Department of Social Pharmacy, College of Pharmacy, Federal University of Minas Gerais, Belo Horizonte 31270-901, Brazil.
SUS Collaborating Centre-Technology Assessment & Excellence in Health, College of Pharmacy, Federal University of Minas Gerais, Belo Horizonte 31270-901, Brazil.
Int J Environ Res Public Health. 2020 Mar 17;17(6):1974. doi: 10.3390/ijerph17061974.
The maintenance of patients with renal transplant typically involves two or more drugs to prevent rejection and prolong graft survival. The calcineurin inhibitors (CNI) are the most commonly recommended medicines in combinations with others. While immunosuppressive treatment regimens are well established, there is insufficient long-term effectiveness data to help guide future management decisions. The study analyzes the effectiveness of treatment regimens containing CNI after renal transplantation during 16 years of follow-up with real-world data from the Brazilian National Health System (SUS). This was a retrospective study of 2318 SUS patients after renal transplantion. Patients were propensity score-matched (1:1) by sex, age, type and year of transplantation. Kaplan-Meier analysis was used to estimate the cumulative probabilities of survival. A Cox proportional hazard model was used to evaluate factors associated with progression to graft loss. Multivariable analysis, adjusted for diabetes mellitus and race/color, showed a greater risk of graft loss for patients using tacrolimus plus mycophenolate compared to patients treated with cyclosporine plus azathioprine. In conclusion, this Brazilian real-world study, with a long follow-up period using matched analysis for relevant clinical features and the representativeness of the sample, demonstrated improved long-term effectiveness for therapeutic regimens containing cyclosporine plus azathioprine. Consequently, we recommend that protocols and clinical guidelines for renal transplantation should consider the cyclosporine plus azathioprine regimen as a potential first line option, along with others.
肾移植患者的维持治疗通常需要两种或两种以上的药物来预防排斥反应并延长移植物的存活时间。钙调神经磷酸酶抑制剂(CNI)是与其他药物联合使用时最常推荐的药物。虽然免疫抑制治疗方案已经确立,但缺乏足够的长期有效性数据来帮助指导未来的管理决策。该研究使用巴西国家卫生系统(SUS)的真实世界数据,对 16 年随访期间含 CNI 的治疗方案在肾移植后的有效性进行了分析。这是一项对 2318 例 SUS 肾移植患者的回顾性研究。患者按性别、年龄、移植类型和年份进行倾向评分匹配(1:1)。Kaplan-Meier 分析用于估计生存的累积概率。Cox 比例风险模型用于评估与移植物丢失进展相关的因素。多变量分析,调整了糖尿病和种族/肤色因素,表明与环孢素加硫唑嘌呤治疗相比,使用他克莫司加霉酚酸酯的患者发生移植物丢失的风险更高。总之,这项巴西的真实世界研究,使用匹配分析相关临床特征和样本代表性,具有较长的随访期,表明含环孢素加硫唑嘌呤的治疗方案具有更好的长期有效性。因此,我们建议肾移植的方案和临床指南应将环孢素加硫唑嘌呤方案作为一种潜在的一线选择,与其他方案一起考虑。