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The
following is a 10618 case report of diabetics who used YU XIAO SAN
8805 during the period of February 1992 to October 1992.
I.
Selecting Cases
1.
Diabetics were confirmed patients under the diagnosis standard
published by WHO.
2. Clinical fasting blood sugar was 7.8 mmol/L (140mg/L) or above,
glucose in urine was positive and with obvious diabetic symptoms.
3. Blood sugar could not be controlled within the normal range
after using Chinese and Western medicine for over 3 months. (equal
to term 2)
4. Blood sugar was abnormal for or over 3 months without using any
Chinese or Western medicine.
II. General Information
Among
the 10618 cases, 5318 cases were provided by our hospital (1268
In-patient cases, 4050 out-patient cases). The rest 5300 cases
were provided by other cooperative medical institutions.
1. Gender: 5204 males, 5414 females. The ratio between male and
female is 1:1.04
2. Age: 1610 cases were under 40 years old, 15.16%: 7116 cases
between 40-60 yeas old, 67.02%; 1892 cases over 60 years old,
17.82%.
3. Duration of illness: 2548 cases were between 3 months to within
one year, 24%; 3398 cases were between one to five years, 32%;
2442 cases were between 5 to 10 years, 23%; 2230 cases were over
10 years, 21%.
4. Patient conditions: Fasting blood sugar of 4791 cases was
between 7.8 to 11.1mmol/L (140-200 mg/L), 45.12%; fasting blood
glucoses of 4486 cases were 11.2-16.6mmol/L(200-300mg/dl), 42.25%; fasting blood
sugar of 1341 cases was 16.7 mmol/L (300mg/), 12.63%.
5. The state of using medicine: 1236 cases were confirmed
insulin-dependent patients (IDDM), which was 11.64% of the total.
Among them, 136 of them used insulin more than 50 units every day,
which was 11% of insulin dependent cases. 9832 cases were
non-insulin dependent (NIDDM), which was 88.36% of the total.
Among them, 3046 cases had taken sulfarea drugs, which was 28.69%
of the total. 2395 cases had taken biguanide drugs, which was
22.56% of the total; 3198 cases had taken both drugs, which was
30.12% of the total; 342 cases without taking any drugs. 3.22%;
401 cases had taken other Chinese medicine
such as YU
QUAN WAN, which was 3.78%.
III.
Observation Method
1.
Comparison method. Observe 2 courses of treatment continuously,
each course lasts 2 months.
2. Take YU XIAO SAN 8805, 8 tablets each time, 350mg/tablet, 4
times/day, one hour before each meal and before going to bed, with
water.
3. For patients using antihyperglycemic drugs during the initial
period of YU XIAO SAN 8805 intake, there is no dosage change of
the original insulin injection or oral antihyperglycemic drugs.
After taking YU XIAO SAN 8805, as fasting blood sugar and
2-hour-after-dinner blood sugar recover to normal levels, start
reducing the original drugs (not YU XIAO SAN) one fourth of the
original daily dosage, step by step each week (reduce the dosage
but not the number of intake.) until the dosage reaches zero. As
for insulin dependent diabetics, reduce 2 units of insulin intake
each week, each time step by step, till the number of units reach
zero. If during the reduction blood sugar and urine sugar rebound,
return to the original dosage before the last reduction, until the
blood sugar and urine sugar reach normal level. And then,
continue to reduce the dosage at a slower pace. After taking YU
XIAO SAN 8805 exclusively, if the blood sugar test stays normal
for the next continuous 3 months, YU XIAO SAN 8805 could also be
stopped.
4. BUN Test, C-Ti, insulin release test, pancreatic glucagons
test, sacharogenic hemoglobin test, renal function test, liver
function test, blood rheology test, fasting blood sugar,
2-hour-after-dinner blood sugar, and urine sugar are to be taken
at least once a month before and until four months after taking YU
XIAO SAN 8805.
5. Patients are treated under the conditions of proper diet,
moderate exercises, avoiding anger, exhaustion, and spicy food.
