心血管手术术后三种静脉镇痛方法疗效与安全性研究

Intravenous flurbiprofen axetil and tramadol as adjunctive treatment for postoperativepain after car- diovascular surgery:a double blind randomized controlled trial

目的探讨氟比洛芬酯与曲马多分别复合芬太尼用于心血管手术围术期的镇痛效果及副作用,及对细胞因子的影响。方法150例择期行正中开胸心血管手术的患者,随机双盲对照法分为3组:氟比洛芬酯组(FF),曲马多组(QF),芬太尼组(F)。分别于深静脉通路建立后和缝心包时给予研究药物,FF组为氟比洛芬酯1 mg/kg,QF组为曲马多2 mg/kg,F组为空白脂肪乳5 ml;手术结束时连接静脉恒速镇痛泵,内装研究药物与脂肪乳混合液100 ml,流速2 ml/h,FF组为氟比洛芬酯200 mg和芬太尼1.0mg,QF组为曲马多700mg和芬太尼1.0mg,F组为芬太尼2.5 mg。分别于围术期各观察点记录患者的VAS评分、恶心评分,镇静评分,胸液量,初醒时间,拔除气管插管时间,镇痛效果与副作用,是否追加镇痛药物,ICU停留时间,出院时间。其中每组随机抽取30例病例,分别于深静脉通路建立后(T_0),缝心包时(给与研究药物之前,T_1),术后4h(T_2),20 h(T_3),24 h(T_4)抽取静脉血,检测细胞因子IL-1,IL-10,TNF-.PGE2。结果(1)VAS评分三组间相似,但术后追加镇痛药物F组明显高于其余两组(P<0.05);(2)F组恶心评分较高(P<0.05),镇静评分,呕吐、皮肤瘙痒、排尿困难等副作用的发生率三组患者无明显差异(P>0.05);(3)T_1-T_4,F组IL-1较T0升高明显,且明显高于FF,QF组(P<0.05);术后各组各时间点IL-10,PGE2较T0升高明显,F组升高持续时间较长(P<0.05);F组TNF-在T2,T_4较T_0明显升高(P<0.05),T_2时明显高于FF,QF组;(4)初醒时间,拔出气管插管时间,ICU停留时间,24 h胸液量,肝肾功能等三组患者无明显差异。结论静脉给予氟比洛芬酯或曲马多复合芬太尼的镇痛方法可安全、有效的应用于心血管手术术后镇痛,减少阿片类药物的用量,减轻术后炎症反应。

Objective To examine the efficacy of intravenous flurbiprofen axetil and tramadol as an adjunctive analgesic respectively to a fentanyl-based background analgesia after cadiovaseular surgery. Methods 150 patients participated in this single center, placebo-controlled, double-blind, randomized trial who were divided into 3 groups equally with 50 cases each. Intravenous study drugs were administered after jugular venous cannnlmion and before suture pericardium respectively, the study drugs were flurbiprofen axetil 1 mg/kg in group FF, tramadol 2 mg/kg in group QF and fat emulsion 5 ml in group F. Patients received intravenous study drugs continuously（2 ml/h） in the disposable syringer pump filled with the study drugs diluted to 100 ml volume during 48 h after the end of operation. The disposable syringer pump was filled with flurbiprofen axetil 200 mg mixed with fentanyl 1.0 mg in group FF, tramadol 700 mg mixed with fentanyl 1. 0 mg in group QF, and fentanyl 2.5 mg in group F. Anti-emetic prophylactic regimen （tropisetron） were available to three patient groups at the end of the surgery. Postoperative pain was evaluated by visual analog scale, and it was measured at rest and cough. To random choose 30 cases from every group, and withdrawal 5 ml venous blood at induction （ before administered, To ）, suture pericardium （ before administered, T1 ）,4 h,20 h and 24 h after operation to check the concentrations of IL-1 ,IL-10,TNF- , PGE2 in the plasma. Results Baseline characteristics and the VAS scores were equivalent among the 3 groups. But group F needed more morphine than group FF and QF after operation （ P 〈 0.05 ）. Group F had higher score of nause than other groups （P 〈 0. 05）. Group F had higher concentration of cytokines than group FF and QF （P 〈 0.05）. Conclusions In patients undergoing cardiovascular surgery, intravenous infusion of flurbiprofen axetil or tramadol combined with fentanyl provides reliable pain control and reduces opioids drugs and inflammatory response.