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

作　　者：陈功 欧阳文[1] 戴茹萍[2] 胡啸玲[3] 郭华静[4] 蒋海涛 王志萍 柴小青 王纯辉 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] Chen Gong;Ouyang Wen;Dai Ruping;Hu Xiaoling;Guo Huajing;Jiang Haitao;Wang Zhi-ping;Chai Xiaoqing;Wang Chunhui;Xia Zhongyuan;Luo Ailin;Wang Qiang;Zeng Ruifeng;Huang Yanjuan;Zhao Zhibin;Wang Saiying(Department of Anesthesiology,The Third Xiangya Hospital of Central South University,Changsha 410013,China;Department of Anesthesiology,The Second Xiangya Hospital of Central South University,Changsha 410011,China;Department of Anesthesiology,The First Affiliated Hospital of University of South China,Hengyang 421001,China;Department of Anesthesiology,The First People′s Hospital of Changde City,Changde 415003,China;Department of Anesthesiology,The Second People′s Hospital of Yueyang City,Yueyang 414000,China;Department of Anesthesiology,The Affiliated Hospital of Xuzhou Medical University,Xuzhou 221000,China;Department of Anesthesiology,The First Affiliated Hospital of University of Science and Technology of China,Hefei 230000,China;Department of Anesthesiology,The Fourth Affiliated Hospital of Anhui Medical University,Hefei 230000,China;Department of Anesthesiology,Renmin Hospital of Wuhan University,Wuhan 430060,China;Department of Anesthesiology,Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430030,China;Department of Anesthesiology,The First Affiliated Hospital of Xi′an Jiaotong University,Xi′an 710061,China;Department of Anesthesiology,The Second Affiliated Hospital of Wenzhou Medical University,Wenzhou 325027,China;Department of Anesthesiology,The Second People′s Hospital of Nanning City,Nanning 530031,China;Department of Anesthesiology,The First People′s Hospital of Lianyungang City,Lianyungang 222002,China)

机构地区：[1]中南大学湘雅三医院麻醉科,长沙410013 [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

出　　处：《中华麻醉学杂志》2024年第2期135-139,共5页Chinese Journal of Anesthesiology

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。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 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.

关 键 词：镇痛药 阿片类 疼痛 手术后 疼痛管理 

分 类 号：R614.2[医药卫生—麻醉学]