RESUMEN
Sucralfate, which is a sucrose octasulfate aluminum complex, is an active pharmaceutical ingredient (API) falling in the category of cytoprotective agents which are very effective for gastric and duodenal ulcers. On interaction with stomach acid, it ionizes into aluminum and sucrose octasulfate ions to form a protective layer over the ulcerated region inhibiting further attack from acid. The mechanism of action of sucralfate in the context of its structure is not well understood. Considering that at least two forms of this API are available in the market, there are no reports on the various forms of sucralfate and differences in their pharmacological action. We characterized the two forms of sucralfate using multinuclear, multidimensional solid-state NMR, and the results show significant structural differences between them arising from variation in the aluminum environment and the level of hydration. The impact of structural differences on pharmacological action was examined by studying acid-induced Al release by 27Al liquid-state NMR. The sucralfate, European pharmaceutical standard, Form I, undergoes faster disruption in acid compared to Form II. The difference is explained on the basis of structural differences in the two forms which gives significant insights into the action of sucralfate in relation to its structure.
Asunto(s)
Antiulcerosos , Úlcera Duodenal , Humanos , Sucralfato/uso terapéutico , Sucralfato/química , Sucralfato/farmacología , Aluminio/farmacología , Úlcera Duodenal/tratamiento farmacológico , Espectroscopía de Resonancia Magnética , Imagen por Resonancia Magnética , Antiulcerosos/uso terapéuticoRESUMEN
BACKGROUND AND AIMS: A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that act as a mechanical barrier to facilitate healing. The aim of this prospective, observational study was to determine patient- and physician-assessed effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for the treatment of hemorrhoidal symptoms in routine clinical practice. METHODS: Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate were enrolled. Patients were administered treatment twice per day for at least 1 week until symptom resolution and/or for a maximum of 4 weeks. The primary endpoint was patient-assessed effectiveness on a modified Symptom Severity Score (mSSS, range 0 to 14). Physician-assessed effectiveness (9 symptoms, 0 to 5 Likert scale), hemorrhoid grade, and patient satisfaction were also determined. RESULTS: Five investigators enrolled 60 patients; mean age was 48.4 ± 16.6 years and 72.4% were female. Pain or pressure sensitivity was reported as the most severe symptom by patients, and pressure sensitivity, discharge, soiling, and prolapse by physicians. Mean patient-assessed mSSS at baseline was 6.6 ± 1.9 and was significantly improved overall and in the ointment and suppository groups individually by -4.6 ± 2.0, -4.4 ± 1.8, and -4.8 ± 2.2, respectively (p < 0.0001). Investigator-assessed mean baseline symptom score was 18.1 ± 3.9 and improved by -7.1 ± 4.5, -6.9 ± 5.4, and -7.3 ± 3.5, respectively (p < 0.0001). Investigator-assessed symptoms of pressure sensitivity, swelling, and discharge were improved to the greatest extent. Hemorrhoid grade was improved in 38% of patients at the end of treatment. Compliance with treatment was 97.4% and patient satisfaction with application and onset of action was high (81.3% and 76.2%, respectively). Both the ointment and suppository were well tolerated. CONCLUSIONS: The effectiveness of topical ointment or suppository containing sucralfate on patient- and investigator-assessed hemorrhoidal symptoms in real-life clinical practice was demonstrated. Patient satisfaction was high and treatments were well tolerated. Larger controlled trials are warranted to confirm the results.
Asunto(s)
Hemorroides , Pomadas , Sucralfato , Humanos , Sucralfato/administración & dosificación , Sucralfato/uso terapéutico , Hemorroides/tratamiento farmacológico , Femenino , Supositorios , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Satisfacción del Paciente , Adulto , Anciano , Administración RectalRESUMEN
BACKGROUND: Oral mucositis (OM) is considered one of the most common side effects of patients undergoing cancer therapy. OM prevention plays a crucial role in the effectiveness of cancer treatment and the patient's quality of life. Different preventive treatments have been proposed in clinical trials, however with inconclusive results. MATERIALS AND METHODS: A systematic review search was conducted in PubMed, Scopus, Web of Science, and Cochrane Database to answer the PICO question: in cancer patients, do specific topical agents compared to standard treatments or placebo reduce the onset and severity of oral mucositis? The risk of bias was assessed, and a network meta-analysis was conducted. RESULTS: Of 2913 results, 30 randomized clinical trials were considered suitable for inclusion. A total of 2564 patients were analyzed, of which 1284 belonged to the test group and 1280 belonged to the control group. Natural products were the most used, followed mainly by antimicrobial agents, coating agents, and basic oral care measures. Topical sucralfate resulted in the most powerful intervention for the OM prevention (OR = 0.04, 95%C.I. = 0.01-0.25, p-value = 0.001). CONCLUSION: Due to its cytoprotective action, low cost, ease of administration, and safety, sucralfate could become a potential ally to prevent the onset of OM during cancer therapy.
