The nation’s leading heart organizations released new guidelines on Tuesday that will fundamentally reshape the use of cholesterol-lowering statin medicines that are now prescribed for a quarter of Americans over 40. Patients on statins will no longer need to lower their cholesterol levels to specific numerical targets monitored by regular blood tests, as has been recommended for decades. Simply taking the right dose of a statin will be sufficient, the guidelines say.

周二，美国领先的心脏病治疗机构公布了新的治疗指南，这将会从根本上改变降低胆固醇的他汀药物的使用。现在，在40岁以上的美国人中，有四分之一正在服用这些处方药。过去几十年来，治疗指南向服用他汀药物的病人建议说，他们需要进行定期血液检查，以显示胆固醇指标降低到一定数值之内。但是这将不再是推荐的做法了。根据周二公布的治疗指南，病人仅仅服用正确剂量的他汀就已经足够了。

The new approach divides people needing treatment into two broad risk categories. Those at high risk because, for example, they have diabetes or have had a heart attack should take a statin except in rare cases. People with extremely high levels of the harmful cholesterol known as LDL — 190 or higher — should also be prescribed statins. In the past, people in these categories would also have been told to get their LDL down to 70, something no longer required.

新的治疗方法将需要治疗的人群分成了两大风险类型。比方说，对于那些患有糖尿病，或者曾经发生过心肌梗死的高风险人群，除了少数情况，都需要服用他汀。低密度脂蛋白(LDL)是一种非常危险的胆固醇。如果这项指标非常高，例如在190甚至以上的话，病人也需要服用他汀类药物。过去，医生一般会建议这类人群将他们的低密度脂蛋白控制到70，但是今后将不会这样做了。

Everyone else should be considered for a statin if their risk of a heart attack or stroke in the next 10 years is at least 7.5 percent. Doctors are advised to use a new risk calculator that factors in a person’s blood pressure, age and total cholesterol levels, among other things.

对于其他的所有人来说，只要在接下来的10年里，他们出现心肌梗死或者中风的可能性在7.5%以上，他们也应该考虑服用他汀。治疗指南建议医生采用全新的风险计算公式，综合考虑一个人的血压，年龄和整体的胆固醇水平，以及其他各项因素。

“Now one in four Americans over 40 will be saying, ‘Should I be taking this anymore?'” said Dr. Harlan M. Krumholz, a cardiologist and professor of medicine at Yale who was not on the guidelines committee.

哈兰·M·克鲁姆霍尔茨博士(Dr. Harlan M. Krumholz)是耶鲁大学(Yale)的医学教授和心脏病学家，他不是制定治疗指南的委员会成员。他说，“现在，那些年龄超过40岁的美国人中，四个人里就有一个会问，‘我现在究竟还需不需要继续服用这些药物？’”

The new guidelines, formulated by the American Heart Association and the American College of Cardiology and based on a four-year review of the evidence, simplify the current complex, five-step process for evaluating who needs to take statins. In a significant departure, the new method also counts strokes as well as heart attacks in its risk calculations, a step that will likely make some additional people candidates for the drugs.

美国心脏学会(American Heart Association)和美国心脏病学会(American College of Cardiology)根据一项历时四年对相关证据的考察所得出的结论，制定了这套新的治疗指南。这套治疗指南将简化现在复杂的治疗流程，即分为五步来评估病人究竟是否需要服用他汀。与现行方法大相径庭的是，新的方法在计算风险因素的时候，除了考虑病人是否曾发生心肌梗死之外，还要考察病人中风的风险，而这一步骤很有可能会要求更多病人开始服用他汀药物。

Zetia has been viewed with increasing skepticism in recent years since studies showed it lowered LDL cholesterol but did not reduce the risk of cardiovascular disease or death. Still, it is among Merck’s top-selling drugs, earning $2.6 billion last year. Another drug, Vytorin, which combines Zetia with a statin, brought in $1.8 billion in 2012, according to company filings. And in May, Merck won approval for another drug, Liptrzeut, which also contains the active ingredient in Zetia and a statin, a development that surprised many cardiologists because of questions about its effectiveness.

