Despite recommendations, many Americans in the target age group are not getting screened for colorectal cancer.
尽管医生推荐，但许多处在目标年龄组的美国人仍没有接受结直肠癌筛查。
However, a new blood-based screening test may help boost those rates because of its simplicity and convenience for the patient.
然而，一个新型的基于血液的筛查测试可以帮助提高筛查率，因为它对于患者来讲简便快捷。
The downside is that the new test is not as sensitive or accurate as a colonoscopy or the other recommended screening approaches.
不好的一面是，新的测试方式不像结肠镜检查或其他推荐的筛查手段一样敏感或精确。
Approved in April 2016, the Epi proColon (Epigenomics AG) is the first blood-based colorectal screening test to get a thumbs-up from the US Food and Drug Administration (FDA).
在2016年8月由美国食品与药品管理局批准的，Epi proColon (Epigenomics AG)是第一个基于血液并得到肯定的结直肠癌筛查测试。
This molecular test detects methylated Septin 9 DNA in plasma, which is increased in colorectal cancer and can be found in tumor DNA that has been shed into the bloodstream from both colon and rectal sites. This makes it a differential biomarker for the early detection of colorectal cancer, according to the manufacturer.
此项分子测试在血浆中发现甲基化的氯苄乙胺9号DNA，它在结直肠癌中增加并可以在从结肠和直肠脱落到血流中的肿瘤DNA中发现。在早起检测结直肠癌时，根据制造者，它是一个有差别的生物标记。
Available in Europe since 2012, it is also being marketed in other countries, including China.
从2012起可以在欧洲使用，它也在其他国家被推向市场，包括中国。
The major advantage of the Epi proColon is that because it is fast, easy, and noninvasive, it may appeal to individuals who have shunned other screening approaches.
Epi proColon主要的优势是快速、简单和非侵袭性，他可能更适合想要避免其他筛查方式的个体。
“I believe that any screening test is better than no screening,” Dr Chan told Medscape Medical News. “But we also have to be cautious about using screening tests simply because they are easy to employ. Screening also involves a follow-up and a discussion of the results.”
“我相信，任何筛查测试都要比没有筛查好，”Chan博士说。“但是我们也必须要谨慎使用简单的筛查测试，因为它们使用起来太简单了。筛查也应包含随访和结果讨论。”
What isn’t clear is whether the benefits outweigh the risks, he explained. “Or if there are tradeoffs, such as the test picking up false-positives or the consequence of false-negatives, which may give the patient an inappropriate sense of security.”
获益是否大于风险并不清晰，他解释道：“如果有折衷，例如该测试给出假阳性和假阴性的结果，患者可能会对结果的安全性感到不安。”
Basically, there are a lot of caveats with this test, and it shouldn’t be considered an easy alternative. “This blood test hasn’t been shown to reduce mortality from colon cancer, which is the most important data,” Dr Chan emphasized. “So we don’t know how it is going to compare to the other established screening tests.”
基本上，该测试有很多注意事项，而且他不应被作为一个简易的选项进行考虑。“该血液测试并没有显示出结肠癌死亡率的下降，死亡率是最重要的数据，”Chan博士强调。“所以我们不知道它如何去对比于其他既定的筛查测试。”
Need for More Options
需要更多选择
Both the incidence of and mortality from colorectal cancer have been declining in recent years, and much of that is attributed to screening.
结直肠癌的发病率和死亡率在近些年已经下降，其中很大一部分原因是因为筛查。
However, screening rates are well below the targets designated by public health agencies. According to National Health Interview Survey data, screening use overall was below the targets; there were no improvements from 2010 to 2013 for not only colorectal cancer screening but also for breast and cervical cancer.
然而，筛查率要比公共卫生保健所指定的目标低。根据国家健康访问调查的数据，筛查使用总体全部低于目标；在2010年到2013年中，不仅仅是结直肠癌，乳腺癌和卵巢癌的筛查也没有任何提高。
But for colorectal cancer screening, after adjustments were made for age, 58.2% of survey respondents aged 50 to 75 years reported getting screened.
