Abstract: 【Abstract】 Objective To compare the efficacy and safety of Fuzhiqing ointment and triamcinolone acetonide and econazole nitrate cream in the treatment of chronic perianal eczema. Method This study was a multicenter, randomized, double?blind, controlled clinical trial. A total of 292 patients with chronic perianal eczema were enrolled from the proctology departments of 18 hospitals. Eligible patients were randomly assigned in a 1∶1 ratio to receive either Fuzhiqing ointment or triamcinolone acetonide and econazole nitrate cream. Both treatments were administered topically to the affected area twice daily （morning and evening） for 4 consecutive weeks. At weeks 1, 2, and 4 after treatment initiation, pruritus severity was evaluated using the numeric rating scale （NRS） and the patient?oriented eczema measure （POEM）. the severity of perianal skin lesions was assessed using the modified eczema area and severity index （EASI）, and quality of life was evaluated using the dermatology life quality index （DLQI）. in addition, treatment efficacy and patient satisfaction were compared between the two groups. Adverse events were recorded throughout the study period to assess safety. Statistical analysis was performed using the chi?square test for categorical variables and generalized estimating equations （GEE） for repeated measures data. Result A total of 292 patients were enrolled. In the Fuzhiqing ointment group, there were 72 male cases and 74 female cases, with an average age of 41.49 ± 14.94 years. In the triamcinolone acetonide econazole cream group, there were 75 male cases and 71 female cases, with an average age of 40.47 ± 14.02 years. The numbers of patients included in the analysis were 262 at week 1, 259 at week 2, and 256 at week 4. There were no significant differences between the two groups in sex, age, educational level, body mass index, employment status, smoking status, or alcohol consumption （all P > 0.05）. At week 1, the overall response rates were 37.3% （50/134） in the Fuzhiqing ointment group and 42.2% （54/128） in the triamcinolone acetonide and econazole nitrate cream group （P = 0.273）. At week 2, the rates were 70.7% （94/133） and 71.4% （90/126）, respectively （P = 0.860）, and at week 4, 82.4% （108/131） and 83.2% （104/125）, respectively （P = 0.703）. There were no significant differences in efficacy between the two groups at any time point. At baseline and at weeks 1, 2, and 4, there were no significant differences between the two groups in NRS, POEM, modified EASI, or DLQI scores （all P > 0.05）. In both groups, all scores decreased significantly over time compared with the previous time point （all P < 0.05）. There were no significant differences in patient satisfaction between the two groups at weeks 1, 2, or 4 （all P > 0.05）. One patient in the Fuzhiqing ointment group and two patients in the triamcinolone acetonide and econazole nitrate cream group discontinued treatment due to adverse events, including perianal rash and worsening pruritus; all patients recovered after drug withdrawal. Conclusion Fuzhiqing ointment and triamcinolone acetonide and econazole nitrate cream demonstrate comparable clinical efficacy in the treatment of chronic perianal eczema, with a low incidence of adverse events.

Key words: Eczema, Chronic perianal eczema, Therapy, Fuzhiqing ointment, Triamcinolone acetonide and econazole nitrate cream, Equivalence trial, Comparative effectiveness research, Safety