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一项双盲、安慰剂对照研究,旨在评估A型肉毒杆菌毒素治疗帕金森病流涎的疗效和安全性。

Double-blind, placebo-controlled study to evaluate the efficacy and safety of botulinum toxin type A in the treatment of drooling in parkinsonism.

作者信息

Mancini Francesca, Zangaglia Roberta, Cristina Silvano, Sommaruga Maria Grazia, Martignoni Emilia, Nappi Giuseppe, Pacchetti Claudio

机构信息

Parkinson's Disease and Movement Disorders Unit, C. Mondino Institute of Neurology, IRCCS, Pavia, Italy.

出版信息

Mov Disord. 2003 Jun;18(6):685-8. doi: 10.1002/mds.10420.

Abstract

Drooling is a frequent symptom in Parkinson's disease (PD), occurring in almost 75% of all patients. Although it is now well known that drooling in PD is the result of swallowing difficulties rather than excessive saliva production, few treatments have been developed to reduce it. Clinical studies suggest that botulinum toxin A (BTX) injections into salivary glands are effective in decreasing drooling in PD patients. In this double-blind, placebo-controlled study, 20 patients with parkinsonism (idiopathic PD or multiple system atrophy), were randomly assigned to receive 450 U of BTX (Dysport; Ipsen, Berkshire, UK) or 2 ml of placebo, injected into the parotids and submandibular glands under ultrasonographic guidance. Treatment efficacy and safety were assessed at baseline, 1 week and 3 months after BTX injections using clinical scales (Drooling Severity and Drooling Frequency scales) and side effects surveillance. After treatment, the average secretion of saliva in the BTX group was significantly lower than in the placebo group, as appraised by clinical measurements. No side effects were observed in either group. BTX injection into parotids and submandibular glands, under ultrasonographic guidance, is an effective and safe treatment for drooling in parkinsonism.

摘要

流涎是帕金森病(PD)的常见症状,几乎75%的患者都会出现。虽然现在已经清楚地知道,PD患者流涎是吞咽困难的结果,而非唾液分泌过多,但针对减少流涎的治疗方法却很少。临床研究表明,向唾液腺注射A型肉毒毒素(BTX)对减少PD患者的流涎有效。在这项双盲、安慰剂对照研究中,20例帕金森综合征(特发性PD或多系统萎缩)患者被随机分配,在超声引导下向腮腺和颌下腺注射450 U的BTX(Dysport;益普生公司,英国伯克郡)或2 ml安慰剂。在BTX注射后的基线、1周和3个月,使用临床量表(流涎严重程度和流涎频率量表)和副作用监测来评估治疗效果和安全性。治疗后,通过临床测量评估,BTX组的唾液平均分泌量显著低于安慰剂组。两组均未观察到副作用。在超声引导下向腮腺和颌下腺注射BTX,是治疗帕金森综合征患者流涎的一种有效且安全的方法。

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