Faculty of Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
Department Health Sciences Research, Mayo Clinic, Rochester, MN, United States.
Eur J Intern Med. 2021 Aug;90:66-70. doi: 10.1016/j.ejim.2021.04.022. Epub 2021 May 10.
Serum bile acid (BA) levels testing is used for the diagnosis of intrahepatic cholestasis of pregnancy (ICP). We aimed to determine the performance of routine liver tests in the evaluation of ICP.
A retrospective cohort study conducted at a university hospital, including all pregnant women who underwent serum BA levels testing due to suspected ICP during 2007-2019. Liver tests were performed in all women including: aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALK), gamma-glutamyl transferase (GGT), and total bilirubin (TB). The optimal combination of laboratory values was determined by an algorithm developed in the Python programming language.
Of 640 women who met the inclusion criteria, 22% (n = 142) were diagnosed with ICP (serum BA>10 μmol/L). A combined laboratory score of: (TB>11 μmol/L) or (ALK>255 U/L) or (GGT>32 U/L) or (AST>31 U/L), had a sensitivity of 94%, negative predictive value (NPV) of 97%, specificity of 50%, positive predictive value of 35%, and a negative likelihood ratio of 0.11 for the diagnosis of ICP. The AUC of the laboratory model alone was 0.72 (95% CI: 0.69-0.75). The addition of history of ICP to the suggested laboratory score resulted in a sensitivity of 97%, NPV of 98% and a negative likelihood ratio of 0.06. The AUC of the final model was 0.76 (95% CI: 0.72-0.79).
A combined laboratory score incorporating AST, GGT, ALK and TB was shown to reliably exclude the diagnosis of ICP. This may be particularly useful in settings with limited access to BA levels testing.
血清胆汁酸 (BA) 水平检测用于诊断妊娠肝内胆汁淤积症 (ICP)。本研究旨在评估常规肝功能检查在 ICP 评估中的作用。
这是一项在大学医院进行的回顾性队列研究，纳入了 2007 年至 2019 年间因疑似 ICP 而接受血清 BA 水平检测的所有孕妇。所有女性均进行了肝功能检查，包括天冬氨酸转氨酶 (AST)、丙氨酸转氨酶 (ALT)、碱性磷酸酶 (ALK)、γ-谷氨酰转肽酶 (GGT) 和总胆红素 (TB)。通过在 Python 编程语言中开发的算法确定最佳实验室值组合。
符合纳入标准的 640 名女性中，22%（n=142）被诊断为 ICP（血清 BA>10 μmol/L）。实验室评分组合为：(TB>11 μmol/L) 或 (ALK>255 U/L) 或 (GGT>32 U/L) 或 (AST>31 U/L)，其对 ICP 的诊断具有 94%的敏感性、97%的阴性预测值 (NPV)、50%的特异性、35%的阳性预测值和 0.11 的负似然比。单独使用实验室模型的 AUC 为 0.72（95%CI：0.69-0.75）。将 ICP 病史添加到建议的实验室评分中可使敏感性提高至 97%、NPV 提高至 98%和负似然比降低至 0.06。最终模型的 AUC 为 0.76（95%CI：0.72-0.79）。
AST、GGT、ALK 和 TB 联合的实验室评分可准确排除 ICP 的诊断。在 BA 水平检测有限的情况下，该评分可能特别有用。