但是对于结直肠癌筛查，在调整了年龄之后，58.2%的年龄在50到75岁的研究对象接受了筛查。
This rate falls short of the Healthy People 2020 target of 70.5% (2008 baseline, 52.1%). In addition, screening was lower among Asians and all Hispanic subgroups except Puerto Ricans, and younger individuals were less likely to be screened (50 to 64 years, 52.8%) compared with older persons (age 65 to 75 years, 69.4%).
该概率没有达到 Healthy People 2020年制定的70.5%的目标（2008的基准线，52.1%）。另外，除了波多黎各人筛查在亚洲和拉丁美洲的分组都较低，而且相对年轻的个体(50 to 64 years, 52.8%)相比于年龄大的人接受筛查的更少(年龄65 到75 岁，69.4%)。
“Anything that brings more people into screening is great,” commented David Johnson, MD, a past president of the American College of Gastroenterology (ACG) and coauthor of the ACG’s colorectal cancer screening guideline. But this new blood test “is not meant to replace any of the better tests that are available now, and that is the undercurrent message.”
“任何使更多的人接受筛查的东西都很棒，”David Johnson表示，医学博士，美国胃肠病学会前主席（ACG）和ACG结直肠癌筛查指南的合著者。但是这项新的血液测试“并不意味着替代现有的更好的测试，而且这也已经不是新消息了。”
The Epi proColon is primarily meant for people who have declined other types of screening, he told Medscape Medical News. “This is a test that only detects cancer, and the best test should be able to prevent cancer, and recognize precancerous polyps.”
Epi proColon通常意味着拒绝其他类型筛查的人群，David Johnson说。“这项测试只检测癌症，而且更好的测试应该可以预防癌症，并且辨别出癌变前的息肉。”
The ultimate screening test should mitigate toward cancer prevention rather than detection, explained Dr Johnson, who is also professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk.
基本的筛查测试应该更倾向于癌症预防而不是癌症检测， Johnson医生解释道，他是诺福克东部弗吉尼亚医学院胃肠病学部门主任和主任医师。
Colonoscopy has been proven to decrease the incidence of colon cancer and prevent colon cancer-related death, and it remains the preferred strategy in the ACG’s guidelines, last published in 2009, he noted.
结直肠镜检查已被证明能减少结直肠癌发病率并预防结直肠癌相关死亡，而且它仍然是ACG最新在2009年发表的指南中的首选方式。
“It is the best test is to prevent cancer because it can detect polyps and in turn decreases mortality and colon cancer incidence,” he said. “For every 1% in adenoma detection rate, there was a 3% reduction in the incidence in colon cancer and a 4% reduction in death, and it comes down to polyp removal.”
“能预防癌症才是最好的测试，因为它能发现息肉并依此减少死亡率和结直肠癌发病率，”他说。“腺癌的检出率每升高1%，结直肠癌的发病率就减少3%，死亡率减少4%，而且可以作为息肉被切除。”
All of this needs to be put into context in primary care, where most patients will most likely be counseled about screening. “In primary care, when patients ask about the Epi proColon, it should be put into context as to how it compares with other tests,” he said. “And importantly, that the test is just for cancer detection and will not detect precancerous polyps.”
所有的这些需要放在初级治疗的说明中，初级治疗中大部分患者可能被劝说接受筛查。“在初级治疗中，当患者询就Epi proColon进行咨询时，应该把它相比于其他测试的程度放在说明中，”Johnson医生说。“而且重要的是，这项测试只针对癌症检测，并不检测癌变前息肉。”
The Centers for Disease Control and Prevention, in conjunction with other groups, has set a goal for a screening rate of 80% by 2018 in order to reduce colon cancer incidence and death rates.
