環(huán)泊酚與丙泊酚在全身麻醉誘導(dǎo)和維持的有效性和安全性：一項多中心、單盲、隨機、平行組、3期臨床試驗
貴州醫(yī)科大學(xué) 麻醉與心臟電生理課題組
翻譯：宋雨婷 編輯：柏雪 審校：曹瑩
背景：HSK3486（環(huán)泊酚）是一種2，6-二取代苯酚衍生物，其作用類似于丙泊酚，可作為γ-氨基丁酸-A（GABAA）受體的激動劑。
目的：探討環(huán)泊酚全身麻醉誘導(dǎo)和維持的有效性和安全性。
設(shè)計：一項單盲、隨機、平行組、3期試驗。
地點：涉及10個學(xué)習(xí)中心，從2020年11月24日至2021年1月25日。
病人：共納入129例接受非急診、非心胸外科和非神經(jīng)外科擇期手術(shù)的患者。
干預(yù)措施：患者以2：1的比例隨機分配到環(huán)泊酚組和丙泊酚組，誘導(dǎo)劑量：環(huán)泊酚 0.4mg/kg，丙泊酚 2.0mg/kg；維持劑量：環(huán)泊酚 0.8mg/kg·h，丙泊酚5.0mg/kg·h，維持腦電雙頻譜指數(shù)（BIS）在40-60區(qū)間，直到手術(shù)結(jié)束。
主要結(jié)局指標：兩組藥物之間的非劣效性評估為麻醉維持成功率（主要指標）組間差異的95%置信區(qū)間（CI）下限>-8%。次要結(jié)局指標包括麻醉誘導(dǎo)是否成功、完全覺醒和自主呼吸恢復(fù)時間、離開麻醉恢復(fù)室的時間以及BIS的變化，還進行了安全性評估。
結(jié)果：在129名患者中，128名完成此次研究，其中環(huán)泊酚組86名，丙泊酚組42名。兩組全身麻醉的維持成功率為100%，環(huán)泊酚的非劣效性得到證實（95%CI，-4.28%—8.38%）。兩組患者在次要指標方面的差異無統(tǒng)計學(xué)意義（P >0.05）。在環(huán)泊酚組和丙泊酚組中，緊急不良事件（TEAEs）（80.2%比81.0%，P =1.000）和藥物相關(guān)的TEAEs（57.0%比64.3%，P =0.451）的治療率似乎相當。
結(jié)論：與丙泊酚相比，HSK3486具有不劣的功效特征，表現(xiàn)出優(yōu)異的耐受性。
原始文獻來源：Liang, Peng; Dai, Meng; Wang, Xiao; Wang, Dongxin; Yang, Mengchang; Lin, Xuemei; Zou, Xiaohua; Jiang, Ke; Li, Yalan; Wang, Liangrong; Shangguan, Wangning; Ren, Jinghua; He, Hefan. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. European Journal of Anaesthesiology 40(6):p 399-406, June 2023.
Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial
BACKGROUND: HSK3486 (ciprofol) is a 2,6-disubstituted phenol derivative that acts like propofol as an agonist at the gamma-aminobutyric acid-A (GABAA) receptor.
OBJECTIVE: To investigate the efficacy and safety of HSK3486 for general anaesthesia induction and maintenance.
DESIGN: A single-blinded, randomised, parallel-group, phase 3 trial.
SETTING: Involving 10 study centres, from November 24, 2020 to January 25, 2021.
PATIENTS: A total of 129 patients undergoing nonemergency, noncardiothoracic, and nonneurosurgical elective surgery.
INTERVENTION: Patients were randomly assigned at a 2:1 ratio into HSK3486 or propofol groups, to receive HSK3486 (0.4 mg/kg) or propofol (2.0 mg/kg) for induction before a maintenance infusion at initial rates of 0.8 and 5.0mg kg?1 h?1
, and were adjusted to maintain a bispectral index (BIS) of 40–60 until the end of surgery.
MAIN OUTCOME MEASURES: Noninferiority between the drugs was evaluated as the lower limit of the 95% confidence interval (CI) for the between-group difference in the success rate of anesthetic maintenance (primary outcome) >?8%. Secondary outcomes included successful anaesthetic induction, full alertness and spontaneous breathing recovery, time until leaving the postanaesthesia care unit and changes in BIS. Safety profiles were also measured.
RESULTS: Of 129 enrolled patients, 128 completed the trial, with 86 in the HSK3486 group and 42 in the propofol group. The success rate for the maintenance of general anaesthesia was 100% for both groups, and noninferiority of HSK3486 was confirmed (95% CI ?4.28% to 8.38%). No significant differences were found between the two groups of patients with regard to secondary outcomes (all P > 0.05). There appeared to be a comparable incidence of treatment for emergency adverse events (TEAEs) (80.2% vs. 81.0%, P = 1.000) and drug-related TEAEs (57.0% vs. 64.3%, P = 0.451) in the HSK3486 and propofol groups.
CONCLUSION：HSK3486 had a noninferior efficacy profile compared to propofol, exhibiting excellent tolerance.
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