Nature communications · 2026
NH600001, an etomidate analogue, provides gastrointestinal endoscopy sedation/anesthesia and reduces adrenocortical depression: two randomized controlled trials.
Клиническое исследование II фазыКлиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Zhou Yingyong, Duan Kaiming, Luo Shichao, Liu Shengping, Li Qiongcan, Liu Songhua, Guo Huajing, Jiang Haitao, Wang Guyan, Wang Huijun, Wang Zhiping, Zhang Xiaobao, Sun Canlin, Wang Qiang, Gao Wei, Shangguan Wangning, Xia Zhongyuan, Luo Ailin, Chen Chun, Yang Mengchang, Su Wenjie, Zou Xiaohua, Li Yalan, Wang Hao, Huang Yanjuan, Dai Ruping, Zhao Qian, Jing Shuan, Zhang Linzhong, Yan Wenjun, Qin Xingang, Wang Juan, Chen Jingli, Cao Jun, Zhang Minsheng, Yu Shuchun, Ouyang Wen, Wang Saiying
Аннотация
To evaluate the efficacy and safety of NH600001, a novel etomidate derivative, in gastrointestinal endoscopy, as well as its impact on adrenocortical function, two multicenter, double-blind, randomized, controlled clinical trials(NH600001-21 [Phase II trial] and NH600001-31 [Phase III trial]) were conducted in China. In NH600001-21, 160 gastroscopy subjects were randomized 1:1:1:1 to receive NH600001 (0.20, 0.25, or 0.30 mg/kg) and etomidate (0.30 mg/kg). In NH600001-31, 344 gastroscopy or colonoscopy subjects were randomized in a 1:1 ratio to receive NH600001 (0.25 mg/kg) and etomidate (0.30 mg/kg). The primary efficacy outcome was the rate of endoscopic success. Additionally, Safety and effects on adrenocortical function were also assessed. In NH600001-21, the 0.25 mg/kg NH600001 showed non-inferiority to etomidate based on the prespecified non-inferiority margin of -8% (Rate Difference [95% confidence interval], 5.0[-4.49 to 14.49]), whereas the 0.20 mg/kg and 0.30 mg/kg NH600001 did not meet statistical non-inferiority criteria (0[-11.54 to 11.54]; 0[-11.54 to 11.54]). The area under curve (AUC) of plasma cortisol change values within 0-4 h (∆Cortisol AUC0-4h) were significantly higher in the NH600001 treatment groups than in the etomidate group (P < 0.01). In NH600001-31, NH600001 (0.25 mg/kg) showed non-inferiority to etomidate (1.16[-0.44 to 2.76]). ∆Cortisol AUC0-4h in the NH600001 group, versus the etomidate group, were significantly higher (P < 0.001). Furthermore, NH600001 had a safety profile comparable to etomidate and elicited fewer myoclonus adverse events. In Conclusions, NH600001 has a sedative/anesthetic effect comparable to etomidate while reducing the risk of adrenocortical depression with a favorable safety profile. Chictr.org.cn identifier: ChiCTR2300069841, ChiCTR2400084095. Clinical Trial Number and Registry URL: NH60001-21, Identifier, ChiCTR2300069841 (Changsha, China;, principal investigator: Wen Ouyang, first registration date: March 28, 2023), https://www.chictr.org.cn ; NH60001-31, Identifier, ChiCTR2400084095 (Changsha, China, principal investigator: Wen Ouyang, first registration date: May 10, 2024), https://www.chictr.org.cn .