治疗多囊卵巢综合征处方的超药品说明书用药分析

Analysis of Off-label Drug Use in the Polycystic Ovary Syndrome Prescriptions

目的:分析治疗多囊卵巢综合征处方超说明书用药的合理性。方法:选取本院2013年1-6月治疗多囊卵巢综合征的门诊处方1 978张进行处方分析,通过查阅国外说明书、国内外指南、MICROMEDEX Health Care Series数据库、国内外文献等对该超说明书用法进行合理性评价。结果:超说明书用药药物包括二甲双胍、小檗碱、螺内酯、来曲唑、屈螺酮炔雌醇片,超说明书处方所占处方比例为45.90%。二甲双胍、螺内酯、来曲唑、屈螺酮炔雌醇超说明书用药均有国内外指南推荐,有较好的循证医学证据级别,小檗碱有国内外大量临床研究文献支持。结论:所评价处方的超说明书用药有指南推荐或有合理的医学实践证据,患者用药有指征,处方合理。

OBJECTIVE： To analyze the rationality of off-label drug use in polycystic ovary syndrome prescriptions. METHODS： 1 978 outpatient prescriptions of polycystic ovary syndrome selected from our hospital during Jan.-Jun. in 2013 were analyzed. Rationality of the off-label drug use was evaluated by searching foreign package inserts, guidelines at home and abroad, MICROMEDEX Health Care Series database, domestic and foreign literatures and so on. RESULTS： The off-label drug use included metformin, berberine, spironolactone, letrozole, Drospirenone and ethinylestradiol tablets; 45.90% of prescriptions were involved in off-label drug use. The off-label use of metformin, spironolactone, letrozole, drospirenone and ethinylestradiol were recommend- ed by domestic and overseas guidelines, with better evidence of evidence-based medicines. Berberine was supported by literatures of clinical studies at home and abroad. CONCLUSIONS： Off-label drug use in evaluated prescriptions is recommended by guide- lines or supported by rational evidence of medical practice. The drug use in patients is according to indications, and the prescriptions are all reasonable.