Efficacy and Safety of Delivery Timolol Maleate via Nanometer Microneedles among Superficial Infantile Hemangioma: a retrospective study in China

Abstract Background: Infantile hemangioma is common and affects multidemensionally. Drug therapy is a commonly used method in clinical practice, but its effect needs to be improved. The main challenge derives from the drug penetration and safety. The emergence of nanometer microneedle technology seems to solve these problems. The proposed study aims to review the efficacy and safety of the nano-microneedle by comparing with other drug therapy methods.Methods: A retrospective study reviewed patients with infantile hemangioma who were admitted to a tertiary stomatological hospital from January 2014 to October 2021. The cases were divided into three groups according to the different drugs and the different methods of drug administration, namely timolol maleate solution introduced by nanometer microneedle technology (NM), timolol maleate drops dipped with a medical swab (MS), and propranolol orally (PO). The effective rate, the cure rate, the rate of adverse reactions, and the time for treatment to be effective were recorded and compared.Results：A total of 307 cases were reviewed in the study (NM=97, MS=107, PO=103). The total effective rate, total cure rate, total rate of adverse reactions were 87.6%, 65.2%, 9.4%, respectively. There was statistically significant difference in the effective rate, the cure rate, the rate of adverse reactions, the time for treatment to be effective between the three groups. The results of the pairwise comparison showed that the effective rate of NM was higher than that of MS (P＜0.05), the cure rate of NM was higher than that of MS (P＜0.05), the rate of adverse reactions of OP was higher than that of MS (P＜0.05), the time for treatment to be effective of NM was shorter than that of MS and OP (P＜0.05).Conclusions: Our study revealed that delivery timolol maleate via nanometer microneedle is an efficacy and safety in infantile with superficial hemangioma. It has the highest effective rate and cure rate, lower incidence of adverse reactions, and shortest time for treatment to be effective.