Asunto(s)
Administración Tópica , Metaanálisis en Red , Estomatitis , Humanos , Estomatitis/prevención & control , Estomatitis/tratamiento farmacológico , Estomatitis/etiología , Sucralfato/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias/complicaciones , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico , Productos Biológicos/uso terapéutico , Antiinfecciosos/uso terapéutico , Antiinfecciosos/administración & dosificaciónRESUMEN
BACKGROUND: Hemorrhoidal disease (HD) significantly impacts patients' quality of life. This study aimed to evaluate the effectiveness of preoperative treatment with the micronized purified flavonoid fraction (MPFF) and a sucralfate-based rectal ointment in managing HD symptoms and reducing interventions. METHODS: A prospective quasi-experimental study including consecutive cases and controls matched on the basis of sex was performed in a tertiary referral center. Cases received systemic and local therapy for HD, consisting of a rectal ointment containing 3% sucralfate and herbal extracts plus MPFF, in addition to conservative therapy, while controls received conservative therapy alone. The hemorrhoidal disease symptom score (HDSS), the Short Health Scale for HD (SHS-HD) score, and the Vaizey Incontinence Score were used to evaluate symptoms severity and their impact on quality of life and continence. Intervention requirements were assessed at baseline (T0) and after 60 days of treatment (T1). RESULTS: Between January and December 2023, a total of 98 patients were assessed for eligibility. After exclusions, 56 patients were enrolled, with 28 in each group. Significant improvements were observed in HD symptom scores from T0 to T1: the intervention group showed a mean change in HDSS of -9 [95% confidence interval (CI) -10 to -8], and the control group showed no significant change (mean change of 0; 95% CI -1.5 to 0). At T1, a higher proportion of patients in the intervention group underwent less invasive interventions compared with controls (18% versus 11%). Age, treatment group, and baseline symptom severity significantly predicted post-treatment symptom scores. CONCLUSIONS: In our study the preoperative treatment with MPFF and a sucralfate-based rectal ointment demonstrated clinical benefits in managing HD symptoms and reducing interventions. Further prospective trials are warranted to confirm and explore additional therapeutic strategies.
Asunto(s)
Flavonoides , Hemorroides , Pomadas , Cuidados Preoperatorios , Sucralfato , Humanos , Sucralfato/uso terapéutico , Sucralfato/administración & dosificación , Masculino , Femenino , Persona de Mediana Edad , Estudios Prospectivos , Estudios de Casos y Controles , Resultado del Tratamiento , Flavonoides/administración & dosificación , Cuidados Preoperatorios/métodos , Adulto , Calidad de Vida , Anciano , Administración Rectal , Índice de Severidad de la Enfermedad , Extractos Vegetales/administración & dosificación , Extractos Vegetales/uso terapéuticoRESUMEN
OBJECTIVE: This work aims to present a Quality-by-Design (QbD) step-by-step methodology to formulate anti-ulcer and gastro-protective oral suspensions. METHODS: Sucralfate was used as a drug model. The Quality Target Product Profile was established early during preformulation. Viscosity, resuspendability, pH, and density were assessed through the screening of several suspension platforms based on different prototype compositions. A compatibility study between the active pharmaceutical ingredient and the excipients was performed by thermal analysis and infrared spectroscopy. An Ishikawa fishbone diagram and Failure Mode and Effect Analysis were employed to identify the Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs). CMAs' and CPPs' impact on identified CQAs was further assessed through a 22 full factorial experimental design at normal conditions after manufacture and one month at super-accelerated stress conditions. Results: The lead prototype exhibited no physicochemical incompatibilities. The risk assessment tools revealed that the concentration of the wetting agent and the total concentration of thickening agents represented critical factors for the quality profile of the preparation in terms of viscosity. The optimized formulation comprising 1.125 w/v% total concentration of Natrosol 250 HX and Avicel RC 591 exhibited an enhanced performance according to the established profile. CONCLUSIONS: The analytical and physicochemical tests showed the robustness and compliance of the final preparation with the quality profile. The proposed step-by-step methodology based on QbD, Design of Experiments, and Quality Risk Management presented in our research holds practical implications for local industries and formulation scientists involved in the development of oral suspensions.
