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ABSTRACT
Objective
In order to study the effect of long-term and safety with treatment
of Xuezhikang, 38 patients with hyperlipidemia, after taking it
for 24 weeks, the level of lipid and safety index were monitored.
After 24 weeks of treatment TC decreased by 20.0%, LDL-c decreased
by 27.2%, TG decreased by 31.6%, and HDL-c increased by 15.7%. The
above-mentioned various criteria were significantly different as
compared with that of pretreatment (P<0.001-0.01). After 24 weeks
of medication, body weight(BW), blood pressure(BP), EKG, ALT, CK,
BUN, Cr, BS and etc. of the patient, has no significant difference
as compared with that of pretreatment (P>0.05). The drug can
be tolerated and no evident side effect observed, indicated that
received Xuezhikang over half a year, the curative effect is not
only obvious, stable, and also without toxic effects.
Key Words
Xuezhikang, Total Cholesterol (TC), low density lipoprotein
(LDL), triglyceride (TG)
INTRODUCTION
Xuezhikang is a lipid-adjusting medicines , rich in composition
of HMG-CoA reductase inhibitors and multiple kinds of essential
amino acids and unsaturated fatty acids, manufactured with modern
biotechnology and refinement by the WBL Peking University Biotech
Co.Ltd, from the red yeast rice. In order to further to make clear
the effect of long-term treatment and the safety of Xuezhikang,
we adopted Xuezhikang curing 38 patients with hyperlipidemia since
October in 1997 to April in 1998, and observed its clinical efficacy.
The report is as follows:
OBJECT
AND METHOD
Selection
of Patients
Hyperlipidemic patients in out-patient clinic (OPD) or on
admission, through the dietary propaganda and education for 2-4
weeks, and take samples of blood twice within 2-4 weeks, check serum
total cholesterol (TC) still =5.95mmol/L (230mg/dl) and/or triglyceride(TG)
between in =2.26-4.52mmol/L(=200 - =400mg/dl). Among them 38 cases
were selected, and excluded from this in case of follow condition:
(1) within the last 6 months had suffered from myocardial infarction,
stroke, severe trauma or major surgery; (2) nephrotic syndrome,
hypothyroidism, acute or chronic hepatobiliary disorders, diabetes
mellitus (DM) or gout; (3) Homozygote familial hypercholesterolemia;
(4) Drug induced hyperlipemia (such as phenothiazine, beta-blocking
agent, adrenocortical steroid, and some contraceptives and etc.);
(5) Took depo-heparin, anti-thyroid and other preparations that
influencing the metabolism of blood lipid, and other measurement
for suppressing the lipid within recent 4 weeks; (6) The age of
patient is under 18 years old; (7) gravida and women in lactation;
(8) patients with irritability physique and metal diseases; (9)
complicated with other severe diseases and conditions admitted unsuitable
for trial by physician. 38 cases were selected, 25 male and 13 female.
Age range was 40 to 82 years and average 61 years old. 11 patients
were complicated with CHD, 15 with hypertension, 1 with DM and 4
with others.
Method of Observation
All of the selected 38 patients, took Xuezhikang 2 capsule (0.6g)
each time, twice a day, 24 weeks for a course. During observation,
maintained the similar diet and living style and medication as same
as that before the trial. Reserve the original treatment for hypertension,
CHD, basically maintained the dosage and method of medication as
before, and no other drugs influencing the metabolism of blood lipid.
Before and at end of the 8th,16th,and 24th weeks after the treatment,
patients were followed up in OPD, included symptoms taking, examine
body weight, BP, heart rate, cardiac rhythm, liver and spleen palpation,
and EKG, laboratory examination of lipid, routine of blood and urine,
BS, BUN, Cr, ALT, CK.
- Blood
Lipid Assay
Prohibit drinking and do not take high fat diet during the last
dinner before drawing blood; take samples of venous blood after
fasting for at least 12 hours on an empty stomach, separate blood
serum promptly, to examine TC, TG and HDL-c in the special laboratory,
where are under strict quality control.
- Evaluation
of Curative Effect
Evaluation is curative effect is according to the "Clinical
Research Guidance Principle on Cardiovascular Drug" by the
Ministry of Health in 1988. Evident Effects: TC decreased =20%;
TG decreased =40%; HDL-C increased=20%, respectively. Effective:
TC decreased =10%-20%; TG decreased =20%-40%; HDL-C increased
=0.10-0.26mmol/L. Invalid: did not reach the above-mentioned effective
level. Worsen: TC increased =10%; TG increased =10%; HDL-C decreased
=0.10mmol/L.
