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The clinical utility and cost impact of cystatin C measurement in the diagnosis and management of chronic kidney disease: A primary care cohort study.
胱蛋白酶抑制剂 C 测定在慢性肾脏病诊断和管理中的临床效用和成本影响: 一项初级保健队列研究。

摘要

To reduce over-diagnosis of chronic kidney disease (CKD) resulting from the inaccuracy of creatinine-based estimates of glomerular filtration rate (GFR), UK and international guidelines recommend that cystatin-C-based estimates of GFR be used to confirm or exclude the diagnosis in people with GFR 45-59 ml/min/1.73 m2 and no albuminuria (CKD G3aA1). Whilst there is good evidence for cystatin C being a marker of GFR and risk in people with CKD, its use to define CKD in this manner has not been evaluated in primary care, the setting in which most people with GFR in this range are managed.A total of 1,741 people with CKD G3a or G3b defined by 2 estimated GFR (eGFR) values more than 90 days apart were recruited to the Renal Risk in Derby study between June 2008 and March 2010. Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations, we compared GFR estimated from creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys) at baseline and over 5 years of follow-up. We analysed the proportion of participants with CKD G3aA1 reclassified to 'no CKD' or more advanced CKD with the latter two equations. We further assessed the impact of using cystatin-C-based eGFR in risk prediction equations for CKD progression and all-cause mortality and investigated non-GFR determinants of eGFRcys. Finally, we estimated the cost implications of implementing National Institute for Health and Care Excellence (NICE) guidance to use eGFRcys to confirm the diagnosis in people classified as CKD G3aA1 by eGFRcreat. Mean eGFRcys was significantly lower than mean eGFRcreat (45.1 ml/min/1.73 m2, 95% CI 44.4 to 45.9, versus 53.6 ml/min/1.73 m2, 95% CI 53.0 to 54.1, P < 0.001). eGFRcys reclassified 7.7% (50 of 653) of those with CKD G3aA1 by eGFRcreat to eGFR ≥ 60 ml/min/1.73 m2. However, a much greater proportion (59.0%, 385 of 653) were classified to an eGFR category indicating more severe CKD. A similar pattern was seen using eGFRcreat-cys, but lower proportions were reclassified. Change in eGFRcreat and eGFRcys over 5 years were weakly correlated (r = 0.33, P < 0.001), but eGFRcys identified more people as having CKD progression (18.2% versus 10.5%). Multivariable analysis using eGFRcreat as an independent variable identified age, smoking status, body mass index, haemoglobin, serum uric acid, serum albumin, albuminuria, and C reactive protein as non-GFR determinants of eGFRcys. Use of eGFRcys or eGFRcreat-cys did not improve discrimination in risk prediction models for CKD progression and all-cause mortality compared to similar models with eGFRcreat. Application of the NICE guidance, which assumed cost savings, to participants with CKD G3aA1 increased the cost of monitoring by £23 per patient, which if extrapolated to be applied throughout England would increase the cost of testing and monitoring CKD by approximately £31 million per year. Limitations of this study include the lack of a measured GFR and the potential lack of ethnic diversity in the study cohort.Implementation of current guidelines on eGFRcys testing in our study population of older people in primary care resulted in only a small reduction in diagnosed CKD but classified a greater proportion as having more advanced CKD than eGFRcreat. Use of eGFRcys did not improve risk prediction in this population and was associated with increased cost. Our data therefore do not support implementation of these recommendations in primary care. Further studies are warranted to define the most appropriate clinical application of eGFRcys and eGFRcreat-cys.

