ABSTRACT
Objective To evaluate the efficacy and safety of Chushizhiyang ointment for the treatment of mild atopic dermatitis in infants.Methods A multicenter,randomized,open,active-controlled clinical trial was conducted.A total of 204 infants with atopic dermatitis were enrolled and randomly divided into 2 groups to be topically treated with Chushizhiyang ointment (test group,n =103) and hydrocortisone butyrate cream (control group,n =101),respectively,for 2 weeks.The improvement of eczema area and severity index (EASI) scores and quality of life was evaluated at 7 days and 14 days after the treatment,so was the incidence of adverse events and adverse reactions.Results Ninety-eight infants in the test group and 101 in the control group were included in the full analysis set,which revealed that the disease severity significantly decreased after the treatment in both groups.The EASI scores at the baseline and on days 7 and 14 were 2.47 ± 4.04,0.92 ± 1.25 and 0.39 ± 1.04 respectively in the test group,as well as 2.13 ± 2.01,0.85 ± 1.58 and 0.45 ± 1.65 respectively in the control group.Furthermore,the test group and control group both showed that EASI scores on days 7 and 14 significantly decreased compared with those at the baseline (the test group:T =-1 666,-1 793,respectively,both P ＜ 0.001;the control group:T =-1 951,-1 941,respectively,both P ＜ 0.001).No significant differences in EASI scores at the baseline or on days 7 and 14 were observed between the test group and control group (all P ＞ 0.05).The response rates in the test group and control group were 47.96％ (47/98) and 55.44％ (56/101) respectively on day 7,as well as 79.59％ (78/98) and 84.16％ (85/101) respectively on day 14,and there were also no significant differences between the two groups (both P ＞ 0.05).The adverse reactions mainly manifested as erythema,itching and scaling in the test group,as well as hypopigmentation,telangiectasia,scaling and hyperpigmentation in the control group.No significant difference in the incidence of adverse events was found between the test group (2.9％,3/103) and control group (6.9％,7/101).Conclusion Chushizhiyang ointment shows definite efficacy for mild atopic dermatitis in infants with good safety and tolerability,and can be a teatment option for mild atopic dermatitis in infants.
ABSTRACT
Objective To explore the anti-inflammatory and antipruritic effects of Chushizhiyang ointment in a mouse model. Methods A total of 40 male 8-week-old BALB/c mice were included in this study, and randomly and equally divided into 4 groups. A mouse model of atopic dermatitis (AD)was established in three groups of mice by repeated application of 2,4-dinitroflurobenzene (DNFB)to shaved abdominal skin for sensitization and to shaved dorsal skin for stimulation. After establishment of the AD model, the three groups were topically treated with sodium chloride physiological solution (model group), hydrocortisone cream (hydrocortisone group)and Chushizhiyang ointment (Chushizhiyang group)respectively for 14 consecutive days. The remaining group receiving no sensitization or treatment served as the normal control group. All the mice were sacrificed 12 hours after the final treatment, and the dorsal skin of mice was resected followed by the determination of skin thickness and weight as well as hematoxylin-eosin(HE)staining and toluidine blue staining for the counting of leukocytes and mast cells respectively. Moreover, enzyme-linked immunosorbent assay(ELISA)was performed to measure the levels of interferon-gamma(IFN-γ), tumor necrosis factor alpha(TNF-α), interleukin 4(IL-4)and IL-5 in dorsal skin lesions. In addition, a local skin itching model was induced by histamine phosphate in Hartley guinea pigs, which was used to explore the effect of Chushizhiyang ointment on itch thresholds. Results Compared with the model group, both the Chushizhiyang group and hydrocortisone group showed reduced thickness and weight of dorsal skin in mice (all P < 0.01), numbers of infiltrating lymphocytes and mast cells (all P < 0.01)and levels of IFN-γ, TNF-α, IL-4 and IL-5 in skin lesions (P < 0.05 or 0.01)on day 15 after the start of treatment. The thickness and weight of dorsal skin in mice were significantly decreased in the hydrocortisone group (P <0.01), but experienced no significant changes in the Chushizhiyang group compared with the normal control group. Additionally, Chushizhiyang ointment could significantly increase itch thresholds in guinea pigs induced by histamine phosphate(P < 0.01). Conclusions Chushizhiyang ointment can significantly inhibit DNFB-induced AD in mice, likely by restoring the balance between Th1 and Th2 type cytokines. Moreover, Chushizhiyang ointment could markedly relieve itching induced by histamine phosphate in guinea pigs.