|
25
|
43.3
|
33.3
|
80.0
|
50.0
|
23.3
|
20.0
|
10.0
|
Control
|
C
|
12
|
8
|
56.4±10.07
|
38~70
|
7.98±7.06
|
0.67~32
|
4
|
16
|
40.0
|
45.0
|
85.0
|
35.0
|
30.0
|
25.0
|
15.0
|
D
|
11
|
9
|
55.65±9.71
|
39~70
|
4.27±4.48
|
0.30~15
|
6
|
14
|
40.0
|
30.0
|
65.0
|
50.0
|
20.0
|
25.0
|
25.0
|
A,C:
simple DM.; B,D: DM complicating with hyperlipemia. PN: peripheral
neuropathy; HD: hypertensive disease; CHD: coronary heart disease;
CD: Cerebral vessels disease |
The
living style is relatively stable. Drugs maintained basically unchanged
during the course. Supper must be light before the days withdraw
blood. In groups A and B, in addition to drugs for lowering blood
sugar, added Xuezhikang 2 capsules (0.6g), bid, and Xuezhikang were
taken on groups C and D, two months for the course. Before and after
the treatment measured blood pressure, body weight, heart rate,
withdraw blood with emptying stomach for 12 hours (over night) for
fasting blood sugar, TC, TG, HDL-C, ALT, AST, bilirubin, BUN, Cr,
CPK, ALP, LDH, test A1C(HbA1C) of whole blood, and 2-hr post-prandial
blood sugar, urine routine and record drug reaction once month.
Perform palpation of the liver and spleen, ECG, blood routine and
platelet count before and after the treatment.
STANDARD OF EVALUATION OF EFFECT
According
to 'Clinical Research Guidance Principle of Drugs', advocated by
the Ministry of Health (1993), the effect for lowering blood are
divided into evidently effective, effective, and invalid.
- Evidently
effective
Fasting blood sugar <7.2 mmol/L, 2-hr post-prandial BS <8.3
mmol/L, 24h urine sugar <10g quantitatively or decreased >30%
within 24 hours.
- Effective
Above criteria are <8.3mmol/L, <10mmol/L, <25g or decrease
>10% respectively. Invalid: No obvious improvement of diabetic
symptoms observed, and blood and urine sugar are not reach the
above mentioned criteria.
STATISTICAL MANAGEMENT
Data
were processed by personal computer after entered. Quality Material
analyzed with t test, and count analyzed with chi-square test. The
results of various groups are compared with that before treatment
(self-contrast), inter-group effect are compared with changed percentage.
RESULTS
Influence
of Xuezhikang on blood sugar of type II DM.
Compared with that before treatment, in all the 4 groups, there
are no difference of average value (p>0.1 and 0.05> respectively)
on clinical data, occurrance of complication and fasting blood sugar,
2h-BS, HbA1C, therefore it has comparability. Shown in Table II.
Table
II: Blood sugar changes in various group of type II DM before
and after Xuezhikang treatment (x±S) |
|
|
Fasting
Blood Glucose
|
2-hr
post-prandial
blood sugar
|
HbA1C
|
Group
|
Case
|
Pre
mmol/L
|
After
1 month(%)
|
After
2 month(%)
|
Pre
mmol/L
|
After
1 month(%)
|
After
2 month(%)
|
Pre
mmol/L
|
After
1 month(%)
|
After
2 month(%)
|
Xuezhikang
|
A
|
30
|
9.0±
|
<7.3±
|
<7.6±
|
11.1±
|
<10.9±
|
<1.41±
|
9.0±
|
<7.6±
|
<11.0±
|
|
|
1.0
|
7.7
|
7.7**
|
0.7
|
8.6**
|
9**
|
1.2
|
5.1**
|
5.4**
|
B
|
30
|
8.4±
|
<7.7±
|
<10.8±
|
10.9±
|
<7.1±
|
12.2±
|
8.5±
|
<4.0±
|
<6.3±
|
|
|
1.3
|
8.4**
|
9.6**
|
1.1
|
10.2**
|
10.5**
|
1.0
|
9.2**
|
7.8**
|
Control
|
C
|
20
|
8.5±
|
<1.2±
|
>0.0±
|
10.8±
|
>2.6±
|
>2.1±
|
8.6±
|
<1.3±
|
<1.8±
|
|
|
1.7
|
9.4
|
9.6
|
0.9
|
10.3
|
6.6
|
1.6
|
7.6
|
9.8
|
D
|
20
|
8.1±
|
<1.7±
|
<3.9±
|
10.8±
|
<0.2±
|
>2.3±
|
8.5±
|
<1.9±
|
<1.4±
|
|
|
0.9
|
8.4
|
6.3
|
1.0
|
12.9
|
7.2
|
1.5
|
6.5
|
7.1
|
t
value, between groups comparison
|
A&B
|
|
|
0.41
|
2.10
|
|
2.27
|
2.57
|
|
4.60*
|
8.44**
|
A&C
|
|
|
8.71**
|
7.36**
|
|
9.36**
|
20.21**
|
|
17.30**
|
21.11**
|
B&D
|
|
|
15.70**
|
27.86**
|
|
4.00
|
13.50
|
|
8.02**
|
10.81**
|
<:decreased,>:
increased. *P<0.05, **P<0.01; A,C simple DM; B,D: DM:
complicating with hyperlipemia |
Action of Xuezhikang on blood sugar of type II DM. (Table III.)
