Magnesium Sulfate

硫酸镁
  • 文章类型: Journal Article
    背景:本研究通过评估术后早期结果,研究了在成人心脏手术中,与传统血液心脏停搏液相比,DelNido心脏停搏液的疗效。
    方法:共119例接受单纯常规冠状动脉旁路移植术的患者,根据使用的心脏停搏液类型分为两组(DelNido心脏停搏液组[n=36]和血液心脏停搏液组[n=50])。本研究比较了术前特点,术中数据,和术后早期结果。对高危患者组进行了进一步的亚组分析。
    结果:两组间30天死亡率和发病率无显著差异。delNido心脏停搏液组表现出有利的心肌保护结果,手术后肌钙蛋白I水平的升高明显较小(2.8[-0.4;4.2]vs.4.5[2.9;7.4]ng/mL,p=0.004),体外循环断奶期间的除颤尝试较少(0.0±0.2vs.0.4±1.1倍,与血液心脏停搏液组相比,p=0.011)。此外,delNido组减少了手术时间,主动脉交叉钳夹时间减少(64.0[55.5;75.5]vs.77.5[65.0;91.0]分钟,p=0.001)和总手术时间(287.5[270.0;305.0]vs.315.0[285.0;365.0]min,p=0.008)。亚组分析一致表明,在所有亚组中,delNido心脏停搏组的术后肌钙蛋白I水平增加明显较小(p<0.05)。
    结论:delNido心脏停搏液与血液心脏停搏液相比可提供心肌保护和良好的术后早期结局,使其成为常规冠状动脉旁路移植术的可行选择。需要就成人手术中DelNido心脏停搏液的给药方案达成共识。
    BACKGROUND: This study examined the efficacy of del Nido cardioplegia compared with traditional blood cardioplegia in adult cardiac surgery for isolated coronary artery bypass grafting by evaluating the early postoperative outcomes.
    METHODS: A total of 119 patients who underwent isolated conventional coronary artery bypass grafting were enrolled and divided into two groups (del Nido cardioplegia group [n = 36] and blood cardioplegia group [n = 50]) based on the type of cardioplegia used. This study compared the preoperative characteristics, intraoperative data, and early postoperative outcomes. Further subgroup analyses were conducted for high-risk patient groups.
    RESULTS: The 30-day mortality and morbidity rates were not significantly different between groups. The del Nido cardioplegia group exhibited advantageous myocardial protection outcomes, demonstrated by a significantly smaller rise in Troponin I levels post-surgery (2.8 [-0.4; 4.2] vs. 4.5 [2.9; 7.4] ng/mL, p = 0.004) and fewer defibrillation attempts during weaning off of cardiopulmonary bypass (0.0 ± 0.2 vs. 0.4 ± 1.1 times, p = 0.011) when compared to the blood cardioplegia group. Additionally, the del Nido group achieved a reduction in surgery duration, as evidenced by the reduced aortic cross-clamping time (64.0 [55.5; 75.5] vs. 77.5 [65.0; 91.0] min, p = 0.001) and total operative time (287.5 [270.0; 305.0] vs. 315.0 [285.0; 365.0] min, p = 0.008). Subgroup analyses consistently demonstrated that the del Nido cardioplegia group had a significantly smaller postoperative increase in Troponin I levels across all subgroups (p < 0.05).
    CONCLUSIONS: del Nido cardioplegia provided myocardial protection and favorable early postoperative outcomes compared to blood cardioplegia, making it a viable option for conventional coronary artery bypass grafting. Establishing a consensus on the protocol for Del Nido cardioplegia administration in adult surgeries is needed.
