Department of Gastroenterology, Kitasato University Medical Center, Japan.
Department of Risk Management and Health Care Administration, Kitasato University School of Medicine, Japan.
Intern Med. 2021 Aug 15;60(16):2557-2568. doi: 10.2169/internalmedicine.6370-20. Epub 2021 Mar 15.
Objective This study examined whether or not the Digestive Disease Week-Japan (DDW-J) 2004 scale proposed over 15 years ago can be applied to current cases of drug-induced liver injury (DILI). Methods The new patients group included 125 patients from 2012 to 2019 and was divided into 2 subgroups: 96 patients in the new DILI group and 29 patients in the new non-DILI group. Similarly, the old patients group included 105 patients from 1997 to 2002 and was divided into 2 subgroups: 59 patients in the old DILI group and 46 patients in the old non-DILI group. Patients were assessed by the DDW-J 2004 scale; those with a score ≥3 were defined as having DILI. Results The total score of the new DILI group was significantly lower than that of the old DILI group [6 (1-11) vs. 6 (3-9), p=0.004]. The sensitivity, specificity, positive predictive value, and negative predictive value (NPV) were 94.8%, 65.6%, 90.1%, and 79.2%, respectively, in the new patients group and 100%, 91.4%, 93.7%, and 100%, respectively, in the old patients group. The specificity and NPV of the new patients group were significantly lower than those of the old patients group. Conclusion The DDW-J 2004 scale maintains a stable diagnostic ability for DILI, regardless of differences in eras and verification methods. However, differential diagnoses can affect the scoring, and new types of DILI, such as immune-related adverse events, must be addressed. Therefore, upgrading the scale should be considered.
目的 本研究旨在探讨 15 年前提出的消化疾病周-日本（DDW-J）2004 量表是否适用于当前的药物性肝损伤（DILI）病例。
方法 新患者组纳入了 2012 年至 2019 年的 125 例患者，分为新 DILI 组（96 例）和新非 DILI 组（29 例）；同样，旧患者组纳入了 1997 年至 2002 年的 105 例患者，分为旧 DILI 组（59 例）和旧非 DILI 组（46 例）。采用 DDW-J 2004 量表评估患者；评分≥3 定义为患有 DILI。
结果 新 DILI 组的总分明显低于旧 DILI 组[6（1-11）比 6（3-9），p=0.004]。新患者组的灵敏度、特异度、阳性预测值和阴性预测值（NPV）分别为 94.8%、65.6%、90.1%和 79.2%，旧患者组分别为 100%、91.4%、93.7%和 100%。新患者组的特异度和 NPV 明显低于旧患者组。
结论 无论时代和验证方法存在差异，DDW-J 2004 量表对 DILI 仍保持稳定的诊断能力。然而，鉴别诊断会影响评分，且必须考虑新型的 DILI，如免疫相关不良事件，因此应考虑对量表进行升级。
