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:随机、盲法、阳性对照、多中心临床试验
Efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia:a prospective,randomized,double-blinded,multicenter,positive-controlled clinical trial
陈功 1欧阳文 1戴茹萍 2胡啸玲 3郭华静 4蒋海涛 5王志萍 6柴小青 7王纯辉 8夏中元 9罗爱林 10王强 11曾睿峰 12黄燕娟 13赵志斌 14汪赛赢1
作者信息
- 1. 中南大学湘雅三医院麻醉科,长沙41013
- 2. 中南大学湘雅二医院麻醉科,长沙 410011
- 3. 南华大学附属第一医院麻醉科,衡阳 421001
- 4. 常德市第一人民医院麻醉科,常德 415003
- 5. 岳阳市二人民医院麻醉科,岳阳 414000
- 6. 徐州医科大学附属医院麻醉科,徐州 221000
- 7. 中国科学技术大学附属第一医院麻醉科,合肥 230000
- 8. 安徽医科大学第四附属医院麻醉科,合肥 230000
- 9. 武汉大学人民医院麻醉科,武汉 430060
- 10. 华中科技大学同济医学院附属同济医院麻醉科,武汉 430030
- 11. 西安交通大学第一附属医院麻醉科,西安 710061
- 12. 温州医科大学附属第二医院麻醉科,温州 325027
- 13. 南宁市第二人民医院麻醉科,南宁 530031
- 14. 连云港市第一人民医院麻醉科,连云港 222002
- 折叠
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.
Abstract
Objective 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 be-tween 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 oliceri-dine,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 devel-opment 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 pa-tients,oliceridine provides comparable analgesic efficacy to morphine,with a faster onset.
关键词
镇痛药,阿片类/疼痛,手术后/疼痛管理Key words
Analgesics,opioid/Pain,postoperative/Pain management引用本文复制引用
出版年
2024
NETL
NSTL
万方数据