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目的探讨国产A型肉毒毒素(CBTX-A)肌肉注射治疗脑卒中后上肢痉挛的疗效和安全性。方法选取43例脑卒中患者为研究对象。根据随机数字表将患者分为两组:CBTX-A +康复治疗组(治疗组)和单纯康复治疗组(对照组)。治疗组患者除康复训练外,肱二头肌肌肉注射CBTX- A。分别于治疗前及治疗后2、4、8、12周对患者上肢功能进行评价。评价内容包括改良的Ashworth计分(MAS)、关节活动度(ROM)、上肢的Fugl-Meyer(FMA-上肢)计分和上肢的FIM运动能力(mot- FIM-上肢)。结果治疗组CBTX-A局部注射治疗后,85.7%(18/21)的患者有效。两组在MAS、ROM、FMA-上肢计分和mot-FIM-上肢方面,治疗后比治疗前均有显著改善。治疗后2、4、8周MAS计分治疗组分别为1.74±0.41,1.62±0.35,1.60±0.41,对照组分别为2.50±0.51,2.27±0.53, 2.18±0.55,各期两组间差异有统计学意义(P<0.01)。但是在治疗后12周时,两组间差异无统计学意义(P>0.05)。治疗后4-12周,ROM计分治疗组分别为57.81±57.60,66.43±64.38,68.14±65.99,对照组分别为27.91±30.13,30.73±34.03,33.73±34.50,各期治疗组比对照组均有显著性增加,差异有统计学意义(P<0.05)。治疗组治疗后FMA-上肢计分和mot-FIM-上肢计分与对照组相比均无统计学意义(P>0.05)。结论通过实验可以得出CBTX-A肌肉注射结合康复治疗可以达到提前缓解局部肌张力,扩大关节活动度,减轻疼痛,改善肢体功能的目的,这种治疗方法安全有效,具有良好的耐受性。
Objective To investigate the efficacy and safety of domestic botulinum toxin type A (CBTX-A) intramuscular injection in the treatment of post-stroke upper extremity spasticity. Methods 43 cases of stroke patients were selected as the research object. Patients were divided into two groups according to random number table: CBTX-A + rehabilitation group (treatment group) and simple rehabilitation group (control group). Patients in the treatment group received CBTX- A intramuscular injection in addition to rehabilitation training. Patients were evaluated for upper limb function before treatment and at 2, 4, 8, 12 weeks after treatment. Assessments included improved Ashworth score (MAS), ROM, Fugl-Meyer score for upper limbs and motility of FIM-upper limbs for upper limbs. Results After treatment with CBTX-A in treatment group, 85.7% (18/21) patients were effective. In both groups, MAS, ROM, FMA-upper limb scores and mot-FIM-upper limbs were significantly improved after treatment than before treatment. MAS scores at 2, 4, and 8 weeks after treatment were 1.74 ± 0.41, 1.62 ± 0.35 and 1.60 ± 0.41 in the control group, and 2.50 ± 0.51, 2.27 ± 0.53 and 2.18 ± 0.55 in the control group, respectively Statistical significance (P <0.01). However, at 12 weeks after treatment, there was no significant difference between the two groups (P> 0.05). After treatment for 4-12 weeks, ROM score treatment group were 57.81 ± 57.60,66.43 ± 64.38,68.14 ± 65.99, the control group were 27.91 ± 30.13,30.73 ± 34.03,33.73 ± 34.50, the treatment group than the control group There was a significant increase, the difference was statistically significant (P <0.05). There was no significant difference in FMA-upper limb score and mot-FIM-upper limb score between the two groups after treatment (P> 0.05). Conclusions It can be concluded through experiments that CBTX-A intramuscular injection combined with rehabilitation therapy can achieve the purpose of alleviating local muscle tension, expanding joint activity, relieving pain and improving limb function in advance. The treatment is safe, effective and well tolerated.