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  • 文章类型: Journal Article
    头孢曲松(CTRX)是一种常用的头孢菌素类抗生素。建议监测血浆/血清浓度有助于其安全使用。本研究旨在根据国际协调会议指南M10开发和验证一种用于测量人血清中CTRX浓度的分析方法。使用硫酸镁的盐析辅助液-液萃取程序纯化十微升血清样品。然后将上层稀释三倍,并使用基于液相色谱-串联质谱的方法进行分析,总运行时间为12分钟。在5-500μg/ml的浓度范围内获得线性校准曲线。运行中的精度从0.2%到6.5%不等,精密度≤8.0%。运行间准确度和精密度范围为0.7%至5.6%,≤6.4%,分别。通过在高浓度CTRX样品后注射四个空白来解决显著的残留。低浓度和高浓度加标血清的回收率分别为44.4和43.4%,分别。其他因素,包括选择性,矩阵效应,稳定性,稀释完整性和回注再现性也符合验收标准。使用该方法成功地测定了从接受2g/天CTRX的两名参与者获得的14个样品中的血清浓度。
    Ceftriaxone (CTRX) is a commonly used cephalosporin antibiotic. It is suggested that monitoring plasma/serum concentrations is helpful for its safe use. This study aimed to develop and validate an analytical method for measuring CTRX concentrations in human serum according to International Conference on Harmonization guideline M10. Ten microliters of serum sample was purified using a salting-out assisted liquid-liquid extraction procedure with magnesium sulfate. The upper layer was then diluted threefold and analyzed using a liquid chromatography-tandem mass spectrometry-based method with a total run time of 12 min. The linear calibration curve was obtained over the concentration range 5-500 μg/ml. The within-run accuracy varied from 0.2 to 6.5%, and the precision was ≤8.0%. The between-run accuracy and precision ranged from 0.7% to 5.6% and ≤6.4%, respectively. Significant carryover was resolved by injecting four blanks after high-concentration CTRX samples. The recovery rates from spiked serum at low and high concentrations were 44.4 and 43.4%, respectively. Other factors, including selectivity, matrix effects, stability, dilution integrity and reinjection reproducibility also met the acceptance criteria. Serum concentrations in 14 samples obtained from two participants receiving 2 g/day of CTRX were successfully determined using this method.
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  • 文章类型: Journal Article
    目的:比较硫酸镁对肢体截肢术后静脉注射吗啡总剂量的影响以及对抢救镇痛的要求。疼痛评分和副作用。
    方法:这种前瞻性,三盲,随机对照研究于2021年10月至2022年5月在ShaukatKhanum纪念癌症医院和研究中心进行,拉合尔,巴基斯坦,由计划截肢的病人组成。他们被随机分为2组。所有患者的麻醉方案是统一的。干预A组静脉给予30mg/kg负荷剂量和10mg/kg/hr维持剂量的硫酸镁,而对照组B患者接受等量的普通等渗盐水。吗啡消耗,包括用于抢救镇痛和病人自控镇痛,术后24小时测量。采用数值评定量表对两组患者术后15min疼痛进行评价,1h,2h,从麻醉后护理室出院时以及在病房的12h和24h。数据采用SPSS23进行分析。
    结果:在24名患者中,20人(83.33%)完成研究.A组患者10例(50%);男性8例(40%),女性2例(20%),平均年龄24.8±14.14岁,平均手术时间130.5±47.86分钟。B组患者10例(50%);男性8例(40%),女性2例(20%),平均年龄23.2±7.4岁,平均手术时间117±23.85分钟(p>0.05)。A组24小时内使用的总吗啡为16±3.1mg,而B组为29.6±11.2mg(p<0.05)。与B组(25±26.68分钟)相比,A组到达麻醉后首次使用患者自控镇痛的时间(72.2±24.95分钟)明显延迟(p<0.05)。15min时B组疼痛评分明显高于A组(p<0.05),但在其余时间点没有(p>0.05)。
    结论:静脉硫酸镁被证明可有效降低截肢术后阿片类药物的需求。
    OBJECTIVE: To compare the effects of magnesium sulphate on the total dose of intravenous morphine consumption postoperatively following limb amputations along with rescue analgesia requirement, pain scores and side effects.
    METHODS: This prospective, triple-blinded, randomised controlled study was conducted from October 2021 to May 2022 at the Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, and comprised of patients scheduled for limb amputations. They were randomised into 2 equal groups. The anaesthesia protocol was uniform for all patients. Intervention group A was administered 30mg/kg loading dose and 10mg/kg/hr maintenance dose of magnesium sulphate intravenously, while patients in control group B received the same amount of plain isotonic saline. Morphine consumption, including that used for rescue analgesia and patient-controlled analgesia, was measured for 24 hours postoperatively. Numeric rating scale was used for the evaluation of postoperative pain in both groups at 15min, 1h, 2h, at discharge from the post-anaesthesia care unit and at 12h and 24h in the ward. Data was analysed using SPSS 23.
