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Preclinical Assessment of Tissue Effects by Gastrointestinal Endoscope Tip Temperature 胃肠道内窥镜尖端温度对组织效应的临床前评估
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100693
Luise Jäger MSc , Enrique Morales-Orcajo PhD , Anna Gager Mag. med. vet. , Anke Bader (Dr) , Anja Dillinger Dipl.-Ing. , Andreas Blutke (Prof Dr)

Background

Endoscope tips are heated by their electrical and illuminating components. During the procedure, they might get in close or even direct contact with intestinal tissues.

Objective

To assess endoscope tip and tissue temperature as well as histopathologic changes of gastrointestinal (GI) tissues when exposed to the heated tip of GI endoscopes.

Methods

The endoscope tip temperatures of four GI endoscopes were measured for 30 minutes in a temperature-controlled chamber. The temperature of ex vivo porcine GI tissues was measured for 5-, 15-, and 120-minute exposure to endoscope tips within a climate chamber to control environmental factors (simulation of fever as worst-case). Exposed tissues were histopathologically examined afterward. Control samples included untreated mucosa, tissue samples exposed to endoscope tips for 120 minutes, as well as tissue samples thermally coagulated with a bipolar high-frequency probe.

Results

Actual endoscope tip temperatures of 59 to 86°C, dependent on the endoscope type, were measured. After 10 to 15 minutes, the maximum temperatures were reached. Maximum tissue temperatures of 44 to 46°C for 5 and 15 minutes, as well as up to 50°C for 120 minutes, were recorded dependent on tissue and endoscope type. No direct heat-induced histopathologic tissue alterations were observed in the 5- and 15-minute samples.

Conclusions

Both clinically relevant and a worst-case control were tested. Even though elevated temperatures were recorded, no heat-related tissue alterations were detected. This overall supports the safety profile of GI endoscopy; however, the study findings are limited by the ex vivo setting (no metabolic tissue alterations accessible, no blood flow) and small sample number.

背景内窥镜尖端由其电气和照明组件加热。在手术过程中,它们可能会与肠道组织密切接触,甚至直接接触。目的评价胃肠道(GI)内窥镜尖端受热后的组织温度和组织病理学变化。方法在温度控制室中对四个胃肠道内窥镜的内窥镜尖端温度进行30分钟的测量。测量离体猪胃肠道组织在气候室内暴露于内窥镜尖端5分钟、15分钟和120分钟的温度,以控制环境因素(最坏情况下模拟发烧)。随后对暴露的组织进行组织病理学检查。对照样品包括未经处理的粘膜、暴露于内窥镜尖端120分钟的组织样品,以及用双极高频探针热凝固的组织样品。结果根据内窥镜类型,测量到实际内窥镜尖端温度为59至86°C。10至15分钟后,达到最高温度。根据组织和内窥镜类型,记录了5分钟和15分钟内44至46°C的最高组织温度,以及120分钟内最高50°C的组织温度。在5分钟和15分钟的样本中没有观察到直接热诱导的组织病理学组织改变。结论测试了临床相关性和最坏情况对照。即使记录到温度升高,也没有检测到与热相关的组织变化。这总体上支持胃肠道内窥镜的安全性;然而,研究结果受到离体环境(无代谢组织改变,无血流)和少量样本的限制。
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引用次数: 0
A Review of the Categorizations of Mild, Moderate, and Severe Bacterial Keratitis Ulcers and Day-1 Treatment Regimen When Using the Topical Fluoroquinolones 0.3% Ciprofloxacin and 0.3% Ofloxacin 轻度、中度和重度细菌性角膜炎溃疡的分类及局部使用氟喹诺酮类药物0.3%环丙沙星和0.3%氧氟沙星第1天治疗方案的综述
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100729
John Graham Pearce PhD , Ozge Sarac MD , Ted Maddess PhD

Background

There are published suggestions that bacterial keratitis (BK) can be classified as mild, moderate, or severe and that the day-1 antibiotic drop regimen may differ for each category using the topical second-generation fluoroquinolones 0.3% ciprofloxacin and 0.3% ofloxacin (2FQ). The classification criteria are not consistently defined and the suggested regimens are often unreferenced and so here, the evidence base for applying such regimens in clinical practice is examined.

Objective

To examine the evidence base regarding the categorization criteria used for BK and determine whether any evidence exists to support suggestions that different day-1 treatment regimen using the 2FQ may be applied based on any assigned categorization.

