PDF(Pubmed)
Abstract：
UNASSIGNED: YS-1402, which is a polymerized form of the synthetic prostacyclin agonist ONO-1301, has been proven in several preclinical studies to induce therapeutic effects for patients with ischemic cardiomyopathy (ICM). In this human study, we assessed the safety, tolerability, and efficacy of YS-1402, combined with coronary artery bypass grafting (CABG), for ICM.
UNASSIGNED: Twenty-four patients with ICM whose left ventricular ejection fraction was <40% with an indication for CABG were double-blindly assigned to four groups: placebo, 10-mg YS-1402, 30-mg YS-1402, and 100-mg YS-1402. YS-1402 or placebo medications were administered on the surface of the left ventricle at the time of the CABG. Pre- and postoperative cardiac function and myocardial blood flow were assessed for 6 months postoperatively, along with a safety assessment.
UNASSIGNED: No severe adverse events were related to YS-1402. The maximum blood concentration of ONO-1301 was less than that of the no observable adverse effect level. Significantly increased myocardial blood flow (MBF) and cardiac function were observed in the YS-1402 group 26 weeks postoperatively, although no improvement in MBF occurred in the placebo group.
UNASSIGNED: This Phase I/IIa parallel group-controlled, dose-escalation study of YS-1402 combined with CABG for ICM demonstrated the safety, tolerability, and potential efficacy of YS-1402.
UNASSIGNED: Twenty-four patients with ICM whose left ventricular ejection fraction was <40% with an indication for CABG were double-blindly assigned to four groups: placebo, 10-mg YS-1402, 30-mg YS-1402, and 100-mg YS-1402. YS-1402 or placebo medications were administered on the surface of the left ventricle at the time of the CABG. Pre- and postoperative cardiac function and myocardial blood flow were assessed for 6 months postoperatively, along with a safety assessment.
UNASSIGNED: No severe adverse events were related to YS-1402. The maximum blood concentration of ONO-1301 was less than that of the no observable adverse effect level. Significantly increased myocardial blood flow (MBF) and cardiac function were observed in the YS-1402 group 26 weeks postoperatively, although no improvement in MBF occurred in the placebo group.
UNASSIGNED: This Phase I/IIa parallel group-controlled, dose-escalation study of YS-1402 combined with CABG for ICM demonstrated the safety, tolerability, and potential efficacy of YS-1402.
摘要：
未经证实：YS-1402是合成前列环素激动剂ONO-1301的聚合形式，已在一些临床前研究中被证明可诱导缺血性心肌病（ICM）患者的治疗效果。在这项人类研究中，我们评估了安全性,耐受性,YS-1402联合冠状动脉旁路移植术（CABG）的疗效，ICM。
UNASSIGNED：24例左心室射血分数<40％并具有CABG适应症的ICM患者被双盲分配到四组：安慰剂，10-mgYS-1402、30-mgYS-1402和100-mgYS-1402。在CABG时,在左心室表面施用YS-1402或安慰剂药物。术后6个月评估患者的心功能和心肌血流量,以及安全评估。
未经批准：无严重不良事件与YS-1402相关。ONO-1301的最大血药浓度低于未观察到的不良反应水平。YS-1402组术后26周观察到心肌血流量（MBF）和心功能明显升高，尽管安慰剂组的MBF没有改善。
未经评估：此阶段I/IIa并行组控制，YS-1402联合CABG用于ICM的剂量递增研究证明了安全性，耐受性,和YS-1402的潜在功效。
UNASSIGNED：24例左心室射血分数<40％并具有CABG适应症的ICM患者被双盲分配到四组：安慰剂，10-mgYS-1402、30-mgYS-1402和100-mgYS-1402。在CABG时,在左心室表面施用YS-1402或安慰剂药物。术后6个月评估患者的心功能和心肌血流量,以及安全评估。
未经批准：无严重不良事件与YS-1402相关。ONO-1301的最大血药浓度低于未观察到的不良反应水平。YS-1402组术后26周观察到心肌血流量（MBF）和心功能明显升高，尽管安慰剂组的MBF没有改善。
未经评估：此阶段I/IIa并行组控制，YS-1402联合CABG用于ICM的剂量递增研究证明了安全性，耐受性,和YS-1402的潜在功效。
