中华皮肤科杂志 ›› 2026, e20250421.doi: 10.35541/cjd.20250421

• 药物与临床 •    

肤痔清软膏与曲安奈德益康唑乳膏治疗肛周慢性湿疹的临床疗效和安全性：一项多中心、随机、对照、双盲、等效性研究

孙松朋1    龙俊红1    曹波2    徐月3    张相安4    曹晖5    谢钧6    桂平7    孙小君8    张波9    许志杰10    李进安11    王志刚12    吴伟13    杨会举14    韦平15    刘丛丛16    沈庆波17    俞凡18    褚洪川1    周阳洋1    刘甲鑫1    刘彦1    霍兴霄1    陈航1    荆涛1    高静1    王艳逊1    王锐1    李振宇1    张书信1   

  1. 1北京中医药大学东直门医院肛肠科，北京 100700；2贵州中医药大学第一附属医院肛肠科，贵阳  550001；3重庆市中医院肛肠科，重庆 400013；4河南中医药大学第一附属医院肛肠科，郑州 451200；5湖南中医药大学第一附属医院肛肠科，长沙  410007；6昆明医科大学第二附属医院中医科，昆明650101；7广东医科大学附属东莞第一医院肛肠外科，东莞523888；8青海省中医院肛肠科，西宁810000；9东南大学附属中大医院肛肠科，南京210009；10南华大学附属第二医院肛肠科，衡阳421001；11重庆大学附属三峡医院肠道中心，重庆404000；12沈阳市肛肠医院肛肠外科，沈阳110002；13云南省中医医院肛肠科，昆明650021；14河南中医药大学第三附属医院肛肠医院，郑州450000；15连云港市中医院肛肠科，连云港222000；16山东中医药大学附属医院肛肠科，济南250011；17乐山市人民医院肛肠科，乐山614000；18武汉市第八医院肛肠疾病诊疗中心，武汉430033
  • 收稿日期:2025-08-01 修回日期:2026-03-06 发布日期:2026-04-27
  • 通讯作者: 孙松朋 E-mail:sspbeijing@126.com

Efficacy and safety of Fuzhiqing ointment versus triamcinolone acetonide and econazole nitrate cream in the treatment of chronic perianal eczema: a multicenter, randomized, double?blind, controlled, equivalence trial

Sun Songpeng1, Long Junhong1, Cao Bo2, Xu Yue3, Zhang Xiang′an4, Cao Hui5, Xie Jun6, Gui Ping7, Sun Xiaojun8, Zhang Bo9, Xu Zhijie10, Li Jin′an11, Wang Zhigang12, Wu Wei13, Yang Huiju14, Wei Ping15, Liu Congcong16, Shen Qingbo17, Yu Fan18, Chu Hongchuan1, Zhou Yangyang1, Liu Jiaxin1, Liu Yan1, Huo Xingxiao1, Chen Hang1, Jing Tao1, Gao Jing1, Wang Yanxun1, Wang Rui1, Li Zhenyu1, Zhang Shuxin1   

  1. 1Department of Anorectal Surgery，Dongzhimen Hospital，Beijing University of Chinese Medicine，Beijng 100700，China; 2Department of Anorectal Surgery，The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine，Guiyang 550001, China; 3Department of Anorectal Surgery, Chongqing Traditional Chinese Medicine Hospital, Chongqing 400013, China; 4Department of Anorectal Surgery, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 451200, China; 5Department of Anorectal Surgery，The First Hospital of Hunan University of Chinese Medicine，Changsha 410007, China; 6Department of Traditional Chinese Medicine, The Second Affiliated Hospital of Kunming Medical University, Kunming 650101, China; 7Anorectal Surgery Department, The First Dongguan Affiliated Hospital, Guangdong Medical University，Dongguan 523888, China; 8Proctology Department, Qinghai Provincial Hospital of Traditional Chinese Medicine，Xining 810000, China; 9Department of Anorectal Surgery，Zhongda Hospital Southeast University，Nanjing 210009, China; 10Department of Anorectal Surgery, The Second Affiliated Hospital of University of South China, Hengyang 421001, China; 11Intestinal Center of the Three Gorges Hospital Affiliated to Chongqing University，Chongqing 404000, China; 12Anorectal Surgery Department, Shenyang Coloproctology Hospital，Shenyang 110002, China; 13Department of Anorectal Medicine, Yunnan Provincial Hospital of Traditional Chinese Medicine，Kunming 650021, China; 14Department of Anorectal Surgery, The Third Afffliated Hospital of Henan University of Traditional Chinese, Zhengzhou 450000, China; 15Department of Anorectal, Lianyungang Hospital of Traditional Chinese Medicine，Lianyungang 222000, China; 16Department of Coloproctology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine，Jinan 250011, China; 17Department of Anorectal Surgery，The People's Hospital of Leshan，Leshan 614000, China; 18Anorectal Disease Diagnosis and Treatment Center of Wuhan Eighth Hospital，Wuhan 430033, China
  • Received:2025-08-01 Revised:2026-03-06 Published:2026-04-27
  • Contact: Sun Songpeng E-mail:sspbeijing@126.com