Methods

The literature on BK treatment was reviewed, as were the clinical studies involving the commercially available 2FQ. All statements pertaining to classification and treatment paradigms involving BK were then collated and reviewed, as were the methodologies employed in the 2FQ clinical studies.

Results

There have been no clinical trials using the 2FQ, or indeed any other topical antibiotics, which have used different day-1 drop regimen depending on the size, depth, and location of the ulcer or for ulcers classified as mild, moderate, or severe. Thus, there is no evidence to support the suggestion that a lower number of drops on day 1 is as effective as a higher number on categorized BK ulcers.

Conclusions

No standardized method of categorizing BK was found, and there is no evidence to support the contention that mild, moderate, or smaller BK ulcers should be treated any differently to larger or severe ulcers on day 1. The manufacturers of 2FQ do not supply different treatment regimens for different ulcer sizes and severity categories. When using the 2FQ, all BK ulcers should be treated equally in line with the manufacturers’ recommended day-1 treatment regimen.

已有研究表明细菌性角膜炎(BK)可分为轻度、中度或重度,并且第1天的抗生素滴药方案可能因不同类别而不同,局部使用第二代氟喹诺酮类药物0.3%环丙沙星和0.3%氧氟沙星(2FQ)。分类标准没有一致的定义,建议的方案往往没有参考,因此在这里,在临床实践中应用这些方案的证据基础进行了检查。目的检查BK分类标准的证据基础,确定是否有证据支持根据任何指定的分类采用不同的第1天治疗方案使用2FQ。方法回顾有关BK治疗的文献,以及市售2FQ的临床研究。所有涉及BK的分类和治疗范例的陈述,以及在2FQ临床研究中使用的方法,随后被整理和审查。结果:目前尚无临床试验使用2FQ或任何其他局部抗生素,根据溃疡的大小、深度和位置或轻度、中度或重度溃疡使用不同的第1天滴药方案。因此,没有证据支持这样的建议,即第1天较少的滴剂数量与较多的滴剂数量对分类BK溃疡同样有效。结论:没有发现标准化的BK分类方法,也没有证据支持轻度、中度或较小的BK溃疡在第1天应与较大或严重溃疡区别对待的观点。2FQ的制造商不针对不同的溃疡大小和严重程度类别提供不同的治疗方案。使用2FQ时,所有BK溃疡应按照制造商推荐的第1天治疗方案进行平等治疗。
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引用次数: 0
Editorial: Publishing in 2023 and Beyond 社论:2023年及以后的出版
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100706
Catherine M. Sherwin PhD
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引用次数: 0
Hemoglobin and End-Organ Damage in Individuals with Sickle Cell Disease 镰状细胞病患者的血红蛋白和终末器官损伤
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100696
William B. Ershler MD , Laura M. De Castro MD, MHSc , Zahra Pakbaz MD , Aaron Moynahan MA , Derek Weycker PhD , Thomas E. Delea MSIA , Irene Agodoa MD , Ze Cong PhD

Background

Sickle cell disease (SCD) is an inherited, chronic, multifaceted blood disorder. Patients with SCD develop anemia, which has been associated with end-organ damage (EOD).

Objectives

This retrospective, observational, repeated-measures study systematically characterizes the relationship between hemoglobin (Hb) level and EOD in adolescent and adult patients with SCD.

Methods

The study population comprised patients with SCD aged ≥12 years with available Hb data from a US provider-centric health care database. For each patient, each Hb value over time was included as a separate observation. Study outcomes—the onset of any new EOD, including chronic kidney disease, pulmonary hypertension, stroke, and leg ulcer—were ascertained during the 1-year period after each Hb assessment. The association between Hb levels and risk of new EOD was estimated using multivariable generalized estimating equations.

Results

A total of 16,043 unique patients with SCD contributed 44,913 observations. Adjusted odds of any EOD during the 1-year follow-up were significantly lower with higher Hb level. Risk reductions with higher Hb levels for chronic kidney disease, pulmonary hypertension, and leg ulcer were comparable. The risk of new EOD was significantly lower among adolescent and adult patients with higher Hb levels.

