“Appropriate Treatment” and Therapeutic Window in Spasticity Treatment with IncobotulinumtoxinA: From 100 to 1000 Units
Abstract
:1. Introduction
2. Results
Adverse Events
- -
- local muscle weakness: no case in group A, two cases in group B (5%) and two cases in group C (4%);
- -
- transient generalized weakness: no cases in group A and B, two cases in group C (4%);
- -
- mild dysphagia: no case in group A and B, one case in group C (2%; in the first cycle of injection, we also treated in this patient the left sternocleidomastoid muscle with 50 U of IncobotulinumtoxinA 1% saline due to muscle dystonia; this probably caused an adverse event because in the second cycle we treated the same muscle with 35 U of drug with good clinical response of dystonia and no dysphagia).
3. Discussion
4. Conclusions
5. Materials and Methods
5.1. Study Design
- (1)
- Group A (30 patients) up to 400 U
- (2)
- Group B (40 patients) from 400 U to 700 U
- (3)
- Group C (50 patients) from 700 U to 1000 U (maximum dose 600 U per limb).
5.2. Outcome Measures
5.3. Statistical Analysis
Acknowledgments
Author Contributions
Conflicts of Interest
References
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Time | GR A 100–400 U | GR B 400–700 U | GR C 700–1000 U |
---|---|---|---|
t 0 (beginning) | 30 | 40 | 50 |
t 1 (after 9 months) | 20 | 42 | 58 |
1°GR 100–400 U BTX A | 2°GR 400–700 U BTX A | 3°GR 700–1000 U BTX A | |
---|---|---|---|
Local muscle weakness | - | 5% | 4% |
Transientgeneralized weakness | - | - | 4% |
Bradycardia | - | - | - |
Dysphagia | - | - | 2% |
Dysphonia | - | - | - |
Dyspnea | - | - | - |
Constipation | - | - | - |
GR A 100–400 U BTX A | GR B 400–700 U BTX A | GR C 700–1000 U BTX A | |
---|---|---|---|
N° patients | 30 | 40 | 50 |
Age | 64 ± 6.2 | 63 ± 8.4 | 66 ± 3.2 |
Sex M/F | 17/13 | 23/17 | 28/22 |
Clinical: Hemip.dx | 4 | 8 | 5 |
Hemip. sx | 13 | 14 | 22 |
Monoparesis | 4 | 1 | 0 |
Paraparesis | 8 | 6 | 7 |
Tetraparesis | 1 | 11 | 16 |
Muscles Treated | GR A 100–400 U N° Patients | GR B 400–700 U N° Patients | GR C 700–1000 U N° Patients |
---|---|---|---|
Biceps brachii | 28 93.3% | 40 100% | 43 86% |
Brachioradialis | - | 32 80% | 41 82% |
Triceps brachii | - | 1 2.5% | 38 76% |
Superficial flexorumdigitorum | 26 86.6% | 34 85% | 43 86% |
Ulnar flexorumcarpis | - | 22 55% | 41 82% |
Opponens pollicis | - | 34 85% | 43 86% |
Rectus femoris | - | - | 40 80% |
Adductor magnus | - | 26 65% | 38 76% |
Tibialis anterior | - | - | 16 32% |
Flexor alluci longus | - | 18 45% | 34 68% |
Gastrocnemius medialis | 27 90% | 39 97.5% | 50 100% |
Gastrocnemius lateralis | 27 90% | 39 97.5% | 50 100% |
Soleus | 30 100% | 39 97.5% | 50 100% |
Tibialis posterior | - | 26 65% | 45 90% |
Flexor digitorum brevis | - | 16 40% | 36 72% |
Biceps Femoris | - | 26 65% | 36 72% |
Muscles | GR A 100–400 U Min-Max (Average ± SD) | GR B 400–700 U Min-Max (Average ± SD) | GR C 700–1000 U Min-Max (Average ± SD) |
---|---|---|---|
Biceps brachii | 50–80 (60.2 ± 10.3) | 70–90 (82.3 ± 10.1) | 80–100 (91.2 ± 10.1) |
Brachioradialis | 50–60 (55.5 ± 10.4) | 70–80 (75.3 ± 2.2) | |
Triceps brachii | 50–60 (55.2 ± 10.1) | 80–90 (85.6 ± 2.2) | |
Superficial flexorumdigitorum | 50–80 (60.6 ± 10.2) | 50–90 (75.3 ± 10.3) | 100–150 (122.3 ± 20.1) |
Ulnar flexorumcarpis | 50–60 (55.5 ± 2.2) | 80–100 (85.6 ± 2.1) | |
Opponenspollicis | 20–30 (22.2 ± 10.3) | 30–40 (33.4 ± 1.1) | |
Rectus femoris | 70–80 (74.2 ± 1.1) | ||
Adductor magnus | 50–60 (55.3 ± 10.2) | 100–150 (132.3 ± 20.2) | |
Tibialis anterior | 50–60 (55.3 ± 2.4) | ||
Flexor alluci longus | 40–50 (44.2 ± 3.3) | 50–60 (54.2 ± 1.3) | |
Gastrocnemius medialis | 60–80 (73.4 ± 10.5) | 80 | 100–150 (132.4 ± 10.4) |
Gastrocnemius lateralis | 60–80 (72.5 ± 10.4) | 80 | 100–150 (122.4 ± 11.6) |
Soleus | 70–80 (76.3 ± 2.5) | 80–90 (88.3 ± 1.3) | 100–150 (135.7 ± 17.4) |
Tibialis posterior | 70–80(84.9 ± 3.3) | 100–120 (111.2 ± 2.4) | |
Flexor digitorum brevis | 50–60 (55.6 ± 3.4) | 80–100 (89.9 ± 5.6) | |
Biceps Femoris | 70–90 (84.6 ± 9.7) | 100–150 (145.7 ± 14.9) |
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Ianieri, G.; Marvulli, R.; Gallo, G.A.; Fiore, P.; Megna, M. “Appropriate Treatment” and Therapeutic Window in Spasticity Treatment with IncobotulinumtoxinA: From 100 to 1000 Units. Toxins 2018, 10, 140. https://doi.org/10.3390/toxins10040140
Ianieri G, Marvulli R, Gallo GA, Fiore P, Megna M. “Appropriate Treatment” and Therapeutic Window in Spasticity Treatment with IncobotulinumtoxinA: From 100 to 1000 Units. Toxins. 2018; 10(4):140. https://doi.org/10.3390/toxins10040140
Chicago/Turabian StyleIanieri, Giancarlo, Riccardo Marvulli, Giulia Alessia Gallo, Pietro Fiore, and Marisa Megna. 2018. "“Appropriate Treatment” and Therapeutic Window in Spasticity Treatment with IncobotulinumtoxinA: From 100 to 1000 Units" Toxins 10, no. 4: 140. https://doi.org/10.3390/toxins10040140
APA StyleIanieri, G., Marvulli, R., Gallo, G. A., Fiore, P., & Megna, M. (2018). “Appropriate Treatment” and Therapeutic Window in Spasticity Treatment with IncobotulinumtoxinA: From 100 to 1000 Units. Toxins, 10(4), 140. https://doi.org/10.3390/toxins10040140