乔治临床( George Clinical )为世界上最常见的呼吸道疾病(包括哮喘和慢性阻塞性肺疾病(COPD))提供了广泛的临床研究服务(包括全球科学领导力)。
乔治临床( George Clinical )为世界上最常见的呼吸道疾病(包括哮喘和慢性阻塞性肺疾病(COPD))提供了广泛的临床研究服务(包括全球科学领导力)。
在亚太地区,哮喘和COPD尤为相关,原因是吸烟、生物质燃料、污染和结核病(TB)等风险因素高于其他地区。大多数哮喘相关死亡在低收入至中等收入国家仍在发生。COPD目前是第四大导致死亡的主要原因,预计截至2030年,将成为第三大主要原因。
COPD患者也受到合并症(如心脏病和糖尿病)的严重影响,而心脏病和糖尿病正是乔治临床( George Clinical )的主要专业领域。
我们在呼吸健康方面的服务包括:
我们在呼吸健康方面的服务包括:
Jenkins博士的研究方向是呼吸道疾病的临床管理,以及治疗性干预的患者报告结局(patient reported outcomes)。她是乔治全球健康研究院呼吸小组的负责人、悉尼Concord医院胸内科资深在职专家、悉尼大学临床教授兼呼吸学科负责人,以及新南威尔士大学(悉尼)呼吸内科教授。此外,她还担任“全国哮喘运动”和联邦政府的全国哮喘咨询组主席。
Jenkins博士担任过主要研究者并领导了许多由研究者发起的、竞争性资助的呼吸道疾病临床试验。作为一名活跃的临床医生,她积极倡导并领导澳大利亚的肺健康活动,主持过许多地方和国际指南的制定和实施倡议,以改善呼吸道疾病的资源、技能、能力和临床结果。她是澳大利亚肺脏基金会的理事会成员,也是澳大利亚和新西兰胸科学会、美国胸科学会、欧洲呼吸学会和亚太呼吸病学会的会员。
实际上,所有哮喘患者中只有一小部分有重症哮喘。看一下西方,西方对哮喘患病率的理解清晰、衡量准确,重症哮喘患者很可能仅占所有哮喘患者的5%。重要的一点是,我们以前对重症哮喘的定义是如你曾有过严重的哮喘发作,最终住院了,或者甚至不得不接受诸如重症监护或呼吸机之类的干预类的治疗,就是重症哮喘。现在我们知道,许多可能出现过类似症状的人根本没有重症哮喘,他们只是未服用自己的哮喘药物。因此,现在我们将重症哮喘定义为尽管在接受最佳药物治疗包括遵医嘱和开药两方面,但是哮喘症状和肺功能异常依然持续的病症。当你确定患者按医嘱服药,正在使用现有的最佳药物,也在追求健康的生活方式,但仍然有症状、肺功能异常和加重的情况时,他们就是患有重症哮喘。
任何年龄阶段的人都可能患重症哮喘,从五、六岁到96岁不等。任何人都可能患重症哮喘。重症哮喘的一些特征往往意味着它更能影响青年到中年人。自童年起就患有哮喘、症状一直伴随的人更容易患重症哮喘,而那些只在年幼时有过轻微或轻度哮喘的人很少会患重症哮喘,但是长大后病情突然加重并不是常见的发作形式。更常见的是在童年或青春期时出现哮喘,如影相随,也就是说这些人一直都有症状。他们的治疗从未在阻止病情加重方面完全控制住哮喘的发作,因此他们从未在长时间内无症状,而有很多治疗良好的患者只要吃药,就可以做到很长时间无症状。
严重哮喘急性发作的人或是突发呼吸极度困难,甚至无法呼吸。他们经常描述自己喘息,无法用吸入器缓解,尤其是缓解药物无效。在这种情况下,他们病情迅速加重,呼吸更加困难,发作的诱因可能很多,常见的如病毒性呼吸道感染。另一方面,突然暴露在他们可能过敏的东西里,如猫狗,或是对霉菌或房屋灰尘反应强烈,对身体负担够大的话,就可能导致哮喘发作。但对某些人来说,哮喘发作就是个演变过程,永远找不到完整答案。你总也说不清触发的原因,但他们的哮喘就是控制不住。症状大量增多、呼吸非常困难、咳嗽、喘息、平常做的事情做不大了、缓解药物无法缓解。这种情况发生时,他们需要更多消炎药,需要口服以及吸入药物,而且他们很可能要经常住院,偶尔需要进重症监护病房和使用辅助呼吸。因此,严重的发作可能危及生命。
