CAJ | 학술논문

目的评价缬沙坦(80 mg)/氨氯地平(5 mg)复方片剂(复方片剂)治疗经氨氯地平5 mg或缬沙坦80 mg控制不良的轻、中度原发性高血压患者疗效和安全性.方法采用多中心、双盲、双模拟、随机、活性药物对照、平行试验方法进行两项临床研究.在两项研究中对经1～4周洗脱期的轻、中度原发性高血压患者[坐位舒张压≥95 mm Hg(1 mm Hg=0.133 kPa)且<110 mm Hg]分别采用单药氨氯地平5 mg或缬沙坦80 mg治疗4周,在单药导入结束后,坐位舒张压仍然≥90mm Hg且<110 mm Hg的患者随机进入复方片剂组或继续原有的单药治疗,共8周.其间,在治疗4周和试验结束时评估药物的安全性及有效性.结果治疗结束时,复方片剂组平均坐位收缩压/平均坐位舒张压下降幅度较氨氯地平单药治疗组多4.4mm Hg/3 mm Hg(P<0.0001);较缬沙坦80 mg组多6.4 mm Hg/4.2 mm Hg(P<0.0001).两项研究中复方片剂组的血压控制率(血压<140/90 mmHg)分别为71.0%及71.2%,显著优于氨氯地平或缬沙坦单药治疗组,不良事件发生率与单药治疗组相当.结论复方片剂组的血压控制率显著优于其两种成分(氨氯地平5 mg或缬沙坦80 mg)单药的治疗,且具有良好的安全性和耐受性.
목적 평개힐사탄(80 mg)/안록지평(5 mg)복방편제(복방편제)치료경안록지평5 mg혹힐사탄80 mg공제불량적경、중도원발성고혈압환자료효화안전성.방법 채용다중심、쌍맹、쌍모의、수궤、활성약물대조、평행시험방법진행량항림상연구.재량항연구중대경1～4주세탈기적경、중도원발성고혈압환자[좌위서장압≥95 mm Hg(1 mm Hg=0.133 kPa)차<110 mm Hg]분별채용단약안록지평5 mg혹힐사탄80 mg치료4주,재단약도입결속후,좌위서장압잉연≥90mm Hg차<110 mm Hg적환자수궤진입복방편제조혹계속원유적단약치료,공8주.기간,재치료4주화시험결속시평고약물적안전성급유효성.결과 치료결속시,복방편제조평균좌위수축압/평균좌위서장압하강폭도교안록지평단약치료조다4.4mm Hg/3 mm Hg(P<0.0001);교힐사탄80 mg조다6.4 mm Hg/4.2 mm Hg(P<0.0001).량항연구중복방편제조적혈압공제솔(혈압<140/90 mmHg)분별위71.0%급71.2%,현저우우안록지평혹힐사탄단약치료조,불량사건발생솔여단약치료조상당.결론 복방편제조적혈압공제솔현저우우기량충성분(안록지평5 mg혹힐사탄80 mg)단약적치료,차구유량호적안전성화내수성.
Objective To evaluate the efficacy and safety of a once daily valsartan/amlodipine 80/ 5 mg combination tablet in Chinese mild to moderate hypertensive patients without adequate blood pressure control by monotherapy. Methods Two muhicenter, randomized, double-blind, doubledummy, active-controlled, parallel group trials were conducted. After a washout period (no medication) of 1-4 weeks, patients with Mean Sitting Diastolic Blood Pressure (MSDBP) ≥95 nun Hg (1 mm Hg = 0.133 kPa) and < 110 mm Hg received a monotherapy of either Amlodipine 5 mg (in study 1) or valsartan 80 mg (in study 2) for 4 weeks. Patients with MSDBP ≥90 mm Hg and < 110 mm Hg at the end of the monotherapy period were randomized to receive valsartan/amlodipine 80/5 mg treatment, or continue with the monotherapy. Results In study 1, compared with amlodipine 5 nag, valsartan/amlodipine 80/5 nag once daily further reduced mean sitting systolic blood pressure (MSSBP)/MSDBP 4.4/3 mm Hg (P <0.0001). In study 2, compared with valsartan 80 mg, valsartan/amlodipine 80/5 mg once daily further reduced MSSBP/MSDBP 6.4/4.2 mm Hg (P<0.0001). The blood pressure (BP) control rates (BP < 140/90 mm Hg) of combination treatment group were 71.0% and 71.2% respectively, and significantly higher than the monotherapy groups in both trials. Incidence of adverse events was comparable in monotherapy and combination therapy groups. Conclusion Our results showed that valsartan/amlodipine 80/5 mg was superior to amlodipine 5 mg or valsartan 80 mg done in lowering blood pressure and BP control in patients with mild to moderate hypertension not adequately controlled with tanlodipine 5 mg or valsartan 80 mg monotherapy. No new or unexpected safety issues were identified with valsartan/amlodipine combination therapy compared with monotherapy.