术后镇痛中帕瑞昔布钠对吗啡用量的节俭作用和安全性—前瞻性、多中心、随机、双盲、安慰剂对照、平行分组研究

Morphine-spartng effect and safety of parecoxlb for postoperative analgesia

目的 评价术后镇痛中帕瑞昔布钠对吗啡用量的节俭作用和安全性。方法前瞻性、多中心、随机、双盲、安慰剂对照、平行分组研究，18．64岁、ASAⅠ或Ⅱ级、择期硬膜外腔阻滞下骨科和妇科手术病人，手术结束时，随机静脉注射帕瑞昔布钠加mg或生理盐水2ml，12h后再静脉注射帕瑞昔布钠加mg或生理盐水2ml，同时采用吗啡进行病人白控静脉镇痛。观察术后吗啡的用量、病人白控镇痛（PCA）总次数和PCA有效次数、术后2、4、6、12和24h的疼痛强度（VAS评分）、镇痛的补救措施、不良反应和病人对镇痛的满意度以及给药前后的生化指标和生命体征。结果 共完成223例，其中采用帕瑞昔布钠114例，安慰剂109例。与安慰剂组相比，帕瑞昔布钠组术后12h和24h吗啡用量减少（分别平均减少加．9％和46．1％），术后12h和24hPCA总次数和PCA有效次数降低（P〈0．05或0．01），术后4、6、12和24hVAS评分降低，术后24h满意度明显提高（P〈0．01），而有关不良反应和化验结果异常发生率的差异无统计学意义（P〉0．05）。结论 在我国妇科和骨科手术后静脉给予帕瑞昔布钠40mg bid可安全地减少术后吗啡用量，提高病人术后镇痛质量。

Objective To evaluate the morphine-sparing effect and side effects of intravenous parecoxib sodium for pain relief following gynecological or orthopedic surgery. Methods This was a prospective, randomized, double-blind, placebo-controlled multi-center study. After obtaining ethic committee approval and written informed consent, 223 ASA Ⅰ or Ⅱ patients aged 18-64 yr undergoing abdominal hysterectomy or operation on lower limb under epidural anesthesia were randomly allocated to one of 2 groups： A parecoxib group received intravenous perecoxib 40 mg immediately and 12 h after the end of operation （n = 114） and B control group received normal saline instead of parecoxib. The patients in both groups received IV PCA with morphine （0.25 mg·ml^-1）. The PCA pump was set up to deliver a bolus dose of morphine 1 mg （lockout interval 10 rain） and background infusion of 0.25mg·h^-1. The total dose limit of morphine during 24 h was 〈 144 rag. The intensity of pain was measured using VAS score （0-100, 0 = no pain, 100 = worst pain）, and recorded at 2, 4, 6, 12 and 24 h after operation. The number of unsatisfied demand and the number of successfully delivered doses; the morphine consumption at 12 and 24 h after operation; the patients＇ global evaluation of the postoperative analgesia and the number of the patients who received rescue medication were recorded and compared between the two groups. Safety evaluation included vital signs, adverse effects and results of clinical laboratory tests. Results The 2 groups were comparable with respect to age, body weight, height and the types of operation performed. The morphine consumption at 12 h and 24 h after operation was significantly less in parecoxib group than in control group and was reduced by40.9% （at 12 h） and 46.1% （at 24 h） respectively. The number of unsatisfied demand and successfully delivered doses were sigrtificantly higher in control group than in parecoxib group. The VAS scores at the different time points were significantly lower in parecoxib group than in control group. The percentage of the patients who considered the postoperative analgesia ‘good＇ or ‘ excellent＇ was 75 % in parecoxib group and 36% in control group. There were no serious adverse effects in both groups. Conclusion Parecoxib 40 mg given Ⅳ twice a day can reduce the morphine consumption and improve postoperative analgesia.