Asunto(s)
Antiulcerosos , Química Farmacéutica , Composición de Medicamentos , Excipientes , Sucralfato , Suspensiones , Antiulcerosos/administración & dosificación , Antiulcerosos/química , Viscosidad , Excipientes/química , Sucralfato/administración & dosificación , Sucralfato/química , Administración Oral , Composición de Medicamentos/métodos , Química Farmacéutica/métodos , Concentración de Iones de HidrógenoRESUMEN
Ingestion of caustic agents by children is a serious health issue that can affect the patient for the rest of his life. The role of sucralfate in preventing stricture caused by caustic agents is controversial, and limited studies have been conducted in this field. We aimed to investigate the effect of sucralfate on preventing esophageal stricture in children. Sixty children with mean age of 36.69 ± 20.50 months and grade II B esophageal burns due to ingestion of caustic agents were enrolled in the study. In the intervention group, in addition to the usual treatment, sucralfate was administered orally at a dose of 80 mg/kg every 2 h for 3 days. For the control group, only the usual treatment was prescribed. Stricture development was compared between groups based on endoscopic and radiologic findings. Of the 60 patients enrolled in the study, 53 were examined. The incidence of esophageal stricture in the intervention group was significantly lower than in the control group (37% versus 67%, P-value = 0.042). In addition, the odds of esophageal stricture after sucralfate intervention was significantly reduced after adjustment for potential confounders (OR = 0.198, P-value = 0.031). Conclusions: The results of this study showed that sucralfate may reduce the development of esophageal stricture in children when used to manage IIB esophageal burns due to ingestion of caustic agents. What is Known: ⢠Ingestion of caustic agents by children is a serious health issue that can affect the patient for the rest of his life. ⢠The role of sucralfate in preventing stricture caused by caustic agents is controversial and limited studies have been conducted in this field. What is New: ⢠It seems that sucralfate significantly reduces the incidence of esophageal stricture following the ingestion of caustic agents in children compared to the control group. ⢠We believe that the prognosis may be improved and the risk of stricture formation may be reduced with high doses of sucralfate therapy in grade IIB esophageal injury.
Asunto(s)
Quemaduras Químicas , Cáusticos , Estenosis Esofágica , Humanos , Niño , Lactante , Preescolar , Estenosis Esofágica/inducido químicamente , Estenosis Esofágica/prevención & control , Cáusticos/toxicidad , Sucralfato/uso terapéutico , Constricción Patológica/complicaciones , Quemaduras Químicas/tratamiento farmacológico , Quemaduras Químicas/etiología , Ingestión de AlimentosRESUMEN
Pain and wound after haemorrhoidectomy constantly bothered the patient's convenience. Recurrently, topical sucralfate is used to treat excoriations and burns. It is considered to enhance epidermal growth and tissue granulation, thus, alleviating patients' problems. This study evaluated topical sucralfate's feasibility, safety, and superiority after haemorrhoidectomy. We searched randomised controlled trial (RCT) studies in PubMed, Google Scholar, Europe PMC, and ClinicalTrials.gov until March 29th, 2022. We investigated the influence of topical sucralfate on pain score postoperatively (24 hours, 7 days, and 14 days), pethidine usage, diclofenac usage, and wound healing rate compared to placebo. This study was conducted following the PRISMA guidelines. This study sorted the final six studies with 439 patients underwent haemorrhoidectomy. Topical sucralfate demonstrated significant outcomes on VAS 24 hours post-operative [Std. Mean Difference -1.00 (95% CI -1.70, -0.31), P = .005], VAS 7 days post-operative [Std. Mean Difference -2.29 (95% CI -3.34, -1.25), P < .0001], VAS 14 days post-operative [Std. Mean Difference -1.88 (95% CI -2.74, -1.01), P < .0001], pethidine usage within 24 hours post-operative [Std. Mean Difference -0.62 (95% CI -0.96, -0.27), P = .0004], diclofenac usage 7 days post-operative [Std. Mean Difference -1.76 (95% CI -2.61, -0.92), P < .0001], diclofenac usage 14 days post-operative [Std. Mean Difference -1.64 (95% CI -2.38, -0.91), P < .0001], and wound healing rate at 28-day post-operative [RR 1.45 (95% CI 1.25-1.68), P < .00001]. Topical sucralfate alleviated pain, improved wound healing, and minimised the usage of pethidine and diclofenac compared to placebo.