    RESULTS: Of the 24 patients enrolled, the study was completed by 20(83.33%). There were 10(50%) patients in group A; 8(40%) males and 2(20%) females with mean age 24.8±14.14 years and mean surgery time 130.5±47.86 minutes. There were 10(50%) patients in group B; 8(40%) males and 2(20%) females with mean age 23.2±7.4 years and mean surgery time 117±23.85 minutes (p>0.05). Total morphine used over 24 hours in group A was 16±3.1 mg compared to 29.6±11.2 mg in group B (p<0.05). The time for first use of patient-controlled analgesia after arriving in the postanaesthesia care unit was significantly delayed in group A (72.2±24.95 minutes) compared to that in group B (25±26.68 minutes) (p<0.05). Pain scores were significantly higher in the group B at 15min compared to group A (p<0.05), but not at the rest of the time points (p>0.05).
    CONCLUSIONS: Intravenous magnesium sulphate proved to be effective in lowering postoperative opioid requirement following limb amputations.
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  • 文章类型: Journal Article
    目的:系统评价delNido心脏停搏液与冷血心脏停搏液在成人心脏手术中的安全性。
    方法:我们系统地搜索了PubMed,EMBase,Cochrane图书馆和ClinicalTrials.gov进行随机临床试验(于2024年1月14日发布),比较成人的delNido心脏停搏液与冷血心脏停搏液。我们的主要终点是心肌损伤标志物和临床结果。我们通过使用随机效应模型或固定效应模型评估了合并数据。
    结果:共确定了10项研究,纳入889名接受delNido心脏停搏液的患者和907名接受冷血心脏停搏液的患者。荟萃分析结果显示,与冷血停搏液相比,delNido心脏停搏液的体积较少,交叉钳夹释放后自发节律恢复率较高,术后心肌肌钙蛋白T和肌酐激酶-心肌带水平降低,所有这些都有统计学意义。然而,术后肌钙蛋白I和术后左心室射血分数差异无统计学意义。临床结果包括机械通气时间,重症监护室停留时间,住院时间,术后中风,术后新发房颤,术后心力衰竭需要主动脉内球囊泵机械循环支持,和住院死亡率两者相当。
    结论:现有证据表明,delNido心脏停搏液减少了心脏停搏液的给药体积和尝试除颤。CTnT和CK-MB的良好术后结果可能为进一步研究改善心脏停搏液的成分提供方向。
    OBJECTIVE: Systematic evaluation of the safety of del Nido cardioplegia compared to cold blood cardioplegia in adult cardiac surgery.
    METHODS: We systematically searched PubMed, EMbase, The Cochrane Library and ClinicalTrials.gov for randomized clinical trials (published by 14 January 2024) comparing del Nido cardioplegia to cold blood cardioplegia in adult. Our main endpoints were myocardial injury markers and clinical outcomes. We assessed pooled data by use of a random-effects model or a fixed-effects model.
    RESULTS: A total of 10 studies were identified, incorporating 889 patients who received del Nido cardioplegia and 907 patients who received cold blood cardioplegia. The meta-analysis results showed that compared with the cold blood cardioplegia, the del Nido cardioplegia had less volume of cardioplegia, higher rate of spontaneous rhythm recovery after cross clamp release, lower levels of postoperative cardiac troponin T and creatinine kinase-myocardial band, all of which were statistically significant. However, there was no statistically significant difference in postoperative troponin I and postoperative left ventricular ejection fraction. The clinical outcomes including mechanical ventilation time, intensive care unit stay time, hospital stay time, postoperative stroke, postoperative new-onset atrial fibrillation, postoperative heart failure requiring intra-aortic balloon pump mechanical circulation support, and in-hospital mortality of both are comparable.
    CONCLUSIONS: Existing evidence suggests that del Nido cardioplegia reduced volume of cardioplegia administration and attempts of defibrillation. The superior postoperative results in CTnT and CK-MB may provide a direction for further research on improvement of the composition of cardioplegia.
