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Cochrane Corner: Corticosteroids for viral myocarditis - Servicios Personalizados



  Archivos Venezolanos de Farmacología y Terapéutica consult for skin lesions that worsened after treatment with prednisone for (30 mg/day) 3 months. Prednisone is an anti-inflammatory steroid drug widely used in clinical practice. However, no high- performance liquid chromatographic (HPLC) method has. Affiliations. 1 Laboratório de Farmacologia Clínica e Terapêutica, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal;. ❿  


Prednisone farmacologia. Effects of salbutamol, montelukast and prednisone on orthodontic tooth movement in rats



 

Objective : To evaluate the effect of salbutamol, montelukast, and prednisone on orthodontic tooth movement in rats. Material and Methods: In vivo experimental preclinical study. The sample consisted of 48 rats randomly distributed in four study groups. All were fitted with orthodontic devices and the medications were administered intraperitoneally every 12 hours for 5 days. The clinical evaluation variation in the interincisal distance was performed at one, three, five, and seven days and the histopathological analysis cell count at five and seven days.

It was found that the salbutamol group presented higher variation values in the interincisal distance on all the days evaluated. Conclusion : The administration of salbutamol increased the magnitude of orthodontic tooth movement; nonetheless, the administration of montelukast and prednisone did not modify the magnitude of orthodontic tooth movement in rats. Alqahtani H. Medically compromised patients in orthodontic practice: Review of evidence and recommendations.

Int Orthod. Modifying oxygen tension affects bone marrow stromal cell osteogenesis for regenerative medicine. World J Stem Cells. Impact of inhaler use on dental caries in asthma pediatrics patients: A case-control study. Arch Argent Pediatr. Medication effects on the rate of orthodontic tooth movement: a systematic literature review.

Am J Orthod Dentofacial Orthop. Effect of the leukotriene receptor antagonist montelukast on orthodontic tooth movement. J Oral Sci. Prevention of glucocorticoid induced-apoptosis of osteoblasts and osteocytes by protecting against endoplasmic reticulum ER stress in vitro and in vivo in female mice. Histomorphometric study of the periodontal ligament in the initial period of orthodontic movement in Wistar rats with induced allergic asthma.

Juveniles versus adults: differences in PGE2 levels in the gingival crevicular fluid during orthodontic tooth movement. Braz Oral Res. J Cell Biochem. Biochem Bioph Res Co. Pharmaceuticals Basel, Switzerland. Effect of acetaminophen, ibuprofen and methylprednisolone on different parameters of human osteoblast-like cells. Arch Oral Biol.

Seminars in Orthodontics. World J Neurosci. Experimental tooth movement and photobiomodulation on bone remodeling in rats.

Lasers Med Sci. Magdalena CM. J Dent Res. Experimental tooth movement-induced osteoclast activation is regulated by sympathetic signaling.

Oral Diseases. Low dose propranolol decreases orthodontic movement. Bioorg Med Chem. The relevance of leukotrienes for bone resorption induced by mechanical loading. Prednisolone treatment reduces the osteogenic effects of loading in mice.

Blocking glucocorticoid signaling in osteoblasts and osteocytes prevents mechanical unloading-induced cortical bone loss. Suppression of autophagy in osteocytes does not modify the adverse effects of glucocorticoids on cortical bone. Animal models to explore the effects of glucocorticoids on skeletal growth and structure.

J Endocrinol. Table of Contents. Read More. Highlited Articles. CiteTrack Scopus. Contact Us. Author Biographies Victor Chumpitaz-Cerrate, 1. Downloads PDF. Published Issue Vol. Clinical or Laboratorial Research Manuscript Prosthetic design and restorative material effect on the biomechanical behavior of dental implants: strain gauge analysis.

Longevity of bonded composite restorations after dentin biomodification with neolignans obtained from Nectandra leucantha. Prosthesis and implant survival in immediately loaded full arch restorations using fiber-reinforced versus non-reinforced temporary frameworks: a randomized clinical trial. All the contents of this journal, except where otherwise noted, is licensed under a Creative Commons Attribution License.

