Please share your oppinion:

请分享你的观点

Recently I noticed this topic in another cytology website in China. Let us have a discussion here.

最近我在另一个中国的细胞学网站中注意到这个主题。让我们一起在这里讨论。

1. Are all cervical carcinoma related to HPV infection?

所有的宫颈癌都是由HPV导致的吗？

2. When the women or who should have high risk HPV (hrHPV) testing?

那些女性需要或者什么时候做高危HPV检测呢？

3. What methods to detect hrHPV do you used in your hospitals?

你们医院用的是那种方法检测高危HPV？

4. What should the women do if she has positive hrHPV result?

如果她的高危HPV的结果是阳性的，她们该怎么办？

5. hrHPV testing should be performed for women with AGC?

细胞学结果为AGC的女性应该进行高危的HPV检测吗？

6. Any question, experience or oppinion you have, please share or discuss.

所有以上问题，就你个人的观点或经验来分享和讨论吧。

We as pathologists should know some basic information about HPV even though HPV testing might not be oerformed in your hospital, or the patients might not be able to pay for the test.

 即使HPV检测在你们医院没有开展或病人没有经济能力支付这项检测。我们做为病理学医生应该知道一些关于HPV的基本知识。 

从实用的角度，我们仅对可疑的病例建议检测HPV。我们医院用杂交捕获法。

可疑的病例，是指细胞学ASCUS或AGC，或活检发现不典型湿疣改变者。这些患者如果高危型HPV阳性，需要密切随访。

如果细胞学为明确病变（HSIL或LSIL），或活检也能明确诊断，则不需要检测HPV。

临床医师要求做HPV检测，有些是从经济收入考虑的，我们这边350元的检测费，开单费就有50元。我们这边是放在妇科来做的，更加加重了患者的经济负担。

 1。几乎所有的宫颈鳞状细胞癌中高危型HPV检测呈阳性

 2。妇女可以在任何时候（性生活开始3年后）检测HPV（低危+高危），尤其是抵抗力（免疫力）较低生活质量欠佳人群，以达到防治目的

 3。我们用HC2+原位杂交两种HPV检测法

 4。高危HPV如检测呈阳性，应结合细胞学或组织学结果处理，形态学阴性者随访（重取材、阴道镜、复查HPV等）

 5。细胞学结果为AGC的，应常规检测HPV

You did right thing

FDA NEWS RELEASE

For Immediate Release: April 24, 2014
Media Inquiries: Susan Laine, 301-796-5349, susan.laine@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves first human papillomavirus test for primary cervical cancer screening 

The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.

Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs. 

Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, an exam using a device that illuminates and magnifies the cervix so a physician can directly observe the cervical cells. Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Health care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.    

“Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

The FDA first approved the test, called the cobas HPV Test in 2011 for use in conjunction with or as a follow-up to a Pap test (cell cytology), which examines cervical cells for changes that might become cervical cancer.

Today’s approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test, however; it does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed and modified by groups other than the FDA.

Genital HPVs are a group of more than 40 related viruses and, according to the Centers for Disease Control and Prevention (CDC), are the most common sexually transmitted infections. Approximately 14 “high-risk” HPV types are associated with cervical cancer. 

In most cases, a high-risk HPV infection goes away on its own and does not cause any health problems. However, about 10 percent of women infected with high-risk HPV develop a persistent infection which may put them at risk of cancer. Virtually all cervical cancers are caused by HPV infections, with just two types, HPV 16 and HPV 18, responsible for approximately 70 percent of cervical cancers.

Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women 25 years and older undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included three years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use. 

The cobas HPV Test is manufactured by Roche Molecular Systems, Incorporated, Pleasanton, Calif.

In April 2014 US FDA approved cobas HPV test can be used as a primary screening test for women 25 and older.

Currently there are three optios for cervical cancer screening in the USA:

1. Pap test for women 21 or older, every three years

2. Cotesting (Pap+HPV) for women 30 and older, every five years

3. cobas HPV test for women 25 and older.

