巴西国家卫生系统中肝移植的16年队列研究：免疫抑制维持疗法分析
Sixteen-Year Cohort of Liver Transplantation in the National Health System in Brazil: Analysis of Immunosuppression Maintenance Therapies.
作者信息
Nascimento Guilherme Fagundes, Gomes Rosângela Maria, Alvares-Teodoro Juliana, Ribeiro Nélio Gomes, Cherchiglia Mariângela Leal, Simão-Filho Charles, Acurcio Francisco Assis, Sarmento Tulio Tadeu Rocha, Gargano Ludmila Peres, Guerra Augusto Afonso
机构信息
Department of Social Pharmacy, College of Pharmacy, Federal University of Minas Gerais, Belo Horizonte, Brazil.
SUS Collaborating Centre-Technology Assessment & Excellence in Health, College of Pharmacy, Federal University of Minas Gerais, Belo Horizonte, Brazil.
出版信息
Front Pharmacol. 2020 Oct 6;11:572043. doi: 10.3389/fphar.2020.572043. eCollection 2020.
OBJECTIVE
To evaluate factors related to liver graft survival with a focus on immunosuppressive schemes based on calcineurin inhibitors (tacrolimus or cyclosporine).
METHODOLOGY
This study was carried out through an open cohort constructed by deterministic and probabilistic matching through three databases of the SUS with assessment of liver graft survival from 2000 to 2015 in Brazil. From this first cohort, a second cohort was constructed by pairing 1: 1 to more precisely assess the effect of the immunosuppressive scheme on graft survival. The Kaplan-Meier method and was used to estimate the probability of survival. Cox's model of proportional risks was used to assess factors related to graft loss.
RESULT
We found 12,687 patients in the Full cohort and 470 patients in the Matched cohort. The overall graft survival rates at 1, 5, 10, and 16 years were 72.6, 63.3, 52.8, and 45.3%, respectively. Patients younger had a longer graft survival than older ones. In the Full cohort, male patients had a higher survival rate than female ones. Therapeutic schemes based on tacrolimus were more prevalent and had a better survival rate when compared to schemes that used cyclosporine. Tacrolimus without association with antiproliferative agents or rapamycin inhibitors was the therapeutic scheme associated with greater survival rate in both cohorts (HR = 0.81, 95% CI = 0.72-0.91), (HR = 0.50, 95% CI = 0.30-0.85). In addition, white-skinned patients had longer survival rate in both cohorts (HR = 0.55, 95% CI = 0.50-0.61 and HR = 0.50, 95% CI = 0.34-0.75). On the other hand, patients who a greater time ratio without using an immunosuppressant had lower graft survival rate (HR = 6.46, 95% CI = 5.05-8.27 and HR = 6.57, 95% CI = 2.66-16.22).
CONCLUSION
This 16-year cohort showed that the older age and the greater time ratio without using an immunosuppressant are risk factors for liver graft loss. White-skinned patients and tacrolimus-based regimens, especially tacrolimus without other immunosuppressants, are factors of better prognosis to the graft.
目的
评估与肝移植存活相关的因素，重点关注基于钙调神经磷酸酶抑制剂（他克莫司或环孢素）的免疫抑制方案。
方法
本研究通过一个开放队列进行，该队列通过巴西统一卫生系统的三个数据库进行确定性和概率性匹配构建而成，评估2000年至2015年肝移植的存活情况。从这个第一个队列中，通过1:1配对构建了第二个队列，以更精确地评估免疫抑制方案对移植存活的影响。采用Kaplan-Meier方法估计存活概率。使用Cox比例风险模型评估与移植失败相关的因素。
结果
我们在全队列中发现了12687例患者，在匹配队列中发现了470例患者。1年、5年、10年和16年的总体移植存活率分别为72.6%、63.3%、52.8%和45.3%。年龄较小的患者移植存活时间比年龄较大的患者更长。在全队列中，男性患者的存活率高于女性患者。与使用环孢素的方案相比，基于他克莫司的治疗方案更为普遍且存活率更高。在两个队列中，不与抗增殖剂或雷帕霉素抑制剂联合使用的他克莫司是与更高存活率相关的治疗方案（风险比=0.81，95%置信区间=0.72-0.91），（风险比=0.50，95%置信区间=0.30-0.85）。此外，在两个队列中，白皮肤患者的存活率更高（风险比=0.55，95%置信区间=0.50-0.61；风险比=0.50，95%置信区间=0.34-0.75）。另一方面,未使用免疫抑制剂时间比例较高的患者移植存活率较低（风险比=6.46，95%置信区间=5.05-8.27；风险比=6.57，95%置信区间=2.66-16.22）。
结论
这个为期16年的队列研究表明，年龄较大以及未使用免疫抑制剂的时间比例较高是肝移植失败的危险因素。白皮肤患者和基于他克莫司的治疗方案，尤其是不与其他免疫抑制剂联合使用的他克莫司，是移植预后较好的因素。
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