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Prednisone farmacologia.Corticosteroid safety in COVID-19 patients: a pharmacovigilance study



    Pharmaceuticals Basel, Switzerland. All were fitted with orthodontic devices and the medications were administered intraperitoneally every 12 hours for 5 days.

Validation was performed according to current Brazilian legislation. Additionally, the assumptions for a linear regression model were evaluated. The developed method was applied for the assay and content uniformity determination of three batches of prednisone capsules.

Prednisone reference standard Capsules of gelatin containing 20 mg of prednisone in three different formulations, prepared by three compound pharmacies with undisclosed origin, were used. Samples of prednisone API as well as a mixture of the excipients placebo have also been provided. The composition of each batch and the role of each excipient are presented in Table I. Chromatographic separation was accomplished in a Zorbax C18 x 4.

The mobile phase was filtered at 0. Linearity was assessed from three analytical curves for prednisone reference standard solutions in the concentrations of Both regression equation and the determination coefficient r 2 were obtained by ordinary least squares method. The obtained data were further statistically analyzed to prove that they met the assumptions for a linear regression. The Jacknife test was used in order to evaluate the presence of outliers. Ryan-Joiner, Durbin-Watson, and Brown-Forsythe tests were performed to assess normality, independency, and homoscedasticity of residuals, respectively.

Excipient samples used in the three batches A, B, and C were prepared in order to check any interfering peak eluting at the same retention time as the peak of prednisone at the lowest concentration Selectivity was further assessed by analyzing prednisone peak purity. The solutions of placebo were prepared by weighing an amount of excipient equivalent to the amount of excipient present in capsules containing 5 mg of prednisone.

Repeatability intra-day precision was evaluated calculating the relative standard deviation RSD of six independent solutions of prednisone API at Intermediate precision inter-day precision was assessed repeating the procedures of repeatability on two different days by two analysts, and the RSD of the 12 solutions was determined.

Accuracy was estimated by spiking known amounts of prednisone reference standard at Recovery was determined as the percentage ratio between the average concentration obtained experimentally and the corresponding theoretical concentration at each level. The parameters ratio of methanol in mobile phase, mobile phase flow-rate, and oven temperature were varied in order to test robustness as shown in Table II.

The optimized and validated method was employed in assay and content uniformity determination of three batches of prednisone capsules. Assay was performed in triplicate for each batch. Samples of capsules were prepared by weighing an appropriate mass of the powder equivalent to the amount of prednisone required to obtain the concentration used in the developed method Since there are no methods described in the literature for determination of prednisone in capsules, those for determination in API and in tablets were primarily tested in this study.

However, these methods were not reproducible, being not suitable for the quantification in capsules. However, according to our results, this method was not selective, as some excipients used in the formulation were absorbed significantly at the same wavelength as prednisone.

The solutions of placebo from batches A, B, and C presented absorbances of about 9. Therefore, the results found with the spectrophotometric method were overestimated when compared to those using the chromatographic method developed in this study. The high amount of tetrahydrofuran in the mobile phase resulted in an unstable baseline, which may lead to uncertainty of measurement.

The probable reason for this behavior is the peroxide formation, which occurs when tetrahydrofuran is exposed to light, as already described in the literature Clark, In this context, a new chromatographic method was developed and validated. Tetrahydrofuran was excluded and the mobile phase was composed of methanol and water in an optimized ratio to achieve a reduced analysis time. The best conditions were those described in the section Apparatus and chromatographic conditions , which were used to validate the method.

The retention time for prednisone was 3. Plate number and tailing factor were 8, and 1. The analytical curve, as well as parameters of the linear regression is presented in Figure 2 and Table III. The coefficient of determination r 2 obtained was higher than the preconized minimal value of 0. Since a high value of determination coefficient does not necessarily mean a linear model, the assumptions concerning the residuals were tested Souza, Junqueira, SOUZA, S.

A procedure to assess linearity by ordinary least squares method. Acta, v. No outliers were found according to the Jacknife test, at a significance level of 0. Normality of residual distribution was confirmed by the Ryan-Joiner test, as the correlation coefficient obtained 0. Independency of residuals was verified using the Durbin-Watson test. There was no correlation between the residuals; i. The homoscedasticity was proved by the Brown-Forsythe test, with t L t from Levene of 0.

