这个问题有点难以回答,因为本届年会涉及了从基础科学到临床科学的多方面内容。今年最明确的一个亮点就是新指南的发布。在发布现场及网络上分别有3000人及2000观众见证了指南发布的神圣时刻。我认为新指南将为致力于及活跃在高血压领域的人们提供其感兴趣的内容。
Giuseppe Mancia ESH大会主席 意大利米兰大学医学院教授
<International Circulation>: As Chairman of the 2013 Annual ESH Scientific Meeting, what do you think are the highlights for this year’s conference?
Dr. Mancia: It is always difficult to reply to this question because there are so many things from basic science through to clinical science. I can say however, that this year clearly the highlight has been the presentation of the new guidelines. There were almost 3000 people in the room and in addition there were 2000 viewers on the internet watching the presentation of the guidelines. I think this really demonstrates the great interest in these new guidelines for those working with and active in the field of hypertension.
《国际循环》:作为2013年ESH科学年会的主席,您认为本届年会有哪些亮点?
Mancia博士:这个问题有点难以回答,因为本届年会涉及了从基础科学到临床科学的多方面内容。今年最明确的一个亮点就是新指南的发布。在发布现场及网络上分别有3000人及2000观众见证了指南发布的神圣时刻。我认为新指南将为致力于及活跃在高血压领域的人们提供其感兴趣的内容。
<International Circulation>: As a co-chair of those new ESH Guidelines, could you provide a brief summary of some of the more important aspects that have been released this year?
Dr. Mancia: There are many interesting new aspects or refinements of old aspects. There are also interesting confirmations because confirmation is not less important than novelties as it indicates that the previous evidence is standing the test of time. If I can mention a few novel elements: There is a slightly more conservative attitude on drug treatment in some conditions. For example, in grade 1 hypertension in low risk patients, what has been said is that before using drugs, one should explore completely the ability of lifestyle changes to reduce blood pressure. This is due to the fact that the available evidence is there, but some of the patients recruited in trials were not really at low risk. Then there is a unified concept on target blood pressure. The recommendation to lower blood pressure aggressively in high-risk individuals disappears and now the recommendation is to lower systolic blood pressure below 140mmHg in almost everybody and again being a bit more conservative in the elderly. No recommendation to use drug treatment in high-normal blood pressure individuals. Confirmation that because the large proportion of the benefit associated with antihypertensive treatment is due to blood pressure lowering per se, several drug classes with documented evidence of protection can be used including beta-blockers. The remark here is that drugs should probably not be ranked anymore in order of choice but a greater effort should be made to have physicians give the proper drug in the proper clinical circumstances. In this perspective, beta-blockers are clearly not indicated in some conditions such as in patients prone to developing diabetes, but they are certainly a first-choice drug in other conditions. This is the case for every drug class. Strong support for combination treatment. And also confirmation that in high-risk individuals, combination treatment might be considered as the initial first-line therapy, with the report of new evidence supporting this decision. Then there is a very detailed recommendation on nineteen different clinical conditions from white coat hypertension to masked hypertension to resistant hypertension, post-stroke, post-myocardial infarction, in pregnancy and so forth.
《国际循环》:作为ESH新指南的联合主席,您能否简要介绍一下今年发布的新指南中的重要内容?
Mancia博士:与旧指南相比,新指南有很多有趣的更新及确认,这些确认提示既往证据经得起时间的考验,与更新同等重要。我可以提到以下更新:在某些情况下略微保守的药物治疗态度。例如,对1级高血压低危患者而言,推荐在启用药物治疗前应先进行生活方式干预来降低血压。这主要是因为存在大量相关证据提示应该这样做,但是有些试验中所招募的患者其实并不是低危患者。另外,新旧指南所推荐的降压目标值也有所不同。新指南取消了对高危患者积极进行降压治疗的推荐,将几乎所有患者的收缩压降压目标值改为<140 mmHg,在老年人中其降压目标值更为保守。对处于正常血压高值的患者,新指南不推荐行药物治疗。同时新指南,进一步确认降压治疗的获益主要归因于降压本身,包括β受体阻滞剂在内的几大类有充分的保护效应证据的药物均可选用。此处需要说明的是,这些降压药物并无推荐的先后顺序,应用时需要由临床医生结合患者的临床情况选择合适的药物。从这个角度来说,很显然,虽然β受体阻滞剂不适用于某些患者(如糖尿病高危患者),但却肯定是其他情况下某些患者的一线药物。同样,其他类药物的情况也是如此。还有就是新指南强力支持联合治疗。鉴于有新证据的支持,确认在高危患者中,可考虑将联合治疗作为初始一线治疗。同时,新指南还对白大衣高血压、隐匿性高血压、顽固性高血压、卒中后高血压、心肌梗死后高血压、妊娠高血压等19种特殊临床情况下的高血压进行了非常详细的推荐。
<International Circulation>: Updates to the recommendations are often based on clinical evidence. What would you say are some of the major clinical data that have led to the new guidelines?
