氟比洛芬酯脂微球载体注射液治疗中度术后疼痛的Ⅱ期临床试验

Phase Ⅱ clinical study for flubiprofen axetil injection in treatment of moderate postoperative pain

目的：考察氟比洛芬酯脂微球载体注射液对中度术后疼痛患者的止痛效果及安全性。方法：采用多中心随机双盲对照试验设计。试验药和对照药分别为氟比洛芬酯脂微球载体注射液和安慰剂。选骨科、普通外科和妇科术后中度疼痛(疼痛强度4-6)的受试者197例，试验组99例，对照组98例。试验组与对照组均单次给药，缓慢静脉注射1支(5mL)。用药前及用药后6h内评价疼痛强度(PI)、疼痛强度差(PID)、疼痛缓解率(PAR)和有效率。结果：试验组单次用药后6h的PI，PID和PAR分别为1．3，4．1，98．0％，显效率为89.9％；对照组则分别为3．3，1．7，43．9％，25．5％，2组比较差异有显著性(P<0．01)，氟比洛芬酯脂微球载体的镇痛效果明显优于安慰剂。结论：氟比洛芬酯脂微球载体注射液是安全有效的中等强度靶向镇痛药。

Objective: To assess efficacy and safe of flubiprofen axetil injection in the relief of moderate postoperative pain. Methods: A multi-center, randomized, double blind, comparative clinical trial studied 197 patients with moderate postoperative pain (pain intensity = 4-6). They were intravenously given with either a single dose of flubiprofen axetil injection at 5mL (n =99) or placebo at 5mL (n=98).Pain intensity (PI),pain intensity difference (PID),pain relief (PAR) and response rate were measured prior to and post the administration of study medication for 6 hours. Results:Patients treated with Flubiprofen Axetil post 6 hours showed PI,PID,PAR and response rate at 1.3, 4.1,98.0% and 89.9% .respectively,as compared to 3.3,1.7,43.9% ,25.5% .respectively,for those receiving placebo (P<0.01).Conclusion:Flubiprofen axetil injection is effective in the relief of moderate postoperative pain.