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目的:评价伊贝沙坦(irbesartan)治疗轻、中度原发性高血压的疗效和安全性。 方法:选取 137例坐位舒张压(SeDBP)95~115 mmHg(lmmHg= 0. 133 kPa)[根据 1993年《新药(西药)临床研究指导原则》:治疗前舒张压水平分成轻(95~104 mmHg)、中(105~114 mmHg)和重(>115 mmHg)三类]的轻、中度原发性高血压患者,随机分为伊贝沙坦组(150 mg每日 1次)和贝那普利(benazepril)组(10 mg每日1次)。于4周末SeDBP≥90 mmHg者剂量分别加倍,继续服用4周。于安慰剂期末及治疗2、4、6、8周测诊室血压、心率并记录症状、体征;试验前后行实验室检查。 结果:有效率伊区沙坦组81.2%,贝那普利组70.5%,两组比较无显著性差异(P>0.05)。8周伊贝沙坦组及贝那普利组SeSBP/SeDBP均下降,其中2、4、6、8周伊贝沙坦组SeDBP的下降幅度大于贝那普利组,两组有显著性差异(4周P<0。·05,2、6、8周P均<0.01)。贝那普利组咳嗽5例,发生率8%。 结论;伊贝沙坦 150~300 mg/d治疗轻、中度原发性高血压的有效率近似于贝那普
Objective: To evaluate the efficacy and safety of irbesartan in the treatment of mild to moderate essential hypertension. Methods: 137 Sedentary diastolic blood pressure (SeDBP) of 95-115 mmHg (lmmHg = 0.133 kPa) were selected [according to the Guiding Principles of New Drugs (Western Medicine) Clinical Research 1993: Diastolic blood pressure before treatment was divided into mild (95-104 mmHg ), Moderate (105 ~ 114 mmHg) and heavy (> 115 mmHg) categories of patients with mild to moderate essential hypertension were randomly divided into two groups: irbesartan group (150 mg once daily) Benazepril group (10 mg once daily). The dose of SeDBP≥90 mmHg was doubled at 4 weeks and continued for 4 weeks. At the end of placebo and 2,4,6,8 weeks of treatment, blood pressure and heart rate were measured and symptoms and signs were recorded. Laboratory tests were performed before and after the test. Results: Efficacy of iridosartan 81.2%, benazepril group 70.5%, no significant difference between the two groups (P> 0.05). SeSBP / SeDBP decreased in the 8-week irbesartan group and the benazepril group, and the decrease of SeDBP in the 2, 4, 6, and 8-week irbesartan group was greater than that in the benazepril group, with significant difference between the two groups (P <0.05 for 4 weeks, P <0.01 for 05, 6, 6 and 8 weeks). Benazepril cough in 5 cases, the incidence of 8%. Conclusion; Irbesartan 150 ~ 300 mg / d treatment of mild to moderate essential hypertension efficiency is similar to that of benazepril