Objective:To compare the clinical characteristics of patients with drug-induced liver injury (DILI) caused by Polygonum multiflorum and other drug-induced liver injuries (DILI).Methods:A retrospective cohort study was conducted. Clinical data of seventy-three cases confirmedly diagnosed with DILI caused by Polygonum multiflorum, 168 cases diagnosed with DILI caused by other traditional Chinese medicines, and 225 cases diagnosed with DILI caused by modern medicines admitted to Peking University First Hospital, the Fipth People's Hospital of Wuxi, Yantai Qishan Hospital, and Qinhuangdao Third Hospital from January 1995 to August 2019 were selected and collected as the research subjects. The Mann-Whitney U test was used for comparison of skewed distribution of continuous data between two groups. The Kruskal-Wallis rank-sum test was used for comparison between three groups. The χ2 test was used for comparing count data between groups. Results:Among the 73 cases with DILI caused by Polygonum multiflorum, 11 (15.1%) took a single herb of Polygonum multiflorum (including its powder and boiled water), 37 (50.7%) took traditional Chinese patent medicines containing Polygonum multiflorum, and 25 (34.2%) took a traditional Chinese medicine formula containing Polygonum multiflorum. The age of the DILI group caused by Polygonum multiflorum was 48 years old, which was lower than the other two groups (the DILI group caused by other traditional Chinese medicines: 55 years old, the DILI group caused by modern medicines: 52 years old; P<0.01). The levels of alanine aminotransferase (ALT), aspartate aminotransferase, and alkaline phosphatase were all higher than the other two groups ( P<0.05). The proportion of patients with antinuclear antibody positivity rate and severity of liver damage grade 3 was higher in the DILI group induced by Polygonum multiflorum than those in the modern drug-induced DILI group ( P<0.05). The liver cell injury type accounted for 96.6% (57/59) in the DILI group caused by Polygonum multiflorum, which was higher than that in the modern drug-induced DILI group (69.3%, 156/225) ( P<0.001). There was no statistically significant difference ( P>0.05) in gender, age, medication duration, and various biochemical indicators between patients with DILI caused by Polygonum multiflorum monotherapy and compound preparations in terms of compatibility. The ALT level in the DILI group caused by raw Polygonum multiflorum was higher than that in the DILI group caused by processed Polygonum multiflorum [the DILI group caused by raw Polygonum multiflorum: 1 289.0(921.8, 1 851.8)U/L, the DILI group caused by processed Polygonum multiflorum: 890.0(304.0,1 320.0)U/L; P<0.05] according to the comparison of processing methods. Conclusion:The degree of DILI caused by Polygonum multiflorum is more obvious than that caused by other drugs. There was no difference in the degree of DILI caused by the single and the compound formulation. However, the liver damage caused by raw Polygonum multiflorum was more severe than that caused by processed Polygonum multiflorum.

Objective:To compare the clinical characteristics of patients with drug-induced liver injury (DILI) caused by Polygonum multiflorum and other drug-induced liver injuries (DILI).Methods:A retrospective cohort study was conducted. Clinical data of seventy-three cases confirmedly diagnosed with DILI caused by Polygonum multiflorum, 168 cases diagnosed with DILI caused by other traditional Chinese medicines, and 225 cases diagnosed with DILI caused by modern medicines admitted to Peking University First Hospital, the Fipth People's Hospital of Wuxi, Yantai Qishan Hospital, and Qinhuangdao Third Hospital from January 1995 to August 2019 were selected and collected as the research subjects. The Mann-Whitney U test was used for comparison of skewed distribution of continuous data between two groups. The Kruskal-Wallis rank-sum test was used for comparison between three groups. The χ2 test was used for comparing count data between groups. Results:Among the 73 cases with DILI caused by Polygonum multiflorum, 11 (15.1%) took a single herb of Polygonum multiflorum (including its powder and boiled water), 37 (50.7%) took traditional Chinese patent medicines containing Polygonum multiflorum, and 25 (34.2%) took a traditional Chinese medicine formula containing Polygonum multiflorum. The age of the DILI group caused by Polygonum multiflorum was 48 years old, which was lower than the other two groups (the DILI group caused by other traditional Chinese medicines: 55 years old, the DILI group caused by modern medicines: 52 years old; P<0.01). The levels of alanine aminotransferase (ALT), aspartate aminotransferase, and alkaline phosphatase were all higher than the other two groups ( P<0.05). The proportion of patients with antinuclear antibody positivity rate and severity of liver damage grade 3 was higher in the DILI group induced by Polygonum multiflorum than those in the modern drug-induced DILI group ( P<0.05). The liver cell injury type accounted for 96.6% (57/59) in the DILI group caused by Polygonum multiflorum, which was higher than that in the modern drug-induced DILI group (69.3%, 156/225) ( P<0.001). There was no statistically significant difference ( P>0.05) in gender, age, medication duration, and various biochemical indicators between patients with DILI caused by Polygonum multiflorum monotherapy and compound preparations in terms of compatibility. The ALT level in the DILI group caused by raw Polygonum multiflorum was higher than that in the DILI group caused by processed Polygonum multiflorum [the DILI group caused by raw Polygonum multiflorum: 1 289.0(921.8, 1 851.8)U/L, the DILI group caused by processed Polygonum multiflorum: 890.0(304.0,1 320.0)U/L; P<0.05] according to the comparison of processing methods. Conclusion:The degree of DILI caused by Polygonum multiflorum is more obvious than that caused by other drugs. There was no difference in the degree of DILI caused by the single and the compound formulation. However, the liver damage caused by raw Polygonum multiflorum was more severe than that caused by processed Polygonum multiflorum.