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BMC Medical Informatics and Decision... May 2021Adverse drug reactions (ADRs) are regarded as a major cause of death and a major contributor to public health costs. For the active surveillance of drug safety, the use... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Adverse drug reactions (ADRs) are regarded as a major cause of death and a major contributor to public health costs. For the active surveillance of drug safety, the use of real-world data and real-world evidence as part of the overall pharmacovigilance process is important. In this regard, many studies apply the data-driven approaches to support pharmacovigilance. We developed a pharmacovigilance data-processing pipeline (PDP) that utilized electronic health records (EHR) and spontaneous reporting system (SRS) data to explore pharmacovigilance signals.
METHODS
To this end, we integrated two medical data sources: Konyang University Hospital (KYUH) EHR and the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). As part of the presented PDP, we converted EHR data on the Observation Medical Outcomes Partnership (OMOP) data model. To evaluate the ability of using the proposed PDP for pharmacovigilance purposes, we performed a statistical validation using drugs that induce ear disorders.
RESULTS
To validate the presented PDP, we extracted six drugs from the EHR that were significantly involved in ADRs causing ear disorders: nortriptyline, (hazard ratio [HR] 8.06, 95% CI 2.41-26.91); metoclopramide (HR 3.35, 95% CI 3.01-3.74); doxycycline (HR 1.73, 95% CI 1.14-2.62); digoxin (HR 1.60, 95% CI 1.08-2.38); acetaminophen (HR 1.59, 95% CI 1.47-1.72); and sucralfate (HR 1.21, 95% CI 1.06-1.38). In FAERS, the strongest associations were found for nortriptyline (reporting odds ratio [ROR] 1.94, 95% CI 1.73-2.16), sucralfate (ROR 1.22, 95% CI 1.01-1.45), doxycycline (ROR 1.30, 95% CI 1.20-1.40), and hydroxyzine (ROR 1.17, 95% CI 1.06-1.29). We confirmed the results in a meta-analysis using random and fixed models for doxycycline, hydroxyzine, metoclopramide, nortriptyline, and sucralfate.
CONCLUSIONS
The proposed PDP could support active surveillance and the strengthening of potential ADR signals via real-world data sources. In addition, the PDP was able to generate real-world evidence for drug safety.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; United States; Watchful Waiting
PubMed: 34001114
DOI: 10.1186/s12911-021-01520-y -
International Journal of Clinical and... 2021Solitary rectal ulcer syndrome (SRUS) is an uncommon disorder of the rectum. While benign, it can cause concern for patients and affect quality of life. Reported studies...
Solitary rectal ulcer syndrome (SRUS) is an uncommon disorder of the rectum. While benign, it can cause concern for patients and affect quality of life. Reported studies on SRUS worldwide are scarce. The aim of this study is to describe the clinicopathologic characteristics of SRUS in a cohort of children based in Saudi Arabia. In this study, children with a confirmed diagnosis of SRUS at King Abdulaziz University Hospital (KAUH) were included, during the period November 2003 to November 2017. Data were collected from hospital medical records. The study comprised twenty-one patients: 17 males (81%) and 4 females (19%); the median age was 11.4 years (range, 5.43-17.9 years). The most common presenting symptoms were rectal bleeding in 21 patients (100%), passage of mucus in 16 (76.1%), abdominal pain in 14 (66.6%), constipation in 13 (61.9%), straining in 9 (42.9%), and rectal prolapse in 5 (23.8%). The most common finding at initial colonoscopy was a single ulcer in 7 patients (33.3%), multiple ulcers in 6 (28.5%), polypoid lesions in 5 (23.8%), and hyperemic mucosa in 3 (14.2%). All patients received medical treatment and 14 (81%) continued to manifest one or more of the symptoms following treatment, which required subsequent modification of the treatment course. None of the patients required surgery. In conclusion, the study found rectal bleeding to be the most common presentation, with a single ulcer being the most prevalent lesion in endoscopy. Treatment response was variable, but almost half of patients reported relief of symptoms following treatment.
PubMed: 33936361
DOI: No ID Found -
Pharmaceutics Apr 2021Fluoroquinolones (FQs) are a widespread class of broad-spectrum antibiotics prescribed as a first line of defense, and, in some cases, as the only treatment against...
