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Thursday, August 11, 2011

友華生技與美國Medinox 開發透析中低血壓(Intradialytic hypotension)新藥: NOX-100

Medinox, Orient Europharma form partnering agreement for NOX-100 anti-hypotensive drug April 12, 2010  Medinox, Inc. in Carlsbad, California and Orient Europharma in Taiwan announce today that they have entered into a partnering agreement to develop and market NOX-100, a new anti-hypotensive drug. Under the terms of the agreement, Orient Europharma holds the exclusive distribution rights of NOX-100 in Taiwan, China, Korea, Australia, New Zealand and Southeast Asia.  Medinox retains the marketing rights in the United States, Japan and Europe. NOX-100 is an investigative new drug developed by Medinox to treat conditions associated with excessive production of nitric oxide, such as in hemodialysis, cardiopulmonary bypass surgery and septic shock.  NOX-100, a small-molecule nitric oxide scavenger, binds nitric oxide and inactivates its properties. Intradialytic hypotension (IH) is a significant complication of routine hemodialysis in end-stage renal disease patients. Complications of IH include headache, muscle cramps, and increase in mortalities.   At present, there is no FDA-approved therapy available for treating and/or preventing IH. Medinox completed a Phase 1 safety study of NOX-100 in hemodialysis patients in the US. A Phase 2 trial of NOX-100 in hemodialysis will be conducted in Taiwan. This multicenter study will determine if NOX-100 lowers the incidence of IH, decreases the frequency of nurse intervention, and reduces the number of patient complaints and discomfort.  Over 380,000 end-stage renal failure patients in the US require dialysis.  In Taiwan, more than 60,000 patients are currently in dialysis.

 

透析中低血壓(Intradialytic hypotension) 作者:林玉傳醫師

1.透析中低血壓是血液透析最常見的併發症,50%的血液透析患者皆曾有透析中低血壓的經驗. 2.低血壓的原因很多: A.常見的原因:(1).與血容量大量減少有關的: a.透析間隔體重增加太多,導致透析中需使用較大的脫水率(UF rate).b.乾體重設定的太低.c.透析液鈉濃度設定的太低.(2).與血管缺乏收縮性有關的:a.使用純醋酸鹽透析液.b.透析液溫度太高.c.透析中進食導致臟腑血管擴張.d.組織缺血(與腺甘酸(adenosine)的釋放有關,Hct低時會更加劇).e.自主神經障礙,如糖尿病患.(3). 與心臟因素有關的:a.心臟舒張功能失調(如左心室肥大,缺血性心臟病等).b.心搏加速功能失調(如服用β-阻斷劑,尿毒神經病變,年邁者).c.心輸出量無法增加(因年邁,高血壓,血管粥樣硬化,心肌鈣化,心瓣膜疾病,類粉沉著症等).B. 較少見原因:(1). 心包積血(pericardial tamponade). (2). 心肌梗塞. (3). 體內有潛在性的出血. (4). 敗血症. (5). 心律不整. (6). 對透析器過敏起反應. (7). 溶血. (8). 空氣栓塞

3.低血壓的預防: (1). 確定體重磅秤正確無誤,有懷疑時應重秤一次. (2). 確定脫水量計算正確無誤. (3). 使用有超過濾控制器(ultrafiltration controller)的透析機(現今所有機種皆有). (4). 衛教病人控制鹽分的攝取並控制每日體重不超過1kg/day或透析間體重增加不超過其乾體重的5%. (5). 重新評估病患乾體重是否設定得太低. (6). 透析液鈉濃度設在病患血清鈉濃度值之上. (7). 透析當天來院前不服用降血壓藥. (8). 使用重碳酸鹽透析溶液. (9). 某些特定病患可將透析液溫度設在3436度之間. (10) 透析前的Hct儘量能維持在33%以上. (11) 在透析中儘量不要進食或食用過於熱燙的食物. (12) 可考慮在透析中使用血容量監視器(blood volume monitor). (13) 可考慮透析前使用α-促效劑(α-agonist,midodrine (Gutron))提升血壓.

4 低血壓的處理: (1).停止脫水,按下UF鍵使其歸零. (2).快速給予N.S 100300 ml. (3).低血壓合併抽筋時,若病患血糖不高,可追加50% Glucose 12 Ampules IV緩慢注射. (4).低血壓合併抽筋而病患血糖偏高時,若有3% N.S可給 50100 ml IV,若沒有3%N.S可用calcium gluconate calcium chloride 1 Ampule IV 緩慢注射. (5).若上述方法用盡,症狀仍無法解除,可將血液全部趕回暫停透析並給予氧氣吸入. (6).若症狀仍然持續,便應該考慮低血壓較少見之原因,如心肌梗塞,心律不整,空氣栓塞等. (7).AlbuminMannitol也可使用於透析時的低血壓,但因為價格昂貴,故較少使用. 5. T位的迷思(Tredelenburg position myth)     T位也就是頭低腳高的位置,是洗腎室醫護人員遇到病患低血壓時最常做的動作,這種姿勢是否對病患血壓的回復有幫忙?目前有人研究對低血壓的回復是沒有幫助的,而且可能還會有些害處:  (1).研究發現,採取這種姿勢只會使靜脈壓上升,並不會使靜脈回流增加,當然也不會使心輸出量增加,而對低血壓就沒有幫助. (2).這種姿勢對有肺水腫的病人可能會加劇其病情. (3).當病人因低血壓嘔吐時,這種姿勢可能會造成吸入性肺炎. (4).這種姿勢也可能造成腦水腫.

Source: http://tw.myblog.yahoo.com/jw!f0qNOSKWHxlheqLCkbjf3Aw-/article?mid=13&prev=14&next=11&l=a&fid=6

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