人体捐献器官获取与分配管理规定(试行)

<正>国卫医发〔2013〕11号各省、自治区、直辖市卫生厅局(卫生计生委),新疆生产建设兵团卫生局:自2007年国务院公布《人体器官移植条例》以来,我国人体器官移植工作逐步走上法制化、规范化轨道,人体器官捐献工作有序推进,取得积极进展。为保障人体器官捐献工作顺利开展,不断完善科学、高效、公平、公正、公开的人体捐献器官获取与分配工作体系,我委依据《人体器官移植条例》和《中国人体器官分配与共享基本原则和肝脏与肾脏移植核心政策》等相     

多方协作，全民参与，全面推进我国人体器官捐献体系建设

我国人体器官移植事业逐渐发展的同时也面临诸多问题与挑战,器官短缺严重阻碍着我国器官移植事业的发展。要摆脱人体器官移植工作面临的困境,在加强监管的同时,需从根本上解决器官来源问题,唯一途径就是建立既符合国际社会广泛认可的伦理学原则,又切合我国国情的人体器官捐献体系。为此,中华人民共和国国家卫生和计划生育委员会（原卫生部）委托中国红十字会总会开展人体器官捐献相关工作,并出台配套政策措施推动这项工作顺利开展。在各方的共同努力下,我国人体器官捐献体系初具规模,工作成绩显著。今后,只有多方协作．全民参与,才能全面推进我国人体器官捐献体系建设,开创我国人体器官捐献工作的新局面,使我国的人体器官移植事业再上一个新台阶,为世界器官移植事业做出中国应有的贡献。     

中国人体器官捐献与移植委员会成立

为贯彻落实国务院《人体器官移植条例》,依法推进人体器官捐献与移植工作,国家卫生和计划生育委员会（以下简称卫生计生委）计生委与中国红十字会总会决定将人体器官移植技术临床应用委员会（OTC）与中国人体器官捐献工作委员会（CODC）合并,成立中国人体器官捐献与移植委员会。     

中国心脏死亡捐献器官评估与应用专家共识(2014版)

自2010年原卫生部启动人体器官捐献工作以来,经过各界努力,目前人体器官捐献尤其是心脏死亡器官捐献(donation after cardiac death,DCD),在全国范围内已得到广泛开展.亟待制订相关专家共识来指导全国DCD器官的质量评估,推动其在临床上更规范、有效、安全地应用.中华医学会器官移植学分会、中华医学会外科学分会移植学组及中国医师协会器官移植医师分会组织专家制订了《中国心脏死亡捐献器官评估与应用专家共识(2014版)》,重点阐述了中国DCD与心脏死亡诊断标准、器官获取、DCD器官在肝移植和肾移植中的评估和应用以及移植受者围术期的特殊干预.     

等级医院评审人体器官捐献与移植技术评价标准专家共识

公民逝世后器官捐献是器官移植器官来源的根本途径, 但捐献数量不足所导致的器官短缺是目前最突出的问题。在等级医院评审标准中纳入人体器官捐献与移植相关指标, 有利于国家政策的落实, 实现人体器官捐献数量的大幅增长, 满足移植就医需求, 促进移植事业发展和移植质量的提升, 提高整体医疗水平。中华医学会器官移植学分会和中国医师协会器官移植医师分会基于国家卫生健康委员会《三级医院评审标准(2022年版)》及《肝脏移植技术医疗质量控制指标(2020年版)》《肾脏移植技术医疗质量控制指标(2020年版)》《心脏移植技术医疗质量控制指标(2020年版》《肺脏移植技术医疗质量控制指标(2020年版》等国家文件精神和要求, 在国家卫生健康委员会医政司的指导下, 组织全国专家制定了等级医院评审人体器官捐献与移植技术评价标准专家共识, 供各省、自治区、直辖市卫生健康委员会在制定评审标准和评审过程中参考。     

近十年免疫抑制剂在肾移植中的应用及趋势——OPTN/SRTR2009年度报告解读

国家器官获取及移植网络/器官移植受者科学登记系统(OPTN/SRTR)的报告几乎囊括了美国器官移植领域的各个方面,下面,就让我们一起简单回顾该报告中有关肾移植的内容,以了解美国肾移植领域概况,并为进一步改善我国肾移植现状提供重要参考.     

人体捐献器官获取与分配管理规定(试行)

正第一章总则第一条为保障人体器官捐献工作顺利开展,不断完善科学、高效、公平、公正、公开的人体捐献器官获取与分配工作体系,维护人体器官捐献人(以下简称捐献人)及人体器官接受人(以下简称接受人)权益,依据《人体器官移植条例》和《中国人体器官分配与共享基本原则和肝脏与肾脏移植核心政策》(以下简称《基本原则和核心政策》)等法规政策,结合工作实际,制定本规定。第二条本规定适用于公民捐献的身故后尸体器官(以下简称捐献器官)的获取与分配。     

人源化CD52单克隆抗体在器官移植中的应用

免疫抑制方案的进步极大地改善了器官移植的疗效,尤其是近5年人源化CD52单克隆抗体(eampath-1H,又称alemtuzumab)被越来越多的应用于各实体器官移植.据文献[1]美国器官获取和移植网络/器官移植受者科学登记系统(OPTN/SRTR)2007年度报告,以肾移植为例.     

