【文献阅读】HSK3486对择期手术患者全身麻醉诱导和维持的有效性和安全性研究

2022-11-11 09:28

HSK3486在全麻诱导和维持方面有良好的有效性，接受择期手术的患者对HSK3486具有良好的耐受性。

Efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients: a multicenter, randomized, open-label, propofol-controlled phase 2 clinical trial HSK3486对择期手术患者全身麻醉诱导和维持的有效性和安全性研究:一项多中心、随机、开放标签、丙泊酚对照的2期临床试验

Abstract

OBJECTIVE:
01、To evaluate the efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients, but excluding emergency, cardiothoracic, cerebral and endoscopic sinus cases.

摘要-目的：评价HSK3486用于择期手术患者全身麻醉诱导和维持的有效性和安全性，但不包括急诊手术、心胸外科手术、颅脑手术和内窥镜鼻窦手术。

PATIENTS AND METHODS:
02、A total of 40 eligible patients were randomly assigned to HSK3486 (n = 30) or propofol (n = 10) dosage groups in a ratio of 3:1. Drugs were administered as a bolus injection of 0.4 mg/kg (HSK3486) or 2.0 mg/kg (propofol) for induction, followed by maintenance infusion with the same anesthetic. An additional 6 non-randomized patients received propofol (2.0 mg/kg) for induction and were given HSK3486 for maintenance.

患者和方法：总共40例符合条件的患者被随机分配到HSK3486 (n = 30)或丙泊酚(n = 10)组，两组患者的比例为3:1。使用0.4 mg/kg 的HSK3486或2.0 mg/ kg的丙泊酚进行全麻诱导，随后输注相同的药物进行全麻维持。另外6名非随机患者接受丙泊酚2.0 mg/kg进行全麻诱导，并给予HSK3486进行全麻维持。

RESULTS:
03、The primary efficacy endpoint – the success rate of anesthesia maintenance – was 100% in the 3 arms. The secondary efficacy endpoints included times from discontinuation of HSK3486 or propofol maintenance to full alertness, respiratory recovery, extubation and reaching the goal of the Aldrete score. Also, the proportion of patients who constantly maintained BIS40-60 or those with a period of BIS40-60 during maintenance anesthesia showed no significant difference in the HSK3486 and propofol

groups (all p > 0.05).

Patients who received HSK3486 exhibited a higher satisfaction score from anesthesiologists during the induction period (p = 0.024). The

occurrence and types of treatment-emergent adverse events were similar among the 3 arms, both with a severity of grade 1 or 2. Drug-related hypotension occurred in 14 (46.7%) and 7 (70.0%) patients treated with HSK3486 and propofol, respectively.

结果：三个研究组主要有效性终点全麻维持成功率均为100%。次要有效性终点包括从停药（HSK3486或丙泊酚）到完全觉醒、呼吸恢复、拔管和达到Aldrete目标评分的时间。全麻维持期间维持BIS 40-60或BIS 40-60的患者比例在HSK3486组与丙泊酚组之间无显著性差异（均p>0.05）。在全麻诱导期，HSK3486组麻醉医生的满意度评分更高 (p=0.024)。3个研究组中不良事件的发生率和类型相似，不良事件的严重程度均为1级或2级。HSK3486组和丙泊酚组分别有14例(46.7%)和7例(70.0%) 患者发生药物相关性低血压。

CONCLUSIONS:
04、HSK3486 exhibited good efficacy for the induction and maintenance of general anesthesia and was well tolerated by patients who underwent elective surgery.

结论：HSK3486在全麻诱导和维持方面有良好的有效性，接受择期手术的患者对HSK3486具有良好的耐受性。

图1 试验流程图

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