Hurme M, Himanen P
Int J Clin Pharmacol Res. 1986;6(1):53-8.
An open trial with diflunisal (500 mg twice daily) in 766 outpatients consulting their doctor for low back pain, was carried out as part of the project "Back Pain 1981" in Finland. Of the patients (mean age 41 years), 460 had acute lumbago, 144 sciatica and 162 had chronic low back pain as a clinical diagnosis. In each diagnostic group there was a control group of patients receiving no drug therapy. Of the patients 65 percent were men and 35 percent women and the groups did not differ from this distribution in any diagnosis. The efficacy of the treatment was evaluated using four criteria: change of pain at rest and during exercise, patient's evaluation of the efficacy of the treatment, and the need for any supportive treatment. Side-effects of the drug therapy were registered. In all diagnostic groups the relief of pain both at rest and during exercise was greater in patients receiving diflunisal than in the controls. The greatest difference was found in lumbago. The patient's evaluation did not differ between the groups. The drug therapy diminished the need for supportive physical therapy. The frequency of side-effects was 8.6%. They led to the discontinuation of medication in 14 cases (3%). No severe side-effects were found. Diflunisal therapy for the relief of low back pain is therefore considered to be indicated in outpatient care.
作为芬兰“1981年背痛”项目的一部分,对766名因腰痛前来就医的门诊患者进行了双氟尼酸(每日两次,每次500毫克)的开放试验。这些患者(平均年龄41岁)中,临床诊断为急性腰痛的有460人,坐骨神经痛的有144人,慢性腰痛的有162人。在每个诊断组中,都有一组患者不接受药物治疗作为对照。患者中65%为男性,35%为女性,各诊断组的性别分布无差异。使用四个标准评估治疗效果:静息和运动时疼痛的变化、患者对治疗效果的评价以及是否需要任何支持性治疗。记录药物治疗的副作用。在所有诊断组中,接受双氟尼酸治疗的患者在静息和运动时的疼痛缓解程度均高于对照组。腰痛组的差异最大。两组患者的评价无差异。药物治疗减少了对支持性物理治疗的需求。副作用发生率为8.6%。有14例(3%)因副作用停药。未发现严重副作用。因此,双氟尼酸治疗腰痛在门诊治疗中被认为是适用的。