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NICE建议设备诊断肝损伤,可以帮助成千上万避免活检 [复制链接]

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发表于 2015-9-24 14:41 |只看该作者 |倒序浏览 |打印
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22 September 2015

                           
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        NICE recommends device for diagnosing liver damage which could help thousands avoid biopsy         

New NICE guidance recommends a device that could save thousands of people from needing an invasive procedure to diagnose and monitor liver damage.  

                                                   

The NICE guidance supports the NHS using the device, Virtual Touch Quantification (VTq), in people with chronic hepatitis B or C who need liver fibrosis assessment. Using this device could mean these patients can avoid having a biopsy – where a small piece of the liver is removed for examination.

Liver fibrosis occurs when there is a lot of scar tissue in the liver, and makes the liver’s texture stiff. The scar tissue can result from damage to liver cells caused by infections such as chronic hepatitis B or C, inflammation and injury.  VTq is a software application which assesses the stiffness of the liver based on readings of a high intensity ultrasound wave which is transmitted through the liver. The wave travels at different speeds through liver tissue depending on whether the liver is flexible and healthy, or whether it is stiff due to fibrous scar tissue caused by damage. The device measures the speed of the sound waves to determine the condition of the liver tissue and allows the liver to be imaged at the same time.

The benefits of VTq include the procedure being painless and possibly safer than liver biopsy, and reduced costs: using VTq could save around £434 per patient compared with liver biopsy and around £53 per patient compared with transient elastography[1].
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “This new NICE guidance recommending VTq for diagnosing and monitoring liver fibrosis is good news for people with chronic hepatitis B or C, and for the NHS. As well as meaning that these patients could avoid having invasive liver biopsies, the associated savings of more than £400 per person could result in significant savings in hospitals where liver biopsy is the primary method for diagnosing and monitoring liver fibrosis.
“Liver fibrosis can result from infections such as chronic hepatitis B and C – conditions which affect hundreds of thousands of people in the UK. Diagnosing and monitoring any liver damage caused by these infections is important for ensuring that an affected person receives appropriate care and treatment. The guidance, developed by the independent Medical Technologies Advisory Committee, says that VTq should be considered as an option for assessing liver fibrosis in people with chronic hepatitis B or C. Using the device may have benefits for people who need monitoring for fibrosis progression including  those for whom liver biopsy affects their quality of life. We hope that this guidance leads to wider use of VTq in the NHS to improve the care of patients with chronic hepatitis B or C.”
Welcoming the NICE guidance, Andrew Langford, Chief Executive of the British Liver Trust, said: “Liver disease is the third main cause of premature death and of the top five causes is the only one that continues to increase. It is vital that early diagnosis is increased so that each person can make the necessary lifestyle changes or receive treatments that will prevent progression and possibly reverse or cure their disease. VTq is an invaluable addition to making diagnosis and on-going monitoring as easy and patient centred as possible, so it’s good that the NICE guidance encourages its use.”
The guidance on the VTq device is available at http://www.nice.org.uk/mtg27.
ENDS
For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142, or out of hours on 07775 583 813.
Notes to EditorsExplanation of terms[1] The standard methods of assessing whether there is damage in the liver are ultrasound scans, transient elastography, and biopsy. Transient elastography is a procedure which measures the stiffness of the liver tissue based on measuring the time it takes for a wave generated at the skin surface to travel to a point within the liver. Biopsy is an invasive procedure where a small sample of liver tissue is removed using a fine needle and then assessed for changes. The guidance recommendations say that VTq is as accurate as transient elastography in diagnosing and staging liver fibrosis, and may offer other benefits in terms of imaging the liver and sampling selected areas to assess fibrosis and identify associated pathologies.
About the NICE guidance
1. The medical technologies guidance, “Virtual Touch Quantification to diagnose and monitor liver fibrosis in chronic hepatitis B and C”, is available at https://www.nice.org.uk/mtg27 from 23 September 2015.
2. Virtual Touch Quantification (VTq) is manufactured by Siemens. The VTq software application uses acoustic radiation force impulse (ARFI) imaging technology to measure the elasticity of liver tissue. VTq is used in combination with a Siemens Acuson S2000 or S3000 ultrasound platform. Liver tissue can be damaged by inflammation, causing high levels of collagen to be deposited in the liver cells (fibrosis), which become stiff. ARFI imaging involves generating a shear wave by applying an acoustic ‘push pulse’ lateral to the area of interest identified during a conventional ultrasound scan. The speed of the shear wave is proportional to the stiffness of the tissue.
3. Cost modelling suggests that using VTq is cost saving compared with transient elastography and liver biopsy, whether or not a compatible Siemens ultrasound machine needs to be purchased. Compared with transient elastography, the estimated overall cost saving for VTq is around £53 per person. This saving assumes that 10% of the ultrasound machine capacity would be used for VTq measurements, leaving 90% to be applied to other uses. Compared with liver biopsy, the corresponding saving is around £434 per person.
4. The cost of the VTq software stated in the company’s submission is £4415. A compatible Siemens Acuson S2000 ultrasound system costs from £50,000 with annual maintenance costs, starting in year 2, from £2000. All costs are excluding VAT.
5. In England, chronic hepatitis B affects an estimated 273,000 people (Hepatitis B Foundation, 2007), and around 160,000 individuals have long-term (chronic) infection with hepatitis C (Public Health England, 2014).
6. Other causes of liver fibrosis (not considered in this guidance) can include heavy alcohol consumption, toxins and some rare inherited diseases.
7. NICE is currently developing a clinical guideline on the ‘Assessment and Management of Cirrhosis’ expected to be published in June 2016.
About the Medical Technologies Evaluation Programme
8. The focus of Medical Technologies Evaluation Programme is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory. More information is available at http://www.nice.org.uk/MT.
                    
