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 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
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.
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
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
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.
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.
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,
Chao Yung Hospital of Beijing Red Cross(Hu Dayi, Gao Miogming, Xu
Airforce Beijing Hospital(Chen Xuili, Dai Chenxiang)
Pravastatin Multinational Study Group for cardiac risk patients.
Effects of pravastatin in patients with serum total cholestrol
levels from 5.2 to 7~8 mmoI/L(200mg ~ 300mg) plus two additional
atheroselerosis risk factors. Am J Cardial, 1993,72-131-1037.
Ferrari P, Weidmann P, Riesen WF, et al Pravastatin zur Behandlung
der primaren Hypercholesterimanie Schweizer Multizenter Studie
Scheiz Med Wochensche, 1993, 18, 123; 1736-1741