血清半胱氨酸蛋白酶抑制剂C、肌酐评估慢性肾脏病患者肾小球滤过功能价值的Meta分析

摘要/Abstract

摘要： 目的　评价血清半胱氨酸蛋白酶抑制剂C(Cys C)、肌酐(Cr)对慢性肾病肾小球滤过功能的诊断价值。方法　检索1966 年～ 2010年9月MEDLINE、EMbase、Cochrane 图书馆等数据库，收集关于检测血清Cys C、Cr对肾小球滤过功能的诊断价值的相关研究文献并进行质量评价，采用Cochrane 协作网提供的RevMan 4.2.7 软件进行异质性分析，Meta-Disc软件进行Meta 分析及绘制合并受试者工作特征(SROC)曲线。结果　共检索到相关文献231篇，最终纳入14篇文献，研究实验对象2 169例。Meta分析结果显示，肾小球滤过率（GFR）以80～90 mL/min为诊断截点，Cys C诊断研究存在明显异质性［P=0.098、变异比率(I²)=34.7%、合并敏感度(SEN)=0.873、合并特异度(SPE)=0.791］；Cr诊断研究无明显异质性（P=0.56、I²=0.0%、SEN=0.740、SPE=0.867）。5篇文献对GFR分期研究，合并GFR轻度减低(60～90 mL/min)组分析结果，Cys C、Cr均无明显异质性。Cys C：P=0.708、I²=0.0%、比值比(OR)=7.04［95%可信区间(CI)：4.54~10.92］；Cr：P=0.945、I²=0.0%、OR=9.4(95%CI：5.75~15.3)。Cys C对慢性肾病GFR轻度减低的诊断敏感度高于Cr、特异性低于Cr［Cys C：SEN=0.813，SPE=0.609、SROC曲线下面积(SAUC)=0.822 6；Cr：SEN=0.605、SPE=0.819、SAUC=0.826 3］。结论　Cys C、Cr与GFR有良好相关性。Cys C对早期慢性肾病患者GFR诊断敏感性高于Cr、特异性低于Cr。慢性肾病患者GFR分期研究不多，仍需要高质量的研究文献。

关键词: 半胱氨酸蛋白酶抑制剂C, 肌酐, 肾小球滤过率, Meta分析

Abstract: Objective　To evaluate the diagnostic value of serum cystatin C (Cys C) and creatinine (Cr) in glomerular filtration rate (GFR) of chronic kidney disease patients. Methods　MEDLINE, EMbase, the Cochrane Library and other databases (1966 to 2010 September) were searched for collecting studies which evaluated the diagnostic value of serum Cys C and Cr in evaluating GFR in patients with chronic kidney disease. The heterogeneity was tested by the Cochrane Collaboration′s software RevMan 4.2.7. The summary receiver operating characteristic (SROC) curve and Meta-analysis were performed by Metadisc. Results　A total of 231 relevant articles were searched, and 14 articles were included in the study. The study subjects were involved 2 169 patients. Meta-analysis showed that the cut-off value of GFR was 80-90mL/min, the Cys C heterogeneity was high ［P=0.098, I²=34.7%, summary sensitivity (SEN)=0.873, summary specificity (SPE)=0.791］, and Cr had no heterogeneity (P=0.56，I²=0.0%，SEN=0.740, SPE=0.867）. In 5 articles with various stages of GFR, Meta-analysis of GFR (60-90mL/min) group showed that Cys C and Cr had no heterogeneity {Cys C：P=0.708，I²=0.0%，odds ratio (OR)=7.04 ［95% confidence interval (CI): 4.54-10.92］, SEN=0.813，SPE=0.609，the area under the SROC curve (SAUC)=0.822 6；Cr：P=0.945，I²=0.0%，OR=9.4(95%CI:5.75-15.3), SEN=0.605，SPE=0.819，SAUC=0.826 3}. Conclusions　There are significant correlations between Cys C, Cr and GFR. As for early chronic kidney disease, CysC has more sensitivity but less specificity than Cr for evaluation of GFR. Further high quality researches on various stages of GFR in chronic kidney disease patients are still required.

Key words: Cystatin C, Creatinine, Glomerular filtration rate, Meta-analysis

马清光;李慧敏;沈　丽. 血清半胱氨酸蛋白酶抑制剂C、肌酐评估慢性肾脏病患者肾小球滤过功能价值的Meta分析[J]. 检验医学, 2012, 27(5): 352-357.

