Experimental Study On The Safety And Clinical Efficacy Of Cang Ai Volatile Oil In The Treatment Of Ear Itch Disease

Objective:1.To investigate the acute toxicity,skin hypersensitivity and external auditory canal skin irritation reactions of Cang Ai volatile oil administered via the external ear canal,in order to evaluate the preclinical safety of Cangai Volatile Oil aqueous solution.2.To observe the clinical efficacy of Cang Ai volatile oil in the treatment of damp-heat-infested ear itch disease(Otitis Externa Mycotica),in order to further explore the possible mechanism of action of Cang Ai volatile oil,It lays the foundation for the development research and clinical promotion of Chinese volatile oil,and also provides new ideas and methods for the treatment of Otitis Externa Mycotica in Chinese medicine.Methods:Part1:(1)Acute toxicity test in external auditory canal: guinea pigs with intact skin and broken skin models were used respectively,and Cangai Volatile Oil was administered at a concentration of 15% and observed continuously for 7 days after 4 times intra-ear canal administrations in 1 days;(2)Dermal allergenicity test: guinea pigs with intact skin and broken skin models were used respectively,and different concentrations(1%,5%,15%)of Cangai Volatile Oil were applied for 7 days,and polysorbate 80 solution as the blank control.(3)External auditory canal skin irritation test: according to the above model using the intact skin and the broken skin group,and cotton balls soaked with different concentrations(1%,5%,15%)of Cangai Volatile Oil were placed in the ear canal for 7day,and polysorbate 80 as the blank control,and removed after 6 hours administration,and treatment lasted for 7 days.Part2:Forty-six patients who met the inclusion criteria for damp-heat-infested ear itch disease(Otitis Externa Mycotica)were collected and given ear drops with aqueous solution of Cang Ai volatile oil for 7 days as a course of treatment,and observed for 2courses of treatment.The primary and secondary symptoms and signs were recorded before,after 7 days of treatment(day 8)and after 14 days of treatment(day 15),respectively.Statistical analysis was performed afterwards to reflect the clinical efficacy of the aqueous solution of Chinese herbal volatile oil in treating patients with ear itch disease(Otitis Externa Mycotica).Results:Part1:(1)In the acute toxicity test,there were no significant changes in external auditory canal,tympanic membrane and body weight in all guinea pigs,and no systemic toxic reactions observed;(2)No erythema and edema were observed in the Cangai Volatile Oil and polysorbate80 in all guinea pigs,which were evaluated as non-sensitizing;(3)No erythema,edema and tympanic membrane changes were observed in the intact and damaged external auditory canal skin groups which were evaluated as non-irritating.Part2:(1)clinical efficacy: comparing 46 study subjects who completed the clinical study,clinical efficacy evaluation revealed that the patients were clinically cured in 4cases,showed efficacy in 16 cases,effective in 22 cases and ineffective in 4 cases,with an overall effective rate of 91.3%.indicating that Cang Ai volatile oil aqueous solution has good clinical efficacy in treating damp-heat-infested ear itch disease(Otitis Externa Mycotica).(2)Improvement of clinical symptoms: patients’ primary and secondary symptoms were compared after one week and two weeks of treatment,and it was found that both clinical symptoms improved significantly,and their mean values of both scores decreased compared with those before treatment.There was a significant difference(P<0.05).The most significant improvement in the primary symptoms was ear itching,and the most significant improvement in the secondary symptoms was tinnitus.(3)Improvement in clinical signs: patients’ sign scores were compared after one week and two weeks of treatment and were found to be significantly lower compared to pre-treatment,with significant differences(P<0.05).Among the signs,the most significant improvement was seen in the ear canal moldy spots or filaments.Conclusion :(1)aqueous solution of Cangai Volatile Oil at lower concentration(less than 15%)is safe,non-irritating and non-sensitizing to the external auditory canal and tympanic membrane of guinea pigs,a topical Chinese medicine with high safety,which could be used for topical application of external auditory canal treatment in clinical practice.(2)Through this clinical observation,it was found that the treatment of damp-heat-infested ear itch disease(Otitis Externa Mycotica)with an aqueous solution made of 15% Cang Ai volatile oil has good efficacy,can significantly improve the symptoms and signs of patients,and no significant adverse reactions occurred during the treatment,which is a relatively safe and effective treatment method,opens up ideas for the treatment of ear itch disease(Otitis Externa Mycotica),and expands the clinical use of volatile oil.It can be promoted for clinical use.