对同种异体骨质量管理体系风险控制重点和存在问题的探讨

从控制同种异体骨在临床使用时存在的潜在风险的角度,探讨对该类产品进行风险控制的措施和质量管理的重点关注环节,并汇总介绍了国内现有生产企业在质量管理体系方面存在的主要问题。     

同种异体骨材料的研究进展及临床应用

骨移植目前已广泛用于修复创伤、疾病、手术或先天性畸形引发的骨缺损。近年来，同种异体骨的技术逐渐成熟，具有来源稳定且能满足各种部位骨缺损的优势，临床应用广泛，但仍存在感染、无菌性骨不连接、骨折、过度吸收及免疫排斥等问题。现围绕同种异体骨材料的研究进展和临床应用进行综述。     

同种异体新鲜胎骨移植治疗骨肿瘤刮除后骨缺损(附9例报告)

该文报告了９例应用同种异体新鲜胎骨移植治疗骨肿瘤刮除后骨缺损，经９～４８个月随访，均见新骨形成、骨愈合良好。根据该组资料认为同种异体新鲜胎骨具有来源丰富、取材容易、保存方法简单、使用方便、骨愈合快、免疫反应弱的特点。     

骨科移植物的分类及其研究进展

每年全世界都有超过200万的骨移植手术,骨移植材料的需求越来越大。自体骨是骨移植的黄金标准,但来源有限。同种异体骨和异种骨,具有骨传导,但是骨诱导弱,且仍存在对感染风险、成本和供者有效性问题的担忧。陶瓷类和骨水泥类骨移植材料在临床实践中得到广泛应用,但其骨诱导性和机械性能存在不足,无法承受负载部位的应用,为了增强这些材料的成骨性能,纳米材料和仿生复合材料在骨移植材料中得到发展。此外,骨组织工程是一个具有前景的研究领域,有望克服各种骨移植材料的不足,为增强临床骨修复效果提供新的方向。本文针对有关目前骨移植材料的文献作一综述,总结不同材料的特点,旨在提高骨科医生以及相关研究人员对目前骨移植材料的认识。     

ACPC载药核心块状同种异体骨修复长段感染性骨缺损研究

目的探讨自固化磷酸钙人工骨(ACPC)载药核心块状同种异体骨创伤性骨髓炎骨缺损的临床意义。方法应用ACPC载药核心块状同种异体骨治疗27例创伤性骨髓炎患者,男21例,女6例,平均年龄为45.2岁,骨髓炎病程为10～18个月。骨缺损范围6～124cm2。观察:患者手术前后的全身及局部组织反应、ESR及CRP、X线摄片和CT扫描。随访时间为12～24个月,平均18.5个月。结果全部患者未见明显全身反应,31例局部软组织愈合好,窦道消除,X线显示ACPC与骨髓炎清除区局部骨质直接愈合,CT示界面处未见间隙存在,基本恢复骨缺损处的解剖形状。Ⅰ期治愈率为86.1%。另5例需要第二次清创、ACPC载药核心块状同种异体骨植入填充的手术,获治愈。结论 ACPC载药核心块状同种异体骨创伤性骨髓炎骨缺损具有治疗彻底、骨缺损修复好、能较好恢复负重肢体功能的优点。     

同种异体骨的灭菌方法研究进展

随着骨移植术的发展和骨库的建立，同种异体骨的应用日趋广泛。但有报道骨库收集的异体骨不合格率为30％，而临床应用大段异体骨移植的感染率达11．7％，故对异体骨的无菌处理技术至关重要。对同种异体骨灭菌的关键在于彻底灭菌的同时最大限度地保留其成骨能力和生物力学强度，因而选择适当和有效的灭菌处理方法仍是目前研究的热点。以下我们就目前采用的灭菌方法的种类、原理、灭菌效果以及对同种异体骨的成骨能力及生物力学的影响进行分析。     

手术治疗跟骨骨囊肿28例分析

目的 评价跟骨骨囊肿手术治疗疗效.方法 所有患者均行瘤体刮除、瘤腔灭活和自体或同种异体骨植骨,合并病理骨折应用跟骨金属板内固定治疗.结果 术后均获随访,时间18～24(平均20)个月.术后自体骨移植3个月、异体骨移植6个月,X线片显示植骨块与周围正常骨质基本融合,但异体骨移植仍能看到植骨块影的轮廓.随访期内均无复发.结论 跟骨骨囊肿瘤体刮除、瘤腔灭活和自体或同种异体骨植骨,合并病理骨折应用跟骨金属板内固定治疗效果满意.     

