目的 比较阿齐沙坦与奥美沙坦酯治疗轻中度原发性高血压的临床疗效。方法 2015年9月—2017年2月从全国多家研究中心筛选轻、中度原发性高血压304例，随机分为奥美沙坦酯组和阿齐沙坦组。受试者从起始剂量开始，阿齐沙坦片20 mg/次和奥美沙坦酯片模拟剂，1次/d，或奥美沙坦酯片20 mg/次和阿齐沙坦片模拟剂，1次/d，开始治疗。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≥140 mmHg（1 mmHg=133 Pa）和/或舒张压≥90 mmHg则试验药物剂量加倍（阿齐沙坦片40 mg/次口服或奥美沙坦酯片40 mg/次，1次/d）继续治疗8周，如果服药前（药物浓度谷值时）坐位收缩压<140 mmHg且舒张压<90 mmHg则维持原剂量继续治疗8周。治疗总周期16周。观察两组的有效率和达标率。比较两组治疗前，治疗8、12、16周收缩压、舒张压，血压与治疗前差值的变化情况。结果 用药8、16周，奥美沙坦酯组有效率分别是66.89%、69.59%；阿齐沙坦组有效率分别是59.60%、58.94%，两组有效率比较差异没有统计学意义。用药8、16周，奥美沙坦酯组达标率分别是62.16%、61.49%；阿齐沙坦组达标率分别是56.95%、56.29%，两组达标率比较差异均没有统计学意义。治疗8、12、16周，两组受试者的坐位收缩压、舒张压逐渐降低，与同组治疗前比较差异均有统计学意义（P<0.05）；治疗后，两组血压比较差异无统计学意义。用药后两组受试者的坐位收缩压和舒张压均逐渐降低，至16周末时，两组间坐位舒张压下降值比较差异具有统计学意义（P<0.05）；16周末时两组收缩压下降值差异均没有统计学意义。结论 有效性方面，阿齐沙坦组疗效未达非劣效于奥美沙坦酯组，但阿齐沙坦自身的降压效果显著并具临床意义；安全性方面，阿齐沙坦组与奥美沙坦酯组不良事件、严重不良事件、不良反应发生率相当，安全性良好。

Objective To compare the efficacy of azilsartan and olmesartan medoxomil in treatment of mild and moderate essential hypertension. Methods From September 2015 to February 2017, 304 patients with mild and moderate essential hypertension were screened from several research centers across the country, and they were randomly divided into omesartan group and Azirartan group. Subjects began treatment at the starting dosage, Azilsartan Tablets 20 mg/time and Olmesartan Medoxomil Tablets analog, once daily, or Olmesartan Medoxomil Tablets 20 mg/time and Azilsartan Tablets analog, once daily. Blood pressure was evaluated at the end of the 8th week after administration. If the sitting systolic blood pressure was greater than or equal to 140 mmHg and/or diastolic blood pressure was greater than or equal to 90 mmHg before administration, the dosage of the test drug was doubled (Azilsartan Tablets 40 mg/time or Olmesartan Medoxomil Tablets 40 mg/time, once daily) and continued for 8 weeks. If the sitting systolic blood pressure was less than 140 mmHg and the diastolic blood pressure was less than 90 mmHg before taking the drug (when the drug concentration was at a trough), the original dosage was maintained for 8 weeks. Subjects were required to complete ambutral blood pressure monitoring at the end of the 14th week. The total treatment period was 16 weeks. The efficiency and compliance rates of the two groups were observed. The changes of systolic blood pressure, diastolic blood pressure and the difference between the two groups before treatment were compared at 8, 12 and 16 weeks after treatment. Results After 8 and 16 weeks, the effective rates of the olmesartan medoxomil group were 66.89% and 69.59%, respectively. The effective rates of azisartan group were 59.60% and 58.94%, respectively, and there was no statistical difference between two groups. After 8 and 16 weeks of administration, the compliance rates of olmesartan medoxomil group were 62.16% and 61.49%, respectively. The compliance rate of azisartan group was 56.95% and 56.29%, respectively, and the difference between the two groups was not statistically significant. After 8, 12 and 16 weeks of treatment, the sitting systolic blood pressure and diastolic blood pressure of the two groups gradually decreased, with statistically significant differences compared with the same group before treatment (P<0.05). After treatment, there was no significant difference in blood pressure between two groups. After the treatment, the sitting systolic blood pressure and diastolic blood pressure of the two groups gradually decreased. At the end of the 16th week, there was statistically significant difference between the two groups in the decreased sitting diastolic blood pressure (P<0.05). At the end of 16th, there was no significant difference in systolic blood pressure drop between two groups. Conclusion In terms of effectiveness, azisartan group did not have a non-inferior effect on the efficacy compared with the olmesartan medoxomil group, but azisartan group had significant and clinical significance in reducing blood pressure. In terms of safety, the incidence of adverse events, serious adverse events and adverse reactions was similar between azirartan group and olmesartan medoxomil group, and the safety was good.

R972

国家自然科学基金资助项目（81970312）；河南省自然科学基金资助项目（182300410304）