摘要Background:Atopic eczema is the most common type of skin disorder in both children and adults.It is characterized by erythema,pruritus,papules,xeransis,and lichenification.The Kangmin Ⅰ decoction,a Chinese herbal medicine prepared with several ingredients and used to treat eczema,was formulated according to traditional Chinese medicine theory.Objectives:To investigate the efficacy and safety of Kangmin Ⅰ decoction for treating atopic eczema compared to that of loratadine.Methods:90 patients were enrolled at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine and randomly divided into the Kangmin Ⅰ decoction treatment group(n=45)and loratadine control group(n=45).Clinical efficacy was evaluated using the Eczema Area and Severity Index(EASI),Dermatology Life Quality Index(DLQI),adverse events(AEs),and recurrence rates,which were compared between the groups.Results:Compared to the loratadine control group(51.16％,18.60％),the Kangmin Ⅰ decoction group(7.72％,4.55％)displayed a significantly reduced effective rate(x2=8.324,P=0.040)and recurrence rate(x2=4.225,P=0.040).The incidence of AEs was similar between the groups(P=0.502).Conclusions:These results support further development of Kangmin Ⅰ decoction for the treatment of eczema.The Kangmin Ⅰ decoction showed good efficacy with a low recurrence rate and tolerable AEs.The main limitations of this study include the small sample size and the short treatment and follow-up periods.Larger controlled studies are needed to more adequately evaluate both safety and efficacy.