| Objective To study the efficacy and safety of Bitter Ginseng Tang modified formula in the treatment of mild to moderate atopic dermatitis in infancy,to explore the possible mechanism of Bitter Ginseng Tang modified formula in the treatment of atopic dermatitis in infancy,and then to promote the application of Bitter Ginseng Tang modified formula in clinical practice.Methods From June 2021 to December 2021,a total of 60 children who met the diagnosis of mild to moderate atopic dermatitis in infancy were screened at Dongyang Dermatology Hospital and randomly divided into a test group and a control group,with 30 children in each group.In the test group,an appropriate amount of room-temperature bitter ginseng formula solution was taken,and sterilized cotton balls or gauze were soaked in the solution for 1-2 minutes and then the affected area was rubbed with the sterilized cotton balls or gauze full of the solution,which was repeated 3-5 times after the skin dried,twice a day.In the control group,an appropriate amount of the original bitter ginseng formula solution was taken at room temperature and applied in the same way as the test group.The EASI scores,IGA scores and BSA scores of the two groups were recorded at the follow-up visits on days 0,8 and 15,respectively,and the relevant rash scores of the two groups were compared within and between groups at different visit points to compare whether their differences in efficacy were significant.A 2-week observation period was conducted at the end of the treatment,and the safety and recurrence of the two groups were evaluated by observation of local skin tolerance and related test results on the 29th day.Results A total of 60 children in the current clinical study met the entry criteria,with an average age of 15 months,33 male children and 27 female children.Thirty were treated with the original recipe and 30 with the modified recipe.At day 8,the mean percentage change of EASI score in the test group was-41.66%,and-34.37%in the control group,the difference was significant（P<0.05）.The mean percentage change in BSA score was-37.01%,-33.07%in the control group,P<0.05,with a significant difference between groups,indicating that the treatment interim trial group had better efficacy than the control group.The mean percentage change in EASI score in the test group at day 15 was-76.23%and-66.79%in the control group,P<0.05,and was statistically significant.The mean percentage change of BSA score in the test group was-71.68%,and-57.17%in the control group.The difference between the two groups was P<0.05.In conclusion,the efficacy of the test group at the end of the treatment period was still significantly higher than that of the control group.At day 15,the number of the trial group reaching the primary efficacy endpoint was 20,accounting for 66.67%,and 12 in the control group,the percentage was 40.00%,P>0.05,with no statistically significant difference.The number of people who reached EASI-50 was 30,accounting for 100.00%,and the number in the control group was 27,accounting for 90.00%.Statistical difference between the two groups was significant（P<0.05）,indicating that the two groups had significant differences in EASI improvement greater than or equal to 50%.The number of people reaching EASI-75 was 17,the percentage was 56.67%,and that in the control group was 8,accounting for 26.67%,P>0.05,indicating that there was no significant difference between the two groups in EASI improvement greater than or equal to 75%.The number of people reaching EASI-90 was 6,accounting for 20.00%,and the control group was 2.accounting for 6.67%,P>0.05,also no statistical difference.At day8,15,29,the observed score difference of local skin tolerance was compared between the two groups,and P was all less than 0.05,indicating that the test group had better safety and tolerance.Conclusion The modified formulation of bitter ginseng formula is more effective and safe in the treatment of mild to moderate atopic dermatitis in infancy. |
PDF Full Text Request