A型肉毒杆菌毒素水凝胶去神经支配作用的定量研究

QUALITATIVE ANALYSIS ON THE DENERVATING ACTION OF BOTULINUM TOXIN A IN GEL

目的:探讨改变剂型后的A型肉毒杆菌毒素(BTXA)的生物活性是否存在,并对其去神经支配作用进行定量分析。方法:SD大鼠36只,随机分成4组。A^D组随机一侧腓肠肌肌内注射BTXA水溶液0.1 ml(5U)、BTX-A水凝胶0.1 ml(12.5U)、0.1 ml(5U)及0.1 ml(2U),对侧腓肠肌肌内注射0.1 ml相应溶剂。于用药前、用药后5d、2周、3周、1个月、2个月及3个月分别测定双侧腓肠肌复合动作电位(CMAP),并记录波幅。结果:不同时间段用药侧与对侧腓肠肌CMAP波幅的下降幅度比较有非常显著性差异(P<0.01),用药后的用药侧与对侧腓肠肌CMAP波幅的下降幅度均明显高于用药前(P<0.01);各组间的用药侧与对侧CMAP波幅的下降幅度比较有非常显著性差异(P<0.01),A组及B组的下降幅度明显高于C组及D组(P<0.01),A组及B组比较则没有显著性差异,C组的下降幅度高于D组(P<0.01)。结论:水凝胶剂型的BTXA不仅保存了其去神经支配的生物活性,且表现明显的量效关系和时效关系。

Aim： To ascertain the bioactivity and to analyse quantificationally the denervating action of botulinum toxin A （BTXA） in gel. Methods： 36 Spragne-Dawley rats were randomized into four groups. In group A--D, the gastroenemius muscle of one leg was randomly selected to receive injection of BTXA solution 5U in 0.1 ml, BTXA gel 12 .SU in 0.1 ml, BTXA gel 5U in 0.1 ml and BTXA gel 2U in 0.1 ml respectively, while the gastrocnemius muscle of other leg was injected with 0.1 ml of saline solution in group A and 0.1 ml of gel in group B to group D as control. Compound muscle action potential （CMAP） of both gastrocnemius muscles were measured and the amplitudes were recorded before injections, and 5 days, 2 weeks, 3 weeks, 1 month, 2 months and 3 months after the injections respectively. Results： The reduction of CMAP amplitude was significantly different at various time（ P 〈 0.01 ）, and CMAP amplitude decreased significantly after the treatment of BTXA（P〈0.01）. The reduction of CMAP amplitude was significantly dif- ferent in group A to D（P〈0.01）,and more reduction was found in group A and B（P〈0.01）, and the reduction was higher in group C than in group D（P 〈 0.05）. However, there were no significant differences in the reduction of CMAP amplitude between group A and group B. Conclusion： Bioactivity of BTXA in gel was showed and the denervating action of BTXA in gel was demonstrated in a dosage and time dependent manner.