HPV test as a primary test is a big news in cervical cancer screening. It needs time for people to accept the concept and also it needs more clinical data to support the new screening way.

 请教在中国现在有否用HPV 检查做为唯一的宫颈癌筛查方法？

 无论病理医师,还是临床医师,暂无法用HPV作为唯一筛查方法,仍以细胞学为主.

HPV高危阳性或一般的细胞学异常,离癌都还有一定距离.相对地,细胞学异常 "可能" 更近. 即HPV检查的积极意义在于,对宫颈癌的筛查,较细胞学可能"更高""更早""更敏感".然而,这也只是一种风险提示.正如用低密度脂蛋白胆固醇及脂蛋白A预估冠脉硬化的风险一样.

HPV阳性病例,也得经过: 细胞学,阴道镜,活检,手术这些过程.最关键可能还是细胞学.对细胞学阴性的HPV阳性病例,估计也只是随访的多.

换一种思维,或许会得出另一个结论:

HPV阳性病例的结局只有三种: 癌, 病变,健康.

HPV阴性病例的结局也只有三种:癌,病变,健康.

结局都一样???

当然有一种现象值得注意: 随着年龄的增加,HPV感染或持续的风险会降低..................

巴山夜雨涨秋池: Good point. Thanks. Still is there no one in the web knowing you in person?

USA FDA approved Roche HPV test can be used as the primary screening for the women 25 years and older. FDA approved it based on the clinial trial. But currently no clinical data demonstrate the safity of the approach.

 对,作为初步筛选,是完全可以接受的. HPV阴性病例理论上暂时可以不作细胞学及后续检查,前提是HPV检测的可靠性要相当高.这是基于宫颈癌均由HPV持续所致细胞及组织病变的理论.大概FDA的理由正在于此.然而,对HPV阳性病例,我认为仍应当且有必要履行细胞学,阴道镜,活检等相关检查手段.当然是一步接一步,不是一步所有手段全用完.

HPV检测与细胞学检查均属于筛查手段.活检属于诊断手段.阴道镜有的说是诊断手段,有的不认同.

HPV检测作为唯一筛查手段的提法,我认为值得商榷.细胞学筛查手段,我认为不应被取代,毕竟其属于"所见即所得".

 Nobody knows me,because everybody thinks I'm a mysterious figure. Haha.

 个人感觉HPV检测仅限于细胞学检查ASCUS的人群，阳性活检，阴性随访；

LSIL,HSIL直接活检的，没必要HPV检测，实际意义不大

也不适合大批量筛查，作为一过性感染，查出阳性，增加心理负担，每年进行细胞学检查足够了

good thought

所有的回复我都看完了。

不赞成开HPV的占多数。

现在妇科开HPV大部分都是看在钱上。

肺癌 食道癌什么的，没有这些病毒感染，但是依然要送胸水，食道，口腔脱落细胞。难道因为不知道如HPV一样的病因就不送吗？

HPV是很鸡肋，就因为探明了是宫颈癌的发病因素，导致现在大行其道，那那些没有探明病因的是不是就不做细胞学了呢？有点本末倒置。

 我也觉得没有必要做HPV检查。我正准备指导研究生写一篇没有必要做HPV普查的文章。我科借助TCT+DNA倍体技术，细胞学诊断现在做得很准确且很好，得到很好的阳性和阴性预值。DNA倍体阴性的肯定没有问题。大于等于3或者5尤其是数字红成一大遍的肯定是HSIL.与活检相比肯定完全相符合。当然要除外阴道镜没有活检到CIN的情况。

 对HPV疫苗或其任何成分（蛋白质和酵母）有严重的过敏反应者，不适宜接种HPV疫苗。孕妇或计划怀孕的女性，怀孕期间不适宜接种，在生育结束后，依然可以正常的接种HPV疫苗。我们和朋友也是选择的九价疫苗，能预防百分之九十以上的hpv病毒，一定要提前预约去打，v信都是可以免费约的hpv163