一项比较多乐泰芬与万络治疗腰痛的随机双盲试验性研究。
A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain.
作者信息
Chrubasik S, Model A, Black A, Pollak S
机构信息
Department of Forensic Medicine, University of Freiburg, 79104 Freiburg, Germany.
出版信息
Rheumatology (Oxford). 2003 Jan;42(1):141-8. doi: 10.1093/rheumatology/keg053.
OBJECTIVE
This randomized, double-dummy, double-blind pilot study of acutely exacerbated low back pain was aimed to inform a definitive comparison between Doloteffin, a proprietary extract of Harpagophytum, and rofecoxib, a selective inhibitor of cyclo-oxygenase-2 (COX-2).
METHODS
Forty-four patients (phyto-anti-inflammatory drug-PAID-group) received a daily dose of Doloteffin containing, inter alia, 60 mg of harpagoside for 6 weeks and 44 (non-steroidal anti-inflammatory drug-NSAID-group) received 12.5 mg/day of rofecoxib. All were allowed rescue medication of up to 400 mg/day of tramadol. Several outcome measures were examined at various intervals to obtain estimates of effect size and variability that might be used to decide the most suitable principal outcome measure and corresponding numbers required for a definitive study.
RESULTS
Forty-three PAID and 36 NSAID patients completed the study. Ten PAID and 5 NSAID patients reported no pain without rescue medication for at least 5 days of the 6th week of treatment. Eighteen PAID and 12 NSAID patients had more than a 50% reduction in the week's average of their pain scores between the 1st and 6th weeks. The mean percentage decrease from baseline in the pain component of the Arhus Index was 23 (S.D. 52) in PAID and 26 (S.D. 43) in NSAID. The corresponding measures for the overall Arhus Index were 11 (31) and 16 (24) and, for the Health Assessment Questionnaire, 7 (8) and 6 (7). Tramadol was used by 21 PAID patients and 13 NSAID patients. Fourteen patients in each group experienced 39 adverse effects, of which 28 (13 in PAID) were judged to some degree attributable to the study medications.
CONCLUSION
Though no significant intergroup differences were demonstrable, large numbers will be needed to show equivalence.
目的
本项关于急性加重性腰痛的随机、双模拟、双盲试验性研究旨在为黑种草属植物的专利提取物多乐芬（Doloteffin）与环氧化酶 -2（COX -2）选择性抑制剂罗非昔布之间的确切比较提供信息。
方法
44 名患者（植物抗炎药组 - PAID 组）接受每日剂量的多乐芬，其中除其他成分外含有 60 毫克哈帕苷，持续 6 周；44 名患者（非甾体抗炎药组 - NSAID 组）接受每日 12.5 毫克的罗非昔布。所有患者均允许使用每日剂量高达 400 毫克的曲马多作为急救药物。在不同时间间隔检查了多项结局指标，以获取效应大小和变异性的估计值，这些估计值可用于确定最合适的主要结局指标以及确定性研究所需的相应样本量。
结果
43 名 PAID 组患者和 36 名 NSAID 组患者完成了研究。10 名 PAID 组患者和 5 名 NSAID 组患者在治疗第 6 周的至少 5 天内未使用急救药物且无疼痛报告。18 名 PAID 组患者和 12 名 NSAID 组患者在第 1 周和第 6 周期间其每周平均疼痛评分降低超过 50%。PAID 组中奥尔胡斯指数疼痛成分较基线的平均百分比下降为 23（标准差 52），NSAID 组为 26（标准差 43）。奥尔胡斯指数总体的相应测量值分别为 11（31）和 16（24），健康评估问卷的相应测量值分别为 7（8）和 6（7）。21 名 PAID 组患者和 13 名 NSAID 组患者使用了曲马多。每组 14 名患者出现了 39 次不良反应，其中 28 次（PAID 组 13 次）在某种程度上被判定归因于研究药物。
结论
尽管未显示出显著的组间差异，但需要大量样本才能证明等效性。
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