苯磺酸瑞马唑仑用于ICU机械通气患者镇静的有效性与安全性

Efficacy and safety of Remimazolam in sedation of ICU patients with mechanical ventilation

目的探讨苯磺酸瑞马唑仑对ICU机械通气患者镇静的有效性及对呼吸循环系统的影响。方法采用前瞻性随机对照研究方法,选择2021年1月至9月信阳市中心医院综合ICU收治的有镇静需求的机械通气患者92例,将其随机分为2组,苯磺酸瑞马唑仑组(R组)45例,丙泊酚组(P组)47例。2组患者分别给予舒芬太尼镇痛,维持镇痛目标为重症监护疼痛观察工具(CPOT)评分<2分。其中R组给予苯磺酸瑞马唑仑7 mg负荷剂量及2.5 mg追加剂量(达不到目标镇静深度时)静脉推注,再以0.1~0.5 mg/(kg·h)静脉泵入维持镇静;P组对于年龄<55岁的患者给予丙泊酚0.5~1.5 mg/kg负荷剂量静脉推注(年龄>55岁患者酌情减量),再以0.1~1 mg/(kg·h)静脉泵入维持镇静。根据Richmond镇静-躁动(RASS)评分标准,维持2组患者的目标镇静深度为-2~-3分。比较2组患者药物起效时间、停药后苏醒时间、用药前(T0)及用药后1 h(T1)、6 h(T6)、12 h(T12)、24 h(T24)时间点的心率(HR)、收缩压(SBP)、舒张压(DBP)、左室射血分数(LVEF)、左室流出道速度-时间积分(VTI)、呼吸频率(RR)、脉搏血氧饱和度(SpO_(2))的变化。结果2组患者性别、年龄、身高、体质量、急性生理学与慢性健康状况评分Ⅱ(APACHEⅡ)等基线资料、用药前呼吸及血流动力学指标等比较,差异均无统计学意义(P>0.05)。给药后R组和P组起效时间比较,差异无统计学意义[(85.7±18.6)s vs(94.7±32.6)s,P=0.108];停药后R组比P组苏醒时间更短,差异有统计意义[(22.6±6.25)s vs(25.9±7.9)s,P=0.028];组内比较,相比于T0时间点,T1、T6、T12、T24时2组的HR、SBP、DBP、RR、LVEF、VTI均有下降,而SpO_(2)上升,差异均有统计学意义(P<0.01);组间比较,2组患者用药后HR_((T1、T6、T24))、SBP_((T1、T6、T12、T24))、DBP_((T1、T6、T12))、LVEF_((T1、T6、T24))、VTI_((T1、T6、T24))比较,差异均有统计学意义(P<0.05),而RR_((T1、T6、T12、T24))、SpO_(2)_((T1、T6、T12、T24))比较,差异无统计学意义(P>0.05)。结论苯磺酸瑞马唑仑、丙泊酚都具有起效快的优点。相比于丙泊酚,苯磺酸瑞马唑仑苏醒快且对于心率、血压、心脏收缩功能影响更小,更适合于ICU患者的镇静治疗。

Objective To explore the sedative effect of Remimazolam on patients with mechanical ventilation in intensive care unit(ICU)and its influence on respiratory and circulatory system.Methods In a prospective randomized controlled study,ninety-two mechanical ventilated patients who needed sedation were enrolled in ICU of Xinyang Central Hospital from January 2021 to September 2021.The patients in two groups were given Sufentanil for analgesia,with critically-ill pain observation tool(CPOT)score less than 2 points,and were randomly divided into two groups,including 45 cases in Remimazolam group(group R)and 47 cases in Propofol group(group P).In group R,patients were received Remimazolam at a loading dose of 7 mg and an additional dose of 2.5 mg(when sedation target of RASS was not reached)by intravenous injection,and then a maintenance dose of 0.1-0.5 mg/(kg·h)by intravenous pump.In group P,patients younger than 55 years old were received Propofol at 0.5-1.5 mg/kg by intravenous injection(patients older than 55 years old were received at a reduced dose as appropriate)followed by a 0.1-1 mg/(kg·h)maintenance dose by intravenous pump.According to RASS sedation score,the target sedation depth of the two groups was maintained at-2--3 points.The time to onset of effect of drugs and the wake-up time of the patients(after the withdrawal of the drug)were recorded and compared between the two groups.The changes of heart rate(HR),systolic blood pressure(SBP),diastolic blood pressure(DBP),left ventricular ejection fractions(LVEF),left ventricular outflow tract velocity time integral(VTI),respiratory rate(RR)and saturation of pulse oxygen(SpO_(2))were recorded and compared between the two groups before(T0)and at 1 h(T1),6 h(T6),12 h(T12)and 24 h(T24)after medication.Results We found no difference between baseline clinical data such as gender,age,height,weight,APACHEⅡscore and hemodynamic or respiratory parameters before treatment between the two groups.There was no significant difference of the time to onset of effect of drugs between group R and group P after treatment[(85.7±18.6)s vs(94.7±32.6)s,P=0.108].After administration stopped,wake-up time of group R was shorter than that of group P[(22.6±6.25)s vs(25.9±7.9)s,P=0.028].Compared with T0 time point,the mean values of HR,SBP,DBP,RR,LVEF and VTI recorded at T1,T6,T12 and T24 time points in the two groups all decreased,while the mean values of SpO_(2) increased.Intra-group analysis showed that there were statistically significant differences between the above parameters at each time point after administration and before administration(P<0.01).Inter-group analysis showed that there were statistically significant differences in mean values of HR_((T1,T6,T24)),SBP_((T1,T6,T12,T24)),DBP_((T1,T6,T12)),LVEF_((T1,T6,T24)) and VTI_((T1,T6,T24)) between the two groups(P<0.05),However,there was no significant difference in RR and SpO_(2) between two groups at T1-T24 time points(P>0.05).Conclusions Either Remimazolam or Propofol have the advantage of rapid onset.When compared with Propofol,patients who received Remimazolam are more easier to wake-up(after administration stopped)and has less influence on heart rate,blood pressure and cardiac systolic function,which is more suitable for sedation treatment of ICU patients.