BACKGROUND: More than 70% children with cerebral palsy belong to the spastic one, and the increased muscular tension results in motor dysfunction and posture abnormality.OBJECTIVE: To observe the assistant effect of the local injection of BTX-A at multiple points in the rehabilitative treatment of spastic cerebral palsy.DESIGN: A comparative observation on the clinical efficacy.SETTINGS: Rehabilitation Center,Loufeng Hospital, Suzhou Industrial Park; Gansu Rehabilitation Center Hospital.PARTICIPANTS: Sixty-nine children with cerebral palsy were selected from the outpatients and inpatients who accepted rehabilitative treatments in the Cerebral Palsy Treatment Center of Gansu Rehabilitation Center Hospital from April 2003 and October 2004. Inclusive criteria: ① Having high risk factors for brain injury before birth and within 1 month after birth, mainly manifested as central motor disorder and posture abnormality; ② Accompanied by increase of muscular tension in both lower limbs, appearing as tiptoes and scissors gaits while in standing position or walking; ③ Without fixed contracture of lower limb; ④ Had never been operated for lower limbs; ⑤ Had never been injected with BTX-A; ⑥ Clearly diagnosed to have spastic palsy. The enrolled children were not screened by disease conditions, course, age, etc., and informed consents were obtained from the parents of all the children. The children whose parents agreed to accept BTX-A treatment were taken as BTX-A treated group (n =45), and the others as control group (n = 24).METHODS: All the children accepted regular rehabilitative training after admission, 6 times a weeks,besides, those in the BTX-A treated group were given local injection of BTX-A at multiple points of target muscles, including bilateral adductor longus muscles, pectineal muscles, gastrocnemius muscles and soleus muscles. BTX-A was diluted with saline (5 U BTX-A in 0.1 mL), 3 - 4 U/kg for each piece of muscle. The number of injected sites depended on the size of target muscle, and no more than 0.5 mL for each site. The injection should be followed by manual massage for 1 - 2 minutes, and electromuscular stimulation for 20 minutes, which were continued for 3 days. They participated in the comprehensive rehabilitative training and treatment at 24 hours after injection.MAIN OUTCOME MEASURES: The comprehensive abilities of cerebral palsy were evaluated, the adductor angle and forced area on soles were measured before treatment and at 3 and 6 months after treatment.RESULTS: All the 69 children with spastic cerebral palsy were involved in the analysis of results.① Efficacy in the BTX-A treated group: BTX-A began to take effect at 48 hours after injection, and the maximal effect was observed in all the cases on the 6th day; 2 weeks later, the scissors gaits and hip adduction were obviously improved in 39 and 11 cases, respectively, and tiptoes gaits were improved in 22 cases; 2 months later, tiptoes gaits were improved in 43 cases. ② Efficacy in the control group: Two months later, certain improvements of scissors gaits were observed in 2 children with mild cerebral palsy; the scissors gaits and tiptoes were obviously improved in 6 cases of moderate cerebral palsy and 3 cases of mild one after 3 months, and there were changes of the parameters after 6 months in 1, 10 and 5 cases of severe,moderate and mild cerebral palsy, respectively. ③ Improvement of adductor angle before and after treatment in both groups: The muscular tension was evaluated according to Komams method. There was no obvious difference in the adductor angle between the two groups before treatment (P ＞ 0.05). The adductor angle had very significant difference (P ＜ 0.01) and significant difference (P ＜ 0.05) between the two groups at 3 and 6 months after treatment. ④ Changes of forced area on soles before and after treatment in both groups: The forced area on soles was assessed referred to the method of foot-print analysis. There was no obvious difference in the forced area on soles between the two groups before treatment (P ＞ 0.05). The forced area on soles had very significant difference (P ＜ 0.01) and significant difference (P ＜ 0.05) between the two groups at 3 and 6 months after treatment.CONCLUSION: BTX-A local injection is an important assistant therapeutic method for treating spastic cerebral palsy. For the patients with moderate and severe cerebral palsy, BTX-A local injection should be combined with rehabilitative training to obviously shorten the course and improve efficacy.