- Statistical
Processing
The level of blood lipid and safety index were analyzed with t
test, and individual effective were analyzed with chi-square test,
and parameter was shown with mean value ± standard deviation
(x±S).
RESULTS
Changes
of level of lipid before and after treatment
38
patients with hyperlipidemia, taking Xuezhikang before and after
8, 16,24 week, changes of various criteria of lipid were analyzed
and the result are shown in Table 1. There are no evident contrast
difference (p>0.05) at various time during the treatment, indicated
the stability of curing with Xuezhikang.
| Table
I. Statistical Table of Effect Before and After Taking Xuezhikang |
|
|
Pre-treatment
|
Changes
after treatment
|
|
Criterion
|
Case
|
(mg/dl)
|
8W
(%)
|
16W(%)
|
24(%)
|
| TC |
35
|
273.4±34.6
|
-19.2
|
-18.1
|
-20.0
|
| LDL-C |
38
|
185.9±38.4
|
-27.6
|
-25.5
|
-27.2
|
| TG |
21
|
369.0±234.1
|
-27.0
|
-29.4
|
-31.6
|
| HDL-C |
26
|
35.2±5.5
|
+15.2
|
+15.6
|
+15.7
|
| (TC-HDLc)/HDL-C |
26
|
35.2±5.5
|
-31.8
|
-33.2
|
-35.0
|
Individual effect: After half a year treated with Xuezhikang, individual
effect of amelioration lipid is shown in Table II.
| Table
II. Table of Individual Effect After 24 Weeks Teatment of Xuezhikang |
| Criterion |
Case |
Highly
Effective |
Effective |
No
Effective |
Worsen |
Total
Effective |
| |
|
n |
% |
n |
% |
n |
% |
n |
% |
|
| TC |
35 |
16 |
45.7 |
12 |
34.3 |
7 |
20.0 |
0 |
- |
80.0 |
| TG |
21 |
6
|
28.6 |
8
|
38.1 |
6 |
28.6 |
1 |
4.7 |
66.7 |
| HDL-C |
26 |
4 |
15.4 |
12 |
46.1 |
10 |
38.5 |
0
|
- |
61.5 |
Detection of safety criteria is shown as Table
III
| Table
III. Detection of Safety After 24 Weeks Treatment of Xuezhiknag
(X±S) |
|
Criteria
|
Case
|
Pre-treatment
|
After
Half Year
|
| ALT(U/L)
|
38
|
25.8±13.2
|
26.3±11.8
|
| CK(U/L)
|
38
|
111.7±38.3
|
103.9±29.5
|
| BUN(mg/dL) |
38
|
16.9±4.5
|
16.5±4.2
|
| Cr(mg/dL) |
38
|
1.04±0.27
|
1.05±0.27
|
| BS(mg/dL) |
38
|
101.4±15.4
|
98.7±20.1
|
Improvement
of Symptoms
11 patients had oppressive feeling over the chest, among them 5
cases released; 7 had shortness of breath, among them 4 disappeared;
5 had inertia, 3 recovered.
Side effects
Among 38 patients, 3 had transient abdominal distention during the
treatment, 2 gastric upset and mild nausea. There were no other
abnormal changes on physical and laboratory examinations observed.
DISCUSSION
Clinical
studies have been proved that many treatments for lipid-adjusting
are effective, which can slow down the progression of coronary atherosclerosis
and inhibit the atherosclerotic plaque formation, to decrease the
incidence of coronary heart disease (CHD) and myocardial infarction,
as well as the requirement to perform coronary artery bypass grafting
(CABG) and percutaneous transluminal coronary angioplasty (PTCA).
The pharmacological experiment proved that Xuezhikang not only can
decrease obviously the TC and TG on animal experiment (in rabbit
and quail), but also inhibit atherosclerotic plaque formation and
lipid deposition in liver. Through observing clinical effect and
safety, 38 patients with primary hyperlipidemia, taking Xuezhikang
for 24 weeks, the results indicated that Xuezhikang is an effective,
stable and safe lipid modulator of domestic production, there are
no significant remarkable difference between short-term and long-term
treatment in efficiency, all are benefit on adjustment.
REFERENCES
|
1.
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Zhuyan,
Li hangling, Wang Yinye. Effect of lipid-adjusting on rabbit
and quail with Xuezhikang. Chin Pharm J 1995; 30:656 |
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