Winter L, Post A
J Int Med Res. 1979;7(3):240-6. doi: 10.1177/030006057900700313.
Two hundred male and female patients underwent a variety of oral surgical procedures and were treated afterwards in four test groups. They took a combination of orphenadrine (25 mg) and acetaminophen (325 mg), either drug alone, or placebo. A double-blind study design was used. All patients had moderately severe baseline pain intensity; post-treatment pain relief was recorded at 30 minutes, one, two, four and six hours. A back-up analgesic (codeine-ASA) was made available if needed. Pain intensity difference (PID) and sums of pain intensity difference (SPID) were calculated using established analgesic study techniques. Statistical analyses indicated better analgesic efficacy in both PID and SPID scores for the orphenadrine-acetaminophen combination over the three other treatments. This was evident at 30 minutes and continued through the sixth hour. Each active drug, in turn, was also significantly better throughout than placebo for pain relief. Sub-groups in each treatment regimen required additional pain relief prior to six hours, with significantly more placebo than orphenadrine-acetaminophen patients needing remedication. Side-effect incidence was very low and randomly distributed among the four groups.
200名男性和女性患者接受了各种口腔外科手术,术后被分为四个试验组进行治疗。他们服用了奥芬那君(25毫克)和对乙酰氨基酚(325毫克)的组合药物、单一药物或安慰剂。采用双盲研究设计。所有患者的基线疼痛强度均为中度至重度;在治疗后30分钟、1小时、2小时、4小时和6小时记录疼痛缓解情况。如有需要,可提供备用镇痛药(可待因-阿司匹林)。使用既定的镇痛研究技术计算疼痛强度差异(PID)和疼痛强度差异总和(SPID)。统计分析表明,与其他三种治疗方法相比,奥芬那君-对乙酰氨基酚组合在PID和SPID评分方面的镇痛效果更好。这在30分钟时就很明显,并持续到第六小时。每种活性药物在缓解疼痛方面也始终比安慰剂显著更好。每个治疗方案中的亚组在6小时前都需要额外的疼痛缓解,需要补救治疗的安慰剂组患者明显多于奥芬那君-对乙酰氨基酚组患者。副作用发生率非常低,且在四组中随机分布。