hypertonic saline

高渗盐水
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    非创伤性脑损伤包括各种病理过程和医疗条件,导致脑功能障碍和神经功能缺损,而没有直接的身体创伤。该研究旨在评估20%甘露醇和3%高渗盐水静脉给药在非创伤性脑损伤中降低颅内压的功效。
    遵循系统评价和荟萃分析指南的首选报告项目进行研究选择和数据提取。搜索是在PubMed中进行的,Embase,和Scopus数据库,包括2003年1月至2023年12月以英文发表的文章。我们的研究包括随机对照试验,比较研究,前瞻性分析,和回顾性队列研究。我们提取了患者基线特征的数据,干预细节,主要成果,和并发症。使用Jadad量表和Robvis评估工具对偏倚风险进行质量评估。
    共有14项研究纳入分析,涉及1,536名患者。七项研究报告高渗盐水对降低颅内压更有效,而三项研究发现两种干预措施的有效性相似。只有三项研究报告了不良事件。报告并发症发生率的研究范围为21%至79%。对五项研究进行了荟萃分析,显示与甘露醇和高渗盐水相关的不良事件发生率不同。
    高渗盐溶液和甘露醇均已被用作降低非创伤性脑损伤颅内压的治疗选择。虽然一些研究表明高渗盐水的优越性,其他人报告两种干预措施的有效性相似。
    ChoudhuryA,Ravikant,BairwaM,JitheshG,KumarS,20%甘露醇与3%高渗盐水在非创伤性脑损伤中降低颅内压的疗效:系统评价和荟萃分析。印度J暴击护理中心2024;28(7):686-695。
    UNASSIGNED: Nontraumatic brain injury encompasses various pathological processes and medical conditions that result in brain dysfunction and neurological impairment without direct physical trauma. The study aimed to assess the efficacy of intravenous administration of 20% mannitol and 3% hypertonic saline to reduce intracranial pressure in nontraumatic brain injury.
    UNASSIGNED: The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed for study selection and data extraction. The search was conducted in the PubMed, Embase, and Scopus databases, including articles published in English from January 2003 to December 2023. Our study included randomized controlled trials, comparative studies, prospective analyses, and retrospective cohort studies. We extracted data on baseline characteristics of patients, intervention details, major outcomes, and complications. Quality assessment was performed using the Jadad scale and the Robvis assessment tool for risk of bias.
    UNASSIGNED: A total of 14 studies involving 1,536 patients were included in the analysis. Seven studies reported hypertonic saline as more effective in reducing intracranial pressure, while three studies found similar effectiveness for both interventions. Adverse events were reported in only three studies. The studies that reported complication rates ranged from 21 to 79%. A meta-analysis was conducted on five studies, showing varying rates of adverse events associated with mannitol and hypertonic saline.
    UNASSIGNED: Both hypertonic saline solution and mannitol have been explored as treatment options for decreasing intracranial pressure in nontraumatic brain injuries. While some studies indicate the superiority of hypertonic saline, others report similar effectiveness between the two interventions.
    UNASSIGNED: Choudhury A, Ravikant, Bairwa M, Jithesh G, Kumar S, Kumar N. Efficacy of Intravenous 20% Mannitol vs 3% Hypertonic Saline in Reducing Intracranial Pressure in Nontraumatic Brain Injury: A Systematic Review and Meta-analysis. Indian J Crit Care Med 2024;28(7):686-695.
