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published in(发表于) 2016/5/3 5:37:55
Expert: “immunotherapy“ Wei Zexi illnesses is a mature therapy

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Expert: "immunotherapy" Wei Zexi illness is mature therapy immunotherapy | w | West _ news

On May 2, Tingzhen biological clinic hospitals of Chinese armed police forces Beijing city centre, only a security guard to stay. Beijing News reporter Wang Jianing photography


51 holidays, "Wei XI" became the most popular name for rare diseases "synovial Sarcoma" let this young life gone, Baidu also followed early this year "contracted hemophilia stick incident" after once again became the target.


University student Wei Zexi, died from suffering from synovial sarcoma. His death-seeking process, by Baidu search top hospitals of armed police corps in Beijing, in the bio-medical center of the hospital received "immunotherapy" treatment costs more than 200,000 yuan to no avail, to public attention.


On May 2, Baidu was under investigation, the same day, the squad, 37th (app ID:zhonganzu37) sent several officers from the road, visit the armed police hospital bio-medical center and ask for a number of medical and legal experts, comb, asking every aspect of this event.


 Progress events


  Bio-medical centre Tingzhen, patient fees


At noon on May 2, Squad, 37th (app ID:zhonganzu37) officers came to the second hospital outpatient service building of the Chinese armed police forces Beijing city, the "Wei XI" events related to the bio-medical center, is located on the East side of the hospital inpatient building of a floor.


Officers from the registration office is aware, every day at 11 o'clock in the morning as the registration deadline, but the hospital has informed the bio medical center yesterday to stop registration, stop when the diagnosis and referral, the officer indicated that he did not know. Later, officers came to the Hospital North of the bio medical center, triage nurse figure disappeared, only a man in work clothes of the security guards on duty.


The security guard said he had on duty at the gates, was temporarily reassigned to come over yesterday, triage nurse to go, the Secretary said is not clear.


Triage left the bio medical center specialist clinic, officers knocked on with a nurse to open the door, but stopped after the diagnosis was immediately closed. Consulting room there are several, including the cell door, through the cell door glass can be seen in the figure, but no one knocked on the door the officers.


In addition, walls on either side of the consulting room, has a double-sided adhesive traces. A 8 layer at the hospital patient, after the walls of a bio-medical center of billboards, sign major publicity the Centre's treatments and means "signs last week were still in, I do not know when it disappeared. "The patient said, after the cells with a colored pattern on the Billboard.


Subsequently, officers consulted the Emergency Department physicians, nurses, and hospital floor, are unclear about the bio medical center Tingzhen, and said it is not aware of, "Wei XI". Seven nurses, in consultation with the hospital, they are not familiar with biological treatment center on the first floor.


The same day, and some patients from the Internet to see "Wei Zexi incident" report, to a refund of the cost of treatment to the hospital. A malignant melanoma patients who came from Shandong said himself after two courses of treatment but not against better, requires hospitals to return your last check cost of 10,000 yuan. Eventually, the hospital agreed to the return of these patients are part of the cost.


  Baidu's statement: the welcome presence of joint investigation teams


On May 2, the national Internet Information Office spokesman Jiang Jun spoke pointed out that recent "Wei Zexi event" Internet users received wide attention. National network Office in conjunction with the State administration for industry and commerce, the State Health Commission set up a joint investigation group into the company, to investigate this event and Internet business law matters and dealt with according to law.


In this regard, the squad, Baidu to 37th (app ID:zhonganzu37) officers, welcomed the joint fact-finding Group stationed in Baidu. Network information is healthy and effective, is the responsibility of each participant of the Internet, including Baidu. Baidu will fully cooperate with authorities investigating and accepts their oversight, and don't leave false information and illegal activities on the Internet opportunity.


According to reports, the assigned to Baidu's joint investigation team, coordinated by the national network office networks integrated management and law-enforcement supervision and Fan Li, chaired by the Secretary, the State administration for industry and Commerce advertising supervision Division, the National Health Commission medical hospital and Beijing NET information Office, trade and industry, health, family planning and other related departments, joint investigation teams will be announced in due course investigations and process the results.


  Detective investigations


  Many patients by doctor Baidu search


Rong is a patient with malignant melanoma. In March this year, in Shenzhen she felt unwell after being diagnosed with malignant melanoma.


"Felt the pressure, and check where the disease is better on the Internet. "Rong Rong on April 20, her treatment of malignant melanoma by Baidu search approach, recommended prior to the discovery of several hospitals, and has customer service staff can seek advice.


