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1.
Korean J Gastroenterol ; 84(4): 177-187, 2024 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-39449262

RESUMO

Background/Aims: The use of 1-L polyethylene glycol with ascorbate (PEG/Asc) and oral sulfate tablets (OST) as low-volume bowel preparation agents has gradually increased. However, these agents may induce acute gastropathy during bowel preparation, particularly in elderly populations. This study aimed to compare the incidence of acute gastropathy of 1-L PEG/Asc and OST according to age, as well as efficacy and safety. Methods: This retrospective study included patients who underwent esophagogastroduodenoscopy (EGD) and colonoscopy for screening on the same day and underwent bowel preparation using OST or 1-L PEG/Asc. We collected EGD findings related to acute gastropathy, bowel-cleansing score using the Boston Bowel Preparation Scale (BBPS), polyp or adenoma detection rate (ADR), and laboratory parameters. Results: Of 4,711 patients, 1,758, 2,241, and 712 were in the younger (18-49 years), middle-aged (50-64 years), and older (≥65 years) groups, respectively. In all age groups, the OST group had higher rates of acute gastropathy than the 1-L PEG/Asc group. The younger-, middle-, and older-aged groups had OST and 1-L PEG/Asc usage rates of 42.9% and 11.6%, 41.2% and 16.0%, and 41.5% and 16.4%, respectively. Notably, in the younger group, the total BBPS and ADR scores were significantly higher in the OST group than in the 1-L PEG/Asc group; however, these did not differ in the other age groups. Conclusions: Acute gastropathy was more strongly associated with OST than with 1-L PEG/Asc in all age groups. Therefore, physicians should consider acute gastropathy associated with low-volume agents in all age groups when performing bowel preparation.


Assuntos
Ácido Ascórbico , Catárticos , Polietilenoglicóis , Humanos , Pessoa de Meia-Idade , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/administração & dosagem , Estudos Retrospectivos , Ácido Ascórbico/administração & dosagem , Ácido Ascórbico/uso terapêutico , Idoso , Catárticos/efeitos adversos , Catárticos/administração & dosagem , Masculino , Feminino , Adulto , Adolescente , Fatores Etários , Adulto Jovem , Colonoscopia , Endoscopia do Sistema Digestório , Sulfatos/efeitos adversos , Comprimidos , Administração Oral , Doença Aguda
2.
Clin Endosc ; 2024 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-39434557

RESUMO

Background/Aims: Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation; however, due to the necessity of a large volume, patient tolerance is impaired. Therefore, lactulose is a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy and safety of lactulose-based bowel preparations in comparison with PEG for colonoscopy. Methods: This is a prospective, non-blinded, comparative study. Outpatients were randomly divided into two groups: group 1 (111 patients), PEG; and group 2 (111 patients), lactulose. The following clinical outcomes were assessed in each group: degree of bowel clearance using the Boston bowel preparation score, colorectal polyp detection rate, adenoma detection rate, tolerability, and side effects. Results: The rate of inadequate bowel preparation was 8.1% and 1.8% for the PEG and lactulose groups, respectively (p=0.030). The Boston bowel preparation score for the entire colon was 7.34±1.17 and 8.36±1.09 for the PEG and lactulose groups, respectively (p<0.001). The satisfactory overall experience rates were 27.9% and 62.2% for the PEG and lactulose groups, respectively (p<0.001). Conclusions: The novel bowel preparation with oral lactulose was superior to that with PEG in terms of colon cleansing, adenoma detection rate, tolerance, and patient experience.

3.
World J Clin Cases ; 12(18): 3615-3621, 2024 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-38983420

RESUMO

BACKGROUND: Effective bowel cleansing is essential for a successful colonoscopy. Laxatives, such as polyethylene glycol, are commonly used for bowel preparation. Vomiting is a frequent complication during bowel preparation, and forceful vomiting can potentially lead to esophageal perforation, as reported in several previous cases. However, pharyngeal perforation during bowel preparation has not been previously documented. Here, we present a case of pharyngeal perforation induced by forceful vomiting during bowel preparation. CASE SUMMARY: A 38-year-old man with a history of hypertension, dyslipidemia, diabetes mellitus, and end-stage renal disease on hemodialysis was admitted for evaluation of recurrent abdominal pain. The patient complained of sudden pain in the neck, throat, and anterior chest following forceful vomiting during bowel preparation. Physical examination revealed crepitus under the skin of the neck and anterior chest on palpation, and upper gastrointestinal endoscopy revealed pharyngeal perforation. The perforation site was located above the upper esophageal sphincter, which distinguished it from Boerhaave's syndrome. Conservative medical management was chosen after consultation with a thoracic surgeon and an otolaryngologist, considering the patient's mild symptoms, stable vital signs, and the small size of the lesion; the perforation resolved without endoscopic or surgical intervention. The patient was discharged from hospital two weeks after the perforation. CONCLUSION: Despite its rarity, pharyngeal perforation should be considered a potential complication of bowel preparation for colonoscopy.

