目的 比較阿齊沙坦與奧美沙坦酯治療輕中度原發(fā)性高血壓的臨床療效。方法 2015年9月—2017年2月從全國多家研究中心篩選輕、中度原發(fā)性高血壓304例，隨機分為奧美沙坦酯組和阿齊沙坦組。受試者從起始劑量開始，阿齊沙坦片20 mg/次和奧美沙坦酯片模擬劑，1次/d，或奧美沙坦酯片20 mg/次和阿齊沙坦片模擬劑，1次/d，開始治療。用藥后第8周末對受試者進行血壓評價，如果服藥前（藥物濃度谷值時）坐位收縮壓≥140 mmHg（1 mmHg=133 Pa）和/或舒張壓≥90 mmHg則試驗藥物劑量加倍（阿齊沙坦片40 mg/次口服或奧美沙坦酯片40 mg/次，1次/d）繼續(xù)治療8周，如果服藥前（藥物濃度谷值時）坐位收縮壓<140 mmHg且舒張壓<90 mmHg則維持原劑量繼續(xù)治療8周。治療總周期16周。觀察兩組的有效率和達標率。比較兩組治療前，治療8、12、16周收縮壓、舒張壓，血壓與治療前差值的變化情況。結(jié)果 用藥8、16周，奧美沙坦酯組有效率分別是66.89%、69.59%；阿齊沙坦組有效率分別是59.60%、58.94%，兩組有效率比較差異沒有統(tǒng)計學(xué)意義。用藥8、16周，奧美沙坦酯組達標率分別是62.16%、61.49%；阿齊沙坦組達標率分別是56.95%、56.29%，兩組達標率比較差異均沒有統(tǒng)計學(xué)意義。治療8、12、16周，兩組受試者的坐位收縮壓、舒張壓逐漸降低，與同組治療前比較差異均有統(tǒng)計學(xué)意義（P<0.05）；治療后，兩組血壓比較差異無統(tǒng)計學(xué)意義。用藥后兩組受試者的坐位收縮壓和舒張壓均逐漸降低，至16周末時，兩組間坐位舒張壓下降值比較差異具有統(tǒng)計學(xué)意義（P<0.05）；16周末時兩組收縮壓下降值差異均沒有統(tǒng)計學(xué)意義。結(jié)論 有效性方面，阿齊沙坦組療效未達非劣效于奧美沙坦酯組，但阿齊沙坦自身的降壓效果顯著并具臨床意義；安全性方面，阿齊沙坦組與奧美沙坦酯組不良事件、嚴重不良事件、不良反應(yīng)發(fā)生率相當，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

國家自然科學(xué)基金資助項目（81970312）；河南省自然科學(xué)基金資助項目（182300410304）