"Not only the second Chinese armed police forces Beijing city Corps Hospital at that time, there are several, but I think it forces hospitals to rely on, retrieved it, also found that it was hospital. "Rong said, she assured the staff consultation, they advised her to leave your name and phone number, facilitate communication, and make an appointment can help experts.


Rong recalled, and soon after, a man claiming to be his doctor made a phone call. "Say they are the bio-medical center of the hospital's technology, is specifically designed for the of malignant melanoma, the machines are from the United States imports", Yao also help expert Li Rongrong made an appointment on April 23.


"I asked the price, take a course, no hospitalization, cost about 33,000, hospital prices in 37,000 yuan", Rong said, according to the appointment, she arrived in hospital in the 23rd, at nine o'clock in the morning, no registration, directly to the inpatient building of a layer.


Rong described Lee method used by doctors, is to extract part of blood, cell separation, a week before the new cells into the body.


Rongrong rental house near the hospital with his mother after waiting for a week, on May 2, when returned to the hospital to return to the blood transfusion, only to find the expert office door closed.


And as Rong Rong, in March this year, Beijing song after the medical examination found themselves hpv83. In the Baidu search "HPV" phrases, click into the top few have a Web site. Countersigned a similar QQ pop-up customer service advisory said that Chinese armed police forces Beijing city hospitals in the second hospital for the treatment of this most professional.


Squad, 37th (app ID:zhonganzu37) officers at the hospital, 8/f, met with the face of the Department disseminated Lupus miliary Zhang. She was a few days ago after passing the Baidu search, leave your name and number and then call customer service, said suggested that Chinese armed police forces Beijing city's second hospital for examination, "or it will become more and more serious."


  Depth reading


Here, the crime unit, 37th (app ID:zhonganzu37) officers we know Wei Zexi's illness-"synovial Sarcoma", as well as the symptoms and treatment of this rare disease.


1 "synovial Sarcoma" is kind of what disease? Is a soft tissue sarcomas, no common clinical


There are indications, Wei Zexi "synovial Sarcoma" is derived from the joint, the synovium and synovial tendon sheath of soft tissue cancer.


It is retroperitoneal tumors of soft tissue tumor hospital and Director of the center of Beijing University Hao Chunyi introduced, includes synovial Sarcoma, "Sarcoma", and we used to say "cancer" are two types of malignant tumors of different origin. Among them, occur in is called a sarcoma of soft tissues, such as fat Sarcoma, Leiomyosarcoma, fibrosarcoma, and so on. It and the incidence of cancer, treatments, and treatment effects are different.


Hao Chunyi introduction synovial sarcoma of predilection include limbs, trunk and retroperitoneal.


He said synovial Sarcoma in clinical practice is not common, there is no precise incidence statistics. Location of the retroperitoneal soft tissue sarcoma incidence in one out of 10,000, is a rare disease. One of the characteristics of retroperitoneal soft tissue sarcoma, most of the existing chemotherapy, radiotherapy and other means are less sensitive, surgery is the only one that can give potential chance of cure, treatments to the patient.


2 "immune therapy" is what? "Synovial Sarcoma" immature therapy


Wei Zexi in the second Hospital of the armed police was "immunotherapy with DC technology", has also sparked some controversy. In this regard, Hao Chunyi explains that immunotherapy with DC technology itself is actually very mature technology, the key is how to apply.


The past, tumor treatment includes surgery, radiation therapy, chemotherapy, along with medical advances, such as immunotherapy and hormonal therapy and treatment. According to Hao Chunyi, the "immunotherapy" principle is to mobilize the body's resistance, fighting against tumor cells, rather than such as chemotherapy, radiotherapy, "killing". In theory, this is a development direction for cancer treatment, and current research in the field of cancer treatment.


However, Hao Chunyi pointed out that immunotherapy for the treatment of certain diseases better, such as renal cell carcinoma, melanoma, lymphoma, are carried out in many hospitals. But for many tumors, immunotherapy is still at the research stage, and with no apparent effect. For Wei Zexi synovial Sarcoma cancer, immunotherapy is not ripe for treatment.


