Berry H, Hutchinson D R
King's College Hospital, Denmark Hill, London.
J Int Med Res. 1988 Mar-Apr;16(2):83-91. doi: 10.1177/030006058801600202.
This study reports on 105 patients with acute low-back pain given tizanidine (4 mg three times daily) plus ibuprofen (400 mg three times daily) or placebo plus ibuprofen (400 mg three times daily). Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7. Both groups were treated effectively, but earlier improvement occurred in patients given tizanidine/ibuprofen, particularly regarding pain at night and at rest. Doctors assessed the helpfulness of treatment: tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 (P = 0.05). Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night (P less than 0.05), at rest (P less than 0.05) and those with moderate or severe sciatica (P less than 0.05). Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen (P = 0.002). This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs. More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects (P = 0.025). In patients with severe acute low-back pain, however, some sedation and bed rest is advantageous. This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone.
本研究报告了105例急性腰痛患者，他们被给予替扎尼定（每日三次，每次4毫克）加布洛芬（每日三次，每次400毫克）或安慰剂加布洛芬（每日三次，每次400毫克）。患者通过每日日记使用视觉模拟量表评估疼痛，医生在基线以及第3天和第7天评估他们的病情。两组治疗均有效，但服用替扎尼定/布洛芬的患者改善更早，尤其是在夜间和休息时的疼痛方面。医生评估了治疗的有效性：在第3天，替扎尼定/布洛芬显著优于安慰剂/布洛芬（P = 0.05）。在夜间（P<0.05）、休息时（P<0.05）有中度和重度疼痛以及有中度或重度坐骨神经痛的患者中，替扎尼定/布洛芬治疗组与安慰剂/布洛芬治疗组之间存在显著差异（P<0.05）。与替扎尼定/布洛芬组相比，服用安慰剂/布洛芬的患者出现胃肠道副作用的明显更多（P = 0.002）。这支持了先前在动物身上的研究工作，表明替扎尼定可介导胃黏膜对抗炎药物的保护作用。服用替扎尼定/布洛芬的患者出现嗜睡和其他中枢神经系统副作用的更多（P = 0.025）。然而，对于严重急性腰痛患者，一些镇静和卧床休息是有益的。本研究表明，与安慰剂和单独使用布洛芬相比，替扎尼定/布洛芬在治疗中度或重度急性腰痛方面更有效。
