Jackson Carlayne E, Gronseth Gary, Rosenfeld Jeffrey, Barohn Richard J, Dubinsky Richard, Simpson C Blake, McVey April, Kittrell Pamela P, King Ruth, Herbelin Laura
University of Texas Health Science Center, 7703 Floyd Curl Drive, Mail Code 7883, San Antonio, Texas 78229-3900, USA.
Muscle Nerve. 2009 Feb;39(2):137-43. doi: 10.1002/mus.21213.
Twenty ALS patients with sialorrhea refractory to medical therapy were enrolled in this double-blind, randomized study to receive either 2,500 U of botulinum toxin type B (BTxb) or placebo into the bilateral parotid and submandibular glands using electromyographic guidance. Patients who received BTxb reported a global impression of improvement of 82% at 2 weeks compared to 38% of those who received placebo (P < 0.05). This significant effect was sustained at 4 weeks. At 12 weeks, 50% of patients who received BTxb continued to report improvement compared to 14% of those who received placebo. There were no significant adverse events, including dysphagia, in the BTxb group, and there was no significant increase in the rate of decline of vital capacity.
20例药物治疗难治性流涎的肌萎缩侧索硬化症（ALS）患者被纳入这项双盲、随机研究，在肌电图引导下向双侧腮腺和颌下腺注射2500单位B型肉毒杆菌毒素（BTxb）或安慰剂。接受BTxb治疗的患者在2周时报告总体改善情况的比例为82%，而接受安慰剂治疗的患者为38%（P<0.05）。这种显著效果在4周时得以维持。在12周时，接受BTxb治疗的患者中有50%继续报告有改善，而接受安慰剂治疗的患者中这一比例为14%。BTxb组未出现包括吞咽困难在内的显著不良事件，肺活量下降率也未显著增加。
