阿齐沙坦治疗原发性高血压的临床研究

Clinical study of azilsartan in the treatment of essential hypertension

目的比较阿齐沙坦片与奥美沙坦酯片治疗轻、中度原发性高血压的临床效果。方法从全国16家研究中心抽取轻、中度原发性高血压患者299例,符合入组条件者随机(1∶1)分入试验组(150例)和对照组(149例),进入双盲治疗期,受试者从起始剂量(试验组给予阿齐沙坦片20 mg,口服,1次/d;对照组给予奥美沙坦酯片20 mg,口服,1次/d)开始治疗,动态血压检测在给药前1 d进行,用药后第8周末,对受试者进行血压评价,如果服药前(药物浓度谷值时)坐位收缩压(SBP)≥40 mmHg(1 mmHg=0.133 kPa)和(或)舒张压(DBP)≥90 mmHg,则试验药物剂量加倍(阿齐沙坦片40 mg,口服,1次/d或奥美沙坦酯片40 mg,口服,1次/d),继续治疗8周,如果服药前(药物浓度谷值时)坐位SBP<140 mmHg且DBP<90 mmHg则维持原剂量继续治疗8周。动态血压受试者第14周末需完成动态血压监测。治疗总周期16周。结果用药后两组受试者的坐位血压DBP和SBP均逐渐降低;至第16周末时,两组间坐位血压DBP下降值比较,差异有统计学意义(P<0.05);16周末时SBP下降值、血压达标率、降压有效率比较,差异未见统计学意义(P>0.05)。试验期间试验组32例发生79例次不良事件,对照组22例发生35例次不良事件,两组不良事件发生率比较差异未见统计学意义(P=0.176)。结论阿齐沙坦片20 mg或40 mg治疗轻、中度原发性高血压,经16周治疗后,其降DBP效果非劣效于奥美沙坦酯片,药物不良反应发生率低,安全性和耐受性良好。

Objective To compare the clinical effects of azilsartan tablets and olmesartan kamedoxomil tablets on mild and moderate essential hypertension.Methods A total of 299 patients with mild and moderate primary hypertension were selected from 16 research centers nationwide.Those who met the criteria of inclusion were randomly divided into the study group(150 cases)and the control group(149 cases)(1∶1),and entered the double-blind treatment period.The subjects started treatment from the initial dose(the study group was given azilsartan tablets 20 mg,by oral,once a day,and the control group was given olmesartan kamedoxomil tablets 20 mg,by oral,once a day),the ambulatory blood pressure monitoring was performed one day before administration;and at the end of the 8th week after administration,the blood pressure of the subjects were evaluated.If the sitting systolic blood pressure(SBP)was greater than or equal to 40 mmHg(1 mmHg=0.133 kPa)and(or)the diastolic blood pressure(DBP)was greater than or equal to 90 mmHg before administration(at the drug concentration trough),the dose of the test drug was doubled(azilsartan tablets 40 mg,by oral,once a day;or olmesartan kamedoxomil tablets 40 mg,by oral,once a day),and the treatment lasted for 8 weeks.If the sitting SBP was less than 140 mmHg and DBP was less than 90 mmHg before administration(at the drug concentration trough),the original dose was maintained for 8 weeks.At the end of the 14th week,ambulatory blood pressure monitoring should be completed.The total treatment period was 16 weeks.Results After administration,the sitting DBP and SBP of the subjects in both groups decreased gradually;by the end of the 16th week,there was a statistically significant difference between the two groups in the decrease of sitting DBP(P<0.05);at the end of the 16th week,there was no significant difference in decrease of SBP,blood pressure compliance rate,and blood pressure reduction efficiency(P>0.05).In the study group,79 adverse events occurred in 32 patients.In the control group,35 adverse events occurred in 22 patients.There was no statistically significant difference in the incidence of adverse events between the two groups(P=0.176).Conclusions Azithartan tablet 20 mg or 40 mg,in the treatment of mild and moderate primary hypertension,has a comparable effect with olmesartan kamedoxomil tablet on reducing DBP.The incidence of adverse drug reactions was low,and the safety and tolerance were good.