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  • 文章类型: Journal Article
    目的:本文旨在揭示低分子肝素钙(LMWH)联合硫酸镁和拉贝洛尔对凝血功能的影响。血管内皮功能,早发型重度子痫前期(EOSP)的妊娠结局。
    方法:将妊娠合并EOSP的孕妇分为对照组和研究组,各62例。对照组患者给予拉贝洛尔和硫酸镁治疗,研究组采用LMWH联合对照组治疗血压(收缩压[SBP]和舒张压[DBP]),24小时尿蛋白,凝血指标[D-二聚体(D-D),血浆纤维蛋白原(Fg),凝血酶原时间(PT),活化部分凝血活酶时间(APTT),和凝血酶原时间(TT)],内皮功能[内皮素(ET-1)和一氧化氮(NO)],氧化应激指标[氧化低密度脂蛋白(ox-LDL),脂质过氧化(LPO),超氧化物歧化酶(SOD),和丙二醛(MDA)],妊娠结局,比较两组不良反应发生情况。
    结果:治疗后,降低SBP,DBP,和24小时尿蛋白水平;较低的Fg和D-D水平;较高的PT,APPT,和TT水平;较高的NO水平;较低的ET-1水平;较低的ox-LDL,MDA,与对照组相比,研究组和LPO水平较高;SOD水平较高;不良妊娠和不良反应发生率较低。
    结论:EOSP患者给予LMWH联合硫酸镁和拉贝洛尔可有效降低患者的血压和尿蛋白水平,改善凝血功能,氧化应激,降低不良妊娠结局,提高治疗安全性。
    OBJECTIVE: This paper was aimed at unveiling the effect of low-molecular-weight heparin calcium (LMWH) combined with magnesium sulfate and labetalol on coagulation, vascular endothelial function, and pregnancy outcome in early-onset severe preeclampsia (EOSP).
    METHODS: Pregnant women with EOSP were divided into the control group and the study group, each with 62 cases. Patients in the control group were treated with labetalol and magnesium sulfate, and those in the study group were treated with LMWH in combination with the control grou Blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), 24-h urine protein, coagulation indices [D-dimer (D-D), plasma fibrinogen (Fg), prothrombin time (PT), activated partial thromboplastin time (APTT), and prothrombin time (TT)], endothelial function [endothelin (ET-1) and nitric oxide (NO)], oxidative stress indices [oxidized low-density lipoproteins (ox-LDL), lipid peroxidation (LPO), superoxide dismutase (SOD), and malondialdehyde (MDA)], pregnancy outcome, and adverse effects occurred in the two groups were compared.
    RESULTS: After treatment, lower SBP, DBP, and 24-h urine protein levels; lower Fg and D-D levels; higher PT, APPT, and TT levels; higher NO levels; lower ET-1 levels; lower ox-LDL, MDA, and LPO levels; higher SOD levels; and lower incidence of adverse pregnancy and adverse reactions were noted in the study group in contrast to the control group.
    CONCLUSIONS: EOSP patients given with LMWH combined with magnesium sulfate and labetalol can effectively reduce the patient\'s blood pressure and urinary protein level; improve coagulation function, oxidative stress, and vascular endothelial function indices; reduce the adverse pregnancy outcomes; and improve the safety of treatment.
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  • 文章类型: Journal Article
    基孔肯雅病毒(CHIKV),导致基孔肯雅热,是一种公共卫生问题的虫媒病毒,没有批准的抗病毒疗法。相当比例的患者在感染后发展为慢性关节炎。锌和镁盐帮助免疫系统有效地应对病毒感染。这项研究探索了硫酸锌的抗病毒潜力,醋酸锌,和硫酸镁对抗CHIKV感染.
    盐的最高无毒浓度(100µM)用于评估预防剂,杀病毒,和治疗性抗CHIKV活动。研究剂量依赖性抗病毒作用以找出盐的50%抑制浓度。进行进入旁路测定以查明盐是否影响病毒进入或进入后阶段。所有这些实验中的病毒输出都是使用焦点形成单位测定来估计的,实时RT-PCR,和免疫荧光分析。
    不同的时间和温度依赖性测定揭示了锌盐和镁盐对CHIKV的治疗性抗病毒活性。抑制CHIKV需要最少4小时的暴露和在感染后1至2小时内开始治疗。进入测定显示锌盐影响病毒进入。进入旁路实验表明,两种盐都会影响CHIKV的进入后阶段。在口服锌和镁盐的感染C57BL6小鼠中,观察到病毒RNA拷贝数减少.
