Møller P L, Nørholt S E, Ganry H E, Insuasty J H, Vincent F G, Skoglund L A, Sindet-Pedersen S
Department of Oral and Maxillofacial Surgery, Royal Dental College, Arrhus, Denmark.
J Clin Pharmacol. 2000 Apr;40(4):370-8. doi: 10.1177/00912700022009071.
This randomized, double-blind, placebo-controlled study compared the time to onset of analgesia and the analgesic efficacy of two formulations of acetaminophen 1000 mg--an effervescent solution and tablet--in 242 patients with moderate or severe pain following dental surgery. Onset of analgesia was determined using a two-stopwatch procedure. Analgesia was assessed over a 4-hour period. Treatments were compared using standard indexes of pain intensity and pain relief and summary measures. Both acetaminophen formulations were significantly more effective than their corresponding placebo for all efficacy assessments. The median time to onset of analgesia was significantly shorter with effervescent acetaminophen (20 minutes) compared to tablet acetaminophen (45 minutes). During the first 45 minutes after administration, effervescent acetaminophen was significantly more effective at each scheduled assessment time than tablet acetaminophen. The median time to meaningful pain relief was significantly shorter with effervescent acetaminophen (45 minutes) compared to tablet acetaminophen (60 minutes). At 4 hours after administration, the pain relief was significantly better with tablet acetaminophen than with effervescent acetaminophen. No other significant differences were observed between the active treatments. In conclusion, effervescent acetaminophen produces a significantly faster onset of analgesia than tablet acetaminophen.
这项随机、双盲、安慰剂对照研究比较了1000毫克对乙酰氨基酚的两种剂型——泡腾片溶液和片剂——在242例牙科手术后中度或重度疼痛患者中的镇痛起效时间和镇痛效果。采用双秒表程序确定镇痛起效时间。在4小时内评估镇痛效果。使用疼痛强度和疼痛缓解的标准指标以及汇总测量方法对治疗进行比较。在所有疗效评估中,两种对乙酰氨基酚剂型均比相应的安慰剂显著更有效。与对乙酰氨基酚片剂(45分钟)相比,泡腾对乙酰氨基酚的镇痛起效中位时间显著更短(20分钟)。在给药后的前45分钟内,泡腾对乙酰氨基酚在每个预定评估时间的效果均显著优于对乙酰氨基酚片剂。与对乙酰氨基酚片剂(60分钟)相比,泡腾对乙酰氨基酚实现有意义疼痛缓解的中位时间显著更短(45分钟)。在给药4小时后,对乙酰氨基酚片剂的疼痛缓解效果显著优于泡腾对乙酰氨基酚。在活性治疗之间未观察到其他显著差异。总之,泡腾对乙酰氨基酚的镇痛起效时间比对乙酰氨基酚片剂显著更快。