在亚洲,重症哮喘患病率的记录真的不够完整。 有些国家已经尝试开展哮喘流行病学研究。但亚洲的哮喘患病率的确低于许多盎格鲁—撒克逊人血统的西方国家。 比如在澳大利亚,哮喘的成年人患病率约为12%,儿童约为18-20%。 在亚洲,患病率约为这个比率的一半,我之前提到过,只有小部分哮喘病患者有重症哮喘。 因此,我们只能假设,在亚洲,哮喘患者大约占总人口的10%,重症哮喘的患病率可能仅为0.5-1%, 然而在澳大利亚、新西兰、英国、加拿大和欧洲的某些地区,哮喘和重症哮喘的患病率是要高得多。我们的澳大利亚和新西兰地区实际上也确实有很多哮喘病患者。正是由于这个原因,许多领先的临床研究论文都来自于澳大利亚和新西兰。
我们不知道为什么在澳大利亚和新西兰这样的国家,或者是在英国和加拿大,有更多的哮喘病,显然是因为我们对流行病的记录更好一些,所以亚洲很可能存在一些漏报、漏诊,因为医疗服务的普及不如世界上其他许多地区,另一方面,即使你的确在亚洲进行了严格的流行病学研究,哮喘的患病率似乎也明显低于澳大利亚、新西兰和英国等国家的水平。因此,也许我们盎格鲁-撒克逊人的遗传的确非常重要。我们大多数人肯定都坚信哮喘是基因和环境造成的,两者缺一不可。尽管我们的环境相对干净,但充满过敏原。真菌、螨虫、霉菌和花粉都喜欢我们这样气候温和的环境。暴露在这类东西中是引发哮喘炎症的原因之一。所以说,原因包罗万象,但我们确实看到亚洲的患病率低于澳大利亚和新西兰。
就哮喘临床试验、临床知识、专业知识和哮喘有关的强效方法而言,澳大利亚是个出类拔萃的国家。早在大约2000年,澳大利亚就将哮喘列为国家卫生要务。我们在初级保健中科普做得很好,因此,初级保健医生们都十分清楚哮喘这个问题。尽管我们为下诊断所做的肺功能检测还远远不够,但哮喘的临床护理不错。除护理之外,我们的学术十分优秀,拥有呼吸系统疾病、哮喘和慢性阻塞性肺病(COPD)方面的学术研究人员。他们是国际带头人,进行过真正的创新型、独立的研究者研究,还参加过许多大型的全国性和全球性的随机对照试验。因此,我们经验丰富、专业知识强,有愿意参与试验的患者,可以用可靠的数据进行出色的研究。亚洲的重要性在于它尚未被开发,是一个机遇,其人口中有相当比例的哮喘患者尚未得到良好的药物治疗和高质量的护理。因此,在那里进行临床试验是一个真正的机遇。我们George公司在亚洲设有办事处,能够很好地进行这些试验并达到极高的专业标准。凭借George公司的科研人员、临床医生以及临床运营能力的独特组合,我们在哮喘和COPD研究中可以有力地交付试验。
我认为,重症哮喘患者的前途一片光明,尽管这要真正取决于他们的患病时长。如你一直都患有重症哮喘,现在已经六七十岁,那你多半已丧失了很多肺功能,到目前为止,我们还没有任何可以扭转肺功能的药物。我们现在的确有可以显著减轻症状和减少造成住院或额外大量用药的加重发作的药物。因此,我认为与之前相比,未来更加光明了,但最光明的还是重症哮喘的年轻患者的未来。因为可以用治疗更早地干预疾病,预防久治不愈时丧失肺功能。如你尽管使用了最佳的吸入药物,仍无法很好地控制哮喘,那你会逐渐丧失肺功能。因此,年长后获良好治疗的疗效远不及年幼接收治疗。这就是现在为重症哮喘患者创造光明希望的治疗方法。
I’m professor Christine Jenkins, I’m head of the respiratory group at the George Institute for global health and I particularly run clinical trials here as a scientific leader. I am also a respiratory physician, I’m also head of the respiratory discipline at the university of Sydney and I chair the lung foundation of Australia.
