Englert R, Fontanesi G, Müller P, Ott H, Rehn L, Silva H
Istituto Ortopedico Rizzoli, Bologna, Italy.
Clin Ther. 1996 Sep-Oct;18(5):843-52. doi: 10.1016/s0149-2918(96)80044-0.
An open-label, noncomparative study of the efficacy and tolerability of a once-daily piroxicam fast-dissolving dosage form (FDDF) comprised 157 patients aged 15 to 76 years (56.7% men) with acute low back pain of not more than 48 hours' duration. Patients received 40-mg piroxicam FDDF once daily for the first 2 days and 20 mg once daily for up to a total of 14 days of treatment. Fifteen investigators in three countries examined patients at baseline and at follow-up visits on days 4, 8, and 15. All efficacy assessments-including general low back pain; pain on sitting, standing, and walking; overall severity of night pain; duration of morning stiffness; lumbosacral tenderness on moderate pressure; modified Schober test of ability to bend forward; restriction of passive motion; length of time to resumption of an activity impaired by back pain; and overall restriction of back motion-demonstrated statistically significant improvements from baseline at each follow-up visit. Relief of pain, noted 30 minutes after the first dose, was maintained for the 24-hour dosing interval during the first 3 days. At visit 4, after piroxicam FDDF treatment had been completed, the number of patients being assessed had declined by half, principally because the resolution of symptoms had prompted discontinuation of the study drug. At the end of the treatment, 82.9% of patients evaluated the efficacy of piroxicam FDDF as good or excellent and investigators rated efficacy as good or excellent in 85.6% of patients. Tolerability was also rated highly, with 91% of patients characterizing piroxicam FDDF treatment as good or excellent, and investigators rating the treatment as good or excellent in 92% of patients. In all, 12.7% of the patients experienced drug-related adverse events, most frequently involving the gastrointestinal system. Drug-related adverse experiences prompted discontinuation of the study medication in five (3.2%) patients. These results suggest that the newly developed dosage form, piroxicam FDDF, administered in a dosage of 40 mg/d for the first 2 days and 20 mg/d thereafter (for up to 14 days), is effective and well tolerated in the treatment of patients with acute low back pain.
一项关于吡罗昔康速溶剂型（FDDF）每日一次给药的疗效和耐受性的开放标签、非对照研究，纳入了157例年龄在15至76岁（男性占56.7%）、急性腰痛持续时间不超过48小时的患者。患者在治疗的前2天每日服用40毫克吡罗昔康FDDF，之后每日服用20毫克，总共治疗14天。三个国家的15名研究人员在基线以及第4、8和15天的随访时对患者进行检查。所有疗效评估指标，包括一般腰痛、坐、站及行走时的疼痛、夜间疼痛的总体严重程度、晨僵持续时间、中度按压时腰骶部压痛、前屈能力的改良Schober试验、被动活动受限、因背痛而受损的活动恢复所需时间以及背部活动的总体受限情况，在每次随访时均显示与基线相比有统计学意义的改善。首次给药30分钟后观察到的疼痛缓解在最初3天的24小时给药间隔内得以维持。在第4次随访时，吡罗昔康FDDF治疗完成后，接受评估的患者数量减少了一半，主要是因为症状缓解促使患者停用了研究药物。治疗结束时，82.9%的患者将吡罗昔康FDDF的疗效评为良好或优秀，研究人员将85.6%的患者的疗效评为良好或优秀。耐受性也得到高度评价，91%的患者将吡罗昔康FDDF治疗评为良好或优秀，研究人员将92%的患者的治疗评为良好或优秀。总共有12.7%的患者经历了与药物相关的不良事件，最常见的是涉及胃肠道系统。与药物相关的不良经历促使5名（3.2%）患者停用了研究药物。这些结果表明，新开发的剂型吡罗昔康FDDF，前2天每日剂量为40毫克，之后每日20毫克（最多14天），在治疗急性腰痛患者时有效且耐受性良好。