    研究结果表明,锌盐在病毒生命周期的进入和进入后阶段发挥抗CHIKV活性,而镁盐在进入后阶段会影响CHIKV。总的来说,这项研究强调了硫酸锌的巨大抗病毒潜力,醋酸锌,和硫酸镁对抗CHIKV,可用于设计基孔肯雅患者早期治疗的潜在治疗策略,从而减少病毒相关的持续性关节炎。
    UNASSIGNED: Chikungunya virus (CHIKV), which causes chikungunya fever, is an arbovirus of public health concern with no approved antiviral therapies. A significant proportion of patients develop chronic arthritis after an infection. Zinc and magnesium salts help the immune system respond effectively against viral infections. This study explored the antiviral potential of zinc sulphate, zinc acetate, and magnesium sulphate against CHIKV infection.
    UNASSIGNED: The highest non-toxic concentration of the salts (100 µM) was used to assess the prophylactic, virucidal, and therapeutic anti-CHIKV activities. Dose-dependent antiviral effects were investigated to find out the 50% inhibitory concentration of the salts. Entry bypass assay was conducted to find out whether the salts affect virus entry or post entry stages. Virus output in all these experiments was estimated using a focus-forming unit assay, real-time RT-PCR, and immunofluorescence assay.
    UNASSIGNED: Different time- and temperature-dependent assays revealed the therapeutic antiviral activity of zinc and magnesium salts against CHIKV. A minimum exposure of 4 hours and treatment initiation within 1 to 2 hours of infection are required for inhibition of CHIKV. Entry assays revealed that zinc salt affected virus-entry. Entry bypass assays suggested that both salts affected post-entry stages of CHIKV. In infected C57BL6 mice orally fed with zinc and magnesium salts, a reduction in viral RNA copy number was observed.
    UNASSIGNED: The study results suggest zinc salts exert anti-CHIKV activity at entry and post entry stages of the virus life cycle, while magnesium salt affect CHIKV at post entry stages. Overall, the study highlights the significant antiviral potential of zinc sulphate, zinc acetate, and magnesium sulphate against CHIKV, which can be exploited in designing potential therapeutic strategies for early treatment of chikungunya patients, thereby reducing the virus-associated persistent arthritis.
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  • 文章类型: Journal Article
    优化脊柱手术中的疼痛管理对于预防由于延迟动员引起的不良事件至关重要。硫酸镁由于其镇痛特性和调节神经递质和自主神经系统而在脊柱手术中具有潜在的益处。关于使用硫酸镁的现有证据是部分和有争议的,需要进行全面的荟萃分析来评估其疗效和安全性。这项研究的目的是进行全面的荟萃分析,以评估硫酸镁在脊柱手术中与其他可用选择相比的有效性和安全性。这项荟萃分析遵循PRISMA指南。包括接受脊柱手术的患者,干预组接受各种剂量或组合的静脉注射硫酸镁(MS),而对照组则接受其他替代方案或安慰剂.评估疗效和安全性结果。从多个数据库收集数据并使用ReviewManager版本5.4进行分析。评估异质性,并应用固定或随机效应模型。荟萃分析包括8项研究(n=541)。与安慰剂相比,硫酸镁显示24h疼痛(MD-0.20,95%CI:-0.39至-0.02)和阿片类药物消耗(SMD-0.66,95%CI:-0.95至-0.38)显着减轻。此外,观察到肌肉松弛剂(SMD-0.91,95%CI:-1.65~-0.17)和瑞芬太尼(SMD-1.52,95%CI:-1.98~-1.05)的使用减少.相比之下,与右美托咪定相比,观察到拔管时间(MD2.42,95%CI:1.14~3.71)和言语反应(MD1.85,95%CI:1.13~2.58)增加.总之,在脊柱手术中使用硫酸镁可以减少疼痛和阿片类药物的消耗,以及长时间的定向和口头反应。两组之间的血压或心率没有显着差异。
    Optimizing pain management in spinal surgery is crucial for preventing adverse events due to delayed mobilization. Magnesium sulfate has potential benefits in spinal surgery because of its analgesic properties and modulation of neurotransmitters and autonomic nervous system. Existing evidence regarding the use of magnesium sulfate is partial and controversial, necessitating a comprehensive meta-analysis to evaluate its efficacy and safety. The aim of this study was to conduct a comprehensive meta-analysis to evaluate the efficacy and safety of magnesium sulfate in spinal surgery compared to other available options. This meta-analysis adhered to the PRISMA guidelines. Patients undergoing