Department of Transplant Research, Colombiana de Trasplantes, Bogotá, Colombia.
National University of Colombia, Bogotá, Colombia.
Transplant Proc. 2024 Jul-Aug;56(6):1231-1240. doi: 10.1016/j.transproceed.2024.02.028. Epub 2024 Jul 14.
There is a great debate about the role of biopsies per protocol in kidney transplant recipients, and the published studies show contradictory results. We aimed to assess the safety and effectiveness of protocol biopsies in kidney transplant recipients in improving short- and long-term outcomes.
We conducted searches until July of 2023 to identify all randomized clinical trials (RCT). Studies were identified through search strategies for CENTRAL, MEDLINE, EMBASE, and LILACS. Titles and abstracts were screened independently by 2 authors; 2 authors independently assessed retrieved abstracts and the full text. Assessment of risk of bias was carried out using the Cochrane risk of bias tool. The outcomes of interest were: Acute rejection, graft loss, mortality, glomerular filtration rate, and safety outcomes. Meta-analysis was performed for variables of interest when appropriate. Quality of evidence was assessed using GRADE methodology.
We screened 5,695 records. Four trials met all eligibility criteria. No benefit of protocol biopsy was found in detecting acute rejection (3 studies RR: 2.0, 95% CI: 0.68-5.85, p = .2) or preventing graft loss at 12 months (2 studies, RR 0.33, 95% CI 0.06-1.72, p = .19). No differences were found between the groups in the glomerular filtration rate at 6 months post-transplantation (2 studies, MD 2.97, 95% CI 1.4-7.3, p = .18). A total of 23 safety events were present in the biopsy group compared to six in the control group.
No benefit was found in performing protocol biopsy following kidney transplantation.
关于肾移植受者中按方案进行活检的作用存在很大争议，已发表的研究结果相互矛盾。我们旨在评估肾移植受者中按方案进行活检在改善短期和长期结局方面的安全性和有效性。
我们检索了截至 2023 年 7 月的所有随机临床试验（RCT）。通过 CENTRAL、MEDLINE、EMBASE 和 LILACS 的检索策略确定研究。两名作者独立筛选标题和摘要；两名作者独立评估检索到的摘要和全文。使用 Cochrane 偏倚风险工具评估偏倚风险。主要结局为：急性排斥反应、移植物丢失、死亡率、肾小球滤过率和安全性结局。当合适时，对有意义的变量进行了荟萃分析。使用 GRADE 方法评估证据质量。
我们筛选了 5695 条记录。四项试验符合所有入选标准。按方案进行活检并未发现对检测急性排斥反应（3 项研究 RR：2.0，95%CI：0.68-5.85，p =.2）或预防 12 个月时移植物丢失（2 项研究，RR 0.33，95%CI 0.06-1.72，p =.19）有获益。两组在移植后 6 个月时的肾小球滤过率无差异（2 项研究，MD 2.97，95%CI 1.4-7.3，p =.18）。活检组共有 23 例安全事件，而对照组有 6 例。
在肾移植后进行按方案活检未发现获益。
