uation of the clinical studies.doc

evaluation of the clinical studies -literature review临床研究评估文献综述table of contents 目录1. introduction. 4 引言2. device concerned .5 产品简介 2.1. glossary. .5 术语 2.2. device name/model. .5 产品名称/型号 2.3. functioning principles .5 功能原理 2.4. biological factors (on-site use, organs and tissues).6 生物因素(现场使用，器官和组织) 2.5. clinical indications.6 临床适应症 2.6. different types of existing medical devices .6 现有产品类别3. scope .7 适用范围4. methodology .9 研究方法 4.1. date of search(es) .9 研究日期 4.2. reviewer(s) .9 撰稿人 4.3. period covered by search.9 研究周期 4.4. literature sources .9 文献来源 4.5. methodology .9 研究方法 4.6. search details.10 检索细节 4.7. selection criteria.11 选择标准 4.8. duplication strategy.11 重复策略 4.9. evaluation method .11 评价方法5. data collection .12 数据收集 5.1. collected data for acne: january 2000august 2013 .12 痤疮粉刺数据收集：2000年1月2013年8月 5.2. collected data on hirsutism and hypertrichosis: january 200august 2013.17 多毛症数据收集：2000年1月2013年8月 5.3. collected data on vascular: january 2000march 2013 .24 血管性障碍数据收集：2000年1月2013年3月 5.4. collected data on pigmentary: january 2000march 2013 .25 色素性障碍数据收集：2000年1月2013年3月6. evaluation.26 评价 6.1. acne treatment .26 痤疮粉刺 6.2. hirsutism and hypertrichosis.31 多毛症 6.3. vascular lesions.36 血管性障碍 6.4. pigmentary lesions .38 色素性障碍7. adverse events.39 不良反应 7.1. maude searches : january 2000march 2013 .39 maude数据库搜索：2000年1月2013年3月 7.2. daen july 2012 may 2013 .44 daen2012年7月2013年5月 7.3.conclusion.47 结论8. devices equivalence .49 等值设备9. follow up and update of clinical data.52 临床数据跟进更新 9.1. post market surveillance .52 市场监控 9.2. risk management .52 风险管理 9.3. post market clinical follow-up .52 市场临床跟进10. discussion .54 讨论 10.1. evaluation of publication g1.54 出版物评价g1 10.2. evaluation of publication g2.54 出版物评价g2 10.3. evaluation of publication g3.55 出版物评价g3 10.4. technical performances.55 技术性能 10.5. treatments safety:.55 治疗安全 10.6. machines safety: .56 设备安全 10.7. conclusion.56 结论11. publication retained and appendix .58 出版物及附录 11.1. publication .58 出版物 11.2. appendix .59 . 附录1. introduction 引言 this literature review is one piece of medical documents used in the certification process of the efbs ipl, model adena and anthelia. its purpose is to regroup all datas collected, their analysis and conclusion made through the process of literature review applied to these medical devices. 该文献综述是用于efb强脉冲光设备安黛娜和安赛丽注册所需提供的医学文件的组成部分，目的是将收集到的所有数据归类，并且将文献综述得出的分析和结论应用于医疗器械中。it shall not be used for another purpose other than the one it has been written for: a part of technical and medical documents of the efbs device certification process and post market follow-up. 除用作efb设备申请注册和市场跟进外，该文献不得作其他任何用途。this document shall not be used, copied, transmitted nor duplicated, by any means without efb authorization. 如果没有efb授权，该文件不得使用、拷贝、传播及复制。. 2. device concerned 产品简介 2.1. glossary 术语ipl stands for : intense pulsed light.ipl指：强脉冲光 efb stands for eurofeedbackefb指：法国eurofeedback集团 ppl stands for polychromatic pulsed light ppl指：多色脉冲光md stands for medical devicemd指：医疗设备 sr stands for skin rejuvenationsr指：皮肤修复 hr stands for hair removal hr指：脱毛2.2. device name/model 设备名称/型号this report is written in the context of project ea1675 which aims at adapting the ipl device model adena, with or without gsm option, to comply with the applicable medical norms in order to obtain the ec medical certification for this device. 该报告目的是使ipl设备安黛娜(配备或者不配备gsm)符合医疗器械相关标准从而获得ce证明。