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改良克莱默法与克莱默法用于足月儿和近足月儿黄疸临床评估的比较

Modified Kramer's versus Kramer's Method for Clinical Assessment of Jaundice in Term and Near-Term Neonates.

作者信息

Bansal Shivam, Kumar Vivek, Sharma Akash, Sankar M J, Thukral Anu, Verma Ankit, Agarwal Ramesh

机构信息

Division of Neonatology, Newborn Health Knowledge Centre (NHKC), Department of Pediatrics, All India Institute of Medical Sciences (AIIMS), New Delhi, 110029, India.

出版信息

Indian J Pediatr. 2025 Apr;92(4):351-357. doi: 10.1007/s12098-023-05000-1. Epub 2024 Jan 12.

Abstract

OBJECTIVES

To compare the performance of Modified Kramer's and Kramer's methods in terms of agreement with total serum bilirubin (TSB).

METHODS

This cross-sectional study was done in Level-III neonatal unit in New Delhi. Visibly jaundiced neonates born at ≥35 wk of gestation were enrolled and examined by (i) conventional Kramer's, (ii) Modified Kramer's in artificial (MK-A) and (iii) natural daylight (MK-N), and finally sampled for estimation of TSB by point-of-care spectrophotometry. The primary outcomes were agreement of Kramer's and Modified Kramer's with TSB and accuracy in terms of proportion of bilirubin estimates lying within ±2 mg/dL of TSB; secondary outcome was agreement of MK-A and MK-N with TSB.

RESULTS

A total of 144 neonates with median gestation of 37 wk and mean birth weight of 2788 g were enrolled. Bland Altman analysis between Kramer's and TSB yielded mean difference of 1.7 mg/dL, 95% limits of agreement (LOA) -3.1 to 6.6 mg/dL. For Modified Kramer's and TSB, mean difference was -0.02 mg/dL, 95% LOA -4.7 to 4.7 mg/dL under artificial light; 0.02 mg/dL, 95% LOA -4.2 to 4.2 mg/dL under natural daylight. MK-N had highest proportion of bilirubin estimates lying within ±2 mg/dL of TSB (68.7%) as compared to MK-A (59.7%) [OR, 1.77; 95% CI, 1.09 to 2.86] and Kramer's (45.8%) [OR, 1.65; 95% CI, 1.27 to 2.15].

CONCLUSIONS

Though all the three methods had poor agreement with TSB, Modified Kramer's method when performed in natural light had reasonable accuracy, however limited clinical utility, in evaluation of clinical jaundice.

摘要

目的

比较改良克莱默法和克莱默法在与总血清胆红素(TSB)一致性方面的表现。

方法

本横断面研究在新德里的三级新生儿病房进行。纳入孕周≥35周的明显黄疸新生儿,并通过以下方法进行检查:(i)传统克莱默法,(ii)人工光源下的改良克莱默法(MK-A)和(iii)自然日光下的改良克莱默法(MK-N),最后采用即时分光光度法采集样本以测定TSB。主要结局是克莱默法和改良克莱默法与TSB的一致性以及胆红素估计值在TSB±2mg/dL范围内的比例所体现的准确性;次要结局是MK-A和MK-N与TSB的一致性。

结果

共纳入144例新生儿,中位孕周为37周,平均出生体重为2788g。克莱默法与TSB的布兰德-奥特曼分析得出平均差异为1.7mg/dL,95%一致性界限(LOA)为-3.1至6.6mg/dL。对于改良克莱默法与TSB,人工光源下平均差异为-0.02mg/dL,95% LOA为-4.7至4.7mg/dL;自然日光下平均差异为0.02mg/dL,95% LOA为-4.2至4.2mg/dL。与MK-A(59.7%)[比值比(OR),1.77;95%置信区间(CI),1.09至2.86]和克莱默法(45.8%)[OR,1.65;95% CI,1.27至2.15]相比,MK-N的胆红素估计值在TSB±2mg/dL范围内的比例最高(68.7%)。

结论

尽管这三种方法与TSB的一致性均较差,但改良克莱默法在自然日光下进行时具有合理的准确性,不过在评估临床黄疸方面临床实用性有限。

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