Department of Radiation Oncology, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.
Department of Respiratory Medicine, Respiratory Diseases Institute, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang 471003, China.
Life Sci. 2020 Sep 15;257:118001. doi: 10.1016/j.lfs.2020.118001. Epub 2020 Jul 4.
Pulmonary hypertension (PH) is a severe and prevalent complication of chronic obstructive pulmonary disease (COPD), with low quality of life and poor prognosis. This study was designed to evaluate the efficacy and safety of Sildenafil in the treatment of PH caused by COPD (COPD-PH) and provide reference for clinical treatment.
We systematically searched PubMed, EMBASE, Cochrane Library, Clinical Trials.gov databases, Wanfang Data and CNKI for comprehensive literature reporting Sildenafil for randomized controlled trials (RCT) of COPD-PH. Quality assessment, data analysis used the modified Jadad scale and RevMan5.3 software.
A total of 9 RCTs involving 579 patients were included in our study. The primary outcome measure was Six minutes walking distance (6MWD). Secondary observations were Pulmonary artery systolic pressure (PASP), Borg dyspnea index, and Survey scale (SF-36). Our data demonstrate that Sildenafil can improve 6WMD [29.64, 95% CI (13.78, 45.50), P < 0.00001] and PASP [-7.86, 95% CI (-11.26, -4.46) P < 0.00001] of COPD-PH, compared with the control group. However, SF-36 [2.64, 95% CI (-6.85, 12.14) P = 0.59] and Borg dyspnea index [-0.28, 95% CI (-1.08, 0.52) P = 0.49] have no significant difference between those two groups. Adverse reactions in the Sildenafil treatment group were tolerated headaches and digestive symptoms, which were relatively safe.
Available clinical evidence indicates that Sildenafil seems to be safe and effective for COPD-PH and can improve the patients' 6WMD. However, large-sample, high-quality multicenter RCTs are still needed to provide stronger evidence-based medical evidence.
肺动脉高压（PH）是慢性阻塞性肺疾病（COPD）的一种严重且常见的并发症，其生活质量低，预后差。本研究旨在评估西地那非治疗 COPD 相关肺动脉高压（COPD-PH）的疗效和安全性，为临床治疗提供参考。
系统检索 PubMed、EMBASE、Cochrane 图书馆、ClinicalTrials.gov 数据库、万方数据和中国知网中关于西地那非治疗 COPD-PH 的随机对照试验（RCT）的全面文献报告。使用改良 Jadad 量表和 RevMan5.3 软件进行质量评估和数据分析。
共纳入 9 项 RCT 研究，涉及 579 例患者。主要结局指标为 6 分钟步行距离（6MWD）。次要观察指标为肺动脉收缩压（PASP）、Borg 呼吸困难指数和健康调查简表（SF-36）。我们的数据表明，与对照组相比，西地那非可改善 COPD-PH 患者的 6MWD[29.64，95%CI（13.78，45.50），P<0.00001]和 PASP[-7.86，95%CI（-11.26，-4.46），P<0.00001]。然而，两组之间的 SF-36[2.64，95%CI（-6.85，12.14），P=0.59]和 Borg 呼吸困难指数[-0.28，95%CI（-1.08，0.52），P=0.49]无显著差异。西地那非治疗组的不良反应可耐受头痛和消化道症状，相对安全。
现有临床证据表明，西地那非似乎对 COPD-PH 安全有效，可改善患者的 6MWD。然而，仍需要大样本、高质量的多中心 RCT 提供更强的循证医学证据。
