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目的观察单剂半量赛尼哌对肾移植急性排斥(AR)的预防作用及安全性评估。方法选择同期肾移植病人187例,根据术后肾功能恢复情况及术前是否使用赛尼哌分为A/90例、B/73例、C/11例、D/13例4组,其中A、B组移植后肾功能恢复良好,即术后1周血肌酐<176.6μmol/L,C、D组术后出现移植肾功能延迟恢复,术后1周血血肌酐>353μmol/L。A、C两组术前2h静滴赛尼哌25mg(0.5mg/kg)和口服霉酚酸酯0.75g,B、D组仅口服霉酚酸酯0.75g;术后四组病人均予甲基强的松龙500mg×3d冲击,常规强的松、环孢霉素A和霉酚酸酯三联抗排斥治疗。观察术后6个月内AR发生率、发生时间、强度及排斥逆转率,同时观察胃肠道反应、感染及血液系统损害等副作用。结果A组13例(14.4%)发生AR,B组18例(24.6%),C组6例(54.5%),D组7例(53.8%),A组AR发生率明显低于B、C、D三组(P均<0.01);B组AR发生率显著低于C、D组(P<0.01),C、D组差异不显著(P>0.05),A组排斥开始时间3-9d(6.2±3.2d)较B组2-8d(4.5±3.1d)、C组2-7d(4.3±4.2d)、D组2-9d(3.9±3.5d)明显延迟(P均<0.05)。但B、C、D三组排斥开始时间无明显差异(P>0.05)。A组AR经强化治疗均逆转,B组16例逆转,另2例失败,C组5例逆转,1例因移植肾排斥破裂出血切除,D组5例逆转,2例失败;C、D组各2例于术后13-32d再次排斥,经甲基强的松龙强化治疗逆转。感染、胃肠道反应及血液系统损害四组差异不显著(P均>0.05)。结论移植后肾功能恢复良好病人,术前25mg赛尼哌可显著降低AR发生率,且安全性好。但对于移植肾功能延迟恢复病人,术前25mg赛尼哌并不能有效预防排斥发生。
Objective To observe the prophylactic and safety evaluation of single dose semenate in acute renal transplant recipients (AR). Methods A total of 187 renal transplant recipients were enrolled in this study. A / 90 cases, B / 73 cases, C / 11 cases and D / 13 cases were divided into 4 groups according to the postoperative recovery of renal function, In group B, renal function recovery was good, that is, serum creatinine was less than 176.6μmol / L at 1 week after operation. Delayed graft function recovered after operation in group C and D, serum creatinine> 353μmol / L at 1 week after operation. Patients in groups A and C received meperidine 25 mg (0.5 mg / kg) intravenously and 0.75 g of mycophenolate mofetil 2 hours before operation. Only 0.75 mg mycophenolate mofetil was administered to patients in groups B and D, Kevlar prednisolone 500mg × 3d impact, conventional prednisone, cyclosporine A and mycophenolate mofetil anti-rejection therapy. AR incidence, occurrence time, intensity and rejection rate were observed within 6 months after operation. Gastrointestinal reactions, infections and blood system damage were also observed. Results AR occurred in 13 cases (14.4%) in group A, 18 cases (24.6%) in group B, 6 cases (54.5%) in group C and 7 cases (53.8%) in group D. The incidence of AR in group A was significantly lower than that in group B , And D (all P <0.01). The incidence of AR in group B was significantly lower than that in group C and D (P <0.01), but not in group C and D (P> 0.05) (6.2 ± 3.2d) was significantly delayed than that of group B (4.5 ± 3.1d), group C 2-7d (4.3 ± 4.2d), group D 2-9d (3.9 ± 3.5d) . However, there was no significant difference in the start time of rejection between groups B, C and D (P> 0.05). In group A, AR was reversed by intensive therapy. In group B, 16 cases were reversed and the other 2 cases failed. C group, 5 cases reversed, 1 case was due to rejection of renal allograft rupture, 5 cases reversed in group D and 2 cases failed. The other two cases were excised again 13-32 days after operation and were reversed by intensive treatment with methylprednisolone. There was no significant difference in infection, gastrointestinal reaction and blood system damage between the four groups (all P> 0.05). Conclusions After renal transplantation, the patients with good renal function recovered, preoperative 25mg saenipid can significantly reduce the incidence of AR, and good safety. However, for patients with delayed graft recovery, preoperative 25 mg of saenipide does not prevent rejection effectively.