Said Wei XI using the techniques of immune therapy in the United States was "lost". Hao Chunyi to this view, cannot be generalized to "failure" to describe the immune therapy. From a long-term perspective, it must be the direction, but the key is how to apply. "Treatment of any diseases that do not have a fixed pattern, the key question is whether patients, diseases are applicable. ”


3 "immunotherapy" how to be introduced? Safety and effectiveness requires further validation


"Wei Zexi event", the armed police hospital said the technology introduced by Stanford University. So, at the national level, introduction of new technologies in hospitals need to go through what process?


Insiders yesterday on the squad, 37th (app ID:zhonganzu37) officers said the hospitals for the introduction of major new technologies must adopt the relevant approval and filing procedures. Among them, the experimental study and clinical effect was a "hard"; in addition, hospitals also need to submit includes the feasibility study report and other materials, for auditing by professional bodies. Needs out in the report, is the application of this technology at home and abroad.


Meanwhile, officers learned that, according to the Ministry of health-related approach, immune cell therapy techniques have been considered "involves significant ethical issues, safety and effectiveness of standard clinical trials are needed to further validate the medical technology", but which are not included.


Provisions relating to the introduction of medical technology, officers found queries, in 2009, according to the Ministry of health published the clinical management of application for medical technology, medical technology is divided into three classes, the Ministry of health is responsible for the clinical application of the third class medical management. Specifically, class III medical technologies directory published by the Ministry of health to develop, and according to the clinical situation, be adjusted.


What is a "third-class medical technologies directory" listed in the original statement of Ministry of health in a number of "significant ethical issues, safety and effectiveness of standard clinical trials are needed to further validate the medical technology". Among them, cloning treatment, Autologous stem cells and cell therapy and gene therapy technology.


The same year, the original Ministry of health published the first catalogue of class III medical technology allows clinical application, "autoimmune cells (t-cells, NK cells) treatment technology" to be included. To validate a clinical application of health administrative departments are the Ministry of health.


However, last July, according to the decision on the removal of administrative approval items, State Health Planning Commission issued a notice that, cancel approval class III medical technology clinical practice admittance.


In the notice, State Health Planning Commission said, prohibit clinical application in the medical safety and effectiveness of some of the major issues in medical technology, which "immune cell therapy," not one of them.


Beijing News reporter Li Xiangrong Wen Ru Dai Xuan Li TINGTING interns autumn editor Liu Zening Zhang Tailing



Responsible editor: Zheng Hanxing





Article keywords:
Immunotherapy Wei Zexi

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专家:“免疫治疗”对魏则西病症是非成熟疗法|免疫治疗|魏则西_新闻资讯

5月2日,武警北京市第二医院生物诊疗中心停诊,仅一名保安留守。 新京报记者王嘉宁 摄


  五一假期,“魏则西”成为最受关注的名字,罕见病“滑膜肉瘤”让这个年轻生命逝去,也让百度继年初“血友病贴吧承包事件”之后,再一次沦为众矢之的。


  大学生魏则西,因身患滑膜肉瘤去世。其生前求医过程中,通过百度搜索看到排名前列的武警北京总队第二医院,在该院生物诊疗中心接受“免疫疗法”治疗,花费二十多万元无济于事,引起公众关注。


  5月2日,百度因此事被调查,同一天,重案组37号(微信ID:zhonganzu37)派出多路探员,回访武警二院生物诊疗中心并请教多位医疗、法律专家,对这一事件进行全面梳理、追问。


  事件进展


  生物诊疗中心停诊,有患者退费


  5月2日中午,重案组37号(微信ID:zhonganzu37)探员来到武警北京市第二医院门诊楼,此次“魏则西”事件涉及到的生物诊疗中心,则位于该院东侧的住院楼一层。


  探员从该院挂号处了解到,每天上午11点为挂号截止时间,但医院已通知生物诊疗中心于昨日停止挂号,对于为何停诊及何时复诊,该人员表示不清楚。随后,探员来到住院部一层北侧的生物诊疗中心,分诊台不见护士身影,仅有一名身穿工作服的保安值守。


  该保安称,自己此前在大门处值班,昨日被临时调了过来,对于分诊台的值班护士去了哪里,该保安表示不清楚。


  分诊台左侧即为生物诊疗中心专家诊室,探员敲门后有护士开门,但表达已停诊后便立刻关门。诊室一旁还有包括细胞室在内的几扇房门,透过细胞室的房门玻璃可看到内有人影,但探员敲门后无人开门。


