白蛋白透析系統可拯救末期肝病及腎臟衰竭患者


  July 25, 2005 (洛杉磯) - 國際肝臟移植協會的第11屆年度大會上,Faouzi Saliba醫師發表指出,分子吸收再循環系統(MARS)可以同時清除肝臟與腎臟的毒素。
  
  Saliba醫師為法國Paul Brousse醫院的一位研究員,也是本研究的主導研究員;他向Medscape表示,MARS技術可以允許44%的重疾患者支撐到肝臟移植手術。
  
  傳統的血液透析無法有效的清除急性肝腎衰竭患者的毒性,相對的,MARS器材整合了一套足以將水溶性腎毒素清除的迴路,另一迴路則可清除連結白蛋白的水溶性毒素;Saliba的數據涵蓋了25位患者,這是法國第一次的肝腎雙器官衰竭患者使用MARS系統的系列試驗,期間為2002年6月到2004年12月之間。
  
  患者的人口學特質,平均年齡47.2歲(範圍,16 - 74歲);16位男性,9位女性;病原為末期肝硬化(n = 10)、肝臟移植體衰竭(n = 10),及5位其他的病原。
  
  Saliba醫師向Medscape表示,這些患者的病況相當嚴重,25位中,有11位(44%)的血液動力學不穩定,12位(48%)使用人工呼吸器,15位(60%)有著多重器官衰竭;末期肝病平均模式指數(Mean Model End-Stage Liver Disease score,MELD)為43 ± 14;當MELD低於40時,三個月內的死亡率幾乎100%。
  
  患者皆參與1到8次的MARS療程(平均3.4 ± 1.8次),耗時2到20小時(平均,9.0 ± 3.1小時);在MARS療程前後,研究人員皆分析了患者的臨床與生物參數,總膽紅素濃度從534μmol/L降至451 μmol/L,肌酸酐則從302μmol/L降至167μmol/L;安全性參數並無明顯改變,含凝血酶原時間,國際標準化比值(International normalized ratio;INR),及平均的動脈壓力等;MELD指數亦從43降至35。
  
  整體而言,25位患者中,有11位(44%)存活了1年,並能夠接受第一次(n = 3),第二次(n = 7),或第三次(n = 1)的肝臟移植;兩位在手術後死亡,一位在手術後一天即死亡,另一位則在術後80天去世,原因為敗血症及肝病引發的多重器官衰竭。
  
  MARS是一項補救性的治療法,對於肝腎衰竭患者的安全性良好;雖然該系統目前在美國只能用在治療用藥過量或中毒的症狀,但是另一項更大型的研究正在進行中,目標為肝病患者的治療;Saliba向Medscape表示,希望該器材能在2006年的四月前獲得FDA(美國食品藥物管理局)的核准。
  
  Paul Brousse醫院的Hepato-Biliary中心提供透析器材的採購費用;德國的Teralin公司為MARS的製造者,免費提供MARS器材。

Albumin Dialysis System Rescue

By
Medscape Medical News

July 25, 2005 (Los Angeles) — The Molecular Adsorbent Recirculating System (MARS) detoxifies the liver and the kidney simultaneously, improving clinical conditions in patients with both liver and kidney failure, according to a presentation given here by Faouzi Saliba, MD, at the 11th Annual Congress of the International Liver Transplantation Society.

Dr. Saliba, a researcher at the Paul Brousse Hospital, Villejuif, France, and principal investigator of the study, told Medscape that the MARS technique "allowed 44% of a group of severely ill patients to survive long enough to get access to liver transplant."

Conventional hemodialysis in patients with concomitant acute hepatic and renal failure has little or no effect on liver detoxification. In contrast, the MARS device incorporates one circuit to remove water-soluble toxins from the kidney and another to remove albumin-bound, water insoluble toxins. Dr. Saliba's data on 25 patients represent the first French series of dual hepatic and renal failure patients treated with the MARS system between June 2002 and December 2004.

Patient demographic characteristics included a mean age of 47.2 years (range, 16 - 74 years); 16 were male, and 9 were female. Disease etiologies included cirrhotic end-stage liver disease (n = 10), graft dysfunction after liver transplantation (n = 10), and five other etiologies.

These patients were quite ill, with 11 (44%) of 25 who were hemodynamically unstable, 12 (48%) of 25 who were using mechanical ventilation, and 15 (60%) of 25 in multiple organ failure. The mean Model for End-Stage Liver Disease (MELD) score was 43 ± 14. "When MELD is less than 40, the mortality rate within three months is nearly 100%," Dr. Saliba told Medscape.

Patients participated in between one and eight sessions of MARS therapy (mean, 3.4 ± 1.8), lasting between 2 and 20 hours (mean, 9.0 ± 3.1 hours). Investigators analyzed clinical and biological parameters before and after MARS sessions. Total bilirubin levels dropped from 534 to 451 µmol/L (P = .02), and creatinine levels dropped from 302 to 167 µmol per L (P = .008). There were no significant changes in safety parameters including prothrombin time, international normalized ratio, and mean arterial pressure. MELD score also improved from 43 to 35 (P = .03).

Overall, 11 (44%) of 25 patients survived for one year and were able to undergo a first (n = 3), second (n = 7), or third (n = 1) liver transplantation. Two patients died postoperatively: one patient, 1 day after and the other patient, 80 days after liver transplantation from multiple organ failure secondary to sepsis and liver disease.

The MARS system is a salvage treatment with a good safety profile for patients with both liver and kidney failure. Although the system is currently only approved in the U.S. for treating patients with drug overdose or poisoning, a large trial of MARS in liver disease patients in the U.S. is currently underway. Dr. Saliba told Medscape, "I expect that the manufacturer will earn FDA [Food and Drug Administration] approval by first trimester, 2006."

This study was funded with departmental funds from the Hepato-Biliary Center, Paul Brousse Hospital, Villejuif, France, which were used to purchase dialysis supplies. Teraklin, the maker of MARS, of Rostock, Germany, provided the MARS devices free of charge.

11th Annual Congress ILTS: Abstract 41. Presented July 21, 2005.

Reviewed by Gary D. Vogin, MD

    
相關報導
末期腎臟病變有種族差異趨勢
2007/4/3 上午 09:44:00

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