4.
Sci Rep ; 14(1): 14980, 2024 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-38951137

RESUMO

Polyethylene glycols (PEGs) are used in industrial, medical, health care, and personal care applications. The cycling and disposal of synthetic polymers like PEGs pose significant environmental concerns. Detecting and monitoring PEGs in the real world calls for immediate attention. This study unveils the efficacy of time-of-flight secondary ion mass spectrometry (ToF-SIMS) as a reliable approach for precise analysis and identification of reference PEGs and PEGs used in cosmetic products. By comparing SIMS spectra, we show remarkable sensitivity in pinpointing distinctive ion peaks inherent to various PEG compounds. Moreover, the employment of principal component analysis effectively discriminates compositions among different samples. Notably, the application of SIMS two-dimensional image analysis visually portrays the spatial distribution of various PEGs as reference materials. The same is observed in authentic cosmetic products. The application of ToF-SIMS underscores its potential in distinguishing PEGs within intricate environmental context. ToF-SIMS provides an effective solution to studying emerging environmental challenges, offering straightforward sample preparation and superior detection of synthetic organics in mass spectral analysis. These features show that SIMS can serve as a promising alternative for evaluation and assessment of PEGs in terms of the source, emission, and transport of anthropogenic organics.


Assuntos
Cosméticos , Polietilenoglicóis , Espectrometria de Massa de Íon Secundário , Cosméticos/análise , Cosméticos/química , Espectrometria de Massa de Íon Secundário/métodos , Polietilenoglicóis/química , Polietilenoglicóis/análise , Análise de Componente Principal
5.
J Pediatr Pharmacol Ther ; 29(3): 286-291, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38863850

RESUMO

OBJECTIVE: Though standard household measuring devices (e.g., teaspoons, tablespoons) are often used in clinical practice to measure pediatric doses of polyethylene glycol 3350 (PEG-3350), no published -literature documents the accuracy of these measurements. Standard dosing for adults is 17 grams, which is 1 capful according to the manufacturer. The objective of this study was to determine the weight of household teaspoons and tablespoons of PEG-3350. METHODS: PEG-3350 measurements were performed using 5 different household measuring teaspoons and tablespoons and the cap that accompanies the bottle for 3 different brands of PEG-3350. Using an electronic balance to determine weights, 3 investigators completed 5 measurements for each of the 5 measurement devices and PEG-3350 bottle caps as follows: leveled teaspoons and tablespoons, unleveled teaspoons and tablespoons, "heaping" tablespoons, half-capfuls, and capfuls. RESULTS: A leveled teaspoonful of PEG-3350 weighed ∼3.3 grams and an unleveled teaspoonful weighed ∼3.7 grams. A leveled, unleveled, and heaping tablespoon of PEG-3350 weighed about 10, 11, and 15 grams, respectively. Heaping tablespoons, half-capfuls, and capfuls resulted in the most measurement variability. CONCLUSIONS: Use of a kitchen scale may be the most precise method of measurement, however not all patients have kitchen scales. Standard household measuring devices (teaspoons and tablespoons) may be used to conveniently measure PEG-3350 doses. Using 1 dedicated measurement device and leveling the dose may improve consistency, which could be beneficial for patients who are sensitive to dose variability.

6.
Macromol Rapid Commun ; 45(17): e2400250, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38837471

RESUMO

Two-dimensional porphyrin-based covalent-organic frameworks (2D-por-COFs) have gained significant attention as attractive platforms for efficient solar light conversion into hydrogen production. Herein, it is found that introducing transition metal zinc and polyethylene glycol (PEG) into 2D-por-COFs can effectively improve the photocatalytic hydrogen evolution performance. The photocatalytic hydrogen evolution rate of ZnPor-COF is 2.82 times higher than that of H2Por-COF. Moreover, ZnPor-COF@PEG has the highest photocatalytic hydrogen evolution efficiency, which is 1.31 and 3.7 times that of pristine ZnPor-COF and H2Por-COF, respectively. The filling of PEG makes the layered structure of COFs more stable. PEG reduces the distortion and deformation of the carbon skeleton after the experiment of photocatalytic hydrogen evolution. The layered stacking and crystallization of 2D-por-COFs are also enhanced. Meanwhile, the presence of PEG also accelerates the transfer of excited electrons and enhances the photocatalytic hydrogen evolution activity. This strategy will provide valuable insights into the design of 2D-por-COFs as efficient solid photocatalysts for solar-driven hydrogen production.


