中国临床药理学杂志2025，Vol.41Issue(20)：2875-2880,6.DOI:10.13699/j.cnki.1001-6821.2025.20.005
奥赛利定用于老年患者行防旋股骨近端髓内钉内固定术围术期的临床研究
Clinical trail of oliceridine in elderly patients undergoing proximal femoral antirotation intramedullary nail internal fixation
摘要
Abstract
Objective To investigate the efficacy and safety of oliceridine injection,a novel G protein-biased μ-opioid receptor agonist,compared with sufentanil injection,a traditional μ-opioid receptor agonist,during the perioperative period of proximal femoral nail antirotation(PFNA)internal fixation in elderly patients with intertrochanteric femoral fractures.Methods A toal of 80 elderly patients with intertrochanteric femoral fractures scheduled for PFNA internal fixation from April 2024 to April 2025 were randomly divided into control group and treatment group.In the control group,sufentanil injection 0.3 μg·kg-1 was used for intraoperative induction,and patient-controlled intravenous analgesia(PCIA)after surgery consisted of sufentanil injection 1 μg·kg-1 plus flurbiprofen axetil injection 200 mg.In the treatment group,oliceridine injection 0.06 mg·kg-1 was used for intraoperative induction,and postoperative PCIA consisted of oliceridine injection 0.2 mg·kg-1 plus flurbiprofen axetil injection 200 mg.The time to first ambulation after surgery,15-item Quality of Recovery Scale(QoR-15)scores at 24 and 48 h after surgery,intraoperative hemodynamic changes,visual analogue scale(VAS)scores at 6,12,24 and 48 h after surgery and adverse drug reactions were compared between two groups.Results Forty patients were enrolled in each group.For the primary outcome measures,the QoR-15 scores at 24 hours after surgery(T7)in the treatment group and the control group were(123.23±8.82)and(114.80±10.55)scores,respectively;the QoR-15 scores at 48 hours after surgery(T8)were(126.65±6.13)and(118.20±9.13)scores,respectively;the time to first ambulation after surgery were(43.53±4.44)and(46.83±4.13)hours,respectively.The differencs of above indexes between two groups were all statistically significant(all P＜0.05).For the secondary outcome measures,no statistically significant differences were found between the two groups in intraoperative hemodynamic parameters or postoperative VAS pain scores within 48 hours after surgery(all P＞0.05).The incidence of postoperative dizziness in the treatment group and control group was 7.50％(3 cases/40 cases)and 27.50％(11 cases/40 cases),respectively;the incidence of postoperative nausea and vomiting was 7.50％(3 cases/40 cases)and 25.00％(10 cases/40 cases),respectively;the incidence of postoperative constipation was 5.00％(2 cases/40 cases)and 20.00％(8 cases/40 cases),respectively;statistically significant differences were noted in the incidences of the above adverse reactions between the two groups(all P＜0.05).However,the incidence of postoperative cognitive dysfunction was 2.50％(1 cases/40 cases)and 7.50％(3 cases/40 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion In elderly patients undergoing PFNA internal fixation,oliceridine injection provides intraoperative hemodynamic stability and postoperative analgesic efficacy comparable to sufentanil injection.Moreover,it significantly reduces the incidence of opioid-related adverse reactions such as dizziness,nausea and vomiting,and constipation,shortens the time to first ambulation,improves the early postoperative quality of recovery,and facilitates enhanced recovery after surgery.关键词
奥赛利定注射液/防旋股骨近端髓内钉内固定/老年/术后恢复Key words
oliceridine injection/proximal femoral nail anti-rotation/aged patient/postoperative recovery分类
医药卫生引用本文复制引用
CHEN Pei-yang,CHEN Rong-rong,SHEN Dong-qing,ZHUANG Yuan-zhao..奥赛利定用于老年患者行防旋股骨近端髓内钉内固定术围术期的临床研究[J].中国临床药理学杂志,2025,41(20):2875-2880,6.基金项目
福建医科大学启航基金资助项目(2023QH1308) （2023QH1308）
