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Questionnaire about the adverse events and side effects following botulinum toxin A treatment in patients with cerebral palsy.

Blaszczyk I, Foumani NP, Ljungberg C, Wiberg M - Toxins (Basel) (2015)

Bottom Line: We investigated the relationship between the incidence of AEs or side effects and gender, age, weight, total dose, dose per body weight, Gross Motor Function Classification System (GMFCS) and number of treated body parts.In 54 (51%) of 105 BoNT-A treatments performed in 45 (61%) patients, there were 95 AEs and side effects reported, out of which 50 were generalized and/or focal distant.Consecutive collection of the AE and side-effect incidence using our questionnaire can increase the safety of BoNT-A treatment in patients with CP.

View Article: PubMed Central - PubMed

Affiliation: Department of Hand and Plastic Surgery, University Hospital of Northern Sweden, 90 185 Umea, Sweden. belizabla@gmail.com.

ABSTRACT
Botulinum toxin A (BoNT-A) injections for treatment of spasticity in patients with cerebral palsy (CP) have been used for about two decades. The treatment is considered safe but a low frequency of adverse events (AE) has been reported. A good method to report AEs is necessary to verify the safety of the treatment. We decided to use an active surveillance of treatment-induced harm using a questionnaire we created. We studied the incidence of reported AEs and side effects in patients with CP treated with BoNT-A. We investigated the relationship between the incidence of AEs or side effects and gender, age, weight, total dose, dose per body weight, Gross Motor Function Classification System (GMFCS) and number of treated body parts. Seventy-four patients with CP participated in our study. In 54 (51%) of 105 BoNT-A treatments performed in 45 (61%) patients, there were 95 AEs and side effects reported, out of which 50 were generalized and/or focal distant. Severe AEs occurred in three patients (4%), and their BoNT-A treatment was discontinued. Consecutive collection of the AE and side-effect incidence using our questionnaire can increase the safety of BoNT-A treatment in patients with CP.

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Adverse events and side effects questionnaire.
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toxins-07-04645-f001: Adverse events and side effects questionnaire.

Mentions: All patients (children and adults) who were treated with BoNT-A in our department from February 2010 to May 2011 were informed about the risk of AEs after BoNT-A treatment and received a questionnaire concerning AEs (Figure 1). All patients with CP were included to our study; patients with other diagnosis were excluded.


Questionnaire about the adverse events and side effects following botulinum toxin A treatment in patients with cerebral palsy.

Blaszczyk I, Foumani NP, Ljungberg C, Wiberg M - Toxins (Basel) (2015)

Adverse events and side effects questionnaire.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4663525&req=5

toxins-07-04645-f001: Adverse events and side effects questionnaire.
Mentions: All patients (children and adults) who were treated with BoNT-A in our department from February 2010 to May 2011 were informed about the risk of AEs after BoNT-A treatment and received a questionnaire concerning AEs (Figure 1). All patients with CP were included to our study; patients with other diagnosis were excluded.

Bottom Line: We investigated the relationship between the incidence of AEs or side effects and gender, age, weight, total dose, dose per body weight, Gross Motor Function Classification System (GMFCS) and number of treated body parts.In 54 (51%) of 105 BoNT-A treatments performed in 45 (61%) patients, there were 95 AEs and side effects reported, out of which 50 were generalized and/or focal distant.Consecutive collection of the AE and side-effect incidence using our questionnaire can increase the safety of BoNT-A treatment in patients with CP.

View Article: PubMed Central - PubMed

Affiliation: Department of Hand and Plastic Surgery, University Hospital of Northern Sweden, 90 185 Umea, Sweden. belizabla@gmail.com.

ABSTRACT
Botulinum toxin A (BoNT-A) injections for treatment of spasticity in patients with cerebral palsy (CP) have been used for about two decades. The treatment is considered safe but a low frequency of adverse events (AE) has been reported. A good method to report AEs is necessary to verify the safety of the treatment. We decided to use an active surveillance of treatment-induced harm using a questionnaire we created. We studied the incidence of reported AEs and side effects in patients with CP treated with BoNT-A. We investigated the relationship between the incidence of AEs or side effects and gender, age, weight, total dose, dose per body weight, Gross Motor Function Classification System (GMFCS) and number of treated body parts. Seventy-four patients with CP participated in our study. In 54 (51%) of 105 BoNT-A treatments performed in 45 (61%) patients, there were 95 AEs and side effects reported, out of which 50 were generalized and/or focal distant. Severe AEs occurred in three patients (4%), and their BoNT-A treatment was discontinued. Consecutive collection of the AE and side-effect incidence using our questionnaire can increase the safety of BoNT-A treatment in patients with CP.

Show MeSH
Related in: MedlinePlus