Naumann M, So Y, Argoff C E, Childers M K, Dykstra D D, Gronseth G S, Jabbari B, Kaufmann H C, Schurch B, Silberstein S D, Simpson D M
Department of Neurology, Klinikum Augsburg, Germany.
Neurology. 2008 May 6;70(19):1707-14. doi: 10.1212/01.wnl.0000311390.87642.d8.
To perform an evidence-based review of the safety and efficacy of botulinum neurotoxin (BoNT) in the treatment of autonomic and urologic disorders and low back and head pain.
A literature search was performed including MEDLINE and Current Contents for therapeutic articles relevant to BoNT and the selected indications. Authors reviewed, abstracted, and classified articles based on the quality of the study (Class I-IV). Conclusions and recommendations were developed based on the highest level of evidence and put into current clinical context.
The highest quality literature available for the respective indications was as follows: axillary hyperhidrosis (two Class I studies); palmar hyperhidrosis (two Class II studies); drooling (four Class II studies); gustatory sweating (five Class III studies); neurogenic detrusor overactivity (two Class I studies); sphincter detrusor dyssynergia in spinal cord injury (two Class II studies); chronic low back pain (one Class II study); episodic migraine (two Class I and two Class II studies); chronic daily headache (four Class II studies); and chronic tension-type headache (two Class I studies).
Botulinum neurotoxin (BoNT) should be offered as a treatment option for the treatment of axillary hyperhidrosis and detrusor overactivity (Level A), should be considered for palmar hyperhidrosis, drooling, and detrusor sphincter dyssynergia after spinal cord injury (Level B), and may be considered for gustatory sweating and low back pain (Level C). BoNT is probably ineffective in episodic migraine and chronic tension-type headache (Level B). There is presently no consistent or strong evidence to permit drawing conclusions on the efficacy of BoNT in chronic daily headache (mainly transformed migraine) (Level U). While clinicians' practice may suggest stronger recommendations in some of these indications, evidence-based conclusions are limited by the availability of data.
对肉毒杆菌神经毒素（BoNT）治疗自主神经和泌尿系统疾病以及腰背痛和头痛的安全性和有效性进行循证综述。
进行文献检索，包括检索MEDLINE和《现刊目次》，查找与BoNT及所选适应症相关的治疗性文章。作者根据研究质量（I - IV级）对文章进行审阅、摘要和分类。基于最高级别的证据得出结论并提出建议，并将其置于当前临床背景中。
各适应症现有最高质量文献如下：腋窝多汗症（两项I级研究）；手掌多汗症（两项II级研究）；流涎（四项II级研究）；味觉性出汗（五项III级研究）；神经源性逼尿肌过度活动（两项I级研究）；脊髓损伤所致括约肌逼尿肌协同失调（两项II级研究）；慢性腰背痛（一项II级研究）；发作性偏头痛（两项I级和两项II级研究）；慢性每日头痛（四项II级研究）；慢性紧张型头痛（两项I级研究）。
肉毒杆菌神经毒素（BoNT）应作为腋窝多汗症和逼尿肌过度活动的治疗选择（A级），对于手掌多汗症、流涎以及脊髓损伤后的逼尿肌括约肌协同失调可考虑使用（B级），对于味觉性出汗和腰背痛可考虑使用（C级）。BoNT对发作性偏头痛和慢性紧张型头痛可能无效（B级）。目前尚无一致或有力的证据可就BoNT对慢性每日头痛（主要是转化型偏头痛）的疗效得出结论（U级）。虽然临床医生的实践可能在其中一些适应症上提出更强的建议，但循证结论受到数据可得性的限制。
