A型肉毒毒素超说明书用药分析与循证评价

Evidence-based evaluation of off-label use of botulinum toxin type A

目的回顾性调查本院A型肉毒毒素(BTX-A)的临床使用情况,通过循证医学评价其超说明书用药的合理性,为临床合理用药提供参考。方法抽取本院2019年门诊及住院患者使用BTX-A的处方和病例,以药品说明书为依据,判断是否为超说明书用药,并依照循证医学证据评价其合理性。结果共分析BTX-A处方805张。超说明书用药发生率为88.82%,主要表现为超用法用量、超适应证和超适应人群用药。对超说明书用药进行循证评价,肌内注射100 U用于眼睑痉挛、面部皱纹整容和咬肌肥大,皮内注射100 U用于三叉神经痛、多汗症和腋臭,肌内注射300 U用于痉挛性斜颈以及肌内注射12 U·kg-1用于儿童脑性瘫痪,均为BTX-A的合理用药;而肌内注射100 U BTX-A用于面肌痉挛、右乳腺术后和周围神经病为不合理用药。结论 BTX-A超说明书使用普遍,医疗机构应进一步构建超说明书用药的循证评价和管理系统。

Objective To retrospectively investigate the clinical use of botulinum toxin type A (BTX-A),evaluate the rationality of off-label use by evidence-based medicine,and provide evidence for rational drug use in clinics.Methods The prescriptions and medical records from the outpatients and inpatients who used BTX-A were pooled in our hospital in 2019.The off-label medication was first determined according to the drug instruction,followed by rationality analysis based on evidence.Results A total of 805 BTX-A prescriptions were analyzed.The incidence of off-label drug use was 88.82%,which predominantly were improper dosage,indications and patient groups.After evidence-based evaluation of off-label use,several utilizations of BTX-A were assessed as rational,including 100 U intramuscular for blepharospasm,wrinkled face and masseteric hypertrophy,100 U intradermal for trigeminal neuralgia,hyperhidrosis and axillary osmidrosis,300 U intramuscular for spasmodic torticollis,as well as 12 U·kg-1 intramuscular for cerebral palsy in children.However,100 U of BTX-A intramuscular for hemifacial spasm,right breast surgery and peripheral neuropathy were considered irrational.Conclusion BTX-A is frequently prescribed off-label,indicating the need of evidence-based evaluation and management of off-label drug use in healthcare facilities.