Systemic adverse events following botulinum toxin A therapy in children with cerebral palsy

被引:72
作者
Naidu, Krishant [1 ,2 ]
Smith, Katherine [2 ]
Sheedy, Mary [1 ]
Adair, Brooke [1 ]
Yu, Xavier [1 ]
Graham, H. Kerr [1 ,2 ,3 ]
机构
[1] Royal Childrens Hosp, Melbourne, Vic, Australia
[2] Murdoch Childrens Res Inst, Melbourne, Vic, Australia
[3] Univ Melbourne, Melbourne, Vic, Australia
关键词
PLACEBO-CONTROLLED TRIAL; SONOGRAPHY-GUIDED INJECTION; DOUBLE-BLIND; MANAGEMENT; SPASTICITY; EQUINUS;
D O I
10.1111/j.1469-8749.2009.03583.x
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
AIM We studied the incidence of incontinence and respiratory events in children with cerebral palsy who received injections of botulinum toxin A (BoNT-A). METHOD We used multivariable logistic regression to investigate relationships between (BoNT-A) dose, Gross Motor Function Classification System (GMFCS) level, and the incidence of bladder or bowel incontinence, unplanned hospital admission, emergency department consultation or prescription of antibiotics for respiratory symptoms, and diagnosis of upper respiratory tract infection. RESULTS Of 1980 injection episodes in 1147 children (mean age 4y 7mo, SD 1y 10mo, range 9mo-23y), 488 (25%) were in children with unilateral involvement and 1492 (75%) in children with bilateral involvement. At the time of injection 440 (22.2%) of children were at GMFCS level I, 611 (30.9%) were at level II, 330 (16.7%) were at level III, 349 (17.6%) were at level IV, and 250 (12.6%) were at level V. The incidence of serious adverse events was low, with 19 episodes of incontinence (1% of injection episodes) and 25 unplanned hospital admissions due to respiratory symptoms (1.3%). Incontinence typically resolved spontaneously 1 to 6 weeks after injection. The incidence of adverse events was associated with GMFCS level and dose of BoNT-A. INTERPRETATION The incidence of serious adverse events was low but suggests systemic spread as well as a procedural effect. We recommend reviewing upper dose limits for children at all GMFCS levels, particularly those at levels IV and V with a history of aspiration and respiratory disease. In these children, alternatives to mask anaesthesia may be particularly important.
引用
收藏
页码:139 / 144
页数:6
相关论文
共 29 条
[1]   Comparing botulinum toxin A with casting for treatment of dynamic equinus in children with cerebral palsy [J].
Ackman, JD ;
Russman, BS ;
Thomas, SS ;
Buckon, CE ;
Sussman, MD ;
Masso, P ;
Sanders, J ;
D'Astous, J ;
D Aiona, M .
DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY, 2005, 47 (09) :620-627
[2]   Missing data [J].
Altman, Douglas G. ;
Bland, J. Martin .
BRITISH MEDICAL JOURNAL, 2007, 334 (7590) :424-424
[3]  
[Anonymous], FDA REQ BOX WARN ALL
[4]   Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study [J].
Baker, R ;
Jasinski, M ;
Maciag-Tymecka, I ;
Michalowska-Mrozek, J ;
Bonikowski, M ;
Carr, L ;
MacLean, J ;
Lin, JP ;
Lynch, B ;
Theologis, T ;
Wendorff, J ;
Eunson, P ;
Cosgrove, A .
DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY, 2002, 44 (10) :666-675
[5]   Analgesic effects of botulinum toxin A: a randomized, placebo-controlled clinical trial [J].
Barwood, S ;
Baillieu, C ;
Boyd, R ;
Brereton, K ;
Low, J ;
Nattrass, G ;
Graham, HK .
DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY, 2000, 42 (02) :116-121
[6]   Sonography-guided injection of botulinum toxin in children with cerebral palsy [J].
Berweck, S ;
Schroeder, AS ;
Fietzek, UM ;
Heinen, F .
LANCET, 2004, 363 (9404) :249-250
[7]   Sonography-guided injection of botulinum toxin A in children with cerebral palsy [J].
Berweck, S ;
Feldkamp, A ;
Francke, A ;
Nehles, J ;
Schwerin, A ;
Heinen, F .
NEUROPEDIATRICS, 2002, 33 (04) :221-223
[8]   Botulinum toxin with and without casting in ambulant children with spastic diplegia: a clinical and functional assessment [J].
Bottos, M ;
Benedetti, MG ;
Salucci, P ;
Gasparroni, V ;
Giannini, S .
DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY, 2003, 45 (11) :758-762
[9]   Accuracy of intramuscular injection of botulinum toxin A in juvenile cerebral palsy - A comparison between manual needle placement and placement guided by electrical stimulation [J].
Chin, TYP ;
Nattrass, GR ;
Selber, P ;
Graham, HK .
JOURNAL OF PEDIATRIC ORTHOPAEDICS, 2005, 25 (03) :286-291
[10]   Botulinum toxin A compared with stretching casts in the treatment of spastic equinus: A randomised prospective trial [J].
Corry, IS ;
Cosgrove, AP ;
Duffy, CM ;
McNeill, S ;
Taylor, TC ;
Graham, HK .
JOURNAL OF PEDIATRIC ORTHOPAEDICS, 1998, 18 (03) :304-311