Current Therapeutic Research-clinical and Experimental最新文献

{"title":"Differential Effect of Fixed Ratio Magnitude on the Rate of Lever-Pressing and Interinjection Intervals of Cocaine Self-Administration in Rats","authors":"Jhanvi N. Desai ,&nbsp;Abigail R. Muccilli ,&nbsp;Luis E. Tron Esqueda ,&nbsp;Jeffrey A. Welge PhD ,&nbsp;Andrew B. Norman PhD","doi":"10.1016/j.curtheres.2023.100727","DOIUrl":"10.1016/j.curtheres.2023.100727","url":null,"abstract":"<div><h3>Background</h3><p>Many features of self-administration behavior may be explained by reference to the properties of schedules of reinforcement. Schedules alter the probability of a behavior being reinforced and thereby increase, or decrease, the frequency of the behavior and fixed ratio (FR) magnitude reportedly alters the rate of responding to cocaine. A pharmacokinetic/pharmacodynamic interaction theory states that lever-pressing behavior is induced only when cocaine levels in the body are above the priming/remission threshold and below the satiety threshold—a range termed the compulsion zone. This theory successfully explains cocaine self-administration in rats on a progressive ratio and the FR1 schedule.</p></div><div><h3>Objectives</h3><p>To determine the effects of high FR magnitude on the rate of self-administration of cocaine and the rate of lever-pressing behavior when cocaine levels are within the compulsion zone.</p></div><div><h3>Methods</h3><p>Rats acquired cocaine self-administration on an FR1 schedule and then were switched to sessions that started with FR1 and then FR 5, 10, 20, or 50. An only FR1 session was run each week between FR1/FR50 sessions and then only FR1 sessions were conducted for several weeks.</p></div><div><h3>Results</h3><p>Interinjection intervals at a unit dose of 3 µmol/kg were regular at both FR1 and FR50 but were longer by the time required to complete the 50 presses. When responding by rats was maintained under an FR50 schedule of cocaine presentations, compared to baseline FR1 sessions, dramatic increases in the number of lever-presses were observed after access to cocaine was terminated, a previously unreported finding. However, lever-pressing occurred only when cocaine levels were in the compulsion zone, and this duration was unchanged. The increase in lever-pressing persisted for weeks. Interinjection intervals at FR1 were not altered after exposure to FR50.</p></div><div><h3>Conclusions</h3><p>Although previously considered key to understanding the regulation of cocaine self-administration behavior, FR magnitude simply increased interinjection intervals by the time required to complete 50 lever-presses. The dramatic increase in the rate of lever-pressing was caused by the high FR schedule rather than cocaine. The utility of the schedule-induced increase in the rate of lever-pressing is unclear. The compulsion zone theory provides a rational pharmacological basis for understanding cocaine self-administration behavior.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"99 ","pages":"Article 100727"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X2300036X/pdfft?md5=be8d20eb5e723e485f2f52cf3436426e&pid=1-s2.0-S0011393X2300036X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135455001","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}

{"title":"Optimization of Nasal Liposome Formulation of Venlafaxine Hydrochloride using a Box-Behnken Experimental Design","authors":"Sulekha Khute MPharm,&nbsp;Rajendra K. Jangde PhD, MPharm","doi":"10.1016/j.curtheres.2023.100714","DOIUrl":"10.1016/j.curtheres.2023.100714","url":null,"abstract":"<div><h3>Background</h3><p>Intranasal administration is among the most effective alternatives to deliver drugs directly to the brain and prevent first-pass metabolism. Venlafaxine-loaded liposomes are biocompatible carriers that enhance transport qualities over the nasal mucosa.</p></div><div><h3>Objective</h3><p>This research aimed to develop, formulate, characterize, and observe the prepared formulation.</p></div><div><h3>Methods</h3><p>The formulation was developed using the thin-film hydration technique. The response surface plot interrelationship between three independent variables are lipid, cholesterol and polymer and four dependent variables such as particle size, percentage entrapment efficiency, and percentage drug release were ascertained using the Box-Behnken design.</p></div><div><h3>Results</h3><p>The drug-release chitosan-coated liposomes were reported to have a particle size distribution, entanglement efficiency, and 84%, respectively, of 191 ± 34.71 nm, 94 ± 2.71% and 94 ± 2.71%. According to <em>in vitro</em> investigations, liposomes as a delivery system for the nasal route provided a more sustained drug release than the oral dosing form.</p></div><div><h3>Conclusions</h3><p>The intranasal administration of venlafaxine liposomal vesicles effectively enhanced the absolute bioavailability, retention time, and brain delivery of venlafaxine.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"99 ","pages":"Article 100714"},"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/b4/f9/main.PMC10506098.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41107413","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}