   
                               About NICE                The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
                   Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
                   Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.
            To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.
                           

        
               
        As well as meaning that people with chronic hepatitis B or C could avoid having invasive liver biopsies, the associated savings of more than £400 per person could result in significant savings in hospitals where liver biopsy is the primary method for diagnosing and monitoring liver fibrosis
            Professor Carole Longson, director of the NICE centre for health technology evaluation        
        
        VTq is an invaluable addition to making diagnosis and on-going monitoring as easy and patient centred as possible, so it’s good that the NICE guidance encourages its use
            Andrew Langford, Chief Executive of the British Liver Trust        
        
  
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发表于 2015-9-24 14:42 |只看该作者
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2015年9月22日

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NICE建议设备诊断肝损伤,可以帮助成千上万避免活检

新NICE指南建议的装置,可以拯救成千上万的人从需要侵入性手术诊断和监测肝功能损害。

NICE的指导支持使用该设备,虚拟触摸量化(VTQ),与慢性乙型或丙型肝炎的人谁需要肝纤维化评估NHS。使用这种装置可能意味着这些患者可避免活检 - 在一小块肝脏被审查删除。

发生肝纤维化时,有大量的瘢痕组织在肝脏,使肝脏的质地僵硬。疤痕组织可能是由于造成损坏的感染的肝细胞,例如慢性乙型或丙型肝炎,炎症和损伤。 VTQ是它评估基于其通过肝脏发送的高强度超声波的读数肝脏的刚度的软件应用。波行进在通过肝组织取决于肝是否是柔性的,健康的,或者是否是刚性而引起的损伤纤维疤痕组织不同的速度。该装置测量声波的速度,以确定所述肝组织的状况,并允许肝脏同时进行成像。

VTQ的好处包括程序是无痛的,可能更安全比肝活检,并降低成本:使用VTQ可以节省约£434每名患者的肝活检和周围£53%的患者有瞬时弹性成像[1]比较比较。

阿玲Longson教授,为卫生技术评估NICE中心主任,他说:“这种新的NICE指南推荐VTQ诊断和监测肝纤维化是患有慢性乙型或丙型肝炎的好消息,并为NHS。除了这意味着这些患者可能避免侵入肝活检,相关节省超过每人£400个可能导致显著节省了医院,其中肝活检是诊断和监测肝纤维化的主要方法。

“肝纤维化可导致感染,如慢性乙型肝炎和丙型肝炎 - 影响成千上万的人在英国的条件。诊断和监测由这些感染任何肝功能损害是确保受影响的人得到适当的照顾和治疗非常重要。的指导下,由独立的医疗技术咨询委员会制定,说VTQ应该被视为评估患有慢性乙肝或丙肝使用设备时可能对人谁需要监测纤维化的进展,包括那些好处肝纤维化的选择对他们来说,肝活检会影响他们的生活质量。我们希望本指导导致NHS的广泛应用VTQ来改善慢性乙肝或丙肝的关怀“

欢迎NICE指南,安德鲁·兰福德,英国肝脏信托首席执行官说:“肝病是五大原因导致的过早死亡的第三个主要原因是唯一一个继续增加。至关重要的是,早期诊断增加,使得每个人都可以进行必要的改变生活方式或接收处理,这将防止发展和可能逆转或治疗他们的疾病。 VTQ是一种宝贵的除了使诊断和持续监控一样方便,以病人为中心成为可能,所以这是很好的NICE指南鼓励其使用。“

