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

被引：0

作者：

Zhao, Yanhua ^{[1
,2
]}

Lu, Zhisheng ^{[1
,2
]}

Song, Xuesong ^{[3
]}

Xie, Haihui ^{[4
]}

Xiao, Xungang ^{[5
]}

Wang, Guonian ^{[6
]}

Zhou, Qi ^{[7
]}

Zhang, Qingmei ^{[8
]}

Liu, Liang ^{[9
]}

Lan, Zhijian ^{[10
]}

Bai, Ning ^{[11
]}

Wang, Haiyan ^{[12
]}

Pan, Zhihao ^{[13
]}

Dong, Liang ^{[14
]}

Lin, Xianzhong ^{[15
]}

Chen, Gang ^{[16
]}

Wang, Qinghui ^{[17
]}

Dong, Jiangtao ^{[18
]}

Deng, Jia ^{[19
]}

Nan, Yongshan ^{[20
]}

Zhang, Jiaqiang ^{[21
]}

Zhou, Xiaohua ^{[22
]}

Huang, Yanjuan ^{[23
]}

Chen, Yongquan

He, Huanzhong ^{[24
]}

Yang, Ye ^{[25
]}

Yao, Dengpan ^{[26
]}

Jia, Jintai ^{[27
]}

Jin, Shuan ^{[28
]}

Zhang, Yafeng ^{[29
]}

Luo, Zhonghui ^{[30
]}

Li, Jiangang ^{[31
]}

Zhang, Linzhong ^{[32
]}

Wang, Fang ^{[33
]}

Jing, Juehua ^{[34
]}

Zhu, Jiang ^{[35
]}

Li, Lin ^{[36
]}

Wang, Guangda ^{[37
]}

Guo, Huajing ^{[38
]}

Wang, Qiang ^{[39
]}

Su, Diansan ^{[1
,2
,40
]}

Yu, Weifeng ^{[1
,2
]}

Gu, Xiyao ^{[1
,2
]}

机构：

[1] Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Dept Anesthesiol, Shanghai, Peoples R China

[2] Shanghai Jiao Tong Univ, Key Lab Anesthesiol, Minist Educ, Shanghai, Peoples R China

[3] First Hosp Jilin Univ, Dept Anesthesiol, Changchun, Peoples R China

[4] Southern Med Univ, Dongguan Peoples Hosp, Affiliated Hosp 10, Dept Anesthesiol, Dongguan, Peoples R China

[5] Chenzhou First Peoples Hosp, Dept Orthoped, Chenzhou, Peoples R China

[6] Harbin Med Univ, Dept Anesthesiol, Affiliated Hosp 4, Harbin, Peoples R China

[7] Chifeng Municipal Hosp, Dept Anesthesiol, Chifeng, Peoples R China

[8] Anhui Med Univ, Chaohu Hosp, Dept Anesthesiol, Hefei, Peoples R China

[9] Capital Med Univ, Dept Orthoped, Beijing Luhe Hosp, Beijing, Peoples R China

[10] Jinhua Municipal Cent Hosp, Dept Anesthesiol, Jinhua, Peoples R China

[11] Shaanxi Prov Peoples Hosp, Dept Anesthesiol, Xian, Peoples R China

[12] Shanxi Med Univ, Shanxi Bethune Hosp, Tongji Shanxi Hosp, Shanxi Acad Med Sci,Dept Anesthesiol,Hosp 3, Taiyuan, Peoples R China

[13] Ningbo Med Ctr Li Hui Li Hosp, Dept Anesthesiol, Ningbo, Peoples R China

[14] Guangxi Med Univ, Liuzhou Peoples Hosp, Dept Anesthesiol, Liuzhou, Guangxi, Peoples R China

[15] Fujian Med Univ, Dept Anesthesiol, Affiliated Hosp 1, Fuzhou, Fujian, Peoples R China

[16] Second Hosp Jiaxing, Dept Orthoped, Jiaxing, Peoples R China

[17] Dalian Univ, Affiliated Zhongshan Hosp, Dept Anesthesiol, Dalian, Peoples R China

[18] Hebei Med Univ Third Hosp, Dept Orthoped, Shijiazhuang, Hebei, Peoples R China

[19] Sichuan Prov Peoples Hosp, Dept Anesthesiol, Chengdu, Peoples R China

[20] Yanbian Univ Hosp, Dept Anesthesiol, Yanji, Peoples R China

[21] Zhengzhou Univ Peoples Hosp, Henan Prov Peoples Hosp, Dept Anesthesiol & Perioperat Med, Zhengzhou, Peoples R China

[22] Guizhou Med Univ, Affiliated Hosp, Dept Anesthesiol, Guiyang, Peoples R China

[23] Guangxi Med Univ, Affiliated Hosp 3, Dept Anesthesiol, Nanning, Peoples R China

[24] Wannan Med Coll, Dept Oncol, Affiliated Hosp 1, Wuhu, Peoples R China

[25] Huzhou Cent Hosp, Dept Anesthesiol, Huzhou, Peoples R China

[26] Beijing Jishuitan Hosp, Guizhou Hosp, Dept Anesthesiol, Guiyang, Guizhou, Peoples R China

[27] Changzhi Med Coll, Heping Hosp, Dept Anesthesiol, Changzhi, Shanxi, Peoples R China

[28] Shandong First Med Univ, Dept Anesthesiol, Cent Hosp, Jinan, Peoples R China

[29] Wuxi Tradit Chinese Med Hosp, Dept Joint Orthoped, Wuxi, Peoples R China

[30] Univ South China, Affiliated Hosp 1, Dept Anesthesiol, Hengyang, Peoples R China

[31] Qujing No 1 Hosp, Dept Anesthesiol, Qujing, Peoples R China

[32] Shanxi Med Univ, Dept Anesthesiol, Hosp 2, Taiyuan, Peoples R China

[33] Honghui Hosp, Dept Anesthesiol, Xian, Peoples R China

[34] Anhui Med Univ, Dept Orthoped, Affiliated Hosp 2, Hefei, Peoples R China

[35] Suzhou Univ, Dept Anesthesiol, Affiliated Hosp 2, Suzhou, Peoples R China

[36] Gen Hosp Northern Theater Chinese Peoples Liberat, Dept Anesthesiol, Shenyang, Peoples R China

[37] Yantai Yuhuangding Hosp, Dept Orthoped, Yantai, Peoples R China

[38] First Peoples Hosp Changde City, Dept Anesthesiol, Changde, Peoples R China

[39] Yixing Peoples Hosp, Dept Orthoped, Wuxi, Jiangsu, Peoples R China

[40] Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dept Anesthesiol, Hangzhou, Peoples R China

来源：

PHARMACOLOGICAL RESEARCH | 2025年 / 212卷

关键词：

Postoperative; Analgesia; Patient controlled; Orthopedic surgery; SHR8554; Biased mu-opioid receptor agonist; MU-OPIOID RECEPTOR; PROTEIN-BIASED LIGAND; OLICERIDINE TRV130; OPEN-LABEL; MANAGEMENT; ANALGESIA; PLACEBO;

D O I：

10.1016/j.phrs.2025.107576

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Biased mu -opioid receptor (MOR) agonists enhance pain relief by selectively activating G protein-coupled receptor signaling and minimizing (3-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 similar groupings, including a placebo group. The primary outcome was the resting summed pain intensity points, rescue analgesia received, cumulative dose of analgesics, and satisfaction scores. Safety endpoints

引用

页数：13

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