氟比洛芬酯预防丙泊酚注射痛的临床研究及安全性评价

目的：探讨氟比洛芬酯预防丙泊酚注射痛的最佳剂量、最佳时间,评价氟比洛芬酯注射液复合丙泊酚注射液的安全性。方法：采用生理盐水做对照,比较静注各组药物后丙泊酚注射痛的发生率和严重程度。通过注射给药部位刺激性试验、全身主动过敏试验、常规体外溶血试验评价各组注射液的安全性。结果：与静注生理盐水相比,0.75、1 mg/kg氟比洛芬酯＋止血带阻断静脉2 min均能明显降低注射痛发生率与严重程度,且两组比较差异无统计学意义（P〉0.05）。静注0.75 mg/kg氟比洛芬酯与1.5 mg/kg丙泊酚的混合液组和静注0.75 mg/kg氟比洛芬酯＋止血带阻断静脉2 min组的注射痛发生率与严重程度无明显差异,并优于静注0.75 mg/kg氟比洛芬酯＋止血带阻断静脉1 min组;静注0.75 mg/kg氟比洛芬酯后立即注射丙泊酚组的注射痛发生率与严重程度最高。各组注射部位没有充血、出血、肿胀以及坏死等异常;豚鼠未出现过敏反应症状,无一死亡;且均不引起家兔红细胞溶血或凝聚。结论：在预防丙泊酚注射痛中,0.75 mg/kg的氟比洛芬酯＋止血带阻断静脉2 min即可达到较理想的镇痛效果;静注0.75 mg/kg氟比洛芬酯与1.5 mg/kg丙泊酚的混合液的效果与静注0.75 mg/kg氟比洛芬酯＋止血带阻断静脉2 min相当,并优于静注0.75 mg/kg氟比洛芬酯＋止血带阻断静脉1 min,静注氟比洛芬酯后立即注射丙泊酚的镇痛效果最差。氟比洛芬酯注射液、丙泊酚注射液以及氟比洛芬酯注射液复合丙泊酚注射液无明显的刺激性、过敏性、溶血性,安全可靠。

The Clinical Research and Safety Evaluation of Flurbiprofen Axetil Pretreatment on Propofol Injection Pain

Objective：To explore the optimal dose and the best time of flurbiprofen axetil pretreatment on propofol injection pain and to evaluate the safety of flurbiprofen axetil injection combined with propofol injection.Method：The incidences and severities of injection pain were compared in each group.The safety of those injections were evaluated by conducting injection site irritation test,active systemic anaphylaxis test,conventional in vitro hemolysis test.Result：Compared with saline intravenous injection,0.75,1 mg/kg flurbiprofen axetil intravenous injection ＋ tourniquet venous occlusion for 2 min both obviously decreased the incidence and severity of injection pain,and there was no statistically significant difference between the two groups（P〉0.05）.The incidences and severities of injection pain of 0.75 mg/kg flurbiprofen axetil and 1.5 mg/kg propofol mixture intravenous injection group and 0.75 mg/kg flurbiprofen axetil intravenous injection ＋ tourniquet venous occlusion for 2 min group didn＇t have significant differences and were better than the 0.75 mg/kg flurbiprofen axetil intravenous injection ＋ tourniquet venous occlusion for 1 min group;the incidence and severity of propofol injection pain of propofol immediate injection after 0.75 mg/kg flurbiprofen axetil intravenous injection was highest.There were no hyperemia,bleeding,swelling,necrosis and other abnormal in the injection site in those groups.The guinea rats were not symptoms of allergic reactions and no deaths.They all didn＇t cause rabbit erythrocyte hemolysis or cohesion.Conclusion：In the prevention of propofol injection pain,0.75 mg/kg flurbiprofen axetil ＋ tourniquet venous occlusion for 2 min is able to achieve ideal analgesic effect;the effect of 0.75 mg/kg flurbiprofen axetil and 1.5 mg/kg propofol mixture intravenous injection is same as 0.75 mg/kg flurbiprofen axetil intravenous injection ＋ tourniquet venous occlusion for 2 min,and better than 0.75 mg/kg flurbiprofen axetil intravenous injection ＋ tourniquet venous occlusion for 1 min.Flurbiprofen axetil injection,propofol injection and flurbiprofen axetil injection combined with propofol injection don＇t have apparente irritation,allergic,haemolyticus.