新型生物降解多孔陶瓷人工骨……从无生命的材料到有生命的骨组织

因疾病(如骨肿瘤和骨结核等)和创伤造成的骨缺损常需进行骨移植，而目前可供移植的骨源主要有四种：1．自体骨：来源有限，增加病人痛苦；2．同种异体骨：存在传染疾病(如AIDS等)的可能；3．异种骨：同样存在传染疾病的可能；4．人工骨：来源丰富，不传播疾病，不产生排异反应。因此，人工骨正在取代骨库骨(同种异体骨)而日益为临床医生们所接受。     

同种异体骨治疗骨良性肿瘤摘除术后骨缺损的效果分析

四肢恶性骨肿瘤或巨大骨良性肿瘤切除后常留下较大骨质缺损,自体骨移植是治疗骨缺损的常用方法,但自体骨量有限,且取骨会给患者带来一些并发症。同种异体骨移植是应用时间较长且已证明是一种有效的重建方法,其优点为骨来源丰富,有多种形状及大小选择,骨端可获得牢固的生物愈合以及更容易使重要的肌腱、韧带附着,远期功能较好,越来越受到骨科同仁的关注。我院自2004年1月～2008年1月应用同种异体骨治疗骨良性肿瘤摘除术后骨缺损40例,效果满意,现报告如下。     

同种骨与异种骨治疗骨缺损的疗效观察

目的 探讨同种骨与异种骨治疗骨缺损的疗效,探讨与提高治愈率有关的方法.方法 60例骨缺损患者随机分为治疗组与对照组各30例,在清创切除治疗后,对照组采用异种骨植入治疗,治疗组采用同种骨植入治疗.结果 随访3个月,治疗组的缺损处愈合率明显高于对照组(P<0.05).同时治疗组的平均骨愈合时间也明显短于对照组(P<0.05).结论相对于异种骨,同种骨治疗骨缺损能有效提高愈合率,缩小平均骨愈合时间,值得推广应用.     

Bone transplantation

Bony deficiency, particularly loss of bone stock associated with failed joint replacements or tumours, is a challenging problem in orthopaedic surgery. Bone transplantation techniques provide solutions that can be tailored to the clinical problem. However, the risks of bone transplantation are well documented and the biology of allograft incorporation remains unpredictable and poorly understood.     

Economics, competition and the regulation of public health risks

OBJECTIVE: The efficiency of regulation of public health risks has been questioned on the grounds that the costs of regulation may outweigh the benefits. There are strong arguments that risk management is best left to the market place, where individual consumers can make the trade-off between risk and the forgone benefits of reduced consumption of hazardous products. The paper reviews the economic arguments for the regulation of health risks and the use of safety standards. RESULTS: There are five key arguments for regulation of public health risks. Consumers misperceive the hazards of products and therefore take more risks than they would if fully informed. The provision of information has certain public goods characteristics (it is non-rival). There may be economies of scale in collecting, providing and disseminating information that is costly to acquire. The private decision maker may not be the person bearing the whole risk, exposing others to risk e.g. children. If public policy has chosen to provide public finance for health care it may be efficient to discourage risk taking by individuals even if that risk taking is optimal from the individual's perspective. CONCLUSION: There are arguments for public intervention to reduce private health risks and regulation of risk is a legitimate tool to achieve the socially optimal level of risk in certain circumstances. Private subjective assessment of risk may not capture the full social benefits of risk reduction. Regulation by safety standards however may fail to capture the full range of concerns about risk, including avoiding catastrophe, taking personal control of risk, and a distrust of expert opinion.     

Safety information provided to customers of New York City suntanning salons.

Little is known about the safety information tanning salon operators provide to customers or the extent to which artificial tanning salons adhere to federal regulations designed to protect customers from excessive ultraviolet radiation (UVR) exposure. We surveyed the operators of 20 artificial tanning salons in New York City from 1988 to 1989 concerning salon operating procedures and information provided to potential customers. Results revealed a disparity between known health risks of UVR exposure and safety information provided to tanning salon customers. For example, 75% of salon operators informed potential customers that artificial tanning would not cause a sunburn, and 80% informed potential customers that they would not get skin cancer from artificial tanning. Artificial tanning salons are a rapidly growing industry in the United States, with over two million customers annually. Results from this survey indicate a need for greater regulation of the tanning salon industry and for education of tanning salon operators in the risks associated with the use of artificial tanning devices.     

医疗器械风险分析方法的介绍与应用展望

本文根据ISO14971:2000介绍的风险分析方法,归纳了当前国际医疗器械行业用于分析与医疗器械及其使用有关的风险的主要方法,分析了国际上对这些方法使用及其研究的主要进展,讨论了不同类型分析方法的过程机理、影响因素及其可能的应用。在此基础上,本文还对在我国开展和加强医疗器械风险分析技术的研究前景进行了展望。     

The institutional origins of risk: A new agenda for risk research

The emergence of risk as an organizing concept for regulation and governance has been the subject of considerable comment and debate, most notably in relation to Ulrich Beck's Risk Society thesis. This editorial, however, argues that contemporary preoccupations with risk are driven less by a changing distribution of real, or imagined, ills in society, than by a changing distribution of ills in governance. It argues that the inevitable difficulty of managing threats to society (societal risks) creates threats to organizations managing those risks (institutional risks). The potential for failure has always been part of governance, but contemporary pressures towards greater coherence, transparency and accountability have amplified institutional risks by exposing the practical limits of governance. Framing the objects of governance in terms of risk, however, provides a way of reflexively managing the associated institutional threats by explicitly anticipating the practical limits of governance within probabilistic calculations of success and failure. This editorial outlines how the institutional dynamics of contemporary governance can lead to a phenomenon of ‘risk colonization’, whereby risk increasingly comes to define the object, methods and rationale of governance. It then goes on to consider some of the possible positive and negative consequences of risk colonization and concludes by suggesting ways in which the study of institutional risk can help us understand the relationship between risk and governance.     

