Gall Henning, Sommer Natascha, Milger Katrin, Richter Manuel J, Voswinckel Robert, Bandorski Dirk, Seeger Werner, Grimminger Friedrich, Ghofrani Hossein-Ardeschir
Universities of Giessen & Marburg Lung Center, Medizinische Klinik II, Klinikstraße 33, 35392, Giessen, Germany.
Medical Clinic V, University of Munich, Comprehensive Pneumology Center, Munich, Germany.
BMC Pulm Med. 2016 Jan 12;16:5. doi: 10.1186/s12890-015-0164-2.
Combination therapy is frequently used to treat patients with pulmonary hypertension but few studies have compared treatment regimens. This study examined the long-term effect of different combination regimens of inhaled iloprost and oral sildenafil on survival and disease progression.
This was a retrospective study of patients in the Giessen Pulmonary Hypertension Registry who received iloprost monotherapy followed by addition of sildenafil (iloprost/sildenafil), sildenafil monotherapy followed by addition of iloprost (sildenafil/iloprost), or upfront combination therapy (iloprost + sildenafil). The primary outcome was transplant-free survival (Kaplan-Meier analysis). When available, haemodynamic parameters and 6-minute-walk distance were evaluated.
Overall, 148 patients were included. Baseline characteristics were similar across treatment groups; however, the iloprost + sildenafil cohort had higher mean pulmonary vascular resistance and pulmonary arterial pressure than the others. Transplant-free survival differed significantly between groups (P = 0.007, log-rank test). Cumulative transplant-free survival was highest for patients who received iloprost/sildenafil (1 year survival: iloprost/sildenafil, 95.1%; sildenafil/iloprost, 91.8%; iloprost + sildenafil, 62.9%); this group also remained on monotherapy significantly longer than the sildenafil/iloprost group (median 17.0 months vs 7.0 months, respectively; P = 0.004). Compared with pre-treatment values, mean 6-minute-walk distance increased significantly for all groups 3 months after beginning combination therapy.
In this observational study of patients with pulmonary hypertension receiving combination therapy with iloprost and sildenafil, cumulative transplant-free survival was highest in those who received iloprost monotherapy initially. However, owing to the size and retrospective design of this study, further research is needed before making firm treatment recommendations.
联合治疗常用于肺动脉高压患者，但比较治疗方案的研究较少。本研究探讨吸入伊洛前列素和口服西地那非不同联合方案对生存和疾病进展的长期影响。
这是一项对吉森肺动脉高压登记处患者的回顾性研究，这些患者接受伊洛前列素单药治疗后加用西地那非（伊洛前列素/西地那非）、西地那非单药治疗后加用伊洛前列素（西地那非/伊洛前列素）或初始联合治疗（伊洛前列素+西地那非）。主要结局是无移植生存（Kaplan-Meier分析）。如有可用数据，评估血流动力学参数和6分钟步行距离。
共纳入148例患者。各治疗组的基线特征相似；然而，伊洛前列素+西地那非队列的平均肺血管阻力和肺动脉压高于其他组。各组间无移植生存有显著差异（P = 0.007，对数秩检验）。接受伊洛前列素/西地那非治疗的患者累积无移植生存率最高（1年生存率：伊洛前列素/西地那非，95.1%；西地那非/伊洛前列素，91.8%；伊洛前列素+西地那非，62.9%）；该组单药治疗的时间也显著长于西地那非/伊洛前列素组（中位数分别为17.0个月和7.0个月；P = 0.004）。与治疗前值相比，所有组在开始联合治疗3个月后6分钟步行距离均显著增加。
在这项对接受伊洛前列素和西地那非联合治疗的肺动脉高压患者的观察性研究中，最初接受伊洛前列素单药治疗的患者累积无移植生存率最高。然而，由于本研究的规模和回顾性设计，在做出明确的治疗建议之前还需要进一步研究。
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