IV.
Measurement of Clinical Result:
A.
Clinical Recovery:
1. Fasting blood sugar is <6.1mmol/L(110mg/L), HbAlc<6.8%
2. Blood lipid is normal
3. Twenty-four hour urine sugar quantity is<5g
4. Clinical symptoms and complications are disappeared
5. Insulin or oral drugs are discontinued completely, for at least
3 months.
B.
Obvious Effect:
1. Fasting blood sugar is <7.8mmol/L(140mg/L), HbAlc<8%
2. Blood lipid is reduced, and cholesterol level is
<5.96mmol/L(230mg/L). Triglyceride <1.47mmol/L(130mg/L)
3. Twenty-four hour urine sugar quantity is <10g
4. Clinical symptoms and complications are significantly reduced.
5. Insulin or oral drugs are partially reduced.
C.
Regular Effect:
1. Fasting blood sugar is <8.9mmol/L(160mg/L), HbAlc<9%
2. Blood lipid is reduced, and cholesterol level is <6.48mmol/L
(250mg/L). Triglyceride< 1.70mmol/L(150mg/L)
3. Clinical symptoms and complications are reduced, or with little
development.
4. Twenty-four hour urine sugar quantity is <15g
5. No decrease of insulin units or oral drugs.
D. No Effect: All indexes have no
inclination of improvement.
V.
Treatment Result
1. In total, 1878 cases were fully recovered, which is 17.69% of
total; 2452 cases had obvious effect, 23.09%; 3979 cases were
effective, 37.47%; 23309 cases had no effect, 21.75%. (see Table
1)
Table
1: Treatment Result of 10618 Cases of Diabetic Patients (NIDDM
& IDDM)
| |
Clinical
Recovery |
Obvious
Effect |
Effect |
No
Effect |
| Cases |
1878 |
2452 |
3979 |
2309 |
| Percentage |
17.69% |
23.09% |
37.47% |
21.75% |
2.
Of 5204 male cases, 921 cases were recovered, which is 17.70%;
obvious effect 1201 cases, 23.08%. 1950 cases were effective,
37.47%. 1132 cases had no effect, 21.75%. Of 5414 female cases,
957 cases were recovered, which is 17.68%; 1251 cases had obvious
effects, 23.11%; 2029 cases were effective, 37.48%; 1177 cases had
no effect, 21.74%. (see Table 2)
Table 2: Relation between Gender and Effect
| |
Clinical
Recovery |
Obvious
Effect |
Effect |
No
Effect |
| Male |
921(17.70%) |
1201(23.08%) |
1950(37.47%) |
1132(21.75%) |
| Female |
957(17.68%) |
1251(23.11%) |
2029(37.47) |
1177(21.74%) |
3. Among 2548 cases whose courses of the disease lasted between 3
months to one year, 570 cases were recovered, which is 22.37%,
obvious effect 667 cases, 26.18%, effect 899 cases, 35.28%, no
effect 412 cases, 16.17%. Among those between 1 year and 5 years,
there were 3398 cases. 672 cases were recovered, which is 19.78%;
863 cases had obvious effect, which is 25.40%; 1300 cases were
effective, 38.26%; 563 cases had no effect, 16.57%. Among those
between 5 year and 10 years, there were 2442 cases, in which 398
cases clinically recovered, which is 16.30%; 539 cases obvious
effect, 22.07%; 949 cases effect, 38.86%; 556 cases no effect,
22.77%. There were 2230 cases whose course of disease were more
than 10 years, among which 238 cases were clinically recovered,
which is 0.67%; 383 cases with obvious effect, 17.17%; 831 cases
were effective, 37.26%; 778 cases with no effect, 34.89%. (see
Table 3)
Table
3:
Relation between Courses of Disease and Curative Effects
| |
Clinical
Recovery |
Obvious
Effect |
Effect |
No
Effect |
| 3-12
months |
570(22.37%) |
667(26.18%) |
899(35.28%) |
412(16.17%) |
| 1-5
years |
672(19.78%) |
863
(25.40%) |
1300(38.26%) |
563(16.57%) |
| 5-10
years |
398(16.30%) |
539(22.07%) |
949(38.86%) |
556(22.77%) |
| >10
years |
238(10.67%) |
383(17.17%) |
831(37.26%) |
778(34.89%) |
4.
