Li Shuang, Lian Ya-Jun, Chen Yuan, Zhang Hai-Feng, Ma Yun-Qing, He Cai-Hong, Wu Chuan-Jie, Xie Nan-Chang, Zheng Ya-Ke, Zhang Yi
Department of Neurology, the First Affiliated Hospital, Zhengzhou University, 1 Jianshe East R, Zhengzhou 450052, Henan Province, People's Republic of China.
J Headache Pain. 2014 Jun 22;15(1):43. doi: 10.1186/1129-2377-15-43.
We investigated the long-term effects and safety of botulinum toxin-A (BTX-A) for treating trigeminal neuralgia (TN). We also studied long-term maintenance of this therapeutic effect.
A visual analog scale (VAS) score, pain attack frequency per day, patient's overall response to treatment and side effects during 14-month follow-up were evaluated in 88 patients with TN receiving BTX-A. The primary endpoints were pain severity (assessed by VAS) and pain attack frequency per day. The secondary endpoint was the patient's overall response to treatment, assessed using the Patient Global Impression of Change. The influence of different doses (≤50, 50-100 and ≥100 U) on the therapeutic effect was evaluated.
Treatment was deemed "effective" within 1 month in 81 patients and at 2 months in 88 patients (100%). The shortest period of effective treatment was 3 months, and complete control of pain was observed in a maximum of 46 patients. The therapeutic effect decreased gradually after 3 months, and the prevalence of effective treatment at 14 months was 38.6%, with complete control of pain seen in 22 patients (25%). There was no significant difference in the prevalence of effective treatment between different dose groups at identical time points (p > 0.05). Three patients showed swelling at injection sites and 10 patients showed facial asymmetry, both of which disappeared spontaneously without special treatment.
Local subcutaneous injection of BTX-A for TN treatment has considerable therapeutic effects lasting several months and is safe for this indication. At least one-quarter of patients maintained complete analgesia. The maintenance period of the therapeutic effect may be related to the reduction in the VAS score after the first injection of BTX-A.
我们研究了A型肉毒毒素（BTX-A）治疗三叉神经痛（TN）的长期疗效和安全性。我们还研究了这种治疗效果的长期维持情况。
对88例接受BTX-A治疗的TN患者在14个月的随访期间进行视觉模拟量表（VAS）评分、每日疼痛发作频率、患者对治疗的总体反应及副作用评估。主要终点为疼痛严重程度（通过VAS评估）和每日疼痛发作频率。次要终点为患者对治疗的总体反应，采用患者总体印象变化量表进行评估。评估不同剂量（≤50、50 - 100和≥100 U）对治疗效果的影响。
81例患者在1个月内被认为“有效”，88例患者（100%）在2个月内被认为“有效”。最短有效治疗期为3个月，最多46例患者实现了疼痛完全控制。3个月后治疗效果逐渐下降，14个月时有效治疗的发生率为38.6%，22例患者（25%）实现了疼痛完全控制。相同时间点不同剂量组之间有效治疗的发生率无显著差异（p > 0.05）。3例患者注射部位出现肿胀，10例患者出现面部不对称，两者均未经过特殊治疗自行消失。
局部皮下注射BTX-A治疗TN有显著疗效，可持续数月，且对此适应证安全。至少四分之一的患者维持了完全镇痛。治疗效果的维持期可能与首次注射BTX-A后VAS评分的降低有关。
