-Capital Medicine 1999. Vol.6, No.4-

Observation of Effect and Safety Of Xuezhikang

Quyan, Wanghua, Huangmin et al.
The 2nd Affiliated Hospital, HuBei Medical University

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 (xS).

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
273.434.6
-19.2
-18.1
-20.0
LDL-C
38
185.938.4
-27.6
-25.5
-27.2
TG
21
369.0234.1
-27.0
-29.4
-31.6
HDL-C
26
35.25.5
+15.2
+15.6
+15.7
(TC-HDLc)/HDL-C
26
35.25.5
-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 (XS)
Criteria
Case
Pre-treatment
After Half Year
ALT(U/L)
38
25.813.2
26.311.8
CK(U/L)
38
111.738.3
103.929.5
BUN(mg/dL)
38
16.94.5
16.54.2
Cr(mg/dL)
38
1.040.27
1.050.27
BS(mg/dL)
38
101.415.4
98.720.1

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.
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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