人体捐献器官获取与分配管理规定（试行）

第一章总则 第一条为保障人体器官捐献工作顺利开展,不断完善科学、高效、公平、公正、公开的人体捐献器官获取与分配工作体系,维护人体器官捐献人（以下简称捐献人）及人体器官接受人（以下简称接受人）权益,依据《人体器官移植条例》和《中国人体器官分配与共享基本原则和肝脏与。肾脏移植核心政策》（以下简称《基本原则和核心政策》）等法规政策,结合工作实际,制定本规定。     

近10年免疫抑制剂在器官移植中的应用及趋势

本文根据2008年美国国家器官获取和移植网络/器官移植受者科学登记系统(0PTN/SRTR)年度报告提供的数据,对免疫抑制剂在肾移植和肝移植受者中的应用及其趋势做一简单分析.     

中国移植器官保护专家共识(2022版)

器官移植是治疗终末期器官衰竭最有效的手段,公民逝世后自愿捐献器官已成为我国移植器官的唯一来源。在临床实践中,移植器官保护技术对提升移植器官质量,改善受者预后发挥重要作用。中国医师协会器官移植医师分会、中华医学会外科学分会器官移植学组及中国肝移植注册中心科学委员会组织专家,基于国内外移植器官保护的基础研究与临床实践,根据牛津循证医学证据分级和GRADE推荐意见系统,针对肝脏、肾脏、胰腺、小肠、心脏、肺脏移植器官编写了《中国移植器官保护专家共识(2016版)》。近期,在国家肝脏移植注册中心、国家创伤医学中心、国家人体捐献器官获取质控中心、国家骨科与运动康复临床医学研究中心及国家肝脏移植质控中心的支持下,结合近年来国内外器官移植及器官保护临床实践与研究进展进行总结,形成《中国移植器官保护专家共识(2022版)》。本共识重点更新了相关器官获取、保存、转运、质量评估在临床实践中的技术进展及相应循证医学研究证据。此外,还增加了包括以肢体移植为主的复合组织移植的内容,旨在促进临床器官移植工作科学、规范开展。     

Changes in the Organ Procurement System in South Korea: Effects on Brain-Dead Donor Numbers

In Korea, the Organ Transplantation Act came into effect in 2000, establishing the Korean Network for Organ Sharing (KONOS) with centralized authority for organ procurement as well as for approval of donors and recipients to ensure fair organ allocation. However, the number of brain-dead donors decreased sharply, and the organ allocation system proved inefficient. The government revised the Organ Transplantation Act in August 2002, introducing an incentive system. If a transplantation hospital formed a Committee for Brain Death Evaluation and a Hospital Organ Procurement Organization, it could receive a kidney from a brain dead-donor as an incentive to foster organ procurement regardless of the KONOS wait list. The government also launched a pilot brain-dead donor registry program to strengthen Hospital Organ Procurement Organization activity. If local hospitals collaborated with specialized hospitals in organ procurement, local hospitals obtained financial incentives. But because the organ shortage problem has not been resolved, the government has proposed four initiatives: first, broadening the incentive system, which makes it possible to give each specialized hospital a choice of one of eight organs from each donor as an incentive; second, development of an Independent Organ Procurement Organization; third introduction of an opt-out system; and last, improvement of the Committee for Brain Death Evaluation system. It is uncertain which initiatives will be adopted, but changes in organ procurement systems are nonetheless considered a key to solve the organ shortage problem in Korea.     

Now is the time for the Organ Procurement and Transplantation Network to change regulatory policy to effectively increase transplantation in the United States; Carpe Diem

With the Centers for Medicare and Medicaid Services proposing to remove outcome measures from the transplant centers’ renewal for Conditions of Participation an exciting opportunity surfaces for the Organ Procurement and Transplantation Network to make an equally bold change and allow for increased transplantation options for patients in the United States.     

The Current State of Liver Transplantation in the United States

This article is a review of the salient points and a future prospective based on the 2014 Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) liver donation and transplantation data report recently published by the American Journal of Transplantation. Emphasis of our commentary and interpretation is placed on data relating to waitlist dynamics, organ utilization rates, the impact of recent advances in the treatment of hepatitis C, and the increases in end‐stage renal disease among liver transplant candidates. Finally, we share our vision on potential areas of innovation that are likely to significantly improve the field of liver transplantation in the near future.     

Could more effective use of kidneys recovered from older deceased donors result in more kidney transplants for older patients?

In the face of a severe shortage of kidneys from deceased organ donors that limits access to transplantation for many patients, about one of every seven kidneys (more than 1,500 each year) recovered from deceased donors in the United States are not transplanted. Eurotransplant, which coordinates organ distribution for six countries and a population of about 118 million, discards only one of every 20 kidneys procured for transplantation. We compared kidney procurement, transplants, and discards between January 2000 and June 2003 in the United States and in the Eurotransplant region using the Organ Procurement and Transplantation Network/United Network for Organ Sharing and Eurotransplant databases to examine differences that might account for this wide disparity.     

