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百心安-B(02185.HK)即將於歐洲進行經橈動脈入徑治療未控高血壓及頑固性高血壓的RADIUS-HTN試驗
格隆匯 12-29 23:02

格隆匯12月29日丨百心安-B(02185.HK)公吿,公司已與歐洲心血管研究中心("CERC")訂約進行一項歐洲臨牀試驗,評估公司的第二代Iberis®腎神經阻斷(RDN)系統。第二代Iberis®是我們自主開發的第二代RDN系統,為世界上唯一為醫生及患者提供經股動脈及經橈動脈介入(TRI)方法的RDN在研產品。CERC是一家着名的合約研究組織,專注於心血管裝置的臨牀試驗。有關研究的主要研究員為Felix Mahfoud教授,來自Saarland University Hospital, Homburg/Saar的醫學士,亦為德國心臟病學會動脈高血壓工作小組主席。

儘管有各種抗高血壓藥物,但許多患者仍未能控制其高血壓,面對着可引發心臟病及死亡的危機。提供TRI方法的系統的出現是RDN領域發展的重大進展。現已證明經前臂進入橈動脈的TRI方法可減少許多因經腿部股動脈入徑的傳統方法造成的相關併發症。大量臨牀試驗更指出,通過橈動脈進行導管介入可減少發生重大不良事件及出血併發症。TRI亦可降低手術成本,讓許多患者能夠在手術後即日出院回家。

公司用於RDN的第二代Iberis®是一種通過裝置進行用於治療高血壓的低侵入性手術。手術過程簡要,只需將第二代Iberis導管放置於腎動脈。系統將低水平的射頻能量傳遞至動脈,使腎神經去神經支配,令交感神經系統活動減少,從而可使血壓下降。

最近,歐洲高血壓學會("該學會")所發表的最新論文指出RDN"可有效地減少或干擾傳遞到腎臟的交感信號,令全身交感神經活動減少。"該學會提及五項獨立的偽對照隨機臨牀試驗提供了"確鑿的證據",表明RDN可同時令服用或不服用抗高血壓藥物的患者降低動態血壓及診室血壓。一個美國高血壓專家小組亦指出臨牀試驗顯示RDN能在24小時間隔內持續降低血壓。

高血壓是造成全球疾病負擔最常見因素之一。根據弗若斯特沙利文(北京)諮詢有限公司上海分公司的數據,2019年中國高血壓患者總數約為3.174億。導致心血管疾病發病率及死亡率上升、生活質量下降以及醫療系統成本增加。根據對使用藥物治療的隨機試驗作出的統合分析,估計診室收縮壓降低10mmHg可使心血管事件的發病率降低20%。儘管抗高血壓藥物廣泛可用,但對患者及醫生而言,對藥物的獲取途徑與依從性仍然具有挑戰性。

第二代Iberis®已獲批准在歐盟銷售並附有CE標誌。有關裝置的隨機偽對照臨牀試驗在中國的患者入組工作仍在進行中,並將於2022年初完成。

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