Outcomes and challenges of a kidney transplant programme at Groote Schuur Hospital, Cape Town: a South African perspective

Method:

Data were collected on all
patients who underwent a kidney transplant at GSH from 1st July 2010 to the 30
June 2015. Analyses were performed to assess baseline
characteristics, graft and patient survival, as well as predictors of poor outcome.    

Results

198 patients
were transplanted. The mean age was 38 +/- 10.5 years, 127 (64.1%) were male, and 86 (43.4%) were of African
ethnicity. Deceased donor organs were used for 130 (66.7%) patients and living
donors for 65 (33.3%). There were > 5 HLA mismatches in 58.9% of transplants.
Sepsis was the commonest cause of death and delayed graft function [DGF]
occurred in 41 (21.4%) recipients. Patient
survival was 90.4% at 1 year and 83.1% at 5 years. Graft survival was 89.4% at
1 year and 80.0% at 5 years. DGF (HR 2.83 (1.12 – 7.19), p value = 0.028) and
recipient age > 40 years (HR 3.12 (1.26 – 7.77), p value = 0.014) were predictors
of death.

Ethics Statement:
Ethical approval for the study was received from
the human research ethics committee at University of Cape Town [HREC:
759/2014]. This approval permitted a folder review of patients transplanted
within the specified time period. Informed consent for folder review was
waived. All clinical and laboratory data was obtained from routine clinic
visits (set out by KDIGO best clinical practice guidelines). All kidney
biopsies were only performed for clinical indications including unexplained
haematuria, proteinuria or rising creatinine.

For confidentiality and anonymity all patients
were anonymised prior to statistical analysis. The information was stored on a password
protected research computer, only the primary and sub investigators had access
to the data.

None of the transplant donors were
from a vulnerable population and all donors or next of kin provided written
informed consent that was freely given. The consent for deceased donation was
obtained by dedicated transplant sisters who work as part of the transplant
team. All Living non-related donors are ethically evaluated by a national
Ministry Advisory Committee. Groote Schuur Hospital transplant department
complies with the Declaration of Istanbul.

研究方法：
本研究收集了2010年7月1日至2015年6月30日期间，在格罗特舒尔医院（Groote Schuur Hospital, GSH）接受肾移植的所有患者的临床数据。通过统计分析评估了患者的基线特征、移植物与患者生存率，以及不良预后的预测因素。

研究结果
本研究共纳入198例接受肾移植的患者。患者平均年龄为38±10.5岁，其中男性127例（占比64.1%），非洲裔患者86例（占比43.4%）。130例（66.7%）患者接受尸体供肾移植，65例（33.3%）接受活体供肾移植。58.9%的移植手术存在超过5个人类白细胞抗原（Human Leukocyte Antigen, HLA）错配位点。脓毒症是最常见的死亡原因，共有41例（21.4%）患者出现移植物功能延迟恢复（delayed graft function, DGF）。患者1年存活率为90.4%，5年存活率为83.1%；移植物1年存活率为89.4%，5年存活率为80.0%。多因素分析显示，移植物功能延迟恢复（风险比Hazard Ratio, HR=2.83，95%置信区间1.12–7.19，P=0.028）与受体年龄>40岁（风险比Hazard Ratio, HR=3.12，95%置信区间1.26–7.77，P=0.014）是患者死亡的独立预测因素。

伦理声明
本研究已获得开普敦大学人类研究伦理委员会的伦理批准（伦理编号：HREC: 759/2014），批准内容为对指定时间段内的肾移植患者进行病历回顾性研究。本研究豁免了病历回顾所需的知情同意程序。所有临床与实验室数据均来源于常规门诊随访，该随访流程符合改善全球肾脏病预后组织（Kidney Disease: Improving Global Outcomes, KDIGO）制定的最佳临床实践指南。所有肾脏活检仅基于临床指征实施，包括不明原因血尿、蛋白尿或肌酐水平进行性升高。
为保障患者隐私与匿名性，所有患者在统计分析前均已完成匿名化处理。研究数据存储于受密码保护的科研计算机中，仅主要研究者与亚课题组研究者可访问该数据。

本研究纳入的所有移植供体均不属于脆弱人群，所有供体或其近亲属均签署了自由自愿的书面知情同意书。尸体供体的知情同意由移植团队专职移植护士获取。所有非亲属活体供体均需经过国家卫生部咨询委员会进行伦理评估。格罗特舒尔医院移植科严格遵循《伊斯坦布尔宣言》开展临床工作。