龙珠软膏治疗中度寻常型痤疮的随机、盲法、阳性药平行对照、多中心临床研究OA

Objective To investigate the efficacy and safety of Longzhu ointment in the treatment of moderate acne vulgaris.Methods Moderate acne vulgaris patients who met the inclusion criteria were divided into the treatment group and the control group according to the treatment regiment.The treatment group received topical Longzhu ointment plus benzoyl peroxide gel placebo,while the control group received topical benzoyl peroxide gel plus Longzhu ointment placebo.All medications were applied once daily at night for a 2-week treatment course.The changes in inflammatory lesion count,non-inflammatory lesion count,and Investigator's Global Assessment(IGA)score were recorded at baseline,day 8 of treatment,and day 15 of treatment.Intra-group and inter-group comparison was performed,and adverse drug reaction were documented throughout the study.Results A total of 244 patients were screened,with 120 patients allocated to the treatment group and 120 patients to the control group.In the treatment group,2 patients violated the trial protocol and 1 patient withdrew voluntarily;in the control group,2 patients violated the trial protocol,1 patient was lost to follow-up,and 1 patient dropped out due to adverse events.Finally,117 patients in the treatment group and 116 patients in the control group were included in the efficacy analysis.On day 8 of treatment,the percentage change in inflammatory lesion count was(22.00±30.00)％in the treatment group and(26.00±25.00)％in the control group;the percentage change in non-inflammatory lesion count was(16.00±29.00)％and(22.00±28.00)％,respectively;the IGA treatment success rate was 24.79％(29 cases/117 cases)and 29.31％(34 cases/116 cases),while intergroup comparisons showed no statistically significant differences between the two groups(all P＞0.05).On day 15 of treatment,the percentage change in inflammatory lesion count was(42.00±31.00)in the treatment group and(48.00±27.00)in the control group;the percentage change in non-inflammatory lesion count was(34.00±32.00)％and(40.0±32.00)％,respectively;the IGA treatment success rate was 58.12％(68 cases/117 cases)and 69.83％(81 cases/116 cases)respectively,while intergroup comparisons showed no statistically significant differences between the two groups(all P＞0.05).Adverse drug reactions in the treatment group included mild stinging,mild pruritus,burning sensation and dryness;those in the control group included mild stinging,mild pruritus,dryness and desquamation.The total incidence of adverse drug reactions was 4.17％(5 cases/120 cases)in the treatment group and 13.33％(16 cases/120 cases)in the control group,with a statistically significant difference between the two groups(P＜0.05).Conclusion Longzhu ointment demonstrates comparable clinical efficacy to benzoyl peroxide gel in the treatment of moderate acne vulgaris,with a better safety profile.