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新型口服液episil在国内获批,用于治疗放化疗引起的口腔黏膜炎

2019-02-24 不详 MedSci原创

日本Solasia Pharma KK公司宣布其episil口服液已获得国家食品药品监督管理局(NMPA)的批准,用于缓解化疗/或放疗引起的口腔粘膜炎(OM)。作为缓解口腔粘膜炎的唯一即用型医疗设备,episil将为国内口腔粘膜炎患者提供新的治疗选择,特别是对于接受放疗/或化疗后的癌症患者。

日本Solasia Pharma KK公司宣布其episil口服液已获得国家食品药品监督管理局(NMPA)的批准,用于缓解化疗或放疗引起的口腔粘膜炎(OM)。

OM是一种常见的副作用,化疗后的发生率达20%-40%,大约80%的大剂量化疗(如造血干细胞移植预处理)和大多数接受放疗的头颈癌患者均会产生。OM通常表现为发红、糜烂、溃疡和疼痛,影响吞咽和进食,并且经常导致抗肿瘤疗法的剂量减少、中断或延迟放疗,甚至住院治疗。目前,国内还没有该疾病的治疗方法。

episil使用瑞典Camurus AB的专利技术,是一种基于脂质的不含防腐剂的液体,粘附在口腔粘膜上,并在与口腔粘膜接触后5分钟内形成一层保护膜,从而为口腔敏感和溃疡上皮提供物理保护,缓解疼痛长达8小时。

临床结果显示,单次使用episil可在6小时内显着降低口腔粘膜疼痛评分,局部镇痛和时间持续效果均优于对照组。此外,episil易粘附于粘膜,成膜时间快(5分钟内)。患者报告味道舒适,无刺激。该试验证实了episil在OM治疗中的有效性和安全性。

Solasia公司总裁兼首席执行官Yoshihiro Arai表示:"Solasia公司的使命是"更好的药物,更美好的明天"。我们一直专注于患者,将继续努力开发治疗癌症和支持癌症治疗的创新产品。"

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    2019-10-14 songbq
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    2019-02-26 yzh399
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肿瘤患者放化疗后口腔粘膜炎的处理

肿瘤化疗和放疗过程中都可能对快速增长的黏膜上皮细胞造成损伤,引发口腔黏膜炎和胃肠道黏膜炎。放化疗后口腔黏膜炎是指由于放射线电离辐射损伤或者化疗药物的应用引起免疫力下降,口腔内菌群失调,导致口腔软组织发生炎症病变,是肿瘤患者接受化疗过程中较常见,最痛苦的毒副作用之一。粘膜炎一般具有自愈性,一旦组织不受损伤,就开始愈合。黏膜损伤会在几天内自然地消失,一般在化疗后10~14天内完全愈合。

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