Conclusions

In patients with SCD, higher Hb levels are associated with a reduced risk of developing EOD. Therapeutic strategies that result in higher Hb levels may offer clinical and economic value for patients with SCD. (Curr Ther Res Clin Exp. 2023; 84:XXX–XXX)

镰状细胞病是一种遗传性、慢性、多方面的血液病。SCD患者会出现贫血,这与末端器官损伤(EOD)有关,重复测量研究系统地描述了青少年和成年SCD患者的血红蛋白(Hb)水平与EOD之间的关系。方法研究人群包括年龄≥12岁的SCD患者,其Hb数据来自美国以提供者为中心的医疗保健数据库。对于每个患者,随时间变化的每个Hb值都作为单独的观察结果。研究结果——任何新的EOD的发作,包括慢性肾脏疾病、肺动脉高压、中风和腿部溃疡——都是在每次Hb评估后的一年内确定的。使用多变量广义估计方程估计Hb水平与新EOD风险之间的相关性。结果16043例SCD患者共进行了44913次观察。Hb水平越高,1年随访期间任何EOD的调整后几率越低。Hb水平升高对慢性肾脏疾病、肺动脉高压和腿部溃疡的风险降低具有可比性。Hb水平较高的青少年和成年患者发生新EOD的风险明显较低。结论SCD患者血清Hb水平越高,发生EOD的风险越低。导致Hb水平升高的治疗策略可能为SCD患者提供临床和经济价值。(Curr Ther Res Clin Exp.2023;84:XXX–XXX)
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引用次数: 0
Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial 强化大蒜提取物口服胶囊辅助治疗2019冠状病毒病住院患者的有效性:一项三盲随机对照临床试验
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100699
Mohammad Reza Taghavi MD , Taraneh Tavanaei Tamanaei MD , Mohammad Bagher Oghazian PharmD, BCPS , Erfan Tavana MD , Samaneh Mollazadeh PhD , Parastoo Niloofar MSc , Sahar Oghazian MD , Amin Hoseinzadeh BSc , Amirmohammad Hesari BSc , Mohammad Ansari Mohseni PharmD , Sina Rezaei PharmD , Mahdi Haresabadi MSc, PhD

Background

Herbal medicines have been extensively used to treat coronavirus disease 2019 (COVID-19). Garlic, known to exert antiviral and anti-inflammatory effects, can be coadministered with standard treatments to combat COVID-19.

Objectives

The aim of the study was to evaluate the efficacy and safety profile of Gallecina oral capsules (Samisaz Pharmaceutical Company, Mashhad, Iran), a fortified garlic extract, as adjunctive therapy to improve the clinical status and symptoms in noncritically ill patients hospitalized for COVID-19.

Methods

This triple-blind randomized, placebo-controlled clinical trial was conducted on noncritically ill patients with COVID-19 hospitalized in the nonintensive care wards of Imam Hassan Hospital. Patients received remdesivir plus 90 mg Gallecina capsule or a placebo every 8 hours for 5 days or until discharge. The clinical status, respiratory symptoms, and laboratory parameters were recorded during the study period.

Results

Patients were enrolled between April 24 and July 18, 2021. Data from 72 patients in the Gallecina group and 69 patients in the placebo group were analyzed. Oxygen saturation, C-reactive protein levels, and the distribution of respiratory distress and cough were similar between groups on the day of discharge. Although body temperature was significantly lower in the Gallecina group than that in the placebo group on the day of discharge (P = 0.04), it was within the normal range for both groups. The proportion of patients requiring supplemental oxygen for at least 1 day during the study was significantly reduced in the Gallecina group on days 3 and 4 and the day of discharge (P < 0.05). Gastrointestinal complaints were more prevalent in the Gallecina group than in the placebo group but the difference was not statistically significant (P = 0.12).

Conclusions

There was no significant effect on the primary outcome of clinical status on study day 6. Although the proportion of Gallecina-treated patients who needed supplemental oxygen significantly decreased on days 3 and 4 and the day of discharge, there was no significant difference between the groups on other days. The possible beneficial effects on oxygen requirements in noncritically ill COVID-19 patients may warrant further investigation. (Curr Ther Res Clin Exp. 2023; 84:XXX–XXX). Clinical trial registration: IRCT20201111049347N1.

