Zhang Haifeng, Lian Yajun, Ma Yunqing, Chen Yuan, He Caihong, Xie Nanchang, Wu Chuanjie
Department of Neurology, the First Affiliated Hospital, Zhengzhou University, 1 Jianshe East R, Zhengzhou City, HeNan Province 450052, People's Republic of China.
J Headache Pain. 2014 Sep 27;15(1):65. doi: 10.1186/1129-2377-15-65.
In the majority of cases, trigeminal neuralgia (TN) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve. Although prophylactic pharmacological treatment is first choise, considering of insufficient effect or unacceptable side effects, neurosurgical treatment or lesion treatment should be considered. In addition to all these procedures mentioned above, one approach has been based on local intradermal and/or submucosal injections of Botulinum Toxin Type A (BTX-A).
We conducted a randomized, double-blind, placebo-controlled since November 2012, and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A. Eighty four patients were randomized into following groups: placebo (n = 28); BTX-A 25U (n = 27); BTX-A 75U (n = 29). Follow-up visits were conducted every week after the injection, and the overall duration of the study for each patient were 8 weeks to observe the pain severity, efficacy and adverse reactions at endpoint.
The visual analogue scale (VAS) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1, and sustained until week 8 throughout the study. There was no significant difference in VAS between 25U and 75U groups throughout the study. The response rates of 25U group (70.4%) and 75U group (86.2%) were significantly higher than placebo group (32.1%) at week 8, and there was no significant difference between 25U and 75U groups. Evaluation of the Patient Global Impression of Change (PGIC) demonstrated that 66.7% (25U group) and 75.9% (75U group) of the patients reported that their pain symptoms were 'much improved' or 'very much improved' versus 32.1% of the placebo group, and there was also no significant difference between 25U and 75U groups. All adverse reactions were graded as mild or moderate.
BTX-A injection in TN is safe and efficient. It is a useful treatment for refractory TN. Lower dose (25U) and high dose (75U) were similar in efficacy in short-term.
在大多数情况下，三叉神经痛（TN）是一种单侧疾病，表现为沿三叉神经一个或多个分支分布的超短刺痛。尽管预防性药物治疗是首选，但考虑到效果不佳或副作用难以接受，应考虑神经外科治疗或毁损治疗。除上述所有方法外，一种方法是基于局部皮内和/或黏膜下注射A型肉毒杆菌毒素（BTX-A）。
自2012年11月起，我们进行了一项随机、双盲、安慰剂对照试验，对84例经典型TN患者采用不同剂量的BTX-A进行局部多点注射。84例患者随机分为以下几组：安慰剂组（n = 28）；BTX-A 25U组（n = 27）；BTX-A 75U组（n = 29）。注射后每周进行随访，每位患者的研究总时长为8周，以观察终点时的疼痛严重程度、疗效和不良反应。
早在第1周，25U组和75U组的视觉模拟量表（VAS）评分与安慰剂组相比就显著降低，并在整个研究过程中持续至第8周。在整个研究过程中，25U组和75U组之间的VAS评分无显著差异。在第8周时，25U组（70.4%）和75U组（86.2%）的有效率显著高于安慰剂组（32.1%），25U组和75U组之间无显著差异。患者总体印象变化（PGIC）评估显示，25U组66.7%和75U组75.9%的患者报告其疼痛症状“有很大改善”或“有非常大的改善”，而安慰剂组为32.1%，25U组和75U组之间也无显著差异。所有不良反应均为轻度或中度。
BTX-A注射治疗TN安全有效。它是难治性TN的一种有效治疗方法。低剂量（25U）和高剂量（75U）在短期内疗效相似。
