奥美沙坦治疗老年轻中度原发性高血压患者的效果及安全性研究

Study on clinical efficacy and safety of Olmesartan in elderly patients with mild to moderate primary hypertension

目的 通过与氯沙坦钾比较评价奥美沙坦治疗老年人轻、中度原发性高血压患者的效果和安全性.方法 将106例研究对象随机分为研究组与对照组,分别接受口服奥美沙坦酯20 mg或氯沙坦钾50 mg治疗,qd.用药4周后对患者进行血压评价,如果患者平均舒张压（SeDBP）仍≥90 mm Hg（1 mm Hg=0.133 kPa）,则药物剂量加倍,直至8周试验结束;否则维持原剂量继续治疗至第8周.结果 治疗8周后研究组和对照组患者收缩压（SBP）分别为（133.29±14.05）mm Hg和（138.96±14.17）mm Hg,舒张压（DBP）分别为（84.59±7.64）mm Hg和（88.01±7.83）mm Hg,差异均有统计学意义（t=2.069,P=0.041;t=2.276,P=0.025）.研究组降压的总有效率为83.02％,优于对照组的77.36％,差异无统计学意义（x2=0.726,P=0.696）.24h动态血压监测显示,治疗8周后研究组患者DBP和SBP的谷/峰比值均高于对照组.研究组和对照组药物有关的不良事件的发生率分别为3.77％和7.55％,差异无统计学意义（x2=0.177,P=0.674）.不良反应症状均轻微,不需停药接受特殊治疗.结论 奥美沙坦酯每日口服20～40 mg能够有效、安全地治疗高血压.与氯沙坦钾50～100 mg降压作用相比,奥美沙坦24 h内持续降压时间更长,降压效果更好.

Objective To evaluate the efficacy and safety of Olmesartan compared with Losartan in elderly patients with mild to moderate primary hypertension.Methods A total of 106 subjects were randomly divided into the study group and the control group,which were treated with Olmesartan Medoxomil 20 mg or Losartan Potassium 50 mg,once daily for 8 weeks.The blood pressure was assessed after 4 weeks treatment.If the subject＇s seating diastolic blood pressure （SeDBP） was still≥ 90 mm Hg （1 mm Hg=0.133 kPa）,the dosage was doubled for another 4 weeks：for the other patients,the initial dosage remained unchanged.Results The mean SBP and DBP of the study group and the control group were reduced to （133.29±14.05） mm Hg vs （138.96±14.17） mm Hg and （84.59±7.64） mm Hg vs （88.01±7.83） mm Hg respectively after 8 weeks treatment,the differences were statistically significant （t =2.069,P =0.041; t =2.276,P =0.025）.The effective rates were 83.02% and 77.36% respectively,no statistically significant was found （x2=0.726,P =0.696）.The through/peak ratios of DBP and SBP in 24-hour ambulatory blood pressure monitoring were higher in the study group than the control group.The incidence of drug-related adverse events （AEs） in the study group （3.77%） was similar than that in the control group （7.55%）,but was not statistically significant （x2--0.177,P =0.674）.All of these AEs were mild and transient.Conclusion Olmesartan,at dose of 20-40 mg once daily,is effective and safe for hypertension testament.Compared with Losartan （50-100 mg once daily）,Olmesartan has longer duration of efficacy within 24 h and antihypertensive effect is better.