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中国每年约7.5万宫颈癌新病例 预防疫苗引进难产--亲稳舆论引导监测室
2013-01-23

尽管相隔千里，浙江女孩袁晓芳还是决定专程去香港注射宫颈癌疫苗。这款在全球已经卖出1亿多支的疫苗，尚未在内地上市。 疫苗要注射3次，历时大半年，花费的精力与时间都不少，但袁晓芳觉得自己还算幸运的。毕竟，对于大多数内地女孩而言，这疫苗可望而不可及：中国的医学家还在等待行政审批的结果。 一直关注着宫颈癌疫苗的中国医学科学院、北京协和医学院肿瘤医院肿瘤研究所教授乔友林，对这种漫长的等待显得束手无策：“我有时想想会觉得可悲，这支疫苗在国外上市已经7年，这些年里，中国有多少万人在等待中感染了HPV(人类乳头瘤病毒)？” Although miles away,Zhejiang girl YuanXiaoFang decided to coming to Hong Kong injection cervical cancer vaccine.This section in the global has sold more than 100 million branch of the vaccine,Has not yet listed in the mainland. The vaccine to inject three times,Last few months,Spend a lot of energy and time,But YuanXiaoFang feel still lucky.After all,For most of the mainland for a girl,This vaccine unattainable:China's medical scientist is still waiting for the result of administrative examination and approval. Have been concerned about the cervical cancer vaccine of Chinese academy of medical sciences/Beijing union medical college hospital cancer tumor research institute professor zhang,For this long wait is at a loss what to do:"I sometimes think about will feel sad,A vaccine in foreign listed has seven years,During these years,China has many ten thousand people are waiting in the HPV infection(The human papilloma virus)?"　　世上唯一能预防癌症的疫苗 The world's only can prevent cancer vaccine为了宫颈癌疫苗，北京协和医院妇产科医生龚晓明在微博上激动了一回。1月13日那天，常常在微博上与网友互动的龚医生读到了来自复旦大学教师江静的网上求助：33岁的她被怀疑患了宫颈癌，一个小孩拳头大小的肉瘤盘踞在她的腹腔中。这个两岁孩子的母亲在微博上自述，“最悲哀的是肉瘤对放化疗不敏感，如果贸然动手术摘除会有生命危险”。 这让龚医生感到某种悲愤。想到7年前问世的宫颈癌疫苗至今仍停滞在国内试验阶段，不能到达普通人手上，这位曾留学美国的年轻医生点击键盘，在微博上输入了这样一个问题：“凭啥中国人不能用上好药？” 也许只有医生才能理解这一提问中复杂的情感。毕竟，世界早已不再是那个对宫颈癌病因还茫然不明的时代了。 往前30年，科学家们还普遍以为，这种最常见的女性生殖道恶性肿瘤病因是疱疹病毒。当时，那是国际医学界最火热的研究领域之一。 德国医学家哈拉尔德·楚尔·豪森也是其中一名孜孜不倦的研究者。在改换了对癌症病毒的研究方法后，他证实，疱疹病毒其实只是一种伴随现象，本身并不致病。而几乎所有的宫颈癌都与HPV的感染相关。“在分裂变异的过程中，细胞突变，一不小心HPV病毒的DNA与宫颈上皮细胞DNA整合了，就成了恶性肿瘤。豪森证明的就是这种病因关系。”乔友林解释说。 这一发现，让宫颈癌成为世界卫生组织眼中最有可能被消灭的癌症。 如今在100多个国家与地区上市的“宫颈癌疫苗”真正的名称是HPV疫苗。它并不能治疗宫颈癌，却能预防HPV病毒的感染，对七成的宫颈癌有着预防效果。也正因此，刚过初潮、还未开始性生活的年轻女性是最适宜的接种人群，而国际上普遍认定，宫颈癌疫苗对9岁至45岁女性都有效果。 每年，全球有52.9万新发宫颈癌病例，约有20万人死于宫颈癌，其中90%以上来自发展中国家。 在经过三期临床试验之后，2006年，默沙东公司生产的HPV疫苗“佳达修”(Gardasil)通过优先审批在美国上市。这款疫苗能预防由HPV6、11、16、18所引发的宫颈癌、阴道癌、肛门癌等疾病。此外，葛兰素史克公司也生产了针对HPV16、18型病毒的疫苗“卉妍康”(Cervarix)。后来，这两款疫苗在很多国家都被纳入青少年免疫计划。 两年后，因为发现宫颈癌成因，楚尔·豪森教授获得了诺贝尔医学奖。这两款疫苗很快进入普通人的日常生活。 在悉尼读大一的中国女孩单妮，在社区医院的墙上见到了“宫颈癌疫苗，防患于未然”的海报；当地的医生也会主动向适龄女孩提起这唯一的癌症疫苗，建议她们趁早注射——澳大利亚政府规定，16岁至26岁的女性可以免费接种。单妮很快注射了“佳达修”。 在港台地区，女星张钧甯和蔡卓妍代言了“佳达修”疫苗，出现在电视和海报中鼓励女性接种。在香港上学的大陆女生秦薇，一开学就遇到了学校组织的宫颈癌疫苗讲座与展览，学校医务室还给出了2400港元的学生优惠价(普通人需要花费3700港元)。 从2012年2月起，美国疾控中心更新疫苗接种信息，呼吁不光女童，所有11岁至12岁的男童也接受HPV疫苗注射。 对中国人而言，HPV疫苗也许会更有效。根据乔友林教授的研究，国内84%的宫颈癌患者病因是感染HPV16或18，超过国际平均水平。他的研究还显示，国内女性HPV感染率约在15%左右。 “这不是个小数目，乙肝病毒携带者也才占人群的10%啊。”他说。 但是，没有人说得清，疫苗何时才能在中国上市。两年前，乔友林在接受一家媒体采访时说“我们在等待审批”，今天，他们依然在等待。 In order to cervical cancer vaccine,Beijing union medical college hospital department of gynaecology and obstetrics doctor GongXiaoMing in micro blog excited time.That day on January 13,,Often in micro bo with net friend interactive kung doctor read from fudan university teachers JiangJing online for help:33 years old she was suspected of suffering from cervical cancer,A child fist size sarcoma occupy her in the abdominal cavity.The two years old the mother of the child in micro blog readme,"The most sorrow is not sensitive to chemotherapy is sarcoma,If a removal