Clinical characteristics of 84 cases of drug-induced liver injury caused by Chinese patent medicines

Abstract

Abstract: Objective To analyze the medication usage, laboratory test results, types of liver injury, and clinical outcomes in patients with drug-induced liver injury (DILI) caused by Chinese patent medicines, and to provide robust data support for safe clinical medication practices and pharmaceutical supervision. Methods Patients diagnosed with primarily or secondarily as “drug-induced liver injury” or “drug-induced hepatitis” between January 2022 and December 2024 were sellected. A total of 84 DILI cases caused by Chinese patent medicines were included, comprising 41 cases of hepatocellular injury type, 29 cases of cholestatic type, and 14 cases of mixed type. The suspected ingredients of the Chinese patent medicines and patient prognoses were analyzed. Clinical symptoms and biochemical parameters were compared across different clinical types of DILI. Results The most common suspected ingredients in Chinese patent medicines associated with DILI were Polygonum multiflorum (He Shou Wu) and its related preparations, tripterygium glycosides tablets, and Zhuanggu Guanjie Pills. Among the 84 cases, there were 41 cases of hepatocellular injury type, 29 cases of cholestatic type, and 14 cases of mixed type. The most common clinical symptoms included fatigue, loss of appetite, and jaundice. Comparisons showed no statistically significant differences in the main clinical symptoms among the three types of DILI (P>0.05). However, the incidence of pruritus was significantly higher in patients with cholestatic and mixed types than in those with hepatocellular injury type (P<0.05). Before treatment, ALT and AST levels were significantly higher in the hepatocellular and mixed types compared to the cholestatic type (P<0.05), while ALP and TBil levels were significantly elevated in the cholestatic and mixed types compared to the hepatocellular type (P<0.05). After treatment, liver function indices in all types significantly improved from baseline (P<0.05). All patients recovered and were discharged following the withdrawal of suspected causative agents and standard hepatoprotective therapy. No cases of liver failure or death occurred. Conclusion DILI caused by Chinese patent medicines primarily manifests as hepatocellular and cholestatic types. Clinical symptoms are often non-specific, and diagnosis relies on detailed medication history and dynamic monitoring of liver function indicators. With timely withdrawal of the offending drug and proper hepatoprotective treatment, patients generally have favorable outcomes.

Key words: Drug-induced liver injury, Chinese patent medicine, Hepatocellular injury type

NIE Hong, SONG Jie, ZHANG Hui, WANG Rui, LOU Ting-ting, WU Jian-jun. Clinical characteristics of 84 cases of drug-induced liver injury caused by Chinese patent medicines[J]. Chinese Hepatolgy, 2026, 31(4): 545-548.

References

[1] Zhang Y, Lu C, Xu J, et al. Novel integrative models to predict the severity of inflammation and fibrosis in patients with drug-induced liver injury[J]. Front Med (Lausanne), 2025, 12:1571406.
[2] Pradhan R R, Yadav A K. Incidence, clinical features, associated factors and outcomes of intensive phase antituberculosis drug induced liver injury among patients with tuberculosis at a tertiary care hospital in Nepal: a descriptive cross-sectional study[J]. Health Sci Rep, 2025, 8(4):e70686.
[3] Vincenzi B, Yimin M, Andrade R J, et al. Management of drug-induced liver injury associated with anti-cancer therapy[J]. Front Physiol, 2025, 16:1541020.
[4] Wang Q, Wang L, Lyu W. Understanding drug-induced liver injury from the perspective of traditional Chinese medicine theory-Huohou theory of traditional Chinese medicine[J]. Hepatobiliary Surg Nutr, 2025, 14(1):166-168.
[5] Zhao J, Liang H, Li Y, et al. Impact of traditional Chinese medicine antioxidants on oxidative stress and drug-induced liver injury: a review[J]. Med Sci Monit, 2024, 30:e945147.
[6] Mao Y, Ma S, Liu C, et al. Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update[J]. Hepatol Int, 2024, 18(2):384-419.
[7] 支阳, 董一诺, 茅益民. 2024年度药物性肝损伤领域研究进展[J]. 中华肝脏病杂志, 2025, 33(2):125-127.
[8] 中国医药生物技术协会药物性肝损伤防治技术专业委员会, 中华医学会肝病学分会药物性肝病学组, 茅益民. 中国药物性肝损伤诊治指南(2023年版)[J]. 胃肠病学, 2023, 28(7):397-431.
[9] Zhang L, Niu M, Wei A W, et al. Risk profiling using metabolomic characteristics for susceptible individuals of drug-induced liver injury caused by polygonum multiflorum[J]. Arch Toxicol, 2020, 94(1):245-256.
[10] 余辞源, 刁建萍. 类风湿关节炎患者使用雷公藤多苷片致肝损伤的临床特征分析[J]. 中成药, 2024, 46(6):2115-2117.
[11] Guo L, Yang Y, Ma J, et al. Triptolide induces hepatotoxicity by promoting ferroptosis through Nrf2 degradation[J]. Cell Biol Toxicol, 2024, 40(1):94.
[12] 唐进法, 李伟霞, 王晓艳, 等. 基于代谢组学的壮骨关节丸致特异质肝损伤相关易感生物标志物筛查[J]. 中华中医药杂志, 2018, 33(10):4336-4340.
[13] Yeboah-Korang A, Memon A, Patel N, et al. Impact of prior drug allergies on the risk, clinical features, and outcomes of idiosyncratic drug-induced liver injury in adults[J]. Dig Dis Sci, 2022, 67(11):5262-5271.
[14] Nawaz N, Mistretta T, Karime C, et al. Cholestatic drug-induced liver injury in a patient taking high-dose niacin for hyperlipidemia[J]. J Investig Med High Impact Case Rep, 2024, 12:23247096231224349.
[15] Drees A, Nassiri V, Tabernilla A, et al. Optimization of the drug-induced cholestasis index based on advanced modeling for predicting liver toxicity[J]. Toxicology, 2025, 514:154119.