瑞舒伐他汀对冠心病合并高脂血症的最佳剂量及安全性探讨

Optimal Dose and Safety of Rosuvastatin Treatment for Patients with Coronary Heart Disease Combined Hyperlipidemia

目的探讨瑞舒伐他汀对冠心病合并高脂血症的最佳剂量及安全性。方法将2011年7月至2014年7月陕西中医学院附属医院收治的150例冠心病合并高脂血症患者,按照随机数字表法分为瑞舒伐他汀1组(50例)、瑞舒伐他汀2组(50例)和对照组(50例)。瑞舒伐他汀1组每日晚餐后顿服瑞舒伐他汀片10 mg,瑞舒伐他汀2组每日晚餐后顿服瑞舒伐他汀片20 mg,对照组每日晚餐后顿服阿托伐他汀片10 mg,连续服用16周。分别于用药前和治疗后检测各组患者血脂、血清丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、肌酐水平,并记录各组不良反应发生率。结果三组疗效比较差异有统计学意义(P<0.05),其中瑞舒伐他汀2组总有效率为92.0%(46/50),显著高于瑞舒伐他汀1组76.0%(38/50)和对照组74.0%(37/50)(P<0.05),瑞舒伐他汀1组和对照组比较差异无统计学意义(P>0.05)。治疗后,三组患者总胆固醇(TC)、三酰甘油(TG)、低密度脂蛋白胆固醇(LDL-C)均显著降低,高密度脂蛋白胆固醇(HDL-C)显著上升(P<0.05);其中治疗后瑞舒伐他汀2组TC、TG、LDL-C水平[(4.48±0.54)mmol/L、(1.01±0.14)mmol/L、(2.15±0.49)mmol/L]显著低于瑞舒伐他汀1组[(5.23±0.43)mmol/L、(2.04±0.18)mmol/L、(3.04±0.54)mmol/L]和对照组[(4.76±0.31)mmol/L、(1.71±0.09)mmol/L、(2.44±0.37)mmol/L],HDL-C[(1.91±0.14)mmol/L]显著高于瑞舒伐他汀1组[(0.89±0.11)mmol/L]和对照组[(1.03±0.16)mmol/L](P<0.05);瑞舒伐他汀1组和对照组各血脂指标比较差异无统计学意义(P>0.05)。三组治疗中主要不良反应发生率比较差异无统计学意义(P>0.05)。结论大剂量瑞舒伐他汀能够提高冠心病合并高脂血症患者的临床疗效,且安全性较高,对血脂改善作用明显,值得临床推广。

Objective To explore the optimal dose and safety of rosuvastatin treatment for patients with coronary heart disease combined hyperlipidemia. Methods A total of 150 cases of coronary heart disease combined hyperlipidemia admitted to Shaanxi College of Traditional Chinese Medicine Hospital from Jul.2011 to Jul. 2014 were divided into rosuvastatin group 1 of 50 cases,rosuvastatin group 2 of 50 cases and control group of 50 cases according to random number table method： rosuvastatin group 1 was given rosuvastatin tablets 10 mg,rosuvastatin group 2 was given rosuvastatin 20 mg,control group was given atorvastatin10 mg,continuous administration of 16 weeks. The blood lipid,and serum alanine aminotransferase,aspartate aminotransferase,creatinine level of the three groups before and after treatment were tested,and adverse reaction incidence of each group was recorded. Results There were statistically significant differences in the total effective rate between the three groups（ P 〈 0. 05）,rosuvastatin group 2（ 92. 0%,46 /50） was significantly higher than rosuvastatin group 1（ 76. 0%,38 /50） and control group（ 74. 0%,37 /50）（ P 〈 0. 05）,while the total effective rate of rosuvastatin group 1 and control group had no significant difference（ P 〉0. 05）. After treatment total cholesterol（ TC）,triglyceride（ TG）,low density lipoprotein cholesterol（ LDLC） of the three groups were significantly decreased,high density lipoprotein cholesterol（ HDL-C） was significantly increased（ P 〈 0. 05）,TC,TG,LDL-C levels of rosuvastatin group 2 [（ 4. 48 ± 0. 54） mmol / L,（ 1. 01 ±0. 14） mmol / L,（ 2. 15 ± 0. 49） mmol / L]were significantly lower than those in the rosuvastatin group 1[（ 5. 23 ± 0. 43） mmol/L,（ 2. 04 ± 0. 18） mmol/L,（ 3. 04 ± 0. 54） mmol/L] and control group[（ 4. 76 ±0. 31） mmol / L,（ 1. 71 ± 0. 09） mmol / L,（ 2. 44 ± 0. 37） mmol / L],HDL-C（ 1. 91 ± 0. 14） mmol / L was significantly higher than that in the rosuvastatin group 1（ 0. 89 ± 0. 11） mmol / L and control group（ 1. 03 ±0. 16） mmol / L（ P 〈 0. 05）,the rosuvastatin group 1 and control group had no significant difference in each lipid index（ P 〉 0. 05）. The incidence of main adverse reactions of the three groups had no significant difference（ P 〉 0. 05）. Conclusion Large dose of rosuvastatin can improve the clinical curative effect for patients of coronary heart disease with hyperlipidemia,with high safety and significant improvement on blood lipid,thus is worth the clinical promotion.