原文如下：

New Axial Spondyloarthritis Criteria Poised to Broaden, Hasten Diagnosis

A worldwide team of spondyloarthritis experts published a new set of criteria for classifying the axial form of the disease, an action expected to dramatically expand the number of patients identified with axial spondyloarthritis and enable physicians to flag affected patients sooner and start them on treatment.

A major hope is that earlier treatment, either with nonsteroidal anti-inflammatory drugs (NSAIDs) or tumor necrosis factor (TNF) inhibitors, will help patients by slowing progression of axial spondyloarthritis (SpA). But this anticipated benefit has yet to be supported by study results.

The landmark step in formalizing the early identification of axial SpA was taken by a primarily Eurocentric organization, the Assessment of Spondyloarthritis International Society (ASAS). With the new ASAS classification criteria now published (Ann. Rheum. Dis. 2009;68:770-6; 778-83), it remains unclear whether most U.S. rheumatologists and primary care physicians will buy into the criteria and apply them.

The report, published in June, showed that the new classification criteria (see below) identified people with axial SpA with a sensitivity of 83% and a specificity of 84% when tested on 649 patients. The new classification criteria were compared against identification by expert rheumatologists.

If implemented, the new criteria would “increase the frequency of diagnosing [axial SpA] by probably threefold, to as high as 1.5%” of the adult U.S. population,” said Dr. John D. Reveille, professor of medicine and director of the division of rheumatology and clinical immunogenetics at the University of Texas at Houston. He based his estimate on the application of the new axial SpA criteria to a representative sample of the U.S. population collected in the National Health and Nutrition Examination Survey (NHANES).

“The new criteria will be helpful in identifying more patients with the disease, and also for recognizing the disease very early,” agreed Dr. Muhammad A. Khan, professor of medicine at Case Western Reserve University in Cleveland. “The new criteria are much better than older criteria, which require x-ray evidence of abnormalities in the sacroiliac joints. With the new criteria, you can make the diagnosis [even] when the x-ray is normal, provided you have MRI evidence,” he said in an interview. Dr. Khan was the sole U.S.-based member of ASAS to serve on the expert panel that devised the new classification criteria.

Axial SpA has typically gone undetected until much later in the course of the disease, when it has progressed to ankylosing spondylitis with its characteristic spinal-bone changes that are visible on plain x-ray films.

“The old classification criteria required patients to have x-ray changes of sacroiliitis, which take 6-10 years to develop after patients have other symptoms,” said Dr. Atul Deodhar, medical director of the rheumatology clinics at the Oregon Health and Science University in Portland. “We definitely need new criteria; we can’t call it ankylosing spondylitis if the patient doesn’t have x-ray changes. The diagnosis of axial spondyloarthritis is completely new,” he said in an interview. “We think that some – but not all – patients with axial spondyloarthritis will progress to ankylosing spondylitis.”

Identification of inflammation in axial joints using MRI is a key element in the new axial SpA classification. Axial joint inflammation is often hard to diagnose without MRI because the affected joints are in locations that are impossible to palpate, Dr. Deodhar said.

Early diagnosis that is made possible, at least in part, by MRI evidence of inflammation is vital for timely treatment. Without it, physicians wait to see x-ray evidence of ankylosing spondylitis. A wait of up to 10 years “is a long period of time to deny patients access to medications that have been shown to work in this disease,” Dr. Reveille said.

“We think that if we intervene sooner, we can prevent some of the significant morbidity and disability associated with this condition,” said Dr. John A. Flynn, professor of medicine at Johns Hopkins University in Baltimore. Some rheumatologists “have been doing this [using MRI to help make an early diagnosis of axial SpA] for 5-10 years,” added Dr. Flynn. “Now clinical science is catching up with that experience, saying we realize that the time from symptom onset to diagnosis has been very long” when the diagnosis relies on x-ray changes. “If the [patient’s clinical presentation] sounds good for the condition but the x-rays don’t show anything, we should push to get the MRI.”