Among 1236 IDDM cases, 84 cases were fully recovered, 6.8%; 106
cases had obvious effects, 8.58%; 144 cases were effective,
1165%; 902 cases had no effect, 72.98%. Among 3046 NIDDM cases
administered by Sulfaurea medicine, 557 were cured, 18.29%; 736
had obvious effects, 24.16%; 1478 were effective, 48.52%; 275
had no effect, 9.03%. Among 2395 cases administered by Biguanide
medicine, 575 cases were fully recovered, 24.01%; 647 cases had
obvious effects, 27.01%; 936 cases were effective, 39.08%; 237
cases had no effect, 9.90%. Among 3198 cases combined with both
two types of medicines, 476 were fully recovered, 14.88%; 748
cases had obvious effects, 23.39%; 1109 cases were effective,
34.68%; 865 cases had no effect, 27.05%. Among 401 cases
administered by other Chinese herbs, 96 cases were fully
recovered, 23.94%; 125 cases had obvious effect. 31.17%; 166
cases were effective, 41.4%; 14 cases had no effect, 3.49%.
Among 342 cases that are without the use any medicine, 90 cases
were fully recovered, 26.32%; 90 cases had obvious effects,
26.32%; 146 cases were effective, 42.69%; 16 cases had no
effect, 4.68%. (see Table 4)
Table
4: Effect relation between Type I And Type II
| |
Clinical
Recovery |
Obvious
Effect |
Effect |
No
effect |
Total
Effect |
| Type
I |
84(6.80%) |
106(8.58%) |
144(11.65%) |
902(72.98%) |
27.02% |
| Type
II |
|
|
|
|
85.00% |
| *Sulf |
575(18.29%) |
736(24.16%) |
1478(48.52%) |
275(9.03%) |
|
| *!
*Bigu |
575(23.94%) |
647(27.01%) |
936(39.08%) |
237(9.03%) |
|
| ***Chn |
96(23.94%) |
125(31.17%) |
166(41.40%) |
14(3.49%) |
|
| No
Medicine |
90(26.32%) |
90(26.32%) |
146(42.69%) |
16(4.68%) |
|
*sulf-patients:
patients that take sulfaurea medicine orally
**bigu-patients: patients that take Biguanide medicine orally
***Chn-Patiients: patients that take other Chinese medicine
orally
5. IDDM: Among 136 cases whose daily dosage of Insulin is over
50 units, 5 cases were fully recovered, 3.68%; 7 cases had
obvious effects, 5.15%; 8 cases were effective, 5.88%; 116 cases
had no effect, 85.29%.
Table
5: IDDM Patients With Insulin Daily Dosage Over 50 Unites
| Clinical Recovery |
Obvious
Effect |
Effect |
No
effect |
Total
effect |
| 5(3.68%) |
7(5.15%) |
8(5.88%) |
116(85.29%) |
14.71% |
6.
Changes of blood sugar, blood insulin and blood pancreatic
glucagons. Blood sugar and pancreatic glucagon reduced
significantly after the treatment. It proves "YU XIAO SAN
8805" can reduce blood sugar level significantly. (see
Table 6)
Table 6: Comparison Blood Insulin, Glucose and Glucagon
Before and After the Treatment
| |
Glucose
(mmol/L) |
Insulin
(uu/ml) |
Glucagon
(Pg/ml) |
| Before |
13.41+-2.11 |
8.81+-1.51 |
133.59+-25.85 |
| After |
7.51**+-0.83 |
10.20*+-2.03 |
82.41**+-21.31 |
| |
*p<0.05
**p<0.001 |
|
|
7. Blood
lipid and rheology. cholesterol, triglyceride reduced
significantly (p<0.001). Blood viscosity, plasma viscosity,
PCV, and hemomcyte electrophoresis time reduced obviously.
