商品名:艾苏特®)
Search documents
恒瑞镇痛新药登上Cell子刊,三期临床成功,强效镇痛且副作用更少
生物世界· 2025-12-10 04:00
Core Viewpoint - The article discusses the effectiveness and safety of Tegileridine, a new analgesic developed by Heng Rui Medicine, in managing moderate-to-severe acute pain following abdominal surgery, highlighting its advantages over traditional opioids like morphine [4][6][10]. Group 1: Clinical Trial Results - A randomized, double-blind, phase 3 clinical trial involving 528 patients demonstrated that Tegileridine provided effective pain relief, significantly outperforming a placebo and showing comparable efficacy to morphine [4][6][7]. - The primary endpoint, SPID24 (Sum of Pain Intensity Difference over 24 hours), showed Tegileridine 1.0 mg group at -68.98, morphine group at -71.16, and placebo group at -49.63, indicating similar effectiveness between Tegileridine and morphine [7]. Group 2: Safety and Side Effects - Tegileridine exhibited a lower incidence of gastrointestinal reactions, with moderate to severe vomiting occurring 3.8% less frequently than in the morphine group, and a 6.7% lower need for additional antiemetic medication [8]. - Only one case of transient respiratory depression was reported in the Tegileridine group, contrasting with the higher risks associated with traditional opioids [8]. - Other common opioid side effects, such as dizziness and itching, were reported at lower rates in the Tegileridine group, with all events being mild to moderate [8]. Group 3: Broader Implications - Tegileridine represents a new approach to pain management, balancing effective analgesia with reduced side effects, which could be beneficial for various pain management scenarios, including chronic pain patients and the elderly [10].