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预测心脏病发作的风险-第1页

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Tens of millions of Americans over age 40 have diseased arteries that may put them at significant risk of a heart attack. James Muller, a Boston cardiologist, is on a quest to develop a way to predict who among them is actually likely to have one.


千万40岁以上的美国人有动脉病变，这让他们面临着巨大的心脏病发作的风险。波士顿心脏病学家詹姆斯•穆勒（James Muller）正在努力找出预测他们当中哪些人会实际发病的方法。



Dr. Muller and a company he founded, Infraredx Inc., have developed a tool that analyzes deposits of cholesterol called plaques that accumulate in the coronary arteries and are the telltale signature of the disease that causes heart attacks. Using a combination of ultrasound and infrared spectroscopy, the device takes as many as 30,000 readings of an artery's chemistry in two minutes.


穆勒博士及其创建的公司Infraredx Inc.设计出了一种工具，它可以分析在冠状动脉中沉积的胆固醇──斑块，它是导致心脏病发作的疾病的示警信号。该设备结合超声波与红外线光谱，可以在两分钟内进行多达30,000次动脉化学指标读数。



The result, Dr. Muller says, indicates whether the plaque is 'hot' and poised to burst and potentially cause a heart attack or whether it amounts to a stable plaque that is unlikely to cause trouble.


穆勒博士称，该结果可以显示出斑块是属于"活跃"且面临爆发并可能导致心脏病发作的斑块，还是属于不太可能导致心脏问题的稳定斑块。



If the test proves effective in detecting and stopping heart attacks before they occur, it could be an important advance in the battle against the world's leading killer. While doctors know plenty about what makes people susceptible to heart disease, they aren't very good at identifying in advance the one million Americans who suffer a heart attack each year.


如果事实证明该检测在心脏病发作前就能对其有效测定和预防，那么这将是对抗世界主要致死疾病的战役中的一个重要进步。尽管医生们对于导致人们易患心脏病的因素已经了解得很多，但他们并不能很好地事先确认每年哪100万美国人将发作心脏病。



But bringing Dr. Muller's idea to fruition has been an arduous journey. Technical hurdles plus evolving scientificdebate over whether detecting such 'vulnerable' plaques would make much difference have slowed progress and blunted investor interest.


但让穆勒博士的想法开花结果还有很艰难的路要走。技术障碍加上对检测这种"脆弱"斑块是否有用的科学争论令这项技术进展缓慢，也消磨了投资者的兴趣。



Dr. Muller says 14 years and $125 million have been put into the effort so far. Lately the news has been good, but it could still take several more years to determine whether the device has a role in heart-attack prevention across a broad population.


穆勒博士称，迄今为止他已在这项技术上投入14年的时间和1.25亿美元。最近的进展不错，但可能仍需数年才能确定该设备能否起到在广泛人群中预防心脏病发作的作用。



'It's been a very long road, much longer than I thought,' says Dr. Muller, whose eclectic career includes co-founding an organization of U.S. and Russian doctors called the International Physicians for the Prevention of Nuclear War, which won the Nobel Peace Prize in 1985.


穆勒博士说，"这是一条很长的路，比我想的要长得多。"他的副业包括共同创建了一家叫国际防止核战争医生组织（International Physicians for the Prevention of Nuclear War）的美国与俄罗斯医生组织，该组织曾获得1985年诺贝尔和平奖。



Defusing the Bomb


拆除炸弹



After a decade of research in which he revealed how factors such as anger, stress, physicalexertion and sexual activity serve as 'triggers' for heart attacks, Dr. Muller coined the term 'vulnerable atherosclerotic plaque' in a journal article in 1989. It describes certain fatty deposits harbored in coronary-artery walls that in response to such triggers and other forces are prone to rupture. When they do, they expose their 'lipid core' contents to the bloodstream, potentially provoking a clot that can cause a heart attack.