Asunto(s)
Hemorreoidectomía , Dolor Postoperatorio , Sucralfato , Humanos , Diclofenaco/uso terapéutico , Hemorreoidectomía/efectos adversos , Meperidina/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Sucralfato/uso terapéutico , Cicatrización de HeridasRESUMEN
Wound healing is a dynamic process initiated in response to injury. There are many factors that have detrimental effects on the wound healing process. Numerous studies have been conducted for improving wound healing processes. Dexpanthenol is widely used to accelerate wound healing. Sucralfate is used for the treatment of peptic ulcers. We aimed to compare the efficacy of topical Dexpanthenol and Sucralfate in an experimental wound model in rats via histopathological examinations and immune histochemical determinations, as well, to evaluate their effects on EGF levels. Three different groups were formed: the Control Group, the Dexpanthenol Group and the Sucralfate Group. Full-thickness skin wounds were created on the back of each rat and isotonic saline was applied to the wounds of the rats in the control group, Bepanthol® cream was applied in Dexpanthenol Group and 10% Sucralfate cream was applied in Sucralfate Group, once a day. On the 7th, 14th and 21st days the wounds were measured and seven rats from each group were sacrificed and the wounds were excised for histopathological examination. Sucralfate increased wound healing rates by increasing neovascularization, fibroblast activation, reepithelialization and collagen density, as well as dexpanthenol. Our study revealed that the dexpanthenol and sucralfate groups were better than the control group in terms of their effects on wound healing, however there was no statistically significant difference among these two groups. Sucralfate improves EGF expression in skin wounds and has positive results on skin wound healing comparable to dexpanthenol.
Asunto(s)
Factor de Crecimiento Epidérmico , Sucralfato , Animales , Factor de Crecimiento Epidérmico/farmacología , Ácido Pantoténico/análogos & derivados , Ácido Pantoténico/farmacología , Ratas , Sucralfato/farmacología , Cicatrización de HeridasRESUMEN
Sucralfate is an aluminum salt of sucrose octasulfate, generally considered safe in terms of adverse effects. Systemic sucralfate is FDA-approved for the treatment of duodenal ulcers. Since 1991, topical sucralfate has been used in various mucocutaneous conditions, but it is not approved by the FDA yet. In this systematic review, the online databases were searched with appropriate keywords, and the papers were screened by the authors. After screening steps, the relevant articles were selected according to the inclusions and exclusions criteria. Finally, the full texts of 18 articles were included for final evaluations. In conclusion, topical sucralfate has some clinical benefit in several mucocutaneous conditions, including mucocutaneous inflammatory conditions (e.g., post-radiotherapy reaction, diaper dermatitis, keratoconjunctivitis sicca, etc.), mucocutaneous infectious disorders (e.g., peristomal wound reaction/infection); ulcers; burns, and also pain relief.
Asunto(s)
Quemaduras , Sucralfato , Quemaduras/tratamiento farmacológico , Humanos , Sucralfato/uso terapéutico , Úlcera/tratamiento farmacológicoRESUMEN
There are no standard protocols for peristomal skin care in children with percutaneous endoscopic gastrostomy (PEG) tubes. This clinical study aimed to evaluate the efficacy of topical sucralfate as a prophylactic intervention in the peristomal wound reaction (PWR)/infection-associated PEG insertion in children. This study was a randomized, single-blind, controlled trial recruiting child under 18 years old who submitted for PEG insertion. Patients were randomly divided to receive topical sucralfate + peristomal wound care (intervention) or peristomal wound care alone (control). In the intervention group, the participants used topical 4% sucralfate cream four times a day for 2 months. Participants were assessed using the total peristomal infection score and PWR grading system at baseline week 1, and monthly up to 5 months after the initiation of the study. Forty-four children after PEG insertion were randomly assigned to two groups. Baseline characteristics of both groups were statistically similar (p > 0.05). Friedman test demonstrated statistically significant differences in grades of PWR during the follow-up period in the control group (p = 0.01); while there was not significantly different in the intervention group (p = 0.47). This finding suggests that the intervention had a prophylaxis effect. Also, there were statistically differences in the score of erythema (p = 0.001) and exudate (p = 0.06) at the seven-time points in the control group. Topical 4% sucralfate can be considered an affordable and available prophylactic treatment for reducing the PWR/infection associated with PEG insertion in children.
