Treatment effect observation
report of Jiajun Hypertension Depressor
I. Target Observe
and evaluate the precise treatment effect of Jiajun hypertension depressor,
Including instant blood pressure degrading and the blood pressure status
after one month. The evaluation is emphasized in the treatment effect
of instant blood pressure degrading of Jiajun hypertension depressor.
II. Solution
1. Observation We arranged
two groups for observation. We chose 120 diagnosed hypertension patients from
Beijing TianTan Hospital, Beijing No. 4 Hospital, and the Hypertension
Administration Committee of ChongWen district Stadium Road Hospital and
arranged them to the two groups, 60 persons in each group. One is the
observation group, the other is the comparison group. The standard of
our choose of the patients are: Volunteers, with SBP >=160mmHg, and/or
DBP >=95mmHg, no obvious syndrome of heart, brain, and kidney.
2. Patients to be observed
Among the 120 diagnosed hypertensives male are 53 persons, and female
67 persons. The average age is 66.61+-8.64 years old. (M+-SD) The average
ill history of hypertension is 17.08+-11.02 years (M+-SD). The general
introduction of the observation group and the comparison group see Table
1. The sex and age composition of the two groups are comparable.
Table 1. General introduction
of observation group and comparison group
|
|
Observation group
|
Comparison group
|
|
Numbers (person)
|
60
|
60
|
|
Male (%)
|
27(45.0%)
|
26(43.3%)
|
|
Female (%)
|
33(55%)
|
34(56.7%)
|
|
Age (year)
|
65.98+-9.11
|
67.23+-8.17
|
|
Ill history of hypertension
(year)
|
17.82+-11.31
|
16.35+-10.76
|
|
Medication intake in
recent two months:
|
|
|
|
Ever taken medication
of BP
|
57
|
52
|
|
Never taken medication
of BP
|
3
|
8
|
3. Training and quality control
Before observation, we trained the 11
observers (already trained in blood pressure measure for many times) in
the scheduled observation target, operation and performance of mercury
blood pressure meter, and operation and performance of Jiajun hypertension
depressor. Of the 11 observers, 3 came from Beijing TianTan Hospital,
5 from Beijing No.4 Hospital, 3 from ChongWen district Stadium Road Hospital.
And 5 quality control personals from Beijing Neurosurgery Research Institute
carried on the overall quality control during the complete performance.
4. Blood pressure observation
Blood pressure observation took 4 weeks.
On every Tuesday or Wednesday we conducted one inspection between 9:00am
to 11:00am as scheduled. For the members of observation group it is supposed
to take a rest of 5 - 10 minutes in peaceful status before treatment.
Their blood pressure is measured twice professionally and noted down afterwards,
and then the patients start the treatment with Jiajun hypertension depressor
as required. After the treatment the patients are supposed to relax totally
and sit calmly for 5 - 10 minutes, and again their blood pressure is measured
twice and noted down. The members of comparison group are not required
to use Jiajun hypertension depressor for treatment. Their blood pressure
is also measured twice after a rest of 5 - 10 minutes. The members of
observation group take the device home and do the treatment as required
for 3 - 5 times every day. All members of observation group are not supposed
to intake blood pressure degrading medication within 6 - 8 hours before
treatment in the inspection days.
5. Operation of Jiajun hypertension depressor
5.1) Head comb: Hold the metal ring at the back of the device with one
hand, and apply the three groups of metal pins tightly on the forehead
of the patient with proper pressure, and comb in the middle upwards at
the even speed of 1 - 2 times per minute and down the back of head. One
treatment takes 3 - 5 minutes.
5.2) Hand touch: Hold the metal ring at the
back of the device with one hand, and open the other hand naturally. Apply
the tops of the three groups of metal pins against the paunch of fingertips tightly and hold for 3 - 5 minutes.
Either of the above two methods can be used,
but better not to use them in turn, and the treatment should be taken
every day. The observer is responsible to direct the patients to use the
device correctly.
Of the 60 patients of the observation group,
35 persons chose the method of head comb, which takes 58.3% of the total
members, and 24 chose the method of hand touch, which takes 40.0%. One
person chose both methods of head comb and hand touch, which takes 1.7%.
III. Results
1. It is observed the obvious difference of
blood pressure levels (P<0.01) of both SBP and DBP measured before and
after treatment with Jiajun hypertension depressor, and in the initial
measured group, 1st inspection group and the total group. See Table 2.
