1、定义
需要频频丈量的生物标记物,用于评估疾病或医疗情况的情况,或用于证明接触某种医疗产物或情况造剂(或其影响)。
2、示例
在评估慢性丙型肝炎患者的治疗反响时,丙型肝炎病毒核糖核酸(HCV-RNA)程度可做为监测生物标记物[2, 3];国际一般化比率(INR)或凝血酶原时间(PT)可做为监测生物标记物,用于评估利用华法林的患者能否到达了预期的抗凝效果[12];血液中的单克隆卵白(M卵白)程度可做为监测生物标记物,以评估被诊断为意义不明的单克隆性腺病(MGUS)的个别能否有停顿为其他疾病的迹象,包罗可能需要治疗的某些类型的血癌[15];在评估前列腺癌患者的疾病形态或承担时,可将前列腺特异性抗原(PSA)做为监测生物标记物[8];在评估卵巢癌患者治疗期间和治疗后的疾病形态或承担时,可将癌抗原125(CA125)用做监测生物标记物[9];HIV-RNA可做为监测生物标记物,用于权衡和指点抗逆转录病毒疗法(ART)的治疗[1];B型钠尿肽(BNP)或N端原BNP(NT-proBNP)可做为随访期间的监测生物标记物,以弥补儿科肺动脉高压患者的临床决策[14];一种成瘾药物的血液浓度可做为药物成瘾预防和治疗试验中的监测生物标记物,以权衡戒断和依从性[4];怀孕期间持续丈量骨骺线高度可用于产前筛查,以检测胎儿生长障碍[17];尿液中烟草特定亚硝胺(TSNAs)的浓度(如。总N-亚硝基烟碱(NNN)和总4-(甲基亚硝胺)-1-(3-吡啶基)-1-丁醇(总NNAL)可做为评估烟草和烟草烟雾表露的监测生物标记物[25]。3、详解
在一段时间内被频频评估的生物标记物被称为监测生物标记物,可用于评估:
疾病停顿,包罗新的疾病影响的发作,以前存在的异常的恶化,或疾病严峻水平或特定异常的变革;疾病或病症对治疗的反响,无论是有利的仍是倒霉的。该范畴包罗各类类此外生物标记物(如平安性生物标记物、药效/反响性生物标记物、预后性生物标记物)。
当人们不只对生物标记物的丈量值感兴趣,并且对其随时间变革的速度、变革的幅度、变革与个别或病人(如基因型某人口统计学)或疾病相关特征(如疾病严峻水平、疾病持续时间和特定疾病)的关系感兴趣时,凡是会频频评估生物标记物。
在临床护理情况中或在临床试验的布景下,监测生物标记物能够在病人临床过程的一个或多个期间停止丈量。例如,在疾病或病症诊断后和干涉前(例如,成立基线特征,评估治疗前的停顿率),在供给干涉的期间,或在供给干涉完成后。
当频频评估时,生物标记物的丈量有时能够发现疾病或病情恶化的迹象,那可能表白预后恶化或需要干涉。
干涉过程中的生物标识表记标帜物监测能够到达几个目标,包罗通过监测药物浓度确定药物在病人体内的代谢情况,在治疗过程中或治疗后检测治疗效果或疾病停顿,或检测毒性。
那些用处的例子包罗丈量PT和部门凝血活酶时间(PTT)值,以连结承受抗凝治疗的病人的华法林或肝素程度在治疗范畴内,以及监测HCV-RNA程度,以评估能否存在将受益于治疗的丙型肝炎传染以及对治疗的反响或不反响的证据。
对承受来氟米特和甲氨蝶呤治疗类风湿性关节炎的患者,通过按期丈量肝酶来评估肝脏毒性的证据。持续的影像学研究被常规用于监测实体瘤患者的疾病形态,以检测治疗期间或治疗后的退缩或停顿,或检测初始治疗到达无病形态后的复发情况。
监测生物标记物也被用于整个医疗产物的开发,例如,在新药、生物成品或设备的治疗或预防试验中。
在治疗过程中或治疗后察看到的生物标记物丈量的变革能够供给药效或早期治疗反响的撑持证据。在早期临床试验中频频丈量的平安生物标记物能够是一种监测器官毒性的生物标记物。
此外,生物标记物有时被用于治疗或预防试验,以评估参与者对指定干涉的依从性。例如,生物标记物可能是给药的血液程度,也可能是血清中的可替宁程度(利用烟草成品的目标),做为旨在预防抽烟的干涉性试验的一部门。因而,除了指点临床护理外,监测生物标记物可能有助于促进干涉性研究的可解释性和可信性。
监测生物标记物可用于小我某人群层面的监测,以领会能否存在疾病或医疗情况或开展风险。
被监测的小我可能没有临床上明显的医疗前提或疾病,或者他们可能有一些医疗前提或以前的表露,使他们容易开展成一些新的前提或疾病。
承受年度体检的安康成年人被例行监测血清胆固醇、血糖和尿肌酐等生物标记物的程度,以评估高胆固醇血症、糖尿病和肾功用受损等医疗情况的风险并检测其呈现情况。
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