评价非洛地平缓释片单药与以其为基础的联合降压方案对中国轻、中度原发性高血压患者的有效性、安全性及耐受性

Efficacy,safety and tolerance of Felodipine controlled release tablets and Felodipine controlled release tablets associated combination therapy in the treatment of mild to moderate essential hypertension in China

目的:评价以非洛地平缓释片为基础的联合美托洛尔、赖诺普利或氢氯噻嗪的联合用药方案与非洛地平缓释片单药比较,其对中国轻、中度原发性高血压患者治疗12周后血压达标百分比及安全性、耐受性情况。方法:多中心、随机、开放临床试验。结果:(1)联合治疗12周后血压达标的百分比率:以非洛地平缓释片为基础的联合氢氯塞嗪组意向性治疗(intention-to-treatment,ITT)人群为80.2%;联合美托洛尔组ITT人群为74.1%;联合赖诺普利组ITT人群为80.5%。(2)所有受试者的收缩压和舒张压较基线的下降值:联合氢氯噻嗪组平均为16.8/10.6mmHg,联合美托洛尔组平均为16.6/10.7mmHg,联合赖诺普利组平均为18.0/12.8mmHg。3组之间两两比较差异均无统计学意义(P>0.05)。非洛地平缓释片单药治疗14周平均下降24.8/17.5mmHg。其中非洛地平缓释片联合赖诺普利方案可以使舒张压快速下降,更早达标。(3)所有服药受试者(ITT集)中的服药依从性为:非洛地平缓释片单药组97.7%;以非洛地平缓释片为基础的联合氢氯塞嗪组89.8%,联合美托洛尔组100.0%;联合赖诺普利组96.4%。与研究药物相关的不良事件:非洛地平单药组21.5%,联合氢氯噻嗪组16.3%,联合美托洛尔组20.0%,联合赖诺普利组29.4%。主要不良事件在非洛地平单药组为头痛,而在联合赖诺普利后主要不良事件为咳嗽。结论:非洛地平缓释片单药具有较强的降压效果,而以非洛地平缓释片为基础的联合美托洛尔、赖诺普利或氢氯噻嗪的联合用药方案可使近80%高血压患者治疗达标,且安全性、耐受性好,依从性高。

Objective： To evaluate the efficacy, safety and tolerance of Felodipine controlled release tablets and Felodipine controlled release tablets associated combination each with Metoprolol, Lisinopril or Hydrochlorothiazide in the 12 week＇ s treatment of mild to moderate essential hypertension in China. Methods：Multicenter, random samples, and open study have been processed. Results： （1）After 12 week＇ s associated combination treatment of antihypertension, the percentages of the persons who had attained the target were 80.2% of ITT group in Felodipine controlled release tablets associated combination with Hydrochlorothiazide, 74.1% of ITT group in with Metoprolol,and 80.5% of ITT group in with Lisinopril, respectively. （2）Mean reductions of systolic/diastolic blood pressure from baseline were 16.8/ 10.6 mm Hg in combination with Hydrochlorothiazide, 16.6/10.7 mm Hg in combination with Metoprolol,and 18.0/12.8 mm Hg in combination with Lisinopril each. There was no significant difference among these three groups （P 〉 0.05 ）. With the Felodipine controlled release tablets treatment alone, the mean reductions from baseline was 24.8/17.5 mm Hg. But in combination with Lisinopril, the blood pressure could lower more quickly, and then could reach the target more rapidly. （3）In the ITT group, the drug compliance with Felodipine controlled release tablets was 97.7%, with those in combination with Hydrochlorothiazide 89.8%, with those in combination with Metoprolol 100.0% , and with those in combination with Lisinopril 96.4%. The main adverse event related to Felodipine was headache, and to Lisinopril was cough. Conclusion： Antihypertensive drug Felodipine controlled release tablets are good and effective. And Felodipine controlled release tablet associated combination each with Metoprolol, Lisi-nopril or Hydrochlorothiazide can make most patients reach the treatment target, with safety, good tolerance, and high compliance.