Fluoroquinolones (FQs) are a widespread class of broad-spectrum antibiotics prescribed as a first line of defense, and, in some cases, as the only treatment against bacterial infection. However, when administered orally, reduced absorption and bioavailability can occur due to chelation in the gastrointestinal tract (GIT) with multivalent metal cations acquired from diet, coadministered compounds (sucralfate, didanosine), or drug formulation. Predicting the extent to which this interaction reduces in vivo antibiotic absorption and systemic exposure remains desirable yet challenging. In this study, we focus on quinolone interactions with magnesium, calcium and aluminum as found in dietary supplements, antacids (Maalox) orally administered therapies (sucralfate, didanosine). The effect of FQ-metal complexation on absorption rate was investigated through a combined molecular and pharmacokinetic (PK) modeling study. Quantum mechanical calculations elucidated FQ-metal binding energies, which were leveraged to predict the magnitude of reduced bioavailability via a quantitative structure-property relationship (QSPR). This work will help inform clinical FQ formulation design, alert to possible dietary effects, and shed light on drug-drug interactions resulting from coadministration at an earlier stage in the drug development pipeline.
PubMed: 33919271
DOI: 10.3390/pharmaceutics13050594 -
JGH Open : An Open Access Journal of... Apr 2021Acute esophageal necrosis (AEN) is a rare presentation of severe esophageal injury. The optimal long-term management of complications related to AEN, particularly...
Acute esophageal necrosis (AEN) is a rare presentation of severe esophageal injury. The optimal long-term management of complications related to AEN, particularly stricture formation, are not well defined. We report a case of AEN in a patient who presented with diabetic ketoacidosis (DKA) and had dysphagia due to refractory stricture formation after mucosal healing occurred. A 62-year-old male with diabetes mellitus presented with altered mental status. He was admitted for hypovolemic shock secondary to DKA and treated with vasopressors, fluid resuscitation, and insulin. After resolution of DKA, he reported persistent dysphagia. Upper endoscopy showed circumferential black mucosal discoloration throughout the entire esophagus that spared the gastroesophageal junction. He was diagnosed with AEN and was continued on a proton pump inhibitor and sucralfate with improvement in symptoms. Repeat endoscopy 4 weeks later showed a 10-cm benign-appearing stricture in the mid esophagus. He underwent dilation with temporary symptomatic relief; however, recurrence in symptoms has thus far necessitated a total of 10 repeat upper endoscopies, including repeat dilations along with local steroid injection therapy. AEN is a rare presentation of severe esophageal injury and is typically associated with severe hemodynamic compromise. Although most cases resolve with supportive care and mucosal healing, there is little information regarding prognosis and optimal management of complications, such as refractory esophageal strictures. We describe a case of AEN complicated by refractory symptomatic esophageal stricture despite several dilations and intralesional steroid injections and discuss our approach to treatment.
PubMed: 33869789
DOI: 10.1002/jgh3.12520 -
The Southern African Journal of... 2021Stress ulcer prophylaxis (SUP) is part of the management of critically ill patients in intensive care units (ICUs). However, inappropriate use of these drugs has...
BACKGROUND
Stress ulcer prophylaxis (SUP) is part of the management of critically ill patients in intensive care units (ICUs). However, inappropriate use of these drugs has important clinical implications such as ventilator-associated pneumonia and -associated gastrointestinal tract infections. The overuse of proton pump inhibitors (PPIs) as SUP is a rapidly growing problem globally.
OBJECTIVES
To describe the use of SUP in three selected ICUs in Johannesburg, South Africa (SA).
METHODS
A retrospective, descriptive, contextual study design was used. Data were collected from ICU records of adult patients admitted into these units during the study period (1 August 2013 - 31 October 2013).
RESULTS
A total of 174 patients were included in the study. Of these, 156 were on SUP and only 38.5% (=60/156) were appropriately treated with SUP according to the American Society of Health-System Pharmacists guidelines. There was an inappropriate use of SUP in over 50% of those who were treated. The most frequently prescribed SUP was histamine-2 receptor antagonist (H2RA) (51.3%; =80/156), followed by PPIs (30.8%; =48/156), sucralfate (17.3%; =27/156), and a combination of PPI and H2RA (0.6%; =1/156).
CONCLUSION
The study demonstrated overuse of SUP. The most commonly used drug for SUP was H2RA and not PPIs. This study demonstrates that the problem of SUP overuse internationally also exists locally. The development of local guidelines may help to improve the practice of SUP in SA.
CONTRIBUTIONS OF THE STUDY
This study showed overuse of SUP and should encourage doctors to critically evaluate why they prescribe SUP and whether it is really indicated. This should help in the adoption of practices towards appropriate use of SUP.
PubMed: 35498762
DOI: 10.7196/SAJCC.2021.v37i1.439 -
Acta Bio-medica : Atenei Parmensis Feb 2021A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the...
