Ceska R, Kvasnicka T, Bláha V, Pit'ha J, Soska V
III. interni klinika 1. lékafské fakulty UK a VFN, Praha.
Vnitr Lek. 2002 Oct;48(10):966-70.
Treatment of hyperlipoproteinaemias (HLP) is a basic step in prevention and treatment of atherosclerosis and its complications. Simvastatin is among hypolipidaemic agents a preparation for which at present there is most evidence from intervention trials. On the Czech market are at present in addition to the original one also some other preparations of simvastatin. In the submitted paper the authors present results achieved with the preparation Simvor (Rambaxy, distribution in CR Interchemia), tablets containing 20 mg simvastatin. CHARACTERISTIC OF GROUP AND METHODS: In 15 departments in the CR a total of 185 patients with HLP were examined, 98 men and 87 women, mean age 55.8 years. The patients were treated after a minimal 4-week period of non-pharmacological treatment with simvastatin 20 mg for a period of 6 weeks. The patients were subjected at the onset and end of treatment to a complete medical examination, basic parameters of lipid metabolism were assessed and a safety laboratory was involved. Facultatively in some departments additional examinations were made.
The total cholesterol level 7.26 +/- 1.01 mmol/l declined on average by 1.64 mmol/l i.e. to 5.62 mmol/l, LDL-cholesterol declined from the original value of almost 5 mmol/l to 3.55 mmol/l. The baseline triglyceride concentration 3.07 declined by 1 mmol/l to 2.09 mmol/l, and HDL-cholesterol which was in a normal range already at the onset of treatment did not change significantly, i.e. its slight increase did not reach statistical significance. Treatment was well tolerated and in the safety laboratory no significant deviations from normal were recorded.
The results achieved in our patients are as far as the investigated parameters are concerned, comparable with or even better than the results presented in the ample literature. The safety and tolerance of treatment of the investigated preparation is also very good. Unfortunately we did not have an opportunity during our short-term follow up to evaluate the influence of the investigated preparation on the incidence of cardiovascular diseases or mortality. In this respect we can only refer to positive results assembled with simvastatin in large statin intervention "megatrials".
Treatment with decline of total and LDL-cholesterol and triglycerides. Treatment was well tolerated by the patients, in the safety laboratory no significant deviations were detected.
高脂蛋白血症（HLP）的治疗是预防和治疗动脉粥样硬化及其并发症的基本步骤。辛伐他汀是降血脂药物之一，目前有最多干预试验证据支持的制剂。在捷克市场上，除了原研产品外，目前还有其他一些辛伐他汀制剂。在提交的论文中，作者展示了使用Simvor（兰伯西公司，在捷克共和国由Interchemia公司经销）制剂（含20毫克辛伐他汀的片剂）所取得的结果。
在捷克共和国的15个科室共检查了185例HLP患者，其中男性98例，女性87例，平均年龄55.8岁。患者在经过至少4周的非药物治疗后，用20毫克辛伐他汀治疗6周。在治疗开始和结束时对患者进行全面体检，评估脂质代谢的基本参数，并进行安全性实验室检查。部分科室还进行了其他检查。
总胆固醇水平从7.26±1.01毫摩尔/升平均下降了1.64毫摩尔/升，即降至5.62毫摩尔/升，低密度脂蛋白胆固醇从原来的近5毫摩尔/升降至3.55毫摩尔/升。基线甘油三酯浓度从3.07降至2.09毫摩尔/升，而高密度脂蛋白胆固醇在治疗开始时已处于正常范围，无明显变化，即其轻微升高未达到统计学意义。治疗耐受性良好，安全性实验室检查未发现明显偏离正常情况。
就所研究的参数而言，我们患者所取得的结果与大量文献中报道的结果相当，甚至更好。所研究制剂治疗的安全性和耐受性也非常好。不幸的是，在我们的短期随访期间，没有机会评估所研究制剂对心血管疾病发病率或死亡率的影响。在这方面，我们只能参考辛伐他汀在大型他汀类药物干预“大型试验”中所取得的阳性结果。
治疗可降低总胆固醇、低密度脂蛋白胆固醇和甘油三酯水平。患者对治疗耐受性良好，安全性实验室检查未发现明显偏差。
