TY-JUR T1 - 慢性血栓栓塞肺动脉高压症的安全性（CTEPH）：日本申请非介入研究的临时数据JF - 欧洲呼吸期刊JO - EUR RESPIR J Do - 10.1183 / 13993003.Congress-2018.Pa3054 VL- 52 IS - Spect 62 Sp - PA3054 Au - Tanabe，Nobuhiro Au - Ogo，Takeshi Au - Hatano，Masaru Au - Tazaki，Yoichi Au - Sunaya，Toshiyuki Au - Saikawa，Akira Au - Sakaguchi，Toshiaki Y1 - 2018/09 /15 UR - //www.qdcxjkg.com/content/52/suppl_62/pa3054.abstract n2 - 背景：riociguat在日本批准用于治疗肺动脉高压和肺结滴切除术后肺动脉高血压和无法操作或持久性的cteph：获得关于常规临床实践中CTOOCIGUAT安全的营销后的营销信息。方法：用Riociguat治疗患者的多期，前瞻性，非介入性研究，不可操作或持续/复发性CTEPH（NCT02117791）。Primary outcomes: treatment-emergent adverse events (AEs) and adverse drug reactions over mandatory 12 months’ observation and up to 7 years thereafter.Results: Interim data are available for 684 patients (median age 69.0 years; 75.3% female; 89.6% inoperable; 9.8% persistent/recurrent). Median treatment duration with riociguat 358 (range 2–1128) days; median dose 5.8 mg/day. Prior use of an ERA in 29.8% of patients, PCA in 29.8%, PDE5i in 23.2% and balloon pulmonary angioplasty (BPA) in 27.2%. Concomitant ERA in 29.7%, PCA in 27.5%, PDE5i in 1.5%. AEs were reported in 188 patients (27.5%), drug-related AEs in 118 (17.3%; Table) and serious drug-related AEs in 15 (2.2%): 24 (3.5%) withdrew because of BPA and 44 (6.4%) because of AEs.Conclusions: The AE profile of riociguat in clinical practice in Japan appears consistent with clinical trials globally and in Japan. The most common AEs are consistent with the vasodilating action of riociguat. View this table:FootnotesCite this article as: European Respiratory Journal 2018 52: Suppl. 62, PA3054.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only). ER -