细菌耐药？新型诊断工具来帮你！
检索/翻译：曹峥峥 校对/审核：黄宇琨
本文由Eric Stern博士撰写，SeLux Diagnostics的联合创始人兼首席技术官。
百年前，细菌感染往往是一个死亡判决。但随着青霉素和其他抗生素的出现，这种感染也逐渐变得容易控制，甚至成为常规医疗状态。但今天，随着抗生素耐药性的提升，我们正回到100年前那个危险的状态。
对所有已知的抗生素都进化出耐药性的“超级细菌”目前已出现在全球各地，造成公共卫生和国防的重大危机。仅在美国，每年至少有200万人感染了这种超级细菌，导致23000多人死亡。【1】专家预测，如果今后的治疗模式不发生重大改变，到2050年，超级细菌的死亡人数将超过癌症的死亡人数。【2】
对于败血症这种由感染引发的可能致命的疾病，必须立即使用抗生素。在没有有效抗生素的情况下，每隔一小时，生存率就会降低8%。【3】由于耐药菌非常普遍，治疗败血症需要使用最好的、最广效的广谱抗生素。
败血症和菌血症患者的护理动力学图。
抗生素的每一次使用都给细菌提供了一个进化突变的机会，从而产生了耐药性。【4】由于常规使用广谱抗生素是当下美国所有医院的常态，维持现状，抗生素只会走向未来的消亡。
为了消除广谱抗生素的过度使用，我们必须最大限度地提高精准治疗的开药速度。尽管个性化医疗在其他医疗保健领域取得了进展，但使用诊断测试来开展个性化抗生素治疗通常仍需要三天或更长时间才能完成。
这种时间上的拖延对于那些对标准广谱制剂有耐药性的超级细菌患者来说，危害极大。很多患者在等待检测结果的过程中就会因病情过重而死亡。除了给细菌的耐药性提供进化条件，这种过度治疗还可能造成伤害：损害肾脏、肝脏和听觉功能、误伤正常肠道菌群。
认识到快速诊断对于即将到来的超级细菌危机的重要性，美国政府为了鼓励开发变革性技术，在过去的十年中采取了三个重要的举措：建立医疗保险支付激励机制，开发耐药性生物样本库，以及直接资助该领域的创新。
BioFire公司的FilmArray系统
美国联邦医疗保险和医疗补助服务中心现在已经规定在美国所有医院实施全国性的抗生素管理计划。【5】该机构进一步调整了对传染病住院患者的付款方式，以鼓励医院提供一流的护理，加快患者好转出院。
2015年，FDA和美国疾病控制和预防中心联手创建了耐药性生物样本库。【6】该库向所有合格的研究人员提供稀有的耐多药细菌和真菌菌株，这些菌株对测试新的诊断方式和药物至关重要。通过提供这些稀有的样本，FDA和美国疾病控制和预防中心为所有研究人员和公司提供了公平便利的竞争环境。
2010年，卫生与公众服务部下达给生物医学高级研究与发展局(BARDA)一个任务【7】：应对“超级细菌”这一日益普遍的公共卫生威胁。目前BARDA正直接资助十几家公司开发抗生素和诊断方法。我的公司就是其中之一。
Accelerate Diagnostics公司开发的Pheno系统
这种对诊断创新的支持刺激了大量的风险资本投资，并产生了一连串快速诊断的新方法。例如，Accelerate Diagnostics公司开发的Pheno系统【8】利用强大的显微镜技术，比其他现有平台更快地提供适当的抗生素疗法建议。BioFire公司的FilmArray系统【9】使用尖端的基因型技术来快速识别病原体，在某些情况下可直接从患者样本中识别。在SeLux，我们已经开发出一种新的方法，用于确定对患者的个性化抗生素治疗【10】，包括那些超级细菌感染者。在这场斗争中，时间是至关重要的。
我们希望几十年后，当病患需要抗生素时，我们将创造一个这些药物仍然有效的世界。多亏了政府行动和风险投资共同推动的一连串创新，我们可能正走在正确的道路上。
原文：
New diagnostic tools are essential in the battle against antibiotic resistance
By ERIC STERN
OCTOBER 24, 2019
A century ago, a severe bacterial infection was often a death sentence.
With the advent of penicillin and the antibiotics that followed, such infections became eminently manageable, even routine. Today, though, with the rise of antimicrobial resistance, we are perilously close to returning to where we were 100 years ago.I have a unique and uncomfortable perspective on the looming crisis of antimicrobial resistance. I am the chief technology officer SeLux Diagnostics, a startup focused on the rapid diagnosis of infectious diseases. And as I write this article, I am praying for my grandfather, who played a pivotal role raising me and is now fighting for his life against West Nile encephalitis. While intubated in one of the nation’s best intensive care units and beating the long odds against West Nile — never count out World War II veterans — he has been infected with methicillin-resistant Staphylococcus aureus (MRSA), which exists in most U.S. hospitals, and is now being given broad-spectrum antibiotics.