Asunto(s)
Gastrostomía , Infección de la Herida Quirúrgica , Adolescente , Niño , Gastrostomía/efectos adversos , Gastrostomía/métodos , Humanos , Método Simple Ciego , Cuidados de la Piel , Sucralfato/efectos adversos , Infección de la Herida Quirúrgica/prevención & controlRESUMEN
The study aims to establish the plasma pharmacokinetic parameters of levofloxacin in mixed-breed dogs, at a single dose of 5 mg/kg, intravenously, orally only and orally with sucralfate pre-treatment (1 g per animal), to evaluate its influence on antimicrobial absorption. Concentrations of levofloxacin in plasma were determined using high-performance liquid chromatography (HPLC) with fluorescence detection. After iv of levofloxacin, the mean (±SD) of AUC0-24, Vz, t½λz and MRT, was 19.05 ± 6.4 µg-h/ml, 2.43 ± 0.5 L/kg, 7.93 ± 1.41 hours and 8.7 ± 1.5 hours, respectively. After oral administration, the C max, t½λz and bioavailability were 1.95 ± 0.7 µg/ml, 7.65 ± 1.38 hours and 71.93 ± 9.75%, respectively. In animals given an oral dose of levofloxacin with sucralfate pre-treatment, there was a significant decrease (p < 0.05) in C max (0.57 ± 0.23 µg/ml), AUC (5.73 ± 2.26 µg-h/ml) and bioavailability (31.92 ± 14.19%). In the dogs studied, it is suggested that the dose 5 mg/kg of levofloxacin for both routes is inadequate to meet PK-PD targets for susceptible bacteria using breakpoints established by the Institute of Clinical and Laboratory Standards (CLSI).
Asunto(s)
Antibacterianos/farmacocinética , Levofloxacino/farmacocinética , Sucralfato/farmacocinética , Administración Intravenosa , Administración Oral , Animales , Antiinfecciosos , Área Bajo la Curva , Bacterias , Disponibilidad Biológica , Perros , Interacciones Farmacológicas , MasculinoRESUMEN
The healing of haemorrhoidectomy wounds is a main concern of surgeons and patients. Various modalities can improve the quality of wound care after surgery. Antibiotics and topical agents, such as solutions and ointments, have been evaluated. The current research investigates the effects of sucralfate ointment on wound healing (epithelialisation) and postoperative pain after open haemorrhoidectomy. This trial involves two groups of randomly collected patients (n = 40) who underwent open haemorrhoidectomy surgery by the Milligan-Morgan method. A 10% topical sucralfate ointment was applied to the investigated group's wounds, while the control group patients used Vaseline as a placebo. The present work measured the two outcomes as follows: pain severity by a Visual Analogues Scale (VAS) score and epithelialisation by a surgeon's visual inspection. During the postoperative phase, the mean VAS was 3.70 for the investigated group and 6.90 for the control group. On the average, the completion of epithelialisation for the investigated group was on day 13 as opposed to day 20 for the control group. The topical application of sucralfate ointment on post-haemorrhoidectomy wound is an effective method for the promotion of healing, also lessens the severity of pain, and reduces the need for analgesics.