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  • 文章类型: Journal Article
    尽管诊断和治疗取得了进展,但仍有多达50%的心力衰竭(HF)患者在出院时出现充血。持续充血和利尿剂抵抗均与预后较差相关。高渗盐水和loop利尿剂的组合在不同的研究中显示了有希望的结果。然而,它尚未实现标准化使用,部分原因是氯化钠浓度的巨大异质性,利尿剂的剂量或饮食中钠的量。经典的,由于细胞外渗透压的增加,水从细胞内空间的运动被认为是主要机制。然而,氯化物缺乏被假定为血浆体积变化的主要上调调节剂,其纠正可能是其中的主要机制。这种“以氯化物为中心”的心力衰竭方法为治疗策略打开了大门,其中包括利尿剂以纠正低氯血症,以及不含氯化钠的补充。
    Up to 50% of patients admitted for heart failure (HF) have congestion at discharge despite diagnostic and therapeutic advances. Both persistent congestion and diuretic resistance are associated with worse prognosis. The combination of hypertonic saline and loop diuretic has shown promising results in different studies. However, it has not yet achieved a standardized use, partly because of the great heterogeneity in the concentration of sodium chloride, the dose of diuretic or the amount of sodium in the diet. Classically, the movement of water from the intracellular space due to an increase in extracellular osmolarity has been postulated as the main mechanism involved. However, chloride deficit is postulated as the main up-regulator of plasma volume changes, and its correction may be the main mechanism involved. This \"chloride centric\" approach to heart failure opens the door to therapeutic strategies that would include diuretics to correct hypochloremia, as well as sodium free chloride supplementation.
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  • 文章类型: Letter
    背景:严重症状性低钠血症可能危及生命,高渗盐水(HTS)可有效快速纠正血清钠。一些临床指南旨在标准化HTS的施用。然而,支持指南的证据有限,并对过度修正的可能性提出了担忧。
    目的:评估英国(UK)内分泌学家和受训者在严重症状性低钠血症中使用HTS的做法和看法。
    方法:在2023年10月24日至2023年11月30日之间,使用基于网络的多项选择问卷向内分泌学协会(UK)临床成员进行了匿名在线调查。
    结果:我们收到了133份答复,调查答复率为8.3%(60.1%的顾问,33.1%的学员,其他6.8%)。85%的受访者仅使用HTS进行推注治疗,9.8%同时使用推注和连续输注。大多数(53.2%)首选150毫升推注,其次是100毫升推注(19.8%),而5.5%的受访者使用基于体重的剂量。常用的高温超导强度为2.7%(45.1%),其次是1.8%(31.6%),而指南中推荐的3%HTS强度使用了21.8%。与准则相反,78.6%没有在第一次推注后没有等待钠结果的情况下施用第二次推注。此外,86%有使用静脉血气钠读数监测的经验。用10和8mmol/24h截止值定义的过校正目标分别为48.9%和39.9%,分别。对于明确的或预期的过度校正,75.9%首选5%葡萄糖,而40.6%有去氨加压素的经验。
    结论:在英国,HTS用于严重症状性低钠血症存在显著差异。大多数临床医生更喜欢在管理HTS时采取更谨慎的方法。这些数据提供了对现实生活护理的洞察力,并呼吁未来的研究。
    BACKGROUND: Severe symptomatic hyponatraemia is potentially life-threatening and hypertonic saline (HTS) is effective at rapidly correcting serum sodium. Several clinical guidelines have aimed to standardise the administration of HTS. However, evidence supporting the guidelines is limited, and concerns have been raised regarding the potential for overcorrection.
    OBJECTIVE: To assess the practices and perceptions surrounding HTS use in severe symptomatic hyponatraemia among United Kingdom (UK) endocrinologists and trainees.
    METHODS: An anonymous online survey was disseminated to Society for Endocrinology (UK) clinical members between 24/10/2023 and 30/11/2023 using a web-based multiple-choice questionnaire.
    RESULTS: We received 133 responses with a survey response rate of 8.3% (60.1% consultants, 33.1% trainees, 6.8% others). 85% of respondents employed bolus treatment with HTS only, with 9.8% using both bolus and continuous infusions. Most (53.2%) preferred 150 mL boluses, followed by 100 mL boluses (19.8%), while 5.5% of respondents used weight-based dosage. Commonly used HTS strengths were 2.7% (45.1%), followed by 1.8% (31.6%), while the 3% HTS strength recommended in guidelines was used by 21.8%. Contrary to guidelines, 78.6% did not administer a second bolus without waiting for the sodium result after the first bolus. Moreover, 86% have experience using venous blood gas sodium readings for monitoring. Overcorrection targets defined by 10 and 8 mmol/24 h cut-offs were used by 48.9% and 39.9%, respectively. For definite or anticipated overcorrection, 75.9% preferred 5% dextrose, while 40.6% had experience with desmopressin.
