中华心血管病杂志
中華心血管病雜誌
중화심혈관병잡지
Chinese Journal of Cardiology
2008年
4期
300-304
,共5页
陈绍行%张瑾%陈绍良%陈君柱%严晓伟%柯元南%杜凤和%张承宗%秦永文%蒲奎%朱鼎良
陳紹行%張瑾%陳紹良%陳君柱%嚴曉偉%柯元南%杜鳳和%張承宗%秦永文%蒲奎%硃鼎良
진소행%장근%진소량%진군주%엄효위%가원남%두봉화%장승종%진영문%포규%주정량
高血压%血管紧张素Ⅱ1型受体拮抗剂%氢氯噻嗪%复方合剂%治疗结果
高血壓%血管緊張素Ⅱ1型受體拮抗劑%氫氯噻嗪%複方閤劑%治療結果
고혈압%혈관긴장소Ⅱ1형수체길항제%경록새진%복방합제%치료결과
Hypertension%Angiotensin Ⅱ type 1 receptor blockers%Hydrochlorothiazide%Drug combinations%Treatment outcome
目的 评价复方替米沙坦在替米沙坦单药治疗无充分反应时中国高血压患者中的有效性和安全性.方法 多中心、随机、双盲、双模拟临床试验.经1周安慰剂筛选期,699例符合入选标准的轻、中度高血压患者进入80 mg替米沙坦单药开放治疗期.345例对替米沙坦单药开放治疗8周无充分反应[平均坐位舒张压≥90 mm Hg(1 mm Hg=0.133 kPa)]的患者进入为期8周的随机双盲治疗期.175例患者进入复方替米沙坦治疗组(80 mg替米沙坦加12.5 mg氢氯噻嗪),170例进入80 mg替米沙坦单药治疗组.每次随访测量坐位和立位的收缩压和舒张压谷值,记录不良事件.筛选期以及开放和随机双盲治疗期结束时进行实验室和心电图检查.结果 (1)与开放治疗期结束(基线)比较,随机双盲治疗8周后,复方替米沙坦组坐位舒张压谷值平均下降10.1 mm Hg,替米沙坦单药组平均下降7.7 mm Hg,两组间比较P=0.0017.复方替米沙坦组坐位收缩压谷值平均下降14.2 mm Hg,替米沙坦单药组平均下降7.4 mm Hg,两组间比较P＜0.0001.(2)与基线比较,随机双盲治疗8周后,复方替米沙坦组立位舒张压和收缩压谷值平均下降幅度大于替米沙坦单药组,两组间比较P=0.0350和P＜0.0001.(3)按照平均坐位舒张压谷值＜90 mm Hg和(或)与基线值相比降低≥10 mm Hg评价,随机双盲治疗8周后,复方替米沙坦组有效率为74.6%(129例患者),替米沙坦单药组为59.2%(100例患者),两组间比较P=0.0016.(4)在随机双盲期,两组与试验药物有关的不良事件发生率分别为3.5%和3.6%,两组间比较P＞0.05.结论 替米沙坦单药治疗无充分反应的中国高血压患者,复方替米沙坦每日口服一次能够进一步降低血压,且安全性良好.
目的 評價複方替米沙坦在替米沙坦單藥治療無充分反應時中國高血壓患者中的有效性和安全性.方法 多中心、隨機、雙盲、雙模擬臨床試驗.經1週安慰劑篩選期,699例符閤入選標準的輕、中度高血壓患者進入80 mg替米沙坦單藥開放治療期.345例對替米沙坦單藥開放治療8週無充分反應[平均坐位舒張壓≥90 mm Hg(1 mm Hg=0.133 kPa)]的患者進入為期8週的隨機雙盲治療期.175例患者進入複方替米沙坦治療組(80 mg替米沙坦加12.5 mg氫氯噻嗪),170例進入80 mg替米沙坦單藥治療組.每次隨訪測量坐位和立位的收縮壓和舒張壓穀值,記錄不良事件.篩選期以及開放和隨機雙盲治療期結束時進行實驗室和心電圖檢查.結果 (1)與開放治療期結束(基線)比較,隨機雙盲治療8週後,複方替米沙坦組坐位舒張壓穀值平均下降10.1 mm Hg,替米沙坦單藥組平均下降7.7 mm Hg,兩組間比較P=0.0017.複方替米沙坦組坐位收縮壓穀值平均下降14.2 mm Hg,替米沙坦單藥組平均下降7.4 mm Hg,兩組間比較P＜0.0001.(2)與基線比較,隨機雙盲治療8週後,複方替米沙坦組立位舒張壓和收縮壓穀值平均下降幅度大于替米沙坦單藥組,兩組間比較P=0.0350和P＜0.0001.(3)按照平均坐位舒張壓穀值＜90 mm Hg和(或)與基線值相比降低≥10 mm Hg評價,隨機雙盲治療8週後,複方替米沙坦組有效率為74.6%(129例患者),替米沙坦單藥組為59.2%(100例患者),兩組間比較P=0.0016.(4)在隨機雙盲期,兩組與試驗藥物有關的不良事件髮生率分彆為3.5%和3.6%,兩組間比較P＞0.05.結論 替米沙坦單藥治療無充分反應的中國高血壓患者,複方替米沙坦每日口服一次能夠進一步降低血壓,且安全性良好.