Dr.Mancia: All major clinical studies with an appropriate design are considered. We look also at the quality of the evidence because I don’t think trials and studies should only be judged on their design. Design is important but we have studies that have significantly advanced knowledge within an imperfect design. But on the contrary, we have studies that have the perfect design but poor quality of data collection and they mean very little. So I think assessment of the contribution of individual studies is not an easy thing to do and has to be done by scientists and not by so-called experts in evidence who never really did a study of their own. This was something that was discussed in the taskforce and something which could help future guidelines to continue to be adherent to clinical needs.
《国际循环》:推荐的更新常常是基于临床证据而提出的。促使新指南出台的主要临床数据有哪些?
Mancia博士:所有设计良好的主要临床研究都是其数据来源。同时我们还考虑了证据的质量,因为我认为并不能单以其设计来判断研究对临床实践的指导意义。虽然试验的设计非常重要,但也有一些研究虽然设计并不完善,却仍能为我们提供先进的知识,具有重要意义。与之相反,有些研究虽然设计非常完美,但其数据收集的质量较差,临床意义非常小。我们评估单项临床试验对临床实践的指导价值和意义并不是一件容易的事,应该由科学家而不是从未进行过任何临床研究的所谓专家来进行。这就是指南撰写专家小组的一部分工作,也是确保未来指南能够更好地满足临床需要的重要法宝。
<International Circulation>: As our readers are based in China, are there any examples of good study designs that you think are useful for Chinese researchers to follow?
Dr.Mancia: Study design is important but randomized clinical studies cannot be done with all clinical conditions. There are some clinical conditions in which you cannot conduct a randomized controlled design. Also randomized studies have limitations. For example, randomized controlled studies only last for four, five or six years and we apply the data to a life expectancy which in many cases is thirty years. Extrapolation and interpretation of the evidence is always needed. When we say that guidelines are based on evidence, we can’t say that anything is 100% proven because transferring information from trials to real life needs interpretation and extrapolation.
《国际循环》:因为我们媒体的受众都在中国,您认为有哪些好的研究设计值得中国研究者学习和借鉴?
Mancia博士:虽然研究设计很重要,但并不是所有临床情况都能进行随机临时试验。有些临床情况下,我们无法进行随机对照设计和研究。同时,随机临床试验也有其局限性。例如,一般随机临床试验的持续时间为4年、5年或6年,而我们患者的预期寿命却通常为30年。另外,通常需要对证据进行推断及解释。当我们说指南是以循证为依据时,并不是说其已经被100%地证实,因为将来源于试验的信息转化到实际临床实践需要进一步的解释与推断。
<International Circulation>: The new guidelines have been published to improve and guide clinical practice. What impact do you think the new guidelines will have on daily clinical practice?
Dr.Mancia: This is always a difficult problem because sometimes in the short-term you have the feeling that guidelines don’t matter too much. But if you look over the long-term, then I think guidelines help improve clinical practice both on the side of the diagnosis of hypertension and on the side of treatment. For example, some procedures like out-of-office blood pressure measurements are widely used now compared to ten or twenty years ago. This is a result of how this was reported in the guidelines.
《国际循环》:新指南的发布有助于改善和治疗临床实践。您认为新指南对日常临床实践将产生哪些影响?
Mancia博士:这是一个棘手的问题,因为有时在短期内你会感觉指南的作用并不太大。但长期来看的话,我认为指南还是有助于提高临床实践中高血压的诊断与治疗的。例如,与10或20年前相比,诊室外血压的测量等推荐已经得到了广泛地应用。这都是指南的功劳。
<International Circulation>: Are there any recommendations for a single pill combination in the new hypertension guidelines and for what conditions do these apply?
Dr.Mancia: There is a favorable attitude because as in the past, single pill combinations have been looked at as having the advantage of simplifying treatment and treatment simplification definitely leads to greater adherence to treatment. Improving adherence to treatment is of paramount importance because adherence to treatment is extremely low in hypertension; and not only in hypertension, but any kind of preventative cardiology. People taking statins stop treatment very often also. Even people on anti-diabetic drugs stop their medication. In turn, low adherence to treatment is associated with a greater incidence of cardiovascular events. So working on improvements in adherence to treatment is important and in this perspective, single pill combinations are seen favorably by the new guidelines, as was the case in the old ones.
《国际循环》:新指南中有哪些有关单片复方制剂的推荐?在哪些情况下应推荐应用单片复方制剂?
Mancia博士:新指南对单片复方制剂持支持态度,因为单片复方制剂被认为有简化治疗的优势,而简化治疗能有助于提高患者治疗依从性。提高治疗依从性具有非常重要的意义,因为高血压治疗中的治疗依从性是极低的。当然不仅仅是高血压,心脏病等其他疾病预防的治疗依从性也极低。应用他汀治疗的患者经常终止治疗,甚至接受降糖药物治疗的患者也会停药。治疗依从性较低会增加心血管事件的发病率,因此积极提高治疗依从性具有重要意义。从这个角度上来说,与既往指南一样,新指南推荐应用单片复方制剂。