Pub Date : 2023-01-01DOI: 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.
{"title":"Preclinical Assessment of Tissue Effects by Gastrointestinal Endoscope Tip Temperature","authors":"Luise Jäger MSc , Enrique Morales-Orcajo PhD , Anna Gager Mag. med. vet. , Anke Bader (Dr) , Anja Dillinger Dipl.-Ing. , Andreas Blutke (Prof Dr)","doi":"10.1016/j.curtheres.2023.100693","DOIUrl":"10.1016/j.curtheres.2023.100693","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"98 ","pages":"Article 100693"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e3/c8/main.PMC9937900.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10774204","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}
Pub Date : 2023-01-01DOI: 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.
{"title":"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","authors":"John Graham Pearce PhD , Ozge Sarac MD , Ted Maddess PhD","doi":"10.1016/j.curtheres.2023.100729","DOIUrl":"https://doi.org/10.1016/j.curtheres.2023.100729","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"99 ","pages":"Article 100729"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X23000383/pdfft?md5=1edc409139e75389d761d6f97ccff393&pid=1-s2.0-S0011393X23000383-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138484381","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}
Pub Date : 2023-01-01DOI: 10.1016/j.curtheres.2023.100706
Catherine M. Sherwin PhD
{"title":"Editorial: Publishing in 2023 and Beyond","authors":"Catherine M. Sherwin PhD","doi":"10.1016/j.curtheres.2023.100706","DOIUrl":"10.1016/j.curtheres.2023.100706","url":null,"abstract":"","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"98 ","pages":"Article 100706"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ad/ab/main.PMC10293662.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9739884","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}
Pub Date : 2023-01-01DOI: 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)
{"title":"Hemoglobin and End-Organ Damage in Individuals with Sickle Cell Disease","authors":"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","doi":"10.1016/j.curtheres.2023.100696","DOIUrl":"10.1016/j.curtheres.2023.100696","url":null,"abstract":"<div><h3>Background</h3><p>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).</p></div><div><h3>Objectives</h3><p>This retrospective, observational, repeated-measures study systematically characterizes the relationship between hemoglobin (Hb) level and EOD in adolescent and adult patients with SCD<em>.</em></p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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. (<em>Curr Ther Res Clin Exp</em>. 2023; 84:XXX–XXX)</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"98 ","pages":"Article 100696"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d8/74/main.PMC10025127.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9166593","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}
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.
{"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 , 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","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> < 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}
Pub Date : 2023-01-01DOI: 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.
{"title":"Treatment of Chronic Constipation using Elobixibat in a Real-World Setting: A Retrospective Cohort Study using an Electronic Medical Records Database in Japan","authors":"Hisanori Masaki MS , Koji Shimamoto MS , Shoichiro Inokuchi MD, PhD , Sonoko Ishizaki MS","doi":"10.1016/j.curtheres.2023.100724","DOIUrl":"https://doi.org/10.1016/j.curtheres.2023.100724","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objectives</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"99 ","pages":"Article 100724"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X23000334/pdfft?md5=3505f1515b318297ec9d52499a158f5f&pid=1-s2.0-S0011393X23000334-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134652849","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}
Pub Date : 2023-01-01DOI: 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.
{"title":"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","authors":"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","doi":"10.1016/j.curtheres.2023.100719","DOIUrl":"https://doi.org/10.1016/j.curtheres.2023.100719","url":null,"abstract":"<div><h3>Background</h3><p>Motion sickness (kinetosis) is a common and temporarily incapacitant ailment, manageable with behavioral as well as pharmacological measures.</p></div><div><h3>Objective</h3><p>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 <em>Zingiber officinale</em> (ginger) (Group B) (n = 165) in the management of chronic complaints consistent with motion sickness.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>There was a statistically significant better performance under both study designs for Group A (<em>P</em> = 0.05 using different statistical tests) in all end points. Both regimens were safe, with different neurological and gastrointestinal tolerability outcomes.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"99 ","pages":"Article 100719"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X23000280/pdfft?md5=736b3f768b0eb7b2c6a3bb1f6b818624&pid=1-s2.0-S0011393X23000280-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91955339","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}
Pub Date : 2023-01-01DOI: 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.
{"title":"Combination of Caffeic Acid Phenethyl Ester and Crocin Realign Potential Molecular Markers in U87-MG Glioma Cells","authors":"Ashaq Hussain Mir PhD , Mir Khurshid Iqbal PhD , Mujeeb Zafar Banday PhD , Henah Mehraj Balkhi PhD , Ehtishamul Haq PhD","doi":"10.1016/j.curtheres.2023.100695","DOIUrl":"10.1016/j.curtheres.2023.100695","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>A combination of molecules targeting multiple pathways may prove to be a better alternative.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"98 ","pages":"Article 100695"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ed/d8/main.PMC10015175.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146390","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}
Pub Date : 2023-01-01DOI: 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.
{"title":"Laparoendoscopic Single-Site Technique Contrasted with Conventional Laparoscopy in Cystectomy for Benign Ovarian Cysts","authors":"Xinru Jiang MM, Xin Zuo MM, Hongdi Zhu MM","doi":"10.1016/j.curtheres.2023.100713","DOIUrl":"10.1016/j.curtheres.2023.100713","url":null,"abstract":"<div><h3>Objective</h3><p>To compare the laparoendoscopic single-site (LESS) technique with conventional laparoscopy in cystectomy for benign ovarian cysts.</p></div><div><h3>Materials and methods</h3><p>A retrospective analysis was performed at Yixing People's Hospital from April 2020 until December 2021.</p></div><div><h3>Results</h3><p>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 (<em>P</em> > 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; <em>P</em> = 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; <em>P</em> = 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; <em>P</em> = .001) and the satisfaction score was also significantly higher in the LESS group (<em>z</em> = –2.272; <em>P</em> = 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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"99 ","pages":"Article 100713"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4d/5a/main.PMC10372162.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9921991","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}
Pub Date : 2023-01-01DOI: 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.
{"title":"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","authors":"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","doi":"10.1016/j.curtheres.2023.100725","DOIUrl":"10.1016/j.curtheres.2023.100725","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"99 ","pages":"Article 100725"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X23000346/pdfft?md5=c3d422014fde8355d994a461edf8897f&pid=1-s2.0-S0011393X23000346-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135455594","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}