ABSTRACT

[Objective]: To investigate effect and toxic or side-effect of Xuezhikang, ZOCOR (Simvastatin) and Gangdejian. Method: 158 patients were divided into three groups treated by the above three medicines respectively. Then liver function, levels of serum TC, TG, LDL-C, HDL-C and liver morphological change tested by B-ultrasound are observed in patients before and after the treatment. Results: After 6 months treatment, total efficacy of Xuezhikang reached 90.77%, total efficacy of Simvastatin reached 66.67% and that of Gandejian 52.08%. Conclusion: Xuezhikang had the capacity in lowering blood lipid level and inhibiting the formation of fatty liver. And its effect was superior to Simvastatin and Gandejian, whereas the latter two nearly performed the same. Therefore, Xuezhikang could be used as a new medicine for fatty liver patients.
[Key word]: Xuezhikang, fatty liver effect

PATIENTS AND METHODS

Selection of Patients

• Diagnosis criteria for fatty liver:
  Clinically weakness, fatness and hepatomegaly.
• Slight elevation of ALA, the increase of serum TC, TG, LDL-C and decrease of HDL-C.
• B-ultrasound and CT shows: hepatomegaly, degradation or decline of later liver-wave. B-ultrasound or CT shows were quite sensitive to fatty liver. And the diagnosis of fatty liver occurred when patients meeting the above third standard, with or without the first and/or second standard. All 158 patients in this study met diagnosis criteria with 92 male and 66 female, age from 18 to 65 years old and the average of 32.5 ± 18.8. 65 cases received Xuezhikang treatment, 45 cases got Simvastatin treatment and 48 cases obtained Gandejian treatment. Every case in the three group was comparable in terms of gender, age, state of illness and course of disease (P > 0.05).

Methods
Patients in Xuezhikang group took 0.6g each time and twice a day. Xuezhikang was manufactured by WBL Peking University Biotech Limited Company. Patients in Simvastatin group took 10 mg such agent every evening. Simvastatin is the product of Moshadone China Co. Ltd. Whereas Patients in Gandejian group took Gandejian two tablets a time twice a day. Gandejian is a product of Ronald Plank¾Loann Company of Germany. Every patient in the above groups was provided with routine liver care within 6 months treatment. Post-treatment investigations or follow-up visits were carried out for 3 ~ 6 months. Venous blood samples were taken in the morning on fasting patients before the treatment, and 8 weeks, 16 weeks and 24 weeks after the treatment in order to test concentrations of serum TC, TG (using enzyme method, reagent from German BecMan Co.) HDL-C and LDL-C (immune covering method, reagent from Japan No.1 Chemical Company) and determine ALT, AST, GLB and SB (using Monarch plus automatic biochemical analyzer).

Effects on Weak, Overweight and Hepatomegaly Patients
After 24-week treatment, 59 cases (90.77%) in Xuezhikang group, 15 cases (33.33%) in Simvastatin group, and 21 in Gandejian group (43.75%) had recovered from the symptoms of weakness, overweight and hepatauxe. Inter-group data possessed significant differences in terms of statistics (P < 0.05). This showed a good performance of Xuezhikang in reducing body weight, eliminating weakness and improving hepatauxe

Effects on ALT
After 24-week treatment, 62 cases (95.38%) in Xuezhikang group, 40 cases (88.89%) in Simvastatin group, and 43 cases in Gandejian group (89.58%) obtained normal ALT. Inter-group data had no significant differences in statistical analysis. This means that common liver treatment plays a certain role in curing fatty liver ALT but has little influence on lipid regulating agent.

Effects on Blood Lipid
After 24-week treatment, some effects occurred in reducing serum TC, TG and elevating HDL-C level. Xuezhikang and Simvastatin performed better than Gandejian in declining serum TC and TG. However, total efficacy of Xuezhikang and Gandejian appeared lower than Simvastatin in elevating HDL-C level. ( Table I).

Effect on TG reduction: total sample comparison c2 = 33.64, P < 0.001. Xuezhikang group compared with Simvastatin group c2 = 1.32, P > 0.05. The comparison between Xuezhikang and Gandejian group, c2 = 6.89, P < 0.05. Whereas c2 = 6.79, and P < 0.05 appeared between Simvastatin and Gandejian group.

