Abnormal lipoprotein metabolism often occurs in chronic renal failure patients. And peritoneal dialysis on these patients will enhance their symptom of hyperlipoidemia. [1] From January 1996 to January 1997, we used Xuezhikang to treat chronic renal failure continuous ambulutory peritoneal dialysis (CRF·CAPD) patients associated with hyperlipoidemia by multi-center observation method to investigate its effects. The study is described as the following.

PATIENTS AND METHODS

Patients
30 male and 23 female of the 53 inpatients with the age of 45±12 years old were chosen. They met the following requirements:
Reaching the diagnosis standards of end-stage renal failure (or uremic syndrome stage) specified by the Minute of the Symposium on Classification, Treatment and Diagnosis Standard for Primary Glomerulus Disease held in Taiyuan, Shanxi Province in 1992[2] ­ CAPD treatment was implemented and peritoneal dialysis cure was established on the basis of three index including peritoneal dialysis balance.[1] Patients had been dialyzed for more than 4 weeks. ® Serum TC ³ 5.96 mmol/L or TG ³ 2.6 mmol/L (TC ³ 5.96 32 cases; TG ³ 2.26 mmol/L 49 cases. Among them, male HDL-C < 1.04 mmol/L and 41 cases of female HDL-C < 1.16 mmol/L.) ¯ Two weeks before the treatment, every patient should have their blood sugar at normal level and blood pressure under 120/80 mmHg, hemoglobin level more than 90.0g and plasma protein level higher than 30 g/L.

Treatment Method
53 patients were randomly divided into two groups. 32 patients, male 19 and female 13 with the age of 43 ± 9 years old are in group A and treated with Xuezhikang. 4 weeks after normal treatment of CRF·CAPD, the target patients took Xuezhikang capsules [manufactured by WBL Peking University Biotech Co. Ltd. with license approval number Z-94 (1995)] twice a day, two capsules a time. Whereas the remaining patients were in group B as control group. The only difference between group A and B was that patients in group B did not take any Xuezhikang capsule. The treatment lasted for 8 weeks. During treatment, patients kept the same lifestyle and diet habit as before, any medicine that interfere with lipid metabolism were.

Observational Indexes
Before, 4 weeks and 8 weeks after the treatment, target patients in both group A and group B would be, apart from routine CRF·CAPD observations, tested with the following items: TC, TG, HDL-C, APOA1 and APOB, ALB, 24h-quantity of urinary protein, hemoglobin, blood creatinine, erythrocyte sedimentation, plasma fibrinogen, creatinephosphokinase and alkaline phosphatase. The level of TC and TG were determined by enzyme method. HDL-C is tested by two-stage-precipitation of glucosan Mg++ method and APOA1 and APOB levels by enzyme linked immunoelectrophoresis method. And the level of LDL-C was calculated by Friede Wald formula. All blood samples were sent to The First People's Hospital of Mudanjiang City for unified determination (Patients are prohibited from alcohol and high cholesterol diet before blood sampling. After 12-hour fasting venous blood sample was taken. Serum should be separated in time and stored at -20oC refrigerator ready for testing within 2 days).

Criteria for Effects
Curative effect refered to Standards on Clinical Effect of Lipid-Regulating Medicines stipulated by Ministry of Public Health in July 1988.
Highly effective: TG reduction ³ 40% or TC reduction ³ 20%.
Effective: TG reduction by 20% ~40%, TC decrease 10% ~ 20%.
Ineffective: Laboratory test items can not reach any one of the above standards.
Deterioration: TC increase ³ 10% or TG increase ³ 10%.

Statistical Method
All data were expressed in average value ± standard deviation(x ± s). Serum lipid analysis employed t-test, whereas individual curative effect was processed byx2 test.

RESULTS

Lipid Levels before and after the Treatment in Group A and Group B (See Table I).

Curative Effect of Xuezhikang on Lipid Reduction for CRF·CAPD Patients (See Table II).

This study showed that the concentrations of TG, LDL-C and APOB of CRF·CAPD patients had a clear trend of elevation, whereas HDL-C and APOA1 levels dropped significantly, no clear change occurred in TC level, which was in conformity with literature report.[1] TG increase resulting from the absorption of large amount of glucose in ascites mainly accounted for this phenomenon. Certain amount of clinical CRF patients suffer from hyperlipoidemia and deficiency of necessary amino acid, which was one of the important mechanism of CRF glomerulosclerosis.[1] Therefore, safe and efficient lipid-lowering medicine was essential for these patients. Xuezhikang is mainly HMG-CoA reductase inhibitor made in China, which contains rich composition of unsaturated fatty acids and amino needed by human by. It can alleviate hyperlipoidemia of CRF·CAPD patients and reduce the retention of nitrogen metabolic products in the body thus protecting the remaining renal functions of those patients.

Xuezhikang was employed in this study to treat CRF·CAPD patients and remarkable effect occurs on the reduction of serum TC, TG, LDL-C, APOB and elevation of HDL-C and APOA1 (P < 0.05). The total efficacy on TC, TG reduction and HDL-C increase was 83%, 91% and 33% respectively. And little side-effect occurred during the treatment. Therefore Xuezhikang is a safe medicine for curing abnormal lipid metabolism of CRF·CAPD patients.

REFERENCES