摘要目的:评价奥赛利定治疗全麻患者术后中重度疼痛的有效性和安全性。方法:纳入2021年7月6日至11月9日14家医院的全麻腹部手术后中重度疼痛(数字疼痛评分≥4分)患者，采用随机数字表法分为试验组和对照组，分别给予奥赛利定或吗啡负荷剂量＋PCA＋补充剂量治疗24 h。主要有效性指标为给予负荷剂量后24 h内对试验药物应答率。次要有效性指标包括给予负荷剂量后1 h内对试验药物应答率和补救镇痛率。安全性指标包括治疗期间呼吸抑制和其他不良反应的发生率。结果:经随机化分组，本试验中全分析集和安全性分析集均为180例，试验组92例，对照组88例；符合方案集170例，试验组86例，对照组84例。2组给予负荷剂量后24 h内对试验药物应答率、补救镇痛率、呼吸抑制和其他不良反应发生率比较差异无统计学意义( P>0.05)。全分析集分析显示，试验组给予负荷剂量后5～30 min时对试验药物应答率高于对照组( P<0.05)。符合方案集分析显示，试验组给予负荷剂量后5～15 min时对试验药物应答率高于对照组( P<0.05)。 结论:奥赛利定用于全麻患者术后中重度疼痛的镇痛效果与吗啡相当，且起效更快。

abstractsObjective:To evaluate the efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia in patients.Methods:The patients with moderate to severe pain (numeric pain rating scale ≥4) after abdominal surgery with general anesthesia from 14 hospitals between July 6, 2021 and November 9, 2021 were included in this study. The patients were assigned to either experiment group or control group using a random number table method. Experiment group received oliceridine, while control group received morphine, and both groups were treated with a loading dose plus patient-controlled analgesia and supplemental doses for 24 h. The primary efficacy endpoint was the drug response rate within 24 h after giving the loading dose. Secondary efficacy endpoints included early (within 1 h after giving the loading dose) drug response rates and use of rescue medication. Safety endpoints encompassed the development of respiratory depression and other adverse reactions during treatment.Results:After randomization, both the full analysis set and safety analysis set comprised 180 cases, with 92 in experiment group and 88 in control group. The per-protocol set included 170 cases, with 86 in experiment group and 84 in control group. There were no statistically significant differences between the two groups in 24-h drug response rates, rescue analgesia rates, respiratory depression, and incidence of other adverse reactions ( P>0.05). The analysis of full analysis set showed that the experiment group had a higher drug response rate at 5-30 min after giving the loading dose compared to control group ( P<0.05). The per-protocol set analysis indicated that experiment group had a higher drug response rate at 5-15 min after giving the loading dose than control group ( P<0.05). Conclusions:When used for treatment of moderate to severe pain after surgery with general anesthesia in patients, oliceridine provides comparable analgesic efficacy to morphine, with a faster onset.