Asunto(s)
Analgésicos/uso terapéutico , Antiulcerosos/uso terapéutico , Hemorreoidectomía/efectos adversos , Pomadas/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Sucralfato/uso terapéutico , Cicatrización de Heridas/efectos de los fármacos , Administración Tópica , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos/administración & dosificación , Método Doble Ciego , Femenino , Humanos , Irán , Masculino , Persona de Mediana Edad , Pomadas/administración & dosificación , Sucralfato/administración & dosificación , Resultado del TratamientoRESUMEN
BACKGROUND: This audit was aimed at studying current practices regarding the use of stress ulcer prophylaxis (SUP) in the Indian critical care setup, with the background aim of raising awareness regarding the use and indications of SUP in critically ill patients. MATERIALS AND METHODS: After registering the trial with the clinical trial registry, India, a structured audit questionnaire containing 26 questions pertaining to SUP was distributed through electronic media among clinicians working in the intensive care units (ICUs) across India. Responses obtained were statistically analyzed. RESULTS: The questionnaire was sent to 550 clinicians. Only 197 responded, of whom 91.4% were anesthesiologists, 5.6% were physicians, and 3% were intensivists. The audit revealed that 33% respondents were unaware of the existing SUP guidelines and around 32% did not have protocols for SUP in their ICU. Sixty-nine percent of respondents felt that all ICU patients must receive SUP and 44.7% opined that it should be started on ICU arrival. Almost 94% knew that early enteral feeding is protective against stress ulceration. Only 24.9% responders agreed that there must be clear indications for SUP, and most of them were unaware of all the potential side effects. Once initiated, 43.7% respondents would stop prophylaxis when no indication was left, whereas 69 respondents would stop on ICU discharge. CONCLUSION: There is a lack of awareness regarding initiation, choice of agent, adverse effects as well as termination of SUP in ICU and guidelines for the same. Institutional protocols should be in place and steps need to be taken to prevent unwarranted use. HOW TO CITE THIS ARTICLE: Gupta D, Bhalotra AR, Singh R. Audit on Practices of Stress Ulcer Prophylaxis in Intensive Care Unit Patients. Indian J Crit Care Med 2020;24(3):160-167.
RESUMEN
Radiation dermatitis is a common sequela of radiation therapy; up to 95% of patients will develop moderate-to-severe skin reactions. No criterion standard currently exists for the treatment of acute radiation-induced skin toxicity. It is therefore imperative to develop a greater understanding of management options available to allow clinicians to make informed decisions when managing radiation oncology patients. This literature review discusses the topical agents that have been studied for the treatment of acute radiation dermatitis, reviews their mechanisms of action, and presents a treatment algorithm for clinicians managing patients experiencing radiation dermatitis.
Asunto(s)
Algoritmos , Fármacos Dermatológicos/uso terapéutico , Radiodermatitis/tratamiento farmacológico , Enfermedad Aguda , Corticoesteroides/uso terapéutico , Antiinfecciosos Locales/uso terapéutico , Vendajes , Productos Biológicos/uso terapéutico , Etanolaminas/uso terapéutico , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Preparaciones de Plantas/uso terapéutico , Radiodermatitis/etiología , Radioterapia/efectos adversos , Sulfadiazina de Plata/uso terapéutico , Sucralfato/uso terapéutico , Vitaminas/uso terapéuticoRESUMEN
AIM: To offer a practice insight for the management of chemoradiation toxic mucositis. METHOD: Review chemoradiation toxic mucositis, its pathobiology and breadth of symptom presentation. Review mucositis guidelines and guideline-supported anti-mucositis therapies. Offer guidance on guidelines and an abbreviated review of high potency cross-linked sucralfate for management of chemoradiation toxic mucositis. RESULT: There are six major mucositis guidelines but only one that is current and regularly updated. Guidelines from the Multinational Association Supportive Cancer Care suggest 14 interventions gleaned from controlled trials, 12 of which are off-label uses of therapies that offer statistically significant but incrementally beneficial outcomes. Several evidence-based limitations of guidelines are discussed. Data on high potency polymerized cross-linked sucralfate confirming complete prevention and rapid (2-3 days) elimination, sustained throughout cancer treatment is verified as high quality evidence in accordance to standards adopted by Agency for Healthcare Research and Quality. A 96-97% reduction in mucositis duration qualifies as a positive Glasziou treatment effect, which is discussed as an additional measure of evidence-based medicine. CONCLUSION: Statistically significant but fractional treatment effects of guideline-supported interventions are not likely to substantially alter the course of mucositis when it occurs nor completely prevent its onset. Complete prevention and rapid sustained elimination should be the goal, therefore high potency polymerized cross-linked sucralfate may be useful. Where guidelines fail, institution-based protocols led by oncology pharmacists could succeed. In an effort to eliminate toxic mucositis, enhance compliance to chemoradiation regimens, and improve survival, such protocols for practice may verify pharmacoeconomic benefits, if any, in using high potency polymerized cross-linked sucralfate to manage toxic mucositis.
