Secchi Antonio, Malaise Jacques, Caldara Rossana
Department of Internal Medicine, Vita Salute San Raffaele University, Milan, Italy.
Nephrol Dial Transplant. 2005 May;20 Suppl 2:ii18-24, ii62. doi: 10.1093/ndt/gfh1078.
Simultaneous pancreas-kidney (SPK) transplantation has become accepted therapy for patients with type 1 diabetes and end-stage renal disease. This 3-year study compared the metabolic effects of tacrolimus- and cyclosporin microemulsion (ME)-based immunosuppressive therapy in this clinical setting.
The study population comprised the 205 patients enrolled in the Euro-SPK 001 study. Glucose metabolism parameters [fasting blood glucose, fasting C-peptide and glycated haemoglobin (HbA1c)], blood lipids (total cholesterol and triglycerides) and pancreatic enzymes (lipase and amylase) were monitored at regular intervals during the study. Blood pressure was also carefully monitored and compared with target levels for diabetic patients.
Fasting C-peptide and HbA1c levels were within the normal ranges in the two treatment groups throughout the 3 years. Fasting blood glucose was higher during the first 2 months post-transplant in the tacrolimus group than in the cyclosporin-ME group, but no differences were seen thereafter. From month 2 post-transplant, mean levels of total cholesterol were significantly lower among patients receiving tacrolimus than among those in the cyclosporin-ME group. In addition, patients receiving cyclosporin-ME showed serological features of mild pancreatitis, with elevated blood amylase and lipase levels during the first 6 months post-transplant. The two regimens were comparable with respect to hypertension.
Except for lipid profiles, no major differences in metabolic effects or blood pressure control were observed over the 3 years in SPK transplant patients receiving immunosuppression based on tacrolimus or cyclosporin-ME. In view of the potential risk of hypertension, antihypertensive strategies should be implemented for all patients.
胰肾联合移植(SPK)已成为1型糖尿病合并终末期肾病患者的公认治疗方法。这项为期3年的研究比较了在这种临床情况下,基于他克莫司和环孢素微乳剂(ME)的免疫抑制治疗的代谢效果。
研究人群包括参加欧洲SPK 001研究的205名患者。在研究期间定期监测葡萄糖代谢参数[空腹血糖、空腹C肽和糖化血红蛋白(HbA1c)]、血脂(总胆固醇和甘油三酯)和胰腺酶(脂肪酶和淀粉酶)。还仔细监测血压并与糖尿病患者的目标水平进行比较。
在整个3年中,两个治疗组的空腹C肽和HbA1c水平均在正常范围内。他克莫司组移植后前2个月的空腹血糖高于环孢素-ME组,但此后未见差异。移植后第2个月起,接受他克莫司治疗的患者总胆固醇平均水平显著低于接受环孢素-ME治疗的患者。此外,接受环孢素-ME治疗的患者在移植后前6个月出现轻度胰腺炎的血清学特征,血淀粉酶和脂肪酶水平升高。两种治疗方案在高血压方面具有可比性。
在接受基于他克莫司或环孢素-ME免疫抑制治疗的SPK移植患者中,除血脂情况外,3年内未观察到代谢效果或血压控制方面的重大差异。鉴于高血压的潜在风险,应针对所有患者实施抗高血压策略。