3542例患者使用帕瑞昔布术后镇痛情况的多中心、回顾性分析

A Retrospective,Multi-Center survey of Parecoxib Prescribing Practice in 3 542 Surgical Inpatients

目的调查帕瑞昔布用于术后镇痛的安全性、有效性以及帕瑞昔布对术后镇痛用药模式的改变。方法 本试验是多中心、回顾性研究。回顾性收集术后使用帕瑞昔布镇痛患者的信息,包括围术期用药、术后镇痛以及药物不良事情等相关信息,并对数据进行整理、分析和归纳。结果 本研究共有41家综合性三级甲等医院参加,占全国三级甲等医院的5.4%。入选合格患者3 542名,男性比例为44.7%,患者平均年龄(48.2±16.3)岁。普通外科、骨科和妇科患者分别占24.8%,59.1%和16.1%。帕瑞昔布用于术后镇痛的给药方案主要是单次给药方案(62%);2次给药方案和多次给药方案分别为4.7%和27%。除帕瑞昔布外,其他镇痛药物使用频率依次是曲马朵缓释片/注射液(17.8%)、氟比洛芬酯注射液(14.4%)、塞来昔布胶囊(11.3%)、芬太尼注射液(10.2%)、布托啡诺注射液(7.3%)、吗啡注射液(5.1%)、哌替啶注射液(4.6%);术后约24.6%的患者进行了视觉模拟评分法(visual analogue scales,VAS)评分;术后当日、术后1 d、术后2 d和术后3 d中、重度患者比例依次为19.7%、17.8%、6.8%和5.2%。术后帕瑞昔布的不良事件发生率0.2%,主要表现为低血压、恶心、呕吐、瘙痒和皮疹等。结论帕瑞昔布用于术后镇痛安全性良好,未见严重不良事件;帕瑞昔布用于术后镇痛主要是短期使用,符合目前的循证医学证据。

OBJECTIVE To assess the prescribing practice of parecoxib in surgical inpatients, especially for its efficacy and safety. METHODS This was a retrospective, multi-center survey. Based on medical records,patient＇ s characteristics, perioperative analgesics, postoperative pain intensity scale and drug adverse events were recorded in case report form （CRF）. RESULTS Fortyone comprehensive tertiary hospitals were enrolled in this study, 3 542 inpatients were eligible, 44.7% of whom were male. The most dominant dosing regimen of parecoxib was single dose shot （62%）, 27% of the enrolled patients were given more than two shots, and 4. 7% of the patients were given two shots. Besides parecoxib, the analgesics used postoperatively included tramodal （17.8%）, flurbiprofen axetil （ 14. 4% ）, celecoxib （ 11.3% ）, fentanyl （ 10. 2% ）, butorphanol （ 7. 3% ）, morphine （ 5. 1% ） and pethidine （4. 6% ）. visual analogue., scale was used for pain evaluation in 24. 6% of the enrolled patients. The percentage of patients who had severe pain on the operation day, postoperative day 1, postoperative day 2, and postoperative day 3 were 19.7%, 17.8% , 6. 8% and 5.2% , respectivley. The incidence of drug adverse events of parecoxib was 0. 2% （6/3 542） , most of which were hypotension, nausea, vomiting, pruritus and rash. CONCLUSION This retrospective, multi-center survey reveals that parecoxib had a good safety profile; there is no serious adverse event in 3542 inpatient who received parecoxib postoperatively. Parecoxib is mainly used for short term, which is consistent with the current medical evidences.