[Botulinum toxin type A (Incobotulinum toxin A) in spastic forms of cerebral palsy: a retrospective analysis of clinical experience]. / Botulinicheskii toksin tipa A (IncobotulinumtoxinA) pri spasticheskikh formakh detskogo tserebral'nogo paralicha: retrospektivnyi analiz klinicheskogo opyta.

OBJECTIVE: A retrospective analysis of the experience of using Incobotulinum toxin A injections for the treatment of spasticity in children with cerebral palsy (CP). MATERIAL AND METHODS: One hundred and eighty-five children with spastic forms of CP, including 114 boys (61,6%), were studied. The average age of the patients was 3,8±2,5 years; the average weight was 14,2±6,9. The patients received injections of Incobotulinum toxin A according to registered indications or recommendations of a consultation of specialists and voluntary informed consent of the patient's representative. At least 1 point decrease of muscle tone according to the modified Ashworth scale was used as a criterion of the antispastic effect of Incobotulinum toxin A. RESULTS: The total dose of Incobotulinum toxin A for the whole group of patients with CP was 154,5±67,7 U and 11,6±4,7 U per kg/body weight. The gracilis muscle (65,4% of cases, 95%CI 58,1-72,2) and the gastrocnemius muscle (49,4% of cases, 95%CI 41,8-56,6) were the most frequently injected targets in the lower extremities, and the pronator teres muscle (58,9% of cases, 95%CI 51,5-66,1) - in the upper extremities. Adverse events were observed in 13 patients (7,0%). They were mild in 9 patients and moderate in 4 patients. CONCLUSION: Our data confirmed the effectiveness and safety of Incobotulinum toxin A injections in spastic CP. The calculated average doses of Incobotulinum toxin A for target muscles and the frequency of different spasticity patterns could serve as a reference for the botulinum therapy planning.

[Changes of the spasticity patterns in children with cerebral palsy GMFCS III at the age of 2 to 12 years]. / Izmenenie patternov spastichnosti u detei s tserebral'nym paralichom s III urovnem dvigatel'nogo razvitiya po sisteme klassifikatsii bol'shikh motornykh funktsii (GMFCS III).

Spastic muscles in the pathological motor patterns may change at different ages that leads to the changes in anti-spastic treatment. OBJECTIVE: To study the specific patterns of spasticity in CP patients with level III according to the Gross Motor Function Classification System (GMFCS) in different age periods. MATERIAL AND METHODS: A retrospective analysis of injection protocols of Abobotulinum toxin A for 99 patients with bilateral spastic CP GMFCS III at the age of 2 to 12 years was performed. Spasticity patterns were evaluated according to the frequency of target muscle selection for the botulinum toxin A (Abobotulinum toxin A) injections. RESULTS: The equinus foot deformity (89.7%, 95%CI 72.8-97.2) and its combination with internal hip rotation (79.3%, 95% CI 61.3-90.5) and/or hip adduction (65.5%, 95% CI 47.3-80.2) were the main lower extremity spasticity pattern for the patients aged 2 to 4 years. Between 4 and 6 years, there was the decrease in injections to the gastrocnemius muscle (75%, 95% CI 52.8-89.2), and less to the m. gracilis (70%, 95% CI 47.9-85.7) and hip adductors (55% 95 CI 34.2-74.2). In the 6-12 year old patients, the predominant spasticity patterns were internal hip rotation (80%, 95% CI 66.8-88.9), adduction (54%, 95% CI 40.4-67.0) and knee flexion (66%, 95% CI 52.1-77.6). The leading upper extremity patterns at all observed ages were forearm pronation (70.7%, 95% CI 61.1-78.8) and elbow flexion (47.5%, 95% CI 37.9-57.2). The frequency of injections to these muscles slightly decreased in elder groups. CONCLUSIONS: CP GMFCS III patients demonstrate age-related changes of the spasticity patterns both in lower and upper extremities. These changes and typical spastic muscles should be taken into account during the rehabilitation and botulinum toxin treatment planning, as well as in the detection and prevention of the orthopaedic complications.

