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