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2015-3-11 品格為某醫(yī)療機(jī)構(gòu)提供醫(yī)療器械翻譯,翻譯內(nèi)容:骨密度儀應(yīng)用,翻譯方向:英譯中>。
譯文摘錄:

Comparison of patient DXA studies to reference sets is a critical process in the application of DXA studies to a clinical practice. Two areas in which DXA is being extensively applied in clinical practice today are the assessment of bone disease (especially including osteoporosis and osteopenia) and the assessment of body composition disorders (especially fat and lean disorders). Relevant reference population development in DXA studies has typically taken the form of gathering a large enough dataset of relevant studies in the target population to statistically establish an age and sex description of expected distribution. Once a statistically valid description of a population is defined those studies are then applied to assessing the bone or soft tissue condition presented by the subject that is being evaluated.

在將雙能量X射線骨密度儀(DXA)應(yīng)用到臨床實(shí)踐的過程中,將受試者DXA的分析結(jié)果與標(biāo)準(zhǔn)的骨密度參考值進(jìn)行比較是一個關(guān)鍵性的步驟。在今天的臨床實(shí)踐中,DXA被廣泛應(yīng)用于兩個領(lǐng)域:一是用于骨?。ㄓ绕涫枪琴|(zhì)疏松癥和骨質(zhì)減少癥)的評估,另一個是用于身體成分紊亂(尤其是脂肪和瘦肉含量的紊亂)的評價。在DXA分析研究中,相關(guān)的參考群體的發(fā)展典型地采用了下面這種形式:通過在目標(biāo)人群中收集足夠多的相關(guān)研究資料,在統(tǒng)計學(xué)上建立不同年齡和性別的參考人群的預(yù)期骨密度分布。一旦在統(tǒng)計學(xué)上定義了參考人群骨密度的有效描述,DXA分析方法就可以被用于評價待評估的受試者呈現(xiàn)出的骨狀態(tài)或軟組織狀態(tài)。

When evaluating the condition presented by the subject undergoing a bone density assessment, subjects undergo assessment of a T-score or Z-score values to grade an individual’s distribution against the “sex matched young adult reference value” or against the “age and sex matched reference value”, respectively. The application of the T-score is then tied to a relative risk of fracture documented by prospective fracture risk studies to determine how subjects might be clinically addressed. Typically the T-score is evaluated as Normal if the T-score value is higher than -1.0 SD, is Osteopenic if the T-score value is between -1.0 SD and -2.5 SD or is Osteoporotic if the T-score is below -2.5 SD (El Maghraoui, A and Roux, C (20108)). The Z-score, alternatively, is evaluated as Normal if the value is within士2.0 SD of the age-matched reference value or as Abnormal if the value is outside the士2.0 SD range when compared to the age-match reference value (Gruber, HE and Baylink, DJ (1981)). Because the reference value comparison is critical to reaching this clinical assessment–to the extent that it is possible一elements that directly impact the clinical concern of fracture risk need to be accommodated for in the reference population. These reference set derive their acceptance from recognition that the relationship exists between bone density and fracture risk and from the use of appropriate population statistics.

當(dāng)對一個正在接受骨密度評估的受試者呈現(xiàn)出的狀態(tài)進(jìn)行評價時,受試者要接受T值評分和Z值評分,繼而將評分結(jié)果分別與“相應(yīng)性別青年人的骨密度參考值”和“相應(yīng)年齡和性別的骨密度參考值”進(jìn)行對比,從而得出個體的骨密度分布等級。T值的應(yīng)用之后將會與通過預(yù)期骨折風(fēng)險研究得出的相對骨折風(fēng)險相聯(lián)系,進(jìn)而確定受試者可能要接受的臨床治療方案。通常,當(dāng)個體骨密度值T值大于-1.0 SD時,則認(rèn)為個體骨密度正常;當(dāng)個體骨密度值在-1.0 SD與-2.5 SD之間時,則認(rèn)為個體骨質(zhì)減少;當(dāng)個體骨密度值低于-2.5 SD時,則認(rèn)為個體骨質(zhì)疏松(El Maghraoui, A and Roux, C (20108))。同時,如果Z值在同年齡人群參考值的士2.0 SD范圍內(nèi),則認(rèn)為正常;如果Z值超出同年齡人群參考值的士2.0 SD范圍,則認(rèn)為不正常(Gruber, HE and Baylink, DJ (1981))。由于將受試者的骨密度值與參考值進(jìn)行比較是做出臨床評價的關(guān)鍵,從這個意義上說,與參考值進(jìn)行比較的結(jié)果可能會直接影響需要提供給參考人群的骨折風(fēng)險關(guān)注度。由于這些參考值承認(rèn)骨密度和骨折風(fēng)險之間存在聯(lián)系,且它們是通過使用合適的人口統(tǒng)計學(xué)方法得到的,因此這些參考值具有公認(rèn)意義。

With regards to assessing fracture risk the gender, age, genetics and health makeup of the reference population dataset have been deemed critical to building a relevant reference set. Obviously gender and age very directly impact the prospect of fracture risk and need to be addressed in the makeup of a relevant reference set. In the same way, the health of your reference population is critical because factors of health will directly impact bone remodeling and cause a decrease in bone density and directly increase relative risk of fracture. In a more subtle way, genetic makeup of the reference population is critical because there is a highly significant link (reflected in a heritability index of 0.69) between genetics and individual bone density (Christian, JC, et al (1989)). This relatively high association with genetics is reported一in large part–to explain the ten percent greater bone density seen in the Black populations than seen in the White populations which seem to have an approximately four percent greater bone density than seen in Asian populations. It is this relatively strong link to genetics that justifies comparing a particular patient to a similar reference population. Ultimately it is a large body of literature that justifies the establishment of reference populations with the best possible similarity to a healthy cohort for the patient being evaluated and that is why manufacturers routinely provide documented and validated reference sets that will match for gender, age and ethnic background with the patient to calculate the relevant T-score and Z-score values.

關(guān)于骨折風(fēng)險的評估,參考人群的性別、年齡、基因遺傳學(xué)和健康組成被認(rèn)為是建立一個恰當(dāng)?shù)膮⒖技系年P(guān)鍵。很明顯,性別和年齡會很直接地影響骨折風(fēng)險的預(yù)期,因此需要在相關(guān)參考集合的組成中專門提出來。同樣,參考人群的健康狀況也是至關(guān)重要的,因?yàn)榻】狄蛩貢苯佑绊懝堑闹亟ǎ鸸敲芏鹊慕档?,從而直接提高骨折的相對風(fēng)險。更微妙的是,參考人群的基因組成也很關(guān)鍵,因?yàn)檫z傳學(xué)和個體的骨密度之間存在重大的聯(lián)系(這可以通過0.69的遺傳指數(shù)體現(xiàn)出來)(Christian, JC, et al (1989))。這種與遺傳學(xué)相對較高的聯(lián)系被報道主要是用于解釋下面的現(xiàn)象:黑種人的骨密度比白種人高10%,而白種人的骨密度大約比亞洲人高4%。正是與遺傳學(xué)的這種強(qiáng)烈的關(guān)聯(lián)性證明將個別的患者與其相似的參考群體進(jìn)行比較是合理的。最終,大量文獻(xiàn)證明,為被評估的患者建立與健康人群最相似的參考人群是很合理的,這也是為什么骨密度評估儀器制造商通常會提供與患者性別、年齡和種族背景相匹配的、有證明文件并經(jīng)過驗(yàn)證的參考值來計算與患者有關(guān)的T值和Z值。

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