The effect of sucralfate-containing ointment on quality of life in people with symptoms associated with haemorrhoidal disease and its complications: the results of the EMOCARE survey.
BACKGROUND AND AIM
A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease. This survey evaluated the effect of the mentioned sucralfate ointment, on quality of life (QoL) and symptom frequency in participants seeking treatment for haemorrhoidal disease from community pharmacies in Italy.
METHODS
EMOCARE was a multicentre prospective survey conducted at community pharmacies in Italy. Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile). A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment. The primary endpoint was the change in HEMO-FISS-QoL scores.
RESULTS
Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit. After a mean duration of 13 days, the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: -10.41; 95%CI -11.95, -8.86; P<0.001) and mean scores for all domains of the HEMO-FISS-QoL scale (-11.13 [95%CI -12.95, -9.30] for physical disorders, -6.14 [95%CI -7.42, -4.85] for psychology, -18.79 [95% CI -21.67, -15.90] for defaecation, and -6.46 [95%CI -8.40, -4.51] for sexuality; all P<0.001 versus baseline). At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms and the frequency of all assessed symptoms were reduced significantly from baseline (all P<0.05).
CONCLUSIONS
After a mean 13 days of treatment the sucralfate ointment with herbal extracts improved HEMO-FISS-QoL scores and reduced symptoms in people with haemorrhoidal disease.
Topics: Female; Hemorrhoids; Humans; Italy; Male; Middle Aged; Ointments; Prospective Studies; Quality of Life; Sucralfate
PubMed: 33683221
DOI: 10.23750/abm.v92i1.11309 -
Caspian Journal of Internal Medicine 2020Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge,...
BACKGROUND
Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain. Sucralfate, an aluminum-based salt of sucrose octasulfate, is a cytoprotective agent that forms a coating barrier at injured sites by adhering to mucoproteins. It has been used in topical management of a wide variety of local lesion. This study was designed to evaluate the preventive effect of rectal sucralfate on acute radiotherapy induced proctitis.
METHODS
Seven percent sucralfate ointment was prepared for topical use. Drug quantification, chemical stability and microbial limit tests were performed carefully. In this randomized double blind placebo controlled trial, fifty-seven patients with pelvic malignancies undergoing radiotherapy were allocated to receive either 1 g of sucralfate or 1 g of placebo, given as a twice daily ointment, one day before and during radiotherapy for six weeks. The eligible patients were evaluated based on RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency. The influence of symptoms on lifestyle was also recorded weekly.
RESULTS
Acute proctitis was significantly less prevalent in patients in the sucralfate group. The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group. No statistical significant difference was observed for radiotherapy induced cystitis in the placebo and sucralfate groups (P=0.27).
CONCLUSION
This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.
PubMed: 33680383
DOI: 10.22088/cjim.11.4.410 -
Frontiers in Endocrinology 2020Administration of the optimal dose of levothyroxine (LT4) is crucial to restore euthyroidism after total thyroidectomy. An insufficient or excessive dosage may result in... (Review)
Review
Administration of the optimal dose of levothyroxine (LT4) is crucial to restore euthyroidism after total thyroidectomy. An insufficient or excessive dosage may result in hypothyroidism or thyrotoxicosis, either one associated with a number of symptoms/complications. Most literature regarding the LT4 dosage deals with the treatment of primary hypothyroidism, whereas a limited number of studies handle the issue of thyroxin replacement after total thyroidectomy. A literature review was performed focusing on all papers dealing with this topic within the last 15 years. Papers that reported a scheme to calculate the proper LT4 dose were collected and compared to set up a review exploring limits and drawbacks of LT4 replacement therapy in the wide population of patients who had undergone thyroidectomy. Most of the methods for monitoring and adjusting thyroid hormone replacement after thyroidectomy for benign disease use LT4 at an empirical dose of approximately 1.6 μg/kg, with subsequent changes according to thyroid function test results and assessments of the patient's symptoms. Approximately 75% of patients require a dose adjustment, suggesting that factors other than body weight play a role in the determination of the proper LT4 dose. Hence, several schemes are reported in the literature for the proper initial dose of LT4. An inadequate level of thyroid hormone levels in these patients can be due to several factors. The most common ones that lead to the necessity of LT4 dose adjustments include lack of compliance, changes in LT4 formulation, dosage errors, increased serum levels of T4-binding globulin, body mass changes, and dietary habits. Moreover, concomitant ingestion of calcium supplements, ferrous sulfate, proton-pump inhibitors, bile acid sequestrants, and sucralfate might influence LT4 absorption and/or metabolism. Furthermore, some gastrointestinal conditions and their treatments can contribute to suboptimal LT4 performance by altering gastric acidity and thereby reducing its bioavailability, particularly in the solid form. Beyond the classic tablet form, new formulations of LT4, such as a soft gel capsule and an oral solution, recently became available. The liquid formulation is supposed to overcome the food and beverages interference with absorption of LT4 tablets.
