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目的:评价不同免疫抑制方案在肾移植中应用的安全性。方法:采用前瞻性、随机、对照研究。根据肾移植术后所用免疫抑制方案将180例肾移植患者随机分为3组,A组:环孢霉素A(CsA)+霉酚酸酯(MMF)+泼尼松(Pred);B组:普乐可复(FK506)+MMF+Pred;C组:CsA+硫唑嘌呤(Aza)+Pred。术后随访18～62个月,观察3组用药后的药物不良反应。结果:在不良反应总发生率方面,A、B、C组的差异有统计学意义(x~2=20.05,P<0.05)。在胃肠道反应、肾移植术后糖尿病、感染发生率方面,A、B、C组的差异无统计学意义(x~2=5.07,P>0.05);而在肾毒性、高血压发生率方面,A、B、C组的差异有统计学意义(P<0.05),C组明显高于A、B组;在多毛、牙龈增生、骨髓抑制、高血脂、肝毒性的发生率方面,A、B、C组的差异有统计学意义(P<0.05),A、C组明显高于B组。结论:在药物不良反应方面,以FK506、MMF、Pred组成的免疫抑制方案较CsA、MMF、Pred方案和CsA、Aza、Pred方案相对安全。
Objective: To evaluate the safety of different immunosuppressive regimens in renal transplantation. Methods: A prospective, randomized, controlled study was performed. According to the immunosuppressive regimen used after renal transplantation, 180 renal transplant recipients were randomly divided into 3 groups: group A: cyclosporine A (CsA) + mycophenolate mofetil (MMF) + prednisone; group B (FK506) + MMF + Pred; Group C: CsA + Azathioprine (Aza) + Pred. The patients were followed up for 18 to 62 months. The adverse reactions of the three groups were observed. Results: There was a statistically significant difference in the total incidence of adverse reactions between groups A, B and C (x ~ 2 = 20.05, P <0.05). There was no significant difference in the incidence of gastrointestinal reactions, diabetes mellitus after kidney transplantation, and incidence of infection between groups A, B and C (x ~ 2 = 5.07, P> 0.05) In group A, group B and group C, the difference was statistically significant (P <0.05), and group C was significantly higher than group A and group B. In terms of the incidence of hirsutism, gingival hyperplasia, myelosuppression, hyperlipidemia and hepatotoxicity, A (P <0.05). There was a significant difference between group B and group C (P <0.05). Group A and group C were significantly higher than group B. Conclusion: In the aspect of adverse drug reactions, the immunosuppressive programs with FK506, MMF and Pred are relatively safe compared with those with CsA, MMF, Pred and CsA, Aza and Pred.