Neurology Department, Cairo University, El-Manial 11153, Egypt.
J Headache Pain. 2013 Nov 19;14(1):92. doi: 10.1186/1129-2377-14-92.
Botulinum toxin type A (BTX-A) has been reported to have analgesic effects independent of its action on muscle tone, mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia (TN).The aim of our work was evaluating the efficacy, safety, and tolerability of BTX-A for the treatment of intractable idiopathic TN.
This was a randomized, single-blinded, placebo-control study carried out on 20 Egyptian patients with intractable TN. Patients received a one-time subcutaneous administration of BTX-A using "follow the pain" method. The primary efficacy measure was reduction in pain severity on the 10-cm VAS score as well as in paroxysms frequency from the baseline to week 12 (endpoint last observation carried forward [LOCF]). Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint.
Pain reduction at the 12-week endpoint was significant in BTX-A group (p<0.0001); VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of 6.5 compared with a decrease of 0.3 for placebo, also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale.
These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases.
肉毒毒素 A 型(BTX-A)已被报道具有独立于肌肉张力作用的镇痛作用,主要通过作用于神经源性炎症介质和控制感觉和自主神经末梢的神经递质释放来发挥作用,这些末梢涉及许多慢性疼痛疾病,如慢性难治性三叉神经痛(TN)。我们的工作目的是评估 BTX-A 治疗难治性特发性 TN 的疗效、安全性和耐受性。
这是一项在 20 名埃及难治性 TN 患者中进行的随机、单盲、安慰剂对照研究。患者接受了一次皮下 BTX-A 注射,采用“跟随疼痛”的方法。主要疗效指标是 10cm VAS 评分上疼痛严重程度的降低以及从基线到第 12 周(最后观察到的终点向前 [LOCF])发作频率的降低。次要疗效指标包括 QoL 评估和从基线到终点期间接受的急性药物数量。
BTX-A 组在第 12 周终点时疼痛减轻明显(p<0.0001);BTX-A 组终点 LOCF 相对于基线的 VAS 评分下降了 6.5,而安慰剂组仅下降了 0.3,急性药物数量也显著减少,QoL 功能量表增加。
这些结果表明,BTX-A 在 TN 患者中具有直接的镇痛作用,可以成为难治性病例的治疗选择。