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甲磺酸瑞马唑仑与丙泊酚对行腹腔镜部分肝切除术患者免疫功能和血液动力学影响的比较:一项随机对照试验。

Comparison of the effects of remimazolam tosylate and propofol on immune function and hemodynamics in patients undergoing laparoscopic partial hepatectomy: a randomized controlled trial.

机构信息

Department of Anesthesiology and Perioperative Medicine, the First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, China.

出版信息

BMC Anesthesiol. 2024 Jun 10;24(1):205. doi: 10.1186/s12871-024-02589-4.

Abstract

BACKGROUND

Laparoscopic partial hepatectomy inevitably decrease patient immune function. Propofol has been shown to have immunomodulatory effects but is associated with hemodynamic side effects. Despite studies showing a negligible impact of remimazolam tosylate on hemodynamics, it has not been reported for partial hepatectomy patients. Its influence on immune function also remains unexplored. This study sought to investigate the differences in immune function and intraoperative hemodynamics between patients who underwent laparoscopic partial hepatectomy with remimazolam tosylate and those who underwent laparoscopic partial hepatectomy with propofol.

METHODS

This was a single-center, randomized controlled trial involving 70 patients, who underwent elective laparoscopic partial hepatectomy. The patients were randomly divided into two groups: the remimazolam group (group R) and the propofol group (group P). In this study, the primary outcomes assessed included the patient's immune function and hemodynamic parameters, and the secondary outcomes encompassed the patient's liver function and adverse events.

RESULTS

Data from 64 patients (group R, n = 31; group P, n = 33) were analyzed. The differences in the percentages of CD3, CD4, CD8, and NK cells and the CD4/CD8 ratio between the two groups were not statistically significant at 1 day or 3 days after surgery. Compared with those in group P, the MAP and HR at T2 and the MAP at T1 in group R were significantly increased(P < 0.05). The differences in HR and MAP at T0, T3, T4, T5, T6, and T7 and HR at T1 between the two groups were not statistically significant. There were no differences in liver function or adverse effects between the two groups, suggesting that remimazolam tosylate is a safe sedative drug(P > 0.05).

CONCLUSION

The effects of remimazolam tosylate on the immune function of patients after partial hepatectomy are comparable to those of propofol. Additionally, its minimal effect on hemodynamics significantly decreases the incidence of hypotension during anesthesia induction, thereby enhancing overall perioperative safety.

TRIAL REGISTRATION

The trial was registered on May 9, 2022 in the Chinese Clinical Trial Registry, registration number ChiCTR2200059715 (09/05/2022).

摘要

背景

腹腔镜部分肝切除术不可避免地会降低患者的免疫功能。丙泊酚已被证明具有免疫调节作用,但与血液动力学副作用有关。尽管有研究表明甲苯磺酸雷米唑仑对血液动力学几乎没有影响,但尚未报道用于部分肝切除术患者。其对免疫功能的影响也尚未得到探索。本研究旨在探讨甲苯磺酸雷米唑仑与丙泊酚用于腹腔镜部分肝切除术患者的免疫功能和术中血液动力学的差异。

方法

这是一项单中心、随机对照试验,纳入了 70 例接受择期腹腔镜部分肝切除术的患者。患者随机分为两组:雷米唑仑组(R 组)和丙泊酚组(P 组)。本研究的主要结局评估包括患者的免疫功能和血液动力学参数,次要结局包括患者的肝功能和不良事件。

结果

64 例患者(R 组 n=31,P 组 n=33)的数据进行了分析。术后 1 天和 3 天,两组间 CD3、CD4、CD8 和 NK 细胞的百分比以及 CD4/CD8 比值无统计学差异。与 P 组相比,R 组 T2 时的 MAP 和 HR 以及 T1 时的 MAP 明显升高(P<0.05)。两组间 T0、T3、T4、T5、T6 和 T7 时的 HR 和 MAP 以及 T1 时的 HR 无统计学差异。两组间肝功能或不良事件无差异,提示甲苯磺酸雷米唑仑是一种安全的镇静药物(P>0.05)。

结论

甲苯磺酸雷米唑仑对部分肝切除术后患者免疫功能的影响与丙泊酚相当。此外,其对血液动力学的影响较小,可显著降低麻醉诱导期间低血压的发生率,从而提高整体围手术期安全性。

试验注册

该试验于 2022 年 5 月 9 日在中国临床试验注册中心注册,注册号 ChiCTR2200059715(2022 年 05 月 09 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c50d/11163695/18d5b09d70a5/12871_2024_2589_Fig1_HTML.jpg

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