疾病控制与预防中心，将其他群体连接起来，为了减少结直肠癌发病率和死亡率，设定了2018年筛查率80%的目标。
“This test could help reach that goal,” Dr Johnson said. “But only if the patient has been appropriately counseled and refuses everything else, then this becomes an option. ”
“这项测试可以帮忙达到这个目标，”Johnson医生说。“但只有在患者被适当劝说且拒绝了其他的测试，那么该测试可以作为一个选项。”
Task Force Guidelines
专家组指南
In their updated 2016 guidelines, the US Preventive Services Task Force (USPSTF) found convincing evidence that colorectal cancer screening substantially reduces disease-related mortality, but it did not recommend any one screening approach over any other.
在他们最新升级的2016年指南中，美国预防服务工作组(USPSTF)发现有力证据 结直肠癌筛查大量减少了疾病相关的死亡率，但并不特别推荐某种筛查方法。
The USPSTF now recommends seven different screening strategies: colonoscopy, fecal immunochemical testing (FIT) for occult blood, guaiac-based fecal occult blood testing, sigmoidoscopy alone, sigmoidoscopy plus FIT, the FIT-DNA test, and computed tomographic colonography.
USPSTF现在推荐其中不同的筛查方法：结肠镜检查，粪便免疫化学检测隐性出血(FIT)，基于甲基邻苯二酚粪便检测隐性出血，单独乙状结肠镜检查，乙状结肠镜检查+FIT，FIT DNA测试，和结肠成像。
They all have varying levels of evidence supporting their effectiveness, and the potential harms also differ among the specific approaches.
他们都有不同等级的证据来支持他们的有效性，而且潜在损害在不同的方式之间也不同。
Douglas Owens, MD, former Task Force member, general internist at the Veterans Affairs Palo Alto Health Care System, and professor at Stanford University in California, pointed out that the Epi ProColon test was included in the Task Force’s review.
Douglas Owens，医学博士，工作小组以前的成员，帕洛阿尔托退伍军人医疗保健系统的综合内科医师，及加利福尼亚斯坦福大学的教授，指出：Epi ProColon测试包括在专家小组的回顾内。
“This screening method currently has limited published evidence evaluating its use,” he said. “It had a sensitivity to detect colorectal cancer of under 50%, which is quite low, as we would want sensitivity levels at about 90% or higher. Therefore, it was not included in the table on screening strategies in the final recommendation statement.”
“该筛查办法现在被已发表的评估它使用情况的证据所限制了，”他说。“它对结直肠癌的检测的敏感性在50%以下，非常低，我们想要敏感水平为约90%及以上。因此，它并不包括在筛查的最终推荐的项目表中。”
Dr Owens emphasized that the FDA recommends that the blood test to detect methylated SEPT9 DNA be offered only to patients who have a history of not completing colorectal cancer screening.
Owens医生强调，FDA推荐血液测试检测DNA SEPT9甲基化，只提供给具有不完全结直肠癌筛查病史的患者。
“The FDA also recommends that the available tests included in the Task Force’s 2008 final recommendation be offered first,” he said. “The Task Force bases all of its recommendations on the best evidence that is currently available. As such, the tests with sufficient evidence were listed in the table.”
“FDA也推荐可用的测试，包括在专家小组2008年最终推荐中的将被优先提供，”他说。“专家小组基于所有现在可获得的、他对于最佳证据的推荐。就其本身而言，这些测试有足够充分的证据在表中列出。”
Efficacy of the Test
测试的功效
Two years before the FDA approved the blood test, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee reviewed the data.
在FDA通过血液测试两年前，美国食品和药物管理局医疗设备咨询委员会的分子和临床遗传学小组审查了这些数据。
Most of the panel agreed that the test was safe (yes, 9; abstain, 1).
小组大部分人认为这项测试是安全的（9位赞成，1位弃权）。
But when it came to effectiveness, the panel was decidedly mixed (yes, 5; no, 6), as well as regarding whether its benefits outweigh its risks (yes, 5; no, 4; abstain, 1).
但当到有效性时，小组的判断比较混合（5位赞成，6位反对），是否获益大于风险的判断也是（5位赞成，4位反对，1位弃权）。
Data from two clinical studies were used in the decision making process.
