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目的:评价国产缬沙坦80 mg/氢氯噻嗪12.5 mg复方制剂(复方缬沙坦)治疗原发性轻中度高血压的临床疗效。方法:采用随机、单盲、自身对照的多中心研究,入选轻中度原发性高血压患者222例,年龄18~69岁,坐位舒张压(SeDBP)95~114 mmHg和坐位收缩压(SeSBP)<180 mmHg,不伴有严重的靶器官损害。经2周洗脱期后,全部口服单剂缬沙坦80 mg·d~(-1),qd,服用2周后血压作为观察基线值,未达标者改服复方缬沙坦(80 mg/12.5 mg.qd),服药6周后与自身基线值比较,评价其疗效及安全性。结果:112例患者完成了6周的复方缬沙坦治疗,6周后平均坐位舒张压和收缩压分别下降了(10.04±7.34)mmHg和(14.18±11.83)mmHg,治疗有效率为76.8%(86/112例)。结论:复方缬沙坦治疗国人轻中度原发性高血压安全有效,可维持24 h平稳降压。
Objective: To evaluate the clinical efficacy of domestic valsartan 80 mg / hydrochlorothiazide 12.5 mg compound (compound valsartan) in the treatment of mild to moderate essential hypertension. Methods: A randomized, single-blind, self-controlled, multicenter study was enrolled in 222 patients with mild-to-moderate essential hypertension aged 18-69 years with a SeDBP of 95-114 mmHg and a seated systolic pressure ) <180 mmHg, without serious target organ damage. After two weeks of elution period, all the oral single dose of valsartan 80 mg · d ~ (-1), qd, take blood pressure after 2 weeks as the baseline value of observation, those who fail to change the compound valsartan (80 mg / 12.5 mg.qd), after 6 weeks of taking their own baseline values, evaluate its efficacy and safety. RESULTS: A total of 112 patients completed 6 weeks of valsartan treatment. Mean sitting diastolic and systolic pressures decreased (10.04 ± 7.34) mmHg and (14.18 ± 11.83) mmHg, respectively, after 6 weeks , The effective rate of treatment was 76.8% (86/112 cases). Conclusion: The compound valsartan is safe and effective in treating mild to moderate essential hypertension in our country and can maintain stable blood pressure for 24 hours.