Thus, there was no statistical difference between variances obtained for all tested levels; i. The calculated F value The calculated F value 0. Selectivity was assessed by comparing the chromatograms obtained with a sample of prednisone reference standard at No chromatographic peaks were observed in the chromatograms of placebo samples batches A, B, and C at the same retention time as prednisone in the reference standard sample Figures 3 A and 3B.

B Expanded chromatograms of A. C Spectrum of ultraviolet absorbance in the range nm for prednisone. Chromatographic peak purity of prednisone in capsule samples was confirmed by means of ChemStation software Agilent, USA. Moreover, the spectrum of absorbance in the range between to nm for capsule samples, obtained with ChemStation software Figure 3 C , exhibited a similar profile, with minimums and maximums in the same wavelength of the spectrum of prednisone reference standard found in the literature Moffat, Osselton, Widdop, MOFFAT, A.

Clarke's analysis of drugs and poisons3. London: Pharmaceutical Press, The content of prednisone in samples at In the evaluation of inter-day precision assessed on two different days by two analysts , the mean content was According to current Brazilian legislation, RSD must not exceed the limit of 5. Therefore, the developed method showed appropriate repeatability and intermediate precision. Accuracy was calculated comparing the responses obtained for samples of prednisone reference standard with those obtained for placebo spiked with prednisone at The test was applied separately for batches A, B, and C.

A practical guide to analytical method validation. According to the Pharmacovigilance Program of the Hospital Universitari de Bellvitge, corticosteroids were the drugs with the most side effects reported; infections being the most frequently, followed by complications in diabetic patients and gastrointestinal bleeding The World Health Organization WHO carried out a systematic review of the side effects presented in patients treated with COVID, and reported that serious corticoesteroids-related side effects occurred with high-dose administration, infections being the most frequent.

On the other hand, under lower doses, patient mortality was related to specific causes such as mechanical ventilation and cardiac arrhythmias, but not side effects Pharmacovigilance is important to asses the side effects presented after the administration of drugs; therefore, active pharmacovigilance protocols are useful to stablish the safety of a treatment. In this study, under a method of direct identification of side effects with the execution of multipurpose databases, laboratory studies and changes in the behavior of diseases were recorded after the administration of corticosteroids treatment.

It is important to remember that corticosteroids administered after short periods, present like immunosuppression, associated infections, hyperglycemia and osteoporosis9, Hyperglycemia is one of the most common side effects in SARS-CoV-2 patients treated with corticosteroids because they inhibit gluconeogenesis, decrease pancreatic insulin production, and promote lipolysis in adipose tissue. In patients with a history of diabetes, these effects are perpetuated, leading to severe hyperglycemia In addition, the pancreas also has the ability to release steroids during an infectious process, therefore, the use of corticosteroids in diabetic patients under COVID infections represents a risk of hyperglycemia.

It is of great importance to carry out a thorough review where it is possible to verify the safety of the use of corticosteroids as a treatment for the disease12, What is the safety profile of methylprednisolone and dexamethasone in suspected and confirmed COVID patients under treatment? Currently, there is no specific treatment established worldwide for SARS-CoV-2 disease, the treatments used decrease the symptoms and speed up the recovery process, however, they do not represent a cure for the disease.

These treatment plans have been used in Mexico and have shown favorable results. At the Ignacio Chavez National Institute of Cardiology, methylprednisolone was used as the initial treatment. RECOVERY results demonstrated that dexamethasone reduced endothelial dysfunction and prothrombotic effects, thus reducing symptoms, days of hospitalization and mortality in patients under mechanical ventilation.

The increase of basal glucose levels and the risk of a hospital acquired infection are related to the dose of administration of corticosteroids such as methylprednisolone and dexamethasone at high and low doses respectively in suspected and confirmed patients with COVID As there is no specific treatment for SARS-CoV-2 disease, it is important to ensure that the treatment regimens used are safe.

In addition, they must be effective for the patient and guarantee that the benefit after administration is greater than the risk of presenting side effects and their complications. Hyperglycemia was evaluated in terms of its harshness and severity in relation to the maximum glucose level that the patients presented during the first 10 days after the start of treatment, or the first 10 days of hospitalization in patients without corticosteroids.

