比马前列素用于睫毛增长的安全风险探讨

Discussion on Safety Risk of Bimatoprost for Eyelash Growth

关键词:  比马前列素  前列腺素类似物  不良反应  化妆品  非法添加

Key words:  bimatoprost  prostaglandin analogue  adverse reactions  cosmetics  illegal addition

摘要:

目的 探讨比马前列素用于睫毛增长的安全风险。方法 针对比马前列素的理化性质、药理作用和药动学、临床应用、不良反应、化妆品监管政策等方面进行梳理分析，为监管工作提供理论依据。结果 比马前列素是一种人工合成的前列腺素类似物——前列腺素F_2α类似物，可以有效降低眼压和促进毛发增长。其消除半衰期为45 min，主要通过尿液排泄。FDA孕期评级为C级，可能对胎儿有不利影响；上市后不良反应主要包括眼睛充血、眼睑红斑、眼刺激等，其安全性有必要进行进一步评估；不符合中国化妆品的定义和规定的功效宣称，欧盟和加拿大禁止比马前列素等药物成分用于化妆品，美国将其作为药品管理。结论 为了保证化妆品质量安全，规范和促进行业健康发展，建议中国监管部门跟踪关注比马前列素等前列腺素类似物的使用安全性，必要时调整管理措施。

Abstract:

OBJECTIVE To explore the safety risk of bimaprost for eyelash growth. METHODS The physical and chemical properties, pharmacological effects, pharmacokinetics, clinical application, adverse reaction and cosmetic regulatory policy of bimaprost were combed and analyzed in order to provide a theoretical basis for supervision. RESULTS Bimaprost was a synthetic prostaglandin analogue-prostaglandin F_2α, which could effectively reduce intraocular pressure and promote hair/eyelash growth. The elimination half-life of bimaprost was 45 min and was mainly excreted through urine. Bimatoprost had a FDA rating of C during pregnancy, which might have an adverse effect on the fetus. The adverse reactions of bimaprost after listing mainly include eye hyperemia, eyelid erythema, eye irritation and so on. It was necessary to further evaluates its safety. Bimaprost did not conform to the cosmetic definition, efficacy and claims of China. The European Union and Canada prohibited the use of drug ingredients such as bimaprost in cosmetics, and the United States regulated it as a drug. CONCLUSION In order to ensure the quality and safety of cosmetics, standardize and promote the healthy development of the industry, it is suggested that the regulatory departments of China should follow up and pay attention to the safety of the use of prostaglandin analogs such as bimatoprost and adjust management measures if necessary.