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目的观察国产厄贝沙坦(irbesartan,格平)治疗轻、中度原发性高血压的疗效和安全性。方法采用多中心、双盲、双模拟、随机、平行对照试验,以进口厄贝沙坦(安搏维)为对照药;另设格平开放试验组:①原发性高血压1、2级患者随机分为两组。格平组111例,安搏维组109例,疗程8周。4周时如坐位舒张压(DBP)≥90mmHg,则加服氢氯噻嗪12.5mg/d,直至试验结束。②符合入选和排除标准的567例患者另选为开放组,用药方法同格平和安博维组。结果①双盲对照试验组治疗8周末,格平组和安搏维组(符合方案集人群分别为108例和106例)的DBP及收缩压(SBP)均显著降低。两组比较无显著性差异(P=0.605)。两组坐位DBP降低总有效率分别为79.7%和73.6%(P=0.296)。不良反应:格平组例(87.2%)12起不良事件;安搏维组例(32.8%)5起不良事件(多为头晕、头痛、心悸、恶心),两组比较无显著性差异(P>0.05)。②开放试验组555例完成临床试验。治疗周末,坐位8DBP和SBP均有显著下降。DBP下降总有效率为81.98%。不良反应:例22(3.88%)发生26起不良事件,类型同对照试验组。结论国产厄贝沙坦治疗原发性轻中度高血压的疗效与安全性和进口厄贝沙坦相似。
Objective To observe the efficacy and safety of domestic irbesartan in treating mild to moderate essential hypertension. Methods A multicentre, double-blind, double-dummy, randomized, parallel controlled trial was adopted with irbesartan (Anbo Wei) as the reference drug. Patients were randomly divided into two groups. 111 cases of grid level group, 109 cases of safety level group, the course of treatment was 8 weeks. 4 weeks if the sitting diastolic blood pressure (DBP) ≥ 90mmHg, then add hydrochlorothiazide 12.5mg / d, until the end of the trial. 567 patients who met the inclusion and exclusion criteria were selected as the open group and were given the same treatment with the same level and Anbowei group. Results ① In the double-blind control group, the DBP and systolic blood pressure (SBP) were significantly decreased at the end of the 8th week in both the gepian group and the amphetamine group (108 cases and 106 cases, respectively). There was no significant difference between the two groups (P = 0.605). The total effective rate of DBP reduction in the two groups was 79.7% and 73.6%, respectively (P = 0.296). Adverse reactions: 12 cases of adverse events were treated with gefitinib (87.2%); 5 cases of adverse events (mostly dizziness, headache, palpitations and nausea) were observed in patients with Avastin (32.8%), with no significant difference between the two groups > 0.05). ② 555 open trial group completed the clinical trial. At the weekend of treatment, there was a significant decrease in sitting 8DBP and SBP. DBP decreased the total effective rate was 81.98%. Adverse reactions: Twenty-two adverse events occurred in 22 (3.88%) cases of the same type as the control group. Conclusion The efficacy and safety of domestic irbesartan in the treatment of primary mild to moderate hypertension are similar to that of imported irbesartan.