三种抗痉挛药物治疗卒中后肢体痉挛的疗效比较

Efficacy of three antispasmodics on limb spasticity in patients after stroke: a comparative analysis

目的对替扎尼定、巴氯芬、乙哌立松治疗卒中后肢体痉挛的疗效和不良反应,进行比较和评价。方法采用前瞻性随机对照研究,选取住院治疗的103例卒中患者,按数字法随机分为替扎尼定组30例、巴氯芬组25例、乙哌立松组22例及对照组26例。用药前和用药后4、12周,采用改良Ashworth评分表、Fugl-Meyer评价表(FMA)、改良Bathel指数,分别对肌张力、运动功能、日常生活活动能力(activity of daily living,ADL)进行评价。结果①患者上肢和下肢用药后12周,3个治疗组与对照组相比,改良Ashworth评分均有降低,均P<0.05。与治疗前比较,替扎尼定组、巴氯芬组、乙哌立松组、对照组上肢平均降低分数分别为0.8±0.6、0.7±0.6、0.7±0.4、0.4±0.4,下肢平均降低分数依次为0.8±0.6、0.7±0.5、0.7±0.5、0.5±0.5;但3个药物组间比较,P>0.05。②上肢FMA评分显示,4个组患者治疗前、后评分比较,均P>0.05;下肢FMA评分显示,4组患者在治疗后12周比治疗前显著提高。平均增加分数依次为5±3、6±5、5±4、4±4,均P<0.05。4组间两两比较,均,P>0.05。③改良Bathel指数显示,4组患者的分数在治疗后12周与治疗前比较,均P<0.05,平均增加分数依次为27±12、25±14、25±12、21±11,3个药物组与对照组比较,均P<0.05。④所有患者治疗前后血、尿常规,肝肾功能检查均在正常范围。不良反应的发生率,嗜睡:替扎尼定组为10%,巴氯芬组为8%;胃肠道不适:替扎尼定组为6.7%,巴氯芬组为8%,乙哌立松组为4.5%;血压降低:替扎尼定组为6.7%,巴氯芬组为8%;全身乏力:乙哌立松组为22.7%。所有患者在减量或停药后症状均缓解。结论替扎尼定、巴氯芬和乙哌立松均有较明显的降低肌张力、缓解痉挛的作用,疗效无差异。在功能恢复方面,三者均未显示有明显作用。三种药物安全性均较高。

Objective To compare and evaluate the efficacy and adverse reactions of tizanidine, baclofen and eperisone for treatment of limb spastieity in patients after stroke. Method One hundred and three patients with stroke were enrolled in this prospective, randomized, controlled study. They were randomly divided into 4 groups ： Tizanidine （ n = 30） , baclofen （ n = 25 ）, eperisone （ n = 22 ） and control （ n = 26） groups. The muscular tone, motor function and daily live activities （ADL） were evaluated with the modified Ashworth scale （ MAS）, Fugl-Meyer ssessment （FMA） and modified Bathel index （BI） respectively 4 and 12 weeks before and after the medication. Results （1）Twelve weeks after the medication, the MAS scores of the upper and lower limbs of the patients were decreased in the 3 treatment groups as compared to the control group （ P 〈 0. 05 all ）. The average decrease scores of the upper limbs in the tizanidine, baclofen, eperisone and control group were 0. 8 ± 0. 6, 0. 7± 0. 6, 0. 7 ± 0. 4, and 0. 4 ±0. 4, respectively ;and those of lower limbs were 0. 8± 0. 6, 0. 7±0. 5,0. 7 ± 0. 5, and 0. 5± 0. 5. However, there was no significant difference among the 3 treatment groups （ P 〉 0.05 ）. （2）The FMA scores of the upper limbs in patients of the 4 groups showed that there were no significant differences before and after the treatment （ P 〉 0.05 all ） ; the FMA scores of the lower limbs in patients of the 4 groups after the 12-week treatment were significantly higher than those before treatment. The average increased scores were 5 ± 3, 6 ± 5, 5 ± 4, and 4 ± 4, respectively （ P 〈 0.05 all）, and there were no significant differences between the 4 groups （ P 〉 0. 05）. （3）Compare to the scores before the treatment, the MBI showed that there were significant differences in the average scores in the 4 groups 12 weeks after the treatment （ P 〈0. 05 all）, and the average increased scores were 27 ± 12, 25± 14, 25 ± 12, and 21 ± 11. There were no significant differences between the 3 groups and the control group （P 〉 0. 05）. （4）Blood, urine, liver and renal function tests of all patients were in the normal range before and after treatment. 10% and 8% of patients in the tizanidine and baclofen groups experienced drowsiness; 6. 7% , 8% , and 4. 5% of patients in the tizanidine, baclofen, and eperisone groups had gastrointestinal discomfort; 6. 7% and 8% of patients in the tizanidine and baclofen groups had blood pressure drop; and 22. 7% of patients in the eperisone group had generalized weakness. The symptoms were relieved in all patients after reduce or stop the medication. Conclusion Tizanidine, baclofen and eperisone have obviously effects for reducing muscular tone and relieving spasticity. Their therapeutic effects has no differences, but the three medicines did not show significant effect on functional recovery.