單株抗體預防療法可改善CLKT患者的一年存活率


  July 25, 2005 (洛杉磯) -國際肝臟移植協會的第11屆年度大會上,Richard M. Ruiz醫師發表指出,雖然加州大學洛杉磯分校(UCLA)的肝臟胰臟醫學系在末期肝病模式指數(Model End-Stage Liver Disease score,MELD)的器官分配規範出現之後,才大規模的對重疾患者進行肝腎合併移植手術(CLKT),患者的一年存活期仍由73%升至86%。
  
  自從器官分配的MELD系統取代了器官分享聯合網絡(UNOS)之後,美國即有了更多的CLKT手術;本研究的目的在於,以回顧性的方式評估CLKT患者在分配到移植器官後的效果,以MELD的標準和UNOS的標準作比較,患者資料皆來自UCLA;依據MELD,器官受贈者的病況比UNOS標準所訂定者嚴重,研究人員於是假設,應該會有較少的移植體會存活,死亡率也會比較高。
  
  MELD分配組包含了28位接受CLKT手術的患者,期間在2002年3月至2004年8月間;UNOS分配組的70位患者,皆在1988年10月至2002年3月間進行CLKT手術;根據Ruiz醫師的說法,UCLA的CLKT患者試驗系列是世界上規模最大的試驗。
  
  本試驗系列平均的追蹤期為16個月,根據多項參數評估,MELD分配組的患者病症比UNOS分配組嚴重;平均的MELD指數,MELD分配組為34,UNOS分配組則為24;9位MELD分配組的患者曾經有過肝臟移植手術,UNOS分配組則為7位;MELD組的平均住院及深切照護期分別為50到18天,UNOS組則為38到8天;MELD患者的手術時數較之UNOS組高出一小時,但是肝臟冷缺血時間卻少了2小時,於是需要更大量的輸血。
  
  MELD組中有23位患者(82.1%)接受單株抗體(MAb)誘發治療,使用的藥物為basiliximab或daclizumab,只有兩位患者(8%)出現排斥現象;另一次屬試驗組,8位C型肝炎病毒(HCV)陽性患者亦接受了MAb誘發治療,這一族群未發現有任何肝或腎的排斥現象;這8位患者經過切片發現,只有一位證實在術後6個月內出現HCV復發。
  
  CLKT日益普遍,可能是因為calcineurin-sparing的免疫抑制療法之使用,醫療管理有了改善,及更低的缺血時間等因素使然;另外,MAb誘發治療可以降低CLKT手術接受者的肝臟急性排斥現象,HCV患者看在改善臨床症狀的同時,並不會提升HCV的復發;這些數據顯示,移植外科醫師在考慮進行CLKT時,應該評估患者的適合性,而非病症的嚴重性,亦希望患者的情況能夠穩定,如此才可能進行第二次手術。
  
  本研究由UCLA贊助;Ruiz醫師在胰臟與肝臟移植學系擔任研究人員。

Monoclonal Antibody Prophylaxi

By
Medscape Medical News

July 25, 2005 (Los Angeles) — Although surgeons at the University of California, Los Angeles (UCLA), Liver and Pancreas Transplantation Department perform a larger number of combined liver-kidney transplants (CLKT) on severly ill patients since the advent of the Model End-Stage Liver Disease (MELD) organ allocation process, the one-year patient survival rate improved from 73% to 86%, according to a presentation given here by Richard M. Ruiz, MD, at the 11th Annual Congress of the International Liver Transplantation Society.

Since the MELD system of organ allocation replaced the criteria promulgated by the United Network for Organ Sharing (UNOS), significantly more CLKTs are performed in the U.S. The goal of this study was to retrospectively review the factors affecting the outcomes of CLKT patients allocated organs based on MELD criteria vs those allocated organs based on UNOS criteria in the UCLA patient series. Because these recipients are more severely ill than recipients under the UNOS criteria, investigators hypothesized that fewer grafts would survive and that patient mortality rates would increase.

The MELD-allocation group consisted of the 28 patients who underwent CLKT between March 2002 to August 2004. The UNOS-allocation group consisted of all 70 patients who had undergone CLKT between October 1988 and March 2002. According to Dr. Ruiz, the UCLA CLKT patient series is the largest in the world.

The median follow-up for this series of patients was 16 months. MELD-allocated patients were more severely ill than UNOS-allocated patients based on several measures. Median MELD score was 34 in MELD-allocated patients and 24 in UNOS-allocated patients. Nine MELD-era patients had previous liver transplantations compared with seven under the UNOS criteria. Median hospital and intensive care unit stay were 50 and 18 days, respectively, for MELD-allocated patients compared with 34 and 8 days, respectively, for UNOS-allocated patients. Surgery lasted about an hour longer for MELD patients than for UNOS-allocated patients, but liver cold ischemia time was nearly two hours shorter but required a larger volume of transfused blood.

Of the 23 MELD-allocated patients (82.1%) who underwent monoclonal antibody (MAb) induction therapy with either basiliximab or daclizumab, only two patients (8%) experienced rejection episodes. A subgroup of eight hepatitis C virus (HCV)-positive patients also received MAb induction. No HCV-positive patients experienced rejection episodes of liver or kidney; only one of these eight patients experienced biopsy-proven recurrence of HCV within six months posttransplantation.

CLKT is performed more often today, likely because of calcineurin-sparing immunosuppression, improved medical management, and lower cold ischemia times. In addition, MAb induction therapy reduces liver acute rejection rates in patients undergoing CLKT, including those with HCV who appear to improve clinically without an increase in HCV recurrence. These data reveal that transplant surgeons should consider performing CLKT in appropriate patients rather than focusing on the most serious condition first and hoping that the patient stabilizes enough to be a good risk for a second operation.

This study was sponsored by UCLA. Dr. Ruiz was a Fellow at the department of Pancreatic and Liver Transplantation during the time the study was conducted and has no commercial interests to disclose.

11th Annual Congress ILTS: Abstract 88. Presented July 22, 2005.

Reviewed by Gary D. Vogin, MD

    
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