spinal surgery were included, with the intervention group receiving intravenous magnesium sulfate (MS) at various doses or combinations, whereas the comparison group received other alternatives or a placebo. The efficacy and safety outcomes were assessed. Data were collected from multiple databases and analyzed using Review Manager version 5.4. Heterogeneity was assessed and fixed- or random-effects models were applied. The meta-analysis included eight studies (n = 541). Magnesium sulfate demonstrated significant reductions in pain at 24 h (MD -0.20, 95% CI: -0.39 to -0.02) and opioid consumption (SMD -0.66, 95% CI: -0.95 to -0.38) compared to placebo. Additionally, a decrease in the use of muscle relaxants (SMD -0.91, 95% CI: -1.65 to -0.17) and remifentanil (SMD -1.52, 95% CI: -1.98 to -1.05) was observed. In contrast, an increase in extubation time (MD 2.42, 95% CI: 1.14 to 3.71) and verbal response (MD 1.85, 95% CI: 1.13 to 2.58) was observed compared to dexmedetomidine. In conclusion, magnesium sulfate administration in spinal surgery reduced pain and opioid consumption, and prolonged orientation and verbal response. No significant differences in blood pressure or heart rate were observed between the groups.
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  • 文章类型: Journal Article
    硫酸镁(MgSO4)是麻醉中广泛使用的佐剂。经常使用局部麻醉药,已知在延长镇痛持续时间的同时减少镇痛和阿片类药物的消耗。MgSO4应用扩展到骨科手术,心血管和泌尿生殖系统,提供延长术后疼痛缓解。虽然通常通过各种途径进行管理,关于鞘内(IT)和静脉(IV)MgSO4给药的比较疗效存在研究空白。这篇叙述性综述旨在提供IT和IV给药MgSO4之间的比较,特别是在骨科手术之后,疼痛管理至关重要。在几个电子数据库中进行了全面的文献检索,审判登记处,和灰色文学从成立到2023年。纳入标准包括研究在接受手术的患者中,围手术期IT施用镁与围手术期IV施用MgSO4相比的影响。没有语言限制。我们的搜索识别了4326篇文章,其中9项随机对照试验符合纳入标准.我们总结了这些精选的文章。四项研究讨论了IT硫酸镁(MgSO4)给药,2专注于骨科手术中的IT管理,3探索了骨科手术中MgSO4的IV和IT给药。ITMgSO4在术后疼痛管理中显示出希望,延迟阻滞发作和延长持续时间。个性化管理选择,考虑到患者因素和手术类型,至关重要。需要进一步的研究来完善策略,以获得更好的患者预后,尤其是在整形外科手术之后.
    Magnesium Sulfate (MgSO4) is a widely used adjuvant in anesthesia. Often administered with local anesthetics, it is known to reduce analgesic and opioid consumption while extending the duration of analgesia. MgSO4 applications extend to orthopedic surgeries, cardiovascular and urogenital procedures, offering extended postoperative pain relief. While commonly administered through various routes, there is a research gap concerning the comparative efficacy of intrathecal (IT) and intravenous (IV) MgSO4 administration. This narrative review aims to provide a comparison between IT and IV administration of MgSO4 particularly following orthopedic procedures, where pain management is paramount. A comprehensive literature search was conducted across several electronic databases, trial registries, and gray literature from inception to 2023. Inclusion criteria encompassed studies investigating the effects of perioperative IT administration of magnesium compared to perioperative IV administration of MgSO4 in patients undergoing surgery, with no language restrictions. Our search identified 4326 articles, of which 9 randomized controlled trials met our inclusion criteria. We summarized these selected articles. Four studies discussed IT magnesium sulfate (MgSO4) administration, 2 focused on IT administration in orthopedic surgeries, and 3 explored both IV and IT administration of MgSO4 in orthopedic surgery. IT MgSO4 shows promise in postoperative pain management, delaying block onset and extending duration. Personalized administration choice, considering patient factors and surgery type, is crucial. Further research is needed to refine strategies for better patient outcomes, particularly following orthopedic surgeries.