surgery can have life risk". It makes kung doctors feel some kind of grief and indignation.Think of the cervical cancer vaccine was seven years ago is still stagnant in domestic test stage,Can't arrive on ordinary people,The former study in the United States young doctor click on the keyboard,In micro blog input such a problem:"With what Chinese people can't use good medicine?" Maybe only a doctor can understand this question of complicated emotions.After all,The world is no longer the cause of cervical cancer is at a loss of unknown age. 30 years on,The scientists also generally thought,This kind of the most common malignant tumor of the female genital tract etiology is herpes virus.At that time,It is the hottest international medical research one of the areas. German medical harald DE ChuEr Howe's is also one of the tireless researchers.In the change of cancer virus research method,He confirmed,Herpes virus is just a kind of adjoint phenomenon,Itself is not pathogenic.And almost all of the cervical cancer and HPV infection related."In a split in the process of variation,Cell mutation,Carelessly HPV DNA and cervical epithelial cell DNA integrated,Will become a malignant tumor.Schoenberg's proof of the relationship is the cause."Zhang explained. The discovery,Let the cervical cancer become the world health organization is most likely to be wiped out in cancer. Now in more than 100 countries and regions listed"Cervical cancer vaccine"The real name is HPV vaccine.It is not to treat cerical cancer,But it can prevent HPV infection,To seventy percent of cervical cancer has a preventive effect.Are so,Just after menarche/Is not to have sex of young women is the most appropriate vaccination crowd,And the common international recognition,Cervical cancer vaccine of 9 years old to 45 years old women have effect. Every year,Global 52.9 new TB cases, cases of cervical cancer,About 200000 people died in cervical cancer,More than 90% of them from developing countries. After the third phase of clinical test later,In 2006,,Merck company produces the HPV vaccine"Better to repair"(Gardasil)Through the first approval in the United States listed.This type of vaccine can prevent the HPV6/11/and/And a cervical cancer/Vaginal carcinoma/Anal cancer and other diseases.In addition,Glaxosmithkline also produce to HPVand/And viruses of the vaccine"Energy yan kang"(Cervarix).later,The new vaccine in many countries were incorporated into adolescent immunization program. Two years later,Because that causes cervical cancer,ChuEr Howe's professor won the Nobel Prize in medicine.The new vaccine quickly into ordinary People's Daily life. In Sydney the Chinese girl ChanNi freshman year,In the community hospital see the wall"Cervical cancer vaccine,Nip in the bud"poster;The local doctor will also be active to bring this girl only cancer vaccine,Suggested that they time injection - Australia government regulations,and to 26 years old women can free vaccination.ChanNi soon given"Better to repair". In Hong Kong and Taiwan regions,Actress ZhangJun constructed and charlene choi the endorsement"Better to repair"vaccine,Appeared in the TV and posters urging women vaccinated.In Hong Kong, mainland QinWei girls go to school,A school is in the school organization's cervical cancer vaccine lectures and exhibition,The school clinic also gives