(p<0.01), Blood sedimentation equation K went down
significantly. (p<0.01). Fibrinogen decreased. It indicates
blood viscosity lowered accordingly.
Table 7: Comparison blood lipid and blood rheology before and
after the treatment
| |
Cholesterol |
Triglyceride |
Blood
Viscosity |
Plasma
Viscosity |
HET |
PCV |
Blood
Sedimentation |
K
Fibrinogen |
| |
mmol/L |
mmol/L |
ratio |
ratio |
mm/s |
m% |
ratio |
g/u |
| Before |
6.52+-0.57 |
1.86+-0.15 |
4.90+-0.79 |
1.87+-0.15 |
19.74+-
0.88 |
47.64+-
0.83 |
43.72+-9.33 |
4.44+-0.29 |
| After |
5.04+-0.39 |
1.13+-0.35 |
33.98+-0.66 |
1.64+-0.15 |
16.45+-
0.55 |
46.65+-
0.89
| 37.71+-7.56 |
4.26+-0.24 |
Note:
The above data are kindly provided by corporate units.
VI. CONCLUSION
The
results of clinical and laboratorial (animal test) research
indicate:
1.
YU XIAO SAN 8805 can improve function of the pancreas,
increasing the secretion of insulin and decreasing blood sugar.
Meanwhile, it can decrease blood lipid that is similar to the
finding of the laboratory report of Stanford University Medical
School of YU XIAO SAN 8805.
2. The effective rate of YU XIAO SAN 8805 for IDDM is 27.02%, in
which, among the patients who were followed for at last six
months after the experiment, 6.8% no longer use insulin. 8.85%
of the patients decreased their insulin intake dosage, showing
the increased function of the pancreas. 11.65% patients'
symptoms lessened notably.
3. The effective rate of YU XIAO SAN 8805 for NIDDM is 85%.
Among the 8639 patients who took western medicines, 1608
patients stopped taking western medicine, which is 18.61%
of the total; 2131 patients reduce the intake dosage of western
medicine, 24.67%; 3523 patients' symptoms lessened, 40.78%.
Therefore, YU XIAO SAN 8805 is effective on patients taking
either Sulfured or Biguanide type of medicine. It is also
effective even on patients who failed to react on western
medicines. It is clear to us that the mechanism of YU XIAO SAN
is different from that of the western medicine.
4. YU XIAO SAN 8805 can improve symptoms for those who took
western medicine (Sulfurea and Biguanide) without any side
effects. The effective rate has no relation with the gender or
age but with the length of the disease and degree of the
complications.
5. YU XIAO SAN 8805 showed effects to NIDDM patiens. For
patients whose insulin daily dosage of over 50 units, 3.68% of
them were recovered, 5.15% of them decreased the dosage of
insulin intake, and 5.88% of their blood sugar was lower. The
mechanism of this phenomenon needs further study.
6. YU XIAO SAN 8805's effect of reducing blood sugar and lipid
level is superior than other Chinese medicines that are
currently under use (for example, YU QUAN WAN, which is produced
in BEIJING and SICHUAN). If patients took decoction prescribed
using traditional Chinese medicinal theory based on YU XIAO SAN
8805, the effective rate reached to 95.96%. This is the symbol
that YU XIAO SAN 8805 could be improved from its present form
and extraction.
7. Clinical observations show that YU XIAO SAN 8805 reduced
blood lipid, decreased blood viscosity, promoted blood
circulation and abated and prevented symptoms and complications.
8. The bile is an essential organ for producing insulin. YU XIAO
SAN 8805 is composed of the herbs which can stimulate the
secretion of the bile, thus the increase of the secretion of
insulin is important during the course of blood sugar reduction.
9. During analysis of the YU XIAO SAN 8805, minor essential
mineral traces had been found. The relation between essential
mineral traces and herbs should be considered.
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