Soltesz Stefan, Gerbershagen Mark U, Pantke Bernhard, Eichler Frank, Molter Gerd
Department of Anaesthesia and Intensive Care, Klinikum Leverkusen, Leverkusen, Germany.
Clin Drug Investig. 2008;28(7):421-8. doi: 10.2165/00044011-200828070-00003.
Selective cyclo-oxygenase-2 (COX-2) inhibitors provide postoperative pain relief similar to conventional NSAIDs. However, many of these non-opioid analgesics are available only for oral administration, and are therefore ineffective in patients experiencing postoperative nausea or vomiting. The aim of this study was to compare the analgesic efficacy of the COX-2 inhibitor parecoxib with that of dipyrone (metamizole) administered intravenously for 48 hours after vaginal hysterectomy.
Fifty women undergoing vaginal hysterectomy under general anaesthesia were randomly assigned to two groups: the parecoxib group, who received intravenous parecoxib 40 mg intraoperatively and every 12 hours after surgery over a period of 48 hours, and the dipyrone group, who received intravenous dipyrone 2.5 g injected intraoperatively, followed by dipyrone 1 g every 6 hours after surgery over a period of 48 hours. Because of the double-blinded study protocol, patients in the parecoxib groups were required to receive placebo infusions 6, 18, 30 and 42 hours after the operation. Visual analogue scale (VAS [scale 0-10]) scores were recorded 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 24, 36 and 48 hours after surgery. To assess the cumulative opioid administration, all patients were fitted with an intravenous patient-controlled analgesia (PCA) device containing the opioid piritramide. An alpha value of 0.05 was considered statistically significant.
VAS scores did not differ between groups with one exception: VAS scores were lower in the parecoxib group 12 hours after surgery than in the dipyrone group (1 and 2, respectively; p < 0.05). No significant differences in cumulative piritramide administration were measured between groups 1 hour or 24 hours after surgery (parecoxib 14.7 [+/- SD 4.4] and 30.6 [+/- 12.8] mg, respectively; dipyrone 11.8 [+/- 4.9] and 36.5 [+/- 10.7] mg, respectively).
Parecoxib 40 mg twice daily provides postoperative pain relief equivalent to that of dipyrone 4 g daily during the first 48 hours in patients after hysterectomy.
选择性环氧化酶-2（COX-2）抑制剂提供的术后疼痛缓解效果与传统非甾体抗炎药相似。然而，这些非阿片类镇痛药中的许多仅可口服给药，因此对术后出现恶心或呕吐的患者无效。本研究的目的是比较COX-2抑制剂帕瑞昔布与静脉注射安乃近（甲氨基苯磺酸钠）在阴道子宫切除术后48小时的镇痛效果。
50名在全身麻醉下接受阴道子宫切除术的女性被随机分为两组：帕瑞昔布组，术中及术后每12小时静脉注射40mg帕瑞昔布，共48小时；安乃近组，术中静脉注射2.5g安乃近，术后每6小时注射1g安乃近，共48小时。由于采用双盲研究方案，帕瑞昔布组患者在术后6、18、30和42小时需接受安慰剂输注。在术后0.5、1、2、3、4、6、9、12、15、18、24、36和48小时记录视觉模拟评分（VAS[0-10分]）。为评估累积阿片类药物用量，所有患者均配备含阿片类药物匹利卡明的静脉自控镇痛（PCA）装置。α值为0.05被认为具有统计学意义。
两组VAS评分除一个例外无差异：术后12小时帕瑞昔布组VAS评分低于安乃近组（分别为1分和2分；p<0.05）。术后1小时或24小时两组间匹利卡明累积用量无显著差异（帕瑞昔布分别为14.7[±标准差4.4]和30.6[±12.8]mg；安乃近分别为11.8[±4.9]和36.5[±10.7]mg）。
子宫切除术后患者中，每日两次40mg帕瑞昔布在前48小时提供的术后疼痛缓解效果与每日4g安乃近相当。