adena is available with or without gsm, and with a standard keyboard or a color touch screen. any combination of these option leads to an adena model. no differences in performance or requirements are affected by these options. adena分为键盘式和触屏式，可分别配备gsm，性能不会发生任何变化。the report is mainly based on data and study in report rec_ea1625, on a similar ipl device manufactured by eurofeedback, ec marked: the anthelia ng. given the technical similarities between both products, the objective of this report is entirely adapted to the adena device and takes into account the complementary and relevant new literature. 该报告主要建立在rec_ea1625报告数据和研究的基础上，也是eurofeedback集团生产的另外一款相似的ipl设备，ce注册名为anthelia ng。鉴于这两款产品技术特性相似，该报告以adena为主，并引用补充性和相关性的最新文献。both products are able to achieve the same treatments, therefore this review concerns both models adena and anthelia. for clarity purposes, ipl devices manufactured by efb and concerned by the present literature review will be referred to as adena, anthelia or efbs ipl, without distinction for options or design. 两款产品能够达到同样的治疗效果，因此该综述涉及adena和anthelia。由efb集团生产的ipl设备以及该综述涉及的产品是adena、anthelia或efb集团的ipl设备，在配置或设计上并无本质差别。2.3. functioning principles 功能原理the efbs ipl devices are apparatus which generate polychromatic pulsed light (ppl). in english language literature, this apparatus is named ipl, intense pulse light devices. the emission spectrum of the produced light, as well as its energy is adapted to the chosen application. various applications are intended to eliminate varicosities, pigmentary spots, acne on the skin or undesired hair removal. this is not an implantable active medical device. efb集团的ipl设备是指能够产生多色脉冲光(ppl)的仪器，称为强脉冲光设备。设备发出的光谱及能量能作为特定用途，可用于祛除静脉曲张、色素斑、粉刺痤疮，以及脱毛。该设备为非植入有源医疗器械。the mechanism is a photo-thermal action on the intended target zone; as such the action of the light is defined as being similar to a selective photo coagulation. the functioning principle is simple. an intense flash of light is emitted to penetrate the skin, the objective is to warm a selected target to reach the targets coagulation temperature in a very short period of time. the target is then eliminated or reduced. the aim is not to create any collateral damages. it is achieved thanks to a spectrum of light which is adapted to the spectrum of absorption of the target, and the flash duration is adapted to the dimensions of the target. 该设备采用的机制是在靶位上产生光热作用，该作用与选择性光凝固类似。功能原理很简单。一束强光打入皮肤，目的是使靶位受热并在极短时间内达到凝固温度。之后靶位消失或减少，但不会造成任何附加损伤，归功于光谱能够完全被靶位吸收，以及闪光持续时间与靶位大小相适应。2.4. biological factors (on-site use, organs and tissues) 生物因素(现场使用，器官和组织)the device includes an interchangeable hand piece (pma). each hand piece is used for a specific type of treatments, according to the filter of the incorporated light and the energy mode selected. hand pieces are compounded of an optical canal or light guide, designed to be in direct contact with the skin of the zone treated. 该设备配备可交替使用的手具(pma)。每支手具用于特定的治疗，由探头里的滤光片和选择的能量模式决定。手具上有一块光导，可直接与皮肤接触。2.5. clinical indications 临床适应症clinical indications supported by the apparatus are: 该仪器适用的临床适应症为：photo-depilation: hirsutism, hypertrichosis 光子脱毛：男女性多毛症vascular lesions: port wine stains, rosacea, erythrosis,couperose, telangiectasias, poikiloderma, varicosities血管性障碍：酒色斑、酒糟鼻、皮肤红变、红血丝、毛细血管扩张、皮肤异色症、静脉曲张pigmentary lesions: actinic lentigos, labials lentigos, seborrhoea keratosis. 色素性障碍：日晒斑、唇斑、皮脂溢角化病acne: by hyper seborrhoea, or by hyper-keratinisation of the pilosebaceous canal. 