INTRODUCTION

Type II Diabetes patients usually associates with hyperlipoidemia. In this study, Chinese lipid-lowering medicine Xuezhikang was employed to identify its influence on the levels of blood sugar and lipid.

PATIENTS AND METHODS

Selection of Patients
Patients came from internal medicine division, health and rehabilitation division, Chinese medicine division and inpatient division of the hospital. According to diabetes clinical standards stipulated by diabetes expert committee of WHO, patients with ketoacidosis and serious diseases of heart, liver, kidney and gallbladder were excluded. Those type II diabetes patients, without any endocrinosis or not taking any hypoglycemic agent and antilipemic agent within a month, met one or more of the following requirements were chosen as target patients: (1) Serum TC ³ 5.95 mmol/L (³ 300mg/dl); (2) TG ³ 2.25 mmol/L (³ 200 mg/dl); (3) HDL-C £ 1.04 mmol/L ( £ 40 mg/dl) in male and £ 1.16 mmol/L
(4.5 mg/dL ) in female.

All parameters of the patients in above three group meet comparison principles.
See Table I.

Observational Method
After 2 weeks of diet education and promotion activities, patients in each group took Xuezhikang capsules 0.6 g a time (two capsules), twice a day. Diabetes patients in group 1 and 3 also took hypoglycemic agent Glipizide together with melbine or a-glycosidase inhibitor with their dosage adjusted according to blood sugar level. After 8 weeks of treatment, the curative effect was evaluated. Before and after the treatment, the concentration of serum TC, TG, HDL-C, AS (= TC/HDL-C), FBG and 2h-PG of patients in every group were measured at the same time.

Criteria for Effect
According to the Guiding Standards (Draft Document) of Clinical Application of New Medicines stipulated by the Ministry of Public Health in 1993, the criteria of curative effect is as the following:

• Highly effective
  TC reduction ³ 20% or TG reduction ³ 40%, or HDL-C increase ³ 10 mg/dL
  (0.26 mmol/L), AS decrease ³ 20%.
• Effective
  TC reduction by 10% ~ 20%, or TG reduction by 20% ~ 40%, or HDL-C increase by
  4 ~ 10 mg/dL (0.1 ~ 0.25 mmol/L), AS decrease by 10% ~ 20%.
• Ineffective
  It can not reach any one of the above level.

Criteria for curative effect on blood sugar are:

• Highly effective
  FBG < 7.2 mmol/L, IAPG < 8.3 mmol/L.
• Effective
  FBG < 8.3 mmol/L, 2hPG < 10.0 mmol/L.
• Ineffective
  No improvement occurs in clinical symptoms and every lab test cannot meet the above standard.
  

RESULTS

Examinations were carried out to patients in the three groups treated by Xuezhikang for 8 weeks and 48 cases of type II diabetes patients who only took sugar-reduction agent but no antilipemic agent in the past were chosen randomly. Comparable parameters such as average age, physique index and treatment time were set for comparison. Statistic analysis proved that Xuezhikang could not only regulate blood lipid to normal range, but also obviously reduced blood sugar in conjunction with hypoglycemic agent.

Effects on Blood Sugar of Type II Diabetes Patients
After 8 weeks treatment, FBG and 2h-PG level of group 1 and group 3 patients dropped by 1.08mmol/L, 1.74mmol/L and 1.44mmol/L, 2.28mmol/L respectively, which accounted for 12.05%, 16.0% and 16.0%, 20.9% correspondingly, all with very significant difference
(P <0.001). Although the decreases of FBG and 2h-PG in group 3 were higher than that of group 1, the difference was not significant in statistics (P > 0.05).

Simultaneous administration of Xuezhikang with hypoglycemic agent for diabetes patients will not influence the effectiveness of hypoglycemic agents, on the contrary, it facilitates the decline of blood sugar. It is worth noting here that there were great differences on blood sugar reduction of those patients that only take pure hypoglycemic agent in the past compared with that in group 1 and group 3 (P < 0.05). The total efficacy of FBG and 2h-PG were 85.4%, 92.5%, 78.6% and 74.3%, 76.6%, 64.8% respectively. Whereas no statistic difference exists in efficacy data between group 1 and group 3. The findings indicated that better curative effects could be expected when hypoglycemic agent was taken with antilipemic agent regardless of the lipid level being high or normal in diabetes patients.
(See Table II)

Effects of Xuezhikang on reducing lipid level
There were significant change of various lipid levels in patients of group 1 and group 2 after the treatment (P < 0.001). TC fell by 27.9% in group 1 and 29.6% in group 3. TG drops by 35.9% in group1 and 34.1% in group 3. And HDL-C level went up 23.0% in group1 and 19.0% in group three. Whereas AS decreased by 35.1% in group 1 and 31.9% in group 3. The data of group 3 before and after the treatment showed no difference in terms of statistics ( P > 0.05). The efficacy of TC reduction reached by 93.6% in group 1 and 95.0% in group 2; TG reduction by 90.0% in group 1 and 90.8% in group 2; HDL-C elevation by 84.3% in group 1 and 85.8% in group 2; AS decrease by 91.5% in group 1 and 91.7% in group 2. However, there was no clear difference of the same index between the two groups (P > 0.05). (See Table III)


DISCUSSION

Primary investigations indicated that 53.8 percent (140/260) of type II diabetes patients in Xinjiang Autonomous Region have higher TC, TG and lower HDL-C level than that of common people. And type II diabetes patients possess 2~ 3 times risks of getting cardiocerebrovascular syndromes. Much better curative effects occur when type II diabetes patients with higher lipid level take hypoglycemic agent coupled with Xuezhikang compared with past practice that patients take only hypoglycemic medicine with other conditions the same (P < 0.05). After the treatment, the total efficacy of FBG reduction of patients with normal lipid level is higher than diabetes patients with hyperlipoidemia
(P< 0.05). Whereas no difference occurs in efficacy of 2h-PG data between two groups
(P > 0.05).

Xuezhikang contains HMG-CoA reductase inhibitor and many active components such as unsaturated fatty acids and amino acid necessary for human being. It is an ideal medicine to regulate lipid level. It is found from multi-group curative effect analysis that pure administration of hypoglycemic medicine cannot lead to desired cure, nor can it decrease potential risk of cardiocerebrovascular diseases for diabetes patients. It is particularly true for diabetes patients with high levels TC, TG and low level of HDL-C, as they are major factors affecting curative effects of hypoglycemic medicine. However, Xuezhikang is able to suppress TG and synthesis of fatty acids and accelerate lipometabolism, thus promoting activity of b cells of pancreas islet and prodcing more insulin. In addition, Xuezhikang can cut down lipid level and improve the imbalance among various ingredients. In particular, the decline of AS(TC/HDL-C) can enhance the sensitivity of surrounding tissue to insulin, consequently help to lower blood sugar level. Thus, it is regarded that simultaneous treatment on both blood sugar and lipid is a reasonable cure method for diabetes patients coupled with hyperlipoidemia. And small amount of Xuezhikang will do no harm but good for normal diabetes patients when treated with hypoglycemic medicine.