But Dr. Flynn and Dr. Deodhar stressed that the appearance of axial joint inflammation on MRI is not enough to make the diagnosis, as this can occur in people without axial SpA. Other key factors include age younger than 45 years, slow onset of symptoms, reduced spine mobility, stiffness and pain that worsens with rest but improves with exercise (unlike mechanical back pain that improves with rest and worsens with exercise), and exacerbation of pain and stiffness while sleeping that takes several hours to improve on awakening.

“I’m not getting an MRI on the majority of my patients [with back pain] because the back pain that I see is usually not inflammatory; it’s mechanical,” said Dr. Flynn.

U.S. experts share concern about how widely the criteria will be applied by other U.S. rheumatologists and, perhaps more importantly, by U.S. primary care physicians who see the bulk of these patients initially.

“There clearly is a difference of opinion [in the United States and in Europe],” said Dr. Flynn. “I was amazed when I looked at the centers” that participated in the ASAS study that validated the new axial SpA criteria. “None were in the United States.” The validation study used patients from 25 centers in 16 countries, with 14 of the centers in Europe, 5 in Asia, 4 in Turkey, 1 in Canada, and 1 in Columbia (Ann. Rheum. Dis. 2009;68:777-83).

One possible reason why European rheumatologists have been more active in developing the new criteria is that their population contains a higher proportion of people with the HLA B27 genotype, who are most susceptible to developing axial SpA. “The question is, Are the Europeans not only seeing more, but do they see different patients?” Dr. Flynn noted. “I think you’ve got to validate [the new criteria] with U.S. patients too.”

“American rheumatologists are still not as well versed in spondyloarthritis as our European colleagues,” Dr. Khan said. But if the new classification criteria were followed, it would result in better patient care, Dr. Reveille said.

Treatment today for axial SpA starts with an NSAID, followed by a course with a second NSAID of a different type if the first fails. If both NSAID regimens fail to produce satisfactory results within 3 months, current standards say the next step is treatment with a TNF inhibitor. In the United States, those include adalimumab, etanercept, infliximab, and golimumab. Although none has U.S. Food and Drug Administration approval for use in axial SpA, all four are approved for treating ankylosing spondylitis.

Ideal treatments for axial SpA don’t include nonbiological disease-modifying drugs, such as methotrexate and sulfasalazine.

No study results have yet documented that early treatment with an NSAID or with a TNF inhibitor slows or stops progression of axial SpA, but specialists are optimistic that such is the case, and that these data will eventually exist. “We suspect early treatment might have better outcomes; there is the precedent with rheumatoid arthritis,” Dr. Khan said. In addition, even without evidence of slowed progression, early treatment “clearly improves quality of life and function and reduces time lost from work,” Dr. Flynn said.

The importance of early identification and treatment of spondylitis has been recognized by the leadership of the Spondylitis Association of America (SAA). Researchers working with SAA sponsorship developed a screening tool aimed at helping people with chronic back pain self-identify whether they have indications of an inflammatory process that needs medical evaluation. A report on the development of the SAA screening tool for ankylosing spondylitis is scheduled to appear in the January issue of Arthritis Care and Research, and then the SAA will publicize it as an Internet-based tool, said SAA executive director Laurie Savage.

New Classification Criteria for AS

Patients with back pain for at least 3 months and with an age of onset younger than 45 years are classified as having spondyloarthritis if they have sacroiliitis on imaging plus at least one spondyloarthritis feature (see below), or if they are HLA B27 positive and have at least two other spondyloarthritis features.

Sacroiliitis on imaging is defined as one of the following:
– Active acute inflammation on MRI highly suggestive of sacroiliitis associated with spondyloarthritis.
– Definite radiographic sacroiliitis, according to the modified New York criteria.

