促性腺激素释放激素激动剂相关药物在乳腺癌患者中的药品综合性评价

A comprehensive drug evaluation of GnRHa-related drugs in breast cancer patients

目的对不同规格的戈舍瑞林在乳腺癌患者中的临床应用进行综合评价,为临床合理使用戈舍瑞林提供依据。方法根据《药品临床综合评价指南》,采用病例回顾性分析、问卷调查、专家论证等方法,围绕3.6 mg戈舍瑞林(A组)、10.8 mg戈舍瑞林(B组)、3.75 mg亮丙瑞林(C组)在乳腺癌患者中的安全性、有效性、经济性、创新性、适宜性、可及性等进行卫生技术评估。结果在有效性方面,A、B组雌二醇>5 pg·mL^(-1)的患者比例低于C组(P<0.05)。在安全性方面,胃肠道反应发生率,A、B组低于C组(P<0.05),B组轻、中度不良反应发生率最低(P<0.01)。在经济性方面,B组从日均费用、年疗程费用、给药频次及成分效果比方面均优于A、C组。在创新性方面,专家认为B组更具有机制创新、技术创新,临床需求及推荐度A组占优势。在适宜性方面,B组药品技术特点及使用适宜性综合评分更高。在可及性方面,三组可获得性均较好,均存在短缺现象,可负担性B组更好。结论10.8 mg戈舍瑞林在有效性、安全性、经济性、创新性、适宜性、可及性方面具有较好的表现,但临床需求及推荐度不及3.6 mg戈舍瑞林。

Objective To evaluate the clinical application of different specifications of goserelin in breast cancer patients,to provide a basis for their rational use.Methods According to the Guidelines for Comprehensive Clinical Evaluation of Drugs,the safety,efficacy,economy,innovation,suitability and accessibility of 3.6 mg(group A),10.8 mg goserelin(group B)and 3.75 mg leuprolide(group C)in breast cancer patients were evaluated by case retrospective analysis,questionnaire,and expert demonstration.Results In terms of efficacy,the number of patients with estradiol(E2)>5 pg·mL^(-1) in both group A and group B was lower than that in group C(P<0.05).The incidence of gastrointestinal adverse reactions in groups A and B was lower than that in group C(P<0.05),and the incidence of mild to moderate adverse reactions in group B was the lowest(P<0.01).As to economical efficiency,group B was superior to group A and group C from average cost per day,course cost per year,frequency of administration to ratio of component effect.In terms of innovation,group B was more innovative in mechanism,and technology.But in clinical needs and reconmendation,group A had some advantage.In terms of adaptability,the comprehensive score of technical characteristics and suitability of group B was higher.All three groups had fairly good accessibility,and group B was had affordability.Conclusion Goserelin(10.8 mg)is efficacient,safe,economic,innovative,suitabile and accessibile,but the goserelin(3.6 mg)has more clinical recommendations.