不同评估量表在药物性肝损伤中的诊断价值分析
DOI: 10.12449/JCH240621
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摘要:
目的 采用RUCAM评估量表、Maria & Victorino评估量表、RECAM评估量表3种因果关系评估量表分别对药物性肝损伤(DILI)确诊病例进行评分,比较3种量表之间的诊断准确性差异,探讨其对于DILI诊断的临床意义。 方法 纳入2011年1月—2022年12月于北京大学第一医院住院、肝组织学活检病理结果支持DILI及有明确用药史的98例DILI确诊患者。采集研究对象的临床资料,并用上述因果关系评估量表评分,应用χ2检验分析因果关系评估量表的诊断准确性,应用加权kappa系数(κw系数)分析因果关系评估量表的一致性。 结果 在纳入的所有DILI患者中,RECAM评估量表的准确性最高,与RUCAM评估量表比较差异有统计学意义(χ2=5.667,P=0.017)。RUCAM评估量表和RECAM评估量表的诊断一致性中等(κw=0.469),而RECAM评估量表和Maria & Victorino评估量表的诊断一致性较差(κw=0.156)。在急性DILI患者中,RECAM量表、RUCAM量表、Maria & Victorino量表的不符合诊断率分别为3.7%、11.1%、42.6%;在肝细胞型DILI患者中,RECAM量表、RUCAM量表、Maria & Victorino量表的不符合诊断率分别为8.9%、21.4%、62.5%;在胆汁淤积型和混合型DILI患者中,RECAM量表、RUCAM量表、Maria & Victorino量表的不符合诊断率分别为10.0%、22.5%、47.5%。 结论 在急性DILI中使用RECAM评估量表和RUCAM评估量表能提高诊断率;在肝细胞型DILI和临床表现包含胆汁淤积的DILI(胆汁淤积型DILI和混合型DILI)中使用RECAM评估量表和RUCAM评估量表能提高诊断率;根据不同的病程及临床分型选择诊断准确性较高的因果关系评估量表有助于进一步提高临床诊断率。 -
关键词:
- 化学性与药物性肝损伤 /
- 诊断 /
- 评估量表
Abstract:Objective To determine the scores of patients with a confirmed diagnosis of drug-induced liver injury (DILI) using Roussel Uclaf Causality Assessment Method (RUCAM), Maria & Victorino assessment scale, and Revised Electronic Causality Assessment Method (RECAM), to compare the accuracy of the three scales in diagnosis, and to investigate their clinical significance in the diagnosis of DILI. Methods A total of 98 patients with a confirmed diagnosis of DILI who were hospitalized in Peking University First Hospital from January 2011 to December 2022 were enrolled, with liver biopsy results supporting DILI and a clear history of medication. Clinical data were collected from all subjects, and the above causality assessment scales were used for scoring. The chi-square test was used to analyze the diagnostic accuracy of the causality assessment scales, and the weighted kappa coefficient was used to analyze the consistency between the three scales. Results For all patients with DILI enrolled, RECAM had the highest accuracy, with a significant difference compared with RUCAM (χ2=5.667,P=0.017). RUCAM and RECAM had moderate consistency in diagnosis (κw=0.469), while RECAM and Maria & Victorino scale had poor consistency (κw=0.156). For the patients with acute DILI, RECAM, RUCAM, and Maria & Victorino scales had a diagnostic inconsistency rate of 3.7%, 11.1%, and 42.6%, respectively; for the patients with hepatocellular type DILI, the three scales of a diagnostic inconsistency rate of 8.9%, 21.4%, and 62.5%, respectively; for the patients with cholestasis type or mixed type DILI, the three scales of a diagnostic inconsistency rate of 10.0%, 22.5%, and 47.5%, respectively. Conclusion The use of RECAM and RUCAM scales in acute DILI can improve diagnostic rate, and for hepatocellular type DILI and DILI with the clinical manifestation of cholestasis (cholestasis type DILI and mixed type DILI), the use of RECAM and RUCAM scales can also improve diagnostic rate. The selection of causality assessment scales with a relatively high accuracy based on the course and clinical classification of the disease may help to further improve clinical diagnostic rate. -
Key words:
- Chemical and Drug Induced Liver Injury /
- Diagnosis /
- Assessment Scales
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表 1 纳入患者基本情况
Table 1. Summary of the main characteristics of all the cases