背景草药已被广泛用于治疗2019冠状病毒病(新冠肺炎)。众所周知,大蒜具有抗病毒和抗炎作用,可以与标准治疗方法联合使用以对抗COVID-19。目的本研究的目的是评估Gallecina口服胶囊(Samisaz Pharmaceutical Company,Mashhad,Iran)的疗效和安全性,方法对伊玛目哈桑医院非重症监护病房住院的新冠肺炎非危重症患者进行三盲随机、安慰剂对照临床试验。患者每8小时接受一次瑞德西韦加90 mg加列西纳胶囊或安慰剂治疗,持续5天或直至出院。在研究期间记录临床状态、呼吸道症状和实验室参数。结果患者入选时间为2021年4月24日至7月18日。对Gallecina组72名患者和安慰剂组69名患者的数据进行了分析。出院当天,各组之间的血氧饱和度、C反应蛋白水平以及呼吸窘迫和咳嗽的分布相似。尽管出院当天Gallecina组的体温明显低于安慰剂组(P = 0.04)均在正常范围内。Gallecina组在研究期间需要补充氧气至少1天的患者比例在第3、4天和出院当天显著降低(P<;0.05) = 0.12)。结论研究第6天对临床状态的主要结果没有显著影响。尽管Gallecina治疗的需要补充氧气的患者比例在第3天和第4天以及出院当天显著下降,但在其他日子,两组之间没有显著差异。新冠肺炎非危重患者对氧气需求可能产生的有益影响可能需要进一步调查。(Curr Ther Res Clin Exp.2023;84:XXX–XXX)。临床试验注册号:IRCT2020101111049347N1。
{"title":"Effectiveness of Fortified Garlic Extract Oral Capsules as Adjuvant Therapy in Hospitalized Patients with Coronavirus Disease 2019: A Triple-Blind Randomized Controlled Clinical Trial","authors":"Mohammad Reza Taghavi MD ,&nbsp;Taraneh Tavanaei Tamanaei MD ,&nbsp;Mohammad Bagher Oghazian PharmD, BCPS ,&nbsp;Erfan Tavana MD ,&nbsp;Samaneh Mollazadeh PhD ,&nbsp;Parastoo Niloofar MSc ,&nbsp;Sahar Oghazian MD ,&nbsp;Amin Hoseinzadeh BSc ,&nbsp;Amirmohammad Hesari BSc ,&nbsp;Mohammad Ansari Mohseni PharmD ,&nbsp;Sina Rezaei PharmD ,&nbsp;Mahdi Haresabadi MSc, PhD","doi":"10.1016/j.curtheres.2023.100699","DOIUrl":"10.1016/j.curtheres.2023.100699","url":null,"abstract":"<div><h3>Background</h3><p>Herbal medicines have been extensively used to treat coronavirus disease 2019 (COVID-19). Garlic, known to exert antiviral and anti-inflammatory effects, can be coadministered with standard treatments to combat COVID-19.</p></div><div><h3>Objectives</h3><p>The aim of the study was to evaluate the efficacy and safety profile of Gallecina oral capsules (Samisaz Pharmaceutical Company, Mashhad, Iran), a fortified garlic extract, as adjunctive therapy to improve the clinical status and symptoms in noncritically ill patients hospitalized for COVID-19.</p></div><div><h3>Methods</h3><p>This triple-blind randomized, placebo-controlled clinical trial was conducted on noncritically ill patients with COVID-19 hospitalized in the nonintensive care wards of Imam Hassan Hospital. Patients received remdesivir plus 90 mg Gallecina capsule or a placebo every 8 hours for 5 days or until discharge. The clinical status, respiratory symptoms, and laboratory parameters were recorded during the study period.</p></div><div><h3>Results</h3><p>Patients were enrolled between April 24 and July 18, 2021. Data from 72 patients in the Gallecina group and 69 patients in the placebo group were analyzed. Oxygen saturation, C-reactive protein levels, and the distribution of respiratory distress and cough were similar between groups on the day of discharge. Although body temperature was significantly lower in the Gallecina group than that in the placebo group on the day of discharge (<em>P</em> = 0.04), it was within the normal range for both groups. The proportion of patients requiring supplemental oxygen for at least 1 day during the study was significantly reduced in the Gallecina group on days 3 and 4 and the day of discharge (<em>P</em> &lt; 0.05). Gastrointestinal complaints were more prevalent in the Gallecina group than in the placebo group but the difference was not statistically significant (<em>P</em> = 0.12).</p></div><div><h3>Conclusions</h3><p>There was no significant effect on the primary outcome of clinical status on study day 6. Although the proportion of Gallecina-treated patients who needed supplemental oxygen significantly decreased on days 3 and 4 and the day of discharge, there was no significant difference between the groups on other days. The possible beneficial effects on oxygen requirements in noncritically ill COVID-19 patients may warrant further investigation. (<em>Curr Ther Res Clin Exp</em>. 2023; 84:XXX–XXX). Clinical trial registration: IRCT20201111049347N1.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"98 ","pages":"Article 100699"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10011030/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9363553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Treatment of Chronic Constipation using Elobixibat in a Real-World Setting: A Retrospective Cohort Study using an Electronic Medical Records Database in Japan 在现实世界中使用依洛比昔巴治疗慢性便秘:一项使用日本电子病历数据库的回顾性队列研究
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100724
Hisanori Masaki MS , Koji Shimamoto MS , Shoichiro Inokuchi MD, PhD , Sonoko Ishizaki MS