    CONCLUSIONS: Significant variation exists in HTS use for severe symptomatic hyponatraemia in the UK. Most clinicians prefer a more cautious approach in administering HTS. These data offer insight into real-life care and call for future research.
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  • 文章类型: Journal Article
    背景:雾化高渗盐水(HS)和呼气正压装置(PEP)通常用于支气管扩张患者。我们试图描述使用HS和PEP的患者的临床特征,利用大型国家数据库注册表。
    方法:本研究使用美国支气管扩张和NTM研究注册的数据。包括诊断为支气管扩张的患者。符合条件的患者被分配到四个相互排斥的组之一:仅HS,仅限PEP,HS&PEP,或没有气道清除或粘液活性剂。对整个研究人群进行描述性统计,并按四组进行分层。使用单因素方差分析和卡方检验来测试四组中连续变量的均值差异和分类变量之间的关联(分别)。
    结果:共纳入2195例患者。患有支气管扩张和咳嗽的人中,仅使用HS的患者数量多于仅使用PEP的患者数量(17.5%vs9.1%,p<0.001)。在铜绿假单胞菌中发现了类似的关联(仅22.3%HSvs仅6.5%PEP,p<0.001)。使用HS和PEP联合治疗的患者数量高于单独使用PEP治疗的患者(25.0%vs9.1%,p=0.002),那些有生产性咳嗽的人。
    结论:在支气管扩张伴咳嗽或铜绿假单胞菌的患者中,HS比单独使用PEP更常用。需要进一步分析,以比较这两种模式,并探讨影响其利用的因素。
    BACKGROUND: Nebulized Hypertonic saline (HS) and positive expiratory pressure device (PEP) are often used in patients with bronchiectasis. We sought to describe the clinical characteristics in patients using HS and PEP, utilizing a large national database registry.
    METHODS: Data from the US Bronchiectasis and NTM Research Registry were used in this study. Patients with a diagnosis of bronchiectasis were included. Eligible patients were assigned to one of four mutually exclusive groups: HS only, PEP only, HS & PEP, or no airway clearance or mucoactive agent. Descriptive statistics were computed for the overall study population and stratified by the four groups. One-way ANOVA and chi-square tests were used to test the difference in the means in continuous variables and the association between categorical variables (respectively) across the four groups.
    RESULTS: A total of 2195 patients were included. Of those with bronchiectasis and a productive cough, a greater number of patients utilized HS only vs PEP only (17.5 % vs 9.1 %, p < 0.001). Similar association was found in those with Pseudomonas aeruginosa (22.3 % HS only vs 6.5 % PEP only, p < 0.001). There was a higher number of patients who used HS and PEP therapy in combination vs PEP therapy alone (25.0 % vs 9.1 %, p = 0.002), in those with a productive cough.
    CONCLUSIONS: In patients with bronchiectasis and a productive cough or Pseudomonas aeruginosa, HS is used more often than PEP alone. There is a need for further analysis to compare these two modalities and explore the factors influencing their utilization.
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  • 文章类型: Journal Article
    用高渗剂控制脑损伤后颅内压升高是创伤性脑损伤患者的主要治疗方法之一。在这项研究中,我们比较了高渗盐水(HS)和甘露醇降低颅内压升高的效果.
    共有15项研究的637名患者纳入了我们的荟萃分析。主要结果是死亡率,在医院和ICU的住院时间,以及后续的格拉斯哥结果量表。
    甘露醇组的死亡率与HS组相比无统计学差异(RR=1.55;95%CI=[0.98,2.47],p=0.06)。HS组ICU住院时间明显缩短(MD=1.18,95%CI=[0.44,1.92],p<0.01)。就良好的神经系统结果而言,两种药物之间没有显着差异(RR=0.92,95%CI=[0.11,7.96],p=0.94)。甘露醇组的作用持续时间短于HS组(MD=-0.67,95%CI=[-1.00,-0.33],p<0.01)。
    结果表明,HS和甘露醇在降低ICP方面具有相似的作用。尽管HS与较长的持续时间和较短的ICU住院时间有关,两种药物的其他次要结局(包括死亡率和有利的神经系统结局)相似.总之,考虑到每个病人的情况,与甘露醇相比,HS可能是降低TBI患者ICP的合理选择。
    UNASSIGNED: Controlling elevated intracranial pressure following brain injury with hyperosmolar agents is one of the mainstay treatments in traumatic brain injury patients. In this study, we compared the effects of hypertonic saline (HS) and mannitol in reducing increased intracranial pressure.