粉刺痤疮：炎症性皮脂溢、皮脂腺管道重度角化the type of population targeted is limited to healthy adults or healthy teenagers older than 14. 待治疗患者必须是健康的成年人或14岁以上健康的青少年。2.6. different types of existing medical devices 现有的不同类型的设备there are two types of ipl devices on the market, the ones with lamps cooled down by an air cooling down system, (these devices can be considered to be of low quality), and the high quality ones fitted with a water cooling down system. indeed, the latter provide more energy (fluencies) and a higher flash pace in conformity to the professional demands. moreover, the water cooling system has the specificity of filtering infrareds, a non selective and dangerous light. all efbs ipl have been designed with a water cooling system. 现在市场上有两种不同类型的ipl设备，一类使用空气冷却系统(这类设备质量很差)，另一类使用水冷却系统，质量很好。后者能提供更多能量，速度也更快，符合专业要求。另外，水冷却系统还能过滤红外线一种非选择性危险的光。efb集团的所有ipl设备都使用水冷却系统。. 3. scope 适用范围 the goal of this report is to provide get a conclusion on the efficiency and the benefit/risks balance of the applicable treatments provided by the efbs ipl devices. 该报告的目的是提供从efb的ipl设备治疗的效率和好处/风险评估中所得出的结论。questions 问题answers 回答comments 备注does the device have diagnostic claims that need to be supported by clinical data?该设备有没有需要用临床数据支持的诊断要求?no没有no object不需要does the device have therapeutic claims that need to be supported by clinical data?该设备有没有需要用临床数据支持的治疗要求?yes有reducing vascular lesions on the skin(erythrosis, varicosities, rosacea, portwine stains.)减轻皮肤上的血管性障碍(皮肤红变、静脉曲张、酒糟鼻、酒色斑)reducing inflammation of the sebaceousglands from bacterial origins减轻细菌性皮脂腺炎症reduction of pigmentary spots on theskin (lentigo)减轻皮肤上的色素斑treating hirsutism and hypertrichosis治疗男女性多毛症are the claims of the devices solely technical and can they be demonstrated by experiments in laboratory?设备的这些要求是不是仅仅限于技术上？需不需要实验论证？no没有no object不需要does the device emit energy?该设备发出能量吗？yes是illumination of the skin by a visiblepolychromatic pulsed light, close toinfrared.发出可见多色脉冲光，接近红外线interaction between the light andchromophores (haemoglobins, pigments)and transformation of the light into aheat that leads to coagulation or lyses ofthe tissues, that are naturally eliminatedby the body in a few weeks.光线和色基(氧合血红蛋白、色素)相互作用，光能转换为热能导致组织凝固或溶解，几周内自动排出体外does the device provide substances? 该设备提供物质吗？no没有not applicable不适用does the implementation of the device require a specific operatory mode or an unusual operatory mode different from the usual surgical practice? 启用该设备需不需要特殊的手术模式或者与常规手术不同的模式？no没有non implantable and non invasive device. 非植入非侵入设备the implementation of the device requires the use of specific or unusual ancillary which differs from the usual surgical practice?启用该设备需不需要使用特定的或有异于常规手术的附件？no没有non implantable and non invasive device.非植入非侵入设备according to the answers of the short list above, efb has made the choice to get clinical evaluation of its ipls by leading a pure literature search review. ipl technology is now an old technology (more than 20 years), even if it gained a significant popularity for the last 10 years, and therefore a significant amount of publication should be available to get sufficient evidence of treatments efficiency. 由上表可知，efb决定通过文献检索综述进行临床评价。ipl技术是一项古老的技术(超过20年)，在过去十年中被大量人群接受使用，因此，有大量出版物可供查阅，能够获取足够的治疗效果的证据。chosen option 选项clinical investigation of the designated device指定设备的临床调查chosen option 选项clinical investigations or other studies published in scientific literature on a similar device for which the substantial equivalence can be shown.