Background

Chronic constipation is a common condition affecting people of all ages; therefore, the socioeconomic burden of chronic constipation is nonnegligible. Elobixibat (ELO), an ileal bail acid transport inhibitor, was launched in Japan in 2018. However, evidence of its use in diverse populations is limited.

Objectives

This study aimed to evaluate the prescription of ELO, risk factors associated with ELO discontinuation, and the continuation of stimulants or saline laxatives during ELO treatment in a real-world setting using an extensive electronic medical records database that primarily includes data from acute-care hospitals.

Methods

Data of patients prescribed for ELO from April 1, 2018, to March 31, 2022, were extracted from the database. The discontinuation of ELO and stimulant or saline laxatives during ELO treatment was evaluated using the Kaplan-Meier method. The Cox proportional hazards model evaluated risk factors associated with laxative discontinuation.

Results

In total, 11,062 patients were evaluated. The rate of ELO discontinuation within 360 days of initiation was 78.7%. Hospitalized at the ELO initiation, stage 5 chronic kidney disease, and diagnosis of constipation by departments of obstetrics and gynecology or by departments of malignant neoplasm were identified as risk factors for discontinuation. Diagnosis of constipation, diabetes mellitus, Parkinson's disease, and previous laxative treatment was associated with a lower risk of ELO discontinuation. The prescription rate of stimulants and saline laxatives markedly decreased after ELO initiation; furthermore, nearly half of patients who were continuously prescribed ELO discontinued these laxatives within 360 days.

Conclusions

The discontinuation of ELO was associated with various factors and using ELO may be beneficial in the withdrawal of concurrent stimulants and saline laxatives. These findings may help effectively manage chronic constipation.

背景:慢性便秘是一种影响所有年龄段人群的常见疾病;因此,慢性便秘的社会经济负担是不可忽视的。Elobixibat (ELO)是一种回肠bail酸转运抑制剂,于2018年在日本上市。然而,它在不同人群中使用的证据有限。本研究旨在评估ELO的处方、与ELO停药相关的风险因素,以及在ELO治疗期间继续使用兴奋剂或生理盐水泻药的情况,该研究使用了一个广泛的电子病历数据库,主要包括来自急诊医院的数据。方法从数据库中提取2018年4月1日至2022年3月31日ELO处方患者的数据。使用Kaplan-Meier法评估ELO治疗期间ELO和兴奋剂或生理盐水泻药的停药情况。Cox比例风险模型评估了与停药相关的危险因素。结果共评估11,062例患者。起始治疗360天内ELO停药率为78.7%。ELO开始时住院、5期慢性肾脏疾病、妇产科或恶性肿瘤部门诊断为便秘被确定为停药的危险因素。诊断为便秘、糖尿病、帕金森病和既往泻药治疗的患者,其ELO停药的风险较低。ELO开始后,兴奋剂和生理盐水泻药的处方率明显降低;此外,近一半持续服用ELO的患者在360天内停用了这些泻药。结论ELO的停药与多种因素有关,使用ELO可能有利于同时停用兴奋剂和生理盐水泻药。这些发现可能有助于有效地控制慢性便秘。
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引用次数: 0
A Combination of Gamma-Aminobutyric Acid, Glutamic Acid, Calcium, Thiamine, Pyridoxine, and Cyanocobalamin vs Ginger Extract in the Management of Chronic Motion Sickness: A Clinical Evaluation γ -氨基丁酸、谷氨酸、钙、硫胺素、吡哆醇和氰钴胺与生姜提取物联合治疗慢性运动病的临床评价
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100719
Carlos P. Nunes MD , Claudio Rodrigues MD , Mendel Suchmacher MD , Claudia Regina Esteves MD , Karin Gonçalves PhD , Hélio Rzetelna MD , Rafael V. Rodrigues MD , Luciana Regina de Vasconcelos MD , Spyros G.E. Mezitis MD, PhD , Heros Rabelo MSc , Renato Kaufmann MD, PhD , Fernanda Schwarz MChem , Henrique Goldberg (In Memoriam) MD , Aline Sintoveter MD , Mauro Geller MD, PhD

Background

Motion sickness (kinetosis) is a common and temporarily incapacitant ailment, manageable with behavioral as well as pharmacological measures.

