Th17 lymphocyte levels are higher in patients with ruptured than non-ruptured lumbar discs,and are correlated with pain intensity

Background

Th17 lymphocytes have important roles in inflammation and autoimmune disease. Research on relationship between Th17 lymphocytes and pain associated with lumbar disc herniation (LDH) is limited. The purpose of this study was to examine the association of pain and Th17 lymphocyte and interleukin (IL)-17 levels in patients with herniated and non-herniated lumbar discs.

Methods

Thirty-four patients with single lumbar intervertebral disc herniation (median age, 44 years), and 17 healthy adults (median age, 37 years) were enrolled. Patients were divided into 2 groups depending on their magnetic resonance imaging (MRI) results and visual observations during surgery (group P, non-ruptured disc, n = 15; group E, ruptured disc, n = 19). Patients received posterior or transforaminal lumbar interbody fusion. Preoperative pain intensity was recorded using a visual analogue scale (VAS) score. The percentage of Th17 lymphocytes and IL-17 and prostaglandin E2 (PGE2) levels in peripheral blood were determined. Disc tissue was examined by immunohistochemistry for Th17 and IL-17 expression.

Results

Preoperative VAS pain scores were significantly higher in group E than group P (8.32 ± 1.04 vs. 6.33 ± 2.68, respectively, p = 0.009). Similarly, PGE2 level was greater in group E than group P (3.75 ± 1.41 pg/ml vs. 2.63 ± 0.89 pg/ml, respectively, p = 0.011). Compared to healthy controls (1.05 ± 0.19%), the percentage of Th17 cells was significantly greater in group P (1.52 ± 0.62%, p = 0.031), and the percentage in group E (2.99 ± 1.09%, p < 0.001) was significantly greater than in group P. The IL-17 expressions were similar. VAS pain score was positively correlated with Th17 proportion (r = 0.489, p = 0.003), and IL-17 concentration (r = 0.458, p = 0.007). PGE2 was also positively correlated with Th17 proportion (r = 0.539, p = 0.001), and IL-17 concentration (r = 0.500, p = 0.003). The expression of IL-17 was higher in the cells of group E and group P compared with normal tissue (p < 0.001).

Conclusions

Immune system activation is responsible, at least in part, for the pain experienced by patients with LDH, and increased levels of Th17 lymphocytes and IL-17 contribute to the pain.     

Annulus fibrosus tissue engineering using lamellar silk scaffolds

Degeneration of the intervertebral disc (IVD) represents a significant muscular skeletal disease. Recently, scaffolds composed of synthetic, natural and hybrid biomaterials have been investigated as options to restore the IVD; however, they lack the hallmark lamellar morphological features of annulus fibrosus (AF) tissue. The goal of regenerating the disc is to achieve anatomical morphology as well as restoration of mechanical and biological function. In this study, two types of scaffold morphology formed from silk fibroin were investigated towards the goal of AF tissue restoration. The first design mimics the lamellar features of the IVD that are associated with the AF region. The second is a porous spongy scaffold that serves as a control. Toroidal scaffolds were formed from the lamellar and porous silk material systems to generate structures with an outer diameter of 8 mm, inner diameter of 3.5 mm and a height of 3 mm. The inter‐lamellar spacing in the lamellar scaffold was 150–250 µm and the average pore sizes in the porous scaffolds were 100–250 µm. The scaffolds were seeded with porcine AF cells and, after growth over defined time frames in vitro, histology, biochemical assays, mechanical testing and gene expression indicated that the lamellar scaffold generated results that were more favourable in terms of ECM expression and tissue function than the porous scaffold for AF tissue. Further, the seeded porcine AF cells supported the native shape of AF tissue in the lamellar silk scaffolds. The lamellar silk scaffolds were effective in the formation of AF‐like tissue in vitro. Copyright © 2012 John Wiley & Sons, Ltd.     

体外诊断医用设备系统电击防护要求浅析

我国现行体外诊断医用设备安全标准GB4793.1-2007和YY0648-2008中,未对体外诊医用设备系统安全要求进行规定。本文论述了体外诊断医用设备系统电击危害原理及相关评估建议。     

Progress in automation of LC-MS in laboratory medicine

Background

LC-MS/MS is an almost universal technology for the quantification of small molecules in human sample materials. The widespread use of this technology in laboratory medicine is so far limited mainly by the extensive occupation of highly trained personnel which is required for method implementation and application. Furthermore, robustness of function and results is still a critical issue of routine quantitative applications of LC-MS/MS.

Content

This article reviews approaches to the automation of essential processes of LC-MS/MS applications in clinical laboratories. Furthermore, perspectives of further steps towards highly robust and fully automated LC-MS/MS methods and instrument configurations are discussed.

