Reid S M, Johnstone B R, Westbury C, Rawicki B, Reddihough D S
Developmental Disability Research, Murdoch Childrens Research Institute, University of Melbourne, Victoria, Australia.
Dev Med Child Neurol. 2008 Feb;50(2):123-8. doi: 10.1111/j.1469-8749.2007.02010.x.
The primary aim of this randomized, controlled trial was to assess the effectiveness of botulinum toxin A (BoNT-A) injections into the submandibular and parotid glands on drooling in children with cerebral palsy (CP) and other neurological disorders. Secondary aims were to ascertain the duration of any such effect and the timing of maximal response. Of the 48 participants (27 males, 21 females; mean age 11y 4mo [SD 3y 3mo], range 6-18y), 31 had a diagnosis of CP and 15 had a primary intellectual disability; 27 children were non-ambulant. Twenty-four children randomized to the treatment group received 25 units of BoNT-A into each parotid and submandibular gland. Those randomized to the control group received no treatment. The degree and impact of drooling was assessed by carers using the Drooling Impact Scale questionnaire at baseline and at monthly intervals up to 6 months postinjection/baseline, and again at 1 year. Maximal response was at 1 month at which time there was a highly significant difference in the mean scores between the groups. This difference remained statistically significant at 6 months. Four children failed to respond to the injections, four had mediocre results, and 16 had good results. While the use of BoNT-A can help to manage drooling in many children with neurological disorders, further research is needed to fully understand the range of responses.
这项随机对照试验的主要目的是评估向患有脑瘫（CP）和其他神经障碍的儿童的下颌下腺和腮腺注射A型肉毒杆菌毒素（BoNT-A）对流涎的疗效。次要目的是确定这种效果的持续时间以及最大反应的时间。48名参与者（27名男性，21名女性；平均年龄11岁4个月[标准差3岁3个月]，范围6-18岁）中，31名被诊断为CP，15名患有原发性智力残疾；27名儿童不能行走。随机分配到治疗组的24名儿童每侧腮腺和下颌下腺各接受25单位的BoNT-A注射。随机分配到对照组的儿童不接受治疗。在基线时以及注射后/基线后长达6个月的每月间隔时间，以及在1年时，由护理人员使用流涎影响量表问卷评估流涎的程度和影响。最大反应出现在1个月时，此时两组的平均得分存在高度显著差异。这种差异在6个月时仍具有统计学意义。4名儿童对注射无反应，4名效果一般，16名效果良好。虽然使用BoNT-A可以帮助控制许多神经障碍儿童的流涎，但需要进一步研究以充分了解反应范围。
