氟比洛芬酯脂微球载体制剂与注射用酮洛芬对照治疗术后及癌性疼痛

Comparison of flurbiprofen axetil injection for postsurgical and carcinous pain relief to ketoprofen

目的：观察氟比洛芬酯与酮洛芬对照治疗术后及癌性疼痛患者的有效性。方法：日本36家医院共入选腹部术后患者224例，癌性疼痛患者163例，随机分为氟比洛芬酯组192例与酮洛芬组195例，分别用氟比洛芬酯与酮洛芬安慰剂和酮洛芬与氟比洛芬酯安慰剂。氟比洛芬酯及其安慰剂5mL静脉内注射，酮洛芬及其安慰剂每瓶用2．5mL溶液溶解臀部肌内注射。结果：可评价病例氟比洛芬酯组对术后疼痛111例患者改善率为73．9％，高于酮洛芬组(n=109)的66．1％，但2组差异无显著性(P>0．05)；药效持续时间氟比洛芬酯组比酮洛芬组延长(P<0．05)。氟比洛芬酯组癌性疼痛(n=77)改善率为77％，高于酮洛芬组(n=81)的59．3％(P>0．05)，药效持续时间氟比洛芬酯组比酮洛芬组延长(P<0．05)。结论：在治疗术后疼痛和癌性疼痛时，氟比洛芬酯的疗效与酮洛芬相近，但镇痛时间明显延长。

Objective:To compare the effectiveness of flurbiprofen axetil injection for the treat-ment of post-surgical and carcinous pain to ketoprofen. Methods:224 patients with post-surgical pain and 163 patients with carcinous pain were randomized to receive an intravenous bolus of flurbiprofen axetil injection or matching placebo at 5mL( n = 192), or im ketoprofen or matching placebo at 2.5mL (n = 195).Results:Pain relief in the flurbiprofen axetil injection group was not significantly more superior than in ketoprofen group (P >0. 05). However, the maintenance period in pain relief in flurbiprofen group was significantly longer than in ketoprofen group (P < 0.05 ). Conclusion: Flurbiprofen axetil injection shows the equivalent efficacy and longer maintenance in the post-surgical and carcinous pain relief to ketoprofen.