Topics: Animals; Biomarkers; Dose-Response Relationship, Drug; Humans; Hypothyroidism; Thyroid Function Tests; Thyroid Neoplasms; Thyroidectomy; Thyroxine
PubMed: 33584551
DOI: 10.3389/fendo.2020.626268 -
Frontiers in Medicine 2020This work aims to study the gastrointestinal (GI) symptoms in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected patients and the susceptibility...
This work aims to study the gastrointestinal (GI) symptoms in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-infected patients and the susceptibility factors of the stomach for SARS-CoV-2. We investigated the SARS-CoV-2 susceptibility by analyzing the expression distribution of viral entry-associated genes, and , in single-cell RNA sequencing data derived from 12 gastric mucosa samples. We also analyzed the epidemiological, demographic, clinical, and laboratory data of 420 cases with SARS-CoV-2-caused coronavirus disease 2019 (COVID-19). and are specifically expressed in enterocytes which are mainly from gastric mucosa samples with () infection history and intestinal metaplasia (IM). A total of 420 patients were surveyed, of which 62 were with and 358 were without GI symptoms. There is a significant difference in average hospital stay ( < 0.001) and cost ( < 0.001) between the two groups. Among 23 hospitalized patients including seven with upper GI symptoms and 16 with lower GI symptoms, six (85.7%) and five (31.3%) had infection history, respectively ( = 0.03). Of 18 hospitalized patients with initial upper GI symptoms, none of the eight patients with mucosal protective agent therapy (e.g., sucralfate suspension gel, hydrotalcite tablets) had diarrhea subsequently, whereas six out of 10 patients without mucosal protective agent therapy had diarrhea subsequently ( = 0.01). IM and infection history may be susceptibility factors of SARS-CoV-2, and the mucosal protective agent may be useful for the blockade of SARS-CoV-2 transmission from the stomach to the intestine.
PubMed: 33521016
DOI: 10.3389/fmed.2020.597967 -
The American Journal of Case Reports Jan 2021BACKGROUND Cameron lesions are linear erosions and ulcers on the crests of gastric mucosal folds in the neck of a hiatal hernia and can be difficult to diagnose and...
A 61-Year-Old Woman with Chronic Iron-Deficiency Anemia Due to a Cameron Lesion and a Response to Oral Application of Combined Poloxamer 407 with Hyaluronic Acid and Chondroitin Sulfate Following Single Treatment with Pantoprazole: A Case Report.
BACKGROUND Cameron lesions are linear erosions and ulcers on the crests of gastric mucosal folds in the neck of a hiatal hernia and can be difficult to diagnose and treat. This report is of a case of chronic iron deficiency in a 61-year-old woman with a late diagnosis of a Cameron lesion, who did not respond to a single treatment with the proton pump inhibitor (PPI) pantoprazole, but was then treated with oral poloxamer 407 with hyaluronic acid and chondroitin sulfate in addition to PPI. CASE REPORT We report the case of a 61-year-old women with recurrent iron-deficiency anemia, first diagnosed 40 years prior to her presentation at our Endoscopy Unit, and an ongoing melena. We discovered an intrahiatal gastric mucosal defect, which we at first treated with proton pump inhibitors and sucralfate. After a follow-up gastroscopy revealed the persistence of the lesion, we decided to incorporate into the treatment a gel-like substance containing, among others, hyaluronic acid and chondroitin sulfate, and observed that the lesion resolved completely. CONCLUSIONS This report highlights that Cameron lesions should be considered in patients with hiatal hernia who have iron-deficiency anemia and can be diagnosed on upper endoscopy. Further clinical studies are required to determine the role of combined poloxamer 407 with hyaluronic acid and chondroitin sulfate in the management of Cameron lesions.
Topics: Adjuvants, Immunologic; Anemia, Iron-Deficiency; Chondroitin Sulfates; Chronic Disease; Drug Carriers; Female; Gastroscopy; Hernia, Hiatal; Humans; Hyaluronic Acid; Middle Aged; Pantoprazole; Poloxamer; Proton Pump Inhibitors; Stomach Ulcer
PubMed: 33473099
DOI: 10.12659/AJCR.928021