伊诺前列素联合小剂量他达那非治疗成人先天性心脏病并重度肺动脉高压的单中心、开放、对照研究
이낙전렬소연합소제량타체나비치료성인선천성심장병병중도폐동맥고압적단중심、개방、대조연구
Effects of iloprost combined with low dose tadalafil in adult congenital heart disease patients with severe pulmonary arterial hypertension: a single-center, open-label controlled study
  • 万方数据
    中华心血管病杂志 중화심혈관병잡지
    Chinese Journal of Cardiology
    2014年 6期 474-480 ,共7页

    张曹进%黄奕高%黄涛%夏春丽%黄新胜%张国林%姚桦%陈寄梅%陈纪言

    장조진%황혁고%황도%하춘려%황신성%장국림%요화%진기매%진기언

    高血压,肺性%心脏缺损,先天性%伊诺前列素%他达那非 高血壓,肺性%心髒缺損,先天性%伊諾前列素%他達那非
    고혈압,폐성%심장결손,선천성%이낙전렬소%타체나비
    Hypertension,pulmonary%Heart defects,congenital%Iloprost%Tadalafil
    目的 评价伊诺前列素和小剂量他达那非联合治疗成人先天性心脏病并重度肺动脉高压的疗效.方法 成人先天性心脏病并重度肺动脉高压患者非随机纳入序贯联合治疗组和起始联合治疗组,分别起始给予伊诺前列素和伊诺前列素联合小剂量他达那非治疗,6个月后序贯联合治疗组加用他达那非,起始联合治疗组治疗方案不变.两组患者在基线、治疗6个月和12个月时测试6min步行距离、Borg呼吸指数、血氧饱和度、WHO肺动脉高压功能分级和心导管检查.结果 68例患者完成了12个月的随访.(1)经过6个月的治疗各指标的检测结果:序贯联合治疗组(n=32)和起始联合治疗组(n=36)患者肺血管阻力均明显降低[分别为(16.94±8.11) Wood U比(12.96 ±6.48) Wood U(P＜0.05)和(16.73±9.28) Wood U 比(12.45±7.32) Wood U(P ＜0.05)],肺循环血流量均明显增加[分别为(5.08± 2.36) L/min 比(6.77± 3.17) L/min(P＜0.05)和(5.03 ±2.32) L/min 比 (6.95 ± 3.32) L/min(P＜0.05)],6 min步行距离均明显增加[分别为(427 ± 65)m比 (458±59) m(P＜0.05)和(436±62)m比(494±59) m(P＜0.01)],Borg呼吸指数[分别为(2.52±0.79)分比(2.04±0.72)分(P＜0.05)和(2.51±0.77)分比(1.72±0.73)分(P＜0.01)]和WHO肺动脉高压功能分级[分别为2.59±0.56比2.03±0.59(P ＜0.01)和2.72 ±0.61比2.08 ±0.6(P＜0.01)]均明显改善.起始联合治疗组患者混合静脉血氧饱和度和运动后动脉血氧饱和度序贯联合治疗组改善更为明显[分别为(68.4 ±9.3)％比(62.9±9.5)％(P＜0.05)和(87.2 ±9.7)％比(83.1 ± 15.6)％(P＜0.05)].(2)经过12个月治疗各指标的检测结果:两组患者肺动脉压力、肺血管阻力、肺循环阻力/体循环阻力比值均明显降低,肺循环血流量及心输出量均明显增加.治疗12个月后两组与6个月时比较,运动后动脉血氧饱和度均继续改善,其中序贯联合治疗组改善更明显[(85.7 ± 11.7)％比(83.2 ±9.5)％,P＜0.05].结论 小剂量他达那非能有效加强和延长伊诺前列素降低先天性心脏病并肺动脉高压患者肺血管阻力的疗效,增加6 min步行距离,改善心肺功能.起始联合治疗较法较序贯联合治疗法改善患者临床症状快.
    목적 평개이낙전렬소화소제량타체나비연합치료성인선천성심장병병중도폐동맥고압적료효.방법 성인선천성심장병병중도폐동맥고압환자비수궤납입서관연합치료조화기시연합치료조,분별기시급여이낙전렬소화이낙전렬소연합소제량타체나비치료,6개월후서관연합치료조가용타체나비,기시연합치료조치료방안불변.량조환자재기선、치료6개월화12개월시측시6min보행거리、Borg호흡지수、혈양포화도、WHO폐동맥고압공능분급화심도관검사.결과 68례환자완성료12개월적수방.(1)경과6개월적치료각지표적검측결과:서관연합치료조(n=32)화기시연합치료조(n=36)환자폐혈관조력균명현강저[분별위(16.94±8.11) Wood U비(12.96 ±6.48) Wood U(P＜0.05)화(16.73±9.28) Wood U 비(12.45±7.32) Wood U(P ＜0.05)],폐순배혈류량균명현증가[분별위(5.08± 2.36) L/min 비(6.77± 3.17) L/min(P＜0.05)화(5.03 ±2.32) L/min 비 (6.95 ± 3.32) L/min(P＜0.05)],6 min보행거리균명현증가[분별위(427 ± 65)m비 (458±59) m(P＜0.05)화(436±62)m비(494±59) m(P＜0.01)],Borg호흡지수[분별위(2.52±0.79)분비(2.04±0.72)분(P＜0.05)화(2.51±0.77)분비(1.72±0.73)분(P＜0.01)]화WHO폐동맥고압공능분급[분별위2.59±0.56비2.03±0.59(P ＜0.01)화2.72 ±0.61비2.08 ±0.6(P＜0.01)]균명현개선.기시연합치료조환자혼합정맥혈양포화도화운동후동맥혈양포화도서관연합치료조개선경위명현[분별위(68.4 ±9.3)％비(62.9±9.5)％(P＜0.05)화(87.2 ±9.7)％비(83.1 ± 15.6)％(P＜0.05)].(2)경과12개월치료각지표적검측결과:량조환자폐동맥압력、폐혈관조력、폐순배조력/체순배조력비치균명현강저,폐순배혈류량급심수출량균명현증가.치료12개월후량조여6개월시비교,운동후동맥혈양포화도균계속개선,기중서관연합치료조개선경명현[(85.7 ± 11.7)％비(83.2 ±9.5)％,P＜0.05].결론 소제량타체나비능유효가강화연장이낙전렬소강저선천성심장병병폐동맥고압환자폐혈관조력적료효,증가6 min보행거리,개선심폐공능.기시연합치료교법교서관연합치요법개선환자림상증상쾌.