2. Comparing observation group with comparison
group, it is found that there is no obvious difference of both SBP and
DBP in different groups except SBP in the first inspection. But the blood
pressure degrading of both SBP and DBP of the observation group is more
than comparison group, comparing the forth inspection with the initial
measured. Details see Table
3. The blood pressure of observation group
measured in the last inspection in comparison with those measured initially,
SBP degrades 9.83mmHg and DBP degrades 8.41mmHg. For the comparison group
the degrading of SBP and DBP is respectively 5.77mmHg and 7.84mmHg.
Table 2. Blood pressure levels of observation
group measured before and after treatment
|
SBP (mmHg) |
|
DBP (mmHg) |
|
|
Before treatment |
After treatment |
Before treatment |
After treatment |
| Initial measured |
170.93+-15.20 |
164.35+-17.93** |
94.13+-8.93 |
89.77+-8.63** |
| 1st inspect measured |
161.42+-18.86 |
155.27+-19.80** |
89.82+-9.36 |
86.37+-8.92** |
| 2nd inspect measured |
169.63+-53.28 |
154.48+-18.57* |
86.92+-13.69 |
85.68+-9.47 |
| 3rd inspect measured |
165.68+-48.06 |
154.95+-18.11 |
88.17+-10.77 |
86.43+-9.56 |
| 4th inspect measured |
161.10+-40.28 |
153.73+-18.78 |
85.72+-12.30 |
84.27+-10.22 |
| Total |
165.75+-38.32 |
156.56+-18.96** |
88.95+-11.46 |
86.50+-9.49** |
Note: * P<0.05; ** P<0.01
3. Comparing the BP measured before inspections
and after the last treatments, the BPs have certain upgrades, except the
SBP measured before 1st inspection and the DBP measured before 4th inspection,
but no difference. Details see Table 4.
Table 4. Blood pressure of observation group
measured before 1st inspection and after treatment
|
SBP (mmHg) |
DBP (mmHg) |
| BP after
initial treatment |
164.35+-17.93 |
89.77+-8.63 |
| BP before
1st inspect |
161.42+-18.861 |
89.82+-9.36 |
| BP after 1st inspect |
155.27+-19.89 |
86.37+-8.92 |
| BP before 2nd inspect |
169.63+-53.28 |
86.92+-13.69 |
| BP after 2nd inspect |
154.48+-18.57 |
85.68+-9.47 |
| BP before 3rd inspect |
165.68+-48.06 |
88.17+-10.77 |
| BP after 3rd inspect |
154.95+-18.11 |
86.43+-9.56 |
| BP before 4th inspect |
161.10+-40.28 |
85.72+-12.30 |
4. Intakes of blood pressure degrading
medication
During the observation, majority of the patients were taking blood pressure
degrading medication, except 5 persons in observation group and 3 persons
in comparison group. There is no obvious difference in both observation
group and comparison group among the patients who increased, or made no
change, or decreased the medication dosage, or stopped or changed the
medication. Details see Table 5 and Table 6
Table 5. Medication intakes of observation
group
|
Dosage
Increased
Person(%) |
Dosage
no change
Person(%) |
Dosage
Decreased
Person(%) |
Medication
Stopped
Person(%) |
Medication
changed
Person(%) |
Medication
never taken
Person(%) |
| 1st
week |
/ |
46(76.7%) |
4(6.7%) |
3(5.0%) |
2(3.3%) |
5(8.3%) |
| 2nd week |
3(5.0%) |
46(76.7%) |
4(6.7%) |
/ |
2(3.3%) |
5(8.3%) |
| 3rd week |
5(8.3%) |
45(75.0%) |
2(3.3%) |
1(1.7%) |
2(3.3%) |
5(8.3%) |
| 4th week |
3(5.0%) |
48(80.0%) |
1(1.7%) |
1(1.7%) |
2(3.3%) |
5(8.3%) |
Table 6. Midication intakes of comparison
group
| |
Dosage
Increased
Person(%) |
Dosage
no change
Person(%) |
Dosage
Decreased
Person(%) |
Medication
Stopped
Person(%) |
Medication
changed
Person(%) |
Medication
never taken
Person(%) |
| 1st week |
1(1.7%) |
53(88.3%) |
3(5.0%) |
/ |
/ |
3(5.0%) |
| 2nd week |
1(1.7%) |
53(88.3%) |
1(1.7%) |
/ |
2(3.3%) |
3(5.0%) |
| 3rd week |
1(1.7%) |
56(93.3%) |
/ |
/ |
/ |
3(5.0%) |
| 4th week |
1(1.7%) |
53(88.3%) |
/ |
3(5.0%) |
/ |
3(5.0%) |
IV. Summary Our observation demonstrates that Jiajun hypertension depressor
has obvious treatment effect of instant blood pressure degrading, and
the treatment effect lasts long. Jiajun hypertension depressor, as a no wound,
no obvious side effect, assistant blood pressure degrading device, can
be promoted in more people.
