低浓度硫酸阿托品防控近视进展眼用制剂制备的专家共识(2023)

Experts consensus on preparation of low-concentration atropine sulfate for myopia progression control(2023)

低浓度硫酸阿托品滴眼液点眼已成为儿童及青少年近视控制的主要方法之一,其眼用制剂已越来越多地用于控制儿童近视进展,但目前国内尚无上市的低浓度硫酸阿托品眼用制剂产品,临床上常用的滴眼液多为院内制剂,各家在制备过程中尚无统一标准,给其临床应用的安全性和疗效评价带来一定的不确定性,有必要对相应的眼用剂型的制备方法进行规范指导。为保证低浓度硫酸阿托品眼用制剂的临床防控效果和安全性,上海市眼病防治中心/上海市眼科医院组织上海市医学会视光学专科分会常务委员会、上海市药学会医院药学专委会医院制剂学组以及国内视光学研究者、眼科药物制备的药学专家,针对低浓度硫酸阿托品眼用制剂在制备上的要点和目前国内临床工作的需求,深入讨论并制定《低浓度硫酸阿托品防控近视进展眼用制剂制备的专家共识(2023)》,以供眼科医师、药学工作者以及低浓度硫酸阿托品眼用制剂使用者参考。

Low-concentration atropine sulfate eye drop has been increasingly used to control the progression of myopia in children.At present,most of the domestic low-concentration atropine eye drops are nosocomial preparations,and there is no unified standard for each preparation,which brings lots of uncertainty for the effectiveness and safety assessment.It is necessary to standardize the hospital preparation of low-concentration atropin products.In order to ensure the clinical treatment effect and safety of low-concentration atropine,in view of the key points in the preparation of low-concentration atropine ophthalmic preparations,initiated by Shanghai Eye Disease Prevention and Control Center/Shanghai Eye Hospital,the Standing Committee of the Shanghai Medical Association Optometry Branch,the Hospital Preparation Group of the Pharmacy Special Committee of Shanghai Pharmaceutical Association Hospital,and well-known domestic ophthalmology and pharmaceutical experts,an Experts consensus on preparation of low-concentration atropine sulfate for myopia progression control(2023)was formulated for the reference and application of ophthalmologists,pharmacy workers and users of ophthalmic low-concentration atropine sulfate preparations.