Conclusions

There is a variety of efficient approaches to automation of LC-MS/MS methods in use which mainly address sample preparation. Such configurations allow a substantial increase of sample throughput and convenience when compared to standard protocols. However, these applications still have to be implemented for individual methods in heterogeneous instrument configurations and still require highly trained experts. Based on existing technologies, however, the development of fully automated LC-MS/MS front-end modules or MS/MS-based analyzers which offer a degree of user-friendliness and robustness similar to current standard clinical chemistry analyzers seems feasible today. Only such systems will make the entire analytical potential of LC-MS/MS amenable to clinical medicine also outside from tertiary care centres.     

In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme

Blood transfusion remains a routine life‐saving medical procedure that helps replace blood lost due to surgery, injury or disease. The quality of transfused blood is crucial in this process as blood donors must be free of transfusion‐transmissible infections and donated blood should be compatible to that of the recipient. The quality of donated blood could be affected by the quality of in vitro diagnostic medical devices (IVDs) used in the screening process. Consequently, the need for high‐quality, safe and well‐performing IVDs for use in transfusion medicine arises, accompanied by the need for tight regulations in this domain. In the European Union, the new IVD Regulation will replace the existing IVD Directive within a five‐year transitional period. Manufacturers of IVDs are expected to fully comply with the new Regulation by 26 May 2022. In this review, we address the major differences relating to marketing authorization and testing between this new Regulation and its predecessor. We further present the main elements of the prequalification assessment introduced by the WHO for IVDs, including disease‐specific IVDs for blood screening laboratories.     

新法规体系下体外诊断试剂类产品临床试验要求的变化

《体外诊断试剂注册管理办法》（总局令第5号）已经发布实施,相应的体外诊断试剂临床试验技术指导原则也已配套发布实施,本文结合相关法规和指导原则中对临床试验的要求,阐述新法规体系下体外诊断试剂类产品临床试验的具体要求和变化。     

疼痛管理护理模式在腰椎间盘突出症患者术后镇痛中的作用

目的：探讨疼痛管理护理模式对腰椎间盘突出症术后疼痛的影响。方法：将笔者所在科收治并需要手术治疗的72例腰椎间盘突出症患者随机分为两组：疼痛管理组（实验组）和传统对照组（对照组）各36例,实验组给予疼痛管理护理模式治疗术后疼痛,对照组按传统护理方法处理;采用口头描述评定法（12级评定法）评估两组患者术后疼痛程度,对照分析两组患者术后切口镇痛效果及腰腿痛缓解程度。结果：实验组患者术后切口疼痛评估得分及腰腿痛评估得分均明显低于对照组,差异具有统计学意义（P〈0．01）。结论：实施疼痛管理模式护理,能显著减轻腰椎间盘突出症患者术后切口疼痛及腰腿痛,获得良好的手术效果,拱,岛患者住院满意度,形成和谐的医患及护患关系,具有极高的临床推广应用价值。     

新冠疫情中对《医疗器械应急审批程序》的思考

目的:综合评价目前我国《医疗器械应急审批程序》的应用,提出改进建议。方法:介绍我国《医疗器械应急审批程序》,并以2019新型冠状病毒检测试剂盒为例,重点分析我国《医疗器械应急审批程序》在应对突发公共卫生事件尤其是本次新型冠状病毒肺炎疫情中发挥的作用,为其进一步完善以及生产企业进行应急申报工作提出建议。结果与结论:《医疗器械应急审批程序》保障了临床急需检测试剂的高效审批,满足疫情控制需要,在本次疫情防控中发挥了重要作用。经过综合分析,从医疗器械监管、生产企业研发及生产、各方信息互通等方面提出探索性建议。     

浙江省新生儿异戊酸血症筛查及临床分析

目的了解浙江省新生儿异戊酸血症（IVA）的患病率、临床特征及基因突变特点。方法采用串联质谱技术对2009年1月至2019年12月浙江省新生儿疾病筛查中心的3 510 004名新生儿进行遗传代谢病筛查，结合尿有机酸分析及 IVD基因检测进行IVA诊断。IVA确诊患儿进行饮食和生活管理，补充左卡尼汀和甘氨酸治疗，长期随访观察并评估患儿的生长和智能发育情况。 结果共确诊IVA患儿15例，3例为急性新生儿型，其余无临床症状，患病率为1/234 000。所有患儿的血异戊酰基肉碱浓度均不同程度增加。12例患儿进行尿有机酸分析，其中11例异戊酰甘氨酸升高，4例伴3-羟基异戊酸升高。11例患儿进行基因检测，9例为 IVD基因复合杂合突变，1例为 IVD基因纯合突变，1例只检测出一个 IVD基因位点。发现 IVD基因突变19种（错义突变14种、内含子突变3种、移码突变1种、同义突变1种），其中11种突变未见报道。15例患儿中1例死亡，2例在当地随访，其余暂未发现明显临床症状（随访时间2~79个月），其中3例生长发育落后，其他患儿体格和智力发育均正常。 结论IVA临床表现无特异性，基因谱分散。使用串联质谱开展IVA新生儿筛查，实现早期诊断和治疗能纠正代谢缺陷及其引发的病理生理改变。