Asunto(s)
Quimioradioterapia/efectos adversos , Mucositis/tratamiento farmacológico , Neoplasias/terapia , Manejo de Atención al Paciente , Guías de Práctica Clínica como Asunto , Sucralfato/uso terapéutico , Medicina Basada en la Evidencia , Humanos , Mucositis/etiologíaRESUMEN
OBJECTIVE: Devising effective measures for the prevention of hydrochloric acid (HCl)-induced erosion is of great significance. This is even more important in dentine, in which products have limited diffusion. Therefore, agents that can bind to proteins forming an acid-resistant gel-like coat, such as sucralfate, may stand out as a promising alternative. This study investigated the protective effect of sucralfate suspensions against HCl-induced dental erosion. MATERIALS AND METHODS: In the first experiment, hydroxyapatite (HAp) crystals were pre-treated with a commercial sucralfate suspension (CoSS, pH 5.9), a stannous-containing sodium fluoride solution (NaF/SnCl2 pH 4.5), two prepared sucralfate suspensions (PrSS, pH 5.9 and 4.5), or deionized water (DI, control). HAp dissolution was measured using a pH-stat system. In a subsequent experiment, embedded/polished enamel and root dentine slabs were allocated into five groups to be treated with one of the tested substances prior to and during erosion-remineralization cycles (HCl-2 min + artificial saliva 60 min, two times per day, 5 days). Surface loss was assessed profilometrically. Data were analyzed by ANOVA and Tukey's tests. RESULTS: HAp dissolution was as follows: NaF/SnCl2 < CoSS < PrSS/pH 4.5, while PrSS/pH 5.9 = DI and both did not differ from CoSS and PrSS/pH 4.5. In enamel, surface loss did not differ between CoSS and PrSS/pH 4.5, with both having lower surface loss than PrSS/pH 5.9 and DI and NaF/SnCl2 differing only from DI. In root dentine, surface loss was as follows: CoSS < PrSS/pH 5.9 < (NaF/SnCl2 = DI), while PrSS/pH 4.5 = CoSS = PrSS/pH 5.9. CONCLUSION: Sucralfate suspension provided anti-erosive protection to HCl-induced erosion. CLINICAL RELEVANCE: Sucralfate may protect teeth against erosion caused by gastric acid.
Asunto(s)
Ácido Clorhídrico/efectos adversos , Sucralfato/farmacología , Erosión de los Dientes/prevención & control , Animales , Bovinos , Esmalte Dental/efectos de los fármacos , Dentina/efectos de los fármacos , Durapatita , Fluoruros , Fluoruro de Sodio , Erosión de los Dientes/inducido químicamenteRESUMEN
Bart syndrome consists of aplasia cutis congenita (ACC) and dominant or recessive dystrophic epidermolysis bullosa (DEB), associated with skin fragility and nail dysplasia. ACC in DEB is thought to be caused by trauma, the most cited cause being in utero formation of bullae consequent to friction of the limbs. Epidermolysis bullosa (EB) refers to a hereditary mechanobullous disease following trauma, characterised by formation of blisters on the skin and mucous membranes. There are four categories of the disease, including epidermolysis bullosa simplex, junctional epidermolysis bullosa, dystrophic epidermolysis bullosa and Kindler syndrome. Infection, sepsis and death may occur as a consequence of generalised blistering with complication. We present the case of a newborn diagnosed with DEB and whose lesions became almost fully epithelialised after treatment with 10% topical sucralfate.
Asunto(s)
Antiulcerosos/uso terapéutico , Displasia Ectodérmica/tratamiento farmacológico , Epidermólisis Ampollosa Distrófica/tratamiento farmacológico , Sucralfato/administración & dosificación , Sucralfato/uso terapéutico , Administración Tópica , Humanos , Recién Nacido , Masculino , Resultado del TratamientoRESUMEN
PURPOSE: To determine a correlation between the 99mTc sucralfate scan and the endoscopy findings in children with caustic oesophageal injury. METHODS: This is an observational analytic study of children who had both 99mTc sucralfate scan and endoscopy after caustic substance ingestion at our institution in a period between January 2009 and September 2016. The oesophageal injury was classified into low grade and high grade according to the degree of adhesion on 99mTc sucralfate scan and modification of Zargar endoscopic grading. RESULTS: Out of a total of 197 children, 40 children were identified who had both investigations done on average 26 h post-injury. Low-grade adhesion on 99mTc sucralfate scan was found in 27 children (68%), and all had low-grade Zargar's oesophageal injuries. None of these subsequently developed residual pathology. Thirteen had high-grade adhesion and five of these had high-grade injury on endoscopy. Three (23%) developed oesophageal strictures. Correlation of 99mTc sucralfate and endoscopic findings reached statistical significance with a p value of 0.0014. No morbidity was associated with either the scan or endoscopy. CONCLUSIONS: We concluded that low-grade sucralfate scan finding has the potential to successfully eliminate the need for invasive endoscopy under general anaesthesia and thereby reducing procedure-related morbidity, hospitalization and associated costs. However, mandatory endoscopy is required in children with high-grade adhesion seen on 99mTc sucralfate scan. This requires confirmation using a larger prospective study.
