Abstract:Objective To explore the potential mechanism of bulleyaconitine A soft capsules in relieving osteoarthritis pain based on the changes of serum NOD- like receptor pyrin domain- containing protein 3（NLRP3）inflammasome level. Methods A prospective study was conducted on 80 patients with osteoarthritis admitted to Xi’an Honghui Hospital from January 2022 to December 2023. The patients were randomly divided into the treatment group and the control group，with 40 cases in each group. The control group was treated with imrecoxib tablets，while the treatment group was treated with imrecoxib tablets combined with bulleyaconitine A soft capsules. One course of treatment lasted 4 weeks，and both groups received 2 courses of treatment. The levels of NLRP3 inflammasome and its activated downstream inflammatory factors ［interleukin（IL）- 1β，IL - 18］，joint function［Western Ontario and McMaster Universities Osteoarthritis Index（WOMAC）score］，pain score［Visual Analogue Scale（VAS）score］before treatment，at 4 weeks and 8 weeks after treatment，and clinical efficacy，incidence of adverse reactions were compared between the two groups. Results The total effective rate of the treatment group was higher than that of the control group（95.00% vs 80.00%，χ2=4.114，P<0.05）. After 4 and 8 weeks of treatment，the serum levels of NLRP3，IL-1β，and IL-18 in both groups were lower than those before treatment，and the levels in the treatment group were lower than those in the control group （P<0.05）；the WOMAC scores and VAS scores in both groups were lower than those before treatment，and the scores in the treatment group were lower than those in the control group（P<0.05）. There was no statistically significant difference in the total incidence of adverse reactions between the two groups（P>0.05）.Conclusion Bulleyaconitine A soft capsules can relieve the symptoms of joint pain in patients with osteoarthritis by regulating the level of serum NLRP3，and can help improve the joint function of patients，with certain safety.