Study on the Therapeutic Effect and Antioxidant Mechanism of Shugan Jianpi Granules on Patients with Mild to Moderate Atopic Dermatitis Complicated with Sleep Disturbances

YIN Qiang; LI Danyang; DUAN Xingwu; ZHOU Siyao; WU Zhimin; ZHAO Jiuli

Abstract：Objective To observe the clinical efficacy and explore antioxidant mechanism of Shugan Jianpi granules in treating atopic dermatitis (AD) combined with sleep disturbances (SDs).Methods 58 adult patients meeting the inclusion criteria for mild to moderate AD with SDs were randomly assigned to a treatment group and a control group,with 29 patients in each group.Both groups underwent a 4-week intervention.The treatment group received Shugan Jianpi granules in combination with Chushi Zhiyang ointment,while the control group received Cetirizine Hydrochloride tablets in combination with Chushi Zhiyang ointment.This study assessed and compared the differences in atopic dermatitis index (SCORAD) scores,insomnia severity index (ISI) scores,and hospital anxiety and depression scale (HADS) scores,routine blood tests,liver and kidney function indicators,serum levels of 5-HT,SOD,and MDA between two groups before and after treatment.A correlation analysis was conducted on the aforementioned scores and indicators.Results The treatment group showed a total effective rate of 89.66％,which is significantly higher than 65.52％ observed in the control group (P<0.05).Following the interventions,both groups exhibited a significant reduction in scores of SCORAD,ISI,and HADS,as well as a notable decrease in serum levels of MDA.Concurrently,increased serum levels of 5-HT and SOD were observed in the groups.The treatment group exhibited significantly decreased SCORAD(P<0.05) and ISI(P<0.01) scores and increased serum SOD levels (P<0.05) compared to the control.Additionally,the patients'ISI scores were negatively correlated with serum 5-HT (r=-0.342,P<0.01) and SOD (r=-0.311,P<0.01) levels,while the SCORAD scores were positively correlated with MDA (r=0.329,P<0.01) but negatively correlated with SOD(r=-0.277,P<0.05) levels.Shugan Jianpi granules were also found to be safe throughout the treatment.Conclusion Shugan Jianpi granules have demonstrated notable efficacy in AD complicated by SDs,which may be attributed to its capacity to elevate serum 5-HT levels and reduce oxidative stress.