一种改良诊断量表在急性药物性肝损伤诊断中的应用

Application of a modified diagnostic scale in diagnosis of acute drug-induced liver injury

目的建立一种急性药物性肝损伤(DILI)的改良诊断量表并在临床验证使用。方法收集2011年1月-2015年12月在首都医科大学附属北京佑安医院治疗的82例急性DILI患者,其中DILI组52例,非DILI组30例。在Roussel Uclaf因果关系评价表(RUCAM)基础上,参考DDW-J量表,新增"中药单药或成药有肝损伤的报道"、"嗜酸性粒细胞计数"和"基于CCK-8法的药物淋巴细胞刺激试验"3个参数,建立一种改良诊断量表。对2组患者的每种可疑药物分别进行RUCAM和改良诊断量表评分,验证新量表对DILI诊断的敏感度和特异度。计数资料组间比较采用χ~2检验。结果 DILI组共75个可疑药物;非DILI组共41个可疑药物。与RUCAM相比,改良诊断量表可将DILI组中评估为"高度可能"和"很可能"的诊断敏感度由74.7%提高至94.7%(χ~2=11.554,P=0.001);而非DILI组只有2个药物(4.9%)的评估结果由"可能"变为"很可能",其余药物均维持"可能"、"不太可能"和"可除外",诊断特异度由100%降至95.1%(χ~2=0.512,P=0.474)。结论建立了一种急性DILI的改良诊断量表,与RUCAM相比,诊断敏感度提高,特异度有所降低,可在临床中进一步验证使用。

Objective To investigate the application of a modified diagnostic scale in the diagnosis of acute drug-induced liver injury（DILI）.Methods A total of 82 patients with acute DILI who were treated in Beijing You An Hospital,Capital Medical University from January 2011 to December 2015 were enrolled,among whom 52 were enrolled in DILI group and 30 were enrolled in non-DILI group.On the basis of Roussel Uclaf Causality Assessment Method（RUCAM） scale and with reference to Digestive Disease Week Japan scale,three parameters,i.e.,＂report of liver injury induced by single Chinese materia medica or Chinese patent medicine＂,＂eosinophil count＂,and ＂drug lymphocyte stimulation test based on Cell Counting Kit-8＂,were added to establish a modified diagnostic scale.The RUCAM scale and the modified diagnostic scale were used to evaluate each suspected drug to verify the sensitivity and specificity of this new scale in the diagnosis of DILI.The chi-square test was used for comparison of categorical data between groups.Results There were 75 suspected drugs in the DILI group and 41 suspected drugs in the non-DILI group.Compared with the RUCAM scale,the modified diagnostic scale increased the number of drugs evaluated as ＂highly probable＂ and ＂probable＂ from 74.7% to 94.7%（χ^2=11.554,P=0.001） in the DILI group.In the non-DILI group,only 2 drugs（4.9%） were changed from＂possible＂to＂probable＂,and the other drugs were maintained as ＂possible＂,＂unlikely＂,or＂excluded＂;the specificity of diagnosis was reduced from 100% to 95.1%（χ^2=0.512,P=0.474）.Conclusion Compared with the RUCAM scale,this modified diagnostic scale has an increased sensitivity and a reduced specificity of diagnosis and needs to be further validated in clinical practice.