中华心血管病杂志
中華心血管病雜誌
중화심혈관병잡지
Chinese Journal of Cardiology
2011年
1期
57-60
,共4页
樊朝美%闫丽荣%陶永康%王莉%刘玉清%高明明%王燕妮%李成祥%王效浣%卢晓雷%庞会敏%李一石
樊朝美%閆麗榮%陶永康%王莉%劉玉清%高明明%王燕妮%李成祥%王效浣%盧曉雷%龐會敏%李一石
번조미%염려영%도영강%왕리%류옥청%고명명%왕연니%리성상%왕효완%로효뢰%방회민%리일석
高血压%贝那普利%氨氯地平%药物治疗,联合
高血壓%貝那普利%氨氯地平%藥物治療,聯閤
고혈압%패나보리%안록지평%약물치료,연합
Hypertension%Benazepril%Amlodipine%Druy therapy,combination
目的 评价贝那普利/氨氯地平复方片剂与贝那普利片单药治疗轻、中度高血压患者的有效性和安全性.方法 本研究为多中心、随机、双盲、平行对照研究.356例原发性高血压患者经2周洗脱期后,再给予4周贝那普利片10 mg单药治疗,220例平均坐位舒张压(SeDBP)仍≥90 mm Hg(1 mm Hg=0.133 kPa)的患者随机分为贝那普利(10 mg)/氨氯地平(5 mg)固定剂量复方片剂组(复方制剂组,1片/d,n=113)和贝那普利片单药组(单药治疗组,20 mg/d,n=107),治疗4周末两组诊室SeDBP≥90 mmHg者剂量加倍.SeDBP＜90 mm Hg者续服原剂量,共随机双盲治疗8周.以总有效率和SeDBP下降差值作为主要疗效指标.其中74例患者(复方片剂组38例,单药组36例)完成了24 h动态血压监测,并作为降压疗效的评价指标.结果 随机、双盲治疗8周末,复方片剂组SeDBP下降值为(11.7±6.8)mm Hg、达目的 血压占65.7%、总有效率为88.5%;单药治疗组SeDBP下降值为(7.7±6.9)mm Hg、达目的 血压占35.5%、总有效率为65.5%.两组组间比较差异均有统计学意义(P＜0.001).24 h动态血压监测结果,复方制剂组和单药组的舒张压/收缩压(DBP/SBP)的谷/峰比率(T/P)分别为83.1%/76.0%和85.8%/79.5%(P＜0.05).复方制剂组与单药治疗组的不良反应发生率分别为16.8%和35.5%(P＜0.01).结论 贝那普利/氨氯地平复方制剂治疗原发性高血压患者的降压疗效明显优于贝那普利单药治疗,且有良好的耐受性.
目的 評價貝那普利/氨氯地平複方片劑與貝那普利片單藥治療輕、中度高血壓患者的有效性和安全性.方法 本研究為多中心、隨機、雙盲、平行對照研究.356例原髮性高血壓患者經2週洗脫期後,再給予4週貝那普利片10 mg單藥治療,220例平均坐位舒張壓(SeDBP)仍≥90 mm Hg(1 mm Hg=0.133 kPa)的患者隨機分為貝那普利(10 mg)/氨氯地平(5 mg)固定劑量複方片劑組(複方製劑組,1片/d,n=113)和貝那普利片單藥組(單藥治療組,20 mg/d,n=107),治療4週末兩組診室SeDBP≥90 mmHg者劑量加倍.SeDBP＜90 mm Hg者續服原劑量,共隨機雙盲治療8週.以總有效率和SeDBP下降差值作為主要療效指標.其中74例患者(複方片劑組38例,單藥組36例)完成瞭24 h動態血壓鑑測,併作為降壓療效的評價指標.結果 隨機、雙盲治療8週末,複方片劑組SeDBP下降值為(11.7±6.8)mm Hg、達目的 血壓佔65.7%、總有效率為88.5%;單藥治療組SeDBP下降值為(7.7±6.9)mm Hg、達目的 血壓佔35.5%、總有效率為65.5%.兩組組間比較差異均有統計學意義(P＜0.001).24 h動態血壓鑑測結果,複方製劑組和單藥組的舒張壓/收縮壓(DBP/SBP)的穀/峰比率(T/P)分彆為83.1%/76.0%和85.8%/79.5%(P＜0.05).複方製劑組與單藥治療組的不良反應髮生率分彆為16.8%和35.5%(P＜0.01).結論 貝那普利/氨氯地平複方製劑治療原髮性高血壓患者的降壓療效明顯優于貝那普利單藥治療,且有良好的耐受性.