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  • 文章类型: Journal Article
    目的:建立硫酸镁(MgSO4)在先兆子痫(PE)妇女中的群体药代动力学(PPK)。并确定在中国PE中影响镁药代动力学的关键协变量。
    方法:在2021年4月至2023年4月的这项前瞻性研究中,招募了使用PE处方MgSO4的孕妇。在管理的第一天,患者的负荷剂量为5g,同时给予10g硫酸镁作为维持剂量.第二天,只有维持剂量是给药,在第2天10g维持剂量后0、4、5和12h采集母体血液样本。Phoenix软件用于估计MgSO4的PPK参数,例如清除率(CL)和分布体积(V),并用患者人口统计来建模PPK模型,临床,和实验室协变量。
    结果:共收集了来自51名PE和PPK患者的199份血液样本。MgSO4的PPK与单室模型一致。基础模型充分描述了镁给药后母体血清镁浓度。总体参数估计如下:CL为2.98L/h,V为25.07L。模型预测随协变量(BMI,肌酐清除率,和呋塞米)。呋塞米在统计学上影响V.肌酐清除率,BMI和呋塞米共同影响CL。蒙特卡洛模拟结果表明,需要每天施用负荷剂量与维持剂量相结合以达到治疗性血镁浓度。对于非呋塞米组,最佳给药方案是5g负荷剂量和10g维持剂量的MgSO4.对于呋塞米组,最佳给药方案是2.5g负荷剂量和10g维持剂量的MgSO4.
    结论:在中国先兆子痫人群中成功建立并评估了PPK镁模型,并通过蒙特卡罗模拟完成了MgSO4的剂量优化。
    OBJECTIVE: To establish the population pharmacokinetics (PPK) of magnesium sulfate (MgSO4)in women with preeclampsia (PE), and to determine the key covariates having an effect in magnesium pharmacokinetics in Chinese PE.
    METHODS: Pregnant women with PE prescribed MgSO4 were enrolled in this prospective study from April 2021 to April 2023. On the initial day of administration, the patients were administered a loading dose of 5 g in conjunction with 10 g of magnesium sulfate as a maintenance dose. On the second day, only the maintenance dose was administration, and maternal blood samples were taken at 0, 4, 5, and 12 h after the second day\'s 10 g maintenance dose. The software Phoenix was used to estimate PPK parameters of MgSO4, such as clearance (CL) and volume of distribution (V), and to model PPK models with patient demographic, clinical, and laboratory covariates.
    RESULTS: A total of 199 blood samples were collected from 51 women with PE and PPK profiles were analyzed. The PPK of MgSO4 is consistent with to a one-compartment model. The base model adequately described the maternal serum magnesium concentrations after magnesium administration. The population parameter estimates were as follows: CL was 2.98 L/h, V was 25.07 L. The model predictions changed significantly with covariates (BMI, creatinine clearance, and furosemide). Furosemide statistically influences V. The creatinine clearance, BMI and furosemide jointly affects CL. Monte Carlo simulation results showed that a loading dose combined with a maintenance dose would need to be administered daily to achieve the therapeutic blood magnesium concentrations. For the non-furosemide group, the optimal dosing regimen was a 5 g loading dose combined with a 10 g maintenance dose of MgSO4. For the furosemide group, the optimal dosing regimen was a 2.5 g loading dose combined with a 10 g maintenance dose of MgSO4.
    CONCLUSIONS: The magnesium PPK model was successfully developed and evaluated in Chinese preeclampsia population, and the dose optimization of MgSO4 was completed through Monte Carlo simulation.
