Hofele C M, Gyenes V, Daems L N, Stypula-Ciuba B, Wagener H, Siegel J, Edson K
Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Heidelberg, Im Neuenheimer Feld, Heidelberg, Germany.
Int J Clin Pract. 2006 Mar;60(3):300-7. doi: 10.1111/j.1368-5031.2006.00828.x.
This double-blind, randomised, parallel-group trial compared the analgesic efficacy of single 50 mg doses of diclofenac potassium sachets and tablets with placebo in 184 patients with moderate/severe pain after third molar extraction. The primary efficacy variable was the average pain reduction from baseline during the first 2-h postdose, using a visual analogue scale (VAS). During the first 2-h postdose, sachets and tablets significantly reduced pain (p < 0.05) vs. placebo with an incremental benefit seen for sachets over tablets (p < 0.05). Onset of analgesic effect (VAS) was at 30 min for sachets and 45 min for tablets. Pain reduction vs. placebo (VAS) was maintained for 8 h for sachets and tablets (p < 0.05). VAS-findings were confirmed by pain relief and intensity verbal scale assessments. Fewer patients re-medicated vs. placebo. No safety issues were identified. This study demonstrates that both diclofenac potassium sachets and tablets offer patients suffering from acute pain conditions an effective treatment with incremental analgesic benefits seen for sachets.
这项双盲、随机、平行组试验比较了184例拔除第三磨牙后出现中度/重度疼痛患者中，单次服用50毫克双氯芬酸钾散剂和片剂与安慰剂的镇痛效果。主要疗效变量是给药后前2小时内，使用视觉模拟量表（VAS）测得的相对于基线的平均疼痛减轻程度。给药后前2小时内，与安慰剂相比，散剂和片剂均能显著减轻疼痛（p<0.05），且散剂比片剂有更大的益处（p<0.05）。散剂的镇痛效果（VAS）在30分钟时出现，片剂在45分钟时出现。散剂和片剂相对于安慰剂的疼痛减轻（VAS）持续8小时（p<0.05）。VAS结果通过疼痛缓解和强度言语量表评估得到证实。与安慰剂相比，再次用药的患者更少。未发现安全问题。这项研究表明，双氯芬酸钾散剂和片剂都能为患有急性疼痛的患者提供有效的治疗，散剂具有更大的镇痛益处。