Objective

To assess the effectiveness and safety of a combination of gamma-aminobutyric acid, glutamic acid, calcium, thiamine, pyridoxine, and cyanocobalamin (Group A) (n = 170) and extract of Zingiber officinale (ginger) (Group B) (n = 165) in the management of chronic complaints consistent with motion sickness.

Methods

Both groups were tested according to the following end points, under self-paired as well as comparative study designs: reduction of ≥20 score points in the total motion sickness assessment questionnaire (MSAQ) score, percentage of patients presenting a reduction of the total MSAQ score, absolute MSAQ score reduction, physician's assessment scores, final overall assessment of study medication, and willingness to continue treatment. Safety was also evaluated.

Results

There was a statistically significant better performance under both study designs for Group A (P = 0.05 using different statistical tests) in all end points. Both regimens were safe, with different neurological and gastrointestinal tolerability outcomes.

Conclusions

Group A and Group B regimens were effective and safe in the management of chronic complaints consistent with motion sickness and the Group A regimen was more effective than Group B.

运动病是一种常见的暂时性失能性疾病,可通过行为和药物措施加以控制。目的评价γ -氨基丁酸、谷氨酸、钙、硫胺素、吡哆醇和氰钴胺素(a组)(n = 170)和姜提取物(B组)(n = 165)联合治疗运动病慢性主症的有效性和安全性。方法两组均采用自配对和比较研究设计,根据以下终点进行测试:总晕动病评估问卷(MSAQ)评分降低≥20分、总MSAQ评分降低的患者百分比、绝对MSAQ评分降低、医生评估评分、最终研究药物总体评估和继续治疗的意愿。安全性也进行了评估。结果两种研究设计下,a组在各终点的疗效均有统计学意义上的提高(P = 0.05,采用不同的统计学检验)。两种方案都是安全的,只是神经和胃肠道耐受性结果不同。结论A组和B组治疗运动病慢性主诉有效、安全,且A组治疗效果优于B组。
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引用次数: 0
Combination of Caffeic Acid Phenethyl Ester and Crocin Realign Potential Molecular Markers in U87-MG Glioma Cells 咖啡酸苯乙酯和藏红花素联合重组U87-MG胶质瘤细胞的潜在分子标记
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100695
Ashaq Hussain Mir PhD , Mir Khurshid Iqbal PhD , Mujeeb Zafar Banday PhD , Henah Mehraj Balkhi PhD , Ehtishamul Haq PhD

Background

Glial tumors are the most common primary malignant central nervous system tumors. They are hard to treat, not only because of the deregulation in multiple pathways but also because they are not contained in a well-defined mass with clear borders. The use of a single therapeutic agent to target gliomas has yielded unsatisfactory results.

Objective

A combination of molecules targeting multiple pathways may prove to be a better alternative.

Methods

The effect of caffeic acid phenethyl ester and crocin on the proliferation and death of U87-MG cells over a concentration range was analyzed using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide and lactate dehydrogenase assays. A colony formation assay was used to measure the effect of caffeic acid phenethyl ester and crocin on contact inhibition and anchorage independence ability of U87-MG cells. Furthermore, apoptosis in U87-MG cells was analyzed by propidium iodide assay. Real-time polymerase chain reaction and Western blotting were performed to determine the expression level of p53, epidermal growth factor receptor, and proliferating cell nuclear antigen.

Results

Caffeic acid phenethyl ester and crocin when used in combination present an anticancer potential for glioma. These molecules, in combination, inhibit proliferation and induce apoptosis in U87-MG glioma cells. Our results provide evidence that combination treatment realigns the expression paradigm of p53, epidermal growth factor receptor, and proliferating cell nuclear antigen in cotreated U87-MG cells.

Conclusions

The combination of caffeic acid phenethyl ester and crocin led to inhibition in glioma cell proliferation and might prove to be an effective adjunct to the therapies in vogue.

