摘要
目的评价肝移植术后激素7d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7d激素撤离组(7d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。7d组激素用法:术中静脉滴注1000mg甲泼尼龙,术后按500、240、200、160、80.40和20mg依次递减,7d后停用;3个月组激素用法:按7d组方案静脉滴注甲泼尼龙7d后,改用甲泼尼龙口服,每隔3d依次按48、40、32、24、16、8和4mg递减18d,然后4mg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);7d组术后糖尿病的发生率(17.5%比38.9%,X^2=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7d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。
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 mg and intravenous methylprednisolone 1000 mg during intraoperation and FK506 thereafter was adjusted to predefined 8-12 wg/L from day 1 to month 6. Patients in 7 day steroid withdrawal group received 500,240,200,160,80,40 and 20 mg 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 3^rd 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.
出处
《中华外科杂志》
CAS
CSCD
北大核心
2008年第15期1126-1128,共3页
Chinese Journal of Surgery
基金
国家自然科学基金资助项目(30700398)
广东省自然科学基金资助项目(06021354)
China Medical Board in New York资助项目(06837)
关键词
肝移植
临床方案
激素撤离
有效性
安全性
Liver transplantation
Clinical protocols
Steroid withdrawal
Efficacy
Safety