缬沙坦氨氯地平片(Ⅰ)对难治性高血压患者血压控制及肾脏保护作用的长期随访研究

Long-term Follow-up Study on Valsartan and Amlodipine Tablets(Ⅰ)on Blood Pressure Control and Renal Protection of Patients with Refractory Hypertension

目的:研究缬沙坦氨氯地平片(Ⅰ)对难治性高血压患者血压控制及肾脏保护作用的长期随访效果。方法:120例难治性高血压患者遵循患者意愿分为对照组与观察组,各60例。所有患者住院期间均接受氨氯地平+缬沙坦+氢氯噻嗪三联治疗及生活方式干预,出院时血压控制较好。对照组患者出院后继续给予氨氯地平,观察组患者给予缬沙坦氨氯地平片(Ⅰ)口服,每次1片,qd,根据患者血压水平适当增加剂量,最大剂量不超过2片。所有患者均随访18个月,观察两组患者不同时间点的血压水平和肾功能指标、末次随访时的血压控制率和肾功能损伤率,以及不良反应发生情况。结果:观察组和对照组分别有2、3例患者失访。两组患者随访12、18个月时的24 h收缩压、24 h舒张压、24 h尿蛋白定量均较出院前明显上升,肌酐清除率较出院前明显下降,但观察组的上述指标明显优于对照组,差异均有统计学意义(P<0.05)。末次随访时,观察组患者的血压控制率明显高于对照组(84.5%vs.52.6%),肾功能损伤率明显低于对照组(8.6%vs.24.6%),两组比较差异有统计学意义(P<0.05)。两组患者不良反应发生率比较,差异无统计学意义(P>0.05)。结论:缬沙坦氨氯地平片(Ⅰ)在难治性高血压患者长期随访血压控制中有明显优势,能显著降低肾功能损伤发生率,且安全性较高。

OBJECTIVE：To study the effect of long-term follow-up of Valsartan and amlodipine tablets（Ⅰ）on blood pressure control and renal protection of patients with refractory hypertension. METHODS：120 patients with refractory hypertension were divided into control group and observation group according to the patients＇ wishes,with 60 cases in each group. All patients accepted the triple therapy of amlodipine ＋ valsartan ＋ hydrochlorothiazide and life-style intervention;at the time of discharge from hospital,the blood pressure was well controlled. After discharge from hospital,control group was given amlodipine;observation group was given Valsartan and amlodipine tablet（Ⅰ）orally,1 tablet each time,qd,and dose increasing according to blood pressure,with maximal dose no more than 2 tablets. With 18 months of follow-up,blood pressure and renal function indexes of 2 groups were observed at different time points,and blood pressure control rate and the rate of renal function injury were also observed at the last follow-up;the occurrence of ADR was observed. RESULTS：2 cases and 3 cases were follow-up loss in observation group and control group,respectively. With 12 and 18 months of follow-up,24 h systolic pressure,24 h diastolic pressure and 24 h urine protein of 2 groups increased significantly while creatinine clearance rate decreased significantly compared with before discharge;but the indexes of observation group was better than that of control group,with statistical significance（P〈0.05）. At last follow-up,the rate of blood pressure in observation group was significantly higher than in control group（84.5% vs. 52.6%）,the rate of renal function injury was significantly lower than control group（8.6% vs. 24.6%）,with statistical significance（P〈0.05）. There was no statistical significance in the incidence of ADR between 2 groups（P〉0.05）. CONCLUSIONS：Valsartan amlodipine tablet（Ⅰ）has obvious advantages in long-term follow-up of blood pressure control of patients with refractory hypertension. It can significantly reduce the incidence of renal function injury with good safety.