BACKGROUND: Botulinum toxin type A (BTX-A) is mostly to be used to treat various diseases of motor disorders, whereas its effect on muscle spasm after stroke and brain injury needs further observation.OBJECTIVE : To observe the effect of BTX-A plus rehabilitative training on treating muscle spasm after stroke and brain injury.DESIGN: A randomized controlled observation.SETTINGS: Department of Rehabilitation, Department of Neurology and Department of Neurosurgery, the Second Hospital of Hebei Medical University.PARTICIPANTS: Sixty inpatients with brain injury and stroke were selected from the Department of Rehabilitation, Department of Neurology and Department of Neurosurgery, the Second Hospital of Hebei Medical University from January 2001 to August 2006. They were all confirmed by CT and MRI, and had obvious increase of spastic muscle strength in upper limbs, their Ashworth grades were grade 2 or above. The patients were randomly divided into treatment group (n =30) and control group (n =30).METHODS: ① Patients in the treatment group undertook comprehensive rehabilitative trainings, and they were administrated with domestic BTX-A, which was provided by Lanzhou Institute of Biological Products, Ministry of Health (S10970037), and the muscles of flexion spasm were selected for upper limbs, 20-25 IU for each site.② Patients in the treatment group were assessed before injection and at 1 and 2 weeks, 1 and 3 months after injection respectively, and those in the control group were assessed at corresponding time points. The recovery of muscle spasm was assessed by modified Ashworth scale (MAS, grade 0-Ⅳ; Grade 0 for without increase of muscle strength; Grade Ⅳ for rigidity at passive flexion and extension); The recovery of motor function of the upper limbs was evaluated with Fugl-Meyer Assessment (FMA, total score was 226 points, including 100 for exercise, 14 for balance, 24 for sense, 44 for joint motion, 44 for pain and 66 for upper limb); The ADL were evaluated with Barthel index, the total score was 100 points, 60 for mild dysfunction, 60-41 for moderate dysfunction, ＜ 40 for severe dysfunction).MAIN OUTCOME MEASURES: Changes of MAS grade, FMA scores and Barthel index before and after BTX-A injection.RESULTS: All the 60 patients with brain injury and stroke were involved in the analysis of results. ① FMA scores of upper limbs: The FMA score in the treatment group at 2 weeks after treatment was higher than that before treatment [(14.98±10.14), (13.10±9.28) points, P＜ 0.05], whereas there was no significant difference at corresponding time point in the control group. The FMA scores at 1 and 3 months in the treatment group [(23.36±10.69), (35.36±11.36) points] were higher than those in the control group [(20.55±10.22), (30.33±10.96) points, P ＜ 0.01]. ② MAS grades of upper limbs: There were obviously fewer cases of grade Ⅲ in MAS at 2 weeks after treatment than before treatment in the treatment group (0, 9 cases, P ＜0.05), whereas there was no obvious difference in the control group. There were obviously fewer cases of grade Ⅲ in MAS at 2 weeks and 1 month after treatment in the treatment group (0, 0 case) than the control group (5, 2 cases, P ＜ 0.01). ③ Barthel index of upper limbs: The Barthel index at 2 weeks after treatment was higher than that before treatment in the treatment group [(30.36±22.25), (28.22±26.21) points, P＜ 0.05],whereas there was no significant difference in the control group. The Barthel indexes at 1 and 3 months after treatment in the treatment group were obviously higher than those in the control group [(20.55±10.22), (30.33±10.96) points, P＜ 0.01].CONCLUSION: BTX-A has obvious efficacy on decreasing muscle tension after stroke and brain injury, and relieving muscle spasm; Meanwhile, the combination with rehabilitative training can effectively ameliorate the motor function of upper limbs and ADL of the patients.