Prediction and evaluation of high-risk patients with primary biliary cholangitis receiving ursodeoxycholic acid therapy: an early criterion.
Prediction and evaluation of high-risk patients with primary biliary cholangitis receiving ursodeoxycholic acid therapy: an early criterion.
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接受熊去氧胆酸治疗的原发性胆汁性胆管炎高危患者的预测和评估：早期标准
DOI：
10.1007/s12072-022-10431-7
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发表时间：
2023-02
影响因子：
6.6
通讯作者：
Han, Ying
中科院分区：
文献类型：
--
作者：
Yang, Chunmei;Guo, Guanya;Li, Bo;Zheng, Linhua;Sun, Ruiqing;Wang, Xiufang;Deng, Juan;Jia, Gui;Zhou, Xia;Cui, Lina;Guo, Changcun;Zhou, Xinmin;Leung, Patrick S. C.;Gershwin, M. Eric;Shang, Yulong;Han, Ying
关键词：
目前的治疗指南推荐熊去氧胆酸（UDCA）作为新诊断的原发性胆管炎（PBC）患者的一线治疗。然而，高达40%的患者对UDCA单药治疗不敏感，在12个月时评估UDCA反应可能导致长时间的无效治疗。我们的目标是开发一种新的标准来更早地可靠地识别无反应的患者。569例患者平均随访59个月（中位数：53；IQR: 32-79），随机分为训练组（70%）和验证组（30%）。在UDCA治疗开始后1、3或6个月评估总胆红素（TBIL）、碱性磷酸酶（ALP）和天冬氨酸转氨酶（AST）阈值的不同组合预测预后的效率。终点定义为不良结局，包括肝脏相关死亡、肝移植和肝硬化并发症。使用各种已发表的标准和提出的新标准对无不良预后生存率进行比较。建立1个月UDCA疗效评价新标准：ALP≤2.5 ×正常（ULN）上限，AST≤2 × ULN, TBIL≤1 × ULN（西安标准）。以西安标准定义的UDCA应答者5年无不良结局生存率为97%，显著高于无应答者（64%）。证实西安标准在早期和晚期PBC中具有准确区分高危患者的能力。与其他已公布的标准相比，西安标准在区分高危PBC患者方面具有相似甚至更高的能力。西安标准有助于早期识别需要新治疗方法的患者。在线版本包含补充材料，可在10.1007/s12072-022-10431-7获得。
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Five hundred sixty-nine patients with an average of 59 months (Median: 53; IQR:32–79) follow-up periods were randomly divided into either the training (70%) or the validation cohort (30%). The efficiency of different combinations of total bilirubin (TBIL), alkaline phosphatase (ALP), and aspartate aminotransferase (AST) threshold values to predict outcomes was assessed at 1, 3 or 6 month after the initiation of UDCA therapy. The endpoints were defined as adverse outcomes, including liver-related death, liver transplantation and complications of cirrhosis. Adverse outcome-free survival was compared using various published criteria and a proposed new criterion. A new criterion of evaluating UDCA responses at 1 month was established as: ALP ≤ 2.5 × upper limit of normal (ULN) and AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi’an criterion). The 5 year adverse outcome-free survival rate of UDCA responders, defined by Xi’an criterion, was 97%, which was significantly higher than that of those non-responders (64%). An accurate distinguishing high-risk patients’ capacity of Xi’an criterion was confirmed in both early and late-stage PBC. Xi’an criterion has a similar or even higher ability to distinguish high-risk PBC patients than other published criteria. Xi’an criterion can facilitate early identification of patients requiring new therapeutic approaches. The online version contains supplementary material available at 10.1007/s12072-022-10431-7.
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作者：
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