MA Qing-Guang;LI Hui-Min;SHEN Li. Value of serum cystatin C and creatinine in evaluating glomerular filtration rate in patients with chronic kidney disease ：a meta-analysis[J]. , 2012, 27(5): 352-357.

参考文献

［1］Harmoinen AP, Kouri TT, Wirta OR, et al. Evaluation of plasma cystatin C as a marker for glomerular filtration rate in patients with type 2 diabetes［J］. Clin Nephrol,1999,52(6): 363-370.
［2］Mojiminiyi OA , Abdella N. Evaluation of cystatin C and beta-2 microglobulin as markers of renal function in patients with type 2 diabetes mellitus［J］.J Diabetes Complications,2003,17(3): 160-168.
［3］Aksun SA, Ozmen D, Ozmen B, et al. Beta 2-microglobulin and cystatin C in type 2 diabetes:assessment of diabetic nephropathy［J］. Exp Clin Endocrinol Diabetes, 2004,112(4):195-200.
［4］Oddoze C, Morange S, Portugal H, et al. Cystatin C is not more sensitive than creatinine for detecting early renal impairment in patients with diabetes［J］. Am J Kidney Dis, 2001, 38（2）:310-316.
［5］Laterza OF, Price CP, Scott MG. Cystatin C: an improved estimator of glomerular filtration rate［J］.Clin Chem,2002,48（5）:699-707.
［6］Dharnidharka VR, Kwon C, Stevens G. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis［J］. Am J Kidney Dis,2002,40（2）:221-226.
［7］李　萍,赵　莹, 余　霆.肾脏滤过功能损伤实验室诊断指标半胱氨酸蛋白酶抑制剂C的系统评价［J］.检验医学,2005, 20(5):474-478.
［8］Van Pottelbergh G, Van Heden L, Mathe C, et al. Methods to evaluate renal function in elderly patients: a systematic literature review［J］. Age Ageing, 2010, 39（3）: 542-548.
［9］刘关键, 吴泰相. 诊断性试验的Meta分析——SROC曲线法介绍［J］. 中国循证医学杂志, 2003, 3 (1): 41-44.
［10］张天嵩, 钟文昭.Meta-DiSc软件在诊断试验Meta 分析中的应用［J］. 循证医学，2008，8（2）：97-100.
［11］张春梅. 胱抑素C 测定对评价2 型糖尿病肾病肾小球滤过率的价值［J］. 临床军医杂志, 2008，36（6）：999-1000.
［12］周　游. 健康人群血清胱抑素C 的分布及其用于评价肾小球滤过率的临床研究［J］. 浙江临床医学,2008，10（5）：694-695.
［13］王宏儒,杜国伟,鲍晓荣.血清胱抑素C 在评价慢性肾脏病患者肾小球滤过率中的价值［J］.中国中西医结合肾病杂志,2010，11（5）：421-423.
［14］李海霞,吴红花,徐国宾,等.血清半胱氨酸蛋白酶抑制剂C与肌酐在评价糖尿病患者肾小球滤过功能中的比较研究［J］.中华检验医学杂志,2005，28（6）：602-605.
［15］李　萍,赵　莹,黄亨健，等.胱蛋白酶抑制剂C对肾小球滤过功能的评价［J］.中华检验医学杂志,2005，28（5）：515-516.
［16］李海霞,张春丽,徐国宾，等.健康人群血清半胱氨酸蛋白酶抑制剂C与肌酐分布及其评价慢性肾脏病患者肾小球滤过功能的比较研究［J］.中华检验医学杂志,2006，29（11）:970-974.
［17］Filler G, Priem F, Lepage N, et al .Beta-trace protein, cystatin C, beta(2)-microglobulin, and creatinine compared for detecting impaired glomerular filtration rates in children［J］.Clin Chem, 2002, 48(5):729-736.
［18］Mussap M, Dalla Vestra M, Fioretto P, et al. Cystatin C is a more sensitive marker than creatinine for the estimation of GFR in type 2 diabetic patients［J］.Kidney Int, 2002,61(4):1453-1461.
［19］Chantrel F, Agin A, Offner M, et al. Comparison of cystatin C versus creatinine for detection of mild renal failure［J］.Clin Nephrol,2000,54(5):374-381.
［20］Perlemoine C, Beauvieux MC, Rigalleau V, et al.Interest of cystatin C in screening diabetic patients for early impairment of renal function［J］. Metabolism, 2003,52(10):1258-1264.
［21］Macisaac RJ, Tsalamandris C, Thomas MC, et al. The accuracy of cystatin C and commonly used creatinine-based methods for detecting moderate and mild chronic kidney disease in diabetes［J］. J Diabet Med, 2007, 24(4): 443-448.
［22］Pucci L, Triscornia S, Lucchesi D, et al. Cystatin C and estimates of renal function: searching for a better measure of kidney function in diabetic patients［J］.Clin Chem, 2007,53(3):480-488.
［23］Hoek FJ, Kemperman FA, Krediet RT. A comparison between cystatin C, plasma creatinine and the Cockcroft and Gault formula for the estimation of glomerular filtration rate［J］.Nephrol Dial Transplant,2003,18(10): 2024-2031.
［24］Spanaus KS, Kollerits B, Ritz E, et al. Serum creatinine, cystatin C, and beta-trace protein in diagnostic staging and predicting progression of primary nondiabetic chronic kidney disease［J］. Clin Chem,2010,56(5):740-749.