“Superbugs” that have evolved resistance to all known antimicrobials have now appeared across the globe, creating public health and national defense crises. In the U.S. alone, at least 2 million people each year contract infections that are resistant to antibiotics and antifungals, resulting in more 23,000 deaths. Experts predict that without a major change in today’s treatment paradigm, deaths from superbugs will surpass deaths from cancer by 2050.
For people with sepsis, a potentially deadly condition triggered by infection, antibiotics must be administered immediately: Every hour without effective antibiotics decreases the survival rate by 8%. Because drug-resistant bacteria are so common, treating sepsis requires using the best, most wide-acting broad-spectrum antibiotics.
Because each use of an antibiotic provides an opportunity for bacteria to evolve “survival of the fittest” mutations that confer antimicrobial resistance, routine use of broad-spectrum agents, the norm in all U.S. hospitals, all but ensures the future demise of antibiotics.
To eliminate the overuse of overly toxic broad-spectrum antimicrobials, we must maximize the speed with which precision therapies can be prescribed. Despite advances in personalized medicine in other areas of health care, using diagnostic testing to personalize antibiotic therapy still typically requires three or more days to complete.
This agonizing delay is most harmful for patients with superbugs that are resistant to standard broad-spectrum agents, many of whom die while their doctors are waiting for test results. In addition to creating a fertile ground for antimicrobial resistance, such overtreatment may also do harm, compromising kidney, liver, and auditory function, and eliminating normal gut bacteria.
Recognizing the importance of rapid diagnostics to combat the impending resistance crisis, the U.S. government has taken three important steps in the last decade to create incentives for developing new, transformative technologies: creating Medicare payment incentives, developing a sample bank of resistant organisms, and directly funding innovation in the space.
The Centers for Medicare and Medicaid Services has now mandated nationwide antimicrobial stewardship programs in all U.S. hospitals. CMS has further restructured payments for patients hospitalized with infectious diseases to provide incentives to give the best-in-class care that rapidly transitions patients out of the hospital.
In 2015, the FDA and the Centers for Disease Control and Prevention joined forces to create the Antibiotic Resistance Isolate Bank. This repository provides to all qualified researchers rare strains of multidrug-resistant bacteria and fungi that are essential for testing new diagnostics and drugs. By making these sparse samples available, the FDA and CDC leveled the playing field for all researchers and companies.
In 2010, the Department of Health and Human Services gave the Biomedical Advanced Research and Development Authority (BARDA) the task of addressing the increasingly prevalent public health threat of antimicrobial resistance. BARDA now directly funds a dozen or so companies developing antibiotics and diagnostics. My company is one of these.
This support for diagnostic innovation has spurred significant venture capital investment and produced a flurry of novel approaches for performing and acting on rapid diagnostics. The Pheno system developed by Accelerate Diagnostics, for example, uses powerful microscopy technology to provide information on appropriate antibiotic therapies faster than other available platforms. The FilmArray from BioFire uses cutting-edge genotypic technology to rapidly identify pathogens, in some cases directly from patient samples. At SeLux, we have developed a novel approach for determining personalized antibiotic therapy for patients, including those with superbug infections. Time is of the essence in this fight.
My grandfather’s hospital room is decorated with the artwork of his great-granddaughters. We can only hope that decades from now, when they need antibiotics, we will have created a world in which these drugs still work. Thanks to a flurry of innovation spurred by a combination of government action and venture investment, we may be on the right path.
Eric Stern, Ph.D. is the co-founder and chief technology officer of SeLux Diagnostics.
参考来源：
【1】https://www.cdc.gov/drugresistance/index.html
【2】https://amr-review.org/
【3】Anand Kumar, Daniel Roberts, Kenneth E Wood, et al.Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006 Jun;34(6):1589-96.
【4】https://www.statnews.com/2016/05/27/superbug-antimicrobial-resistance-explainer/
【5】https://www.modernhealthcare.com/safety-quality/cms-finalizes-hospital-antibiotic-stewardship-requirements
【6】https://www.cdc.gov/drugresistance/resistance-bank/index.html
【7】https://www.phe.gov/ASPRBlog/Lists/Posts/Post.aspx?ID=97
【8】http://acceleratediagnostics.com/products/accelerate-pheno-system/
【9】https://www.biofiredx.com/products/filmarray/
【10】https://seluxdx.com/#technology
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