BOTULINUM TOXIN in Visual Studio .NET

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CHAPTER 22 BOTULINUM TOXIN
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BOTULINUM TOXIN TYPE B
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Myobloc
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Myobloc (Solstice Neurosciences, South San Francisco, CA) received FDA approval for use in the United States in December 2000 Myobloc is composed of BTX-B, which acts by cleaving the protein synaptobrevin preventing ACh release in the synaptic cleft The drug is available in a ready-to-use formula that does not require reconstitution, but it should be kept refrigerated Myobloc is stable for up to 21 months in refrigerator storage This product is available in three-vial configurations of 2500, 5000, and 10,000 U, with a composition of 5000 U BTX-B/mL Once the bottle has been opened, Myobloc begins to lose its potency A physician who performs few Myobloc injections per week can opt to use a smaller size bottle to avoid wasting the residual toxin, thus ensuring that the toxin is as potent as possible The FDA has approved Myobloc for the treatment of cervical dystonia; however, its use in cosmetics has not yet been approved Phase III clinical trials of the drug for the treatment of cervical dystonia reported a 12- to 16week duration of effect In a study by Baumann et al, 20 patients were treated for crow s feet with Myobloc and the maximum efficacy was determined to be at day 30, with the effect beginning to dissipate at a mean of 675 days26 Approximately 50 U of Myobloc are equivalent to 1 U of Botox Although Myobloc is shipped in a reconstituted form, preservative-free saline may be added to change the amount of units in 01 cc When diluting a bottle of Myobloc, it is important to recognize
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TABLE 22-3 Reloxin Dilution Tablea DILUENT: 09% SALINE 10 mL 20 mL 25 mL 30 mL
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300 U VIAL 30 U 15 U 12 U 10 U
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125 U VIAL 125 U 625 U 5U 41 U
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Units per 01 mL
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that the bottles are overfilled and actually contain slightly more Myobloc than the label states in order to compensate for the volume that may be lost in the needle tip and on the edges of the bottle (Table 22-4)
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DIFFUSION CHARACTERISTICS OF BOTULINUM TOXINS
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With the emergence of different brands of botulinum toxins, differences in preparations and effects need to be assessed for optimal patient benefit with minimal complications Although the various BTX preparations have very similar results, there are a few differences to take into account Diffusion rates may result in different fields of effects or surface area affected by the toxin The diffusion potential of botulinum neurotoxins and their migration is dependent on a number of factors such as the size and structure of the molecule,27 the subtype of the toxin,28,29 the volume of injections,30 the protein load and the formulation s excipient content,31 and finally on the muscle and site of injection19 The field of effects or diffusion of BTX-A and BTX-B have been characterized and targeted in a few studies concerned with their extent of diffusion and potential complications Myobloc appears to have a greater field of effect than Botox One study compared the radius of diffusion of Myobloc to Botox in eight patients with moderate to severe forehead wrinkles Patients were injected with 5 U of Botox on one side of their frontalis muscle and with 500 U of Myobloc to the other side (1:100 Botox:Myobloc conversion rate) The field of effect of Myobloc was assessed using a digital micrometer on traced scanned images and demonstrated a higher diffusion32 In another comparative study of Botox and Myobloc, Matarasso showed that treat-
ing crow s feet with Myobloc produces more sensation of tightness and freezing in comparison to Botox and he speculated that the observation is caused by increased Myobloc diffusion33 An increased field of effect may be advantageous in that it would allow fewer injection points to produce the same effect This is particularly beneficial when treating hyperhidrosis of the palms, where the pain of injection is significant In fact, in the primary author s experience, Myobloc is the most efficacious toxin in the treatment of hyperhidrosis because of the greater amount of diffusion34 Reloxin/Dysport may also have a greater field of effect than Botox In a recent study, the diffusions of Botox and Dysport were compared in 20 patients with forehead hyperhidrosis35 Patients were randomly injected with 3 U of Botox or Dysport (conversion rate of 1:25, 1:3, and 1:4 correlating to 75, 9, or 12 U) in four areas of the forehead The injection volume was consistent in all treatments The anhidrotic area was assessed by using the starch-iodine test Subjects who received Dysport had a significantly higher mean area of anhidrosis on their forehead as compared to patients treated with Botox Another study compared 12 healthy volunteers who were randomly assigned to receive three 01 mL intradermal injections in their forehead: 4 U Botox on one side, 12 U Dysport (conversion rate of 1:3) on the contralateral side, and saline in the center The anhidrotic area was assessed by using the starch-iodine test A higher mean area of anhidrosis was observed in 11 of the 12 subjects who received Dysport and the authors concluded that Dysport has a higher migration potential than Botox36 A higher migration potential would likely result in fewer injections required in a treated area (Box 22-3 for a brief discussion related to the number of injections and the business aspects of these treatments) This would be beneficial in
BOX 22-3 The Business Side of Botulinum Toxin The amount of BTX needed per site depends on the musculature of the individual patient Therefore, BTX should be priced by the number of units used and not by the area treated When using a consistent dilution technique, one can charge by the number of units used The price per unit varies geographically The patient should understand that additional injections (and charges) may occur at the next visit because individual musculature varies In other words, if you charge by the number of units, you will likely need to charge for touch-ups as well
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