中国临床药理学杂志2026，Vol.42Issue(14)：1992-1996,5.DOI:10.13699/j.cnki.1001-6821.2026.14.007
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
Clinical trial of Longzhu ointment on moderate acne vulgaris:A randomized,blinded,positive-drug parallel-controlled,multicenter study
张丰川 1闫小宁 2李文彬 2邹雅欣 2李琳琳 2陈璐 2贾敏 3曾义燕 3文昌晖 3胡文韬 3吴然 3蔡玲玲 1贺爱娟 3叶建州 4黄虹 4张佩莲 4杨瑾 4王金容 4胡桂兰 4孔宇虹 1孙占学 5杨嫣然 5聂晶 5李悦 5陈信生 6莫秀梅6
作者信息
- 1. 北京中医药大学东方医院皮肤科,北京 100078
- 2. 陕西省中医医院皮肤科,陕西西安 710003
- 3. 贵州中医药大学第一附属医院皮肤科,贵州贵阳 550001
- 4. 云南省中医医院皮肤科,云南 昆明 650032
- 5. 北京中医药大学第三附属医院皮肤科,北京 100191
- 6. 广东省中医皮肤病研究所,广东 广州 510120
- 折叠
摘要
Abstract
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.关键词
龙珠软膏/过氧苯甲酰凝胶/寻常型痤疮/炎性皮损计数Key words
Longzhu ointment/benzoyl peroxide gel/acne vulgaris/inflammatory lesion count分类
医药卫生引用本文复制引用
张丰川,闫小宁,李文彬,邹雅欣,李琳琳,陈璐,贾敏,曾义燕,文昌晖,胡文韬,吴然,蔡玲玲,贺爱娟,叶建州,黄虹,张佩莲,杨瑾,王金容,胡桂兰,孔宇虹,孙占学,杨嫣然,聂晶,李悦,陈信生,莫秀梅..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[J].中国临床药理学杂志,2026,42(14):1992-1996,5.