在VTQ设备上的指导,请http://www.nice.org.uk/mtg27

ENDS

欲了解更多信息,请致电汤妮雅吉利斯博士在NICE新闻办公室于0300 323 0142,或出于小时07775 583 813。
编者注
名词解释

[1]评估是否有在肝损伤的标准方法是超声波扫描,瞬时弹性成像和活检。瞬时弹性是测量肝组织的基于测量花费在皮肤表面产生的波行进到肝脏内的一个点的时间的刚度的步骤。活检就是肝组织的一个小样本用细针取出,然后评估变更侵入性手术。指导建议说VTQ一样精确的诊断和分期肝脏纤维化瞬时弹性,并且可以提供其它好处在成像肝脏和取样选择的区域,以评估纤维化,并确定相关的病理学方面。

关于NICE指南

1.医疗技术指导,“虚拟触摸量化诊断和监测慢性乙型和丙型肝炎肝纤维化”,可在https://www.nice.org.uk/mtg27从2015年9月23日。

2.虚拟触摸定量(VT​​Q)由西门子制造。该VTQ软件应用程序使用声辐射力脉冲(ARFI)成像技术来测量肝组织的弹性。 VTQ组合使用与西门子美国Acuson S2000或S3000的超声平台。肝脏组织可以通过炎症被损坏,从而导致高水平的胶原蛋白,以在肝细胞(纤维化),它变得僵硬沉积。 ARFI成像,是形成通过将声'推压脉冲“横向到常规超声检查过程中发现的感兴趣区域横波。横波的速度成比例的组织的硬度。

3.成本模型表明,使用VTQ是节省成本与瞬时弹性成像与肝活检相比,兼容西门子超声波机器是否需要购买。与瞬时弹性成像相比,估计总成本节约为VTQ大约是每人£53心动假设将用于VTQ测量的超声机容量的10%,留下90%至可以应用于其他用途。与肝活检相比,相应节约大约是每人£434

4.在公司提交规定的VTQ软件的成本为£4415。兼容西门子美国Acuson S2000超声系统从£50,000,每年的维护费用,从第2年的费用,从2000年£。所有费用均不含增值税。

5.在英格兰,慢性乙型肝炎影响了大约273,000人(B型肝炎基金会,2007年),大约16万个人有长期(慢性)感染丙型肝炎(公众卫生英格兰,2014年)。

肝纤维化(在本指南中没有考虑)6.其他原因可能包括大量饮酒,毒素和一些罕见的遗传性疾病。

7. NICE目前正在制定关于预计将刊登在2016年六月的“评估肝硬化和管理”临床指导。

关于医疗技术评价方案

8.医疗技术评估计划的重点是具体的创新医疗技术,包括设备和诊断评估。产品的类型可能被包括的是提供治疗诸如那些在外科手术过程,技术,为更大的独立性对患者,和用于检测或监测医疗状况的诊断设备或测试植入的医疗设备。独立的医疗技术咨询委员会有两个核心职权范围:由NICE指南节目中选择的医疗技术进行评估,并制定医疗技术指导本身。指导适用于英国NHS,和不是强制性的。更多信息,请http://www.nice.org.uk/MT
关于NICE

美国国家卫生研究院和保健卓越(NICE)负责驾驶改进和卓越的健康和社会保健系统的独立机构。我们开发的指导,对高品质的健康和社会保健标准和信息。我们还就如何促进健康生活,防止生病。

我们的目的是帮助从业者提供最好的照顾,并给人们的最有效的治疗方法,它是基于最先进的最新证据,并实现资金提供价值,以减少不平等和差异。

我们的产品和资源产生了NHS,地方当局,服务提供者,慈善组织,和任何人谁也进行调试或提供医疗服务,公共卫生,社会照料服务的责任。

要了解更多关于我们做什么,请访问我们的网站:www.nice.org.uk,并按照我们在Twitter:@NICEComms。

    除了这意味着患有慢性乙肝或丙肝可能避免侵入肝活检,相关节省超过每人£400个可能导致显著节省了医院,其中肝活检是诊断和监测肝纤维化的主要方法
    阿玲Longson教授,为卫生技术评估NICE中心主任

    VTQ是一种宝贵的除了使诊断和持续监控一样方便,以病人为中心成为可能,所以这是很好的NICE指南鼓励其使用
    安德鲁·兰福德,英国肝脏信托首席执行官

相关资源

    虚拟触摸量化诊断和监测慢性乙型和丙型肝炎肝纤维化

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发表于 2015-9-24 15:08 |只看该作者
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发表于 2015-9-24 15:12 |只看该作者
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VTQ组合使用与西门子美国Acuson S2000或S3000的超声平台
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