The infections were evaluated taking into account the temporality, relating them to the administration of corticosteroids or hospital admission, in the control group. Documented infections during the first two days of treatment were not attributed to corticosteroids or hospitalization in the control group. It was confirmed that the infection identified in microbiological studies correlated with the therapeutic need for the administration of an antibiotic.

It was considered a harsh side effect if the patient died during the infectious process or during the administration of the antibiotic. A side effect was considered moderate when the patient only required taking an antibiotic and did not die, and severe when the patient required the administration of a double antibiotic regimen to treat the infection, or died during the infectious process as exemplified in image 2.

The distribution of the cases with hyperglycemia was 33 in high doses and 82 with low doses of corticosteroids and both high and low doses have the similar distribution in cases of infections as exemplified in graphic 1. The distribution of cases is exemplified in graphic 1 B. It is relevant to consider that this side effects could be conditioned by the presence of risk factors and previous comorbidities that we do not consider on the evaluation.

Drugs are not completely safe, so the risk of side effects that represent harm or severity to the patient is always there. With this study, it is possible to establish a possible relationship between the use of high-dose corticosteroids and a greater distribution of harsh and severe hyperglycemia, as well as a greater number of infections with a greater harshness and severity, when compared with low-dose corticosteroids.

The use of glucocorticoids at high and low doses as a treatment for COVID disease has been shown to be effective in reducing symptoms and days of hospitalization in these patients. However, based on the results obtained, it was concluded that the use of these drugs can cause changes in the basal glucose of patients, in addition to increasing the risk of contracting in-hospital infections due to immunosuppression secondary to the use of glucocorticoids.

Despite the fact that the results of this study do demonstrate a relationship between the use of dexamethasone and methylprednisolone with the mentioned side effects, it is recommended to carry out a broader investigation and with a greater cutoff of the values used, in order to establish a closer relationship between the use of glucocorticoids with hyperglycemia and related infections. Conflict of interests: The authors declare that they do not present a conflict of interest.

Singhal, Tanu. The Indian Journal of Pediatrics. Vol 87 4 , Cytokine and growth factor reviews. Vol 54, Journal of Infection. Vol 80, Mayo Diabetes research and clinical practice. Zabuliene Lina. Hyperglycemia and the novel Covid infection: Possible pathophysiologic mechanisms. Vol , Balanciano, Giselle.

Prednisone is an anti-inflammatory steroid drug widely used in clinical practice. However, no high-performance liquid chromatographic HPLC method has been described in the literature for the determination of prednisone in capsules until now.

The developed method was validated following current Brazilian legislation. Additionally, linearity was assessed by evaluating the assumptions of normality, homoscedasticity, and independency of residuals, and the fit to the linear model. The chromatographic procedure was applied for assay and uniformity content determination of three different batches of prednisone capsules, showing to be suitable for their quality control.

Anti-inflammatory drugs have been widely used in clinical practice due to their ability to suppress inflammation signs and symptoms and also to exert a strong antipyretic and analgesic effect Rang et al. Rio de Janeiro: Elsevier, Rio de Janeiro: MGraw Hill, Anti-inflammatory drugs may be classified as non-steroidal drugs NSAIDs and steroids, the latter also referred to as corticosteroids Gilroy et al. Inflammatory resolution: new opportunities for drug discovery.

Drug Discov, v. Corticosteroids are naturally produced by the adrenal cortex and are involved in carbohydrate metabolism regulation and electrolyte balance. Glucocorticosteroids in the management of rheumatoid arthritis. Reumathology, v. While presenting a slower onset of action compared to NSAIDs, steroids have therapeutic advantages such as less interference in hemostasis and lower incidence of gastrointestinal disorders. Moreover, they possess considerably higher anti-inflammatory activity and a more favorable cost-effectiveness ratio Rodrigues et al.

Prednisone, a glucocorticoid, is a potent synthetic anti-inflammatory drug widely used in clinical practice for the treatment of inflammatory and autoimmune diseases. Prednisone is a prodrug extensively converted in vivo to its active form, prednisolone, through hepatic metabolism Sagcal-Gironella et al. Pharmacokinetics of prednisolone in childhood-onset systemic lupus erythematosus cSLE. Currently, tablets reference, similar, and generic drugs and capsules prepared only in pharmacies are available in the Brazilian market.