近年来，很多人对艾泽庭(Zetia)越来越怀疑，因为研究显示，这种药物虽然能够降低低密度脂蛋白类的胆固醇，但是却不能降低心血管疾病或者死亡的风险。但是，这是默克公司(Merck)卖得最好的药物之一，去年取得26亿美元（约合158亿元人民币）的销售额。维多灵(Vytorin)是将艾泽庭和他汀混合后制成的药物，根据公司提交的材料，2012年的销售额达到18亿美元。今年5月，默克公司的另一种药物Liptrzeut也获得了批准。这种药物混合了艾泽庭和另一种他汀的主要成分，这一新发展让很多心脏病学家都感到惊讶，因为对于这种药物的疗效，人们还存在质疑。

The new guidelines are part of a package of recommendations to reduce the risk of heart attack and stroke that includes moderate exercise and a healthy diet. But its advice on cholesterol is the flash point, arousing the ire of critics who say the authors ignored evidence that did not come from gold-standard clinical trials and should also have counted less rigorous, but compelling, data.

这次的新治疗指南是一整套建议的一部分。为了控制心肌梗死和中风的风险，病人还需要进行适度运动，并且采用健康的饮食。但是治疗指南中对于胆固醇的建议则引发了争议，外界均感到愤怒，表示治疗指南的作者忽视了很多证据；虽然这些证据并不是从最标准的临床试验中获得的，但是确实也应该考虑这些不太严谨，但是却很说明问题的数据。

For example, Dr. Daniel J. Rader, the director of the preventive cardiovascular medicine and lipid clinic at the University of Pennsylvania, points to studies of people with genes giving them low LDL levels over a lifetime. Their heart attack rate is greatly reduced, he said, suggesting the benefits of long-term cholesterol reduction.

比如，丹尼尔·J·雷德(Daniel J. Rader)博士就指出，有些实验的研究对象的基因让他们在一生中的低密度脂蛋白水平都比较低。雷德博士是宾夕法尼亚大学(University of Pennsylvania)心血管疾病预防药物和脂质诊所的主任，他表示，这些人出现心肌梗死的概率相当低，表明长期来说降低胆固醇水平确有好处。

Committee members counter his view, saying that cholesterol lowered by drugs may not have the same effect.

委员会成员对他的观点提出了反驳，表示通过药物降低胆固醇水平并不会获得同样的效果。

Critics also question the use of a 10-year risk of heart attack or stroke as the measure for determining who should be treated. Many people will have a lower risk simply because they are younger, yet could benefit from taking statins for decades to keep their cholesterol levels low, they say.

批评人士同时质疑，究竟应不应该使用10年内出现心肌梗死或中风的风险这一指标，来评估病人究竟应不应该接受治疗。他们认为，很多人之所以风险较低，只不过因为他们比较年轻；但是通过坚持几十年服用他汀药物，能够将他们的胆固醇指标控制在较低水平。

He and other experts also worry that without the goad of target numbers, patients and their doctors will lose motivation to control cholesterol levels.

包括雷德博士在内的其他专家同时担忧地表示，如果没有明确目标数据的激励，病人和他们的医生就不再有动力去控制胆固醇水平。

Experts say it is still unclear how much the new guidelines will change clinical practice. Dr. Rader suspects many cardiologists will still strive for the old LDL targets, at least for patients with heart disease who are at high risk. “They are used to it and believe in it,” he said.

专家说，目前还不清楚这份新的治疗指南会在多大程度上改变现有的临床实践。雷德博士怀疑说，很多心脏病学家还是会把注意力放在原来的低密度脂蛋白指标上，至少对于那些有心脏病，而且风险很高的病人来说会是这样的。他说，“病人们已经习惯了，而且很相信这些。”

Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, said he thought it would take several years for doctors to change their practices.