危险源风险体积法分析探索

[目的]以"风险体积"概括和展现危险源风险构成的整体性,探索破解危险源风险的理论途径。[方法]从经典风险理论,导出"风险体积"的概念,对危险源存在的事故风险进行三维分析,界定出危险源风险与隐患,体现从危险源到隐患再到风险的溯源关系。[结果]提出"一元隐患"、"二元隐患"和"三元风险"的观点。[结论]对于风险体积(三元风险),可通过降低(或消除)其中一种构成因素,使其缩小(或为零),事故风险下降(或消失)。     

The best way to manage hypertension after renal transplantation.

Hypertension in renal allograft recipients is a common problem arising from multiple factors, including peripheral vascular damage caused by pretransplant hypertension, side effects of immunosuppressive medications, allograft dysfunction, renal artery stenosis, recurrent glomerulonephritis, synthesis of vasoconstrictive hormones by the native kidneys, and excessive dietary salt intake. Identification of modifiable factors causing hypertension and concurrent medical conditions, and measurement of glomerular filtration rate, cyclosporine/tacrolimus blood levels, and magnitude of proteinuria are essential to tailor treatment for an individual patient. Lifestyles that exacerbate hypertension should be modified. For pharmacological therapy, diuretics and calcium channel blockers are first-line agents in patients on cyclosporine shortly after transplant. Angiotensin-converting enzyme inhibitors are good choices for patients with significant proteinuria. Reduction of immunosuppression will improve hypertension in some patients, but entails a potential risk of rejection or graft loss. Angioplasty is necessary in patients with a functionally significant stenosis of the allograft renal artery. Other patients on maximal medical therapy may benefit from native nephrectomy.     

Fördern positive Gefühle die physische Gesundheit? — Eine Forschungsnotiz

The impact of emotions on bodily functions and, moreover, on health and well-being of man has found more and more interest in interdisciplinary oriented health research. Up to now, investigations were predominantly focussed on acute and chronic physiological effects and related health risks of negative emotions like stress. In contrast, positive feelings like happiness, joy or humor have not been addressed, although, these may have protective or curative effects. A summary of recent research on physiological effects of positive emotions on the autonomous nervous system, the endocrine and the immune system is presented and reveals first evidence supporting our hypothesis of positive health outcomes from the experimental standpoint. Further research is needed to clarify potential causal mechanisms between positive emotions and physiological correlates, and to relate coping and the regulation of emotions to health outcomes.     

天然胶乳橡胶避孕套产品比较研究及风险管理建议

目的：为我国完善天然胶乳橡胶避孕套产品的管理提供风险管理建议。方法：采用比较研究方法,研究我国与世界卫生组织、FDA对避孕套产品技术要求;同时采用文献研究方法,总结我国避孕套产品监督抽验中发现的主要问题。结果：产品风险主要体现在技术要求不完善、监督抽验质量不合格、原材料和工艺自身风险以及市场流通风险四个方面。结论：建议重点从避孕套产品生命周期的生产、注册、上市后监管三个环节加强管理,降低产品风险,以确保其安全、有效地使用。     

On regulating perceived risk.

Modern society increasingly depends on government regulation to manage risks. Until recently, evaluation of risks of technology was primarily considered a technical problem. However, public controversy has politicized the issue of risk, raising questions about the role of experts. This paper briefly explores the nature of technical risks of aircraft, nuclear energy and medicines. It is contended that in the case of aircraft intensive regulation has led to a measurable improvement of its safety record. The constant call for more regulation in the areas of medicines and nuclear energy on the other hand seems more the result of public controversy, since the actual effect of regulatory measures on safety is too difficult to show. This stresses the important role of the media, a theme, which is elaborated by reviewing a number of cases. The general conclusion is concerned with the notion that public pressure is the only rationale which makes regulators step in. Regulatory decision-making about risk, then, is more anecdotal than systematic, because public controversy is unpredictable. As a consequence regulators can no longer seek to minimize harm, but must now move towards the aim of minimizing perceived harm. Finally, in the light of this assumption, some thought is given to costs and benefits of medicines and nuclear energy. It is appropriate to make a strong case for medicines in this context, for, as opposed to nuclear energy, alternatives are usually not available.