穆勒博士经过10年的研究，发现了愤怒、压力、体力消耗与性活动等因素如何"诱发"心脏病，并在1989年的一篇期刊论文中首先提出了"脆弱动脉粥样硬化斑块"的说法。它描述了在冠状动脉壁上沉积的某些易受这些诱因和其他因素激发而破裂的脂肪块。当它们破裂时，内部的"脂质核"将暴露在血液中，可能会形成诱发心脏病的血栓。



If such plaques could be identified and defused with treatment before they burst, many heart attacks could be prevented, Dr. Muller reasons.


穆勒博士推论，如果能识别出这种斑块，并在它们破裂之前通过治疗消灭它们，许多心脏病便可得以预防。



The idea has attracted other approaches, ranging from genetic testing to implantable devices that might detect an impending heart attack, though none have yet proved effective.


在这种想法的启发下，人们提出了其他方法，从基因检测到可能检测出即将发作的心脏病的可植入设备，但没有一种方法被证实有效。



The Infraredx device grew out of a conversation Dr. Muller had with a spectroscopy expert in the late 1990s, who told him it would be 'a piece of cake' to find lipid-core plaques with the technology. They launched the company in 1998 with an initialinvestment of $600,000. At first, 'every time we tried something it worked,' Dr. Muller recalls. In tests on diseased aortas obtained from autopsies, the deviceeffectively picked out plaques that were loaded with cholesterol versus more fibrotic deposits that were stable.


Infraredx的设备灵感来自于20世纪90年代末穆勒博士与一位光谱学专家的谈话，那位专家告诉他，用该技术找出脂质核斑块"易如反掌"。他们在1998年创建了这家公司，初始投资额为600,000美元。穆勒博士回忆道，起初，"我们的每次尝试都成功了。"在对尸体解剖获得的病变主动脉进行检测时，该设备有效找出了富含胆固醇的斑块，而不是稳定的纤维性沉积物。



But to analyze plaque, the device has to be deployed on the end of a catheter inserted into an artery in the groin and snaked into the coronary arteries. Making it small enough to travel inside blood vessels and fast enough to quickly get readings proved daunting. In 2003, after spending several million dollars more on the project, the company was within days of closing before a couple of investors rescued it.


但为了分析斑块，该设备必须被放置在导管末端，插入腹股沟的动脉，并伸入冠状动脉。事实证明，要让设备小到足以在血管内移动，并移动得足够快以迅速获得读数是很困难的。2003年，在该项目上又花费了数百万美元后，该公司几近破产，直到几位投资者施以援手。



Finally, in 2008, the Food and Drug Administration cleared the device for finding lipid-core plaques in the coronary arteries.


最终，2008年，美国食品和药品管理局（Food and Drug Administration）称该设备可以找出冠状动脉中的脂质核斑块。



Cardiologists and hospitals were unimpressed. 'They said, 'Yes, you can find these plaques, but so what?' ' Dr. Muller says. ' 'What's the clinical benefit of finding them?' It was an appropriate question, and we didn't have the data.'


心脏病学家和医院不为所动。穆勒博士说，"他们说：'是的，你能找到这些斑块，但那又怎么样？找到他们有什么临床意义？'这是个切中要害的问题，而我们没有相关数据。"



Prospects Brighten


前景光明



So the next critical task for the company is proving in clinical trials that plaques identified by the device are associated with heart-attack risk, and that 'treating' them reduces risk.


因此，该公司的下一个重要任务是在临床实验中证明该设备识别出的斑块与心脏病发作风险相关，且"治疗"它们可以降低发病风险。



Success isn't assured. Just last month, researchers led by Armin Arbab-Zadeh of Johns Hopkins University School of Medicine in Baltimore published a comprehensivereview of the biology of heart attacks in the journal Circulation, which said that vulnerable plaques often rupture without causing a heart attack and that a 'perfect storm' of other conditions is required before one occurs.


