Yun Zhu1,2, Ming Niu1, Jing Chen1,2,3, Zheng-Sheng Zou4, Zhi-Jie Ma1,5, Shu-Hong Liu6, Rui-Lin Wang7, Ting-Ting He2, Hai-Bo Song8, Zhong-Xia Wang2, Shi-Biao Pu1, Xiao Ma1, Li-Fu Wang2, Zhao-Fang Bai1, Yan-Ling Zhao1, Yong-Gang Li7, Jia-Bo Wang1, Xiao-He Xiao2. 1. China Military Institute of Chinese Medicine, 302 Military Hospital, Beijing, China. 2. Integrative Medical Center, 302 Military Hospital, Beijing, China. 3. Luhe Hospital of Tongzhou District, Beijing, China. 4. Diagnosis and Treatment Center for Non-infectious Diseases, 302 Military Hospital, Beijing, China. 5. Beijing Friendship Hospital, Capital Medical University, Beijing, China. 6. Department of Pathology, 302 Military Hospital, Beijing, China. 7. Department of traditional Chinese medicine, 302 Military Hospital, Beijing, China. 8. Center for Drug Reevaluation, China Food and Drug Administration, Beijing, China.
Abstract
BACKGROUND AND AIM: Chinese herbal medicine (CHM), as well as Western medicine (WM), is an important cause of drug-induced liver injury (DILI). However, the differences between CHM and WM as agents implicated in liver injury have rarely been reported. METHODS: Overall, 1985 (2.05%) DILI cases were retrospectively collected from the 96 857 patients hospitalized because of liver dysfunction in the 302 Military Hospital between January 2009 and January 2014. RESULTS: In all the enrolled patients with DILI, CHM was implicated in 563 cases (28.4%), while 870 cases (43.8%) were caused by WM and the remaining patients (27.8%) by the combination of WM and CHM. Polygonum multiflorum was the major implicated CHM. Compared with WM, the cases caused by CHM showed more female (51 vs 71%, P < 0.001) and positive rechallenge (6.1 vs 8.9%, P = 0.046), a much greater proportion of hepatocellular injury (62.2 vs 88.5%, P < 0.001), and a higher mortality (2.8 vs 4.8%, P = 0.042); however, no differences in the rates of chronic DILI and ALF were found (12.9 vs 12.4%, P = 0.807; 7.6 vs 7.6%, P = 0.971). Based on Roussel Uclaf Causality Assessment Method, 75.6% of cases caused by CHM were classified as probable and only 16.6% as highly probable, significantly different from WM (38.4 and 60.3%, all P < 0.001). CONCLUSIONS: The causal relationship between CHM and liver injury is much complex, and the clinical characteristics of DILI caused by CHM differ from those caused by WM.
BACKGROUND AND AIM: Chinese herbal medicine (CHM), as well as Western medicine (WM), is an important cause of drug-induced liver injury (DILI). However, the differences between CHM and WM as agents implicated in liver injury have rarely been reported. METHODS: Overall, 1985 (2.05%) DILI cases were retrospectively collected from the 96 857 patients hospitalized because of liver dysfunction in the 302 Military Hospital between January 2009 and January 2014. RESULTS: In all the enrolled patients with DILI, CHM was implicated in 563 cases (28.4%), while 870 cases (43.8%) were caused by WM and the remaining patients (27.8%) by the combination of WM and CHM. Polygonum multiflorum was the major implicated CHM. Compared with WM, the cases caused by CHM showed more female (51 vs 71%, P < 0.001) and positive rechallenge (6.1 vs 8.9%, P = 0.046), a much greater proportion of hepatocellular injury (62.2 vs 88.5%, P < 0.001), and a higher mortality (2.8 vs 4.8%, P = 0.042); however, no differences in the rates of chronic DILI and ALF were found (12.9 vs 12.4%, P = 0.807; 7.6 vs 7.6%, P = 0.971). Based on Roussel Uclaf Causality Assessment Method, 75.6% of cases caused by CHM were classified as probable and only 16.6% as highly probable, significantly different from WM (38.4 and 60.3%, all P < 0.001). CONCLUSIONS: The causal relationship between CHM and liver injury is much complex, and the clinical characteristics of DILI caused by CHM differ from those caused by WM.
Authors: Juan Liu; Tingting Li; Ruihong Li; Jie Wang; Pengyan Li; Ming Niu; Le Zhang; Chunyu Li; Tao Wang; Xiaohe Xiao; Jia-Bo Wang; Yunfang Wang Journal: Front Pharmacol Date: 2022-05-17 Impact factor: 5.988