缬沙坦/氨氯地平复方制剂治疗中重度高血压的临床研究

Clinical trial of the valsartan/amlodipine compound preparations and the single of two drugs for treatment of moderate and severe hypertension

目的观察复方降压药缬沙坦/氨氯地平片和氨氯地平联合缬沙坦治疗中重度高血压的降压疗效及安全性。方法选择门诊高血压患者120例(血压≥160/100 mm Hg)并随机分为2组,每组60例,治疗组口服缬沙坦/氨氯地平(80/5)85 mg,每天1次;对照组口服氨氯地平片5 mg和缬沙坦胶囊80 mg,均每天1次,共8周。观察2组治疗前后的血压变化情况及治疗期间发生的药物不良反应。结果服药后,2组患者血压均有明显下降(P<0.05),2组之间降压效果相似,差异无统计学意义(P>0.05)。结论缬沙坦/氨氯地平复方制剂降压疗效可靠且服用方便,患者依从性好。

Objective To evaluate the clinical efficacy and safety of valsartan/amlodipine compound preparations versus amlodipine combined with valsartan for treatment of moderate and severe hypertension.Methods One hundred and twenty subjects with hypertension （ BP≥160/100 mmHg ） were recruited from our hospital in the outpatient ser-vice department.The recruited 120 cases were randomized divided into treatment group and control group with each group of 60 cases.Patients in the treatment group were given valsartan /amlodipine compound prepa-rations （80/5） 85 mg one pil per day for 8 weeks and patients in the control group were given amlodipine 5 mg qd po plus valsartan 80 mg qd po with a treatment period of 8 weeks.The blood pressure and adverse drugs reaction （ ADR） between the two groups were recorded and com-pared.Results The blood pressure was significant decreased in both of two groups after taken the medicine but no statistical difference between the two groups was found （ P〉0.05 ）.And ADR in the two groups was also no statistical difference （ P〉0.05 ）.Conclusion The monolithic compound antihypertensive valsartan/amlodipine was reliable and similar to that of monolithic joint valsartan amlodipine.