【罂粟摘要】亚甲蓝降低接受重大非心脏手术的老年患者术后早期认知障碍的发生率:一项开放标签的随机对照临床试验

亚甲蓝降低接受重大非心脏手术的老年患者术后早期认知障碍的发生率:一项开放标签的随机对照临床试验

贵州医科大学  高鸿教授课题组

翻译:黄岁岁    编辑:佟睿    审校:曹莹

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研究目的
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本研究旨在探讨亚甲蓝(MB)能否降低老年非心脏大手术患者术后谵妄(POD)和早期术后认知功能障碍(POCD)的发生率。

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试验设计
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前瞻性、随机、开放标签临床试验

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范围设置
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大学附属医院。

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受试患者
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248名计划进行非心脏手术的老年患者。

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干预措施
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行非心脏大手术的老年患者随机分为MB组(n = 124),麻醉诱导后立即在60分钟内静脉滴注2mg/kg MB,或对照组(n = 124),同样方式静脉滴注等量生理盐水。

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观察指标
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所有患者在术前和术后进行谵妄和神经心理,以及围手术期不良事件的评估。术前和术后测定两种血浆生物标志物:超氧化物歧化酶(SOD)和同型半胱氨酸(HCY)。

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指标测量
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其中39例(15.7%)患者发生过POD。MB组的POD发生率显著低于对照组(7.3% vs. 24.2%, OR=0.24, 95%CI: 0.11-0.53, p<0.001)。MB组术后第7天早期POCD发生率也低于对照组(16.1% vs. 40.2%, OR=0.30, 95% CI: 0.16-0.57, p<0.001)。两组不良事件具有可比性。POD/POCD与超氧化物歧化酶(SOD)和同型半胱氨酸(HCY)水平无显著相关性。

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结论
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我们认为术中静脉注射2mg /kg MB可显著降低老年外科患者POD和早期POCD的发生率,但未显著增加围术期不良事件的发生率,提示MB在预防术后早期神经认知障碍方面具有临床有效性和安全性。

Link
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原始文献来源
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Yixu Deng, Ruijing Wang, Shitong Li, et al.Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open–label randomized controlled clinical trial.[J]Journal of Clinical Anesthesia. 68 (2021) 110108.

Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open–label randomized controlled clinical trial

Study objective: The purpose of the present study was to investigate whether methylene blue (MB) could reduce the incidences of postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD) in elderly patients undergoing major non-cardiac surgery.

Design:Prospective, randomized, open–label clinical trial.

Setting:University-affiliated hospital.

Patients:Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery.

Interventions:Elderly patients undergoing non-cardiac major surgery were randomly assigned to MB group (n = 124), who receiving intravenous infusion of 2 mg/kg MB within 60 min immediately after anesthetic induction, or control group (n = 124), who receiving equal volume saline in the same way.

Measurements: All patients were evaluated with delirium and neuropsychological batteries before and after surgery, as well as perioperative adverse events. Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.

Main results:There were total 39 cases(15.7%)experienced POD. The incidence of POD in MB group was significantly less than that in control group (7.3% vs. 24.2%, OR = 0.24, 95%CI: 0.11–0.53, p < 0.001). The incidence of early POCD at postoperative 7th day in MB group was also less than that in control group (16.1% vs. 40.2%, OR = 0.30, 95% CI: 0.16–0.57, p < 0.001). The adverse events were comparable in both groups. In addition, there was no significant correlation between POD/POCD and levels of SOD or HCY.

Conclusion:We conclude that intraoperative intravenous 2 mg/kg MB could significantly reduce the incidences of POD and early POCD in elderly surgical patients, while not remarkably increase incidence of perioperative adverse events, suggesting MB may be clinically effective and safe for prevention of early postoperative neurocognitive disorders.

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