中华皮肤科杂志 ›› 2025, Vol. 58 ›› Issue (2): 178-181.doi: 10.35541/cjd.20230561

• 药物与临床 • 上一篇    下一篇

罗浮山百草油治疗白纹伊蚊叮咬的临床疗效与安全性配对自身平行对照研究

李红毅1    吴盼盼2    吴汶丰3    彭俊胜3    刘秦3    陆颖珊3    董金典3    杨志波4   

  1. 1广东省中医院皮肤科,广州  510120;2广东省江门市五邑大学生物科技与大健康学院皮肤科,江门  529020;3广州中医药大学第二临床医学院,广州  510405;4湖南中医药大学第二附属医院皮肤科,长沙  410005
  • 收稿日期:2023-09-25 修回日期:2024-05-08 发布日期:2025-02-07
  • 通讯作者: 杨志波 E-mail:dr.yang888@126.com

Clinical efficacy and safety of Luofushan-Baicao oil in the treatment of Aedes albopictus bites: a paired, self-controlled study

Li Hongyi1, Wu Panpan2, Wu Wenfeng3, Peng Junsheng3, Liu Qin3, Lu Yingshan3, Dong Jindian3, Yang Zhibo4   

  1. 1Department of Dermatology, Guangdong Province Hospital of Chinese Medicine, Guangzhou 510120, China; 2Department of Dermatology, College of Biotechnology and Health, Wuyi University, Jiangmen 529020, Guangdong, China; 3The Second Clinical Medical College, Guangzhou University of Traditional Chinese Medicine, Guangzhou 510405, China; 4Department of Dermatology, Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Changsha 410005, China
  • Received:2023-09-25 Revised:2024-05-08 Published:2025-02-07
  • Contact: Yang Zhibo E-mail:dr.yang888@126.com

摘要: 【摘要】 目的 观察罗浮山百草油和风油精治疗白纹伊蚊叮咬的有效性及安全性。方法 本研究为配对设计、自身平行对照研究。以2023年2 - 3月广东省中医院招募的36例健康受试者为研究对象,受试者双前臂均予白纹伊蚊叮咬处理,每只手臂各叮咬3处,前18例左臂外用罗浮山百草油,右臂外用风油精;后18例左臂外用风油精,右臂外用罗浮山百草油,观察时间为24 h。蚊虫叮咬后,前3 h内每隔1小时给药1次,共3次,用给药器以叮咬点为中心涂抹,给药直径约为2 cm,给药量约为50 μl/次;3 h后由受试者自行涂抹,直到症状消退或观察24 h结束。所有受试者均在叮咬出现皮损后、用药后0 ~ 3 h、用药后24 h随访评估,观察两种药物对瘙痒、红斑、丘疹或风团的影响以及药物使用频率的差异,同时记录治疗相关不良事件。用药后瘙痒消失时间采用Kaplan-Meier法进行统计描述,组间差异采用Log Rank (Mantel-Cox)检验进行比较。其他计量资料组间比较采用两独立样本t检验;计数资料组间比较采用Pearson卡方检验或Fisher精确检验。结果 用药3 h内百草油组瘙痒首次消失时间[(20.71 ± 1.92) min]短于风油精组[(28.30 ± 2.20) min],差异有统计学意义(P < 0.05)。累积痒症率与时间变化曲线图示,瘙痒消失情况随时间变化呈现总体平稳的波动状态,百草油组所有观察点累积痒症率均低于风油精组,两组差异有统计学意义(P<0.05)。用药3 h,百草油组与风油精组红斑直径变化值均值分别为25.83 mm与26.24 mm,丘疹或风团直径变化值均值分别为8.25 mm和9.18 mm;用药24 h,两组丘疹或风团平均消失时间分别为71.85 min和73.01 min,红斑平均消失时间分别为82.27 min和84.86 min;两组间的差异均无统计学意义(均P > 0.05)。百草油组与风油精组用药24 h内发生痒症均为56次,使用药物频率均为107次,差异也无统计学意义(P > 0.05)。试验期间,无不良事件与不良反应发生。结论 罗浮山百草油针对白纹伊蚊叮咬的瘙痒消失时间短于风油精。