a hk $2400 students preferential price(People need to spend hk $3700). From 2012 2 month,The United States centers for disease control and update vaccination information,Calls for not only girls,All 11 to 12 years old boy also accept HPV vaccination. For Chinese people,HPV vaccine may be more effective.According to the research of professor zhang,Domestic 84% of patients with cervical cancer etiology is infection HPVand or eighteen,More than the international average level.His research showed that,HPV infection in women in about 15%. "This is not a small number,Hepatitis b virus carriers and it only accounts for 10% of the people ah."He said. but,No one knows,When will the vaccine in Chinese listed.Two years ago,Zhang accepted in a media interview"We are waiting for approval",today,They are still waiting for.在中国，每年大约有7.5万宫颈癌新发病例 In China,Each year about 75000 new cases of cervical cancer“中国人什么时候才能用上宫颈癌疫苗？你们的阻碍在哪里？”2011年，满头银发的楚尔·豪森应乔友林教授、郎景和院士等人的邀请访问中国，在前往拉萨访问的途中，这位发现宫颈癌病因的医学家一路都在与乔友林讨论这个问题。 龚晓明也困惑于此。在“凭啥中国人不能用上好药”的问题之后，他还加上了一串解释：“通过FDA认证的药物在全球大多数国家可以直接进入临床应用，但是中国来了一条规定，药物进入中国必须要有中国人的研究，这才导致了宫颈癌疫苗现在不能入中国。” 确切地说，由于需要等待再做一次专属于中国人的三期临床试验的结果，宫颈癌疫苗一直未能获得国家食品药品监督管理局下发的进口药品注册证。 龚晓明微博中的FDA，指的是美国食品和药物管理局。该机构由医生、药理学家、微生物学家和统计学家等专业人士组成，其认证被世界贸易组织(WTO)与世界卫生组织(WHO)认定为食品与药品方面的最高安全标准。 早在2002年至2005年期间，默沙东与葛兰素史克公司就在台湾等亚洲地区进行过临床试验，结果证明疫苗有效。不过，中国大陆并不承认FDA的审批结果。 “FDA认证的时候只问产品是否符合严格的科学标准，不会在乎试验在哪里完成，而国内就要‘中国人’自己的数据。”龚晓明想不明白，对于一款在国际上已经得到普遍认可、世卫组织也在积极推广使用的药物，进入国门为什么如此之难？ “除了中国等少数几个国家，世界上大多数国家承认美国FDA的批准，都不需要再重做三期临床试验。”乔友林对中国青年报记者说。因在宫颈癌筛查和预防研究方面作出的成绩，他在2011年被世界卫生组织授予年度国际癌症研究署荣誉奖章。但对于某些事，他只能眼睁睁地看着它们发生。 如今，两款进口疫苗的临床试验正由中国医学科学院、北京协和医学院肿瘤医院肿瘤研究所、北京大学人民医院、江苏疾控中心等单位的学者负责。前两期临床试验分别验证药品的毒性与剂量，花费一年左右的时间就能完成，但到了验证药物有效性的三期试验阶段，学者们陷入了漫长的等待。 “如果是治疗型的药物，疗效很快，一般几天或者几星期就能见效。”乔友林解释说，“但疫苗是一种预防性的药物，第三期试验需要挑正常人来进行对照，一半人打疫苗，一半人打安慰剂。对那些注射了安慰剂的对照组而言，要出现有足够统计学差异数量的癌或癌前病变，才算有结果。可是，谁知道她们什么时候会感染这病毒？” “现在这两家大公司已经做了3年试验，还没有出结果。”乔教授预计，三期试验至少要持续5年时间。 默沙东公司向中国青年报记者回应，“目前正在进行有效性临床研究，尚无具体上市时间可供披露”。上市至今的7年中，这款疫苗在全球已经卖出了超过1亿支；而在中国，每年大约有7.5万宫颈癌新发病例。 "When will the Chinese use cervical cancer vaccine?Your obstacles in where?"In 2011,,The silver-haired ChuEr Howe's should be professor zhang/Et academician, invitation to visit China,On the way to visit Lhasa on the way,The found of the medical cause cervical cancer in all the way with zhang to discuss the problem. GongXiaoMing also puzzled by this.in"With what Chinese people can't use good medicine"Problem after,He also added a bunch of interpretation:"Through the FDA authentication of the drugs in most of the world's countries can directly go to the clinical application,But China is a law,Drugs to enter the Chinese must have Chinese study,This can cause cervical cancer vaccine now can't into China." exactly,Due to the need to wait for do it again belong to the Chinese three phase of clinical trial results,Cervical cancer vaccine had been unable to get the state food and drug administration issued the imported drugs registration certificate. GongXiaoMing micro bo the FDA,Refers to the United States food and drug administration.The mechanism consists of a doctor/pharmacologist/Microbiologist and statisticians and other professional source is composed,The certification by the world trade organization(wto)And the world health organization(Who)Identified as food and drug of the highest safety standards. As early