  此外,在诊室一侧的墙壁上,有着双面胶的痕迹。一名住院部8层的患者称,此前墙壁上有生物诊疗中心的宣传牌,牌子上主要宣传该中心的治疗方法及手段,“牌子上周都还在,不知道啥时候给摘了。”该患者称,此前的宣传牌上还印有彩色的细胞图案。


  随后,探员咨询该院急诊科医生,及住院楼护士,均表示对生物诊疗中心停诊一事不清楚,并称未听说“魏则西”一事。七层一名护士表示,有事情咨询医院,他们与一楼的生物诊疗中心并不熟悉。


  当天,还有一些患者从网上看到“魏则西事件”的报道后,到医院来要求退还治疗费用。一位从山东赶来的恶性黑色素瘤患者称,自己经过两个疗程的治疗但并无反好转,要求医院返还最后一次检查的一万元费用。最终,医院答应返还这些患者部分费用。


  百度声明:欢迎联合调查组进驻


  5月2日,国家互联网信息办公室发言人姜军发表谈话指出,近日“魏则西事件”受到网民广泛关注。国家网信办会同国家工商总局、国家卫生计生委成立联合调查组进驻百度公司,对此事件及互联网企业依法经营事项进行调查并依法处理。


  对此,百度向重案组37号(微信ID:zhonganzu37)探员表示,欢迎联合调查组进驻百度。网络信息健康有效,是包括百度在内的每个互联网参与者的责任。百度将全力配合主管部门调查,接受监督,不给互联网虚假信息和违法行为留下可乘之机。


  据介绍,此次入驻百度的联合调查组,由国家网信办网络综合协调管理和执法督查局局长范力任组长,国家工商总局广告监管司、国家卫生计生委医政医管局及北京市网信办、工商局、卫生计生委等相关部门组成,联合调查组将适时公布调查和处理结果。


  探员调查


  多名患者通过百度检索求医


  荣荣是一名恶性黑色素瘤患者。今年3月,在深圳打工的她觉得身体不适,后被确诊恶性黑色素瘤。


  “当时很紧张,就在网上查哪里看这个病好些。”荣荣介绍,4月20号,她通过百度搜索治疗恶性黑色素瘤的办法,发现前几条有推荐医院,并有网络客服人员可以咨询。


  “当时不仅武警北京市总队第二医院,有好几家,但我觉得部队上的医院靠谱,检索了一下,还发现它是三甲医院。”荣荣称,她向客服人员咨询后,对方建议她留下姓名及手机号,已方便沟通,并且可以帮忙预约专家。


  荣荣回忆,不久之后,一名自称姚医生的人打来电话。“说他们医院的生物诊疗中心的技术,是专门针对恶性黑素素瘤的,机器都是从美国进口的”,姚医生还帮荣荣预约好了4月23日的专家李医生。


  “我询问了价格,先做一个疗程,不住院的话,价格在3.3万左右,住院价格在3.7万元”,荣荣称,按照预约时间,她在23日上午九点到达医院,没有挂号,直接到达住院楼一层。


  荣荣介绍,李医生所采用的方法,是先抽取一部分血液后,进行细胞分离,一周后再将新细胞输回体内。


  荣荣与母亲在医院附近的出租屋内等待一周后,于5月2日回到医院准备回输血时,却发现专家诊室房门紧闭。


  和荣荣一样,今年3月,北京宋女士体检后发现自己为hpv83阳性。在百度检索“hpv”关键词后,点击进入了排在前几得一个网站。一个类似QQ弹窗的客服回签咨询称,武警北京市第二医院为治疗此方面最专业得医院。


  重案组37号(微信ID:zhonganzu37)探员在该医院8楼住院部见到了患了颜面播散性粟粒狼疮的张女士。她也是前几日通过百度检索后,留下姓名电话,随后有客服人员打电话,说建议来武警北京市第二医院检查,“不然会越来越严重”。


  纵深阅读


  在这里,重案组37号(微信ID:zhonganzu37)探员还要带大家认识下魏则西所患的疾病——“滑膜肉瘤”,以及这种罕见病的症状与治疗。


  1“滑膜肉瘤”是种什么病?属软组织肉瘤,临床不常见


  有资料显示,魏则西所患的“滑膜肉瘤”是源于关节、滑膜及腱鞘滑膜的软组织的恶性肿瘤。


  据北大肿瘤医院软组织和腹膜后肿瘤中心主任郝纯毅介绍,包含滑膜肉瘤在内的“肉瘤”、和我们常说的“癌”属于不同起源的两大类型恶性肿瘤。其中,发生于软组织的叫做肉瘤,比如脂肪肉瘤、平滑肌肉瘤、纤维肉瘤等。它和癌的发病率、治疗方式、和治疗效果等都不尽相同。


