缬沙坦治疗轻中度高血压疗效和安全性的研究

Safety of valsartan in treatment for mild and middle hypertension

目的评价缬沙坦治疗轻中度原发性高血压降压疗效和安全性。方法选择轻中度原发性高血压患者132例,采用随机、平行对照的方法,分成缬沙坦组(66例),每日1次80 mg口服;氨氯地平组(66例),每日1次5 mg口服。治疗4周末血压仍>140/90 mm Hg者剂量加倍。在8周观察期内不联用其他降压药。于治疗开始2、4、6、8周末测量诊室坐位谷值血压,同时记录性交次数、自觉症状及不良反应。实验开始前及结束时进行实验室检查。结果两组服药后2、4、6、8周收缩压和舒张压与服药前比较均有明显降低,差异有统计学意义(P<0.01);两组服药后2、4、6、8周血压下降对应组间比较差异无统计学意义(P>0.05);服药8周后,缬沙坦组和氨氯地平组血压达标率分别为89%和88%,组间比较差异无统计学意义。不良反应的发生率分别为缬沙坦组8%,氨氯地平组为6%,组间比较差异无统计学意义。两组试验结束时主要实验室检查指标,除缬沙坦组血钾与试验前比较差异有统计学意义外(P<0.05),其他差异均无统计学意义。缬沙坦组性功能均有不同程度的改善。结论缬沙坦对轻中度高血压患者疗效确切,安全可靠。

Objective To assess the efficacy and safety of vaLe,arran treating mild and middle essential hypertension （EH）. Methods Selected 132 patients with mild and middle EH at random, and were divided equally into two groups by way of parallel control：group Ⅰ given valsartan 80 mg once daily, and group Ⅱ given amlodipine 5 mg once daily. The patients whose blood pressure was still higher than 140/90 mm Hg at the end of 4-week treatment were given double dosage. The patients were not given other anti-hypertensive drugs in 8 week-observing durition. At the end of weeks 2,4,6 and 8 of the treatment, the patients＇ sitting blood pressure was measured, and coition times, subjective symptoms and the drug side-effects were recorded. The laboratory examination was made before and after the experiment. Results Systolic pressure and diastolic pressure of patients in both groups significantly decreased at the end of weeks 2, 4, 6 and 8 in comparison with th^se before the treatment, and the changes were statistically significant （P〈 0.01 ）. The difference in blood pressure decrease between both groups showed no significance （ P 〉 0.05）. Eight weeks after the treatment, the rate up to the standard blood pressure of valsartan group was 89%, and of amlodipine group was 88 %. There was no difference between the two groups. The incidence rate of drug side-effects was 8 % in valsartan group and 6% in amlodipine group, and there was also no statistical difference between the two groups. The laboratory results at the end of the experiments presented no statistical difference except the change of blood potassium in valsartan group. The sexual function of all the patients in valsartan group got different degrees of improvements. Conclusion For patients with mild and middle EH, valsartan treatment is satisfactory, safe and reliable.