国产与进口奥美沙坦酯对轻中度原发性高血压患者降压疗效与安全性的比较

目的通过与进口奥美沙坦酯比较,评价国产奥美沙坦酯治疗轻中度原发性高血压患者的疗效和安全性。方法采用随机、双盲、双模拟、阳性对照、多中心临床试验方法。入选轻中度原发性高血压患者222例,按11比例随机分为试验组110例和对照组112例,分别接受国产或进口奥美沙坦酯20mg口服治疗。4周后如诊室坐位血压<140/90mm Hg(1mm Hg=0.133kPa)则维持原剂量;血压未达标者加量至国产奥美沙坦酯40mg+安慰剂2片,或进口奥美沙坦酯40mg+安慰剂2片,服药至8周末。在基线和第8周时分别进行24h动态血压监测,观察治疗前后血压变化。结果与基线比较,治疗4周后,试验组与对照组诊室坐位血压平均降幅分别为(20.24±13.13)/(15.03±6.79)mm Hg vs(18.66±10.41)/(14.24±5.90)mm Hg;8周后分别为(22.50±11.61)/(16.57±6.33)mm Hg vs(21.78±11.24)/(16.08±6.02)mm Hg,差异无统计学意义(P>0.05)。治疗8周后,试验组与对照组24h血压平均降幅分别为(8.8±3.0)/(10.8±2.8)mm Hg vs(8.9±4.0)/(9.2±4.2)mm Hg,差异无统计学意义(P>0.05)。结论轻中度原发性高血压患者服用国产奥美沙坦酯治疗能有效、安全地降低血压,其降压幅度及平稳性与进口奥美沙坦酯相似。

Effecacy and safety of domestic and foreign olmesartan medoxomil in mild-moderate essential hypertension patients

Objective To assess the efficacy and safety of domestic olmesartan medoxomil in mildmoderate hypertension patients.Methods Two hundred and twenty-two mild-moderate hypertension patients were randomly divided into treatment group(n=110)and control group(n=112).The patients received 20 mg oral domestic or foreign olmesartan medoxomil for 4weeks.If their blood pressure at sitting position was still≥140/90 mm Hg,they were given 40 mg domestic olmesartan medoxomil plus 2placebo tablets or 40 mg foreign olmesartan medoxomil plus 2placebo tablets for 8weeks.Then their baseline and 24 hambulatory blood pressures were measured.Changes in blood pressure were observed before and after treatment.Results No significant difference was found in the mean reduction of clinic systolic blood pressure/diastolic blood pressure at sitting position between two groups after 4and 8weeks of treatment(20.24±13.13)/(15.03±6.79)mm Hg vs(18.66±10.41)/(14.24±5.90)mm Hg,(22.50±11.61)/(16.57±6.33)mm Hg vs(21.78±11.24)/(16.08±6.02)mm Hg,P>0.05).No significant difference was found in the mean reduction of 24 hambulatory blood pressure between the two groups after8 weeks of treatment(8.8±3.0)/(10.8±2.8)mm Hg vs(8.9±4.0)/(9.2±4.2)mm Hg,P>0.05).Conclusion Domestic olmesartan medoxomil is effective and safe as foreign olmesartan medoxomil for mild-moderate essential hypertension.