목적 평개복방체미사탄재체미사탄단약치료무충분반응시중국고혈압환자중적유효성화안전성.방법 다중심、수궤、쌍맹、쌍모의림상시험.경1주안위제사선기,699례부합입선표준적경、중도고혈압환자진입80 mg체미사탄단약개방치료기.345례대체미사탄단약개방치료8주무충분반응[평균좌위서장압≥90 mm Hg(1 mm Hg=0.133 kPa)]적환자진입위기8주적수궤쌍맹치료기.175례환자진입복방체미사탄치료조(80 mg체미사탄가12.5 mg경록새진),170례진입80 mg체미사탄단약치료조.매차수방측량좌위화립위적수축압화서장압곡치,기록불량사건.사선기이급개방화수궤쌍맹치료기결속시진행실험실화심전도검사.결과 (1)여개방치료기결속(기선)비교,수궤쌍맹치료8주후,복방체미사탄조좌위서장압곡치평균하강10.1 mm Hg,체미사탄단약조평균하강7.7 mm Hg,량조간비교P=0.0017.복방체미사탄조좌위수축압곡치평균하강14.2 mm Hg,체미사탄단약조평균하강7.4 mm Hg,량조간비교P＜0.0001.(2)여기선비교,수궤쌍맹치료8주후,복방체미사탄조립위서장압화수축압곡치평균하강폭도대우체미사탄단약조,량조간비교P=0.0350화P＜0.0001.(3)안조평균좌위서장압곡치＜90 mm Hg화(혹)여기선치상비강저≥10 mm Hg평개,수궤쌍맹치료8주후,복방체미사탄조유효솔위74.6%(129례환자),체미사탄단약조위59.2%(100례환자),량조간비교P=0.0016.(4)재수궤쌍맹기,량조여시험약물유관적불량사건발생솔분별위3.5%화3.6%,량조간비교P＞0.05.결론 체미사탄단약치료무충분반응적중국고혈압환자,복방체미사탄매일구복일차능구진일보강저혈압,차안전성량호.
Objective To evaluate the efficacy and safety of a fixed dose combination of telmisartan 80 mg plus hydrochlothiazide(HCTZ)12.5 mg(TH)to telmisartan 80 mg(T)in Chinese patients who failed to respond adequately to treatment with T.Method This is a multi-center, randomized, doubleblind, double-dummy clinical study.A total of 699 eligible hypertensive patients entered a one-week screening phase prior to the eight-week open-label T period.At the end of eight weeks,345 patients who failed to respond to T(DBP≥90 mm Hg,1 mm Hg=0.133 kPa)were randomized to receive either TH (175 patients)or T(170 patients)for another eight weeks.Sitting and standing BP were taken 24 hours post-dose and adverse events were documented at visit with 4 weeks interval.Laboratory.ECG and physical examination were performed at screening.at baseline and at the final visit.Results After 8 weekstreatment,(1)The mean trough reduction in sitting diastolic blood pressure(SiDBP)from baseline in TH group was greater than that in T group(10.1 mm Hg vs 7.7 mm Hg,P=0.0017).The mean trough reduction in sitting systolic blood pressure(SiSBP)from baseline was 14.2 mm Hg in TH group and 7.4 mm Hg in T group(P＜0.0001).(2)The mean trough reduction in standing DBP and standing SBP from baseline were significantly greater in TH group(8.7 mm Hg and 12.9 mm Hg)compared those in T group (7.3 mm Hg and 7.0 mmHg,P=0.0350,P＜0.0001).(3)The number and percentage of responders in TH group(129,74.6%)were significantly higher than in T group(100,59.2%,P=0.0016).(4)The incidence of the study drug-related adverse events was similar between TH and T group(3.5%vs.3.6%,P＞0.05).Conclusion TH was more effective than T in patients not responded adequately to T in Chinese hypertensive patients.
