Jongerius Peter H, van den Hoogen Frank J A, van Limbeek Jacques, Gabreëls Fons J, van Hulst Karen, Rotteveel Jan J
Department of Rehabilitation, University Medical Centre St Radboud, PO Box 9101 6500HB, Nijmegen 720, Netherlands.
Pediatrics. 2004 Sep;114(3):620-7. doi: 10.1542/peds.2003-1104-L.
To investigate the clinical effectiveness of botulinum neurotoxin type A (BoNT) to reduce drooling in children with cerebral palsy (CP).
A controlled clinical trial was performed in which the results of single-dose BoNT injections in the submandibular glands were compared with treatment with scopolamine. Forty-five children who had CP and experienced severe drooling were enrolled. Drooling severity was measured at baseline, during application of scopolamine, and at different intervals after BoNT injections up to 24 weeks, using the Drooling Quotient (DQ), the Teacher Drooling Scale (TDS), and Visual Analog Scales (VAS).
Drooling was reduced during scopolamine application as well as after BoNT injections. Compared with baseline, the mean DQ showed a significant decrease throughout the study. Greatest reductions were achieved 2 to 8 weeks after BoNT injection. No significant differences were found between scopolamine measurements and those up to 24 months after BoNT injection. Using VAS, parents recorded the effect on drooling in which significant differences were found between baseline VAS score and all follow-up assessments. According to our definition of "success to therapy," demanding a 2-point decrease on the TDS, 61.5% of patients responded to BoNT injections. Analysis of the DQ demonstrated a response rate of 53% of the patients to scopolamine and 48.7% to BoNT until 24 weeks after BoNT injections, the actual duration of this study. As a reaction to scopolamine, 71.1% of the patients had moderate to severe side effects. Only nonsevere, incidental side effects were reported after BoNT injections.
During scopolamine application as well as after intraglandular BoNT injections, a clinically relevant reduction in drooling was achieved in children with CP, demonstrating maximum effect 2 to 8 weeks after injections. This is the first controlled clinical trial that confirmed a significant effect of BoNT injections in the treatment of drooling. General anesthesia was needed for all children. BoNT injections show fewer and less serious side effects than transdermal scopolamine treatment.
探讨A型肉毒杆菌神经毒素（BoNT）减少脑瘫（CP）患儿流涎的临床疗效。
进行一项对照临床试验，比较单剂量BoNT注射至下颌下腺的结果与东莨菪碱治疗的效果。纳入45例患有CP且流涎严重的儿童。在基线、东莨菪碱应用期间以及BoNT注射后长达24周的不同时间间隔，使用流涎商数（DQ）、教师流涎量表（TDS）和视觉模拟量表（VAS）测量流涎严重程度。
东莨菪碱应用期间以及BoNT注射后流涎均减少。与基线相比，整个研究期间平均DQ显著降低。BoNT注射后2至8周减少最为明显。东莨菪碱测量值与BoNT注射后长达24个月的测量值之间未发现显著差异。使用VAS，家长记录了对流涎的影响，基线VAS评分与所有随访评估之间存在显著差异。根据我们对“治疗成功”的定义，要求TDS降低2分，61.5%的患者对BoNT注射有反应。对DQ的分析表明，直至BoNT注射后24周（本研究的实际持续时间），53%的患者对东莨菪碱有反应，48.7%的患者对BoNT有反应。作为对东莨菪碱的反应，71.1%的患者有中度至重度副作用。BoNT注射后仅报告了非严重的偶发副作用。
在东莨菪碱应用期间以及腺体内BoNT注射后，CP患儿的流涎在临床上有显著减少，注射后2至8周效果最佳。这是第一项证实BoNT注射治疗流涎有显著效果的对照临床试验。所有儿童均需要全身麻醉。与经皮东莨菪碱治疗相比，BoNT注射的副作用更少且更不严重。
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