The production of capsules containing prednisone by pharmacies is relevant for the population since it allows achieving individual needs of patients and ensures the availability of drug products at affordable costs Gennaro, GENNARO, A. Rio de Janeiro: Guanabara Koogan, Adolfo Lutz, v. However, compound drugs must prove their efficacy and safety; therefore, the use of suitable analytical methods for quality control is imperative.

Analytical methods for determination of prednisone content in tablets and active pharmaceutical ingredients APIsbut not for capsules, have been published in the literature. It is known that spectrophotometric methods may not be selective. Excipients used in the formulation may be absorbed in the same wavelength as that of the drug, which limits its use.

A high-performance liquid chromatographic method is described in the Brazilian Pharmacopeia for the assay of prednisone API. However, the use of tetrahydrofuran in the mobile phase limits its use, since this solvent has a cut-off at high wavelengths, is toxic, and is unstable due to the formation of peroxides when it is exposed to the air. In this context, this study describes the development and validation of a liquid chromatographic method to determine prednisone in capsules.

Validation was performed according to current Brazilian legislation. Additionally, the assumptions for a linear regression model were evaluated. The developed method was applied for the assay and content uniformity determination of three batches of prednisone capsules. Prednisone reference standard Capsules of gelatin containing 20 mg of prednisone in three different formulations, prepared by three compound pharmacies with undisclosed origin, were used.

Samples of prednisone API as well as a mixture of the excipients placebo have also been provided. The composition of each batch and the role of each excipient are presented in Table I. Chromatographic separation was accomplished in a Zorbax C18 x 4. The mobile phase was filtered at 0. Linearity was assessed from three analytical curves for prednisone reference standard solutions in the concentrations of Both regression equation and the determination coefficient r 2 were obtained by ordinary least squares method.

The obtained data were further statistically analyzed to prove that they met the assumptions for a linear regression. The Jacknife test was used in order to evaluate the presence of outliers. Ryan-Joiner, Durbin-Watson, and Brown-Forsythe tests were performed to assess normality, independency, and homoscedasticity of residuals, respectively.

Excipient samples used in the three batches A, B, and C were prepared in order to check any interfering peak eluting at the same retention time as the peak of prednisone at the lowest concentration Selectivity was further assessed by analyzing prednisone peak purity.

The solutions of placebo were prepared by weighing an amount of excipient equivalent to the amount of excipient present in capsules containing 5 mg of prednisone.

Repeatability intra-day precision was evaluated calculating the relative standard deviation RSD of six independent solutions of prednisone API at Intermediate precision inter-day precision was assessed repeating the procedures of repeatability on two different days by two analysts, and the RSD of the 12 solutions was determined.

Accuracy was estimated by spiking known amounts of prednisone reference standard at Recovery was determined as the percentage ratio between the average concentration obtained experimentally and the corresponding theoretical concentration at each level. The parameters ratio of methanol in mobile phase, mobile phase flow-rate, and oven temperature were varied in order to test robustness as shown in Table II.

The optimized and validated method was employed in assay and content uniformity determination of three batches of prednisone capsules. Assay was performed in triplicate for each batch. Samples of capsules were prepared by weighing an appropriate mass of the powder equivalent to the amount of prednisone required to obtain the concentration used in the developed method Since there are no methods described in the literature for determination of prednisone in capsules, those for determination in API and in tablets were primarily tested in this study.

However, these methods were not reproducible, being not suitable for the quantification in capsules. However, according to our results, this method was not selective, as some excipients used in the formulation were absorbed significantly at the same wavelength as prednisone. The solutions of placebo from batches A, B, and C presented absorbances of about 9. Therefore, the results found with the spectrophotometric method were overestimated when compared to those using the chromatographic method developed in this study.

The high amount of tetrahydrofuran in the mobile phase resulted in an unstable baseline, which may lead to uncertainty of measurement. The probable reason for this behavior is the peroxide formation, which occurs when tetrahydrofuran is exposed to light, as already described in the literature Clark, In this context, a new chromatographic method was developed and validated.

