Abstract: Objective To analyze the traditional Chinese medicine (TCM) syndromes and combined medication of liver injury caused by Tripterygium wilfordii preparation in patients with rheumatoid arthritis. Methods The clinical data of patients with rheumatoid arthritis treated with Tripterygium wilfordii preparation in Honghu Hospital of Traditional Chinese Medicine from December 22, 2014 to December 10, 2020 were retrospectively collected, and divided into observation group and control group according to the presence or absence of liver injury. The SNK-Q test or Nemenyi test was used for comparison between the two groups to explore the characteristics of TCM syndromes and combined medication. Results A total of 635 patients with rheumatoid arthritis who used Tripterygium wilfordii preparation were collected in the past six years; The majority of people aged 40 to 59 years old (56.69%); Adult females are more than males, the ratio of males to females is 1∶3.12; Among them, 349 patients with liver injury (observation group) and 286 patients without liver injury (control group) were matched with the same treatment at the same time. The proportion of patients with liver injury complicated by hypertension (P=0.003) was significantly higher than that of the control group. In the treatment of rheumatoid arthritis, Huangteng extract tablets were used in combination with other TCM based on syndrome differentiation, among which Qingre Tongbi tablets (damp-heat obstruction syndrome) accounted for the most proportion, and the proportion of patients with liver injury decreased (P=0.047). Most of the patients were also combined with other drugs, among which the proportion of liver injury was significantly higher in the patients combined with TCM decoction (P<0.001), TCM liquor (P=0.026), meloxicam (P=0.03), leflunomide (P<0.001) and/or non-steroidal anti-inflammatory drugs (P=0.012). In the observation group of liver injury, the level of serum alkaline phosphatase in patients with damp-heat obstruction syndrome (P=0.008) was significantly higher than that in patients with cold-dampness obstruction syndrome (P=0.029); The serum uric acid level in the damp-heat obstruction syndrome group was significantly higher than that in the qi and blood deficiency syndrome group (P=0.013). The degree of liver injury is mainly mild to moderate, and most patients have a good prognosis. Conclusion Tripterygium wilfordii single preparation (Huangteng extract tablet) combined with other TCM based on syndrome differentiation was the common clinical TCM treatment of rheumatoid arthritis. Reasonable combination of Qingre Tongbi tablet under the damp-heat obstruction syndrome could reduce the occurrence of liver injury to a certain extent. However, the combination of other TCM decoction, TCM liquor, meloxicam, leflunomide or non-steroidal anti-inflammatory drugs increased the incidence of liver injury.

Key words: rheumatoid arthritis, Tripterygium wilfordii, drug induced liver injury, TCM syndrome differentiation, combined medication