Effect on HDL elevation: total sample comparison c2 = 5.69, P > 0.05. Xuezhikang group compares with Simvastatin group c2 = 10.56, P < 0.01. The comparison between Xuezhikang and Gandejian group, c2 = 1.13, P > 0.05. Whereas c2 = 25.11, and P < 0.001 occurred between Simvastatin and Gandejian group. re

Impact on B-ultrasound Morphology

In three group comparison, X2 = 58.14, P < 0.001.
Xuezhikang group compared with Simvastatin group, c2 = 37.73, P < 0.001.
Xuezhikang group compared with Gandejian group, c2 = 39.55, P < 0.001.
Simvastatin group compared with Gandejian group, c2 = 1.86, P > 0.05.
Patients treated with Xuezhikang perform better in the recovery of B-ultrasound hepatauxe and latter half liver-wave decline compared with other two medicines.

Effects on Fatty Liver
After 6 months treatment, 59 cases (90.77%) obtained curative effect, with 53 cases (81.54%) were highly effective, 6 (9.23%) effective and 6 (9.23%) ineffective in fatty liver cure in Xuezhikang group. In Simvastatin group, 30 cases (66.67%) obtained curative effect with 10 patients (22.22%) being highly effective, 20 (44.45%) effective and 15 (33.33%) ineffective. Meanwhile, all together 25 patients got effect in Gandejian group with 10 cases (20.83%) acquiring distinct effect, 15 cases (31.25%) effective and 23 cases (47.92%) ineffective. Statistic analysis indicated P < 0.001 for data between Xuezhikang group and other two groups illustrating a better effect of Xuezhikang than that of Simvastatin and Gandejian. Whereas there were no significant difference between Simvastatin and Gandejian groups (P > 0.05). Simvastatin and Gandejian had similar effect but slightly poorer than Xuezhikang.

Side-Effects
During Xuezhikang treatment, only one case had single ALT 92 mmol/L. Re-examination showed a regular ALT level after 1 month administration of smaller doage. There were also three cases of slight stomach trouble. In Simvastatin group, 3 cases had slight elevation of ALT. But no toxic and side-effects occurred in Gandejian group.


DISCUSSION

Xuezhikang and Simvastatin perform better than Gandejian in regulating lipid. As for the improvement of B-ultrasound fatty liver morphology, Xuezhikang was obviously superior to both Simvastatin and Gandejian. In the treatment of fatty liver, all three medicines acquired some curative effects. But Xuezhikang had much higher efficacy rate than that of Simvastatin and Gandejian. Moreover, the ineffective cases in Xuezhikang group were mainly climacteric women. It is assumed that fatty liver of those women may have something to do with dysfunctions of estrogenic hormone secretion. Thus, the author thinks that curative effect could be improved during Xuezhikang treatment if some estrogenic hormone medicines are employed at the same time.

Xuezhikang is manufactured and refined from Chinese traditional medicine Hongqu (red yeast rice or Monascus purpureus). It has a strong capacity in regulating lipid metabolism and inhibiting the formation of fatty liver resulting from high cholesterol diet. The main ingredient HMG-CoA reductase inhibitor competitively suppresses the speed control enzyme for cholesterol synthesis, thus cutting down the synthesis of liver cholesterol. Meanwhile, HMG-CoA reductase inhibitor stimulates the activity of LDL-C receptor on liver cell surface and facilitates the elimination of serum LDL-C, affects metabolism of cholesterol and TG in human body therefore reduces the concentration of serum TC, TG and LDL-C and fat deposition in liver. Under normal conditions, liver continuously moves fat outward in the form of lipoprotein, and lipoid is the necessary material to synthesize lipoprotein. Thus, the decrease of lipoid affects the formation and output of lipoprotein. Xuezhikang contains various essential amino acids and unsaturated fat acids that nourish liver cells, enhances the cell ability to clear lipid and regulate internal metabolism of lipids. Therefore, Xuezhikang can be used as an effective medicine for curing fatty liver patients.