氯诺昔康用于全子宫切除术后患者自控镇痛的非劣效性  

Non-inferiority study of lornoxicam to patient-controlled analgesia in patients after hysterectomy

作　　者：赵红[1] 叶铁虎[1] 龚志毅[1] 

机构地区：[1]中国医学科学院北京协和医院麻醉科,北京100730

出　　处：《北京大学学报（医学版）》2013年第1期119-122,共4页Journal of Peking University:Health Sciences

摘　　要：目的:评价非甾体类抗炎药物氯诺昔康用于全子宫切除术后患者自控镇痛,及其与芬太尼相比较的非劣效性。方法:本研究为前瞻性随机双盲对照研究,将全身麻醉下行全子宫切除术且术后出现中度以上疼痛[即疼痛视觉模拟评分(visual analogue scale,VAS)≥4]者117例随机分为氯诺昔康组(65例)和芬太尼组(52例),分别予负荷量氯诺昔康4 mg或芬太尼50μg静脉注射用于镇痛。患者自控镇痛药液配置:氯诺昔康0.4 g/L或芬太尼5mg/L,单次给药剂量为2.5 mL,锁定时间10 min,持续观察至术后24 h。比较两组患者术后6、12、24 h VAS疼痛评分、术后即刻与各时间点疼痛评分的差值(即疼痛程度差值,pain intensity difference,PID)以及24 h疼痛程度差值总和(sum of PID,SPID-24,即术后6、12、24 h PID之和)。如果两组SPID-24差值的95%置信区间下限高于预先设定的SPID-24非劣效性界值-3,则可以认为两种药物用于中至重度疼痛的治疗具有非劣效性。结果:两组患者各时间点疼痛评分差异无统计学意义,氯诺昔康组与芬太尼组SPID-24分别为12.0±6.1和10.2±5.4(P>0.05),两组间SPID-24差值为0.66,95%置信区间为(-1.24,2.56),其下限高于非劣效性界值-3,因此在全子宫切除术后氯诺昔康具有相对于芬太尼的镇痛非劣效性。氯诺昔康组不良反应发生率要低于芬太尼组。结论:氯诺昔康在全子宫切除术后中到重度疼痛的治疗中具有与芬太尼相比较的非劣效性。Objective：To evaluate the non-inferiority of lornoxicam to fentanyl in patient-controlled in- travenous analgesia after hysterectomy. Methods： In this prospective randomized controlled study, 117 patients who suffered from moderate to severe pain i. e. pain visual analogue scale （VAS）≥4 after hys- terectomy were allocated to receive lornoxicam （Group L） or fentanyl （Group F） for patient-controlled analgesia. The patients were given a loading dose of lornoxicam 4 mg or fentanyl 50 p,g after the enroll- ment according to the patients＇ grouping and connected to the patient-controlled analgesia device contai- ning lornoxicam 0.4 g/L or fentanyl 5 mg/L with bolus dose set at 2.5 mL and lockout interval set at 10 min. Pain scores were rated using VAS at 6, 12, and 24 h postoperatively. Pain intensity difference （PID） was the difference between pain scores rated immediately after surgery and 6, 12 and 24 h post- operatively. The sum of pain intensity difference over 24 h （SPID-24） was the sum of PID at 6, 12 and 24 h. Non-inferiority could be claimed if the lower limit of the 95 % confidence interval （CI） for SPID-24 difference between the two groups was greater than pre-specified non-inferiority margin - 3. Results： No difference was detected for pain scores at any time point between the two groups. SPID-24 were 12.0± 6.1 and 10.2±5.4 （P 〉0.05）. SPID-24 difference between the two groups was 0.66, 95% CI - 1.24 to 2.56, and the lower limit greater than non-inferiority margin -3. Adverse effects, such as nausea, vomiting, and drowsiness were significantly less in lornoxicam group than in fentanyl group （P 〈 0.05）. Conclusion： Lornoxicam is not inferior to the equivalent dose of fentanyl with regard to the margin pre- specified at -3 in reducing moderate to severe postoperative pain after hysterectomy.

关 键 词：镇痛 病人控制 氯诺昔康 芬太尼 子宫切除术 

分 类 号：R614.1[医药卫生—麻醉学]