Assuntos
Hidrogênio , Estruturas Metalorgânicas , Processos Fotoquímicos , Polietilenoglicóis , Porfirinas , Hidrogênio/química , Catálise , Polietilenoglicóis/química , Porfirinas/química , Estruturas Metalorgânicas/química , Zinco/química
7.
ACS Nano ; 18(4): 3627-3635, 2024 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-38215496

RESUMO

Structural color is a fascinating optical phenomenon arising from intricate light-matter interactions. Biological structural colors from natural polymers are invaluable in biomimetic design and sustainable construction. Here, we report a renewable, abundant, and biodegradable cellulose-derived organic gel that generates stable cholesteric liquid crystal structures with vivid structural colors. We construct the chromatic gel using a 68 wt % hydroxypropyl cellulose (HPC) matrix, incorporating distinct polyethylene glycol (PEG) guest molecules. The PEGs contain peculiar end groups with tailored polarity, allowing for precise positioning on the HPC helical backbone through electrostatic repulsion between the PEG and HPC chains. This preserves the HPC's chiral nematic phase without being disrupted. We demonstrate that the PEGs' polarity tunes the HPC gel's reflective color. Additionally, gels with variable polarities are highly sensitive to temperature, pressure, and stretching, resulting in rapid, continuous, and reversible color changes. These exceptional dynamic traits establish the chiral nematic gel as an outstanding candidate for next-generation applications across displays, wearables, flexible electronics, health monitoring, and multifunctional sensors.

8.
Einstein (São Paulo, Online) ; 22: eAO0764, 2024. graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-1557729

RESUMO

ABSTRACT Objective To evaluate the in vitro and in vivo toxicities of polyethylene glycol-coated gold nanoparticles synthesized using a one-step process. Methods Gold nanoparticles were prepared via a co-precipitation method using polyethylene glycol, and the synthesis product was characterized. For the in vitro evaluation, a flow cytometry analysis with Annexin V and iodide propidium staining was used to assess cytotoxicity in MG-63 cells labeled with 10, 50, and 100µg/mL of nanoparticle concentration. For the in vivo evaluation, nanoparticles were administered intraperitoneally at a dose of 10mg/kg dose in 10-week-old mice. Toxicity was assessed 24 hours and 7 days after administration via histopathological analysis of various tissues, as well as through renal, hepatic, and hematopoietic evaluations. Results Synthesized nanoparticles exhibited different hydrodynamic sizes depending on the medium: 51.27±1.62nm in water and 268.12±28.45nm (0 hour) in culture medium. They demonstrated a maximum absorbance at 520nm and a zeta potential of -8.419mV. Cellular viability exceeded 90%, with less than 3% early apoptosis, 6% late apoptosis, and 1% necrosis across all labeling conditions, indicating minimal cytotoxicity differences. Histopathological analysis highlighted the accumulation of nanoparticles in the mesentery; however, no lesions or visible agglomeration was observed in the remaining tissues. Renal, hepatic, and hematopoietic analyses showed no significant differences at any time point. Conclusion Polyethylene glycol-coated gold nanoparticles exhibit extremely low toxicity and high biocompatibility, showing promise for future studies.

