Essex Margaret Noyes, Cheung Raymond, Li Chunming, Xie Li
Global Medical Affairs, Pfizer Inc., 235 East 42nd St, New York, NY 10017, USA.
Biostatistics & Analysis, Pfizer Inc., 1 Giralda Farms, Madison, NJ 07940, USA.
Pain Manag. 2017 Sep;7(5):383-389. doi: 10.2217/pmt-2017-0017. Epub 2017 Jun 7.
To assess parecoxib safety when used for >3 days for postoperative pain management.
Treatment-emergent adverse event (TEAE) occurrence after day 3 was examined in a pooled analysis of three placebo-controlled trials of parecoxib following general or gynecologic surgery, or total hip arthroplasty. A total of 358 patients received parecoxib, and 318 placebo.
Mean treatment duration was similar between treatment groups. The overall frequency of all TEAEs after day 3 was also similar between treatment groups. Most TEAEs occurred in <1% of patients after day 3; frequencies were similar between treatment groups. Most TEAEs were considered mild or moderate in severity.
TEAE occurrence in patients receiving parecoxib for >3 days was low and similar to placebo after treatment day 3.
评估帕瑞昔布用于术后疼痛管理超过3天时的安全性。
在一项对帕瑞昔布用于普通外科手术、妇科手术或全髋关节置换术后的三项安慰剂对照试验的汇总分析中,检查第3天之后出现的治疗中出现的不良事件(TEAE)。共有358例患者接受帕瑞昔布治疗,318例接受安慰剂治疗。
各治疗组的平均治疗持续时间相似。第3天之后所有TEAE的总体发生率在各治疗组之间也相似。大多数TEAE在第3天之后发生在不到1%的患者中;各治疗组的发生率相似。大多数TEAE的严重程度被认为是轻度或中度。
接受帕瑞昔布治疗超过3天的患者中TEAE的发生率较低,且在治疗第3天之后与安慰剂相似。