HC—AⅡ器官保存液保存供肾的多中心随机对照临床研究

A multicenter randomized controlled trial of HC-A Ⅱ solution in kidney preservation

目的探讨高渗枸橼酸盐嘌呤Ⅱ（HC-AⅡ）器官保存液保存供。肾的有效性及安全性。方法采用多中心、随机、双盲、对照试验设计。2008年1月至2010年12月间，选择9家移植中心等待肾脏移植的患者，随机分为2组。试验组接受以HC-AⅡ保存液灌洗和冷保存的供肾，对照组接受以组氨酸-色氨酸-酮戊二酸盐（HTK）保存液灌洗和冷保存的供肾。结果进入全分析人群（FAS）的患者共277例，其中试验组137例，对照组140例。进入按方案人群（PPS）的患者共262例，其中试验组133例，对照组129例。两组基线具有可比性。FAS中，试验组移植后28d内SCr首次恢复正常的例数占该组总数的86．9％（119／137），对照组占85．0％（119／140），两组差异无统计学意义（P〉0．05）。PPS分析与FAS分析结果一致。试验组与保存液有关的不良事件发生率为2．9％（4／137），对照组为0．7％（1／140），两组的差异无统计学意义（P〉0．05）。未见与试验有关的严重不良事件。结论HC-AⅡ保存液与HTK保存液保存供。肾的效果相当，并具有良好的安全性。

Objective To evaluate the efficacy and safety of HC-AⅡ solution in kidney preservation. Methods A multicenter, randomized, double-blind and controlled clinical trial was conducted. Between Jan. 2008 and Dec. 2010, kidney recipients from 9 transplant centers were randomly divided into two groups. Grafts in each group were perfused and stored in HC-AⅡ or HTK solutions respectively. Results 277 patients were included in the Full Analysis Set （FAS）, 137 of whom were in HC-AⅡ group and 140 in HTK group. Demographic and baseline medical characteristics were similar between the two groups. 262 patients were included in the Per Protocol Set （PPS）, 133 of whom were in HC-AH group and 129 in HTK group. The percentages of patients with a serum creatinine level that returned to normal within 28 days postoperation were 86. 9% in HC-AⅡ group and 85.0% in HTK group respectively （P〈0. 05）. The results from PPS analysis were consistent with those from FAS analysis. The incidence of test-related adverse events was 2.9% in HC-AⅡ group and 0. 7% in HTK group respectively （P〉0. 05）. No test-related serious adverse events occurred throughout the study. Conclusion HC-AⅡ solution, the same as HTK solution, is safe and effective in kidney preservation.