9.
Rheumatol Ther ; 10(4): 825-847, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37069364

RESUMO

INTRODUCTION: SEL-212 is a developmental treatment for uncontrolled gout characterized by serum uric acid (sUA) levels ≥ 6 mg/dl despite treatment. It comprises a novel PEGylated uricase (SEL-037; also called pegadricase) co-administered with tolerogenic nanoparticles containing sirolimus (rapamycin) (SEL-110; also called ImmTOR®), which mitigates the formation of anti-drug antibodies (ADAs) against uricase and SEL-037 (PEGylated uricase), thereby enabling sustained sUA control (sUA < 6 mg/dl). The aim of this study was to identify appropriate dosing for SEL-037 and SEL-110 for use in phase 3 clinical trials. METHODS: This open-label phase 2 study was conducted in adults with symptomatic gout and sUA ≥ 6 mg/dl. Participants received five monthly infusions of SEL-037 (0.2 or 0.4 mg/kg) alone or in combination with three or five monthly infusions of SEL-110 (0.05-0.15 mg/kg). Safety, tolerability, sUA, ADAs, and tophi were monitored for 6 months. RESULTS: A total of 152 adults completed the study. SEL-037 alone resulted in rapid sUA reductions that were not sustained beyond 30 days in most participants due to ADA formation and loss of uricase activity. Levels of ADAs decreased with increasing doses of SEL-110 up to 0.1 mg/kg, with anti-uricase titers < 1080 correlating with sustained sUA control and reductions in tophi. Overall, 66% of evaluable participants achieved sUA control at week 20 following five monthly doses of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg, whereas only 26% achieved sUA control at week 20 when SEL-110 was withdrawn after week 12. Compared to other dose combinations, SEL-037 0.2 mg/kg + SEL-110 0.15 mg/kg achieved the greatest sUA control at week 12 and was well-tolerated with no safety concerns. CONCLUSION: Results provide continued support for the use of multiple monthly administrations of SEL-037 0.2 mg/kg + SEL-110 0.1-0.15 mg/kg in clinical trials for SEL-212. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02959918.

10.
Angew Chem Int Ed Engl ; 62(20): e202301300, 2023 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-36892527

RESUMO

Anion-coordination-driven assembly (ACDA) has proven to be a very effective strategy for the construction of polyhedral structures. Here we demonstrate that variation of the "angle" of the backbone of C3 -symmetric tris-bis(urea) ligands, from triphenylamine to triphenylphosphine oxide, results in the change of the final construct from an A4 L4 tetrahedron to a higher-nuclearity, A6 L6 trigonal antiprism (A=anion, herein PO4 3- ; L=ligand). Most interestingly, this assembly features a huge hollow internal space that is divided into three compartments: one central cavity and two large outer pockets. This multi-cavity character enables the binding of different guests, namely monosaccharides or polyethylene glycol molecules (PEG600, PEG1000 and PEG2000), respectively. The results prove that anion coordination by multiple hydrogen bonds may provide both sufficient strength and flexibility, thus making possible the formation of complicated structures with adaptive guest binding ability.

13.
Eur Ann Allergy Clin Immunol ; 55(5): 229-234, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-36047485

RESUMO

Summary: Background. Hypersensitivity reactions (HSR) to taxanes have been related to a complement activation by their excipients, polyoxyethylated castor oil and Polysorbate 80, structurally related to those of SARS-CoV-2 vaccines. The aim of this study was to verify the presence of a higher risk of HSR to SARS-CoV-2 vaccines in patients with history of HSR to taxanes. Methods. Patients with history of HSR to taxanes were evaluated before the vaccination in our center and underwent skin tests for PEG and Polysorbate 80 (PandP). Some patients completed the vaccination course in other centers without prior PandP skin tests because they had not manifested taxanes hypersensitivity before vaccination, or because those tests were not available. Results. 50 patients were evaluated. 100% of patients with history of hypersensitivity to taxanes completed the vaccine course with no cases of anaphylaxis. 33 underwent skin tests for PandP before the vaccination and no correlation was found between the positivity of PandP and taxanes skin tests (p = 0.538). 7 patients developed mild symptoms during skin tests and vaccination, similar but weaker than those suffered at the time of the taxane infusion, independently from the results of skin tests. Conclusions. In our cohort patients with history of reaction to taxanes were not at higher risk to develop anaphylaxis to SARS-CoV-2 vaccines. However, a common non-IgE mediated mechanism behind those HSRs cannot be completely excluded. This can only account for mild and harmless symptoms in case of SARS-CoV-2 vaccines. However, prudence is still recommended in these patients.