|
|
TC
|
TG
|
HDL-C
|
Group
|
Case
|
Pre
(mmol/L)
|
After
1 month change(%)
|
After
2 month
change(%)
|
Pre
(mmol/L)
|
After
1 month change(%)
|
After
2 month
change(%)
|
Pre
(mmol/L)
|
After
1 month
change(%)
|
After
2 month
change(%)
|
Xuezhikang
group
|
A
|
30
|
5.3±0.5
|
<7±5**
|
<9.0±9.0**
|
1.9±0.2
|
<2±13
|
<4±13*
|
1.1±0.2
|
>4.0±6.0
|
>5.0±8.0
|
B
|
30
|
6.0±1.0
|
<10±7**
|
<15.0±9.0**
|
3.2±1.4
|
<14±21
|
<21±26**
|
1.1±0.2
|
>7.0±14.0
|
>10.0±18.0
|
Control
group
|
C
|
20
|
4.9±0.6
|
>0.1±9.5
|
<0.7±8.5
|
1.4±0.5
|
<4.4±20.9
|
>2.4±18.3
|
1.3±0.4
|
>3.2±15.4
|
<1.8±7.7
|
D
|
20
|
6.2±0.5
|
>3.2±3.4
|
>4.0±4.2
|
2.1±.07
|
>3.5±5.3
|
<0.5±16.8
|
1.2±0.3
|
>3.2±8.1
|
<1.7±6.6
|
t
value, between groups comparison
|
A&B
|
|
|
2.69
|
4.38*
|
|
10.87**
|
13.99**
|
|
0.008
|
1.55
|
A&C
|
|
|
8.71**
|
12.43**
|
|
1.71
|
0.16
|
|
2.55
|
1.99
|
B&D
|
|
|
18.72**
|
23.64**
|
|
7.36**
|
13.28**
|
|
0.002
|
3.93*
|
<:decreased,>:
increased. *P<0.05, **P<0.01 |
Effect of Xuezhikang after 2 months on type II DM.(Table IIII)
Treated
with Xuezhikang for 2 months, compared with that before treatment
on group A and B, shown that the fasting blood sugar evidently decreased
by 7.6%±7.7% and 10.8%±9.6% (P<0.01), 14.1%±9.0%
and 12.2%±10.5% 2h post-prandial blood sugar(P<0.01),
11.0%±5.4% and 6.3%±7.8% HbAlc(P<0.01 and <0.05),
9.0%±9.0% and 15.0%±9.0% respectively, TC(P<0.01),
4%±13% and 21%±26%TG(P<0.05 and <0.01, respectively.
The decrease of TC and TG are much more evident than group A (P<0.05
and <0.01, respectively). Changes of blood sugar and blood lipid
in contrast group C, D are not evident (P>0.05).
Table
IV: Effect of Xuezhikang on blood sugar after 2 months on type
II DMS |
|
Fasting
blood glucose
|
2-hr
post prandial blood sugar
|
Group
|
Case
|
Evidently
|
Effective
|
Total
Effective(%)
|
Evidently
|
Effective
|
Total
Effective(%)
|
Xuezhikang
Group
|
A
|
30
|
3
|
15
|
60.0
|
3
|
23
|
86.7
|
B
|
30
|
6
|
19
|
83.3
|
3
|
19
|
73.3
|
Control
Group
|
C
|
20
|
3
|
8
|
55.0
|
0
|
3
|
15
|
D
|
20
|
2
|
9
|
55.0
|
0
|
6
|
30
|
x2
value, between groups
|
A&B
|
|
15.75**
|
|
|
0
|
|
A&C
|
|
0.16
|
|
|
2.09
|
|
B&D
|
|
10.85**
|
|
|
2.09
|
|
*P<0.05,
**P<0.01 |
SIDE-EFFECTS
Patients
took Xuezhikang orally had no complaints in group A and B. All the
results were in normal range such as hepatic and renal function,
CPK, AKP, LDH, AST as well as blood and urine routine examinations,
checked monthly.
DISCUSSION
Accompanied
with the elevation of living level, changes of living style, social
population aging gradually and accompanied with improvement of the
monitoring measures, there is a tendency of increase the occurrence
of patient suffered from diabetes mellitus especially that of type
II. Accordingly, population over 40 years old, every 10 years of
age promoted, the modality rate increases 0.1%. Induced various
chronic complications, are the main important cause of handicap
and death, and also are the basis arousing cerebro-cardio-vasular
diseases. To prevent and cure diabetes mellitus and its complications,
except control blood sugar to an ideal level, adjusting abnormal
blood lipid eventually play an important roll [3] in this respect.
Xuezhikang contains HMG-CoA reductase inhibitor, multiple unsaturated
fatty acids amd essential amino acids that the human body needs,
and various effective components, dealing with the action of modulating
abnormal blood lipid [4].The mechanism of lowering the sugar probably
is due to multiple unsaturated fatty acids inhibit the synthesis
of triglyceride and fatty acids, and accelerate its metabolism,
therefore increase insulin secretion from the islet cell of the
pancreas or promote sensitivity of peripheral tissue to insulin
[5]. But there may be some other pathway that not discovered yet,
further research is waiting for.
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Shen
Zhiwei, Yu Pulin, Sun Meizhen et al. Prospective Study of
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Li
C,Li Y, Hou Z. Toxicology of Xuezhikang. Inf Chin Pharmacol
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The
diabetes control and Complications Trial Research group. The
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and progression of long-term complications in insulin-dependent
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Brown
MS, Goidstein JL. A Receptor-mediated pathway for cholesterol
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Yang
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