Service de neurologie, CHU Clermont-Ferrand, Université Clermont Auvergne, Clermont-Ferrand, France.
Département de neurologie, Centre Expert et Inter-Régional de Coordination de la Maladie de Parkinson, Groupe Hospitalier Universitaire Pitié-Salpêtrière, APHP, Paris, France.
Parkinsonism Relat Disord. 2018 Jan;46:9-15. doi: 10.1016/j.parkreldis.2017.10.009. Epub 2017 Oct 19.
Plantar flexion of toe dystonia is very painful and leads to difficulties in walking. The objective of this study was to investigate the effect of incobotulinum toxin A (Xeomin) in the treatment of this type of dystonia in parkinsonian patients, using a randomized, double blind, placebo-controlled trial.
45 parkinsonian patients with painful dystonic plantar flexion of toes were injected either with incobotulinum toxin A (Btx group), or with placebo in two muscle targets: the Flexor digitorum longus and the Flexor digitorum brevis. Three groups were compared: the first group received placebo in the Flexor digitorum longus and 100UI of Btx in the Flexor digitorum brevis (n = 16); the second group received 100 UI of Btx in the Flexor digitorum longus and placebo in the Flexor digitorum brevis (n = 13); and the third group, 2 injections of placebo (n = 16). The patients were injected in the same way twice with an interval of 3 months. The primary endpoint was measured six weeks after injections with the Clinical Global Impression (CGI) of change. Dystonia severity and associated pain were also assessed.
Mean CGI was improved in the Btx group compared to the placebo group (P = 0.039). A significant reduction of pain and dystonia severity were observed in patients treated with Btx compared to baseline but no improvement was noted when compared to placebo group. No difference of efficacy was highlighted between the two injection sites.
Btx injections are effective for improving clinical state of parkinsonian patients with plantar flexion of toe dystonia.
足趾屈肌痉挛性疼痛非常痛苦，导致行走困难。本研究的目的是使用随机、双盲、安慰剂对照试验，研究丁丙诺啡毒素 A（Xeomin）治疗帕金森病患者这种类型的痉挛的效果。
45 例伴有疼痛性屈肌痉挛的帕金森病患者，分别接受丁丙诺啡毒素 A（Btx 组）或两种肌肉靶位的安慰剂注射：趾长屈肌和趾短屈肌。三组进行比较：第一组在趾长屈肌中接受安慰剂，在趾短屈肌中接受 100UI 的 Btx（n=16）；第二组在趾长屈肌中接受 100UI 的 Btx，在趾短屈肌中接受安慰剂（n=13）；第三组，2 次注射安慰剂（n=16）。患者以相同的方式每隔 3 个月注射两次。主要终点是在注射后 6 周用临床总体印象（CGI）评估变化。还评估了痉挛严重程度和相关疼痛。
与安慰剂组相比，Btx 组的平均 CGI 有所改善（P=0.039）。与基线相比，接受 Btx 治疗的患者疼痛和痉挛严重程度显著降低，但与安慰剂组相比无改善。两个注射部位的疗效无差异。
Btx 注射可有效改善伴有足趾屈肌痉挛的帕金森病患者的临床状态。