背景胶质瘤是最常见的原发性中枢神经系统恶性肿瘤。它们很难治疗,不仅因为多种途径的放松管制,还因为它们没有被控制在一个有明确边界的明确群体中。使用单一的治疗剂靶向胶质瘤的结果并不令人满意。靶向多种途径的分子组合可能被证明是一种更好的选择。方法采用3-(4,5-二甲基噻唑-2-基)-2,5-二苯基溴化四氮唑和乳酸脱氢酶测定法,分析咖啡酸苯乙酯和番红花苷在不同浓度范围内对U87-MG细胞增殖和死亡的影响。采用集落形成法测定咖啡酸苯乙酯和番红花苷对U87-MG细胞接触抑制和锚定独立能力的影响。碘化丙啶法检测U87-MG细胞凋亡。采用实时聚合酶链式反应和蛋白质印迹法测定p53、表皮生长因子受体和增殖细胞核抗原的表达水平。结果咖啡酸苯乙酯和番红花苷联合应用对神经胶质瘤具有抗癌潜力。这些分子结合在一起,抑制U87-MG神经胶质瘤细胞的增殖并诱导细胞凋亡。我们的结果提供了证据,证明联合治疗重新调整了联合治疗的U87-MG细胞中p53、表皮生长因子受体和增殖细胞核抗原的表达模式。结论咖啡酸苯乙酯和番红花苷联合应用可抑制胶质瘤细胞增殖,可能是目前流行的治疗方法的有效辅助手段。
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引用次数: 0
Laparoendoscopic Single-Site Technique Contrasted with Conventional Laparoscopy in Cystectomy for Benign Ovarian Cysts 腹腔镜单部位技术与常规腹腔镜在良性卵巢囊肿切除术中的比较
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100713
Xinru Jiang MM, Xin Zuo MM, Hongdi Zhu MM

Objective

To compare the laparoendoscopic single-site (LESS) technique with conventional laparoscopy in cystectomy for benign ovarian cysts.

Materials and methods

A retrospective analysis was performed at Yixing People's Hospital from April 2020 until December 2021.

Results

Thirty-seven patients using the LESS technique were compared with a control group of 45 patients who underwent a traditional laparoscopic ovarian cystectomy. There was no statistically significant difference in the perioperative hemoglobin level changes, cyst rupture rate, postoperative recovery of exhausting time, or pain score at 24 hours after surgery between the 2 groups (P > 0.05). The mean operating time was significantly longer in the LESS group than that of the control group (88.38 ± 30.57 minutes vs 59.44 ± 24.22 minutes; P = 0.001). However, the length of postoperative hospital stay was significantly shorter in the LESS group (3.70 ± 0.57 days vs 4.38 ± 0.86 days; P = 0.001). In addition, total hospitalization expenses were higher in the LESS group (14,709.78 ± 1618.63 yuan vs 12,676.73 ± 1411.78 yuan; P = .001) and the satisfaction score was also significantly higher in the LESS group (z = –2.272; P = 0.023). After a follow-up time of 12 to 24 months, no patient in either group showed wound infection, umbilical hernia, or recurrent cysts.

Conclusions

The LESS technique for benign ovarian cystectomy is safe, feasible, and equally effective compared with the multiport laparoscopic oophorocystectomy. Although it currently costs more, patients with benign ovarian cysts are highly satisfied with the LESS technique.

目的比较腹腔镜单点(LESS)技术与传统腹腔镜技术在良性卵巢囊肿切除术中的应用。材料和方法对2020年4月至2021年12月在宜兴市人民医院进行的回顾性分析。结果将37例使用LESS技术的患者与45例传统腹腔镜卵巢囊肿切除术的对照组进行比较。两组围手术期血红蛋白水平变化、囊肿破裂率、术后排气时间恢复率或术后24小时疼痛评分无统计学差异(P>0.05)。LESS组的平均手术时间明显长于对照组(88.38±30.57分钟vs 59.44±24.22分钟;P = 0.001)。然而,LESS组术后住院时间明显缩短(3.70±0.57天vs 4.38±0.86天;P = 此外,LESS组的住院总费用较高(14709.78±1618.63元vs 12676.73±1411.78元;P = .001),并且LESS组的满意度得分也显著更高(z = –2.272;P = 0.023)。随访12至24个月后,两组患者均未出现伤口感染、脐疝或复发性囊肿。结论LESS技术是一种安全、可行、有效的良性卵巢囊肿切除术。尽管目前成本更高,但良性卵巢囊肿患者对LESS技术非常满意。
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引用次数: 0
Safety and Performance of Narhinel 0.9% Sodium Chloride Monodose and Otrisal 0.74% Sodium Chloride Monodose Nasal Saline Solutions and Nasal Aspirators in Real-World Settings: Postmarket Clinical Follow-up Study Results 0.9% NaCl单剂量narhinel和0.74% NaCl单剂量otral鼻盐水喷雾剂和鼻吸入器在现实环境中的安全性和性能:上市后临床随访研究结果
IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2023-01-01 DOI: 10.1016/j.curtheres.2023.100725
Mathieu M. Albasser PhD, MSc, BSc , Edwin Sanchez MSc, BA , Mariane B. Fernandes PhD, BPharm , Nisha Patel BSc, MSc , Petr Novak MUDr, MBA , Martina Hagen PhD, MS

