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Efficacy and safety of SHR8554 on postoperative pain in subjects with moderate to severe acute pain following orthopedic surgery: A multicenter, randomized, double-blind, dose-explored, active-controlled, phase II/III clinical trial

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成果类型:
期刊论文
作者:
Zhao, Yanhua;Lu, Zhisheng;Song, Xuesong;Xie, Haihui;Xiao, Xungang;...
通讯作者:
Su, Diansan;Yu, Weifeng;Gu, XY;Su, DS
作者机构:
[Gu, Xiyao; Yu, Weifeng; Yu, WF; Zhao, Yanhua; Lu, Zhisheng; Su, Diansan] Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Dept Anesthesiol, Shanghai, Peoples R China.
[Yu, Weifeng; Zhao, Yanhua; Lu, Zhisheng; Su, Diansan; Gu, Xiyao] Shanghai Jiao Tong Univ, Key Lab Anesthesiol, Minist Educ, Shanghai, Peoples R China.
[Song, Xuesong] First Hosp Jilin Univ, Dept Anesthesiol, Changchun, Peoples R China.
[Xie, Haihui] Southern Med Univ, Dongguan Peoples Hosp, Affiliated Hosp 10, Dept Anesthesiol, Dongguan, Peoples R China.
[Xiao, Xungang] Chenzhou First Peoples Hosp, Dept Orthoped, Chenzhou, Peoples R China.
通讯机构:
[Gu, XY ; Su, DS; Yu, WF] S
[Su, DS ] Z
Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Dept Anesthesiol, Shanghai, Peoples R China.
Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dept Anesthesiol, Hangzhou, Peoples R China.
语种:
英文
关键词:
Analgesia;Biased μ-opioid receptor agonist;Orthopedic surgery;Patient controlled;Phase II/III clinical trial;Postoperative;SHR8554
期刊:
Pharmacological Research
ISSN:
1043-6618
年:
2025
卷:
212
页码:
107576
机构署名:
本校为其他机构
院系归属:
医学院
摘要:
Biased µ-opioid receptor (MOR) agonists enhance pain relief by selectively activating G protein-coupled receptor signaling and minimizing β-arrestin-2 activation, resulting in fewer side effects. This multicenter Phase II/III trial evaluated the optimal dosage, efficacy, and safety of SHR8554, a biased MOR agonist, for postoperative pain management following orthopedic surgery. In Phase II, 121 patients were divided into four groups to receive varying patient-controlled analgesia (PCA) doses of SHR8554 or morphine. Phase III involved 320 pati...

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