决策制定的过程中使用了来自两项临床研究的数据。
The first study compared the efficacy of Epi proColon to colonoscopy in 1544 samples drawn from individuals aged 50 to 85 years who were at average risk for colorectal cancer.
第一项研究在1544个年龄50到85岁、处在结直肠癌平均风险上的个体的抽取样本中对比了Epi proColon和结肠镜检查的有效性。
The sensitivity of Epi proColon was 68.2% (95% confidence interval [CI], 53% – 80%) and specificity was 80% (95% CI, 77.9% – 82.1%). The negative predictive value was 99.7% (95% CI, 99.6% – 99.8%) and positive predictive value was 2.4% (95% CI, 2% – 3%).
Epi proColon的敏感性为68.2%(95% 置信区间 [CI], 53% – 80%)，特异性为80% (95% CI, 77.9% – 82.1%)。阴性预测值为99.7% (95% CI, 99.6% – 99.8%)，阳性预测值为 2.4% (95% CI, 2% – 3%)。
The second study compared the accuracy of Epi proColon to FIT using matched blood and stool samples from 290 participants. Epi proColon was statistically noninferior to FIT with respect to sensitivity (72.2% for Epi proColon vs 68% for FIT) but not specificity (80.8% vs 97.4%).
第二项研究使用来自290位参与者的配对血样和粪便样本对比了Epi proColon和 FIT的准确性。Epi proColon就敏感性而言，在统计学上要比FIT高( Epi proColon72.2% vs FIT68%)，但在特异性上低于FIT (80.8% vs 97.4%)。
The manufacturer does agree that the Epi proColon test is not meant to be a simple alternative to the other screening strategies — at least not at this time.
制造商十分赞同 Epi proColon测试并不意味着它对于其他的筛查测试只是一个简单的替代品——至少是不在这个时候。
These recommended tests should be offered and declined before Epi proColon is offered as an option for screening, and specifically, the Epi proColon is not intended to replace screening tests recommended by appropriate guidelines, the company emphasizes.
该公司强调：推荐的测试应在Epi proColon作为一个筛查选项之前，先行提供给患者，特别是，Epi proColon并无意代替被通常的指南推荐的筛查测试。
“There are 23 million average risk people who are not getting screened,” said Noel Doheny, CEO of Epigenomics USA. “And those are the people we are targeting.”
“有230万处在平均风险上而没有接受筛查的人，”美国表观基因组学CEO，Noel DohenyNoel Doheny说。
The assumption was that people who were unwilling or unable to undergo screening with the recommended tests might do so if an easier option was available. “The third study we did is pending publication, and it answered the question for the FDA — would somebody who is noncompliant use a blood test,” he explained. “We recruited 413 patients who were twice noncompliant after being told by a physician to get either a colonoscopy or FIT, and 99.5% of those randomized to our test got a blood test on the spot.”
假设为不愿意或不能接受所推荐的测试进行筛查的人群可能会接受这项新方式，如果有更简便的选项的话。“我们所做的第三项研究待发表，而且它回答了FDA的问题——哪一些人不愿接受验血，”他解释道。“我们招募了413位在医生说明需要他们接受结肠镜检查或FIT但两项都拒不接受的患者，且他们中的99.5%在现场随机接受了我们的测试并进行了验血。”
Of 203 individuals in the Epi proColon group, 202 had the test done. Of that group, 30 had a positive test result; of those, 17 individuals went on to have a colonoscopy, with 10 having a polyp removed.
在Epi proColon组中的203位个体，202位进行了测试。该组中，30位取得了阳性测试结果，30位中的17位曾接受过结肠镜检查，10位有过息肉切除。
In the FIT group, of the 210 participants who were offered the stool test, 185 completed it (88.1%). There were 3 positive results, and 1 person had a colonoscopy with a polyp removed.
在FIT组中，提供其中210位参与者验粪检查，185位完成(88.1%)。有3个阳性结果，其中1位接受过结肠镜检查和息肉切除。
“Participation is the key,” said Doheny. “If you can’t get someone tested, the specificity and sensitivity aren’t of any value. But by getting 99.5% tested, you can now answer those questions for those who were previously noncompliant.”
