哪些患者可以从转换西罗莫司中受益?

目的 评价西罗莫司(SRL)替代钙调磷酸酶抑制剂(CNl)类药物的安全性和可行性.方法肾移植术后>3个月,以CNI为基础免疫抑制剂患者157例,按转换SRL的原因分A组(计划性转换,62例)、B组(SCr升高,50例)、C组(高胆红素,37例)和D组(肿瘤,8例),以SRL为基础免疫抑制剂,撤除CNI类药物,观察急性排斥反应和不良事件发生率,随访时间为6个月. 结果 移植肾和患者均存活.发生急性排斥反应2例.SCr和尿酸在转换后1个月开始下降,而肌酐清除率(CCr)开始升高,转换前后尿酸比较差异有统计学意义(P<0.01).A组转换前和转换后1个月SCr分别为99.04、91.86 μmol/L,转换前后比较差异有统计学意义(P<0.01);CCr转换前为70.50ml/min,转换后升至78.27 ml/min.B组转换前和转换后1个月SCr分别为142.96、128.15/μmol/L,CCr分别为47.66、53.38 ml/min.C组SCr分别为97.09、88.34 μmol/L,CCr分别为69.38、75.66 ml/min.D组SCr分别为97.46、88.91 gmol/L,CCr分别为62.29、67.64 ml/min.C组总胆红素和直接胆红素分别由转换前的平均30.45和15.15 μmol/L降至转换后12.13和3.70μmol/L,转换前后比较差异有统计学意义(P<0.01).转换后主要不良事件包括:发热11例(7.0%);总胆固醇和甘油三酯升高者分别由转换前的36例(22.9%)和57例(36.3%)增至转换后的58例(36.9%)和73例(46.5%);转换前有蛋白尿13例(8.3%),转换后增至18例(11.5%). 结论 肾移植术后早期将CNI类药物转换为SRL安全、有效.SCr已升高者要尽早转换SRL治疗,CNI导致高胆红素、高尿酸血症和移植后肿瘤患者均可从转换SRL中受益.

Who will benefit from sirolimus based conversion therapy?

Objective To evaluate the safety and efficacy of conversion from Calcineurin inhibi-tor (CNI) based therapy to sirolimus (SRL) based therapy in renal transplantation. Methods One hundred and fifty-seven renal transplant recipients postoperative 3 months were enrolled to A, B, C and D groups according to different reasons. Group A (n= 62) was consisted of the patients of early conversion, group B (n=50) of increased serum creatinine (SCr), group C (n=37) of increased total bilirubin (TB), and group D (n=8) of neoplasms. All the patients withdrew CNI and received SRL based therapy. All the patients were followed up for 6 months to observe the incidences of acute rejec-tion (AR) and adverse events. Results Both the patient and graft survival rates were 100%. Inci-dence of acute rejection was 1.3% (2/157). After the conversion, SCr and uric acid of the 157 patients decreased, meanwhile creatinine clearance rate (CCr) increased. In group A, SCr decreased from 99.04 μmol/L to 91.86 μmol/L(P<0.01), while CCr increased from 70.50 ml/min to 78.27 ml/min. In group B, SCr decreased from 142.96 μmol/L to 128.15 μmol/L, while CCr increasedfrom 47.66 ml/min to 53.38 ml/min. In group C, SCr decreased from 97.09 μmol/L to 88.34 μmol/L,while CCr increased from 69.38 ml/min to 75.66 ml/min. In group D, SCr decreased from 97.46 μmol/L to 88.91 μmol/L, while CCr increased from 62.29 ml/min to 67.64 ml/min. TB and di-rect bilirubin of group C decreased from 30.45, 15.15 μmol/L to 12. 13, 3.70 μmol/L(P<0.01).Common adverse events included fever, hyperlipidemia and proteinuria. Incidence of fever was 7.0% (11/157). Conclusions Early conversion from CNI based therapy to SRL based immunosuppressive therapy is safe and effective in renal transplantation recipients of increased SCr. And the patients with post-transplant neoplasms and CNI-induced hyperbilirubinemia and hyperuricemia can benefit from SRL based conversion therapy.