Berry H, Hutchinson D R
King's College Hospital, Denmark Hill, London, UK.
J Int Med Res. 1988 Mar-Apr;16(2):75-82. doi: 10.1177/030006058801600201.
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 (300 mg) were taken as required as 'rescue' 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 biochemistry 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.
112名近期突发急性腰痛的患者被纳入这项在全科医疗中进行的双盲、随机、安慰剂对照平行组研究，以评估肌肉松弛剂替扎尼定的疗效和耐受性。他们接受了7天的替扎尼定（每日三次，每次4毫克）治疗或匹配的安慰剂治疗。必要时服用阿司匹林片（300毫克）作为“急救”药物。在治疗前、治疗3天后和7天后，由患者和医生对症状进行评估。患者在每日日记中记录疼痛情况和阿司匹林的服用量。两种治疗方法均有效。在入组前未服用任何药物的患者中，与安慰剂相比，服用替扎尼定的前3天阿司匹林的服用量几乎减半（P = 0.037）。静息痛、夜间痛、活动受限和运动痛的结果表明，替扎尼定可能会带来更大且更早的改善。两组均未观察到严重的药物相关不良事件或异常的生化或血液学指标。服用替扎尼定的患者中有22%出现嗜睡，不过，对于重度急性腰痛患者而言，镇静、镇痛和卧床休息可能有益且是必要的。服用阿司匹林/安慰剂的患者出现胃肠道副作用的比例要高得多（P = 0.018）。总之，替扎尼定可能会减少对镇痛药的需求，对急性腰痛的治疗可能有用。
