本帖最後由 lsc0019 於 2009-6-22 22:43 編輯
作者：Alice McCarthy
出處：WebMD醫學新聞
June 8, 2009(波士頓) — 腎臟移植之後30個月時，及早將cyclosporine(CsA)處方換成sirolimus，可以獲得相當的病患與移植器官存活率，但是腎功能較佳且較少惡性腫瘤。
著眼於在腎臟移植之後12週及早將CsA換成sirolimus的這些結果，屬於最近發表於美國移植期刊 (2009；9:1115-1123)Concept研究的一部份，且發表於2009美國移植研討會：美國移植外科醫學會與美國移植協會聯合年會。
法國François Rabelais大學的Yvon Lebranchu醫師向與會聽眾表示，之前的研究顯示，使用sirolimus對於移植後一年者的腎功能有正向影響。Concept研究最初將235名腎臟移植病患隨機分組。所有病患最初以daclizumab、mycophenolate mofetil、CsA與類固醇治療。
在第12週時，將這些病患(n= 192)隨機分成兩組：維持使用CsA免疫抑制(n= 97)或換成sirolimus (n= 95)。病患數量在第30個月時減少為152人(sirolimus組有71人、CsA組有81人)。
第一年的結果顯示，相較於CsA組，sirolimus組有較優的腎絲球過濾速率(GFR)(64.4 vs 56.2 mL/min/1.73 m2)與腎病飲食控制評分。
【30個月時的助益維持】
Lebranchu醫師表示，30個月時，我們依舊發現sirolimus組有較優的GFR，sirolimus組治療的GFR為64.4 mL/min/1.73?m2，cyclosporine組為53.8 mL/min/1.73 m2；所以，對於腎功能的幫助可維持到30個月。
Lebranchu醫師強調，兩組在30個月時的癌症比率不同。Sirolimus組有1人發生惡性腫瘤，CsA組有6 人。
Lebranchu醫師向Medscape Transplantation表示，兩組在惡性腫瘤的差異並不顯著，但是我認為這個差異在30個月之後會更明顯。這些是30個月時的期中結果，我預測，在四年結束時的最後結果，惡性腫瘤比率會有明顯差異，sirolimus組會比較少。
Lebranchu醫師解釋，CsA組的移植相關惡性腫瘤比率隨著時間增加。他表示，這在最初的12個月不是問題，但是在2、3、5、10年之後，問題開始出現；因此，我們現在發現在30個月時，sirolimus組的惡性腫瘤比率較少，我認為這是重點。
會議主持人、俄亥俄州立大學醫學院腎臟科Todd Pesavento醫師向Medscape Transplantation表示，本研究顯示出腎功能的持續長期好處且無任何副作用，如排斥。維持改善腎功能相當重要。
羅氏藥廠資助本研究。Lebranchu醫師與 Pesavento醫師宣告沒有相關資金上的往來。
2009美國移植研討會(ATC)：美國移植外科醫師協會(ASTS)與美國移植協會(AST)聯合年會：摘要241。發表於2009年6月1日。
ATC 2009: Better Renal Function, Fewer Malignancies With Early Conversion from CsA to Sirolimus
By Alice McCarthy
Medscape Medical News
June 8, 2009 (Boston, Massachusetts) — Early conversion from a cyclosporine (CsA) regimen to a sirolimus regimen results in similar patient and graft survival but better renal function and fewer malignancies at 30 months after kidney transplantation.
These results, looking at early conversion from CsA to sirolimus 12 weeks after kidney transplantation, are part of the Concept study recently published in the American Journal of Transplantation (2009;9:1115-1123) and presented here at the American Transplant Congress 2009: The Joint Annual Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation.
"Previous studies have demonstrated a positive impact of sirolimus use on renal function at 1 year post-transplantation," Yvon Lebranchu, MD, from the University Francois Rabelais in Tours, France, told meeting attendees.
The Concept study initially randomized 235 patients receiving kidney transplantation. All patients were first treated with daclizumab, mycophenolate mofetil, CsA, and steroids.
At week 12, 2 groups from the original patient population (n?= 192) were randomized either to maintain CsA immunosuppression (n?= 97) or to switch to sirolimus (n?= 95). The number of enrolled patients had declined to 152 at 30 months (71 in the sirolimus group and 81 in the CsA group).
Year?1 results showed a superior glomerular filtration rate (GFR) and Modification of Diet in Renal Disease score in the sirolimus group, compared with the CsA group (64.4 vs 56.2?mL/min per 1.73?m2).
Benefit Maintained at 30 Months
"At 30 months, we still saw a difference in GFR in favor of sirolimus, with an on-treatment GFR of 64.4?mL/min per 1.73?m2 for sirolimus vs 53.8 mL/min per 1.73?m2 for cyclosporine," said Dr. Lebranchu. "So, the benefit in renal function is maintained to 30 months."
Dr. Lebranchu highlighted the different rates of cancers in the 2 groups at the 30-month mark. One person in the sirolimus group developed a malignancy, as did 6 in the CsA group.
"The difference between the 2 groups in terms of malignancy is not significant, but I have shown that the difference tended to worsen progressively in time through 30 months," Dr. Lebranchu told Medscape Transplantation. "These are intermediate results at 30 months and I speculate that, at the final results at 4 years, there will probably be a difference in terms of malignancy, with less malignancy in the sirolimus groups."
Dr. Lebranchu explained that the rate of malignancy related to transplantation increased with time in the CsA group. "It is not a problem in the first 12 months, but after 2, 3, 5, 10 years, it starts to be. So we see here after 30 months that the percentage of malignancy is less in the sirolimus group, and I think this is an important point," he said.
"This study showed there was continued long-term benefit in terms of renal function without any adverse events, such as proven rejections," session comoderator Todd Pesavento, MD, from Ohio State University College of Medicine, Division of Nephrology in Columbus, told Medscape Transplantation. "The maintenance of improved renal function is very important."
The study was funded by Roche. Dr. Lebranchu and Dr. Pesavento have disclosed no relevant financial relationships.
American Transplant Congress (ATC) 2009: The Joint Annual Meeting of the American Society of Transplant Surgeons (ASTS) and the American Society of Transplantation (AST): Abstract 241. Presented June 1, 2009. |
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