Assuntos
Anafilaxia , COVID-19 , Hipersensibilidade a Drogas , Humanos , Paclitaxel/efeitos adversos , Hipersensibilidade a Drogas/diagnóstico , Hipersensibilidade a Drogas/epidemiologia , Hipersensibilidade a Drogas/etiologia , Vacinas contra COVID-19/efeitos adversos , Polissorbatos , Anafilaxia/induzido quimicamente , Anafilaxia/diagnóstico , COVID-19/prevenção & controle , SARS-CoV-2 , Taxoides/efeitos adversos , Fatores de Risco
14.
Molecules ; 27(18)2022 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-36144520

RESUMO

The CPA equation of state is applied to model binary, ternary, and multicomponent mixtures that contain CO2 with polyethylene glycols or compounds relevant to biodiesel production, such as glycerol and various triglycerides. Effort has been made to evaluate the model performance on correlating both the liquid and the vapor phase compositions, which is a demanding task, revealing the model's and parameters' limitations, due to the rather low concentrations of heavy compounds in the vapor phase. Initially the model's binary parameters, which in all cases were temperature independent, were estimated using experimental data for binary systems. Those parameters were used to predict the phase behavior of supercritical CO2 containing ternary and multicomponent mixtures. Since no parameter was adjusted to ternary or multicomponent systems' data, the reported CPA results for such mixtures are considered as pure predictions. This is the final part of a series of studies [Tsivintzelis et al. Fluid Phase Equilibria 430 (2016) 75-92 and 504 (2020) 112337] that complete the parameterization of the CPA equation of state for systems relevant to the biodiesel production, which allows the application of the model to multicomponent mixtures of the relevant processes.


Assuntos
Biocombustíveis , Polietilenoglicóis , Dióxido de Carbono , Glicerol , Triglicerídeos
15.
Korean J Gastroenterol ; 80(2): 85-92, 2022 08 25.
Artigo em Inglês | MEDLINE | ID: mdl-36004636

RESUMO

Background/Aims: Recently, 1-L polyethylene glycol-ascorbic acid (PEG-Asc) has been used to reduce the volume of preparation agents in colonoscopy. This clinical trial aimed to compare the efficacy and safety of two types of 1-L PEG-Asc (CleanViewAL® [Tae Joon Pharmaceutical Company, Seoul, Korea] and Plenvu® [Norgine, Harefield, United Kingdom]) in average-aged adults. Methods: This study was a prospective, randomized, non-inferiority, open-label, phase 4 clinical trial. The primary endpoint was the efficacy evaluated using the Boston bowel preparation scale (BBPS), and the secondary endpoint was clinical safety. Results: In total, 173 patients were assigned to either the CleanViewAL® (n=84) or Plenvu® (n=89) group. Overall cleansing successes of 97.6% (82/84) and 98.8% (88/89) were achieved in the CleanViewAL® group and in the Plenvu® group, respectively, showing that CleanViewAL® has similar bowel cleansing efficacy to Plenvu® (95% CI, -0.052 to 0.027; p=0.207). The total BBPS score was 8.67±1.00 and 8.70±0.76 in the CleanViewAL® group and Plenvu® group, respectively (p=0.869). The most common adverse symptom was nausea, and no adverse symptoms requiring hospitalization were reported in either group. There were no cases of critical hypernatremia and liver dysfunction exceeding the common terminology criteria for adverse events grade I. An overall satisfaction score (scale of 1 to 10) showed no difference between the two groups (p=0.289). However, the CleanViewAL® group showed a higher taste satisfaction score (scale of 1 to 5) than the Plenvu® group (CleanViewAL®: 2.90±0.91, Plenvu®: 2.60±0.86, p=0.028). Conclusions: Both types of 1-L PEG-Asc, CleanViewAL® and Plenvu®, are effective and safe bowel cleansing agents in average-aged adults. CleanViewAL® was preferred in terms of taste satisfaction.


Assuntos
Catárticos , Polietilenoglicóis , Adulto , Ácido Ascórbico/uso terapêutico , Catárticos/efeitos adversos , Colonoscopia , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Polietilenoglicóis/uso terapêutico , Estudos Prospectivos
16.
Vasc Specialist Int ; 38: 17, 2022 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-35748180

RESUMO

The ALTO abdominal stent graft system (Endologix Inc., Irvine, CA, USA) is a latest-generation polymer-based device used to treat patients with abdominal aortic aneurysms. The present study describes the first case series of patients with abdominal aortic aneurysms, including two patients with juxtarenal aneurysms, treated using the ALTO stent graft system. Six males were treated using the ALTO device at a single public center. All procedures were uneventful, and the dosimetric results recorded in terms of kerma-area product and fluoroscopy time were similar to those reported in previous studies. At the 1-month follow-up, computed tomography angiography showed no evidence of endoleak, device migration, thrombosis, or structural graft failure. This clinical series demonstrates that the use of the ALTO stent graft system is associated with promising patient outcomes. Lifelong postoperative imaging surveillance may highlight possible late failures and suggest potential graft improvements.