译文

为了减少由于基于肌酐的肾小球滤过率 (GFR) 估计不准确而导致的慢性肾脏疾病 (CKD) 的过度诊断, 英国和国际指南建议使用基于胱蛋白酶抑制剂 C 的肾小球滤过率估计值来确认或排除患有肾小球滤过率 45-59 ml/min/1.73平方米且无蛋白尿症 (CKD G3aA1) 的人的诊断。虽然有很好的证据表明胱蛋白酶抑制剂 C 是 CKD 患者肾小球滤过率和风险的标志,但在初级保健中还没有对其以这种方式定义 CKD 的用途进行评估,管理 GFR 在这个范围内的大多数人的设置。在 2008年6月至 2010年3月期间,共有 1,741 名 CKD G3a 或 G3b 患者被招募到德比研究的肾脏风险中,这些患者被定义为相隔 90 天以上的 2 个估计的 GFR (eGFR) 值。使用慢性肾脏疾病流行病学合作 (CKD-EPI) 方程,我们比较了从肌酐 (eGFRcreat) 、胱蛋白酶抑制剂 C (eGFRcys) 和两者 (eGFRcreat-cys) 估计的肾小球滤过率基线和 5 年以上的随访。我们分析了患有 CKD G3aA1 的参与者的比例,用后两个方程重新分类为 “无 CKD” 或更高级的 CKD。我们进一步评估了在 CKD 进展和全因死亡率的风险预测方程中使用基于胱蛋白酶抑制剂 C 的 eGFR 的影响,并调查了 eGFRcys 的非肾小球滤过率决定因素。最后,我们估计了实施国家健康和护理卓越研究所 (NICE) 指南的成本影响,该指南使用 eGFRcys 在被 eGFRcreat 归类为 CKD G3aA1 的人群中确认诊断。平均 eGFRcys 显著低于平均 eGFRcreat (45.1 ml/min/1.73平方米,95% CI 44.4 至 45.9,而 53.6 ml/min/1.73平方米,95% CI 53.0 至 54.1,P <0.001)。EGFRcys 通过 eGFRcreat 将 CKD G3aA1 患者的 7.7% (653 中的 50) 重新分类为 eGFR ≥ 60 ml/min/1.73 m2。然而,更大的比例 (59.0%,385 的 653) 被归类为 eGFR 类别,表明更严重的 CKD。使用 eGFRcreat-cys 观察到类似的模式,但较低的比例被重新分类。5 年内 eGFRcreat 和 eGFRcys 的变化呈弱相关性 (r = 0.33,P <0.001),但 eGFRcys 确定更多的人患有 CKD 进展 (18.2% 对 10.5%)。多变量分析使用 eGFRcreat 作为自变量确定年龄、吸烟状况、体重指数、血红蛋白、血尿酸、血清白蛋白、蛋白尿, 和 C 反应蛋白作为 eGFRcys 的非 GFR 决定因素。与使用 eGFRcreat 的类似模型相比,使用 eGFRcys 或 eGFRcreat-cys 并没有改善 CKD 进展和全因死亡率风险预测模型中的区分度。对 CKD G3aA1 患者的 NICE 指南的应用假定了成本节约,使每个患者的监测成本增加了 23 英镑, 如果推断在整个英国应用,每年将增加大约 3100万英镑的 CKD 检测和监测成本。本研究的局限性包括缺乏测量的 GFR 和研究队列中潜在缺乏种族多样性。在我们的研究中,在接受初级保健的老年人群中实施目前的 eGFRcys 检测指南,仅导致诊断为 CKD 的人数略有减少,但将更大比例的人归类为患有更晚期的 CKD,而不是 eGFRcreat。EGFRcys 的使用没有改善该人群的风险预测,并且与成本增加有关。因此,我们的数据不支持这些建议在初级保健中的实施。需要进一步的研究来定义 eGFRcys 和 eGFRcreat-cys 的最合适的临床应用。

Cystatin C (Cys C)

肾内泌尿 肾功能检测指标 临床研究术语
概述  :  

胱抑素C(Cystatin C, Cys C)是一种小分子血浆蛋白质,为半胱氨酸蛋白酶抑制剂,人体的有核细胞都能稳定地产生。胱抑素C可被肾小球自由滤过,其浓度与肾小球滤过率呈负相关,不受性别、年龄、饮食、炎症、血脂、肝脏疾病等因素的干扰,是一种理想的反映肾小球滤过率(GFR)变化的内源性标志物。目前国内外都把胱抑素C作为公认的肾功能检测指标。 测定方法一种胱抑素C检测试剂盒的制备方法包括试剂R1的制备方法、试剂R2的制备方法和胱抑素C校准品的制备方法。1、试剂R1的制备方

Cystatin   / sɪs'teɪtɪn /

释    义   n. 半胱氨酸蛋白酶抑制剂

例    句   Indeed, the differences in kidney function were far more pronounced when the researchers looked at cystatin C and not as significant when they applied the standard creatinine test.事实上,当研究人员观察胱抑素C时,肾脏功能的差异更加明显,而当他们应用标准肌酐测试时,差异就不那么明显了。

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