有大量共同点的相似设备的临床调查或其他发表在科学文献上的研究成果chosen option r选项published or unpublished reports, related or not to other clinical tests operated on similar devices for which substantial equivalence can be shown. 公开发表或未公开发表的报告，与有大量共同点的相似设备有关或无关的临床试验the scope of this review addresses two essential requirements of ipl devices: performance of the treatment and reduced risk of side effects of the treatment. 该综述的范围包括ipl设备的两项核心要求：治疗效果和避免治疗副作用的风险。the following characteristics define the technical scope of the present review: 下述特性决定了该综述的技术范围：ipl should provide a light between specific bandwidth: above 610nm for hair treatments, and above 475nm for superficial skin treatment. ipl应提供特定的光谱：高于610nm的光用于脱毛，高于475nm的光用于浅表皮肤治疗。no laser sources 非激光光源。treatments shall be made on healthy patients above 14 years old. 患者必须是14岁以上健康的人。intended use shall be vascular lesions reduction, acne reduction, undesired hair reduction or pigmentary skin spot reduction. 预期目的是减轻血管性障碍、痤疮粉刺、色素斑，或脱毛. 4. methodology 研究方法 4.1. date of search(es) 研究日期 this review is written from 19/08/2013 until 31/08/2013 该综述写于2013年8月19日至2013年8月31日。4.2. reviewer(s) 审稿人reviewer : dr m marest-morchain 审稿人：m marest-morchain博士reviewer : m pizarro (efb aqm) 审稿人：m pizarro(efb助理项目经理)author: g. safraoui (efb technical director) 作者：g safraoui(efb技术总监)author: n. masson (efb project manager) 作者：n masson(efb项目总监)the report is reviewed and approved by an expert, who demonstrates objectivity (as a party that didnt participate in the design of the device, without any financial interest in the company) and has the knowledge of the state of the art generally acknowledged. 该报告由一位持中立立场(没有参与该设备的设计，和公司无经济利益)并且具有丰富知识经验的专家复审批准。4.3. period covered by search 研究周期 periods covered by searches are synthetized in main page, and for each individual search. 研究周期在主页中做综合陈述，包括每个个体研究。4.4. literature sources 文献来源clinical data (information related to safety and other performances obtained during the clinical use of the device) come from: 临床数据(与安全和设备在临床使用中的性能相关的信息) 来源于：maude database by online access: this is a huge adverse events database, in which search is facilitate and data extraction is quite easy for offline analysis. maude数据库联机访问：这是一个很大的不良事件数据库，有助于检索及数据析取以供线下分析。/scripts/cdrh/cfdocs/cfmaude/search.cfm daen database by online access: this adverse events database related to austalian authorities (tga). this is a new database and starts from july 2012 1st. daen数据库联机访问：该不良事件数据库与澳大利亚官方(tga)关联，从2012年7月1日正式使用。.au/safety/daen.htm the mdr database is not used to get adeverse events information, as it covers only a period from 1992 to 1996, which is not relevant enough for our equipment. mdr数据库不用于获取不良事件信息，因为其只包含1992年到1996年的数据，与我们的设备无关。. pubmed database by online access: this is a well-known portal for medical publication which gives easily a lot of various results. pubmed数据库联机访问：这是一个著名的医疗出版物门户网站，可查阅很多数据。/pubmed/u.s. national library of medicinenational institutes of healtheudamed is an european database, but accessible only to authorities, not manufacturers eudamed是一个欧洲数据库，但只允许官方访问。. medeffect is a canadian adverse event database, but this is not intended for medical devices. medical devices alerts and recalls are accessible, but this database doesnt concern adverse event. no canadian medical device advert events database can be found. medeffect是一个加拿大不良事件数据库，但不针对医疗器械。无法找到加拿大医疗器械不良事件数据库。4.5. methodology