史蒂文·E·尼森(Steven E. Nissen)博士是克利夫兰诊所(Cleveland Clinic)的心脏病学家，他认为要让医生改变现在的治疗模式，要花上几年的时间。

The process of developing the new guidelines was rocky, taking at least twice as long as previous efforts. The National Heart, Lung and Blood Institute dropped out, declaring that drafting the guidelines was no longer part of its mission. Several committee members, including Dr. Rader, also dropped out, unhappy with the direction the committee was going.

制定这份新的治疗指南的进程并不顺利，花费的时间是之前工作的两倍以上。美国国家心脏、肺和血液研究所(National Heart, Lung and Blood Institute)中途退出，声称制定这份治疗指南不再是该机构的任务之一。包括雷德博士在内的数名委员会成员也中途退出，他们对委员会前进的方向不满意。

The architects of the guidelines say their recommendations are based on the best available evidence. Large clinical trials have consistently shown that statins reduce the risk of heart attacks and strokes, but the committee concluded that there is no evidence that hitting specific cholesterol targets makes a difference. No one has ever asked in a rigorous study if a person’s risk is lower with an LDL of 70 than 90 or 100, for example.

而治疗指南的制定者则表示，他们提出的建议是基于能够获得的最好的证据。大型临床试验不断表明，他汀药物能够降低心肌梗死和中风的风险；但是委员会则得出结论，认为没有证据证明，达到特定的胆固醇指标能够起到任何效果。比方说，如果一个人的低密度脂蛋白指标为70，而不是90或者100的话，并没有严格的实验证明他的风险会更低一些。

Dr. Neil J. Stone, the chairman of the committee and a professor of preventive cardiology at Northwestern University’s Feinberg School of Medicine, said he was surprised by what the group discovered as it delved into the evidence. “We deliberated for several years,” he said, “and could not come up with solid evidence for targets.”

尼尔·J·斯通(Neil J. Stone)博士是该委员会的主席，也是西北大学(Northwestern University)芬堡医学院(Feinberg School of Medicine)心脏病预防学的教授。他表示，经过对证据的深入分析，他对于委员会的发现表示非常惊讶。他说，“我们讨论了好几年，但是还是没有办法对于设定具体指标拿出坚实的证据。”

Dr. Nissen, who was not a member of the committee, agreed. “The science was never th

ere” for the LDL targets, he said. Past committees “made them up out of thin air,” he added.

尼森博士不是委员会的成员之一，但是他对此也表示同意。他说，设定低密度脂蛋白指标，“从来都没有科学根据”。他还表示，过去的委员会“无端编造出来了这些指标”。

Dr. Paul M. Ridker, the director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital, in Boston, said he worried the new guidelines could easily lead to overtreatment. An older man with a low LDL level who smokes and has moderately elevated blood pressure would qualify for a statin under the new guidelines. But what he really needs is to stop smoking and get his blood pressure under control.

保罗·M·里德克(Paul M. Ridker)是位于波士顿的布莱根妇女医院(Brigham and Women’s Hospital)心血管疾病预防中心主任，他表示，他担心新的治疗指南很容易导致过度治疗。一个低密度脂蛋白指标比较低的老年男性，如果经常抽烟同时血压稍微升高，根据新的治疗指南，就应该服用他汀药物。但是他真正需要的，是停止抽烟，并且控制他的血压。

Dr. Stone said he hoped doctors would not reflexively prescribe a statin to such a patient. Doctors are supposed to talk to their patients and realize that, with a man like the one Dr. Ridker described, the real problem was not cholesterol.

斯通博士表示，他希望医生不会直接给这样一个病人开他汀药物。医生应该跟病人沟通，并且意识到，如果遇到了一位像里德克博士描述的病人，真正的问题并不是胆固醇。

“We are taking people out of their comfort zone,” Dr. Stone said. “Instead of being reassured that reaching this number means they will be fine, we are asking, ‘What is the best therapy to do the job?'”

斯通博士说，“我们正在把人们带离他们的舒适区。现在我们不再向病人保证说，只要达到了这些指标就意味着不会有问题。医生们现在开始问，‘要想控制风险，哪种治疗方式最好？’”