[Multilevel botulinum toxin treatment in severe spastic forms of cerebral palsy (GMFCS IV-V)]. / Mnogourovnevaya botulinoterapiya pri spasticheskikh formakh detskogo tserebral'nogo paralicha s tyazhelymi dvigatel'nymi narusheniyami (GMFCS IV­V).

OBJECTIVE: To evaluate the most typical target muscles and dosages for the first and repeated botulinum toxin A (BTA) injections in cerebral palsy (CP) patients with severe motor deficit - GMFCS IV-V. MATERIAL AND METHODS: A retrospective analysis of 677 protocols of the first and repeated Abobotulinumtoxin A (AboA) injections in 333 patients with CP GMFCS IV and V, aged 1 to 18 years, was carried out. RESULTS: Ninety-seven percent of patients received multilevel injections. In the lower extremities the most typical target muscles were: m.gracilis - 221 (66.4%) patients, hip adductors - 164 (49.2%), medial hamstring - 144 (43.2%). In the upper extremities the most typical muscles were: m.pronator teres - 237 (71.2%) patients, m.biceps brachii+m.brachialis - 197 (59.2%). The total dosages of AboA and dosages for every target muscle were calculated. Several patients required high dosages (more than 30 U/kg of AboA). Higher dosages per kg were used in younger children and for repeated injections. The age-related evolution of spastic patterns was described. Adverse events were observed in 36 cases (5.3% of all injections). CONCLUSION: The majority of patients with GMFCS IV-V required multilevel BTA injections in high dosages, especially in young age. Described selection of target muscles and dosages of AboA could be taken into account as a practical experience and reference for the BTA therapy in GMFCS IV-V patients.

[Efficacy and safety of botulinum toxin type A (IncobotulinumtoxinA) in the treatment of patients with cerebral palsy]. / Éffektivnost' i bezopasnost' primeneniia botulinicheskogo toksina tipa A (IncobotulinumtoxinA) pri lechenii patsientov s detskim tserebral'nym paralichom.

AIM: To assess the safety and clinical and neurophysiological efficacy of xeomin in children with spastic equinus and equinovarus foot deformity in cerebral palsy. MATERIAL AND METHODS: Sixty-four patients with spastic forms of cerebral palsy (levels I-IV on the GMFCS) were enrolled into this multi-center open-label comparative randomized trial. The patients were administered xeomin or botox once, each drug being administered to 32 patients. Efficacy was evaluated based on clinical characteristics (the modified Ashworth scale, goniometry) and electromyography data. The subjects were observed for 3 months (90±7 days) after injections. The incidence, severity and intensity of adverse events (AE) was also determined. RESULTS: Treatment with xeomin according to the suggested protocol has proven its high clinical efficacy. The efficacy was demonstrated by significant, stable and long-term decrease in the gastrocnemius muscle tone: in the xeomin group, the score on the modified Ashworth scale decreased from 2.6±0.49 points at baseline to 1.8±0.54 points (р<0.000001, paired t-test; р<0.000004, Wilcoxon test). In the botox group, this score decreased from 2.4±0.56 points to 1.6±0.45 points (р<0.000001, paired t-test; р<0.000002, Wilcoxon test). The increased range of ankle joint movements at passive and voluntary feet extension. In the xeomin group, the significant proportion of patients (45.1%) moved to the group of lower spasticity defined as less than two score points on the modified Ashworth scale. The clinical data fully matched the changes in electromyography parameters, which were characterized by the lower amplitude and area of the target muscle (lateral and medial gastrocnemius heads) M-responses. AE developed in three patients (9.4%) administered xeomin and in two patients (6.3%) administered botox. The AE recorded in the study are described in the recommendations on the use of xeomin and botox. In three cases (50.0%), AE intensity was determined as mild, in the remaining three cases (50.0%) as moderate. CONCLUSION: The results have shown the safety and efficacy of xeomin in the treatment of gastrocnemius spasticity in pediatric patients with cerebral palsy. These data are confirmed by the lack of significant differences in any clinical or electromyography parameters with the results in the reference group administered botox.