  郝纯毅介绍,滑膜肉瘤的好发部位包括肢体、躯干、腹膜后等。


  他表示,滑膜肉瘤在临床上并不常见,目前没有精准的发病率统计。位置在腹膜后的软组织肉瘤,发病率在十万分之一以下,属于罕见病。腹膜后软组织肉瘤的一大特点,便是大多数对现有的化疗、放疗等手段均不太敏感,手术是唯一一个能够给病人带来潜在治愈机会的治疗手段。


  2“免疫治疗技术”是什么?对于“滑膜肉瘤”非成熟疗法


  魏则西在武警二院使用的是“DC免疫治疗技术”,近日也引发了一些争议。对此,郝纯毅解释称,实际上DC免疫治疗技术本身是很成熟的一种技术,关键是如何应用。


  过去,肿瘤治疗手段主要包含手术、放疗、化疗,近年来随着医学发展,又出现了了免疫治疗和内分泌治疗等治疗手段。据郝纯毅介绍,“免疫治疗”的原理是调动患者自身抵抗力、战斗力抵御肿瘤细胞,而非象化疗、放疗等的“直接杀伤”。在理论上来讲,这是肿瘤治疗的一个发展方向,也是当前肿瘤治疗学领域中的的研究热点之一。


  不过,郝纯毅指出,免疫治疗对于某些病种的治疗效果比较好,像肾癌、黑色素瘤、淋巴瘤等,在很多医院均有开展。但对于很多肿瘤而言,免疫治疗目前还处于研究阶段,并没有取得明显效果。对于魏则西所患的滑膜肉瘤,使用免疫治疗并不是成熟的治疗方法。


  有撰文称,魏则西使用的免疫治疗技术在美国是“失败”的。郝纯毅对此认为,不能够一概而论地以“失败”来形容免疫治疗。从长远来看,它一定是发展方向,但关键是如何应用。“治疗任何疾病都没有一个固定的模式,关键问题是病人、疾病是否适用。”


  3“免疫治疗”如何被引入?安全性、有效性尚需进一步验证


  “魏则西事件”中,武警二院曾称其技术系由斯坦福大学引入。那么,在国内,医院引进新技术需要经过怎样的流程?


  有业内人士昨天对重案组37号(微信ID:zhonganzu37)探员表示,医院对于一些重大新技术的引进,须实行相关审批、备案等程序。其中,临床实验研究和效果算是一个“硬指标”;另外,医院还需要递交包含可行性研究报告等材料,供专业机构审核。报告中需要具明的一点,便是这项技术在国内外的应用情况。


  同时,探员获悉,根据原卫生部相关办法,免疫细胞治疗技术曾被认为是“涉及重大伦理问题,安全性、有效性尚需经规范的临床试验研究进一步验证的医疗技术”,不过不在禁止之列。


  关于医疗技术引进的相关规定,探员查询发现,2009年,根据原卫生部公布的《医疗技术临床应用管理办法》,医疗技术被分为三类,原卫生部负责第三类医疗技术的临床应用管理工作。具体是,第三类医疗技术目录由卫生部制定公布,并根据临床应用实际情况,予以调整。


  对于什么是“第三类医疗技术目录”,原卫生部在说明中列举了一些“涉及重大伦理问题,安全性、有效性尚需经规范的临床试验研究进一步验证的医疗技术”。其中,就有克隆治疗技术、自体干细胞和免疫细胞治疗技术、基因治疗技术等。


  同年,原卫生部公布《首批允许临床应用的第三类医疗技术目录》中,“自体免疫细胞(T细胞、NK细胞)治疗技术”被纳入其中。负责审定技术临床应用的卫生行政部门是原卫生部。


  不过,去年7月,根据国务院《关于取消非行政许可审批事项的决定》,国家卫计委下发通知表示,取消第三类医疗技术临床应用准入审批。


  在通知中,国家卫计委还表示,禁止医疗机构临床应用安全性、有效性存在重大问题的一些医疗技术,其中“免疫细胞治疗技术”不在其列。


  新京报记者 李相蓉 温薷 曾金秋 李婷婷 实习生 戴轩 编辑 刘泽宁 张太凌



责任编辑:郑汉星





文章关键词:
免疫治疗 魏则西

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