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  • 文章类型: Journal Article
    背景:在低资源设置中,用于先兆子痫的硫酸镁(MgSO4)主要通过注射入臀肌4小时,持续24小时。反复注射非常痛苦,可能导致感染,脓肿形成,降低合规性。
    目的:确定Springfusor®泵在先兆子痫和子痫中施用硫酸镁的可接受性。
    方法:随机开放标签临床试验。
    方法:本研究在Kawempe国家转诊医院进行。符合条件的女性收缩压≥140mmHg和/或舒张压>90mmHg,蛋白尿≥+1,以及医生决定开始使用MgSO4。496名参与者被随机分配到Springfusor®泵组(n=248)或对照(标准护理)(n=248)使用MgSO4。干预组使用Springfusor®进行负荷剂量(在20分钟内静脉内4gm50%MgSO4)和维持治疗(每小时静脉内1gm50%MgSO4,持续24小时)。护理标准(SOC)组在15-20分钟内接受了4gm的20%MgSO4IV的负荷剂量,然后肌内注射10gm50%MgSO4(每个臀部5gm),每4小时IM给予5gm50%MgSO4的维持剂量,持续24小时。根据医院指南,两组均接受先兆子痫/子痫的其余护理。使用Likert量表评估给药方法的可接受性(1-5;1和2:可接受,3-5:不可接受)。使用视觉模拟量表1-7评估在MgSO4施用部位的疼痛(1个最小疼痛和7个最差疼痛)。比较采用卡方检验进行评估,MannWhitney-Wilcoxon检验,和学生t检验。
    结果:干预臂;比标准护理臂更可接受,(95.3%vs70.3%;p<0.001),疼痛评分中位数较低,(2(CI:2-2),vs4(CI:4-5)p<0.001),副作用少。两组产妇死亡率相当(干预组0.8%,IM组1.2%)。
    背景:试用编号PACTR201712002887266(https://pactr.Samrc.AC.za/)。
    BACKGROUND: In low-resource settings, magnesium sulphate (MgSO4) for preeclampsia is administered majorly through an injection into the gluteal muscles 4-hourly for 24 hours. The repeated injections are very painful and may lead to infection, abscess formation, and reduced compliance.
    OBJECTIVE: To determine the acceptability of Springfusor® pump for the administration of Magnesium Sulphate in preeclampsia and eclampsia.
    METHODS: Randomized Open Label Clinical Trial.
    METHODS: The study was conducted at Kawempe National Referral Hospital. Eligible women had a systolic blood pressure of ≥140mmHg and or diastolic blood pressure >90mmHg, proteinuria ≥+1, and the physician\'s decision to start on MgSO4. Four-hundred-ninety-six participants were randomized to a Springfusor® pump group (n = 248) or control (standard of care) (n = 248) administration of MgSO4. Intervention group had a loading dose (4gm of 50% MgSO4 intravenously over 20 minutes) and maintenance therapy (1gm of 50% MgSO4 intravenously per hour for 24 hours) administered using the Springfusor®. The standard of care (SOC) group received a loading dose of 4gm of 20% MgSO4 IV over 15-20 minutes, followed by 10gm of 50% MgSO4 intramuscular (5gm in each buttock) and a maintenance dose of 5gm of 50% MgSO4 was administered IM every 4 hours for 24 hours. Both arms received the rest of the care for preeclampsia/eclampsia as per the hospital guidelines. Acceptability of the method of administration was assessed using a Likert scale (1-5; 1 and 2: acceptable and 3-5: unacceptable). Pain at the site of MgSO4 administration was assessed using a Visual Analogue Scale 1-7, (1 minimal pain and 7 worst pain). Comparisons were assessed with the Chi-square test, Mann Whitney-Wilcoxon test, and Students\' t-test.
    RESULTS: Intervention arm; was more acceptable than the standard of care arm, (95.3% vs70.3%; p<0.001), had a lower median pain score, (2(CI: 2-2), vs 4(CI: 4-5) p<0.001), and fewer side effects. Maternal mortality was comparable between groups (0.8% in the intervention arm vs 1.2% in the IM arm).
    BACKGROUND: Trial No PACTR201712002887266 (https://pactr.samrc.ac.za/).
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