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脑瘫患儿流涎症的治疗:一项双盲安慰剂对照试验。

Treatment of sialorrhea in children with cerebral palsy: a double-blind placebo controlled trial.

作者信息

Alrefai Ali H, Aburahma Samah K, Khader Yousef S

机构信息

Jordan University of Science and Technology, Jordan.

出版信息

Clin Neurol Neurosurg. 2009 Jan;111(1):79-82. doi: 10.1016/j.clineuro.2008.09.001. Epub 2008 Nov 1.

DOI:10.1016/j.clineuro.2008.09.001
PMID:18977585
Abstract

OBJECTIVES

To prospectively study the efficacy and safety of intraparotid gland injection of Botulinum neurotoxin serotype A (Dysport) for the treatment of sialorrhea (drooling) in children with cerebral palsy (CP).

PATIENTS AND METHODS

Twenty-four children, ages 21 months to 7 years, were recruited and randomized to receive either treatment with 100U Botulinum toxin or placebo. Rating scales for the frequency and severity of drooling were performed at the time of injection, at 1 month, and at baseline prior to the second injection. A second set of injections of either 140U of drug or placebo was given 4 months later, and the same rating scales were used. Eight patients declined the second injection. Due to high dropouts in the placebo group in second set of injections, statistical analysis was performed for the results of the initial injection only.

RESULTS

Scores of the median frequency (p=0.034) and severity (p=0.026) of drooling were reduced in the treatment group. Median total score also declined in the treatment group (p=0.027). After the second injection, five out of nine patients injected with the drug showed a decline in the total score; including three patients who did not respond to the first injection. Only two patients experienced transient increase in drooling after the treatment with the drug.

CONCLUSION

Botulinum toxin is an effective and safe treatment option for drooling in children with CP.

摘要

目的

前瞻性研究腮腺内注射A型肉毒杆菌神经毒素(Dysport)治疗脑瘫(CP)患儿流涎(流口水)的疗效和安全性。

患者与方法

招募了24名年龄在21个月至7岁之间的儿童,随机分为两组,分别接受100U肉毒杆菌毒素治疗或安慰剂治疗。在注射时、1个月时以及第二次注射前的基线时,对流涎的频率和严重程度进行评分。4个月后进行第二组注射,注射140U药物或安慰剂,使用相同的评分量表。8名患者拒绝第二次注射。由于安慰剂组在第二组注射中的高退出率,仅对首次注射的结果进行了统计分析。

结果

治疗组流涎的中位频率(p = 0.034)和严重程度(p = 0.026)得分降低。治疗组的中位总分也有所下降(p = 0.027)。第二次注射后,9名接受药物注射的患者中有5名的总分下降;其中包括3名对首次注射无反应的患者。仅2名患者在药物治疗后出现流涎短暂增加。

结论

肉毒杆菌毒素是治疗CP患儿流涎的一种有效且安全的治疗选择。

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