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目的评价复方缬沙坦(缬沙坦80 mg/氢氯噻嗪12.5 mg 复方制剂)治疗经单用缬沙坦80 mg 控制不良的轻、中度原发性高血压患者疗效和安全性。方法采用多中心、双盲、双模拟、随机、活性药物对照、平行试验方法。对经2周洗脱期的轻、中度原发性高血压患者[坐位舒张压≥95mm Hg(1 mm Hg=0.133 kPa)且<110 mm Hg]采用单药缬沙坦80 mg/d 治疗4周,在单药导入结束后,坐位舒张压仍≥90 mm/Hg 的864例患者按1:1随机、双盲分为复方缬沙坦组或缬沙坦80 mg/d组,继续治疗8周。在治疗4周和结束时评估药物安全性及有效性。结果在轻、中度原发性高血压患者中复方缬沙坦每日1次比单用缬沙坦80 mg/d 血压进一步下降、达标率提高。治疗结束时平均坐位收缩压多降低3.5 mm Hg,平均坐位舒张压多下降2.2 mm Hg,血压控制<140/90 mm Hg 的患者在复方缬沙坦组和单用缬沙坦80 mg/d 组分别为53.9%及40.9%。结论轻、中度原发性高血压患者采用复方缬沙坦治疗组降压有效率及达标率均优于每日1次服用缬沙坦80 mg/d 组。复方缬沙坦适用于缬沙坦单药控制不良的轻、中度原发性高血压患者。
Objective To evaluate the efficacy and safety of compound valsartan (valsartan 80 mg / hydrochlorothiazide 12.5 mg) in the treatment of mild to moderate essential hypertension controlled by valsartan 80 mg alone. Methods Multi-center, double-blind, double-simulations, randomized, active drug control, parallel test methods. For patients with mild to moderate essential hypertension who had a 2-week washout [sitting diastolic blood pressure> 95 mm Hg (1 mm Hg = 0.133 kPa) and <110 mm Hg], single-agent valsartan 80 mg / d 4 weeks after the introduction of monotherapy, 864 patients with sitting diastolic blood pressure ≥ 90 mm / Hg were randomized into two groups according to the ratio of 1: 1: compound valsartan or valsartan 80 mg / d, and continued treatment 8 weeks. Drug safety and efficacy were evaluated at 4 weeks and at the end of treatment. Results In patients with mild or moderate essential hypertension, compound valsartan once daily decreased more than 80 mg / d valsartan alone, and the compliance rate increased. At the end of treatment, mean systolic blood pressure decreased by 3.5 mm Hg, mean diastolic blood pressure decreased by 2.2 mm Hg, and blood pressure was controlled <140/90 mm Hg in both valsartan and valsartan 80 mg / d Respectively at 53.9% and 40.9%. Conclusions Efficacy and compliance rate of valsartan 80 mg / d in patients with mild to moderate essential hypertension are better than those of valsartan once daily. Compound valsartan for valsartan monotherapy poor control of mild to moderate essential hypertension patients.