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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。
PURPOSE: To evaluate the efficacy and safety of combination therapy with felodipine or metoprolol, lisinopril or hydrochlorothiazide versus felodipine sustained-release tablets. Hypertensive patients after treatment for 12 weeks, the percentage of blood pressure compliance and safety, tolerability. METHODS: A multicenter, randomized, open clinical trial. Results: (1) Percentage of blood pressure achieved after 12 weeks of combination therapy: 80.2% of ITT patients treated with felodipine-based metoprolol combined with hydrochlorothiazide were 80.2% The ITT population in the metoprolol group was 74.1%; the ITT population in the combined lisinopril group was 80.5%. (2) The systolic and diastolic blood pressure values of all subjects were significantly lower than those of the baseline (16.8 / 10.6 mmHg for the combined hydrochlorothiazide group and 16.6 / 10.7 mmHg for the metoprolol group, and for the combined lisinopril group 18.0 / 12.8 mmHg. There was no significant difference between the three groups (P> 0.05). Felodipine sustained-release tablets monotherapy for 14 weeks decreased by an average of 24.8 / 17.5mmHg. The felodipine extended release tablets combined with lisinopril regimen can rapidly reduce the diastolic blood pressure and reach the standard earlier. (3) Compliance with medication in all drug-taking subjects (ITT set) was 97.7% for the felodipine sustained-release tablets monotherapy group, 89.8% for the felodipine-based combination hydrochlorothiazide group, Metoprolol combined group 100.0%; combined lisinopril group 96.4%. Adverse events associated with the study drug were 21.5% in the felodipine monotherapy group, 16.3% in the hydrochlorothiazide group, 20.0% in the metoprolol group, and 29.4% in the lisinopril group. The main adverse event was headache in the felodipine monotherapy group, whereas the main adverse event was cough after co-administration of lisinopril. Conclusion: Felodipine sustained-release tablets have a strong antihypertensive effect, and the combination of metoprolol, lisinopril or hydrochlorothiazide based on felodipine sustained-release tablets can make nearly 80% Hypertensive patients meet the standard, and safety, well tolerated, high compliance.