关键词: 伊蚊属, 虫咬和虫螫, 罗浮山百草油, 风油精, 疗效, 安全性

Abstract: 【Abstract】 Objective To evaluate the efficacy and safety of Luofuoshan-Baicao oil(LBO) and wind medicated oil for the treatment of Aedes albopictus bites. Methods A paired self-controlled study was conducted. Thirty-six healthy volunteers were recruited from Guangdong Provincial Hospital of Traditional Chinese Medicine from February 2023 to March 2023. Each participant's forearms were subjected to Aedes albopictus bites, with 3 bites on each arm. For the first 18 participants, LBO was applied to the left arm, and wind medicated oil to the right arm; for the latter 18 participants, wind medicated oil was applied to the left arm, and LBO to the right arm. The observation period was 24 hours. Within the first 3 hours after the mosquito bites, the topical agents were applied once every other hour for a total of 3 sessions, with an applicator centered on the bite site at a dose of approximately 50 μl, covering the skin area of about 2 cm in diameter; after 3 hours, participants applied the topical agents themselves until symptoms subsided or the 24-hour observation period ended. All subjects were followed up at the occurrence of skin lesions after mosquito bites, 0 to 3 hours after treatment, as well as 24 hours after treatment. During the follow-up, the effects of both topical agents on pruritus, erythema, papules, or wheals were evaluated, differences in treatment frequency were analyzed, and treatment-related adverse events were recorded. The time to disappearance of pruritus after treatment was described using Kaplan-Meier survival analysis, and intergroup differences were analyzed using the log-rank(Mantel-Cox)test. Two independent samples t-test was used for comparisons of other measurement data, and Pearson's chi-square test or Fisher's exact test was used for comparisons of count data between groups. Results Within 3 hours of treatment, the time to initial disappearance of pruritus was significantly shorter in the LBO group (20.71 ± 1.92 min) than in the wind medicated oil group (28.30 ± 2.20 min, P < 0.05). The cumulative pruritus rate over time showed an overall stable fluctuation, and the cumulative pruritus rates at all observation points were significantly lower in the LBO group than in the wind medicated oil group (P<0.05). After 3 hours of treatment, the mean values of changes in erythema diameters were 25.83 mm in the LBO group and 26.24 mm in the wind medicated oil group, while the mean values of changes in papule or wheal diameters were 8.25 mm in the LBO group and 9.18 mm in the wind medicated oil group; after 24 hours of treatment, the average time to disappearance of papules or wheals was 71.85 min in the LBO group and 73.01 min in the wind medicated oil group, while the average time to disappearance of erythema was 82.27 min in the LBO group and 84.86 min in the wind medicated oil group; there were no significant differences in the above observational indices between the two groups (all P > 0.05). The number of pruritus episodes within 24 hours of treatment was 56 times in both the LBO group and wind medicated oil group, and the treatment frequency was 107 times in both two groups; there were also no significant differences in the frequencies of pruritus episodes or treatment (both P > 0.05). No adverse events or reactions occurred during the trial. Conclusion LBO was more effective than wind medicated oil in reducing the time to disappearance of pruritus after Aedes albopictus bites.

Key words: Aedes, Insect bites and stings, Luofushan Baicao oil, Wind medicated oil, Efficacy, Safety

引用本文

李红毅 吴盼盼 吴汶丰 彭俊胜 刘秦 陆颖珊 董金典 杨志波. 罗浮山百草油治疗白纹伊蚊叮咬的临床疗效与安全性配对自身平行对照研究[J]. 中华皮肤科杂志, 2025,58(2):178-181. doi:10.35541/cjd.20230561

Li Hongyi, Wu Panpan, Wu Wenfeng, Peng Junsheng, Liu Qin, Lu Yingshan, Dong Jindian, Yang Zhibo. Clinical efficacy and safety of Luofushan-Baicao oil in the treatment of Aedes albopictus bites: a paired, self-controlled study[J]. Chinese Journal of Dermatology, 2025, 58(2): 178-181.doi:10.35541/cjd.20230561