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关于先前复溶的神经调节剂的储存和再利用的共识声明。

Consensus statement regarding storage and reuse of previously reconstituted neuromodulators.

作者信息

Alam Murad, Bolotin Diana, Carruthers Jean, Hexsel Doris, Lawrence Naomi, Minkis Kira, Ross Edward Victor

机构信息

Departments of *Dermatology, †Otolaryngology, and ‡Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; §Section of Dermatology, University of Chicago Medicine, Chicago, Illinois; ‖Department of Ophthalmology, University of British Columbia, Vancouver, BC, Canada; ¶Department of Dermatology, Pontificia Universidade Catolica do Rio Grande do Sul, Porto Alegre, Brazil; #Brazilian Center for Studies in Dermatology, Porto Alegre, Brazil; **Division of Dermatology, Cooper University Hospital Medical Center, Marlton, New Jersey; ††Department of Dermatology, Weill Cornell Medical College, Cornell University, New York, New York; ‡‡Division of Dermatology, Scripps Clinic, San Diego, California.

出版信息

Dermatol Surg. 2015 Mar;41(3):321-6. doi: 10.1097/DSS.0000000000000303.

DOI:10.1097/DSS.0000000000000303
PMID:25705950
Abstract

BACKGROUND

Legacy recommendations suggest that vials of botulinum toxin be used within 24 hours of reconstitution and in a single patient. Current standard of care is consistent with storage after reconstitution and use of a single vial for several patients.

OBJECTIVE

To develop expert consensus regarding the effectiveness and safety of storage and reuse of botulinum toxin.

MATERIALS AND METHODS

The American Society for Dermatologic Surgery authorized a task force of content experts to review the literature and provide guidance. Data extraction was followed by clinical question review, a consensus Delphi process, and validation of the results by peer review.

RESULTS

After 2 rounds of Delphi process, the task force concluded by unanimous consensus and with the highest level of confidence that a vial of toxin reconstituted appropriately can, for facial muscle indications, be (1) refrigerated or refrozen for at least 4 weeks before injection without significant risk for contamination or decreased effectiveness and (2) used to treat multiple patients, assuming appropriate handling.

CONCLUSION

The standard of care, which allows for use of botulinum toxin more than 24 hours after reconstitution and in more than 1 patient per vial, is appropriate and consistent with the safe and effective practice of medicine.

摘要

背景

传统建议表明,肉毒杆菌毒素小瓶在复溶后24小时内使用,且仅用于单一患者。当前的护理标准与复溶后储存以及使用单个小瓶为多名患者治疗相一致。

目的

就肉毒杆菌毒素储存及重复使用的有效性和安全性达成专家共识。

材料与方法

美国皮肤外科学会授权一个由内容专家组成的特别工作组来回顾文献并提供指导。在数据提取之后进行临床问题回顾、德尔菲共识法,并通过同行评审对结果进行验证。

结果

经过两轮德尔菲法后,特别工作组以一致共识并怀着最高程度的信心得出结论,即适当复溶的一瓶毒素,用于面部肌肉适应症时,可以(1)在冷藏或重新冷冻至少4周后注射,而不会有显著的污染风险或效力降低,并且(2)在适当处理的情况下用于治疗多名患者。

结论

允许在复溶后超过24小时使用肉毒杆菌毒素且每个小瓶用于治疗多名患者的护理标准是恰当的,并且与安全有效的医疗实践相一致。

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