建立医疗器械强制报废制度刻不容缓

本文阐述了建立医疗器械强制报废制度的必要性。     

OPTN/SRTR 2018 Annual Data Report: Deceased Organ Donation

SRTR uses data collected by OPTN to calculate metrics such as donation rate, organ yield, and rate of organs recovered for transplant but not transplanted. In 2018, there were 10,721 deceased donors, and this number has been increasing since 2010. The number of deceased donor transplants increased to 29,676 in 2018 from 28,582 in 2017, and this number has been increasing since 2012. The recent increase may be due in part to the rising number of deaths of young people due to the opioid epidemic. In 2018, 4994 organs were discarded, slightly more than 4813 in 2017. In 2018, 3755 kidneys, 278 pancreata, 707 livers, 3 intestines, 23 hearts, and 317 lungs were discarded. These numbers suggest an opportunity to increase numbers of transplants by reducing discards.     

弃G因子鲎试剂进行替硝唑葡萄糖注射液中的细菌内毒素检测

目的：用弃 Ｇ 因子鲎试剂检测替硝唑葡萄糖注射液中的细菌内毒素。方法：以０ ．４ ％ 的替硝唑葡萄糖注射液及其１∶１的稀释液将细菌内毒素工作标准品稀释成１ ,０ ．５ ,０ ．２５ ,０ ．１２５ Ｅｕ·ｍｌ－ １ ,检测弃 Ｇ 因子鲎试剂的灵敏度。结果：替硝唑葡萄糖注射液及其１∶１ 的稀释液稀释内毒素后测得鲎试剂的灵敏度分别为λ１ ＝ ０ ．１２５ , Ｓ１ ＝ ０ ;λ２ ＝ ０ ．２５ , Ｓ２ ＝ ０ 。结论：０ ．４ ％ 的替硝唑葡萄糖注射液对弃 Ｇ 因子鲎试剂的灵敏度无干扰,故可用鲎试剂法检测其热原。     

Can the Four Principles Help in Genetic Screening Decision-Making?

Although principles, as a framework to resolving moral dilemmas are still debated and seem to be in a philosophical quagmire, there are strong arguments that by specification one can resolve case-specific dilemmas in certain areas of bioethics. When it comes to genetic screening and testing however, the problem at the base is a moral disagreement on higher-order principles—such as the status of the embryo and parental issues. No amount of specification can resolve these issues without a dose of relativism. We explore a possibility of agreement on debatable areas specifically in regard to genetics—such as conferring status to the embryo solely for purposes of preventing genetic selection; but it is difficult to see how this can be incorporated into law without extrapolation to other areas. We conclude therefore that the four-principles approach, albeit valuable for expounding opposing views and discussing issues, cannot either alone or by specification, help resolve issues of genetic screening and testing without agreeing on higher order principle. This does not seem to be a possibility in the near future.     

自体废肢皮瓣修复大面积皮肤缺损疗效分析

目的观察自体废肢皮瓣修复大面积皮肤软组织缺损效果。方法对13例大面积皮肤软组织缺损伴肢体毁损和2例大面积皮肤软组织缺损伴肢体完全离断患者,采用转移或移植修复皮肤软组织缺损。结果本组15例患者术后皮瓣完全成活。术后随访3-12个月,效果满意,毛发生长良好。结论通过自体废肢皮瓣修复大面积皮肤软组织损伤疗效明显,并发症少。     

A call to action: Feasible strategies to reduce the discard of transplantable kidneys in the United States

Changes to the United States kidney allocation system targeted at reducing organ discard have failed to improve organ utilization. High Kidney Donor Profile Index kidneys continue to be discarded at high rates as a result of the regulatory and financial barriers to widespread utilization of these organs. However, there are potential changes to clinical practice that could improve organ utilization. Expediting the time from initial offer to final organ acceptance would reduce cold ischemic time and should improve utilization. Implementation of procurement biopsy standards to avoid biopsy of low risk organs may prevent organ discards due to inaccurate data or excessive cold ischemia time. Further, standardization of procurement biopsy pathological interpretation coupled with electronic accessibility would enable early acceptance of difficult to transplant organs. These changes to allocation practice patterns are vital given proposals to expand the geographic sharing of deceased donor kidneys. Implementation of new allocation policies must be evaluated to ensure they result in higher transplant rates and acceptable post-transplant outcomes.     

Is prolonged cold ischemia a contraindication to using kidneys from acute kidney injury donors?

To determine the impact of prolonged cold ischemia time (CIT) on the outcome of acute kidney injury (AKI) renal grafts, we therefore performed a single‐center retrospective analysis in adult patients receiving kidney transplantation (KT) from AKI donors. Outcomes were stratified according to duration of CIT. A total of 118 patients receiving AKI grafts were enrolled. Based on CIT, patients were stratified as follows: (i) <20 hours, 27 patients; (ii) 20‐30 hours, 52 patients; (iii) 30‐40 hours, 30 patients; (iv) ≥40 hours, nine patients. The overall incidence of delayed graft function DGF was 41.5%. According to increasing CIT category, DGF rates were 30%, 42%, 40%, and 78%, respectively (P = .03). With a mean follow‐up of 48 months, overall patient and graft survival rates were 91% and 81%. Death‐censored graft survival (DCGS) rates were 84% and 88% for patients with and without DGF (P = NS). DCGS rates were 92% in patients with CIT <20 hours compared to 85% with CIT >20 hours (P = NS). In the nine patients with CIT >40 hours, the 4‐year DCGS rate was 100%. We conclude that prolonged CIT in AKI grafts may not adversely influence outcomes and so discard of AKI kidneys because of projected long CIT is not warranted when donors are wisely triaged.