替扎尼定与非甾体抗炎药联合治疗急性痉挛性疼痛的临床研究

Treatment of Acute Painful Muscle Spasms with Tizanidine Plus Diclofenac:A Clinical Analysis

目的:替扎尼定是具有解痉作用的α2肾上腺能受体激动剂,并具有一定的胃肠道保护作用,适用于单一治疗或与非甾体消炎药(NSAIDs)联合治疗急性痉挛性疼痛。通过替扎尼定和非甾体类抗炎药物的联合应用,临床观察和评估联合用药能否增强疗效和增加安全性。方法:急性痉挛性疼痛70例,随机分为两组,一组服用替扎尼定2mg,bid+双氯芬酸50mg,bid,一组服用双氯芬酸50mg,bid+安慰剂2mg,bid。观察药物疗效和不良反应。结果:联用组的总有效率为70%,胃肠道不良反应发生率为12%,中枢神经系统不良反应发生率为18%;单用组的总有效率为56%,胃肠道不良反应发生率为32%,中枢神经系统不良反应发生率为10%。结论:替扎尼定和非甾体类药物联用具有更好的疗效以及更高的药物耐受性。

Objective：Tizanidine is an alpha2-adrenergic receptor agonist with myospasmolytic action,which has the gastroprotect effect.It is indicated for the treatment of back pain as monotherapy or combination with nonsteoidal anti-inflammatory drugs（NSAIDs）.The efficacy and gastroprotective effects of tizanidine plus NSAIDs were compared with placebo plus NSAIDs in patients with painful muscle spasms.Methods：Seventy patients with local pain syndromes of recent onset and clinically discernible muscle spasms were randomly and equally divided into 2 groups.Patients received either tizanidine 2 mg twice daily（bid）with diclofenac 50 mg bid or placebo bid with diclofenac 50 mg for 7 days.Efficacy variables and tolerability were assessed and a test for occult blood in the stool was performed on the day 8.Results：The overall effective rates on the day 8 after administration in two groups were 70%,56% respectively.Considerably more patients given diclofenac/placebo had gastro-intestinal side-effects（P〈0.001）,although more patients taking tizanidine（12%）had drowsiness.Conclusion：The combination of tizanidine with diclofenac was more effective and better tolerated than diclofenac alone in patients with acute painful muscle spasms.