肾移植术后早期主动减少免疫抑制剂用量的前瞻性研究

目的探讨对肾移植术后受者早期主动减少免疫抑制剂用量的临床必要性和安全性。方法随机选择63例尸体肾移植受者为观察组,58例尸体肾移植受者为对照组,两组受者均采用环孢素(CsA)+麦考酚吗乙酯(MMF)+泼尼松三联免疫抑制方案。于术后第6周对观察组63例受者予以主动减少免疫抑制剂用量(将CsA血药谷浓度维持在200～250 ng/ml,MMF按受者体质量主动减药),术后4～6个月开始按个体状况将MMF用量调至减药前水平。对照组按常规免疫抑制方案治疗。观察两组受者术后6周至1年的血清肌酐(Scr)、血尿素氮(BUN)、CsA血药谷浓度、肺部感染发生率、急性排斥反应(AR)发生率。结果随访1年期间,观察组受者Scr、BUN基本稳定在同一水平,且与对照组比较差异无统计学意义(均为P>0.05)。观察组与对照组的AR发生率分别为8%与9%,比较差异无统计学意义(P>0.05)。两组的肺部感染率分别为8%(5/63)和14%(8/58),比较差异有统计学意义(P<0.05),对照组有2例发展为严重的肺部感染。结论肾移植术后早期主动减少免疫抑制剂用量能有效降低此阶段肺部感染发生率,且AR发生率并没有增加。

Prospective study of reducing the dose of immunosuppressive agents intentionally in early stage after renal transplantation

Objective To evaluate the necessity and safety of reducing dose of immunodepressant intentionally at early stage after renal transplantation.Methods One hundred and twenty-one recipients with cadaveric renal transplantation were randomly divided into study group(n=63) and control group(n=58).The recipients in each group received triple-drug immunosuppressive regimen including ciclosporine(CsA),mycophenolate mofetil(MMF) and prednisone.In study group,63 recipients were reduced the dosage of immunosuppressive agents intentionally at week 6 after transplantation.The blood trough concentration of CsA was maintained at 200-250 ng/ml and the dosage of MMF was reduced actively according to the body weight.The dosage of MMF was adjusted to the level before drug reduction at 4-6 months after transplantation according to the patients’ individual situation.In control group,the recipients received conventional immunosuppressive therapy.The serum creatinine(Scr),blood urea nitrogen(BUN),blood valley concentration of CsA,the incidence of pulmonary infection and acute rejection(AR) were observed and compared in the two groups from 6 weeks to 1 year after transplantation.Results During the 1-year follow-up period,the levels of Scr and BUN were stable in the recipients of study group and there was no significant difference between these two groups(all in P>0.05).The incidence of AR was 8% in study group and 9% in control group respectively,which showed no significant difference(P>0.05).The incidence of pulmonary infection was 8%(5/63) in study group and 14%(8/58)in control group respectively and significant difference was observed(P<0.05).Two patients in control group developed severe pulmonary infection.Conclusions Reducing the dose of immunosuppressive agents intentionally at early stage after renal transplantation can reduce the incidence of pulmonary infection without increasing the incidence of AR.