Shakespeare D T, Young C A, Boggild M
The Walton Centre for Neurology and Neurosurgery, Lower Lane, Liverpool, UK, L9 7LJ.
Cochrane Database Syst Rev. 2000;2003(4):CD001332. doi: 10.1002/14651858.CD001332.
Spasticity is a common problem in MS patients causing pain, spasms, loss of function and difficulties in nursing care. A variety of oral and parenteral medications are available.
To assess the absolute and comparative efficacy and tolerability of anti-spasticity agents in multiple sclerosis (MS) patients.
Randomised controlled trials (RCTs) of anti-spasticity agents were identified using MEDLINE, EMBASE, bibliographies of relevant articles, personal communication, manual searches of relevant journals and information from drug companies.
Double-blind, randomised controlled trials (either placebo-controlled or comparative studies) of at least seven days duration.
Two independent reviewers extracted data and the findings of the trials were summarised. Missing data were collected by correspondence with principal investigators. A meta-analysis was not performed due to the inadequacy of outcome measures and methodological problems with the studies reviewed.
Twenty-three placebo-controlled studies (using baclofen, dantrolene, tizanidine, botulinum toxin, vigabatrin, prazepam and threonine) and thirteen comparative studies met the selection criteria. Only thirteen of these studies used the Ashworth scale, of which only three of the six placebo-controlled trials and none of the seven comparative studies showed a statistically significant difference between test drugs. Spasms, other symptoms and overall impressions were only assessed using unvalidated scores and results of functional assessments were inconclusive.
REVIEWER'S CONCLUSIONS: The absolute and comparative efficacy and tolerability of anti-spasticity agents in multiple sclerosis is poorly documented and no recommendations can be made to guide prescribing. The rationale for treating features of the upper motor neurone syndrome must be better understood and sensitive, validated spasticity measures need to be developed.
痉挛是多发性硬化症患者的常见问题,会导致疼痛、痉挛、功能丧失及护理困难。有多种口服和注射药物可供使用。
评估抗痉挛药物对多发性硬化症(MS)患者的绝对疗效和相对疗效以及耐受性。
通过MEDLINE、EMBASE、相关文章的参考文献、个人交流、对相关期刊的手工检索以及制药公司提供的信息,确定抗痉挛药物的随机对照试验(RCT)。
持续时间至少7天的双盲随机对照试验(安慰剂对照试验或比较研究)。
两名独立的审阅者提取数据,并总结试验结果。通过与主要研究者通信收集缺失数据。由于结局指标不充分以及所审查研究存在方法学问题,未进行荟萃分析。
23项安慰剂对照研究(使用巴氯芬、丹曲林、替扎尼定、肉毒杆菌毒素、氨己烯酸、普拉西泮和苏氨酸)和13项比较研究符合选择标准。其中只有13项研究使用了Ashworth量表,在这13项研究中,6项安慰剂对照试验中只有3项、7项比较研究中无一显示受试药物之间存在统计学显著差异。痉挛、其他症状和总体印象仅使用未经验证的评分进行评估,功能评估结果尚无定论。
抗痉挛药物对多发性硬化症的绝对疗效和相对疗效以及耐受性的文献记载不足,无法给出指导处方的建议。必须更好地理解治疗上运动神经元综合征特征的基本原理,需要开发敏感的、经过验证的痉挛测量方法。