Background

Blocked or stuffy nose is a common and bothersome symptom of colds, particularly for young children who are unable to clear their noses on their own. Nasal saline solutions and nasal aspirators are designed to gently cleanse and remove blocking nasal secretions.

Objective

To assess the safety and performance of 2 monodose isotonic saline solutions (Narhinel 0.9% and Otrisal 0.74% sodium chloride; GSK Consumer Healthcare SARL, a Haleon company, Nyon, Switzerland) and 2 nasal aspirators with disposable hard- and soft-nozzle refills used as a standalone or combination treatment.

Methods

We conducted 2 observational, online questionnaire-based, postmarket clinical follow-up studies in Europeans who had used any of the devices ≥1 time in the past 6 months. Coprimary objectives were to confirm the safety and performance of the saline solutions (Narhinel and Otrisal, Study 1) and nasal aspirators (with hard- and soft-nozzle refills, Study 2). Safety was assessed via the proportion of patients reporting adverse events and/or device malfunctions while using the devices within the previous 6 months, and performance was assessed by satisfaction rated on a 5-point scale, with “satisfied” and “very satisfied” being the highest performance ratings.

Results

A total of 1136 (Study 1) and 1237 (Study 2) questionnaires were initiated by volunteer participants. Less than 2% of participants reported adverse events for any evaluated product in the previous 6 months. Most participants were “satisfied” or “very satisfied” with the devices for their intended use, with 78% to 91% of participants in the Narhinel arm, 73%–94% in the Otrisal arm, 71% to 95% in the soft-nozzle arm, and 71% to 80% in the hard-nozzle arm giving these ratings.

Conclusions

These data support the safety and performance of 2 monodose saline solutions (Narhinel and Otrisal) for nasal cleansing, nasal moisturization, and/or loosening nasal secretions, and of nasal aspirators (with hard- and soft-nozzle refills) for clearing a blocked nose and removing nasal secretions.

鼻塞或鼻塞是感冒的一种常见且令人烦恼的症状,特别是对于无法自己清理鼻子的幼儿。鼻盐水溶液和鼻抽吸器的设计是为了温和地清洁和清除阻塞的鼻分泌物。评估2种单剂量等渗盐水溶液(Narhinel 0.9%和Otrisal 0.74% NaCl)和2种一次性硬、软喷嘴鼻吸器单独或联合治疗的安全性和性能。我们对在过去6个月内使用任何一种器械≥1次的欧洲人进行了2项观察性、基于在线问卷的上市后临床随访研究。主要目的是确认生理盐水溶液(Narhinel和Otrisal,研究1)和鼻吸引器(硬嘴和软嘴填充,研究2)的安全性和性能。安全性通过在过去6个月内使用设备时报告不良事件和/或设备故障的受试者比例来评估,性能通过5分制的满意度来评估,“满意”和“非常满意”是最高的性能评级。共有1136份(研究1)和1237份(研究2)问卷由志愿者发起。在过去6个月内,不到2%的参与者报告了任何评估产品的不良事件。大多数参与者对设备的预期用途“满意”或“非常满意”,Narhinel组78%-91%的参与者,Otrisal组73%-94%的参与者,软喷嘴组71%-95%的参与者,硬喷嘴组71%-80%的参与者给出了这些评级。这些数据支持两种单剂量生理盐水溶液(Narhinel和Otrisal)用于鼻腔清洁、鼻腔保湿和/或放松鼻分泌物,以及用于清除鼻塞和清除鼻分泌物的鼻吸引器(带硬喷嘴和软喷嘴)的安全性和性能。
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引用次数: 0
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Current Therapeutic Research-clinical and Experimental
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