现行血清肌酐参考区间的临床应用价值

Clinical value of the current serum creatinine reference interval

目的：探讨卫生行业标准 WS／T 404．5提供的现行血清肌酐参考区间的临床应用价值。方法横断面调查。调取中国医科大学附属第一医院2014年10月1日至2015年9月30日67605例60岁以下成年就诊患者首次血清肌酐和尿白蛋白／肌酐检测结果（ACR），以慢性肾脏病流行病学协作组（CKD－EPI）推荐的估算肾小球滤过率肌酐公式（eGFR）和随机尿白蛋白／肌酐比值作为评价现行、原肌酐参考区间的判断标准。结果采用现行参考区间判断为肌酐正常者中4．3％患者eGFR 下降；采用现行参考区间判断为肌酐升高者中98．0％患者 eGFR 下降。采用现行参考区间判断为升高，原参考区间判断为正常者1378例，其中93．5％患者 eGFR 下降；26例检测了尿蛋白／肌酐比值，其中18例（69．2％）患者 ACR≥30 mg／g，提示蛋白尿。在 eGFR ＜90 ml（min x1．73 m 2）患者中，原参考区间筛查阳性率为43．6％，现行参考区间筛查阳性率为61．9％，后者较前者明显提高（χ2＝212．648，P ＜0．001）。结论现行血清肌酐参考区间有利于及时发现肾功能异常患者，建议临床实验室尽早应用。

Objective We aim to evaluate the value of the current serum creatinine reference interval （ RI ） provided by Industry Standard WS /T 404.5 in clinical practice.Methods The first time serum creatinine levels and urinary albumin /creatinine ratio were obtained from 67 605 adult patients （ 〈60 years old） who were treated in the First Hospital of China Medical University between October 1, 2014 and September 30, 2015 in this cross-sectional study.Estimated glomerular filtration rate （ eGFR ） calculated by chronic kidney disease epidemiology collaboration （CKD-EPI） equation and urinary albumin /creatinine ratio （ACR） were used to evaluate the clinical practical significance of current and old serum creatinine RIs as the criteria.Results 4.3% of normal subjects based on current RI were showed decreased eGFR, 98% of abnormal subjects based on the current RI were founded to have decreased eGFR . 1378 subjects were evaluated as increased based on current RI but as normal based on old RI , and 93.5% of these subjects were showed decreased eGFR .In addition, ACR was measured in 26 cases, and 18 out of 26 cases （69.2%） were confirmed to have elevated ACR （≥30 mg/g） and proteinuria.On the other hand of analysis, screening positive rates of declined eGFR were 43.6% by old RI and 61.9% by current RI in the subjects with eGFR under 90 ml（minx1.73 m 2 ）, and the performance of the current RI was obviously improved（χ2 =212.648,P 〈0.001）.Conclusions The current reference interval of serum creatinine is favorable for the detection of renal dysfunction in patients .It is recommended that the current reference interval can be applied in the clinical laboratories as early as possible .