口服西地那非治疗肺动脉高压的效果和安全性初步研究
구복서지나비치료폐동맥고압적효과화안전성초보연구
Preliminary study on the efficacy and safety of oral sildenafil in pulmonary arterial hypertension in China
  • 万方数据
    中华医学杂志 중화의학잡지
    National Medical Journal of China
    2011年 6期 370-374 ,共5页

    熊长明%何建国%卢献灵%单广良%吴炳祥%朱鲜阳%武广华%曾小峰%郭涛%柳志红%倪新海%程显声%顾晴%赵智慧%田红燕%李为民%张端珍%张成%李梦涛%刘洪明%郭亚娟%沈节艳%张维君%刘双%周达新%鲍春德%黄石安%陈建英%伍伟峰%黄凯%李长岭%王丽华%贺蓓

    웅장명%하건국%로헌령%단엄량%오병상%주선양%무엄화%증소봉%곽도%류지홍%예신해%정현성%고청%조지혜%전홍연%리위민%장단진%장성%리몽도%류홍명%곽아연%침절염%장유군%류쌍%주체신%포춘덕%황석안%진건영%오위봉%황개%리장령%왕려화%하배

    西地那非%高血压,肺性%磷酸二酯酶抑制剂%治疗结果 西地那非%高血壓,肺性%燐痠二酯酶抑製劑%治療結果
    서지나비%고혈압,폐성%린산이지매억제제%치료결과
    Sildenafil%Hypertension,pulmonary%Phosphodiesterase inhibitor%Treatment outcome
    目的 国外研究表明西地那非能有效地降低肺动脉高压,改善活动耐量,提高生活质量.但中国肺动脉高压患者服用西地那非的效果和安全性尚不清楚.本研究旨在明确中国肺动脉高压患者口服西地那非的临床效果及安全性.方法 采用前瞻性、开放、多中心临床研究方法,根据右心导管检查结果进行病例筛选.所有人选患者口服枸橼酸西地那非25 mg,3次/d,共12周.观察基线和12周后所有患者6 min步行距离和血流动力学指标的变化.主要终点是6 min步行距离的变化.次要终点包括:Borg呼吸困难积分、世界卫生组织(WHO)肺动脉高压功能分级的改善、血流动力学指标的变化以及临床恶化(指死亡、心肺移植、再住院等)的情况.还观察了药物的安全性和耐受性.结果 共入选14个中心的90例肺动脉高压患者,其中男性19例,女性71例;年龄18～61岁,平均32.5岁.特发性肺动脉高压患者15例,先天性心脏病相关性肺动脉高压患者60例,结缔组织病相关性肺动脉高压患者9例,慢性血栓栓塞性肺动脉高压患者6例.患者口服西地那非12周后,6min步行距离明显提高,由基线(342±93)m增加到(403±88)m,P＜0.001;Borg呼吸困难积分由基线2.9±2.6降至2.4±2.0,P=0.005;肺动脉平均压由(73±21)mm Hg(1 mm Hg=0.133 kPa)降至(67±19)mm Hg,P=0.001;心指数由(2.6±1.3)L·min-1·m-2增加至(3.2±1.5)L·min-1·m-2,P＜0.001;肺血管阻力由(1744±908)dyn·s·cm-5降至(1334±657)dyn·s·cm-5,P＜0.001;而且世界卫生组织(WHO)肺动脉高压功能分级明显改善;口服西地那非副作用轻微.结论 本研究表明中国肺动脉高压患者口服西地那非可以提高患者的运动耐量、降低肺动脉压、提高生存质量,并有良好的耐受性.
    목적 국외연구표명서지나비능유효지강저폐동맥고압,개선활동내량,제고생활질량.단중국폐동맥고압환자복용서지나비적효과화안전성상불청초.본연구지재명학중국폐동맥고압환자구복서지나비적림상효과급안전성.방법 채용전첨성、개방、다중심림상연구방법,근거우심도관검사결과진행병례사선.소유인선환자구복구연산서지나비25 mg,3차/d,공12주.관찰기선화12주후소유환자6 min보행거리화혈류동역학지표적변화.주요종점시6 min보행거리적변화.차요종점포괄:Borg호흡곤난적분、세계위생조직(WHO)폐동맥고압공능분급적개선、혈류동역학지표적변화이급림상악화(지사망、심폐이식、재주원등)적정황.환관찰료약물적안전성화내수성.결과 공입선14개중심적90례폐동맥고압환자,기중남성19례,녀성71례;년령18～61세,평균32.5세.특발성폐동맥고압환자15례,선천성심장병상관성폐동맥고압환자60례,결체조직병상관성폐동맥고압환자9례,만성혈전전새성폐동맥고압환자6례.환자구복서지나비12주후,6min보행거리명현제고,유기선(342±93)m증가도(403±88)m,P＜0.001;Borg호흡곤난적분유기선2.9±2.6강지2.4±2.0,P=0.005;폐동맥평균압유(73±21)mm Hg(1 mm Hg=0.133 kPa)강지(67±19)mm Hg,P=0.001;심지수유(2.6±1.3)L·min-1·m-2증가지(3.2±1.5)L·min-1·m-2,P＜0.001;폐혈관조력유(1744±908)dyn·s·cm-5강지(1334±657)dyn·s·cm-5,P＜0.001;이차세계위생조직(WHO)폐동맥고압공능분급명현개선;구복서지나비부작용경미.결론 본연구표명중국폐동맥고압환자구복서지나비가이제고환자적운동내량、강저폐동맥압、제고생존질량,병유량호적내수성.
    Objective Sildenafil has been shown to be effective in pulmonary arterial hypertension (PAH).However,the impact of sildenafil on PAH has been under-investigated in China.The aim of the present study was to evaluate the efficacy and safety of oral sildenafil in PAH patients in China.Methods In this prospective,open-label and multi-center study,90 patients were recruited from 14 centers to receive oral sildenafil (75 mg/d) for 12 weeks.They underwent a six-minute walk test (SMWT) and cardiac catheterization at the beginning and the end of 12 weeks.The primary endpoint was the changes in exercise capacity as assessed by SMWT.And the secondary endpoints included assessment of functional class,evaluation of cardiopulmonary hemodynamics and clinical deterioration (defined as death,transplantation and re-hospitalization for PAH).Drug safety and tolerability were also examined.Results There were 19 males and 71 females with an average age of 32.5±12.1 years old(range: 18-61 ).Their etiologies were idiopathic (n=15),related with congenital heart disease ( n = 60 ),or related with connective tissue disease (n=9) and chronic thromboembombolic pulmonary hypertension ( n = 6).Oral sildenafil significantly increased the SMWT distances [(342±93) m vs.(403±88) m,P＜0.001].There was also remarkable improvement in Borg dyspnea score ( 2.9 ± 2.6 vs.2.4 ± 2.0,P = 0.005 ).Furthermore,significant improvements in World Healthy Organization (WHO) functional class and cardiopulmonary hemodynamics were also found ( mean pulmonary artery pressure,P ＜ 0.001; cardiac index,P ＜ 0.001; pulmonary vascular resistance,P ＜ 0.001 ).Side effects were mild and consistent with other reports.Conclusion This study confirms and extends previous studies.Oral sildenafil is both safe and effective for the treatment of adult PAH patients in China.
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