In China, multi-center studies on the long-term curative effects of satins are quite rare and there is no report of the study on the effect of small dosage administration. In this study, small dosage of two satins, i.e.Pravastatin and Xuezhikang were employed to carry out long-term, small scale and multi-center clinical studies so as to investigate a more economical, effective and secure method for lipid regulation.

Patients and Method

Hyperliopoidemia patients undergoing dietary control with the following conditions were chosen as subjects. (1) non-coronary-heart-disease patients with TC=6.2 mmoI/L or low-density lipoprotein (LDL) = 4.2 mmoI/L; (2) possessing two dangerous factors of coronary heart disease patients with TC = 5.2~5.2 mmoI/L or low-density lipoprotein (LDL) = 3.4 mmoI/L; (3) definite coronary heart disease patients with TC = 4.2 mmoI/L or (LDL) = 2.6 mmoI/L. Patients with the following symptoms or conditions were excluded: (1) allergic to HMG-CoA reductase inhibitor; (2) serious dysfunction of liver and kidney; (3) pregnant, gestation and lactation women; (4) taking other lipid-regulating drugs or with pathological changes like hypothyrcosis that will affect lipid level.

243 qualified patients were selected and divided into two group. One was Xuezhikang group (150 cases) treated with 2 capsules of Xuezhikang every evening (each capsule contains 3mg Lovastatin and other active ingredient, the capsule is manufactured by WBL (Peking University Biotech Limited Company). The other (93 cases was Pravastatin group treated with 5mg Pravastatin (product of Sino-American Squibb Company) per night. The data had no statistical difference between the two groups before treatment Serum lipid levels (TC, TG and HDL) were tested before, 8-week, 16-week and 24-week after the treatment. Fredewald Formula was employed to calculate LDL level and HDL-C/LDL. Meanwhile, biochemical indexes like liver and renal functions, routine blood and urine testing and clinical reactios of the subjects were monitored. Then t-test was adopted to compare the difference between the two groups. At the same time, curative effect standard stipulated by The Ministry of Health P.R. China was referred to evaluate the curative effects. Blood samples were taken on the 12h-fasting patients and testing and monitoring activities of every hospital involved meeting their QC standards.


RESULTS

Lipid Changes after 24-week Treatment
TC reduced by 16% in Xuezhikang group and 17% in Pravastatin group. Both groups had reduced TG by 14%. LDL level dropped by 24% in Xuezhikang group and 21% in Pravastatin group. The reduction of LDL/HDL reached 27% in Xuezhikang group and 28% in Pravastatin group. Whereas HDL level elevated by 4% in Xuezhikang group and 10% in Pravastatin group. Statistic analysis showed that the reduction of TC, TG and LDL was quite significant compared with that of before treatment after 6 months treatment. But the rise of HDL level was not significant. Furthermore, there was no statistical difference between the two groups after 24-week treatment.

Comparison of Effect
The total efficacy of Xuezhikang and Pravastatin was 56% and 66% respectively in declining TC level, Total efficacy reached 46% in Xuezhikang group and 40% for Pravastatin in TG decrease , 75% in Xuezhikang group and 78% for Pravastatin in terms of LDL decrease. Whereas the total efficacy of HDL elevation hit 49% for Xuezhikang group and 54% for Pravastatin with no statistical significance between the two groups

Side-Effects
2 cases of abdominal distension and constipation, 1 case of erythra occurred in Xuezhikang group. And 7 cases of abdominal distension, 4 cases of constipation, 3 cases of nausea and weakness, and 2 cases of insomnia occurred in Pravastatin group.
No other side-effects were reported.

DISCUSSION

Small dosage administration of both Xuezhikang and Pravastatin could effectively reduce serum TC, TG, LDL and LDL/HDL, and increase HDL. There were not any significant differences effects between the two groups with little side-effects. Small dosage administration is cheap and will be accepted for long-term treatment. Meanwhile, the average lipid-regulation medicine matches more pratical situation in China. It provides us a more economical, effective and secure approach for lipid regulation and the secondary prevention and cure of coronary heart disease in China with great clinical significance.

(Summarised by Xu Chenbin, Kang Liping)
Organizations of the Medical Coordination Study Group of Small Dosage Medicine for Lipid Regulation
People's Hospital of Beijing Medical University (Xu Chenbin, Kang Liping, Tian Yawen).
Beijing Electric Power Hospital (Jin Sanyou, MA Fengyun, Ma Min).
General Hospital Of Marine Force(Shi Xiangyun, Zhang Baohe, LongNunzhan).
The First Hospital of Beijing Medical University (Li Lin, Xue Lin, Zhang Junhua)
Chao Yung Hospital of Beijing Red Cross(Hu Dayi, Gao Miogming, Xu Zhamin)
Airforce Beijing Hospital(Chen Xuili, Dai Chenxiang)

REFERENCES