国产奥美沙坦酯治疗轻中度原发性高血压的单中心疗效和安全性评价

Efficacy and safety of domestic olmesartan in treatment of mild to moderate essential hypertension

目的：通过与进口奥关沙坦酯（商品名傲坦）比较，单中心评价国产奥美沙坦酯单药治疗轻、中度原发性高血压的疗效和安全性；验证本药与原研药等效。方法：采用随机、双盲、双模拟、阳性对照方法进行研究。57例轻、中度原发性高血压患者分为奥关沙坦酯组（27人、国产奥关沙坦酯20mg＋傲坦模拟片1片20mg）和傲坦组（30人、傲坦20mg＋国产奥关沙坦酯模拟片1片20mg），治疗期为8周，每2周随访1次，观察降压效果和不良反应；治疗2周后若患者坐位舒张压≥90mmHg（1mmHg===0．133kPa）和（或）收缩压≥140mmHg，则将剂量加一倍，至疗程结束。若坐位舒张压〈90mmHg，则维持原剂量。结果：与治疗前比较，治疗8周后奥关沙坦酯组和傲坦组收缩压分别下降（22．5士9．5）mmHg和（21．4±9．5）mmHg（均P〈0．001），舒张压分别下降（16．1±5．5）mmHg和（14．7±4．4）mmHg（均P〈0．001），两组间比较差异无统计学意义（P〉0．05）。国产奥美沙坦酯组与傲坦组降压总有效率（96．30％VS92．60％）和不良反应发生率比较，差异均无统计学意义（P〉0．05）。结论：国产奥关沙坦酯片20～40mg，每日1次是治疗轻中度原发性高血压的安全有效药物。

AIM safety of domestic To evaluate the efficacy and olmesartan in treatment of mild to moderate essential hypertension in comparison with Ao tan and to verify its equivalency with the original study medicine. METHODS： 57 patients with mild to moderate essential hyper- tension were enrolled in a randomized, double- blind, multi-center, paralleded and active-con- trolled trial, and were divided into olmesartan group （27 patients with domestic olmesartan 20 mg＋Ao tan simulated piece 1 piece 20 mg） and Ao tan group （30 patients with Ao tan 20 mgq- domestic olmesartan simulated piece I piece 20 mg） for a 8-week therapy. All patients were fol- lowed up every two weeks, and the efficacy and adverse effects were observed. After treatment for 2 weeks, dosages of drugs were doubled in patients with seated diastolic blood pressure90 mm Hg （1 mm Hg= 0.133 kPa）. RESULTS： Compared with those before treatment, both systolic blood pressure and diastolic blood pres- sure significantly decreased in domestic olmesar- tan group and Ao tan group 8 weeks after treat- ment [-（22.5_---/_-9.5） mm Hg and （21.4±9.5） mmHg, respectively for systolic blood pressure （P〈0. 001） （16.1±5.5） mm Hg and （ 14.7± 4.4） mm Hg, respectively for diastolic blood pressure （P〈0. 001） 1, while there was no sig- nificant difference between these two groups （P 〉0.05）. There was no significant difference in total effective rate （96.30% vs 92.60%） and in- cidence of adverse effect between these two groups （P〈 0.05） . CONCLUSION ： Domestic olmesartan is very effective in treatment of mild to moderate hypertension in a daily dose of 20-- 40 mg with good tolerability. KEY WORDS Domestic olmesartan; Ao tan; Hypertension; Heart rate