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摘要： 【摘要】 目的 比较肤痔清软膏与曲安奈德益康唑乳膏治疗肛周慢性湿疹的临床疗效和安全性。方法 本研究为多中心随机、双盲、对照研究。在18家医院肛肠科纳入292例肛周慢性湿疹患者，随机均分为2组，分别予以肤痔清软膏或曲安奈德益康唑乳膏治疗4周，两药均为早晚各1次外用于患处。在治疗1、2和4周时分别采用数字评分法（NRS）和湿疹患者自我检查评分量表（POEM）评价瘙痒程度，采用改良湿疹面积及严重度指数（EASI）评价肛周皮损状态，采用皮肤病生活质量指数（DLQI）评价患者生命质量，比较两药的治疗效果和患者满意度。同时观察试验期间患者的不良反应用以评价安全性。组间比较采用卡方检验和广义估计方程分析。结果 共纳入病例292例，肤痔清软膏组男72例，女74例，年龄（41.49 ± 14.94）岁；曲安奈德益康唑乳膏组男75例，女71例，年龄（40.47 ± 14.02）岁。1周随访时纳入分析的有效病例为262例，2周时为259例，4周时为256例。两组患者在性别、年龄、文化程度、体重指数、工作状态、吸烟、饮酒情况方面的差异无统计学意义（均P > 0.05）。肤痔清软膏和曲安奈德益康唑乳膏治疗肛周慢性湿疹1周时总有效率分别为37.3%（50/134）和42.2%（54/128）（P = 0.273），治疗2周时分别为70.7%（94/133）和71.4%（90/126）（P = 0.860），治疗4周时分别为82.4%（108/131）和83.2%（104/125）（P = 0.703），两组间疗效差异均无统计学意义。两组在基线、治疗1周、治疗2周、治疗4周时，瘙痒NRS、POEM、改良EASI和DLQI评分差异无统计学意义（均P > 0.05），且两组各项评分在各时间点较相邻的前一时间点均出现下降（均P < 0.05）；治疗1周、2周、4周时，两组患者间的满意度差异均无统计学意义（均P > 0.05）。1例使用肤痔清软膏和2例使用曲安奈德益康唑乳膏的患者因肛周出现皮疹、瘙痒加重的不良反应中止试验，停药后均恢复。结论 肤痔清软膏和曲安奈德益康唑乳膏治疗肛周慢性湿疹的临床疗效相近，不良反应较少。