Spondyloarthritis features include the following:
– Inflammatory back pain
– Arthritis
– Enthesitis
– Uveitis
– Dactylitis
– Psoriasis
– Crohn’s disease/ulcerative colitis
– Good response to NSAIDs
– Family history for spondyloarthritis
– HLA B27 positive
– Elevated C-reactive protein (in the context of chronic back pain)

Source: Ann. Rheum. Dis. 2009;68:777-83

原文翻译如下：

一组来自全球各地的脊柱关节炎专家公布了一套中轴性脊柱关节炎的新分类标准，预计这一举措将大大增加确诊为中轴性脊柱关节炎的患者人数，有助于医生及早确诊，及时开展治疗。

这主要是因为早期治疗，无论是采用非甾体类抗炎药(NSAID)或肿瘤坏死因子(TNF)抑制剂，都将帮助患者减缓中轴性脊柱关节炎(SpA)的进程。但这一预期效果还有待研究结果的证实。

在中轴性SpA早期规范化诊断方面，一个主要以欧洲为中心的国际组织——脊柱关节炎国际评估协会 (ASAS)迈出了具有划时代意义的这一步。ASAS制订的新分类标准现已公布(Ann. Rheum. Dis. 2009;68:770-6; 778-83)，尚不清楚大多数美国风湿科医生和全科医生是否会认同这一新标准，并将其运用于临床。

于今年6月发表的研究报告显示，以649名患者为受试对象，新分类标准(见下文)诊断中轴性SpA的敏感性和特异性分别达到了83%和84%。该研究将参照新分类标准的诊断结果与风湿病学专家作出的诊断结果进行了对照。

美国德克萨斯大学医学教授兼风湿病学与临床免疫遗传学系主任John D. Reveille博士称，新标准一旦实施，“中轴性SpA的诊断率将提高大约3倍之多，达到美国成年人口的1.5%。”Reveille博士将中轴性SpA新标准用于美国国家健康与营养调查(NHANES)收集的美国人代表性样本中，从而做出了上述预测。

美国凯斯西储大学的医学教授Muhammad A. Khan博士在一次采访中也表示认同，“新标准将有助于发现更多的中轴性SpA患者，也有助于该病的早期诊断。新标准明显优于老标准，老标准要求X线检查证实骶髂关节异常，但新标准认为，只要有MRI证据，即便X线检查结果正常，也可以做出诊断。” Khan博士是ASAS唯一一名来自美国的代表，同时也是负责制订新分类标准的专家组成员。

目前，中轴性SpA多在病程晚期才被发现，即已经进展成为强直性脊柱炎，X线平片可见椎骨特征性改变。

美国俄勒冈卫生科技大学风湿病门诊主任Atul Deodhar 博士在采访中指出，“老分类标准要求患者有骶髂关节炎的X线改变，但这在患者出现其他症状后6~10年才会出现。显然，我们需要新的标准；如果患者没有X线改变就不能诊断为强直性脊柱炎。中轴性脊柱关节炎可谓是一个全新的诊断。我们认为部分中轴性脊柱关节炎患者，当然并非所有患者，会进展成强直性脊柱炎。”

Deodhar博士称，经MRI证实有中轴关节炎症是中轴性SpA新分类标准的关键要素之一。不借助MRI通常很难诊断中轴关节炎症，因为受累关节所处部位无法触及。

MRI提供的炎症证据至少能够部分实现早期诊断，这对于及时开展治疗是至关重要的。没有MRI证据，医生只有等到患者出现强直性脊柱炎的X线证据。Reveille博士称，10年的等待“太长了，诊断不能明确，患者就无法进行已经证实对该病有效的药物治疗。”

美国约翰霍普金斯大学的医学教授John A. Flynn博士指出，“如果我们能早期干预，便可预防部分与该病相关的严重疾病和残疾。” Flynn博士补充道，“早在5~10年前，部分风湿科医生就开始借助MRI对中轴性SpA做出早期诊断。如今的临床科学正在逐渐向这一经验性做法靠拢，我们意识到如果仅凭X线改变才能做出诊断，那么从症状发作到确诊需要很长的时间。如果患者的临床表现与中轴性SpA的特征相似，但X线检查结果显示正常，则应行MRI检查。”

但Flynn 博士和Deodhar博士也强调，仅凭MRI提示的中轴关节炎症并不足以做出诊断，因为非中轴性SpA患者也可能出现这种情况。其他诊断要素包括年龄小于45岁、症状发作缓慢、脊柱活动性降低、脊柱强直、疼痛，休息时加重，活动反而能使症状缓解(有别于机械性腰背痛，休息后缓解，活动时加重)。