    Objective To evaluate the therapy efficacy of iloprost combined with low dose tadalafil in adult congenital heart disease (CHD) patients with severe pulmonary arterial hypertension (PAH).Methods Adult CHD patients with severe PAH were included and divided into the sequential combination therapy group [iloprost:10 μg/inhalation,6 times per day for 6 months,and then add oral tadalafil (5 mg/d) till 12 months,n =32] and upfront combination therapy group [iloprost:10 μg/inhalation,6 times per day combined with oral tadalafil (5 mg) for 12 months,n =36].Data on 6 rmin walking test (6MWT),Borg dyspnea score,oxygen saturation measurement,WHO classification,and cardiac catheterization were obtained at baseline,6 and 12 months.Results Seventy-two patients were enrolled in the study and 68 patients completed the study.Pulmonary vascular resistance (PVR) was significantly reduced in the sequential combination therapy group[(12.96 ±6.48) Wood U vs.(16.94 ±8.11) Wood U,P ＜0.05]and in the upfront combination therapy group [(12.45 ±7.32) Wood U vs.(16.73 ±9.28) Wood U,P ＜0.05] while pulmonary blood flow [(6.77 ± 3.17) L/min vs.(5.08 ± 2.36) L/min,P ＜ 0.05 ; (6.95 ± 3.32) L/min vs.(5.03 ±2.32) L/min,P ＜0.05],the 6 MWD were significantly increased [(458 ±59) m vs.(427 ±65) m,P＜0.05; (494 ±59) m vs.(436 ±62) m,P ＜0.01],the Borg dyspnea score (2.04±0.72 vs.2.52 ±0.79,P＜0.05; 1.72 ±0.73 vs.2.51 ±0.77,P＜0.01) was significantly improved in both groups at 6 months compared to baseline levels.In the upfront combination therapy group,venous oxygen saturation [(68.4 ± 9.3) ％ vs.(62.9 ± 9.5) ％,P ＜ 0.05] and systemic oxygen saturation during exercise[(87.2 ±9.7)％ vs.(83.1 ± 15.6)％,P ＜0.05] at 6 months were also significantly improved compared to baseline.At month 12,significantly lowered pulmonary artery pressure,PVR,Rp/Rs and increased pulmonary blood flow and cardiac index were evidenced in both groups compared to baseline.Conclusion Iloprost combined with low dose tadalafil regimen can effectively reduce PVR,increase 6MWD,and improve cardiopulmonary function in adults CHD patients with severe PAH.Compared with the sequential therapy regimen,the upfront combination therapy regimen can more rapidly improve the clinical symptoms of patients.
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