中华心血管病杂志
中華心血管病雜誌
중화심혈관병잡지
Chinese Journal of Cardiology
2011年
2期
124-127
,共4页
代立志%蒋鑫%王勇%余再新%姚桦%王广义%吴炳祥%荆志成
代立誌%蔣鑫%王勇%餘再新%姚樺%王廣義%吳炳祥%荊誌成
대립지%장흠%왕용%여재신%요화%왕엄의%오병상%형지성
高血压,肺性%治疗结果%波生坦
高血壓,肺性%治療結果%波生坦
고혈압,폐성%치료결과%파생탄
Hypertension,pulmonary%Treatment outcome%Bosentan
目的 观察内皮素受体拮抗剂波生坦治疗中国特发性肺动脉高压患者的有效性、安全性及耐受性.方法 全国多中心Ⅳ期临床试验,共入选79例右心导管等技术确诊的新发特发性肺动脉高压患者,口服波生坦每日2次,每次62.5 mg,治疗4周后增至每日2次,每次125 mg至16周试验结束.分别在基线及治疗16周时记录6分钟步行距离,WHO肺高压功能分级、Borg呼吸困难评分及超声心动图评价资料.结果 波生坦治疗16周后,患者6分钟步行距离从(343.7±93.7)m增至(397.5±104.4)m(P<0.01),WHO肺高压功能分级显著改善(P<0.01),Borg呼吸困难评分由3.0±1.5降低至2.5±1.5(P<0.01),超声心动图估测肺动脉收缩压从(97.8±25.2)mm Hg(1 mm Hg=0.133 kPa)下降至(92.8±29.5)mmHg(P<0.05).无患者因无法耐受不良反应退出.结论 波生坦能显著改善中国特发性肺动脉高压患者的运动耐量、心功能,且具有良好的安全性和耐受性.
目的 觀察內皮素受體拮抗劑波生坦治療中國特髮性肺動脈高壓患者的有效性、安全性及耐受性.方法 全國多中心Ⅳ期臨床試驗,共入選79例右心導管等技術確診的新髮特髮性肺動脈高壓患者,口服波生坦每日2次,每次62.5 mg,治療4週後增至每日2次,每次125 mg至16週試驗結束.分彆在基線及治療16週時記錄6分鐘步行距離,WHO肺高壓功能分級、Borg呼吸睏難評分及超聲心動圖評價資料.結果 波生坦治療16週後,患者6分鐘步行距離從(343.7±93.7)m增至(397.5±104.4)m(P<0.01),WHO肺高壓功能分級顯著改善(P<0.01),Borg呼吸睏難評分由3.0±1.5降低至2.5±1.5(P<0.01),超聲心動圖估測肺動脈收縮壓從(97.8±25.2)mm Hg(1 mm Hg=0.133 kPa)下降至(92.8±29.5)mmHg(P<0.05).無患者因無法耐受不良反應退齣.結論 波生坦能顯著改善中國特髮性肺動脈高壓患者的運動耐量、心功能,且具有良好的安全性和耐受性.
목적 관찰내피소수체길항제파생탄치료중국특발성폐동맥고압환자적유효성、안전성급내수성.방법 전국다중심Ⅳ기림상시험,공입선79례우심도관등기술학진적신발특발성폐동맥고압환자,구복파생탄매일2차,매차62.5 mg,치료4주후증지매일2차,매차125 mg지16주시험결속.분별재기선급치료16주시기록6분종보행거리,WHO폐고압공능분급、Borg호흡곤난평분급초성심동도평개자료.결과 파생탄치료16주후,환자6분종보행거리종(343.7±93.7)m증지(397.5±104.4)m(P<0.01),WHO폐고압공능분급현저개선(P<0.01),Borg호흡곤난평분유3.0±1.5강저지2.5±1.5(P<0.01),초성심동도고측폐동맥수축압종(97.8±25.2)mm Hg(1 mm Hg=0.133 kPa)하강지(92.8±29.5)mmHg(P<0.05).무환자인무법내수불량반응퇴출.결론 파생탄능현저개선중국특발성폐동맥고압환자적운동내량、심공능,차구유량호적안전성화내수성.
Objective To investigate the efficacy, safety and tolerance of bosentan, a dual endothelin receptor antagonist, in Chinese patients with idiopathic pulmonary arterial hypertension (IPAH).Methods Totally 79 IPAH patients (hemodynamic criteria confirmed by right heart catheterization) were included in this open-label, prospective multicenter study. Patients received 62. 5 mg of bosentan twice daily for the first 4 weeks, and then up-titrated to 125 mg twice daily for another 12 weeks. The primary end point was the change in exercise capacity showed by six-minute walk distance (6MWD) from baseline to 16 weeks. Secondary end points included the change in World Health Organization (WHO) functional class,Borg dyspnoea scale and systolic pulmonary artery pressure measured by echocardiography. Results The 6MWD increased from (343. 7 ± 93.7) meters at baseline to (397.5 ± 104. 4) meters after 16 weeks ( P <0. 01 ), WHO functional class and Borg dyspnoea scale were also significantly improved after 16 weeks therapy compared to baseline levels (all P <0. 01 ). Furthermore, the systolic pulmonary artery pressure was significantly decreased from (97.8±25.2) mm Hg (1 mm Hg=0. 133 kPa) to (92.8 ±29.5) mm Hg (P <0. 05) after 16 weeks bosentan treatment. There was no patient withdrawal from this study for safety consideration. Conclusion Bosentan therapy is well tolerated and can improve the exercise capacity and WHO functional class in Chinese IPAH patients.