25年磨一见(剑)——环球性器官短缺与移植危机中的中国新(心)路历程

对器官这一稀缺资源的巨大需求,直接导致全球器官买卖相关犯罪率的上升。WHO、国际移植学会、国际器官捐献和获取学会近年来频繁召开各种会议寻求解决途径。2010年新出台的《人体细胞、组织和器官移植指导原则》及《开发公民逝世后器官捐献战略计划》提出3个基本原则:(1)死亡后器官捐献优先于活体器官捐献;(2)脑死亡器官捐献(DBD)优先于心死亡器官捐献(DCD);(3)活体移植有违医学伦理学"无伤害论"原则,应尽量避免。中国器官捐献走过了25年漫长而曲折的道路。2010年初,卫生部和中国红十字会总会联合正式启动了由10个省市参与的器官捐献试点工作,拟逐步建立中国器官捐献系统。自我国2003年第1例DBD及2005年第1例DCD以来,已先后积累了100余例器官捐献成功案例。根据以往经验,建议将我国现阶段公民逝世后器官捐献分为四大类:(1)中国一类(C-Ⅰ):国际标准化DBD;(2)中国二类(C-Ⅱ):国际标准化DCD;(3)中国三类(C-Ⅲ):过渡时期脑死亡加心死亡-双死亡标准器官捐献;(4)中国四类(C-Ⅳ):死刑死亡器官捐献。中国器官捐献赢得公众支持的3块基石为死亡标准、财务标准和分流标准。加快中国器官捐献发展的四大要素是方向、战略、政策及人员,而"公平、公开、公正"则是我国器官捐献和移植事业向公开化、合法化、正规化、国际化方向健康持续发展的基本保证。     

小肠移植免疫抑制方案的发展历史、现状和展望

经过近20多年的发展，小肠移植已成为肠衰竭患者最为理想的临床治疗方式。然而，小肠作为一个特殊的免疫器官，移植肠排斥反应成为影响小肠移植成功的最主要障碍，因此免疫抑制方案的改进在所有小肠移植技术进步中最为关键。本文首先阐述小肠的免疫学特点，然后结合美国器官获取和移植网络／器官移植受者科学登记系统最新资料、全球各主要小肠移植中心的免疫抑制方案演变和我国临床小肠移植实践经验，评述小肠移植免疫抑制方案发展历程，以期预示其今后的发展。     

Scientific Registry of Transplant Recipients: Collecting,analyzing, and reporting data on transplantation in the United States

Founded in 1987, the Scientific Registry of Transplant Recipients (SRTR) operates under a contract from the US government administered by the Health Resources and Services Administration (HRSA). SRTR maintains a database of comprehensive information on all solid organ transplantation in the US. The registry supports the ongoing evaluation of the clinical status of solid organ transplantation, including kidney, heart, liver, lung, intestine, pancreas, and multi-organ transplants. Data in the registry are from multiple sources, but most are collected by the Organ Procurement and Transplantation Network (OPTN) from hospitals, organ procurement organizations, and immunology laboratories. The data include information on current and past organ donors, transplant candidates, transplant recipients, transplant outcomes, and outcomes of living donors. SRTR uses these data to create reports and analyses for HRSA, OPTN committees that make organ allocation policy, and the Centers for Medicare & Medicaid Services to carry out quality assurance surveillance activities; SRTR also creates standard analysis files for scientific investigators. In addition, SRTR and OPTN produce an Annual Data Report and provide information upon request for the general public. Thus, SRTR supports the transplant community with information services and statistical analyses to improve patient access to and outcomes of organ transplant.     

Combined lung and liver transplantation: the United States experience

BACKGROUND: Combined transplantation of the lungs and liver is indicated for patients who would not be expected to survive transplantation of either organ alone. No single center has accumulated a significant experience, and as a result the expectations for this operation in the current era are unknown. METHODS: Patients that have undergone combined lung-liver transplantation in the United States were enrolled through the United Network for Organ Sharing Organ Procurement and Transplantation Network database. In addition, the English-language literature was searched for additional cases of combined lung-liver transplantation. RESULTS: Eleven patients have undergone combined lung and liver transplantation in the United States at different centers. The 1- and 5-year patient survival rates are of 79% and 63%, respectively, and no patient has required retransplantation. These patient survival rates are equivalent to similar a combined lung-liver case series from the United Kingdom (P=0.37, log-rank test) and isolated orthotopic liver transplantation in the United States (P=0.59, log-rank test), and are comparable to patient survival rates following isolated lung transplantation in the United States. CONCLUSIONS: Patient survival of combined lung-liver transplantation is comparable to that of isolated liver and isolated bilateral lung transplantation. This option should be considered for patients with end-stage lung disease and liver disease when transplantation of a single organ transplantation is precluded by severe disease in the other organ system.