Salvadori Maurizio, Tsalouchos Aris
Department of Renal Transplantation, Careggi University Hospital, Florence 50139, Italy.
Division of Nephrology, Santa Maria Annunziata Hospital, Florence 50012, Italy.
World J Transplant. 2022 Mar 18;12(3):27-41. doi: 10.5500/wjt.v12.i3.27.
Due to the optimal results obtained in kidney transplantation and to the lack of interest of the industries, new innovative drugs in kidney transplantation are difficult to be encountered. The best strategy to find the new drugs recently developed or under development is to search in the sections of kidney transplantation still not completely covered by the drugs on the market. These unmet needs are the prevention of delayed graft function (DGF), the protection of the graft over the long time and the desensitization of preformed anti human leukocyte antigen antibodies and the treatment of the acute antibody-mediated rejection. These needs are particularly relevant due to the expansion of some kind of kidney transplantation as transplantation from non-heart beating donor and in the case of antibody-incompatible grafts. The first are particularly exposed to DGF, the latter need a safe desensitization and a safe treatments of the antibody mediated rejections that often occur. Particular caution is needed in treating these drugs. First, they are described in very recent studies and the follow-up of their effect is of course rather short. Second, some of these drugs are still in an early phase of study, even if in well-conducted randomized controlled trials. Particular caution and a careful check need to be used in trials launched 2 or 3 years ago. Indeed, is always necessary to verify whether the study is still going on or whether and why the study itself was abandoned.
由于肾移植取得了理想的效果,且制药行业对此缺乏兴趣,因此很难找到肾移植领域的新型创新药物。寻找近期已开发或正在开发的新药的最佳策略是在肾移植领域中尚未被市场上现有药物完全覆盖的部分进行搜索。这些未满足的需求包括预防移植肾功能延迟恢复(DGF)、长期保护移植肾、使预先形成的抗人白细胞抗原抗体脱敏以及治疗急性抗体介导的排斥反应。由于某些类型的肾移植(如非心脏跳动供体的移植以及抗体不相容移植)的扩展,这些需求尤为重要。前者特别容易发生DGF,后者则需要安全的脱敏以及对经常发生的抗体介导排斥反应进行安全治疗。在治疗这些药物时需要格外谨慎。首先,它们在近期的研究中才有描述,对其效果的随访时间当然相当短。其次,其中一些药物仍处于研究的早期阶段,即使是在进行良好的随机对照试验中。对于两三年前开展的试验需要格外谨慎并仔细核查。确实,始终有必要核实该研究是否仍在进行,或者该研究是否以及为何被放弃。