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目的:比较成人肾移植受者不同钙调神经蛋白抑制剂(CNI)治疗5年疗效与并发症的差异。方法:进行前瞻性实验设计,收集2005年3月至2009年3月四川省人民医院完成的187例肾移植受者的资料,按免疫抑制方案分为环孢素A(Cs A)组(n=67)及他克莫司(FK506)组(n=120),所有患者随访5年,比较两组受者肾移植术后5年内CNI药物转化率及各种临床症状、体征,如多毛症、牙龈增生、排斥反应、感染、术后高血压、神经精神症状、术后新发肿瘤及术后糖尿病发病率,观察两组受者血浆胆固醇、三酰甘油、低密度脂蛋白、高密度脂蛋白、肾移植术后估算的肾小球滤过率(e GFR)及术后血压情况,分析患者1、3、5年人/肾存活率等差异。结果:术后随访5年结果显示,FK506组药物转换率低于Cs A组(11.6%vs 23.9%,P<0.05),FK506组糖尿病发生率高于Cs A组(35.8%vs 19.4%,P<0.05),FK506组神经精神症状发生率高于Cs A组(15%vs 4.5%,P<0.05),多毛症比例(3.3%vs 11.9%,P<0.05)、高血压发病率(72.6%vs 87.3%,P<0.05)及舒张压(80.3±13.5 mm Hg vs 85.1±15.7 mm Hg,P<0.05)均显著低于Cs A组。FK506组的高脂血症发病率低于Cs A组(36.7%vs 64.2%,P<0.05),FK506组的胆固醇(3.85±2.36 vs 4.73±2.71,P<0.05)及低密度脂蛋白(2.74±2.04 vs 3.36±1.97,P<0.05)显著低于Cs A组,e GFR显著高于于Cs A组[92.5±28.8 ml/(min·1.73m2)vs 89.7±33.1 ml/(min·1.73m2),P<0.05]。其余方面无显著性差异。结论:与Cs A比较,FK506更高效,毒副作用相对较少,两组药物疗效及毒副作用各有侧重,临床可根据患者的具体情况个体化用药。
OBJECTIVE: To compare the efficacy and complications of 5-year treatment with different calcineurin inhibitors (CNI) in adult renal transplant recipients. Methods: A prospective experimental design was conducted to collect data of 187 renal transplant recipients completed from March 2005 to March 2009 in Sichuan Provincial People’s Hospital. According to the immunosuppressive regimen, CsA group (n = = 67) and FK506 group (n = 120). All patients were followed up for 5 years. The rates of CNI drug conversion and various clinical symptoms and signs, such as hirsutism, were compared between the two groups after 5 years of renal transplantation , Gingival hyperplasia, rejection, infection, postoperative hypertension, neuropsychiatric symptoms, postoperative new tumor and incidence of postoperative diabetes mellitus. Plasma cholesterol, triglyceride, low density lipoprotein, high density lipoprotein Protein, estimated glomerular filtration rate (e GFR) and postoperative blood pressure after renal transplantation, and analyzed the difference of one-year, three-year and five-year survival rate after renal transplantation. Results: The 5-year follow-up showed that the conversion rate of FK506 was lower than that of CsA (11.6% vs 23.9%, P <0.05), and the incidence of diabetes in FK506 was higher than that of CsA (35.8% vs 19.4%, P 0.05). The incidence of neuropsychiatric symptoms in FK506 group was higher than that in CsA group (15% vs 4.5%, P <0.05), hirsutism rate (3.3% vs 11.9%, P <0.05) vs 87.3%, P <0.05) and diastolic blood pressure (80.3 ± 13.5 mm Hg vs 85.1 ± 15.7 mm Hg, P <0.05) were significantly lower than CsA group. The incidence of hyperlipidemia in FK506 group was significantly lower than that in CsA group (36.7% vs 64.2%, P <0.05), cholesterol in FK506 group (3.85 ± 2.36 vs 4.73 ± 2.71, P <0.05) and low density lipoprotein ± 2.04 vs 3.36 ± 1.97, P <0.05) was significantly lower than that of CsA group (p <0.05). The eGFR of CsA group was significantly higher than that of CsA group [92.5 ± 28.8 ml / (min · 1.73m2) vs 89.7 ± 33.1 ml / (min · 1.73m2 ), P <0.05]. The rest no significant difference. Conclusion: Compared with Cs A, FK506 is more effective and has fewer toxic and side effects. The curative effect and toxic side effects of FK506 are different in both groups. The clinical application of FK506 can be individualized according to the patients’ specific conditions.