Tetrahydrofuran was excluded and the mobile phase was composed of methanol and water in an optimized ratio to achieve a reduced analysis time. The best conditions were those described in the section Apparatus and chromatographic conditionswhich were used to validate the method. The retention time for prednisone was 3. Plate number and tailing factor were 8, and 1. The analytical curve, as well as parameters of the linear regression is presented in Figure 2 and Table III.

The coefficient of determination r 2 obtained was higher than the preconized minimal value of 0. Since a high value of determination coefficient does not necessarily mean a linear model, the assumptions concerning the residuals were tested Souza, Junqueira, SOUZA, S. A procedure to assess linearity by ordinary least squares method. Acta, v. No outliers were found according to the Jacknife test, at a significance level of 0.

Normality of residual distribution was confirmed by the Ryan-Joiner test, as the correlation coefficient obtained 0. Independency of residuals was verified using the Durbin-Watson test. There was no correlation between the residuals; i. The homoscedasticity was proved by the Brown-Forsythe test, with t L t from Levene of 0.

Thus, there was no statistical difference between variances obtained for all tested levels; i. The calculated F value The calculated F value 0. Selectivity was assessed by comparing the chromatograms obtained with a sample of prednisone reference standard at No chromatographic peaks were observed in the chromatograms of placebo samples batches A, B, and C at the same retention time as prednisone in the reference standard sample Figures 3 A and 3B.

B Expanded chromatograms of A. C Spectrum of ultraviolet absorbance in the range nm for prednisone. Chromatographic peak purity of prednisone in capsule samples was confirmed by means of ChemStation software Agilent, USA.

Moreover, the spectrum of absorbance in the range between to nm for capsule samples, obtained with ChemStation software Figure 3 Cexhibited a similar profile, with minimums and maximums in the same wavelength of the spectrum of prednisone reference standard found in the literature Moffat, Osselton, Widdop, MOFFAT, A. Clarke's analysis of drugs and poisons3.

London: Pharmaceutical Press, The content of prednisone in samples at In the evaluation of inter-day precision assessed on two different days by two analyststhe mean content was According to current Brazilian legislation, RSD must not exceed the limit of 5.

Therefore, the developed method showed appropriate repeatability and intermediate precision. Accuracy was calculated comparing the responses obtained for samples of prednisone reference standard with those obtained for placebo spiked with prednisone at The test was applied separately for batches A, B, and C.

A practical guide to analytical method validation. Therefore, the method can be considered robust in the assessed conditions. After development and validation, the proposed method was used to evaluate content and uniformity of dosage units using the content uniformity test in three batches of prednisone capsules.

In assay, six replicates of the samples were prepared for each batch. The results are shown in Table VI.

Affiliations. 1 Laboratório de Farmacologia Clínica e Terapêutica, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal;. Archivos Venezolanos de Farmacología y Terapéutica consult for skin lesions that worsened after treatment with prednisone for (30 mg/day) 3 months. Prednisone is an anti-inflammatory steroid drug widely used in clinical practice. However, no high- performance liquid chromatographic (HPLC) method has. CHARACTERISTICS OF PREDNISONE-. J.L. G6rnez-Arnoza* and N.G. Stanley-Wood**. *Departamento de Farmacologia, Farmacia y Tecnologia Farmacbtica. Facultad de. Affiliations. 1 Laboratório de Farmacologia Clínica e Terapêutica, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal;. What is the safety profile of methylprednisolone and dexamethasone in suspected and confirmed COVID patients under treatment?

The use of oral and intravenous corticosteroids as a treatment for SARS-CoV-2 infection has been shown to inhibit the exaggerated inflammatory response, reducing symptoms and days of hospitalization of patients. However, its use is controversial because not enough clinical studies have been made to verify the safety of the drugs.

Objective: To assess the safety profile of corticosteroids treatment, at high and low doses, in suspected or confirmed patients with COVID, determining the most frequent side effects in patients, and assessing whether the administration of the drugs represents a greater benefit than the risk of presenting these effects.

