【罂粟摘要】环泊酚与丙泊酚在全身麻醉诱导和维持的有效性和安全性：一项多中心、单盲、随机、平行组、3期临床试验

环泊酚与丙泊酚在全身麻醉诱导和维持的有效性和安全性：一项多中心、单盲、随机、平行组、3期临床试验

贵州医科大学    麻醉与心脏电生理课题组

翻译：宋雨婷   编辑：柏雪   审校：曹莹

背景：HSK3486（环泊酚）是一种2，6-二取代苯酚衍生物，其作用类似于丙泊酚，可作为γ-氨基丁酸-A（GABAA）受体的激动剂。

目的：探讨环泊酚全身麻醉诱导和维持的有效性和安全性。

设计：一项单盲、随机、平行组、3期试验。

地点：涉及10个学习中心，从2020年11月24日至2021年1月25日。

病人：共纳入129例接受非急诊、非心胸外科和非神经外科择期手术的患者。

干预措施：患者以2：1的比例随机分配到环泊酚组和丙泊酚组，诱导剂量：环泊酚 0.4mg/kg，丙泊酚 2.0mg/kg；维持剂量：环泊酚 0.8mg/kg·h，丙泊酚5.0mg/kg·h，维持脑电双频谱指数（BIS）在40-60区间，直到手术结束。

主要结局指标：两组药物之间的非劣效性评估为麻醉维持成功率（主要指标）组间差异的95%置信区间（CI）下限>-8%。次要结局指标包括麻醉诱导是否成功、完全觉醒和自主呼吸恢复时间、离开麻醉恢复室的时间以及BIS的变化，还进行了安全性评估。

结果：在129名患者中，128名完成此次研究，其中环泊酚组86名，丙泊酚组42名。两组全身麻醉的维持成功率为100%，环泊酚的非劣效性得到证实（95%CI，-4.28%—8.38%）。两组患者在次要指标方面的差异无统计学意义（P >0.05）。在环泊酚组和丙泊酚组中，紧急不良事件（TEAEs）（80.2%比81.0%，P =1.000）和药物相关的TEAEs（57.0%比64.3%，P =0.451）的治疗率似乎相当。

结论：与丙泊酚相比，HSK3486具有不劣的功效特征，表现出优异的耐受性。

原始文献来源：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.

英文原文：

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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