CAJ | 학술논문

目的比较培哚普利精氨酸盐与培哚普利叔丁胺盐两种剂型治疗原发性轻中度高血压患者的疗效和安全性.方法采用多中心、随机、双盲、活性药物平行对照设计.入选2010年7月至2011年5月北京大学第一医院等全国共19家中心的轻中度高血压患者524例,经过2周安慰剂导入期,最终369例入选,随机接受培哚普利精氨酸盐5 mg(试验组,186例)或培哚普利叔丁胺盐4 mg(对照组,183例)治疗.随机顺序由施维雅国际研究中心的生物统计部生成,在各中心内进行了平衡.经过8周双盲治疗后,根据血压达标情况调整服药剂量,对于血压未达标者,即坐位收缩压≥140 mmHg(1 mmHg =0.133 kPa)和(或)坐位舒张压≥90 mmHg,上调剂量至精氨酸盐10 mg或者叔丁胺盐8 mg,继续双盲治疗4周.同时观察两组患者药物治疗的安全性指标.结果治疗8周时,试验组和对照组患者坐位收缩压分别下降了(19.9±17.2)和(18.5±14.7) mmHg(P=0.0005),舒张压分别下降了(12.0±10.0)和(11.0±8.9) mmHg(P＜0.000 1).治疗12周时两组收缩压及舒张压的降低幅度依然类似.试验组和对照组组间血压达标率和治疗有效率均相当[8周达标率38.5％比31.3％,95％ CI(-2.6 ～ 16.9),12周达标率36.3％比35.7％,95％ CI(-9.3 ～10.4);8周有效率64.3％比63.2％,95％CI(-8.8～11.0),12周有效率65.9％比64.8％,95％ CI(-8.7～ 10.9)].两组患者不良事件发生率均较低.结论对于原发性轻中度高血压患者,培哚普利精氨酸盐的降压疗效与培哚普利叔丁胺盐相当,且安全性良好.
목적 비교배타보리정안산염여배타보리숙정알염량충제형치료원발성경중도고혈압환자적료효화안전성.방법 채용다중심、수궤、쌍맹、활성약물평행대조설계.입선2010년7월지2011년5월북경대학제일의원등전국공19가중심적경중도고혈압환자524례,경과2주안위제도입기,최종369례입선,수궤접수배타보리정안산염5 mg(시험조,186례)혹배타보리숙정알염4 mg(대조조,183례)치료.수궤순서유시유아국제연구중심적생물통계부생성,재각중심내진행료평형.경과8주쌍맹치료후,근거혈압체표정황조정복약제량,대우혈압미체표자,즉좌위수축압≥140 mmHg(1 mmHg =0.133 kPa)화(혹)좌위서장압≥90 mmHg,상조제량지정안산염10 mg혹자숙정알염8 mg,계속쌍맹치료4주.동시관찰량조환자약물치료적안전성지표.결과 치료8주시,시험조화대조조환자좌위수축압분별하강료(19.9±17.2)화(18.5±14.7) mmHg(P=0.0005),서장압분별하강료(12.0±10.0)화(11.0±8.9) mmHg(P＜0.000 1).치료12주시량조수축압급서장압적강저폭도의연유사.시험조화대조조조간혈압체표솔화치료유효솔균상당[8주체표솔38.5％비31.3％,95％ CI(-2.6 ～ 16.9),12주체표솔36.3％비35.7％,95％ CI(-9.3 ～10.4);8주유효솔64.3％비63.2％,95％CI(-8.8～11.0),12주유효솔65.9％비64.8％,95％ CI(-8.7～ 10.9)].량조환자불량사건발생솔균교저.결론 대우원발성경중도고혈압환자,배타보리정안산염적강압료효여배타보리숙정알염상당,차안전성량호.
Objective To compare the efficacy and safety of 5 mg perindopril arginine salt and 4 mg perindopril tert-butylamine salt for patients with mild to moderate essential hypertension.Methods The study was designed as multicenter, randomized, double-blind, active controlled trial with two parallel groups enrolling 524 participants with mild to moderate essential hypertension.After 2-week run-in period, 186 patients were enrolled and randomly treated with 5 mg perindopril arginine salt and 183 patients were enrolled and randomly treated with 4 mg perindopril tert-butylamine salt.The random sequence was generated by the I.R.I.S., and a balance was made in each center.After double-blind treatment for 8 weeks, the dose could be doubled for patients with uncontrolled BP((SBP) ≥ 140 mmHg(1 mmHg =0.133 kPa) or diastolic blood pressure (DBP) ≥ 90 mmHg) and patients were treated for another 4 weeks.Results The sitting SBP was similarly decreased by (19.9 ± 17.2) mmHg in perindopril arginine group and (18.5 ± 14.7) mmHg (P =0.000 5) in perindopril tert-butylamine group post 8 weeks treatment.Dose was doubled in 109 patients(59.9％)in perindopril arginine group and 116 patients (63.7％)in perindopril tert-butylamine group.At 12 weeks post therapy, the sitting SBP decreased by (19.8 ± 16.2) and (19.6 ± 16.3) mmHg respectively in the 2 groups.The decrease of sitting DBP was also similar in both groups (-12.0 ± 10.0) mmHg and (-11.0-8.9) mmHg (P ＜ 0.000 1), respectively.The control rate or response rate was also similar between the two groups(control rate over 8 weeks was 38.5％ vs.31.3％ ,95％ CI(-2.6-16.9) ,control rate over 12 weeks was 36.3％ vs.35.7％, 95％ CI (-9.3-10.4) , response rate over 8 weeks was 64.3％ vs.63.2％ ,95％ CI(-8.8-11.0) ,response rate over 12 weeks was 65.9％ vs.64.8％ ,95％ CI(-8.7-10.9)).Incidence of adverse events was low and similar in both therapy groups.Conclusions The results show that perindopril arginine salt 5 mg is as efficient as perindopril tert-butylamine 4 mg on lowering BP for patients with mild to moderate essential hypertension.Both drugs have good safety profile and are well tolerated by patients in this cohort.