Methods: Ambispective study of active pharmacovigilance at a cohort of confirmed or suspected COVID patients, treated with intravenous and oral corticosteroids. Results: The distribution of the cases with hyperglycemia was 33 in high doses and 82 with low doses of corticosteroids and both high and low doses have a similar distribution in cases of infections. In December , in Wuhan, China, a public health crisis occurred, which spread and caused great global repercussions.

An exaggerated systemic inflammation produced by the disease is the cause that leads to serious complications in patients, for this reason, doctors have resorted to treatments that avoid the response of pro-inflammatory cells, which show great efficacy, and at the same time, that have been shown to reduce mortality.

Although different treatment regimens have been used for COVID, no specific treatment for the disease has been established4,5. Since there is not enough information on the use of corticosteroids in patients with COVID, it is essential to develop a pharmacovigilance study to determine the risk-benefit balance of corticosteroids as a treatment for the disease, and to determine the most frequent side effects after the administration of high and low doses of corticosteroids.

COVID is characterized for producing respiratory symptoms ranging from an ordinary cough to severe acute respiratory syndrome Coronaviruses are unicaternary RNA viruses that belong to the coronaviridae family. They have a spherical shape from which small projections surround them and contain the Spike protein. A poorly regulated inflammatory response, as occurs in patients with severe infection, produces the accumulation of pro-inflammatory cells monocytes and macrophages in the lung tissue, resulting in pulmonary damage3,4.

Subunits 1 and 2 of the Spike proteins interact with angiotensin 2 ACE2 receptors, located in the bronchial tree and alveoli. The binding of the virus-receptor is the entrance gate of the infection to the alveolar cells, where the replication and propagation begins These tests are capable of detecting viral nucleic acids, antigens, antibodies, among others.

The results of each test depend on the stage of the disease. For the detection of viral nucleic acids, the nasopharyngeal swab thru reverse-transcriptase polymerase chain reaction RT-PCR test is used.

The immunoassay serologic test detects IgG and IgM antibodies for COVID; however, the use of this test is not reliable for detecting acute infections because the immune response and detectable levels of immunoglobulins occur approximately 15 to 20 days after symptoms Currently, treatment is mainly based on symptom control and oxygen therapy to maintain adequate oxygen saturation in patients who do not require hospitalization. Patients with moderate to severe symptoms should be hospitalized, and those with acute respiratory failure require intubation and treatment in an intensive care unit.

Among the most commonly used medications in hospitalized patients are corticosteroids, which are used primarily to decrease the excessive inflammatory response.

The use of anticoagulants, have been used to reduce the risk of thromboembolism The use of corticosteroids is indicated in patients with COVID due to their ability to reduce the inflammatory response produced by the disease.

They concluded that the treatment reduced mortality to 28 days in mechanically ventilated patients8. Each patient received a medium dose of mg for 5 to 10 days. The most frequently reported side effects in these patients were bacteremia, in-hospital pneumonia, and gastrointestinal bleeding.

Among the results, it could be observed that the treatment reduced the required days of ventilatory assistance, therefore, days of hospitalization According to the Pharmacovigilance Program of the Hospital Universitari de Bellvitge, corticosteroids were the drugs with the most side effects reported; infections being the most frequently, followed by complications in diabetic patients and gastrointestinal bleeding The World Health Organization WHO carried out a systematic review of the side effects presented in patients treated with COVID, and reported that serious corticoesteroids-related side effects occurred with high-dose administration, infections being the most frequent.

On the other hand, under lower doses, patient mortality was related to specific causes such as mechanical ventilation and cardiac arrhythmias, but not side effects Pharmacovigilance is important to asses the side effects presented after the administration of drugs; therefore, active pharmacovigilance protocols are useful to stablish the safety of a treatment. In this study, under a method of direct identification of side effects with the execution of multipurpose databases, laboratory studies and changes in the behavior of diseases were recorded after the administration of corticosteroids treatment.

It is important to remember that corticosteroids administered after short periods, present like immunosuppression, associated infections, hyperglycemia and osteoporosis9, Hyperglycemia is one of the most common side effects in SARS-CoV-2 patients treated with corticosteroids because they inhibit gluconeogenesis, decrease pancreatic insulin production, and promote lipolysis in adipose tissue.