Medicine Department of Science
&
Technology Development Center
Of China Health Ministry
Nov. 1998
|
National Cerebrovascular Disease
Prevention and Treatment Research Office
Beijing Neurosurgery Research Institute
Nov. 1998 |
Clinic Report (2)
Observation of 611 treatment cases
with Jiajun hypertension depressor
In order to observe the treatment
effect of Jiajun hypertension depressor, which is produced under the supervision
of China Rural Hygiene Association, we conducted continuous treatment observation
to 611 cases of hypertension for a period of 4 weeks. Our summary:
1. Patients to be observed We chose 611 hypertensives
according to WHO 1978 hypertension diagnostic standard, among whom 330
are male, 281 female. Stage I hypertensive 333 persons, Stage II hypertensive
228 persons, Stage III hypertensive 33 persons, critical hypertensive
11 persons, and low blood pressure patient 6 persons. The ages are between
20 to 86 years old, and 53 years old in average. See Table 1 and Table
2.
Table 1. Groups in age
| Age |
20 up |
30 up |
40 up |
50 up |
60 up |
70 up |
80 up |
| Case |
3 |
47 |
187 |
197 |
139 |
34 |
4 |
Table 2. History of illness
| Year |
Less than 2 |
3-5 |
6-10 |
11-15 |
Over 15 |
| Case |
110 |
227 |
136 |
57 |
81 |
2. Observation
Patients use Jiajun hypertension depressor twice a day, 2 - 3 minutes
each time. When using the device, patients must grasp the metal ring with
fingers at the back of the device, and the optimum frequency of combing
is 1 (one) time in a minute, moving from forehead upwards and down at
the back. The metal pins should not be pressed hard against the skin to
avoid hurting. In case the patient is helped by somebody, the helper should
take the patient's hand in one hand, and do the performance as mentioned
above with the other hand. On Monday, Wednesday and Friday, in the morning
and in the afternoon, before treatment and at the peaceful status, the
patients' blood pressure is measured twice and the average value is taken.
Again 3 - 5 minutes after the treatment the patients' blood pressure is
measured twice and the average value is taken. The treatment effect is
observed in this way and the performance is done by specially assigned
people.
3. Judgment of treatment effect
3.1) The treatment effect after first week see Table 3 and Table 4.
Table 3. SBP treatment effect
Patients' status
of Hypertension |
Stage I |
Stage II |
Stage III |
Critical |
Total |
|
2 |
45 |
31 |
7 |
|
83 |
Blood
|
3-5 |
87 |
52 |
7 |
1 |
147 |
| Pressure |
6-10 |
105 |
73 |
10 |
|
188 |
| Degrade |
11-15 |
44 |
28 |
3 |
1 |
76 |
|
16-20 |
11 |
10 |
2 |
|
23 |
| mmHg |
21-30 |
5 |
3 |
3 |
|
11 |
| Total |
297 |
197 |
32 |
2 |
528 cases |
Altogether 528 patients have got their blood
pressure degraded after using the device, among whom Stage I patient are
297 persons, Stage II 197 persons, Stage III 32 persons, and critical
2 persons. The degrade of SBP takes 88.44%, the degrade range from 1 -
10mmHg takes 79.2%, the degrade range over 11mmHg takes 20.8%.
3.2) Table 4. DBP treatment effect
Patients' status
of Hypertension |
Stage I |
Stage II |
Stage III |
Critical |
Total |
|
1 - 2 |
80 |
57 |
8 |
|
145 |
Blood
|
3 - 5 |
119 |
81 |
7 |
2 |
209 |
| Pressure |
6 - 10 |
74 |
47 |
11 |
|
132 |
| Degrade |
11 - 15 |
9 |
7 |
|
|
16 |
| (mmHg) |
16 - up |
1 |
|
1 |
|
2 |
| Total |
283 |
192 |
27 |
2 |
504 cases |
Altogether 504 cases of DBP degrade
are observed after using the device, and it takes 84.4%. Among the
504 cases degrade range from 1 - 10mmHg takes 96.4%, and degrade
range from 11 - 22 up mmHg takes 3.6%.
