A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension
A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension
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DOI：
10.1056/nejm199602013340504
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发表时间：
1996-02-01
影响因子：
158.5
通讯作者：
Crow, JW
中科院分区：
文献类型：
--
作者：
Barst, RJ;Rubin, LJ;Crow, JW
背景。原发性肺动脉高压是一种进行性疾病，前瞻性随机试验尚未显示可提高生存率的治疗方法。方法。我们进行了一项为期 12 周的前瞻性、随机、多中心开放试验，比较了 81 名严重原发性肺动脉高压（纽约心脏协会功能分级 III 或 IV）患者连续静脉输注依前列醇（以前称为前列环素）加常规治疗与单独常规治疗的效果。结果。 41 名接受依前列醇治疗的患者运动能力得到改善（6 分钟步行中位距离，12 周时为 362 m，基线为 315 m），但 40 名仅接受常规治疗的患者运动能力有所下降（12 周时为 204 m，基线为 270 m；治疗组比较 P < 0.002）。仅依前列醇组的生活质量指数有所改善（P < 0.01）。依前列醇治疗患者的血流动力学在 12 周时有所改善。依前列醇组和对照组的平均肺动脉压变化分别为 -8% 和 +3%（平均变化差异，-6.7 mm Hg；95% 置信区间，-10.7 至 -2.6 mm Hg；P < 0.002），依前列醇组和对照组肺血管阻力的平均变化分别为 -21% 和 +9%（平均变化差异， -4.9 毫米汞柱每升每分钟；95% 置信区间，-7.6 至 -2.3 毫米汞柱每升每分钟；八名患者在研究期间死亡，所有患者均被随机分配接受常规治疗（P = 0.003）。严重并发症包括四次导管相关败血症和一次血栓事件。结论。与传统治疗相比，持续静脉输注依前列醇可改善严重原发性肺动脉高压患者的症状和血流动力学，并提高生存率。 (C) 1996 年，马萨诸塞州医学会。
Background. Primary pulmonary hypertension is a progressive disease for which no treatment has been shown in a prospective, randomized trial to improve survival.Methods. We conducted a 12-week prospective, randomized, multicenter open trial comparing the effects of the continuous intravenous infusion of epoprostenol (formerly called prostacyclin) plus conventional therapy with those of conventional therapy alone in 81 patients with severe primary pulmonary hypertension (New York Heart Association functional class III or IV).Results. Exercise capacity was improved in the 41 patients treated with epoprostenol (median distance walked in six minutes, 362 m at 12 weeks vs. 315 m at base line), but it decreased in the 40 patients treated with conventional therapy alone (204 m at 12 weeks vs. 270 m at base line; P < 0.002 for the comparison of the treatment groups). Indexes of the quality of life were improved only in the epoprostenol group (P < 0.01).Hemodynamics improved at 12 weeks in the epoprostenoltreated patients. The changes in mean pulmonary-artery pressure for the epoprostenol and control groups were -8 percent and +3 percent, respectively (difference in mean change, -6.7 mm Hg; 95 percent confidence interval, -10.7 to -2.6 mm Hg; P < 0.002), and the mean changes in pulmonary vascular resistance for the epoprostenol and control groups were -21 percent and +9 percent, respectively (difference in mean change, -4.9 mm Hg per liter per minute; 95 percent confidence interval, -7.6 to -2.3 mm Hg per liter per minute; P < 0.001). Eight patients died during the study, all of whom had been randomly assigned to conventional therapy (P = 0.003). Serious complications included four episodes of catheter-related sepsis and one thrombotic event.Conclusions. As compared with conventional therapy, the continuous intravenous infusion of epoprostenol produced symptomatic and hemodynamic improvement, as well as improved survival in patients with severe primary pulmonary hypertension. (C) 1996, Massachusetts Medical Society.