Rigamonti G, Zanella E, Lampugnani R, Marrano D, Campione O, Bruni G, Mandelli V, Sacchetti G
Br J Anaesth. 1983 Jun;55(6):513-9. doi: 10.1093/bja/55.6.513.
A double-blind, placebo-controlled parallel-group study was carried out in 100 patients with postoperative pain. The analgesic activity of indoprofen given in a single dose as an i.v. bolus followed by a 2-h infusion, at total doses of 100, 200, and 400 mg was investigated. The highest dose of 400 mg was given additionally as an i.v. bolus alone. Intensity of pain was assessed before, and 30 min, 1, 2, 4, 6 and 8 h after treatment on a 0-4 point scale. An overall assessment was made at the end of treatment by the investigator and the patient using a 0-4 point scale and a visual analogue scale. Statistical analyses according to a multiple regression model on rating scale scores at fixed times and on overall assessments showed: (i) indoprofen was always more active than placebo in providing pain relief; (ii) there was a significant dose--response relationship; and (iii) there was no difference between the two schedules of administration of the largest dose.
对100例术后疼痛患者进行了一项双盲、安慰剂对照的平行组研究。研究了静脉推注后持续2小时输注,总剂量分别为100、200和400mg的吲哚美辛单剂量给药的镇痛活性。另外,单独静脉推注给予最高剂量400mg。在治疗前以及治疗后30分钟、1、2、4、6和8小时,采用0 - 4分制评估疼痛强度。在治疗结束时,由研究者和患者使用0 - 4分制和视觉模拟量表进行总体评估。根据固定时间的评分量表得分和总体评估的多元回归模型进行的统计分析显示:(i)吲哚美辛在缓解疼痛方面总是比安慰剂更有效;(ii)存在显著的剂量 - 反应关系;(iii)最大剂量的两种给药方案之间没有差异。