as in 2002-2005,Merck and GSK in Taiwan and Asia had clinical test,Results show that the effective vaccine.but,China does not recognize the FDA approval results. "FDA certificate only ask whether products conform to the strict scientific standard,Don't care where test done,And domestic will‘The Chinese’Own data."GongXiaoMing don't understand,For one in the world has been generally recognized/The world health organization also actively promote the use of drugs,Enter the international why so difficult? "In addition to China, a few countries,Most countries in the world recognize the FDA's approval,Don't need to redo the third phase of clinical trials."Zhang to the China youth daily reporter said.Because in cervical cancer screening and prevention research achievements made,In 2011 he was awarded the world health organization annual international agency for research on cancer of honor.But for some things,He can only watched helplessly as they happen. now,Two paragraphs import vaccine clinical trials is by Chinese academy of medical sciences/Beijing union medical college hospital cancer tumor research institute/The people's hospital of Beijing university/Jiangsu CDC, and other units responsible for the scholars.The first two phase of clinical trials were validation drug toxicity and dose,Spend a year of time to complete,But to verify the effectiveness of the drug three phase test stage,Scholars in the long wait. "If treatment is type of drugs,Curative effect quickly,General a few days or weeks can act."Zhang explained,"But the vaccine is a kind of preventive medicine,The third stage test need to choose normal controls,Half dozen vaccine,Half dozen placebo.To those who are given in terms of placebo,Appear to have enough statistically significant number of cancer and precancerous lesions,Would be a result.but,Who knows when they will become infected with this virus?" "Now the two large companies have done three years test,Haven't the results."Professor Joe is expected to,The third phase of test will take at least five years. Merck company to the China youth daily reporter response,"Currently effective clinical research,There is no specific time to market for disclosure".Listing has seven years,This type of vaccine in the world has sold more than 100 million cigarettes;In China,Each year about 75000 new cases of cervical cancer.　　“现在这个门槛实在太高了” "Now the threshold is too high"本土研究者也在行动。2011年，由养生堂公司投资的首个中国宫颈癌疫苗研制项目启动临床试验。日前，这款国产疫苗进入三期试验。 它们何时上市，都取决于试验的进程或药监局的审批。不过，之前还有很多药物在排着队。 曾在美国生活多年、如今从事创新药物研发的杨建良给记者报出了一串数字：美国FDA药品审评中心有近4000人，在2011年仅批出来30多个创新药物。目前国家药审中心的一线审评员仅有100多人，面对的却是大量待审批的创新药、仿制药。 “评审员身兼数个领域，专业性不强，审评严重滞后。”这位正在南京参加江苏省“两会”的代表说，“那些评审员都是超负荷工作了，我想向国家建议，增加药审中心的编制。” 他与龚晓明医生都同意的一点是，不论是进口还是国产疫苗，等待过程中消耗少则数千万、多则上亿元人民币的成本，最终还是会成为高昂医药费的一部分，摊到普通人的头上。 就在学者等待试验与审批结果的时候，许多城市女性开始为了3针宫颈癌疫苗前往港澳地区。从澳大利亚回国定居的单妮劝她的两个闺蜜去香港完成了接种；浙江女孩袁晓芳也从同事那里听说了这种疫苗，虽然半信半疑，还是走进了香港的医院。 “一个健康产品，能让千千万万人受益的，上市到现在已经7年了，要注射，还只能去香港、澳门和台湾，或者趁着国外旅游的机会偷偷带回来。”乔友林感叹道，“你说可怜不可怜？” 但能够及时得知这一疫苗，并负担起一趟旅行费用的“可怜”女性，也许该算是少数的幸运儿。 复旦教师江静腹中的肉瘤生长迅速，很快压迫到神经和静脉。1月13日，已经无法行走的她在微博上发出“我想活下去，我还有父母要养，老公要爱，儿子要疼，我希望大家救我一命”的求助。她想通过网络寻找一种能有效控制肉瘤生长的药物，据说目前在国外正处在试验阶段。 龚晓明在微博上读到这段话，内心五味杂陈，他并不知道江静寻找的是哪种药物，但显而易见，和宫颈癌疫苗一样，短时间内，国人不可能享受到这些药物。 在看到这条微博的前一天，他从一名同行那里听说，最近国际上出了一种新药，是可以改善卵巢癌治疗效果的，可药厂在评估了进军中国所需要的成本之后，最终决定放弃进入中国市场。 龚晓明说，类似的案例为数不少，作为一个医生，有时明知病人并非无药可救，只因某些药无法落户中国，只能为病人感到遗憾和惋惜。 “也许需要对外来药品设一个门槛，但现在这个门槛实在太高了”。 Local researchers also in action.In 2011,,YangShengTang company investment by the first China cervical cancer vaccine development project start clinical trials.a,This kind of domestic vaccine into the third phase of test. When they listed,Depends on the test process or the administration's approval.but,There are many drugs before the row of the team. In the United States had lived for many years/Now engaged in drug development YangJianLiang innovation to the reporter quoted a series of Numbers:American FDA drug evaluation center has nearly 4000 people,In 2011 only batch out more than 30 innovative drugs.At present the country medicinal center line evaluation member only 100 people,Face to the innovation of the examination and approval is a lot of medicine/generics. "Reviewers body and a number of areas,Professional is not strong,Evaluation serious lag."This is in nanjing in jiangsu province"lianghui"Representative said,"The reviewers are overload work,I'd like to suggest countries,Increase the center of the medicinal preparation." He and GongXiaoMing doctors agree that,Whether imported or domestic vaccine,In the process of waiting for the tens of millions of consumption/, the cost of hundreds of millions of yuan,Eventually will become part of the high medical bills,Stand to the head of the ordinary people. The scholars waiting for test and approval results,Many cities women began to 3 needle cervical cancer vaccine to Hong Kong and Macao regions.From Australia to return to China for permanent residence ChanNi advised her two ladies honey to Hong Kong finished inoculation;Zhejiang girl YuanXiaoFang from my colleagues also heard the vaccine,Although salt,Or into the Hong Kong hospital. "A health products,Can make ten million people benefit,It has been listed 7 years,To injection,Also can only go to Hong Kong/Macao and Taiwan,Or while traveling abroad of the opportunity secretly brought back."Zhang sighed,"You don't have mercy on the poor?" But can be known in time this vaccine,And afford the cost of a trip"poor"women,Maybe this is a few lucky dog. Fudan teachers JiangJing the womb sarcoma growth rapidly,Soon oppression to the nerve and vein.On January 13,,Has been unable to walk out on her in micro bo"I want to live,I have parents to raise,The husband must love,Son to hurt,I hope you save my life"to.She wants to through the network to find a kind of can effectively control the growth of sarcoma drug,It is said that at present in a foreign country is in test stage. GongXiaoMing in micro bo read this passage,Inner mixed emotions,He did not know JiangJing looking for is what kind of medicine,But it is clear,And as a vaccine,Short time,People may not enjoy these drugs. This article in view of the micro bo,He heard from a peer,Recent international out of a new drug,That can help improve ovarian cancer treatment effect,But in the evaluation of the pharmaceutical companies into China need cost later,Finally decided to give up to enter the Chinese market. GongXiaoMing said,A few such cases,As a doctor,Sometimes knowing the patient is not hopeless,Because some medicine cannot be settled in China,For the patient can only regret and regret. "May need to foreign drugs have a threshold,But now the threshold is too high".


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