In patients with a history of diabetes, these effects are perpetuated, leading to severe hyperglycemia In addition, the pancreas also has the ability to release steroids during an infectious process, therefore, the use of corticosteroids in diabetic patients under COVID infections represents a risk of hyperglycemia.

It is of great importance to carry out a thorough review where it is possible to verify the safety of the use of corticosteroids as a treatment for the disease12, What is the safety profile of methylprednisolone and dexamethasone in suspected and confirmed COVID patients under treatment?

Currently, there is no specific treatment established worldwide for SARS-CoV-2 disease, the treatments used decrease the symptoms and speed up the recovery process, however, they do not represent a cure for the disease.

These treatment plans have been used in Mexico and have shown favorable results. At the Ignacio Chavez National Institute of Cardiology, methylprednisolone was used as the initial treatment. RECOVERY results demonstrated that dexamethasone reduced endothelial dysfunction and prothrombotic effects, thus reducing symptoms, days of hospitalization and mortality in patients under mechanical ventilation.

The increase of basal glucose levels and the risk of a hospital acquired infection are related to the dose of administration of corticosteroids such as methylprednisolone and dexamethasone at high and low doses respectively in suspected and confirmed patients with COVID As there is no specific treatment for SARS-CoV-2 disease, it is important to ensure that the treatment regimens used are safe.

In addition, they must be effective for the patient and guarantee that the benefit after administration is greater than the risk of presenting side effects and their complications.

Hyperglycemia was evaluated in terms of its harshness and severity in relation to the maximum glucose level that the patients presented during the first 10 days after the start of treatment, or the first 10 days of hospitalization in patients without corticosteroids.

The infections were evaluated taking into account the temporality, relating them to the administration of corticosteroids or hospital admission, in the control group. Documented infections during the first two days of treatment were not attributed to corticosteroids or hospitalization in the control group. It was confirmed that the infection identified in microbiological studies correlated with the therapeutic need for the administration of an antibiotic.

It was considered a harsh side effect if the patient died during the infectious process or during the administration of the antibiotic. A side effect was considered moderate when the patient only required taking an antibiotic and did not die, and severe when the patient required the administration of a double antibiotic regimen to treat the infection, or died during the infectious process as exemplified in image 2.

The distribution of the cases with hyperglycemia was 33 in high doses and 82 with low doses of corticosteroids and both high and low doses have the similar distribution in cases of infections as exemplified in graphic 1. The distribution of cases is exemplified in graphic 1 B. It is relevant to consider that this side effects could be conditioned by the presence of risk factors and previous comorbidities that we do not consider on the evaluation.

Drugs are not completely safe, so the risk of side effects that represent harm or severity to the patient is always there. With this study, it is possible to establish a possible relationship between the use of high-dose corticosteroids and a greater distribution of harsh and severe hyperglycemia, as well as a greater number of infections with a greater harshness and severity, when compared with low-dose corticosteroids.

The use of glucocorticoids at high and low doses as a treatment for COVID disease has been shown to be effective in reducing symptoms and days of hospitalization in these patients. However, based on the results obtained, it was concluded that the use of these drugs can cause changes in the basal glucose of patients, in addition to increasing the risk of contracting in-hospital infections due to immunosuppression secondary to the use of glucocorticoids.

Despite the fact that the results of this study do demonstrate a relationship between the use of dexamethasone and methylprednisolone with the mentioned side effects, it is recommended to carry out a broader investigation and with a greater cutoff of the values used, in order to establish a closer relationship between the use of glucocorticoids with hyperglycemia and related infections. Conflict of interests: The authors declare that they do not present a conflict of interest.

Singhal, Tanu. The Indian Journal of Pediatrics. Vol 87 4 , Cytokine and growth factor reviews. Vol 54, Journal of Infection. Vol 80, Mayo Diabetes research and clinical practice. Zabuliene Lina. Hyperglycemia and the novel Covid infection: Possible pathophysiologic mechanisms. Vol , Balanciano, Giselle.

Carrasco, Gabriela. Julio Nature reviews: Immunology. Farmacovigilancia hospitalaria. Physiological Reviews. Vol 4 , Covid update: The race to therapeutic development. Drug Resistance Updates. Journal of Hepatology Features, Evaluation, and Treatment of Coronavirus.

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