목적 평개패나보리/안록지평복방편제여패나보리편단약치료경、중도고혈압환자적유효성화안전성.방법 본연구위다중심、수궤、쌍맹、평행대조연구.356례원발성고혈압환자경2주세탈기후,재급여4주패나보리편10 mg단약치료,220례평균좌위서장압(SeDBP)잉≥90 mm Hg(1 mm Hg=0.133 kPa)적환자수궤분위패나보리(10 mg)/안록지평(5 mg)고정제량복방편제조(복방제제조,1편/d,n=113)화패나보리편단약조(단약치료조,20 mg/d,n=107),치료4주말량조진실SeDBP≥90 mmHg자제량가배.SeDBP＜90 mm Hg자속복원제량,공수궤쌍맹치료8주.이총유효솔화SeDBP하강차치작위주요료효지표.기중74례환자(복방편제조38례,단약조36례)완성료24 h동태혈압감측,병작위강압료효적평개지표.결과 수궤、쌍맹치료8주말,복방편제조SeDBP하강치위(11.7±6.8)mm Hg、체목적 혈압점65.7%、총유효솔위88.5%;단약치료조SeDBP하강치위(7.7±6.9)mm Hg、체목적 혈압점35.5%、총유효솔위65.5%.량조조간비교차이균유통계학의의(P＜0.001).24 h동태혈압감측결과,복방제제조화단약조적서장압/수축압(DBP/SBP)적곡/봉비솔(T/P)분별위83.1%/76.0%화85.8%/79.5%(P＜0.05).복방제제조여단약치료조적불량반응발생솔분별위16.8%화35.5%(P＜0.01).결론 패나보리/안록지평복방제제치료원발성고혈압환자적강압료효명현우우패나보리단약치료,차유량호적내수성.
Objective To evaluate the efficacy and tolerability of the fixed combination of amlodipine 5 mg/benazepril 10 mg once-daily therapy, compared with benazepril, 10 mg, monotherapy in patients with mild and moderate hypertension, and to evaluate the 24 h antihypertensive efficacy and the duration of action by ambulatory blood pressure monitoring Methods In a multicenter, randomized,double-blind, parallel controlled trial, 356 cases of hypertensive patients after 2 weeks wash-out, and then given 4 weeks of benazepril 10 mg monotherapy, 220 patients with mean seated diastolic blood pressure (SeDBP)remained ≥90 mm Hg(1 mm Hg = 0. 133 kPa)were randomly divided into benazepril 10 mg/amlodipine 5 mg(BZ10/AML5)fixed-dose combination therapy group(once a day, n = 113), and benazepril monotherapy group(daily 20 mg, n = 107). In the two groups the patients with SeDBP≥90 mm Hg were doubled the dosage of the initial regimen at the end of 4-week treatment for additional 4 weeks , and the patients with SeDBP ＜ 90 mm Hg remained the initial regimen for additional 4 weeks. The primary endpoint was to evaluate the improvement of SeDBP at the end of 8-week treatment. There were 74 patients(the combination therapy group n = 38, monotherapy therapy group n = 36)completed the 24 h ambulatory blood pressure monitoring which was included in the final efficacy analysis. Results The randomized, doubleblind treatment for 8 weeks, the mean value of SeDBP reduction, the reaching target blood pressure rate and total successful response rate to the treatment(a SeDBP ＜ 90 mm Hg or a decrease of 10 mm Hg or more from baseline)were(11.7 ± 6.8)mm Hg, 65.7% and 88.5% in the combination therapy group,respectively, and were(7.7 ±6. 9)mm Hg, 35.5% and 65.5% in the monotherapy group, respectively.There were statistically significant difference between the combination therapy and the monotherapy groups in all the 3 indexs(P ＜ 0. 001). The fixed combination significantly reduced systolic blood pressure(SBP)and diastolic blood pressure(DBP)values throughout the 24 h. The trough to peak ratios of DBP/SBP in the fixed compound of benazepril/amlodipine(10 mg/5 mg)and benazepril(20 mg)alone were 83. 1%/76. 0% and 85.8%/79. 5%, respectively. Adverse events rates were 16. 8% in the combination therapy group and 35.5% in the monotherapy group(P ＜ 0. 001). Conclusions The combination therapy with benazepril/amlodipine was superior to benazepril monotherapy and was well tolerated in patients with essential hypertension and allowing a satisfactory BP control for 24 hours.
