Kobayashi Hiroshi, Akasaka Juria, Naruse Katsuhiko, Sado Toshiyuki, Tsunemi Taihei, Niiro Emiko, Iwai Kana
Department of Obstetrics and Gynaecology, Nara Medical University, Nara, Japan.
J Clin Diagn Res. 2017 Jul;11(7):QC18-QC21. doi: 10.7860/JCDR/2017/26746.10283. Epub 2017 Jul 1.
There are several sets of criteria for the diagnosis of Amniotic Fluid Embolism (AFE), but little is known about their degree of agreement.
To evaluate the concordance of the Japan criteria for AFE in comparison with two definitions: the US AFE registration entry criteria (the US criteria) and UK Obstetric Surveillance System criteria for defining cases of amniotic fluid embolism (the UK criteria).
A retrospective observational study was conducted in which the AFE cases registered in the Obstetrical Gynaecological Society of Kinki District in Japan for the period of April 2005 to December 2012 have been analysed by the expert steering obstetric committee, organized by the members of the Obstetric Research group. Cohen's kappa coefficient was used to calculate the agreement among three clinical diagnoses. For inter-group comparison, the Pearson Chi-square test was used (for categorical) and Mann-Whitney test was used (for continuous variables).
Among the 26 cases registered for this period, a total of 18 women were selected as having AFE according to the Japan criteria. Five women died (case fatality rate 27.8%). Agreement between the Japan criteria and the US and UK criteria was k = 0.453 and k = 0.538, respectively, reflecting moderate agreement. However, only 38.9% were given a diagnosis of AFE according to all three criteria. The factor that most often caused disagreement in diagnosis between the Japan criteria and the US criteria was "onset within 30 minutes postpartum". The UK criteria excluded "women with postpartum haemorrhage as the first presenting feature in whom there was no evidence of cardiorespiratory compromise". The case fatality rates in US and UK are higher than in Japan (50.0% and 38.5% vs 27.8%), but this did not result in a significant difference (p=0.497).
The groups of subjects identified as having AFE by the Japan criteria had a medium agreement with the US (k=0.453) or UK criteria (k=0.538). These three definition criteria identified different subgroups of patients. Such disagreement has serious implications for research and treatment.
目前有几套羊水栓塞（AFE）的诊断标准，但对于它们之间的一致性程度了解甚少。
与两种定义相比较，评估日本羊水栓塞标准的一致性，这两种定义分别是美国AFE登记录入标准（美国标准）和英国产科监测系统定义羊水栓塞病例的标准（英国标准）。
开展一项回顾性观察研究，由产科研究小组的成员组织专家指导产科委员会，对2005年4月至2012年12月期间在日本近畿地区妇产科学会登记的AFE病例进行分析。采用Cohen卡方系数计算三种临床诊断之间的一致性。对于组间比较，使用Pearson卡方检验（用于分类变量）和Mann-Whitney检验（用于连续变量）。
在此期间登记的26例病例中，根据日本标准，共有18名女性被判定为患有AFE。5名女性死亡（病死率27.8%）。日本标准与美国和英国标准之间的一致性分别为k = 0.453和k = 0.538，表明一致性为中等。然而，根据所有三项标准，只有38.9%的病例被诊断为AFE。日本标准和美国标准在诊断上最常导致分歧的因素是“产后30分钟内发病”。英国标准排除了“以产后出血为首发特征且无心肺功能不全证据的女性”。美国和英国的病死率高于日本（分别为50.0%和38.5%，而日本为27.8%），但这并未导致显著差异（p = 0.497）。
根据日本标准判定为患有AFE的受试者组与美国标准（k = 0.453）或英国标准（k = 0.538）有中等程度的一致性。这三项定义标准识别出了不同的患者亚组。这种分歧对研究和治疗具有严重影响。
