Department of Anesthesiology, Peking University, People's Hospital, Beijing, China.
Pain Med. 2011 Aug;12(8):1267-75. doi: 10.1111/j.1526-4637.2011.01196.x. Epub 2011 Aug 3.
To demonstrate the efficacy and noninferiority of loading dose of celecoxib 200 mg compared with 400 mg in pain management after endoscopic nasal surgery.
A prospective randomized controlled study.
A university hospital.
Consecutive 120 patients undergoing endoscopic nasal surgery under general anesthesia were randomly assigned to three groups of 40 patients each, celecoxib 400 mg, celecoxib 200 mg, or a control group with no celecoxib.
Patients received different doses of celecoxib as described 1 hour before anesthesia. Two celecoxib groups received celecoxib 200 mg every 12 hours until the fifth day after surgery.
Noninferiority could be claimed if the lower limit of the confidence interval (CI) for pain score difference was greater than -0.6. At 0, 6, and 48 hours after surgery, prostaglandin E2 (PGE2) and thromboxane A2 (TXA2) to prostaglandin I2 (PGI2) ratios were measured from incision drainage and in plasma.
Estimated difference between two loading doses for pain scores over 5 days was 0.275 (95%CI -0.255 to 0.805, P > 0.05), indicating the noninferiority of celecoxib 200-400 mg. Local PGE2 at 6 hours and 48 hours positively correlated with pain scores, with correlation coefficients 0.371 (P = 0.005) and 0.288 (P = 0.033). Systemic TXA2 to PGI2 ratios did not differ among groups.
An initial dose of celecoxib 200 mg was equivalent to celecoxib 400 mg with regard to the margin previously specified at -0.6 in reducing moderate postoperative pain in endoscopic nasal surgery both in analgesic efficacy and anti-inflammatory property. One hundred and twenty patients were included in this prospective randomized controlled study. Patients treated with celecoxib had lower pain scores than controls, pain scores correlating with local PGE2 level. An initial dose of celecoxib 200 mg was equivalent to 400 mg in reducing moderate pain after endoscopic nasal surgery.
证明在鼻内镜手术的术后疼痛管理中，塞来昔布负荷剂量 200mg 与 400mg 相比的疗效和非劣效性。
前瞻性随机对照研究。
一所大学医院。
连续 120 例在全身麻醉下接受鼻内镜手术的患者被随机分为三组，每组 40 例，分别给予塞来昔布 400mg、塞来昔布 200mg 或对照组（无塞来昔布）。
患者在麻醉前 1 小时接受不同剂量的塞来昔布。两组塞来昔布组均在术后第 5 天前每 12 小时接受塞来昔布 200mg。
如果疼痛评分差值的置信区间（CI）下限大于-0.6，则可以声称具有非劣效性。术后 0、6 和 48 小时，从切口引流和血浆中测量前列腺素 E2（PGE2）和血栓素 A2（TXA2）与前列腺素 I2（PGI2）的比值。
5 天内两种负荷剂量的疼痛评分估计差值为 0.275（95%CI-0.255 至 0.805，P>0.05），表明塞来昔布 200-400mg 具有非劣效性。6 小时和 48 小时的局部 PGE2 与疼痛评分呈正相关，相关系数分别为 0.371（P=0.005）和 0.288（P=0.033）。各组间系统 TXA2 与 PGI2 的比值无差异。
在鼻内镜手术中，与之前规定的-0.6 相比，塞来昔布初始剂量 200mg 在减轻中度术后疼痛方面与塞来昔布 400mg 等效，在镇痛效果和抗炎特性方面均如此。本前瞻性随机对照研究共纳入 120 例患者。与对照组相比，塞来昔布治疗组的疼痛评分更低，疼痛评分与局部 PGE2 水平相关。塞来昔布初始剂量 200mg 与 400mg 等效，可减轻鼻内镜手术后的中度疼痛。