事情并非一帆风顺。就在上个月，巴尔的摩约翰•霍普金斯大学医学院（Johns Hopkins University School of Medicine）的阿明•阿巴卜-扎德（Armin Arbab-Zadeh）领导的研究人员在《循环》（Circulation）杂志上发表了一篇关于心脏病发作的全面生物学综述，该文称，脆弱斑块破裂时往往不会导致心脏病发作，而心脏病发作前，需要一场包含其他一些条件的"完美风暴"。



That complicates efforts to predict which patients are vulnerable to heart attacks, the researchers said, adding: 'Intervening exclusively on single, potentially vulnerable plaques is unlikely to reduce the incidence of acute coronary events.'


研究人员称，这让预测哪些病人易发作心脏病的努力更加复杂，他们还说，"只干预一种易破裂的斑块不太可能降低急性心脏病的发病率。"



Dr. Muller takes issue with some details in the report, and other research convinces him he is on the right track.


穆勒博士不同意该报告中的某些细节，其他研究让他相信，他走的是一条正确的路。



Even if the trials succeed, another concern is that because the device is threaded into the heart, it carries its own risk for complications as an invasive procedure. It isn't desirable to cause a heart attack in the name of trying to prevent one.


即使实验成功，也还有另一种担心，因为该设备将穿入心脏，所以鉴于侵入式治疗的复杂性其本身也有风险。出发点是要预防心脏病，结果却引发了心脏病，这可不是为人所乐见的。



To avoid that issue, Dr. Muller envisions the technology as part of a strategy in which people would first be identified as at risk through a genetic test and a noninvasive imaging test such as a CT scan before being referred for the spectroscopy analysis.


为了避免这个问题，穆勒博士将这项技术设想为以下策略的一部分：首先通过基因检测和CT扫描等非侵入式成像检测识别出有心脏病风险的人群，然后再对他们进行光谱分析。



Despite these challenges, the device's prospects have recently brightened, Dr. Muller says. Last year, researchers published a study suggesting the device could help prevent small heart attacks that occasionally occur in about 10% of procedures when stents are deployed to prop open diseased coronary arteries.


穆勒博士说，尽管有这些挑战，但该设备的前景最近变得更加光明。去年，研究人员发表的一项研究称，该设备有助于预防轻度心脏病发作，在扩张病变冠状动脉的支架植入手术中，这种情况的发生几率约为10%。



The study found that such heart attacks occurred in 50% of cases when the stent was implanted directly over a cholesterol-rich plaque, compared with 4% involving stable plaque.


该项研究发现，当支架直接植入高胆固醇斑块时，发生这种心脏病的机率为50%，而植入稳定斑块时，发生这种心脏病的机率仅有4%。



By knowing in advance if they were stenting a hot plaque, doctors could recommend other options such as bypass surgery or drug treatment, Dr. Muller says.


穆勒博士说，如果医生们在危险斑块上放置支架前预先了解这一信息，那么他们就可以推荐采取其他措施，例如心脏搭桥手术或药物治疗。



Some are skeptical. Kirk Garratt, cardiologist at Lenox Hill Hospital in New York, says heart attacks are too rare among stent patients to justify the added cost of a routine spectroscopy test.


有些人对此表示怀疑。纽约勒诺克斯山医院（Lenox Hill Hospital）的心脏病医生柯克•加勒特（Kirk Garratt）称，接受支架手术的病人中心脏病发作的病例非常少，无法证明增加常规光谱检测这项费用的合理性。



But Dr. Muller says interest in the idea is growing. Revenue in the first quarter broke all records, and the company is scrambling to meet demand from more than a half-dozen countries. 'The reason we built the company is not the reason we're being used,' he says. 'But we're getting traction.'


但穆勒博士说，人们对该想法的兴趣正在增加。该公司今年第一季度的收入打破了历史纪录，并正力争满足七、八个国家的需求。他说，"我们现在被顾客青睐的原因与我们当初创建这家公司的初衷并不相同。但我们正在得到人们的注意。"



He likens realizing the broader goal to climbing Mount Everest. 'We're currently at base camp,' he says.


他将实现更广阔的目标比作攀登珠穆朗玛峰。他说，"现在我们还在大本营。"



RON WINSLOW

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