[The First Russian Consensus on the Multilevel Abobotulinumtoxin A Injections in Spastic Forms of Cerebral Palsy]. / Pervyi Rossiiskii konsensus po primeneniyu mnogourovnevykh in''ektsii abobotulinumtoxin A pri lechenii spasticheskikh form detskogo tserebral'nogo paralicha.

Spasticity treatment is one of the key aspects of the contemporary cerebral palsy (CP) rehabilitation that influences on the effectiveness of other methods. The paper presents the first Russian document that unites the recommendations for the BTA treatment of CP and could be used as the guideline for the multilevel injections. The Russian consensus on the multilevel botulinum toxin A (BTA) treatment of spastic CP is based on the international data and the results of national studies. The authors describe typical CP spasticity patterns in the upper and lower extremities, give recommended intervals for the BTA (Abobotulinum toxin A) dosages for the whole injection procedure and for the separate muscles. The method of dosage calculation for functional segments is also described. Attention is paid to the frequency, optimal intervals between the repeated injections and the whole duration of BTA treatment. The authors discuss effectiveness and safety of BTA, factors that potentially influence the results of the injections, including ultrasound and electromyography control, and indications for the continuation and termination of treatment.

[Selection of a dose of the botulinum toxin A in spastic forms of cerebral palsy]. / Vybor dozy preparata botulinicheskogo toksina tipa A pri lechenii spasticheskikh form detskogo tserebral'nogo paralicha.

AIM: To analyze the efficacy and safety of dose ranges of abobotulinum toxin A (BTA) for multilevel injections into upper and lower extremity muscles in children with spastic forms of cerebral palsy (CP). MATERIAL AND METHODS: We analyzed retrospectively multilevel BTA injections for 216 patients, aged from 2 to 17 years. Children received 1-6 repeated injections and complex physiotherapy. Patients were classified according to the GMFCS. Treatment results were evaluated with the modified Ashworth and Tardieu scales. RESULTS: Multilevel BTA injections were indicated for the most (89/8%) of the patients with spastic forms of CP, and in most of them the total dosage exceeded 30 U/kg. In the bilateral forms of CP, the total dosage (U and U/kg) was higher compared to the unilateral forms. Doses for each muscle in U/kg were similar in all CP forms. The total doses of BTA and the intervals between the repeated injections were stable for each patient. CONCLUSION: The dose ranges suggested for CP are effective and safe for the reduction of spasticity in several functional segments of upper and lower extremities in one treatment session.

[Clinical experience of the repeated multilevel injections of the botulinum toxin type A (abobotulinum toxin A) in the spastic forms of cerebral palsy].

OBJECTIVE: Our aim was to analyze the dosages of Abobotulinum toxin A used for each muscle in the clinically effective and safe repeated multilevel injections in CP children, and the intervals between injections. METHODS: Retrospective analysis of 229 injection sessions into 359 muscles of the upper and 361 muscles of the lower extremities in 133 children (2-18 years) with spastic CP. Analysis included only patients who were injected for the first time and demonstrated decrease of spasticity in injected muscles according to modified Ashworth and/or Tardieu scales without significant side effects 2-4 weeks after injections. Motor deficit according to GMFCS was: GMFCS I--16(12%) children, GMFCS II--26 (19.6%), GMFCS III--43 (32.3%), GMFCS IV--30 (22.6%), GMFCS V--18 (13.5%). Repeated injections (up to 5 sessions) were done in 59 children. Maximum follow-up perion was 22 months. 40 patients (30.1%) had one-sided injections, 93 (69.9%)--two-sided, 125 (94%)--multilevel injections. RESULTS: We presented minimal and maximal dosages, interquartile ranges for each injected muscle, also "off-label" and our proposition of per-segment calculation of dosages in multilevel injections in CR. We also demonstrated the stability of intervals between repeated injections and dosages per kg in a patient. These results are compared with the official Russian and international recommendations of BTX-A treatment for children. CONCLUSION: We presented our experience of BTX-A dosages calculation for the spastic CP treatment which could be used as a recommendation and guide for the multilevel injections treatment according to the aims of rehabilitation, spasticity level, muscle size and motor deficit of a concrete patient.