    UNASSIGNED: A total of 637 patients from 15 studies were included in our meta-analysis. The primary outcomes were mortality, the length of stay in the hospital and ICU, and the Glasgow Outcome Scale at follow-up.
    UNASSIGNED: The mortality in the mannitol group was not statistically different compared to the HS group (RR = 1.55; 95% CI = [0.98, 2.47], p = 0.06). The length of stay in the ICU was significantly shorter in the HS group (MD = 1.18, 95% CI = [0.44, 1.92], p < 0.01). In terms of favorable neurological outcomes, there was no significant difference between the two agents (RR = 0.92, 95% CI = [0.11, 7.96], p = 0.94). The duration of the effect was shorter in the mannitol group than in the HS group (MD = -0.67, 95% CI = [-1.00, -0.33], p < 0.01).
    UNASSIGNED: The results showed that HS and mannitol had similar effects in reducing ICP. Although the HS was associated with a longer duration of effect and shorter ICU stay, other secondary outcomes including mortality rate and favorable neurological outcomes were similar between the two drugs. In conclusion, considering the condition of each patient individually, HS could be a reasonable option than mannitol to reduce ICP in TBI patients.
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  • 文章类型: Journal Article
    本研究旨在对等渗量的高渗盐水(HS)和甘露醇在促进择期开颅手术患者脑松弛方面的疗效和安全性进行全面评估。
    本系统综述和荟萃分析,遵循系统评价和荟萃分析指南的首选报告项目,比较等渗浓度甘露醇和HS在选择性开颅手术中的疗效和安全性。PubMed,Scopus,科克伦图书馆,ScienceDirect,使用与甘露醇相关的关键字搜索Proquest数据库,HS,开颅手术.结果通过使用Mantel-Haenszel风险比和标准平均差异的随机效应模型进行分析。P<0.05被认为是显著的。
    分析了13项随机对照试验,包括965例患者(HS组516例,甘露醇组448例)。研究质量是中等到高的,并且没有观察到显著的发表偏倚.主要结果,大脑放松,HS优于甘露醇,没有明显的异质性。与HS相比,甘露醇与尿量增加有关,无论剂量如何,具有高度异质性。HS与显著减少的液体输入有关,通过亚组分析证实,异质性较低。两种试剂之间的血清渗透压没有发现显着差异。血清钠(Na+)水平有利于HS,尽管存在相当大的异质性,但动脉血Na水平也有利于HS。HS组最大平均动脉压较高,但它表现出显著的异质性。两种药物之间的最大中心静脉压没有显着差异,具有中等异质性。
    HS在实现大脑放松方面似乎比甘露醇更有效,它可以在流体管理和Na+平衡方面提供优势。临床医生在选择高渗药物进行神经外科手术时应考虑这些发现。需要进一步的研究来解决某些结果的异质性并指导临床实践。
    UNASSIGNED: This study strives to provide a current and thorough assessment of the comparative efficacy and safety between equiosmolar quantities of hypertonic saline (HS) and mannitol in facilitating brain relaxation for patients undergoing elective craniotomies.
    UNASSIGNED: This systematic review and meta-analysis, following preferred reporting items for systematic reviews and meta-analyses guidelines, compared the efficacy and safety of equiosmolar concentrations of mannitol and HS in elective craniotomies. PubMed, Scopus, Cochrane Library, ScienceDirect, and Proquest databases were searched using keywords related to mannitol, HS, and craniotomy. Results were analyzed through a random-effects model using Mantel-Haenszel risk ratio and standard mean difference. P < 0.05 was considered significant.