17.
Membranes (Basel) ; 12(5)2022 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-35629843

RESUMO

Processing robust mechanical properties is important for elastomeric materials. In this work, different molecular weights of polyethylene glycols (PEG) were used to modify graphene oxide (GO) in order to study the relationship between the number of hydrogen bonds and the properties of the polyurethane/graphene oxide membrane. The fact of PEG was successfully grafted onto the surface of GO was certified by Fourier transform infrared spectra, Raman spectra, X-ray photoelectron spectroscopy. The graft ratio was indicated by thermogravimetric analysis. The presence of hydrogen bonds in PUR/MGO composites membrane was proved by the cyclic loading-unloading test and stress relaxation test. The thermal stability and low-temperature resistance performance of PUR/MGO had been improved compared with PUR/GO. When the molecular weight of PEG grafted on the surface of GO was 600, the tensile strength and elongation at break of the composite membrane were optimal. The reason for the improvement of physical and mechanical properties was that the dispersion of filler in the rubber matrix and the compatibility between filler and rubber had been improved.

19.
Clin Transl Allergy ; 12(1): e12111, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35028130

RESUMO

BACKGROUND: During the COVID-19 pandemic focus has been on polyethylene glycol (PEG) and polysorbate as these excipients are constituents in the first vaccines and possible elicitors of allergic reactions to the vaccines. We aimed to evaluate the possibility of vaccinating patients with PEG and/or polysorbate allergy against COVID-19. METHODS: Twenty-five patients with a history of an allergic reaction to drugs, vaccines and mouth hygiene products containing PEG or polysorbate and sensitization (skin test or in vitro test) or a positive challenge were included. We re-evaluated 19 of 21 patients diagnosed before 2021 and four new patients by skin prick tests (SPT) and Basophil Histamine Release (BaHR) for PEGs, polysorbates and approved COVID-19 vaccines as well as measurement of specific IgE (PEG 2000, 10,000). Patients were offered vaccination based on decision points from the primary diagnosis and re-evaluation. RESULTS: Most common primary elicitors were depot-steroids and laxatives. Most patients had experienced more than one reaction. SPT was superior to BaHR test although many SPTs became negative over time. After careful re-evaluation three patients were successfully vaccinated with the Pfizer/BioNTech vaccine. Three were vaccinated before referral. Eleven were offered the Johnson-Johnson vaccine; four were vaccinated successfully, seven abstained. Six patients could not be vaccinated with PEG or polysorbate containing vaccines. CONCLUSION: Hypersensitivity to excipients in COVID-19 vaccines constitutes a risk to patients with allergy to PEG or polysorbates. After diagnostic evaluation, a safe COVID-19 vaccine could be offered to most patients, the remainders will await new vaccines containing different excipients.

20.
Gut Liver ; 16(2): 259-268, 2022 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-34810296

RESUMO

BACKGROUND/AIMS: Polyethylene glycol (PEG)-based bowel preparations are effective cleansing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG. METHODS: Patients undergoing colonoscopy were randomized (1:1:1) to receive TJP-008 as 1-day split dose (TJP-008-1) or 2-day split dose (TJP-008-2) regimen or to receive 2LPEG as a 2-day split dose regimen. Cleansing efficacy was evaluated using the Harefield Cleansing Scale. The primary endpoint was overall bowel cleansing success. Full analysis set (FAS) and per protocol set (PPS) analyses were performed. RESULTS: Of the 314 screened patients, efficacy was assessed in the following patient numbers (FAS/PPS): total (293/285), TJP-008-1 (98/94), TJP-008-2 (97/95), and 2LPEG (98/96). FAS revealed noninferiority between TJP-008 and 2LPEG with regard to overall success (TJP-008-2, 99.0%; TJP-008-1, 95.9%; 2LPEG, 94.9%; p=0.100 and p=0.733, respectively). PPS also showed noninferiority (p=0.721 and p=0.211, respectively). However, the PPS analyses showed a higher bowel cleansing score for TJP-008-2 for high-quality cleansing in the right colon (TJP-008-2 83.2% vs 2LPEG 62.5%; p=0.005). CONCLUSIONS: TJP-008 is a new low-volume cleansing agent with a colon cleansing efficacy comparable to that of standard 2LPEG that exhibits significant safety and tolerability.


Assuntos
Catárticos , Polietilenoglicóis , Ácido Ascórbico , Colo , Colonoscopia/métodos , Humanos
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