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혼합 용매에 따른 보툴리눔 A형 독소의 역가 차이

The Potency Difference of Botulinum Toxin Type A according to Reconstituting Media

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초록

Objectives: The purpose of this study is to compare the potency of botulinum toxin type A (BTA) reconstituted with preserved saline to that with nonpreserved saline in humans. Methods: We conducted double blinded controlled study of injecting BTA reconstituted with normal saline to one side of extensor digitorum brevis (EDB) and BTA reconstituted with preserved saline to the other side of EDB in 11 healthy volunteers. Amplitude of the EDB compound muscle action potentials (CMAP) was compared between both sides before and 1 week, 4 weeks, 8 weeks and 12 weeks after the injection. Results: At 1 week after the injection, there was no difference in potency between two sides. However, there was a significant potency difference at 4 weeks, 8 weeks and 12 weeks after the injection, showing reduced potency of BTA reconstituted with preserved saline compared to BTA reconstituted with normal saline. Conclusion: Potency of the BTA might be reduced when it is reconstituted with preserved saline as compared to normal saline, therefore reconstituting BTA with preserved saline should be reconsidered.

Abstract

Objectives: The purpose of this study is to compare the potency of botulinum toxin type A (BTA) reconstituted with preserved saline to that with nonpreserved saline in humans. Methods: We conducted double blinded controlled study of injecting BTA reconstituted with normal saline to one side of extensor digitorum brevis (EDB) and BTA reconstituted with preserved saline to the other side of EDB in 11 healthy volunteers. Amplitude of the EDB compound muscle action potentials (CMAP) was compared between both sides before and 1 week, 4 weeks, 8 weeks and 12 weeks after the injection. Results: At 1 week after the injection, there was no difference in potency between two sides. However, there was a significant potency difference at 4 weeks, 8 weeks and 12 weeks after the injection, showing reduced potency of BTA reconstituted with preserved saline compared to BTA reconstituted with normal saline. Conclusion: Potency of the BTA might be reduced when it is reconstituted with preserved saline as compared to normal saline, therefore reconstituting BTA with preserved saline should be reconsidered.

참고문헌 (14)

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