本系统综述确定了纳入FRAX的骨质疏松症评估指南。少数论文给出了干预阈值的基本原理。干预阈值(固定或取决于年龄)需要针对特定国家。
在大多数评估指南中,骨质疏松症的治疗被推荐在个体与先前的脆性骨折,尤其是脊柱和髋部骨折.然而,对于那些没有骨折的人来说,干预阈值可以使用不同的方法得出。本报告的目的是对评估指南中使用FRAX®的现有信息进行系统审查,特别是阈值的设置及其验证。
我们确定了120篇纳入FRAX的指南或学术论文,其中38篇没有明确说明如何将所得出的骨折概率用于临床实践的决策。其余的建议使用固定的干预阈值(n=58),最常见的是作为更复杂的指导(例如骨矿物质密度(BMD)阈值)或年龄依赖性阈值(n=22)的组成部分。两项准则采用了年龄依赖性阈值和固定阈值。
固定的概率阈值对于主要骨折为4%至20%,对于髋部骨折为1.3%-5%。在58种出版物中,超过一半(39种)使用了20%的严重骨质疏松性骨折的阈值概率,其中许多还提到3%的髋部骨折概率作为替代干预阈值.在几乎所有情况下,除了这是美国国家骨质疏松基金会使用的阈值外,没有提供任何理由.在进行的地方,从歧视测试(香港)确定了固定概率阈值,健康经济评估(美国,瑞士),与骨质疏松症的患病率相匹配(中国)或与现有的指导方针或报销标准(日本,波兰)。年龄依赖性干预阈值,首先由国家骨质疏松指南小组(NOGG)制定,基于这样的理由,即如果患有脆性骨折的女性有资格接受治疗,然后,在任何给定的年龄,具有相同骨折概率但没有先前骨折(即在骨折阈值下)的男性或女性也应符合资格.根据现行的NOGG准则,基于年龄相关的概率阈值,尤其是在年龄较大(≥70岁)时,根据是否存在既往骨折,治疗机会不平等会出现.使用混合模型的替代阈值减小了这种差异。
使用FRAX(固定或年龄相关阈值)作为评估的门户,比使用BMD更有效地识别高风险个体。然而,干预门槛的设定需要针对具体国家。
This systematic review identified assessment
guidelines for osteoporosis that incorporate FRAX. The rationale for intervention thresholds is given in a minority of papers. Intervention thresholds (fixed or age-dependent) need to be country-specific.
In most assessment
guidelines, treatment for osteoporosis is recommended in individuals with prior fragility fractures, especially fractures at spine and hip. However, for those without prior fractures, the intervention thresholds can be derived using different methods. The aim of this report was to undertake a systematic review of the available information on the use of FRAX® in assessment guidelines, in particular the setting of thresholds and their validation.
We identified 120 guidelines or academic papers that incorporated FRAX of which 38 provided no clear statement on how the fracture probabilities derived are to be used in decision-making in clinical practice. The remainder recommended a fixed intervention threshold (n = 58), most commonly as a component of more complex guidance (e.g. bone mineral density (BMD) thresholds) or an age-dependent threshold (n = 22). Two
guidelines have adopted both age-dependent and fixed thresholds.
Fixed probability thresholds have ranged from 4 to 20 % for a major fracture and 1.3-5 % for hip fracture. More than one half (39) of the 58 publications identified utilised a threshold probability of 20 % for a major osteoporotic fracture, many of which also mention a hip fracture probability of 3 % as an alternative intervention threshold. In nearly all instances, no rationale is provided other than that this was the threshold used by the National Osteoporosis Foundation of the USA. Where undertaken, fixed probability thresholds have been determined from tests of
discrimination (Hong Kong), health economic assessment (USA, Switzerland), to match the prevalence of osteoporosis (China) or to align with pre-existing guidelines or reimbursement criteria (Japan, Poland). Age-dependent intervention thresholds, first developed by the National Osteoporosis
Guideline Group (NOGG), are based on the rationale that if a woman with a prior fragility fracture is eligible for treatment, then, at any given age, a man or woman with the same fracture probability but in the absence of a previous fracture (i.e. at the \'fracture threshold\') should also be eligible. Under current NOGG guidelines, based on age-dependent probability thresholds, inequalities in access to therapy arise especially at older ages (≥70 years) depending on the presence or absence of a prior fracture. An alternative threshold using a hybrid model reduces this disparity.
The use of FRAX (fixed or age-dependent thresholds) as the gateway to assessment identifies individuals at high risk more effectively than the use of BMD. However, the setting of intervention thresholds needs to be country-specific.