Flynn博士表示，“我并没有让大多数的腰背痛患者都接受MRI检查，因为我所接触到的腰背痛患者通常并非炎症性的，而是机械性的。”

美国专家也关心这一新标准是否会被美国其他风湿科医生广泛使用，可能更重要的是，美国的全科医生是否会采用，因为大部分患者最初都会到他们那里就诊。

Flynn博士称，“显然，美国医生和欧洲医生的观念存在分歧。参与确证中轴性SpA新标准的ASAS研究的试验中心中，竟然没有一个位于美国，对此我感到非常吃惊。确证研究纳入了来自16个国家25个中心的患者，其中14个中心位于欧洲，5个在亚洲，4个在土耳其，加拿大和哥伦比亚各有1个(Ann. Rheum. Dis. 2009;68:777-83)。”

欧洲的风湿病学专家之所以更加积极地制订中轴性SpA新标准，可能是因为欧洲人群中带有HLA-B27基因型的人比例更高，这类人最容易罹患中轴性SpA。Flynn博士指出，“欧洲医生的确收治了更多的中轴性SpA患者，但这些患者是否与美国医生接触到的患者完全相同？我认为还应该在美国患者中对新标准进行确证。”

Khan博士称，“美国的风湿科医生在处理脊柱关节炎方面仍不如欧洲医生那么有经验。” Reveille博士认为，但如果采纳了新分类标准，我们将能够更好的服务于这类患者。

目前，中轴性SpA的治疗多从NSAID开始，如果第一种NSAID治疗失败，则改用另一种NSAID再治疗一个疗程。如果3个月内两种NSAID方案都未能达到满意的治疗效果，现行标准认为下一步应该采用TNF抑制剂。在美国，常用的TNF抑制剂包括阿达木单抗、依那西普、英夫利昔单抗和戈利木单抗。虽然上述药物均未经美国食品药品管理局批准用于中轴性SpA的治疗，但所有4种药物都获准用于强直性脊柱炎的治疗。

非生物缓解病情药并非中轴性SpA的理想治疗药物，如甲氨喋呤和柳氮磺吡啶。

目前尚无研究结果证实采用NSAID或 TNF抑制剂早期治疗能够减缓或阻断中轴性SpA的进展，但专家们对此持乐观态度，认为迟早会得出数据证实这一点。Khan博士称，“我们猜测早期治疗可改善预后；类风湿性关节炎就是一个先例。”此外Flynn博士认为，即便没有疾病进展减缓的证据，早期治疗也“明显改善了患者的生活质量和功能，缩短了休假的时间。”

美国脊柱炎协会(SAA)的领导层也意识到了早期诊断并治疗脊柱炎的重要性。受SAA资助的研究者开发了一种筛查工具，旨在帮助慢性腰背痛患者自我鉴别其是否出现了炎性反应的指征，一旦出现则需接受临床评价。SAA的执行主席Laurie Savage表示，有关SAA强直性脊柱炎筛查工具的研发报告计划发表在《关节炎治疗与研究》(Arthritis Care and Research)的明年1月刊上，随后SAA将通过互联网公布并推广这一工具。

AS新分类标准

对于腰背痛持续至少3个月，发病年龄小于45岁的患者，若符合以下任何一条标准，即可诊断为脊柱关节炎：1)经影像学证实的骶髂关节炎+至少一项脊柱关节炎特征(见下文)；2) HLA B27阳性+至少另外两项脊柱关节炎特征。

经影像学证实的骶髂关节炎定义如下(符合任意一条)：
–MRI检查提示骶髂关节活动性急性炎症，高度提示与脊柱关节炎相关的骶髂关节炎。
–根据修订后的纽约标准，骶髂关节炎影像学改变确切。

脊柱关节炎的特征包括：
–炎性腰背痛
–关节炎
–附着点炎
–葡萄膜炎
–指(趾)炎
–银屑病
–克罗恩病/溃疡性结肠炎
–对NSAID治疗反应良好
–有脊柱关节炎家族史
–HLA B27阳性
–C反应蛋白升高(适用于慢性腰背痛患者)

资料来源: Ann. Rheum. Dis. 2009;68:777-83

此翻译来源于：爱思唯尔中国医学网站。

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