{"title":"In Vitro Inhibition of Evaporation with Perfluorohexyloctane, an Eye Drop for Dry Eye Disease","authors":"Jason Vittitow Ph.D. ,&nbsp;Robert Kissling M.D. ,&nbsp;Heleen DeCory Ph.D. ,&nbsp;Douglas Borchman Ph.D.","doi":"10.1016/j.curtheres.2023.100704","DOIUrl":"10.1016/j.curtheres.2023.100704","url":null,"abstract":"<div><h3>Objective</h3><p>Perfluorohexyloctane (PFHO) MIEBO^TM, formerly (NOV03) is a single component, water-free eye drop approved by the Food and Drug Administration in the United States for the treatment of dry eye disease. We evaluated the in vitro inhibitory effect of PFHO on the evaporation rate (R_evap) of saline.</p></div><div><h3>Methods</h3><p>Evaporation rates were measured gravimetrically at 25°C or 35°C. The evaporation rate (R_evap) of phosphate-buffered saline (PBS) was measured following the application of 11-200 µL PFHO or 100 µL artificial tears (Soothe XP [Bausch + Lomb, Bridgewater, New Jersey], Systane Balance [Alcon, Fort Worth, Texas], and Systane Ultra [Alcon]). The effect of PFHO on the R_evap of PBS was further evaluated following the addition of 50 mg/mL mucin to PBS and compared with that of meibum lipid collected from a 68 year-old White volunteer.</p></div><div><h3>Results</h3><p>At 25°C the mean (SEM) R_evap of PBS alone or PFHO alone was 4.06 (0.06) and 0.137 (0.004) µm/min, respectively. Layering 100 µL PFHO over PBS inhibited the R_evap of PBS by 81% (<em>P</em> &lt; 0.0001), whereas artificial tears had no effect. The presence of mucin attenuated the inhibition of the R_evap of PBS by PFHO by 17% (<em>P</em> &lt; 0.0001). At 35°C, the R_evap of PBS was inhibited by 88% when layering 100 µL PFHO over PBS and 28% when applying a single 11 µL drop of PFHO (<em>P</em> value &lt; 0.0001 for both). Meibum lipid inhibited the R_evap of PBS by 8% at this temperature, whereas the combination of a drop of PFHO plus meibum inhibited the R_evap of PBS by 34%.</p></div><div><h3>Conclusions</h3><p>PFHO significantly inhibited the R_evap of saline in this in vitro model. The data support the idea that PHFO may form an antievaporative layer on the tear film surface and may be a functional substitute for the native tear-film lipid layer in patients with dry eye disease.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"98 ","pages":"Article 100704"},"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/0d/b9/main.PMC10300294.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9730174","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}

{"title":"Preclinical Assessment of Tissue Effects by Gastrointestinal Endoscope Tip Temperature","authors":"Luise Jäger MSc ,&nbsp;Enrique Morales-Orcajo PhD ,&nbsp;Anna Gager Mag. med. vet. ,&nbsp;Anke Bader (Dr) ,&nbsp;Anja Dillinger Dipl.-Ing. ,&nbsp;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}

{"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 ,&nbsp;Ozge Sarac MD ,&nbsp;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}

{"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}

{"title":"Hemoglobin and End-Organ Damage in Individuals with Sickle Cell Disease","authors":"William B. Ershler MD ,&nbsp;Laura M. De Castro MD, MHSc ,&nbsp;Zahra Pakbaz MD ,&nbsp;Aaron Moynahan MA ,&nbsp;Derek Weycker PhD ,&nbsp;Thomas E. Delea MSIA ,&nbsp;Irene Agodoa MD ,&nbsp;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}

{"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}

{"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 ,&nbsp;Koji Shimamoto MS ,&nbsp;Shoichiro Inokuchi MD, PhD ,&nbsp;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}

{"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 ,&nbsp;Claudio Rodrigues MD ,&nbsp;Mendel Suchmacher MD ,&nbsp;Claudia Regina Esteves MD ,&nbsp;Karin Gonçalves PhD ,&nbsp;Hélio Rzetelna MD ,&nbsp;Rafael V. Rodrigues MD ,&nbsp;Luciana Regina de Vasconcelos MD ,&nbsp;Spyros G.E. Mezitis MD, PhD ,&nbsp;Heros Rabelo MSc ,&nbsp;Renato Kaufmann MD, PhD ,&nbsp;Fernanda Schwarz MChem ,&nbsp;Henrique Goldberg (In Memoriam) MD ,&nbsp;Aline Sintoveter MD ,&nbsp;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}