“参与者是关键，”Doheny说。“如果你没有接受测试的人，特异性和敏感性就没有任何价值。但是99.5%都接受测试，你先在就可以回答那些先前不接受这项测试的人的问题了。”
These are the only data available right now, but he explained that his company is currently in a dialog with the FDA about postapproval studies.
现在只有这项数据是可获得的，但他解释道：他的公司现在正处在FDA关于批准后研究的数据资料中。
“We are planning trials that will confirm the adherence number and look at the test’s usage over a number of years,” he said.
“我们正在计划可以证实 the adherence number的试验，并分开来研究这些年以来的测试的使用。”
In addition, there are also trials in place with high-risk patients, and a similar trial in lung cancer has been initiated.
另外 ，在高危人群中也有适当的试验，且在肺癌中也开始进行小型的试验。
Regarding insurance coverage, Doheny pointed out that the Epi proColon test was actually available for several years before its FDA approval.
关于保险范围，Doheny指出，在FDA批准之前，Epi proColon现如今已经投入使用很多年了。
“The test was developed over 4 years ago with the help of Quest Diagnostics and ARUP [Associated Regional and University Pathologists] as a laboratory developed test,” he said. “They configured it and offered it, and over the years, a majority of payers have been paying for it.”
“该测试在Quest诊断公司和ARUP（相关的区域和大学病理学家）支持下，作为一项实验开发测试已经发展了4年，”他说。“他们配置并提供该测试，并在这些年中，大部分购买者都持续使用。”
“Since we received approval, the number of payers is now likely to be even higher,” Doheny added.
“自从我们收到了批准，购买人的数量现在可能更高了，”Doheny补充道。
Database reveals surgical techniques with better outcomes for gastric sleeve gastrectomy patients
数据显示，外科技术使袖状胃切除的患者有更好的预后
By analyzing information included in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database, the largest bariatric-specific nationwide registry, researchers found that laparoscopic sleeve gastrectomy is a safe procedure with a low morbidity rate. But to achieve even better outcomes, common surgical techniques used in this procedure should be examined more closely. Study results are published in the September issue of the Annals of Surgery.
通过分析包括在代谢和减肥手术的认证和质量改进计划(MBSAQIP)数据库中的信息，最大的特殊肥胖症治疗全国登记处的研究者们发现，腹腔镜下袖状胃切除术手术过程安全且发病率低。但是为了达到更好的结果，在过程中使用的平常的手术技巧应更仔细的进行检查。研究结果出版在9月刊的外科学年鉴（Annals of Surgery）中。
“The MBSAQIP registry is a powerful tool that allows us to look at process measures on a national level so that we can improve the quality of care in bariatric surgery,” said first author Elizabeth R. Berger, MD, a general surgery resident at Loyola University Chicago Stritch School of Medicine, Illinois, and an American College of Surgeons Clinical Research Scholar at the time this study was conducted. “This resource allows us to do very highly powered studies that we were not able to do before.”
“MBSAQIP登记处是一个有力的工具，使我们能够观察处于国家水平的过程评价，使我们能提高减肥手术中的医疗质量，”第一作者Elizabeth R. Berger说，她是伊利诺斯芝加哥洛约拉大学医学院普外科住院医师，以及进行了这项研究的期间美国外科医师协会的临床研究学者。“这个资源让我们可以去做高质量的，我们以前不能做的研究。”
Laparoscopic sleeve gastrectomy is a common bariatric procedure, accounting for 42 percent of these weight loss operations. Growing in popularity, the procedure helps obese patients lose up to 70 percent of their excess body weight during the 12 months following surgery.
腹腔镜下袖状胃切除术是一项普通的肥胖症治疗方式，这是42%减重手术的实施原因。在大众中普及后，该方式帮助了肥胖患者在12个月连续的手术期间减少了他们体重的70%。
（责任编辑：sgx）