    UNASSIGNED: Thirteen randomized controlled trials encompassing 965 patients (516 in the HS group and 448 in the mannitol group) were analyzed. The quality of studies was moderate-to-high, and no significant publication bias was observed. The primary outcome, brain relaxation, favored HS over mannitol without significant heterogeneity. Mannitol was associated with increased urine output compared to HS, irrespective of dose, with high heterogeneity. HS was linked to significantly reduced fluid input, confirmed by subgroup analysis with lower heterogeneity. No significant difference was found in serum osmolality between the two agents. Serum sodium (Na+) levels favored HS, whereas arterial blood Na+ levels also favored HS despite considerable heterogeneity. Maximum mean arterial pressure was higher with HS, but it displayed significant heterogeneity. Maximum central venous pressure showed no significant difference between the two agents, with moderate heterogeneity.
    UNASSIGNED: HS appears more effective than mannitol in achieving brain relaxation, and it may offer advantages in fluid management and Na+ balance. Clinicians should consider these findings when selecting hyperosmotic agents for neurosurgical procedures. Further research is needed to address heterogeneity in certain outcomes and guide clinical practice.
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  • 文章类型: Journal Article
    目的:皮下血清肿形成(SF)常见于腋臭手术后,其治疗可能具有挑战性和长期性。目前的预防方法并不一致,治疗包括反复的抽吸和排水,两者都与较高的感染风险相关.本文的目的是提出一种新颖而简单的术中高渗盐水冲洗(IHSI)技术,以腋窝腋臭皮下死腔,这可以防止术后SF,并由于分泌物减少而实现早期引流。
    方法:从2015年到2022年,我们对100例原发性腋臭患者通过生理盐水进行了腔内冲洗。通过中央腋窝折痕处大约3厘米长的切口,包含大汗腺的整个皮下组织最初在腋窝区域内用直剪刀解剖,然后,用弯曲的剪刀去除受损的大汗腺。将皮肤脱脂以变成全厚度皮瓣。任何可疑的出血点立即电手术凝固。放置负压排水管,术中通过引流管冲洗腔,在同一患者中使用20mlNaCl0.9%或10%NaCl放置10分钟。
    结果:B组术后第1天的引流量为6.54±0.36mL,明显低于A组的15.23±0.42mL(p<0.05)。B组引流时间为24h,A组短于48h。B组,4%的腋窝术后表现出显著的SF,低于与A组相关的20%的腋窝(p<0.05)。B组切口感染率为2%,明显低于A组腋窝的6%(p<0.05)。B组术后有2%的腋窝表现为皮肤边缘坏死,低于与A组相关的10%的腋窝(p<0.05)。
    结论:IHSI可增强腋臭腋臭手术后皮下夹层空间的粘连形成并降低分泌率,因此,可以早期去除排水口并防止SF,切口感染和皮肤边缘坏死。因此,减轻患者的痛苦,减少多次门诊就诊或额外手术的不便和成本节约。
    方法:本期刊要求作者为每篇文章分配一定程度的证据。对于这些循证医学评级的完整描述,请参阅目录或在线作者说明www。springer.com/00266.
    OBJECTIVE: Subcutaneous seroma formation (SF) is commonly seen after axillary bromhidrosis surgeries and its treatment can be challenging and long. Current prevention methods are not consistent, and the treatment includes repeated aspirations and drains, both are associated with higher risk for infections. The purpose of this article is to present a novel and simple technique of intraoperative hypertonic saline irrigation (IHSI) to axillary bromhidrosis subcutaneous dead space, which prevents postoperative SF and enables early drain removal due to reduced secretions.
    METHODS: From 2015 to 2022, we performed the intraoperative irrigation of the cavity through normal saline in 100 patients with primary axillary bromhidrosis. Through an incision approximately 3 cm long at the central axillary crease, the entire subcutaneous tissues containing apocrine glands were initially dissected with straight scissors within the axillary area, and then, the undermined apocrine glands were removed with curved scissors. The skin was defatted to become a full-thickness skin flap. Any suspected hemorrhagic spots were immediately coagulated electrosurgically. Negative pressure drains were placed, and intraoperative irrigation of the cavity through the drains with 20 ml of NaCl 0.9% or NaCl 10% left at site for 10 min applies different saline solutions in the same patients.
