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生物標誌物是通過測試可測量的任何生物學參數(物質或成分),可用作正常生物學過程,致病過程或對治療干預的藥理反應的指標。
生物標誌物的例子包括:
•對血液和其他組織進行實驗室檢查
•功能測試
•心電圖檢查
•影像學檢查(計算機斷層掃描(CT),磁共振成像(MRI)等)

生物標誌物的主要類型是什麼?
生物標誌物可分為:
•預後生物標誌物
確定具有特定結果(疾病進展或生存)的不同風險的患者。它被定義為根據結果將人群分開的一個或多個特徵,而與治療或治療的類型無關。
該參數例如用於醫生了解疾病的進展或所用藥物的有效性。因此,可以維持或改變規定的治療,從而可以獲得最佳結果。
•預測性生物標誌物
它可以預測特定療法或治療的差異結果。它被定義為基線特徵,根據患者對特定治療的反應程度對患者進行分類。
此類分析有助於例如識別一組更可能從特定療法中受益的人。發現和驗證更多此類生物標誌物對於提高針對不同病理的治療效果非常重要。
•藥效生物標誌物
它用於評估藥物的活性,包括證明新活性成分的功效。它也可以用於優化藥物開發早期階段(體外研究,動物實驗和I期)的藥物遞送時間表。




生物標誌物做什麼?
生物標記物可以執行不同的功能:
•疾病診斷-使診斷更可靠,更快和/或更便宜。
•嚴重度評估-識別患有嚴重疾病的患者。
•風險評估-識別接受干預後結果可能更好或更糟的患者。
•藥物作用的預測-識別暴露於藥物的患者的藥理反應(功效,毒性和藥代動力學)。
•監測-評估對治療干預的反應。


參考文獻
Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 2001, 69, 89–95.
Gosho, M., Nagashima, K. & Sato, Y., 2012. Study Designs and statistical analyses for biomarker research. Sensors (Switzerland), 12(7), pp.8966–8986.
Ray, P. et al., 2010. Statistical evaluation of a biomarker. Anesthesiology, 112(4), pp.1023–1040.
Strimbu, K. & Tavel, J. a, 2011. What are Biomarkers? Curr Opin HIV AIDS, 5(6), pp.463–466.
Sargent, D.J.; Conley, B.A.; Allegra, C.; Collette, L Clinical trial designs for predictive marker validation in cancer treatment trials. J. Clin. Oncol. 2005, 23, 2020–2027.
Chakravarty, A.G.; Rothmann, M.; Sridhara, R. Regulatory issues in use of biomarkers in oncology trials. Stat. Biopharm. Res. 2011, 3, 569–576.
Jenkins, M.; Flynn, A.; Smart, T.; Harbron, C.; Sabin, T.; Ratnayake, J.; Delmar, P.; Herath, A.; Jarvis, P.; Matcham, J.; On behalf of the PSI Biomarker Special Interest Group. A statistician’s perspective on biomarkers in drug development. Pharm. Stat. 2011, 6, 494–507.
Dunstan, R.W. et al., 2011. The use of immunohistochemistry for biomarker assessment–can it compete with other technologies? Toxicologic pathology, 39(6), pp.988–1002.


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