COPD is a disease that most people know as chronic bronchitis and emphysema, that’s the layperson’s term and what that describes are two things that happen to people with COPD. Their air passages become inflamed and they produce mucus and they develop cough and phlegm as a result of that. But also they lose lung tissue – that’s the emphysema part of it and the sacs that exchange oxygen become destroyed and that causes people to become very breathless.
COPD can affect anybody, usually from their middle adult years, from sometime in their forties where their symptoms might be very mild, but it progressively worsens over time and it affects men and women depending on their particular exposures. Many women are not smokers, they develop COPD from biomass fuel exposure and dusty jobs or smoke exposure and men often, who are cigarette smokers develop COPD.
COPD has a big impact not only for the patient but for their families, supporters and carers. The reason for that is that it causes progressive inability to do everyday tasks. People’s activities of daily living are significantly affected. But the other way they’re affected is that it’s really devastating to see somebody who is breathless and breathlessness at rest especially, which cannot be truly relieved; it’s very distressing to watch as well as to experience.
COPD is a very prevalent disease. The WHO predicts that by 2030, COPD will globally be the third leading cause of death behind cardiovascular and cerebrovascular disease. So COPD is growing in prevalence because of the very wide spread exposure particularly to tobacco but still in many countries, to dusty jobs, biomass fuel exposure and significant irritancy that contributes such as air pollution. Air pollution is still a major problem especially in many parts of Asia and along with the other exposures it is contributing to the increase of prevalence in COPD.
Asia is a really important region for running clinical trials in COPD. The main reason is that there is a big burden of disease and that disease is currently not optimally managed. Many Asian countries have guidelines for COPD management but one of the big challenges is access to good quality education, self-management, primary care and medications.
There are real challenges in COPD trials that actually are not specific issues in many other studies; for instance, my experience of asthma trials, some of these problems never arise. One of the big problems for instance for COPD trials is that patients are usually unwell. Simply getting the patients to come back, be able to be at their clinic visits, be able to do all the producers you want them to do, whether it’s to exercise them, whether it’s to measure their lung capacity, whether it’s to fill out their diary cards consistently. Even using electronic diary cards because of the generation of patients, we need to take more time to teach them how to use these really important and valuable ways to measure their disease. Other issues are the fact that because the patients are very symptomatic they often don’t feel the drugs are making a lot of difference. We can measure the difference and particularly in large groups of patients, we can measure exacerbation rates are changing; that’s a key outcome for clinical trials. But in an individual it’s really hard to measure that, so the patients themselves may not know for the sure the drug is affecting them and are often tempted if they have an exacerbation to say ‘oh well it’s not working and I want to pull out’. So it’s really important you’ve got to really encourage the patients to stay in the trial and help them understand why they’re participation is valuable.
I think the future is bright for COPD sufferers; although, many would say it’s been very bleak until recently, and there is some truth in that. We, for instance, had difficulty demonstrating that our key medications can change life expectancy. We’ve shown they change the course of the disease, they reduce the episodes of exacerbations that cause hospital admissions and they can improve quality of life, greatly. But actually impacting on longevity is still a massive challenge for COPD interventions. The other big, bright side of this is that there have been a lot of new COPD medications in the last five years. There are new members of each class and there are medications that last for longer and have fewer side effects. So I think the future is really bright and there are other things in the pipeline that are quite exciting but we’ve still got to test them and we’ve got to see for whom they’re best and it’s a rapidly evolving space.
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