术前自体骨髓间充质干细胞输注用于肾移植诱导治疗的临床研究

The efficacy and safety of induction therapy with autogenous mesenchymal stem cells perfusion before operation in cadaveric kidney transplantation

目的观察骨髓间充质干细胞（BMSC）输注预防肾移植早期急性排斥反应（AR）的有效性和安全性。方法88例肾移植受者分为BMSC组（43例）和对照组（45例），BMSC组于肾移植当天和术后2周时分别经外周静脉输注自体BMSC，对照组不进行任何诱导治疗。观察两组AR的发生情况、移植。肾功能、并发症发生情况，随访时间为24个月。结果两组患者基本资料的差异无统计学意义（P〉0．05）。BMSC组在术后3、6个月AR的发生率分别为4．7％和9．3％，明显低于对照组的20．0％和26．7％（P〈0．05）。BMSC组术后7、14和30d的估算肾小球滤过率（eGFR）分别为（1．28±0．62）、（1．33±0．63）和（1．47±0．49）ml／s，明显高于对照组（P〈0．01，P〈0．01，P〈0．05）。BMSC组并发症的发生率为44．2％，低于对照组的66．7％（P〈0．05）。两组24个月时AR的发生率和eGFR的差异无统计学意义（P〉0．05）。两组移植后感染发生率的差异无统计学意义（P〉0．05）。结论术前自体BMSC输注可降低肾移植后早期AR的发生率，可促进移植肾功能早期恢复，安全性较好。

Objective To evaluate the efficacy and safety of mesenchymal stem cells（MSCs）in preventing early acute rejection after renal transplantation. Methods Eighty-eight primary cadaveric renal allograft recipients in our department were randomized into two groups treated with bone marrow MSCs （BMSCs group, n = 43） or not （control group, n = 45）. Main immunosuppressive therapy regimen consisted of steroids, tacrolimus or cyclosporine and mycophenolate mofetil in all recipients. Estimated glomerular filtration rate （eGFR） of transplant kidney, incidence of acute reaction （AR）, graft survival and incidence of adverse events were recorded within 24 months. Results In BMSCs group, the incidence of AR was 4. 7 % and 9. 3 % at 3rd month and 6th month respectively, significantly lower than 20. 0% and 26. 7% （P〈0. 05） in the control group. The eGFR at day 7, 14 and 30 post-transplantation was significantly higher in the BMSCs group than in the control group （P〈0. 01 ,P〈0. 01 ,P〈0. 05 respectively）. The incidence of adverse events in the BMSCs group and the control group was 44. 2 % （19/43） and 66.7 % （30/45, P〈0.05） respectively and the rate of infection was 37. 2 % （ 16/43 ） and 33. 3 % （ 15/46, P 〉 0. 05 ） respectively within 24 months. Conclusion Induction therapy with autogenous BMSCs appeared to be more effective in the prevention of AR following cadaveric kidney transplantation and was associated with better clinical outcomes as far as early renal graft function without compromising patient safety.