Essex Margaret Noyes, Choi Hee-Youn, Bhadra Brown Pritha, Cheung Raymond
Pfizer Inc., New York, NY, USA.
Pfizer Pharmaceutical Korea Ltd, Seoul, South Korea.
J Pain Res. 2018 Feb 23;11:427-433. doi: 10.2147/JPR.S147481. eCollection 2018.
Parecoxib is an injectable cyclooxygenase-2 inhibitor with proven postoperative analgesic efficacy in a variety of settings, including total knee arthroplasty (TKA). The effect of ethnicity on the efficacy of parecoxib for post-TKA pain has not been studied.
This was a parallel-group, double-blind, randomized, placebo- controlled study of ethnically Korean patients aged ≥18 years who had unilateral TKA. Patients who reported moderate or severe pain 6 hours after the end of postoperative opioid analgesia were randomized to receive a single intravenous dose of parecoxib sodium 40 mg or placebo. Patients were evaluated for 24 hours postdose. The primary efficacy endpoints included time-specific pain intensity difference (PID), time-specific pain relief (PR), and time to rescue medication. The incidence and nature of adverse events (AEs) assessed safety.
Of the 116 patients randomized, 58 received parecoxib and 58 placebo. Mean (SD) PID was significantly greater for parecoxib vs placebo 1 hour postdose (0.69 [0.67] vs 0.40 [0.59], respectively; <0.05), and for each time point up to 24 hours. Similarly, mean (SD) PR was significantly greater for parecoxib vs placebo 1.5 hours postdose (1.63 [0.85] vs 1.07 [0.90], respectively; =0.001), and for each time point up to 24 hours. The median time (hours:minutes) to rescue medication was significantly longer for parecoxib vs placebo (21:30 vs 4:08, respectively; <0.001). Generally, fewer AEs were reported with parecoxib than placebo, and the AE profile was consistent with previous studies. These results are comparable to the findings from a similarly designed study in a Caucasian patient population.
Parecoxib 40 mg significantly improved postoperative pain vs placebo in Korean patients after TKA. The efficacy and safety of parecoxib in Korean patients is similar to that seen in Caucasian patients.
帕瑞昔布是一种注射用环氧化酶-2抑制剂，已证实在包括全膝关节置换术（TKA）在内的多种情况下具有术后镇痛效果。种族对帕瑞昔布治疗TKA后疼痛疗效的影响尚未得到研究。
这是一项平行组、双盲、随机、安慰剂对照研究，研究对象为年龄≥18岁、接受单侧TKA的韩国患者。术后阿片类镇痛结束6小时后报告中度或重度疼痛的患者被随机分配接受单次静脉注射40毫克帕瑞昔布钠或安慰剂。给药后对患者进行24小时评估。主要疗效终点包括特定时间的疼痛强度差异（PID）、特定时间的疼痛缓解（PR）以及使用解救药物的时间。评估不良事件（AE）的发生率和性质以确定安全性。
在116例随机分组的患者中，58例接受帕瑞昔布，58例接受安慰剂。给药后1小时，帕瑞昔布组的平均（标准差）PID显著高于安慰剂组（分别为0.69 [0.67] 对0.40 [0.59]；P<0.05），直至24小时的每个时间点均如此。同样，给药后1.5小时，帕瑞昔布组的平均（标准差）PR显著高于安慰剂组（分别为1.63 [0.85] 对1.07 [0.90]；P=0.001），直至24小时的每个时间点均如此。帕瑞昔布组使用解救药物的中位时间（小时：分钟）显著长于安慰剂组（分别为21:30对4:08；P<0.001）。总体而言，与安慰剂相比，帕瑞昔布报告的AE较少，且AE情况与先前研究一致。这些结果与在白种人患者群体中进行的一项设计相似的研究结果相当。
在韩国TKA患者中，40毫克帕瑞昔布与安慰剂相比能显著改善术后疼痛。帕瑞昔布在韩国患者中的疗效和安全性与在白种人患者中所见相似。
