肝移植术后激素七天撤离方案的临床疗效评价

目的 评价肝移植术后激素7 d撤离方案的临床有效性及安全性.方法 将2005年10月至2007年10月收治的76例供受者血型相同的首次肝移植患者动态随机法分为两组:术后7 d激素撤离组(7 d组,40例)和术后3个月激素撤离组(3个月组,36例),两组均采用以他克莫司(FK506)为基础的免疫抑制方案.7 d组激素用法:术中静脉滴注1000 mg甲泼尼龙,术后按500、240、200、160、80、40和20 mg依次递减,7 d后停用;3个月组激素用法:按7 d组方案静脉滴注甲泼尼龙7 d后,改用甲泼尼龙口服,每隔3 d依次按48、40、32、24、16、8和4 mg递减18 d,然后4 mg口服至术后3个月.随访6个月并评价术后急性排斥反应发生率和不良反应发生率.结果 共有69例完成全部随访,7例患者因死亡和严重细菌感染等原因于相应时间终止实验.两组患者在术后急性排斥反应、高脂血症、高血压发生率方面的差异均无统计学意义(P>0.05);7 d组术后糖尿病的发生率(17.5%比38.9%,X2=4.335,P=0.047)明显低于3个月组.结论 供受者血型相同的肝移植采用以FK506为基础的免疫抑制方案时,术后7 d激素撤离是安全有效的,不增加急性排斥反应发生率,并可以明显降低术后糖尿病发生率.

Evaluatement of efficacy and safety on steroid withdrwal at the seventh day after liver transplantation

Objective To evaluate efficacy and safety on steroid withdrawal at the seventh day after liver transplantation.Methods Seventy-six adult patients undergoing first cadaveric liver transplantation from October 2005 to October 2007 were randomly divided into 7 day ( n = 40) and 3 month ( n = 36) steroid withdrawal groups. All patients received FK506 3 nag and intravenous methylprednisolone 1000 mg during intraoperation and FKS06 thereafter was adjusted to predefined 8-12 μg/L from day 1 to month 6. Patients in 7 day steroid withdrawal group received 500,240,200,160,80,40 and 20 nag intravenous methylprednisolone tapered daily from postoperative day 1 to day 7. In 3 month steroid withdrawal group, patients received the same protocol as 7 day steroid withdrawal group for intravenous methylprednisolone tapered daily from postoperative day 1 to day 7 and thereafter received oral prednisone 48,40,32,24,16,8,4 mg tapered every 3 days and maintained 4 mg to the 3rd month. All patients were followed up for 6 months. The incidence of treated acute rejection and side effects were evaluated between two groups. Results A total of 69 cases were fully followed up, and 7 cases were discontinuated including death ( n = 2 ), server infection ( n = 2), protocol violation ( n = 2) and retransplantation ( n = 1 ). There were no statistical difference between 2 groups concerning the incidence of acute rejection, hypertension, hyperlipemia and other adverse events( P>0.05), but significant difference in incidence of diabetes (17.5% vs. 38.9%, P = 0. 047 ). Conclusion Steroid withdrawal strategy at day 7 is same safety and efficacy as steroid withdrawal at 3 month.