复方缬沙坦治疗轻中度原发性高血压的疗效观察  

Randomised double-blinded trial evaluating valsartan/ hydrochlorothiazide for patients with mild to moderate essential hypertension

作　　者：张烁[1] 李丽丽[1] 杜秀敏[1] 李厚伟[1] 杨爽[1] 赵德超[1] 于波[1] 关振中[1] 

机构地区：[1]哈尔滨医科大学第二临床医学院心内科,黑龙江哈尔滨150081

出　　处：《哈尔滨医科大学学报》2009年第5期507-510,共4页Journal of Harbin Medical University

基　　金：国家863计划课题(2004AA2Z3761)

摘　　要：目的观察复方缬沙坦(VAL/HCT)对我国东北方地区轻中度原发性高血压患者的疗效及安全性。方法123例轻中度原发性高血压患者随机分为试验组及对照组,分别给与VAL/HCT或缬沙坦(VAL)双盲治疗6周,评价两组患者治疗前后平均坐位收缩压(MSSBP)和平均坐位舒张压(MSDBP)的降低情况,同时观察用药后不良事件的发生率。另选19例轻中度原发性高血压患者给予复方缬沙坦开放治疗4周,在治疗前后行24 h动态血压监测进行降压疗效及安全性评价。结果双盲治疗6周后,两组MSSBP和MSDBP均显著下降(P<0.001),试验组较对照组下降更多(P<0.05),试验组MSDBP的降低亦较对照组更明显,但未达到有统计学意义(P>0.05)。试验组总疗效高于对照组,但差异未达到统计学意义(P>0.05)。不良事件发生率试验组和对照组无显著差别无明显差别(P>0.05)。开放试验总有效率为89.47%,收缩压T/P比值平均估计值为59.6%,舒张压T/P比值平均估计值为66.4%。结论与单用缬沙坦相比复方缬沙坦可更显著地降低收缩压,并可有效降低舒张压,且有较良好的降压稳定性,且不良反应轻微,安全性高。Objective To evaluate the efficacy and safety of combination therapy with valsartan and hydrochlorothiazide for patients with mild to myderate essential hypertension in north China. Methods One hundred and twenty-three patients were randomly divided into the V80/H12. 5 （valsartan 80 mg/ hydroehlorothiazide 12. 5 mg） group or the V80 （ valsartan 80 mg） group. Six weeks after treatment, the mean decrease from baseline in sitting systolic blood pressure （SSBP） and sitting diastolic blood pressure （SDBP） were measured. The incidence of side adverse events was also observed. In addition, another 19 patients was also enrolled to accept VSO/H12.5 therapy for 4 weeks： Ambulatory blood pressure monitor （ABPM） was conducted before and after drug therapy. Results Six weeks after treatment, compared with baseline, the SSBP and SDBP were significantly decreased in both the V80 group and the V80/H12.5 group. But the decrease from baseline in SSBP was significantly higher in the V80/H12. 5 group than the V80 group （P 〈 0.05 ）, and there was no difference in the change of SDBP between the two groups （P 〉 0.05 ）. There was no significantly difference in therapeutic efficacy between the two groups （P 〉 0.05）. The incidence of adverse events was also similar in the two groups （ P 〉 0.05 ）. Furthermore, the results of ABPM also showed thatthe systolic T/P ratio was 59.6% and the diastolic T/P ratio was 66.4%. Conclusion Compared with nontherapy with Valsartan 80 mg, the combination therapy with V80/H12.5 can significantly decrease systolic blood pressure and also can decrease diastolic blood pressure. Furthermore, the combination with V80/H12.5 can decrease blood pressure steadily and be well tolerated.

关 键 词：血管紧张素受体拮抗剂 缬沙坦 氢氯噻嗪 原发性高血压 

分 类 号：R972.4[医药卫生—药品]