他克莫司软膏治疗特应性皮炎的疗效与安全性及经济性评价OA

Objective This study evaluates the efficacy,safety,and economic viability of a domestic brand compared to the original imported 0.03%and 0.1%tacrolimus ointments for treating atopic dermatitis(AD).Methods Evidence of efficacy and safety was obtained through pharmacokinetic studies on laboratory animals,in vitro percutaneous tests,and studies on skin irritability and allergenicity.An economic evaluation was conducted from the perspective of the whole society,taking into account that there were no differences in direct non-medical costs,indirect costs,and hidden costs,and that the original and generic drugs had the same dosage forms,routes of administration,and treatment courses,thereby considering the only difference in direct medical costs to be the drug prices.Prices from provincial tender procurement winning bids since 2021 were collected,and the evaluation was carried out using the cost minimization analysis.Results The blood exposure levels of the domestic brand tacrolimus ointment in SD rats,rabbits,and Bama miniature pigs were comparable to those of the original imported drug;skin penetration amount,rate,and retention were essentially the same;no local irritation reactions such as redness,congestion,exudation,degeneration,or necrosis were caused on intact or damaged rabbit skin,and no allergic reactions occurred in guinea pig skin after repeated contact with the domestic drug.The average prices of the domestic brand tacrolimus ointment 0.03%and 0.1%were ¥79.80 and ¥91.10,respectively,compared to ¥109.79 and ¥125.29 for the original imported drug.At the lowest price comparison,the domestic brand tacrolimus ointment 0.03%was 27.08%lower than the imported drug,and 0.1%was 27.3%lower.Conclusion The domestic drug and the original imported drug 0.03%and 0.1%tacrolimus ointment are equivalent in efficacy and safety,with the domestic brand tacrolimus ointment being more cost-effective due to its lower cost.