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一项比较IGL - 1与威斯康星大学保存液在肝移植中应用的随机研究。

A randomized study comparing IGL-1 to the University of Wisconsin preservation solution in liver transplantation.

作者信息

Dondéro Fédérica, Paugam-Burtz Catherine, Danjou Fabrice, Stocco Jeanick, Durand Francois, Belghiti Jacques

机构信息

Beaujon Hospital, Assistance Publique Hôpitaux de Paris, Clichy, France.

出版信息

Ann Transplant. 2010 Oct-Dec;15(4):7-14.

Abstract

BACKGROUND

Institut Georges Lopez-1 (IGL-1) is a new preservation solution with lower potassium and lower viscosity than University Wisconsin solution (UW). These characteristics which improve liver preservation lead us to evaluate clinical effects of IGL-1 in a randomized controlled study with UW.

MATERIAL/METHODS: From June 2007 to July 2009, after exclusion of partial graft, combined transplantation and fulminant hepatic failure, 140 deceased donor allografts were randomly assigned to IGL-1 (n=48) or UW (n=92) solution. Variables concerning donors and recipients were collected including liver tests (total serum bilirubin, prothrombin time and transaminases) were analyzed until postoperative day 30. Incidences of hepatic artery thrombosis (HAT), primary non function (PNF) and biliary non anastomotic strictures (NAS) were analyzed. The comparative analysis of costs was realized.

RESULTS

Donor and recipients characteristics were similar in both groups. Volume of preservation solution utilized for harvesting was identical. Duration of cold ischemia (472±142 vs. 477±122 min), surgery (427±97 vs. 437±94 min) and proportion of extended criteria donor was similar. Postoperative kinetic and level liver tests were similar. Rate of PNF (2% vs. 4%), early retransplantation (6% vs. 7%), incidence of biliary NAS (2% vs. 3%) and HAT (6% vs. 4%) were similar. Mean intensive care unit (ICU) stay was similar (5.6 vs. 6.1 days). However costs related to preservation solution for one liver procurement were 992.0 for IGL-1 vs. 1609.0 Euros for UW.

CONCLUSIONS

Results of this randomized study shows that the efficacy and safety of IGL-1 are comparable to those of the reference UW with a lower cost.

摘要

背景

乔治·洛佩斯研究所1号溶液(IGL-1)是一种新型的保存液,其钾含量和粘度均低于威斯康星大学溶液(UW)。这些改善肝脏保存的特性促使我们在一项与UW的随机对照研究中评估IGL-1的临床效果。

材料/方法:从2007年6月至2009年7月,在排除部分移植物、联合移植和暴发性肝衰竭后,将140例脑死亡供体的同种异体移植物随机分配至IGL-1组(n = 48)或UW组(n = 92)。收集供体和受体的相关变量,包括肝功能检查(总血清胆红素、凝血酶原时间和转氨酶),并分析至术后第30天。分析肝动脉血栓形成(HAT)、原发性无功能(PNF)和胆管非吻合口狭窄(NAS)的发生率。进行成本的对比分析。

结果

两组的供体和受体特征相似。用于获取移植物的保存液体积相同。冷缺血时间(472±142 vs. 477±122分钟)、手术时间(427±97 vs. 437±94分钟)以及扩大标准供体的比例相似。术后肝功能的动态变化和水平相似。PNF发生率(2% vs. 4%)、早期再次移植率(6% vs. 7%)、胆管NAS发生率(2% vs. 3%)和HAT发生率(6% vs. 4%)相似。重症监护病房(ICU)的平均住院时间相似(5.6天 vs. 6.1天)。然而,获取一个肝脏时与保存液相关的成本,IGL-1为992.0欧元,UW为1609.0欧元。

结论

这项随机研究的结果表明,IGL-1的有效性和安全性与参考的UW相当,且成本更低。

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