匹伐他汀钙治疗高胆固醇血症的有效性和安全性

目的观察匹伐他汀钙治疗高胆固醇血症的安全性和有效性。方法采用随机、双盲、阳性药物平行对照方法,将入选的高胆固醇血症48例经4周停用降血脂药物处理后,随机接受A药(匹伐他汀钙每日1 mg,A组)、B药(匹伐他汀钙每日2 mg,B组)和C药(辛伐他汀胶囊每日20 mg,C组)治疗,疗程8周。分别于治疗前、治疗4周及8周末检测计算血清低密度脂蛋白胆固醇(LDL-C)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)改变百分数,并记录血常规、尿常规、心电图、血生化检测结果及不良反应发生情况,分析降脂效果和安全性,并对3组进行比较。结果治疗前3组年龄、性别、身高、体重、收缩压、舒张压、心率以及LDL-C、TC、TG水平比较差异均无统计学意义(P>0.05);HDL-C水平比较差异有统计学意义(P<0.05),行Kruskal-Wallis检验,发现B组与C组比较差异有统计学意义(P<0.05)。与治疗前比较,治疗4周和8周末3组LDL-C、TG、TC水平均下降,差异有统计学意义(P<0.05)。3组血脂改变百分数比较差异均无统计学意义(P>0.05)。3组均未出现严重不良反应及紧急破盲事件,且无未预知的不良反应发生。结论临床使用匹伐他汀钙每日1～2 mg治疗高胆固醇血症,能有效降低LDL-C、TC、TG水平,效果确切、安全。

Therapeutic Effects and Safety of Pitavastatin Calcium Tablets on Clinical Hypercholesterolemia

Objective To observe the therapeutic effects and safety of Pitavastatin Calcium on hypercholesterolemia.Methods In a randomized,double-blind,positive-controlled trial,48 patients with hypercholesterolemia were screened out after 4-weeks of stopping of hypolipidemic treatment,during which patients received drug A(1 mg of Pitavastatin Calcium once daily,group A),drug B(2 mg of Pitavastatin Calcium once daily,group B) or drug C(20 mg of Simvastatin once daily,group C) for 8 weeks.The change percentage of serum low-density lipoprotein cholesterol(LDL-C),total cholesterol(TC),triglyceride(TG) and high-density lipoprotein cholesterol(HDL-C) were detected and compared before treatment,and 4 and 8 weeks after treatment and the blood routine,the urine routine,electrocardiogram,the blood biochemical indexes and adverse reactions were recorded and compared among the three groups and the safety and therapeutic effects in reducing blood lipids were observed.Results There were no significant differences among the three groups in the age,sex,height,weight,systolic blood pressure,diastolic blood pressure,heart rate,LDL-C,TG and TC before treatment(P>0.05);the HDL-C levels of three groups showed significant differences(P<0.05),the differences between group B and C were statistically significant by Kruskal-Wallis test(P<0.05).When compared with that before treatment,LDL-C,TC and TG among the three groups decreased in the 4th and 8th week after treatment,and the difference was statistically significiant(P<0.05).No Significant difference of ratio change of blood lipid was found among the three groups(P>0.05).No adverse,emergent and unpredictable events occurred in the three groups.Conclusion 1-2 mg of Pitavastatin Calcium once daily can reduce the levels of LDL-C,TC,TG.It is an efficient and safe approach in the treatment of hypercholesterolemia.