关键词: 湿疹, 肛周慢性湿疹, 治疗, 肤痔清软膏, 曲安奈德益康唑乳膏, 等效性试验, 疗效比较研究, 安全性

Abstract: 【Abstract】 Objective To compare the efficacy and safety of Fuzhiqing ointment and triamcinolone acetonide and econazole nitrate cream in the treatment of chronic perianal eczema. Method This study was a multicenter, randomized, double?blind, controlled clinical trial. A total of 292 patients with chronic perianal eczema were enrolled from the proctology departments of 18 hospitals. Eligible patients were randomly assigned in a 1∶1 ratio to receive either Fuzhiqing ointment or triamcinolone acetonide and econazole nitrate cream. Both treatments were administered topically to the affected area twice daily （morning and evening） for 4 consecutive weeks. At weeks 1, 2, and 4 after treatment initiation, pruritus severity was evaluated using the numeric rating scale （NRS） and the patient?oriented eczema measure （POEM）. the severity of perianal skin lesions was assessed using the modified eczema area and severity index （EASI）, and quality of life was evaluated using the dermatology life quality index （DLQI）. in addition, treatment efficacy and patient satisfaction were compared between the two groups. Adverse events were recorded throughout the study period to assess safety. Statistical analysis was performed using the chi?square test for categorical variables and generalized estimating equations （GEE） for repeated measures data. Result A total of 292 patients were enrolled. In the Fuzhiqing ointment group, there were 72 male cases and 74 female cases, with an average age of 41.49 ± 14.94 years. In the triamcinolone acetonide econazole cream group, there were 75 male cases and 71 female cases, with an average age of 40.47 ± 14.02 years. The numbers of patients included in the analysis were 262 at week 1, 259 at week 2, and 256 at week 4. There were no significant differences between the two groups in sex, age, educational level, body mass index, employment status, smoking status, or alcohol consumption （all P > 0.05）. At week 1, the overall response rates were 37.3% （50/134） in the Fuzhiqing ointment group and 42.2% （54/128） in the triamcinolone acetonide and econazole nitrate cream group （P = 0.273）. At week 2, the rates were 70.7% （94/133） and 71.4% （90/126）, respectively （P = 0.860）, and at week 4, 82.4% （108/131） and 83.2% （104/125）, respectively （P = 0.703）. There were no significant differences in efficacy between the two groups at any time point. At baseline and at weeks 1, 2, and 4, there were no significant differences between the two groups in NRS, POEM, modified EASI, or DLQI scores （all P > 0.05）. In both groups, all scores decreased significantly over time compared with the previous time point （all P < 0.05）. There were no significant differences in patient satisfaction between the two groups at weeks 1, 2, or 4 （all P > 0.05）. One patient in the Fuzhiqing ointment group and two patients in the triamcinolone acetonide and econazole nitrate cream group discontinued treatment due to adverse events, including perianal rash and worsening pruritus; all patients recovered after drug withdrawal. Conclusion Fuzhiqing ointment and triamcinolone acetonide and econazole nitrate cream demonstrate comparable clinical efficacy in the treatment of chronic perianal eczema, with a low incidence of adverse events.

Key words: Eczema, Chronic perianal eczema, Therapy, Fuzhiqing ointment, Triamcinolone acetonide and econazole nitrate cream, Equivalence trial, Comparative effectiveness research, Safety

引用本文

孙松朋 龙俊红 曹波 徐月 张相安 曹晖 谢钧 桂平 孙小君 张波 许志杰 李进安 王志刚 吴伟 杨会举 韦平 刘丛丛 沈庆波 俞凡 褚洪川 周阳洋 刘甲鑫 刘彦 霍兴霄 陈航 荆涛 高静 王艳逊 王锐 李振宇 张书信. 肤痔清软膏与曲安奈德益康唑乳膏治疗肛周慢性湿疹的临床疗效和安全性：一项多中心、随机、对照、双盲、等效性研究[J]. 中华皮肤科杂志, 2026,e20250421. doi:10.35541/cjd.20250421

Sun Songpeng, Long Junhong, Cao Bo, Xu Yue, Zhang Xiang′an, Cao Hui, Xie Jun, Gui Ping, Sun Xiaojun, Zhang Bo, Xu Zhijie, Li Jin′an, Wang Zhigang, Wu Wei, Yang Huiju, Wei Ping, Liu Congcong, Shen Qingbo, Yu Fan, Chu Hongchuan, Zhou Yangyang, Liu Jiaxin, Liu Yan, Huo Xingxiao, Chen Hang, Jing Tao, Gao Jing, Wang Yanxun, Wang Rui, Li Zhenyu, Zhang Shuxin. Efficacy and safety of Fuzhiqing ointment versus triamcinolone acetonide and econazole nitrate cream in the treatment of chronic perianal eczema: a multicenter, randomized, double?blind, controlled, equivalence trial[J]. Chinese Journal of Dermatology,2026,e20250421. doi:10.35541/cjd.20250421