一个关于替扎尼定在治疗急性腰背痛患者时的疗效与安全.doc

The Journal of International Research 1988; 16: 75-82 一个关于替扎尼定在治疗急性腰背痛患者时的疗效与安全性评价的多中心安慰剂对照临床研究 ―――H.Berry and D.R.Hutchinson 112名最近患有急性腰背疼痛的患者参加了一个双盲、随机、安慰剂控制的平行组临床研究以评估肌肉松弛药——替扎尼定的疗效和耐受性。他们服用替扎尼定（4mg,TID）共7天，或者服用对照的安慰剂，阿司匹林片（300mg）P=0.037）P=0.018） A Multicentre Placebo-controlled Study in General Practice to Evaluate the Efficacy and Safety of Tizanidine in acute Low-Back Pain ―――H.Berry and D.R.Hutchinson Coordinators of a General Practitioner Research Panel, UK Patients (112) with acute low-back pain of recent onset were recruited to this double-blind, randomized, placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant, tizanidine. They were treated for 7 days with tizanidine (4 mg three times daily) or matching placebo. Aspirin tablets (300mg) were taken as required as “rescues” medication. Symptoms were assessed by the patient and doctor before treatment, and after 3 and 7 days. Patients recorded pain and aspirin consumption in a daily diary. Both treatments were effective. In patients who had taken no medication prior to entry, aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo (P=0.037). Results for pain at rest, pain at night, restriction of movement and pain on movement suggest that tizanidine may give greater improvement, earlier. No serious drug-related adverse events or abnormal biochmistry or haematology were observed in either group .Drowsiness occurred in 22% of patients taking tizanidine although, in patients with severe acute low-back pain, sedation, analgesia and bed rest might be beneficial and desired. Considerably more patients given aspirin/placebo had gastro-intestinal side-effects (P=0.018). In conclusion, tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain. KEY WORDS: Tizanidine; muscle relaxant; low-back pain. 前言 急性腰背痛是一种常见的疾病，Fry1估计每年平均2500名到在全科诊断的病人，就有超过60名急性发作的患者。也就是每