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中国循证儿科杂志

中国循证儿科杂志 ›› 2020, Vol. 15 ›› Issue (6): 411-418.

• 论著 • 上一篇    下一篇

新生儿胆道闭锁筛查和诊断系统评价和Meta分析

汤悦1,3,朱叶1,3,姜璟?1,王瑞2,沈桢1,郑珊1,陈功1,张崇凡2   

  1. 复旦大学附属儿科医院 上海，201102； 1 外科，2 临床指南制作和评价中心，3 共同第一作者
  • 收稿日期:2020-11-25 修回日期:2020-11-25 出版日期:2020-12-25 发布日期:2020-12-25
  • 通讯作者: 陈功；张崇凡

Screening and diagnosis of biliary atresia in neonates: A Systematic review and meta-analysis

TANG Yue1,3, ZHU Ye1,3, JIANG Jingying1, WANG Rui2,  SHEN Zhen1, ZHENG Shan1, CHEN Gong1, ZHANG Chongfan2   

  1. Children's Hospital of Fudan University, Shanghai 201102, China; 1 Department of Pediatric Surgery, 2 Center for Clinical Practice Guideline Development and Evaluation, 3 Co-first authors
  • Received:2020-11-25 Revised:2020-11-25 Online:2020-12-25 Published:2020-12-25
  • Contact: CHEN Gong；ZHANG Chongfan

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摘要： 目的:考察大便比色卡、足跟血片胆红素筛查新生儿胆道闭锁（BA）的价值，肝穿刺活检、十二指肠引流液、基质金属蛋白酶-7（MMP-7）、γ-谷氨酰转肽酶（GGT）］诊断BA的价值。方法:检索英文（PubMed、Embase、Medline）数据库（起于建库）和中文CBM数据库（起于2000年1月1日止于2020年4月26日），按BA临床实践指南的纳入排除标准筛选文献，并使用QUADAS-2量表对纳入文献偏倚风险及临床适用性进行评价。结果:大便比色卡纳入5项研究，敏感度84%（95%CI：76%~90%），特异度100%（95%CI：100%~100%），I2分别为0%和86.37%， AUC为0.99（95%CI：0.98~1.00）；新生儿生后即行足跟血质谱检测胆红素筛查纳入1项研究，敏感度100% (95% CI 56.1%~100%)，特异度99.9% (95% CI 99.9%~99.9%)；肝穿刺活检诊断BA纳入8项研究，敏感度96% (95%CI：91%~98%)，特异度96%（95%CI：92%~97%），AUC为0.98（95%CI：0.97~0.99）；十二指肠引流液诊断BA纳入7项研究，敏感度96%(95%CI：92%~96%)，特异度86%（95%CI：79%~91%），AUC为0.97（95%CI：0.96~0.98）；MMP-7诊断BA纳入4项研究，敏感度96%（95%CI：93%~98%），特异度91%（95%CI：85%~95%），AUC为0.97（95%CI：0.95~0.98）；GGT诊断BA纳入15项研究，敏感度81%(95%CI：73%~88%)，特异度79%（95%CI：72%~84%），AUC为0.87（95%CI：0.83~0.86）。结论:大便比色卡是无创、便捷、有效的胆道闭锁筛查手段；新生儿期足跟血质谱检测胆红素筛查仍需更大规模临床研究验证。肝穿刺活检及十二指肠引流液均对胆道闭锁具有诊断价值，但血清学标志物MMP-7作为更为便捷、准确的诊断方法，临床应用前景更为广阔。尽管临床上有着广泛应用，GGT对于诊断胆道闭锁的价值有限。

关键词: 胆道闭锁；大便比色卡；足跟血片胆红素；肝穿刺；十二指肠引流液；基质金属蛋白酶-7；&gamma, -谷氨酰转肽酶；诊断比值比

Abstract: Objective:To determine the value of stool color card and bilirubin measurements in biliary atresia(BA) screening. Methods:According to the retrieval method, literature was searched in PubMed, Embase, Medline from the establishment of the database and in the Chinese CBM database from January 1, 2000 to April 26, 2020. Literature was screened and selected based on the inclusion and exclusion criteria set by the ongoing clinical practice guideline on BA. The QUADAS-2 scale was used to evaluate the risk of bias and applicability concerns. Data were extracted and diagnostic parameters were calculated for the combined data. ResultsF:ive studies on stool color card screening were included in this meta-analysis. The combined sensitivity and specificity were 84% (95% CI: 76%-90%) and 100% (95% CI: 100%-100%) respectively with I2 of 0% and 86.37%. The AUC was 0.99 (95% CI: 0.98-1.00). One study was included for bilirubin detection of heel-prick blood by mass spectrum. The sensitivity was 100% (95% CI: 56.1%-100%) and specificity was 99.9% (95% CI: 99.9%-99.9%). Ten studies were included in the liver biopsy meta-study. The combined sensitivity was 96% (95% CI: 91%-98%), specificity was 96% (95% CI: 92%-97%), and the AUC was 0.98 (95% CI: 0.97-0.99). MMP-7 included 4 studies, with sensitivity of 96% (95% CI: 93%-98%) and specificity of 91% (95% CI: 85%-95%). AUC of SROC curve was 0.97 (95% CI: 0.95-0.98). Seven studies were included in meta-analysis of the duodenum drainage fluid study. The combined sensitivity was 96% (95% CI: 92%-96%), specificity was 86% (95% CI: 79%-91%), and the AUC was 0.97 (95% CI: 0.96-0.98). The GGT test included 15 studies. The sensitivity was 81% (95% CI: 73%-88%) and specificity was 79% (95% CI: 72%-84%). The SROC curve showed the area under curve (AUC) was 0.87 (95% CI: 0.83-0.86). Conclusion:Stool color card is a noninvasive, convenient and effective way to screen biliary atresia. Bilirubin measurements from neonatal heel stick, however, need more clinical trials to determine its value in BA screening. Duodenal drainage and liver biopsy are both valuable way to diagnosis BA, but MMP-7 exceeds those tests in its convenience and precision. Although as a clinical routine, GGT tests showed a limited value in diagnosing BA.

Key words: &gamma, Biliary atresia, Bilirubin measurements from neonatal heel stick, Duodenal drainage fluid, -glutamyl transpeptidase, Liver biopsy, Matrix metalloproteinase-7, Stool color card