[1]	李莲, 黄晓玲, 姚娟. 高浓度肌酸致血清肌酐酶法检测结果假性升高病例分析[J]. 检验医学, 2023, 38(5): 497-501.
[2]	顾刚, 欧维正, 陶铜芳, 董江义. 改良肌氨酸氧化酶法肌酐试剂抗高IgM干扰分析[J]. 检验医学, 2023, 38(3): 294-296.
[3]	张水检, 周琰, 邵文琦, 张春燕, 潘柏申, 王蓓丽, 郭玮. 半定量干化学法检测尿白蛋白/肌酐比值的临床应用价值[J]. 检验医学, 2022, 37(5): 463-465.
[4]	姬智, 邓玲艳, 李娇元, 王旭, 李辉军, 程黎明. 武汉地区健康成人血清细胞角蛋白19片段参考区间的建立[J]. 检验医学, 2021, 36(5): 490-494.
[5]	邵文琦, 于正麟, 吴群, 张春燕, 王蓓丽, 潘柏申, 郭玮. 盐酸利多卡因致血清干化学肌酐定量结果异常1例报道[J]. 检验医学, 2021, 36(4): 381-383.
[6]	张卫威, 景蓉蓉, 季伙燕, 王建新, 王峰, 王惠民. 同位素稀释质谱法测定血清肌酐浓度的不确定度评定[J]. 检验医学, 2021, 36(3): 263-269.
[7]	徐文俊, 李甲勇, 李会丹. 不同eGFR公式与ACR联合应用在肾功能损伤高危人群中的临床价值[J]. 检验医学, 2021, 36(1): 13-19.
[8]	李世超, 申梁, 王春花, 童艳飞, 张冀. SARS-CoV-2抗体用于COVID-19诊断的Meta分析[J]. 检验医学, 2021, 36(1): 39-43.
[9]	万文婷, 于波, 弓孟春, 史文钊, 郭昊, 杨杰. 循环肿瘤DNA对黑色素瘤诊断价值的Meta分析[J]. 检验医学, 2020, 35(8): 784-790.
[10]	张科, 童书韬, 张德太. 初发甲状腺功能异常患者血清甲状腺激素与Cr、Cys C的相关性[J]. 检验医学, 2020, 35(7): 691-694.
[11]	张敏杰, 高玉芳, 杨飞飞, 徐晓莉. 中国人群传染性单核细胞增多症患者抗EB病毒抗体阳性检出率的Meta分析[J]. 检验医学, 2020, 35(3): 214-223.
[12]	李琳芸, 彭长华, 梅冰, 董莉. 中国人群强直性脊柱炎与ERAP-1基因多态性的相关性Meta分析[J]. 检验医学, 2018, 33(6): 481-485.
[13]	金中淦, 居漪, 李卿, 唐立萍, 虞啸炫, 刘文彬, 欧元祝. 2016年上海地区肌酐、尿酸、尿素正确度验证结果分析[J]. 检验医学, 2018, 33(4): 348-352.
[14]	王正印, 尹元, 王伟灵. 肌酐检测方法及常见药物对肌酐检测干扰的研究进展[J]. 检验医学, 2018, 33(4): 370-373.
[15]	张如霖, 王弘明, 彭霞, 李甲勇, 李莉. 血清淀粉样蛋白A、胱抑素C与尿白蛋白/肌酐比值联合检测在早期糖尿病肾病中的诊断价值[J]. 检验医学, 2018, 33(2): 97-100.