摘要
目的评价盐酸羟考酮注射液用于全麻患者术后镇痛的有效性和安全性。方法本研究为前瞻性、随机、盲法、多中心、阳性对照临床研究。选择择期全麻下腹部手术和骨科手术患者240例，年龄18～64岁、体重40～95kg、性别不限、ASA分级I或Ⅱ级。采用随机数字表法，将其分为2组（n=120）：硫酸吗啡注射液组（M组）和盐酸羟考酮注射液组（0组）。术毕拔除气管导管或喉罩后当患者主诉疼痛时，立即静脉注射吗啡或羟考酮1mg，必要时重复给药，直至VAS评分≤40mm，随后开启PCA泵（0．9％生理盐水将研究药物稀释至0．5mg／m1，总量100m1）行术后PCIA镇痛48h，背景输注速率0．5mg／h，PCA量吗啡或羟考酮1mg／次，锁定时间5rain。疗效指标：于用药后3、24、48h时行静态和动态VAS评分，并行非劣效检验。记录术后48h内研究药物总用量、补救镇痛药物使用情况、PCA无效按压次数和总次数、镇痛满意度。安全性指标：记录用药后72h内不良事件的发生情况，并行实验室检查（血常规、尿常规和血生化检查）。结果2组各时点静态和动态VAS评分、补救镇痛率、PCA无效按压次数和总按压次数、镇痛满意度、研究药物总用量、不良事件比较差异无统计学意义（P〉0．05）。2组均无严重不良事件发生。不良事件中发生率最高的是恶心，其次为呕吐。2组恶心、呕吐发生率和严重程度比较差异无统计学意义（P〉0．05），而骨科手术患者0组恶心、呕吐的发生率低于M组（P〈0．05）。2组其他不良事件及实验室检查异常发生率均较低。2组各时点静态和动态VAS评分均数之差的95％可信区间皆在15mm之内（假设非劣效检验界值）。结论盐酸羟考酮注射液术后PCIA可安全有效地减轻中、大型手术后患者疼痛，其镇痛效果与硫酸吗啡注射液相似，而骨科手术患者应用盐酸羟考酮注射液术�
Objective To evaluate the efficacy and safety of oxycodone hydrochloride injection for postop- erative analgesia in patients undergoing the operation under general anesthesia in a prospective, randomized, blind, muhicenter, positive-controlled, clinical trial. Methods Two hundred and forty ASA I or Ⅱ patients of both sexes, aged 18-64 yr, weighing 40-95 kg, scheduled for elective abdominal operation or orthopedic surgeries under general anesthesia, were randomly divided into 2 groups （ n = 120 each） ： morphine sulfate injection group （group M） and oxycodone hydrochloride injection group （group 0）. Morphine or oxycodone 1 mg was injected intraveno-usly when the patients complained of pain after tracheal extubation or removal of the laryngeal mask, and adminis- tration was repeated if necessary until VAS ≤ 40 mm. Then patient-controlled intravenous analgesia （PCIA） （100 ml, 0.5 mg/ml） with morphine or oxycodone was used for postoperative analgesia （lasting for 48 h）. The PCIA pump was set up with a 1 ml bolus dose, a 5 min lockout interval and background infusion at a rate of 0.5 mg/h. Pain at rest and during movement was assessed using VAS score at 3, 24 and 48 h after administration, and non- inferiority test was performed. Total morphine or oxycodone consumption, requirement for rescue analgesic, the number of unsuccessfully delivered dose, the niamber of attempts, and the level of patient＇ s satisfaction were recorded within 48 h after operation. The adverse events were recorded and laboratory examinations （ blood and urine routine test, blood biochemical examination） were performed within 72 h after administration. Results There was no significant difference in the VAS scores at rest and during movement at different time points, requirement for rescue analgesic, the number of unsuccessfully delivered doses and attempts, level of patient＇ s satisfaction, total morphine or oxycodone consumption, and adverse events between the two groups （ P 〉 0.05）. No serious adverse
出处
《中华麻醉学杂志》
CAS
CSCD
北大核心
2013年第3期269-274,共6页
Chinese Journal of Anesthesiology
关键词
羟可酮
镇痛
病人控制
疼痛
手术后
Oxycodone
Analgesia, patient-controlled
Pain, postoperative
