Abstract: Objective To report a case of severe liver injury caused by Xinyuan capsule and to explore the general rules and clinical characteristics of liver injury caused by Polygonum multiflorum in the main components of Xinyuan capsule, as to provide a reference for clinical rational drug use. Methods A case of liver injury caused by Xinyuan capsule was reported and analysed. Case reports of liver injury caused by Polygonum multiflorum and its preparations were retrieved and anaylsed.from CNKI, Wanfang Medical Database, and VIP full-text database. Results The top 3 liver injury induced by Polygonum multiflorum preparations were the Polygonum multiflorum decoction (21%), Shouwu Tablet (18%) and Ganoderma lucidum Yishou capsule (16%). The incidence rate of male and female was 1.4: 1. Mostly middle-aged patients aged 51 to 60, accounting for 30.5%. The type of liver injury was mainly hepatocyte injury (94.4%). The time span of liver function injury occurred over a large period, and the incidence was 1 to 3 months after administration, accounting for 61%. Liver injury recovered well after treatment and the average recovery time was (43.19 ± 28.92) days. The patient conditions to the general rules and clinical characteristics of liver injury caused by Polygonum multiflorum preparations. Conclusion Xinyuan capsules and other Polygonum multiflorum preparations can cause liver injury. Clinicians and pharmacists should pay close attention to rational use of drugs to reduce and avoid liver injury.

Key words: Xinyuan capsule, Processed Polygoni Multiflori Radix, drug-induced liver injury, adverse reactions