项目 数值 性别[例(%)] 男 29(29.6) 女 69(70.4) 受损靶细胞[例(%)] 肝细胞损伤型 56(57.1) 胆汁淤积型 24(24.5) 混合型 16(16.3) 血管损伤型 2(2.1) 病程[例(%)] 急性 54(55.1) 慢性 44(44.9) 致病药物[例(%)] 草药产品 45(45.9) 处方药和非处方药 30(30.6) 保健品 5(5.1) 毒素 2(2.1) 其他种类 16(16.3) 表 2 全部DILI患者的评估量表诊断分类
Table 2. The diagnostic categories of the assessment scales for overall DILI patients
评估量表 符合诊断[例(%)] 疑诊[例(%)] 不符合诊断[例(%)] RUCAM量表 30(30.6) 47(48.0) 21(21.4) Maria & Victorino量表 8(8.2) 36(36.7) 54(55.1) RECAM量表 29(29.6) 60(61.2) 9(9.2) 表 3 全部DILI患者不同因果关系评估量表之间的一致性检验结果
Table 3. The agreement among the different causality assessment scales using weighted kappa values for overall DILI patients
项目 诊断一致(例) 诊断不一致(例) κw系数 95%CI P值 RUCAM量表 vs Maria & Victorino量表 40 58 0.207 0.098~0.316 <0.001 Maria & Victorino量表 vs RECAM量表 39 59 0.156 0.061~0.252 0.001 RECAM量表 vs RUCAM量表 62 36 0.469 0.325~0.613 <0.001 表 4 在急性DILI患者中各评估量表诊断分类
Table 4. The diagnostic categories of the assessment scales for acute DILI patients
评估量表 符合诊断[例(%)] 疑诊[例(%)] 不符合诊断[例(%)] RUCAM量表 20(37.0) 28(51.9) 6(11.1) Maria & Victorino量表 7(13.0) 24(44.4) 23(42.6) RECAM量表 19(35.2) 33(61.1) 2(3.7) 表 5 加权kappa检验评估急性DILI患者不同因果关系量表之间的一致性
Table 5. The agreement among the different causality assessment scales using weighted kappa values for acute DILI patients
项目 诊断一致(例) 诊断不一致(例) κw系数 95%CI P值 RUCAM量表 vs Maria & Victorino量表 19 35 0.125 -0.027~0.277 0.098 Maria & Victorino量表 vs RECAM量表 23 31 0.121 -0.017~0.259 0.054 RECAM量表 vs RUCAM量表 35 19 0.415 0.211~0.619 <0.001 表 6 在慢性DILI患者中各评估量表诊断分类
Table 6. The diagnostic categories of the assessment scales for chronic DILI patients
评估量表 符合诊断[例(%)] 疑诊[例(%)] 不符合诊断[例(%)] RUCAM量表 10(22.7) 19(43.2) 15(34.1) Maria & Victorino量表 1(2.3) 12(27.3) 31(70.4) RECAM量表 10(22.7) 27(61.4) 7(15.9) 表 7 加权kappa检验评估慢性DILI患者不同因果关系量表之间的一致性
Table 7. The agreement among the different causality assessment scales using weighted kappa values for chronic DILI patients
项目 诊断一致(例) 诊断不一致(例) κw系数 95%CI P值 RUCAM量表 vs Maria & Victorino量表 21 23 0.237 0.104~0.371 0.006 Maria & Victorino量表 vs RECAM量表 16 28 0.147 0.028~0.266 0.018 RECAM量表 vs RUCAM量表 28 16 0.510 0.314~0.707 <0.001 表 8 在肝细胞型DILI患者中各评估量表诊断分类
Table 8. The diagnostic categories of the assessment scales for hepatocellular DILI patients
评估量表 符合诊断[例(%)] 疑诊[例(%)] 不符合诊断[例(%)] RUCAM量表 16(28.6) 28(50.0) 12(21.4) Maria & Victorino量表 4(7.1) 17(30.4) 35(62.5) RECAM量表 18(32.2) 33(58.9) 5(8.9) 表 9 加权kappa检验评估肝细胞型DILI患者不同因果关系量表之间的一致性
Table 9. The agreement among the different causality assessment scales using weighted kappa values for hepatocellular DILI patients
项目 诊断一致(例) 诊断不一致(例) κw系数 95%CI P值 RUCAM量表 vs Maria & Victorino量表 20 36 0.135 0.012~0.258 0.063 Maria & Victorino量表 vs RECAM量表 19 37 0.097 -0.004~0.199 0.069 RECAM量表 vs RUCAM量表 37 19 0.507 0.320~0.695 <0.001 表 10 在胆汁淤积型和混合型DILI患者中各评估量表诊断分类
Table 10. The diagnostic categories of the assessment scales for cholestatic and mixed DILI patients
评估量表 符合诊断[例(%)] 疑诊[例(%)] 不符合诊断[例(%)] RUCAM量表 12(30.0) 19(47.5) 9(22.5) Maria & Victorino量表 4(10.0) 17(42.5) 19(47.5) RECAM量表 9(22.5) 27(67.5) 4(10.0) 表 11 加权kappa检验评估胆汁淤积型和混合型DILI患者不同因果关系量表之间的一致性
Table 11. The agreement among the different causality assessment scales using weighted kappa values for cholestatic and mixed DILI patients
项目 诊断一致(例) 诊断不一致(例) κw系数 95%CI P值 RUCAM量表 vs Maria & Victorino量表 20 20 0.334 0.138~0.530 0.001 Maria & Victorino量表 vs RECAM量表 20 20 0.276 0.085~0.467 0.001 RECAM量表 vs RUCAM量表 24 16 0.403 0.172~0.634 <0.001 -
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