The treatment effect after forth week
see Table 5 and Table 6.
3.3) Table 5. SBP treatment effect
Patients'
status
of Hypertension |
Stage I |
Stage II |
Stage III |
Critical
|
Total |
Blood
|
2 |
38 |
22 |
5 |
|
65 |
| Pressure |
3-5 |
105 |
59 |
4 |
1 |
159 |
| Degrade |
6-10 |
69 |
76 |
13 |
1 |
16 9 |
|
11-15 |
37 |
19 |
3 |
1 |
60 |
| mmHg |
16-20 |
4 |
7 |
|
|
11 |
| Total |
253 |
185 |
25 |
3 |
466 cases |
3.4) Table 6. DBP treatment effect
Patients'
status
of Hypertension |
Stage I |
Stage II |
Stage III |
Critical
|
Total |
Blood
|
2 |
61 |
57 |
7 |
1 |
126 |
| Pressure |
3-5 |
119 |
69 |
8 |
1 |
197 |
| Degrade |
6-10 |
58 |
37 |
7 |
|
102 |
|
11-15 |
1 |
1 |
1 |
|
3 |
| mmHg |
|
|
|
|
|
|
| Total |
239 |
164 |
23 |
2 |
428 cases |
It is observed:
In the forth week SBP keeping going
down are 466 persons, among whom Stage I are 253 persons, Stage
II are 185 persons, Stage III are 25 persons, critical are 3 persons.
The blood pressure degrade rate takes 88.1%, among whom SBP degrade
from 1 - 10mmHg takes 84.3%, from 11 - 20mmHg takes 5.2%, down from
20mmHg takes 0.5%.
In the forth week DBP keeping going
down are 428 persons, among whom Stage I are 239 persons, Stage
II are 164 persons, Stage III are 23 persons, Critical are 2 persons.
The blood pressure degrade rate takes 80.91%, among whom DBP degrade
from 1 - 10mmHg takes 99.3%, down from 10mm Hg takes 0.7%.
3.5) Table 7.
The blood pressure measured before and
after the first treatment with the device, and measured before and
after the last treatment with the device after 4 weeks, are averaged
as below:
| Time |
Before treatment |
After treatment |
| First week |
|
BP average
(mmHg)
|
Difference to
standard |
BP average
(mmHg) |
Difference to
standard |
|
SBP |
152.70 |
17.49 |
146.41 |
17.55 |
|
DBP |
95.10 |
10.60 |
91.43 |
10.58 |
| Last week |
SBP |
145.29 |
14.46 |
140.19 |
14.16 |
|
DBP |
90.33 |
8.60 |
87.38 |
8.38 |
3.6) Among the 611 cases 605 are high
blood pressure patients, and 6 are low blood pressure patients.
After treatment with the device, the SBP and DBP of the low blood
pressure patients all rise to certain extent, among whom 2 patients
got their SBP rising 10mmHg, and 2 patients rising 8 mmHg, the other
2 patients got no obvious change in SBP. Meanwhile all 6 patients
got their DBP rising, ranging from 2 - 10 mmHg.
4. Summary
The data obtained in 4 weeks demonstrates
that:
4.1) Using Jiajun hypertension depressor
can bring down high blood pressure in 3 - 5 minutes, and the degrading
of BP is smooth. That is in average SBP degrades 7.3mmHg, and DBP
degrades 7.4mmHg.
4.2) The blood pressure average value
before the first treatment and after the last treatment indicates
degrade of 12.51mmHg in SBP, and 7.72mmHg in DBP.
4.3) After 4 weeks, BP degrade can still
be observed. In terms of the whole observation period (over 4 weeks),
the BP average taken after the last treatment also indicates degrade
in comparison with the BP average taken before the first treatment.
That is 7.41mmHg in SBP, and 4.77mmHg in DBP.
4.4) Jiajun hypertension depressor also
has good treatment effect to low blood pressure patients.
4.5) This product has its value to be
used and promoted in the people of hypertension for prevention
and treatment of high blood pressure.
Beijing Cerebrovascular Disease
Prevention and Treatment Office
Jan. 6, 1995 |
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