    RESULTS: The volume of drainage on the 1st postoperative day was 6.54±0.36 mL for the group B, which was significantly less than 15.23±0.42 mL for the group A (p < 0.05). The time of drain removal for the group B was 24 h, which was shorter than 48 h for the group A. In group B, 4 percent of axillae showed significant SF postoperatively, which was lower than the 20 percent of axillae associated with the group A (p < 0.05). The rate of incision infection for the group B was 2 percent, which was significantly lower than the 6 percent of axillae in the group A (p < 0.05). Two percent of axillae showed skin edge necrosis postoperatively in the group B, which was lower than the 10 percent of axillae associated with the group A (p < 0.05).
    CONCLUSIONS: IHSI enhances adhesion formation and reduces secretion rate in subcutaneous dissection space after axillary bromhidrosis surgeries, therefore enables early drain removal and prevents SF, incision infection and skin edge necrosis. As a result, reducing the pain of patients, decreasing inconveniency and cost saving of multiple outpatient visits or additional surgery.
    METHODS: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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  • 文章类型: Journal Article
    目的:渗透治疗药物通过从大脑中抽水增加血管内容量,随后由于利尿导致相对低血容量,导致全身血流动力学发生显著变化,这可能对老年人产生不利影响。我们使用经食管超声心动图研究了甘露醇(20%)和高渗盐水(3%)对老年患者进行幕上神经外科手术的左心室流出道速度-时间积分(LVOT-VTI)和心输出量的影响。
    方法:我们招募了28名年龄在65岁以上接受幕上开颅手术的患者,这些患者接受了5.35ml/kg的3%高渗盐水的等渗溶液(HS组,n=14)或5ml/kg的20%甘露醇(M组,n=14)。LVOT-VTI记录在基线,输注后15、30、45、60和90分钟,得出心输出量(CO)。我们还记录了心率,血压,流体平衡,大脑放松,血管加压药的使用,并发症和神经系统的结果。
    结果:我们发现,与HS组相比,M组45分钟和60分钟的LVOT-VTI显着降低[平均值(SD),16.76(1.81)v/s20.78(1.87),P<0.001,17.4(2.38)v/s19.16(2),P=0.044,分别]。我们还发现CO[3863.16(845.87)v/s4745.59(1209.33)ml/min,P=0.034]和收缩压(P=0.039),M组45分钟尿量高于M组(P<0.001)。所有其他参数是可比较的。
    结论:高渗盐水似乎与更好的全身血流动力学相关(LVOT-VTI,CO),同时在老年患者中提供与甘露醇等效的脑松弛。未来需要更大的研究来证实我们的初步发现。
    OBJECTIVE: Osmotherapeutic agents increase the intravascular volume by withdrawing water from the brain followed by relative hypovolemia due to diuresis leading to significant changes in systemic hemodynamics which might have adverse consequences in the elderly. We studied the effect of mannitol (20%) and hypertonic saline (HTS) (3%) on left ventricular outflow tract velocity time integral (LVOT-VTI) and cardiac output (CO) in elderly patients undergoing supratentorial neurosurgical procedures using transesophageal echocardiography.
    METHODS: We recruited 28 patients aged above 65 years undergoing supratentorial craniotomy who received equiosmolar solutions of 5.35 ml/kg of 3% HTS (group HS, n = 14) or 5 ml/kg of 20% mannitol (group M, n = 14). LVOT-VTI was recorded at baseline, 15, 30, 45, 60, and 90 minutes postinfusion and CO was derived. We also recorded heart rate, blood pressure, fluid balance, brain relaxation, vasopressor use, complications, and neurological outcome.
    RESULTS: We found a significant decrease in LVOT-VTI at 45, and 60 minutes in group M as compared to group HS [mean (standard deviation), 16.76 (1.81) vs. 20.78 (1.87), P < 0.001, 17.4 (2.38) vs. 19.16 (2), P = 0.044, respectively]. We also found a corresponding significant fall in CO [3863.16 (845.87) vs. 4745.59 (1209.33) ml/minute, P = 0.034] and systolic blood pressure (P = 0.039), at 45 minutes in group M. Urine output was higher in group M (P < 0.001). All other parameters were comparable.
