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. 2021 Jun 28;9(3):345-352.
doi: 10.14218/JCTH.2020.00124. Epub 2021 Mar 31.

Validation of the Nanjing Criteria for Diagnosing Pyrrolizidine Alkaloids-induced Hepatic Sinusoidal Obstruction Syndrome

Affiliations

Validation of the Nanjing Criteria for Diagnosing Pyrrolizidine Alkaloids-induced Hepatic Sinusoidal Obstruction Syndrome

Wei Zhang et al. J Clin Transl Hepatol. .

Abstract

Background and aims: Hepatic sinusoidal obstruction syndrome (HSOS) is caused by toxic injury to sinusoidal endothelial cells in the liver. The intake of pyrrolizidine alkaloids (PAs) in some Chinese herbal remedies/plants remains the major etiology for HSOS in China. Recently, new diagnostic criteria for PA-induced HSOS (i.e. PA-HSOS) have been developed; however, the efficacy has not been clinically validated. This study aimed to assess the performance of the Nanjing criteria for PA-HSOS.

Methods: Data obtained from consecutive patients in multiple hospitals, which included 86 PA-HSOS patients and 327 patients with other liver diseases, were retrospectively analyzed. Then, the diagnostic performance of the Nanjing criteria and simplified Nanjing criteria were evaluated and validated. The study is registered in www.chictr.org.cn (ID: ChiCTR1900020784).

Results: The Nanjing criteria have a sensitivity and specificity of 95.35% and 100%, respectively, while the simplified Nanjing criteria have a sensitivity and specificity of 96.51% and 96.33%, respectively, for the diagnosis of PA-HSOS. Notably, a proportion of patients with Budd-Chiari syndrome (11/49) was misdiagnosed as PA-HSOS on the basis of the simplified Nanjing criteria, and this was mainly due to the overlapping features in the enhanced computed tomography/magnetic resonance imaging examinations. Furthermore, most of these patients (10/11) had occlusion or thrombosis of the hepatic vein, and communicating vessels in the liver were found in 8/11 patients, which were absent in PA-HSOS patients.

Conclusions: The Nanjing criteria and simplified Nanjing criteria exhibit excellent performance in diagnosing PA-HSOS. Thus, both could be valuable diagnostic tools in clinical practice.

Keywords: Drug-induced liver injury; Hepatic sinusoidal obstruction syndrome; Pyrrolizidine alkaloids; Sensitivity; Specificity.

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Conflict of interest statement

The authors have no conflict of interests related to this publication.

Figures

Fig. 1
Fig. 1. Flow diagram for the patient enrollment.
Fig. 2
Fig. 2. Representative CT images and pathological findings for PA-HSOS patients.
(A) The CT imaging revealed diffuse hepatomegaly, ascites, and plain scans showing the heterogeneous decreased density of the hepatic parenchyma. (B) The CT enhancement characterized a map-like or mottle-like nonhomogeneous appearance in the equilibrium phase. (C) The CT images showed that the hepatic vein lumen was obscured, and the hepatic segment of the inferior vena cava was compressed and thinner. (D) hematoxylin-eosin (HE) ×40, Zone III, Zone I; (E) HE ×100, Zone III, Zone I. The pathological findings confirmed edema, necrosis, detachment of hepatic sinusoidal endothelial cells in hepatic acinus zone III, significant dilation and congestion of hepatic sinusoids, but showed no significant changes in zone I.
Fig. 3
Fig. 3. Receiver operating characteristic curves for the Nanjing criteria and simplified Nanjing criteria in the study patients.
The AUC for the Nanjing criteria in the diagnosis of PA-HSOS was 0.977 (95% CI: 0.951–1.000, p<0.01), while the AUC for the simplified Nanjing criteria was 0.964 (95% CI: 0.939–0.990, p<0.01).

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