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使用制造商的产品概述比较两种A型肉毒杆菌毒素制剂。

Comparing two botulinum toxin type A formulations using manufacturers' product summaries.

作者信息

Wenzel R, Jones D, Borrego J A

机构信息

Diamond Headache Clinic Inpatient Unit, Chicago, IL 60657, USA.

出版信息

J Clin Pharm Ther. 2007 Aug;32(4):387-402. doi: 10.1111/j.1365-2710.2007.00835.x.

DOI:10.1111/j.1365-2710.2007.00835.x
PMID:17635341
Abstract

BACKGROUND AND OBJECTIVE

Because of the unique pharmacology and clinical versatility of botulinum toxin (BoNT), particularly BoNT serotype A (BoNTA), a need exists for discussion of the current data on similarities and differences between two BoNTA products, BOTOX and Dysport.

METHODS

We compared the physiochemical and pharmacological properties of BOTOX and Dysport using information from the Summary of Product Characteristics (SmPC) documents from a number of countries around the world.

RESULTS AND DISCUSSION

Our analysis based on the SmPC documents demonstrated distinct differences in physical characteristics, breadth of approved indications, dosing and administration, and the incidence and severity of adverse events.

CONCLUSION

BOTOX and Dysport are not bioequivalent. Many of the differences between BOTOX and Dysport discussed within are probably related to the differences in their physical characteristics.

摘要

背景与目的

由于肉毒杆菌毒素(BoNT),特别是A型肉毒杆菌毒素(BoNTA)具有独特的药理学特性和临床多功能性,因此有必要对两种BoNTA产品保妥适(BOTOX)和吉适(Dysport)之间异同的现有数据进行讨论。

方法

我们利用来自世界多个国家的产品特性摘要(SmPC)文件中的信息,比较了保妥适和吉适的理化性质和药理特性。

结果与讨论

我们基于SmPC文件的分析表明,在物理特性、批准适应症的范围、给药剂量和方式以及不良事件的发生率和严重程度方面存在明显差异。

结论

保妥适和吉适并非生物等效。本文讨论的保妥适和吉适之间的许多差异可能与它们的物理特性差异有关。

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