Asunto(s)
Quemaduras Químicas/diagnóstico por imagen , Endoscopía , Esófago/lesiones , Compuestos de Organotecnecio , Radiofármacos , Sucralfato , Cáusticos/toxicidad , Preescolar , Estenosis Esofágica/etiología , Esófago/diagnóstico por imagen , Femenino , Humanos , Lactante , Puntaje de Gravedad del Traumatismo , Tiempo de Internación/estadística & datos numéricos , Masculino , CintigrafíaRESUMEN
Approximate oncology-wide incidence, duration, costs and deaths associated with mucositis and identify health economic benefits of antimucositis therapies. Review the literature relevant to the clinical experience of mucositis by pathophysiology, incidence, duration, costs and deaths. Use US insurance actuarial and epidemiology on cancer to generalize an oncology-wide impact of toxic mucositis. Toxic mucositis causes oropharyngoesophageal ulcerations, chemo-induced nausea, vomiting and diarrhea. Acutely, it lasts 102 days/six cycles of chemotherapy, 60 days in human stem-cell transplantation patients and 70-84 days in head and neck cancer patients at annual costs of US$13.23 billion/522,166 treated patients (US$20,892/erosive-type mucositis patient, US$25,337/physiologic mucositis patient) and 46,699 deaths. Using antimucositis therapies prior to 2013 provided fractional benefits at high costs. By completely preventing and rapidly reversing mucositis, high-potency polymerized cross-linked sucralfate promises superior health economic benefits.
Asunto(s)
Quimioradioterapia/efectos adversos , Mucositis/epidemiología , Mucositis/etiología , Neoplasias/complicaciones , Quimioradioterapia/métodos , Costo de Enfermedad , Análisis Costo-Beneficio , Femenino , Costos de la Atención en Salud , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Hospitalización , Humanos , Incidencia , Masculino , Mortalidad , Mucositis/diagnóstico , Mucositis/terapia , Neoplasias/terapia , Guías de Práctica Clínica como Asunto , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Ventilator-associated pneumonia (VAP) is a common cause of infectious morbidity and mortality in the intensive care unit (ICU). The type of stress-ulcer prophylaxis (SUP) given to ventilated patients may, in part, be responsible. We observed an increase in VAP as ventilator bundle compliance increased and a decrease in VAP when bundle compliance decreased. We reasoned that SUP which raises gastric pH such as proton-pump inhibitors (PPIs) and histamine II (H2) receptor antagonists as opposed to SUP which does not raise pH such as sucralfate (S) may be responsible and also may alter the causative bacteria. MATERIALS AND METHODS: This is a single-center retrospective cohort analysis of all intubated, adult surgical patients admitted to the surgical ICU between January and June during the 3-y period 2012-2014. Demographics, APACHE II, Injury Severity Score, VAP occurrence, culprit bacteria, ventilator days, and ICU days were recorded based on the type of SUP given. RESULTS: There were 45 instances of VAP in the 504 study patients, 33 in the PPI/H2 group, and 12 in the S group (P < 0.01). VAP per 1000 ventilator days were 10.2 for PPI/H2 and 3.7 for S (P < 0.01). Culprit bacteria were mostly Pseudomonas, gram-negative bacilli, and methicillin-resistant Staphylococcus aureus in PPI/H2 patients (n = 29) compared with oropharyngeal flora in S patients (n = 6; P < 0.001). CONCLUSIONS: There was a substantial difference in VAP occurrence and in the culprit bacteria between S and PPI/H2 treated patients due perhaps to gastric alkalization.