口服洛索洛芬钠片在胸腔穿刺闭式引流术中的超前镇痛临床研究

Preemptive Analgesia of Oral Loxorprofen Sodium Tablets in Closed Thoracic Drainage

目的:研究口服洛索洛芬钠片在胸腔穿刺闭式引流术中超前镇痛的疗效及安全性。方法:选取2017年9月至2019年8月符合入组条件的肺癌患者,随机分为试验组及对照组。试验组患者术前30分钟口服洛索洛芬钠片60 mg,然后予2%盐酸利多卡因行局部麻醉下手术操作,术后每8小时口服洛索洛芬钠片60 mg,共服药3次;对照组在3个相同的时间点均给予口服安慰剂,2%盐酸利多卡因注射液行局部麻醉。主要研究终点:两组患者术后12 h中度疼痛人数、中度疼痛缓解率。次要研究终点:两组患者各时段的视觉模拟评分法(visual analogue scales,VAS)评分、术后吗啡注射频次、药物不良反应、患者焦虑程度及患者满意度。结果:试验组及对照组患者各50例,试验组术后12 h中度疼痛为5人、中度疼痛缓解率90%,对照组术后12 h中度疼痛24人、中度疼痛缓解率52%(P<0.05);试验组患者麻醉后、穿刺置管成功时、操作结束时及术后4 h、8 h、12 h、24 h、48 h VAS评分分别为1.14±0.40,2.32±0.71,1.76±0.66,2.64±0.60,2.12±0.63,2.20±0.70,1.74±0.63,0.96±0.53,低于对照组患者VAS评分:2.08±0.60,3.22±0.74,2.46±0.61,3.24±1.13,2.78±1.11,2.90±0.93,2.38±0.75,1.98±0.80(所有时间点P<0.05);试验组患者皮下注射吗啡2人,低于对照组26人(P<0.05);试验组患者胃部不适感、恶心、呕吐、头昏、嗜睡等不良反应低于对照组(P<0.05);试验组状态-特质焦虑量表评分低于对照组,而医患关系量表评分高于对照组。结论:洛索洛芬钠用于胸腔穿刺置管闭式引流术可有效缓解患者的疼痛程度,减少吗啡急性镇痛用药频次及副作用,减轻患者焦虑程度,并提高患者的满意度。

Objective:To study the efficacy and safety of oral loxorprofen sodium tablets in preemptive analgesia in closed thoracic drainage.Methods:Eligible lung cancer patients from September 2017 to August 2019 were randomly assigned to the experimental group and the control group.30 minutes before the operation,patients in the experimental group were given local anesthesia with 2%lidocaine hydrochloride after oral administration of loxorprofen sodium tablets 60mg which were added every 8 hours after the operation for three times.The control group was given an oral placebo at three identical time points,2%lidocaine hydrochloride was injected for local anesthesia.The primary endpoints were the number of patients with moderate pain and the rate of pain relief 12h after surgery in two groups.The secondary endpoints were Visual Analogue Scale(VAS)scores,frequency of postoperative morphine injection,adverse drug reactions,anxiety level and satisfaction of patients in both groups.Results:There were 50 patients in each group.In the experimental group,there were 5 patients with moderate pain at 12h after surgery,and the rate of pain relief was 90%;in the control group,there were 24 patients,and the rate of pain relief rate was 52%(P<0.05).VAS scores in the experimental group were 1.14±0.40,2.32±0.71,1.76±0.66,2.64±0.60,2.12±0.63,2.20±0.70,1.74±0.63 and 0.96±0.53,lower than those in the control group(2.08±0.60,3.22±0.74,2.46±0.61,3.24±1.13,2.78±1.11,2.90±0.93,2.38±0.75 and 1.98±0.80,respectively)at the end of anesthesia,at the end of operation,and at 4h,8h,12h,24h and 48h after operation(all P<0.05).2 and 26 patients in the experimental group and the control group received hypodermic injection of morphine(P<0.05).The adverse reactions in the experimental group were lower than that in the control group(P<0.05).The score of the State-Trait Anxiety Inventory in the experimental group was lower than that in the control group,while the score of the Patient-Doctor Relationship Questionnaire was higher than that in the control group(P<0.05).Conclusion:The application of loxoprofen sodium in closed thoracic drainage can effectively alleviate pain and anxiety of patients,reduce the frequency and side effects of morphine acute analgesia,and improve the satisfaction of patients.