目的:评价布洛芬注射液用于全麻患者术后镇痛的有效性及安全性。方法:本研究为前瞻性、多中心、随机、双盲、阴性对照临床研究。选择择期全麻下行开腹手术或骨科手术患者360例，年龄18～75岁，性别不限，ASA分级Ⅰ～Ⅲ级，采用随机数字表法分为3组(n n＝120)：对照组(C组)、布洛芬注射液400 mg组(B1组)和布洛芬注射液800 mg组(B2组)。手术结束前30 min时，B1组和B2组分别经30 min静脉输注布洛芬注射液400和800 mg(均溶于0.9%氯化钠注射液200 ml)，C组经30 min静脉输注0.9%氯化钠注射液200 ml，此后，每6 h输注1次，直至术后48 h。手术结束后连接镇痛泵行PCIA，药物配方：0.5 mg/ml吗啡溶于0.9%氯化钠注射液中，背景输注速率0.25 mg/h，PCA剂量2 mg/次，锁定时间5 min，镇痛至术后48 h，维持VAS评分≤4分。有效性指标：记录术后24 h内和48 h内吗啡用量、PCA按压总次数和有效按压次数，以及术后48 h内补救镇痛情况和术后48 h时患者对镇痛效果的总体评价。安全性指标：记录用药后48 h内不良反应(恶心、呕吐、皮肤瘙痒、注射痛、头晕等)的发生情况；用药后48 h时行实验室检查，包括血生化检查、血常规检查、凝血功能检查和尿常规，记录异常情况。n 结果:与C组比较，B1组和B2组术后吗啡用量、PCA总按压次数、有效按压次数和补救镇痛率降低，患者对镇痛效果总体评价极好率和极好＋很好率升高(n P0.05)。3组恶心、呕吐、皮肤瘙痒、注射痛、头晕发生率和实验室检查异常率比较差异无统计学意义(n P>0.05)。n 结论:布洛芬注射液可安全、有效地用于全麻手术患者术后镇痛。“,”Objective:To evaluate the efficacy and safety of ibuprofen injection for postoperative analgesia in the patients undergoing general anesthesia.Methods:This prospective, multicenter, randomized, double-blind, negative-controlled trial was conducted in 360 patients of both sexes, aged 18-75 yr, of American Society of Anesthesiologists physical statusⅠ-Ⅲ, scheduled to undergo elective abdominal or orthopedic surgery under general anesthesia.All the patients were assigned to one of 3 groups (n n=120 each) using a random number tale method: control group (group C), ibuprofen injection 400 mg group (group B1), and ibuprofen injection 800 mg group (group B2). At 30 min before the end of surgery, ibuprofen injection 400 and 800 mg (in 0.9% sodium chloride injection 200 ml) were intravenously infused over 30 min in B1 and B2 groups, respectively, and 0.9% sodium chloride injection 200 ml was intravenously infused over 30 min in group C, and then infusion was performed every 6 h until 48 h after operation.The analgesic pump was connected after operation to perform patient-controlled intravenous analgesia (PCIA), and the PCIA solution contained 0.5 mg/ml morphine in 0.9% sodium chloride injection.The PCA pump was set up with a 2 ml bolus dose, a 5 min lockout interval and background infusion at a rate of 0.25 ml/h.The analgesia lasted for 48 h after operation, and the visual analog scale score was maintained ≤ 4 points.Effectiveness index: the consumption of morphine within 24 and 48 h after operation, the total pressing times of PCA and effective pressing times of PCA, the requirement for rescue analgesia within 48 h after operation and patient′s overall evaluation of the analgesia effect at 48 h after operation were recorded.Safety index: the occurrence of adverse reactions (nausea, vomiting, pruritus, injection pain, dizziness, etc.) within 48 h after medication were recorded; the laboratory examinations including blood biochemical examination, blood routine examination, blood coagulation function examination and urine routine examination were performed at 48 h after medication, and abnormal conditions were recorded.n Results:Compared with group C, the postoperative consumption of morphine, total pressing times of PCA, effective pressing times of PCA, and requirement for rescue analgesia were significantly decreased, and the rates of excellent and excellent+ good evaluation of analgesic effects by patients were increased in B1 and B2 groups (n P0.05). There was no significant difference in the incidence of nausea, vomiting, pruritus, injection pain and dizziness and rates of abnormalities in laboratory examinations among the three groups (n P>0.05).n Conclusion:Ibuprofen injection can be safely and effectively used for postoperative analgesia in the patients undergoing general anesthesia.