    CONCLUSIONS: HTS appears to be associated with better systemic hemodynamics (LVOT-VTI, CO) while providing equivalent brain relaxation as mannitol in elderly patients. A future larger study is required to confirm our preliminary findings.
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  • 文章类型: Journal Article
    介绍和目的温和的高渗盐水是更有效地缓解症状的鼻塞相比,安慰剂或等渗盐水。最近,一个独特的装置,输送2.3%高渗海盐盐水的软雾(NasoclearPureHaleTM;ZydusHealthcareLtd.,印度)已在印度引入。该装置使用无功率手动技术以1ml/min的软雾形式释放盐水。方法这是一项回顾性研究,多中心,单臂研究,以评估通过软雾装置提供的2.3%高渗海盐盐水鼻腔冲洗在有鼻部症状的患者中的安全性和有效性。这是对从印度11名执业儿科医生的医疗记录中收集的130名患者数据的分析。结果患者的平均年龄为5.23±4.24岁;63%为男孩,37%为女孩(n=130)。随访时鼻部症状总评分(TNSS)从基线的平均降低为6.28±0.18(中位天数=7)(95%CI=5.92至6.64;p<0.0001;基线时的平均TNSS=7.75±2.01,随访时的平均TNSS=1.47±1.30)。在130名患者中,33例患者(25.3%)显示TNSS完全改善,93例(71.5%)患者的TNSS改善≥50%,4例(3.07%)患者的TNSS改善<50%。在41和74名患者中,该设备的有效性被评为优秀(改善75%-100%)和非常好(改善50%-75%),分别。62名患者和57名患者将其评为非常易于使用和易于使用,分别。119名患者(91.5%)符合设备的规定频率,110名患者(84.6%)符合设备的规定使用时间。没有严重不良事件的报告;两名患者报告了轻微的副作用-刺痛和喉咙刺激。结论:在现实世界的临床环境中,通过软雾装置输送的2.3%高渗海盐盐水鼻腔冲洗对鼻部症状的患者具有良好的耐受性和有效性。临床试验编号本研究的临床试验编号为CTRI/2022/07/043751。
    Introduction and aims Mildly hypertonic saline is more effective in relieving symptoms of nasal congestion compared to placebo or isotonic saline. Recently, a unique device, delivering a soft mist of 2.3% hypertonic sea-salt saline (Nasoclear PureHaleTM; Zydus Healthcare Ltd., India) has been introduced in India. The device uses a power-less manual technique to release the saline as a soft mist at 1 ml/min. Methods This is a retrospective, multi-centric, single-arm study to evaluate the safety and effectiveness of 2.3% hypertonic sea-salt saline nasal irrigation delivered through a soft mist device in patients with sino-nasal symptoms. This is an analysis of data of 130 patients collected from the medical records of 11 practicing pediatricians across India. Results The mean age of the patients was 5.23 ± 4.24 years; 63 % were boys and 37% were girls (n = 130). The mean reduction in total nasal symptom score (TNSS) at follow-up from baseline was 6.28 ± 0.18 (median days = 7) (95% CI = 5.92 to 6.64; p<0.0001; mean TNSS at baseline = 7.75 ± 2.01, mean TNSS at follow-up = 1.47± 1.30). Out of 130 patients, 33 patients (25.3%) showed complete improvement in TNSS, 93 patients (71.5%) had ≥ 50% improvement in TNSS while 4 patients (3.07%) showed <50% improvement in TNSS. The effectiveness of the device was rated as excellent (75%-100% improvement) and very good (50%-75% improvement) in 41 and 74 patients, respectively. It was rated as very easy to use and easy to use by 62 patients and 57 patients, respectively. One hundred nineteen patients (91.5%) were compliant with the prescribed frequency of the device and 110 patients (84.6%) were compliant with the prescribed duration of use of the device. No serious adverse events were reported; two patients reported mild side effects - stinging and irritation of the throat. Conclusions The 2.3% hypertonic sea-salt saline nasal irrigation delivered through the soft mist device was found to be well-tolerated and effective in patients with sino-nasal symptoms in real-world clinical settings. Clinical trial number The clinical trial number of this study is CTRI/2022/07/043751.
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