Clinical significance of serum microRNA-146a and inflammatory factors in children with Mycoplasma pneumoniae pneumonia after azithromycin treatment

Abstract Objective This study aimed to investigate the clinical significance of serum microRNA-146a and pro-inflammatory factors in children with Mycoplasma pneumoniae pneumonia after azithromycin treatment. microRNA-146a is known to regulate inflammatory responses, and excessive inflammation is a primary characteristic of MPP. Methods Children with MPP received conventional symptomatic therapy along with intravenous administration of azithromycin for one week. Serum levels of microRNA-146a and pro-inflammatory factors were measured using RT-qPCR and ELISA kits, respectively. The correlation between microRNA-146a and pro-inflammatory factors was analyzed by the Pearson method. Pulmonary function indexes were assessed using a pulmonary function analyzer, and their correlation with microRNA-146a and pro-inflammatory factors after treatment was evaluated. Children with MPP were divided into effective and ineffective treatment groups, and the clinical significance of microRNA-146a and pro-inflammatory factors was evaluated using receiver operating characteristic curves and logistic multivariate regression analysis. Results Serum microRNA-146a was downregulated in children with MPP but upregulated after azithromycin treatment, contrasting with the trend observed for pro-inflammatory factors. MicroRNA-146a showed a negative correlation with pro-inflammatory cytokines. Pulmonary function parameters were initially reduced in children with MPP, but increased after treatment, showing positive/inverse associations with microRNA-146a and pro-inflammatory factors. Higher microRNA-146a and lower pro-inflammatory factors predicted better efficacy of azithromycin treatment. MicroRNA-146a, tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), interleukin-8 (IL-8), and forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) were identified as independent factors influencing treatment efficacy. Conclusion Azithromycin treatment in children with MPP upregulates microRNA-146a, downregulates pro-inflammatory factors, and effectively improves pulmonary function.

Anti-infection treatment and pharmaceutical care for a patient with severe pneumonia caused by Chlamydia psittaci / 中国药房

OBJECTIVE To provide ideas and reference for the anti-infection treatment and pharmaceutical care for severe pneumonia caused by Chlamydia psittaci. METHODS Clinical pharmacists participated in the whole process of the treatment for a patient with C. psittaci-induced severe pneumonia. According to the patient’s medical history， clinical symptoms and test results， clinical pharmacists assisted the physician to dynamically adjust the anti-infective scheme； for C. psittaci infection， the patient was treated with tigecycline combined with azithromycin successively， and other infection therapy plans were dynamically adjusted according to the results of pathogen examination. During the treatment， the patient suffered from suspicious adverse drug reactions such as prolonged QTc interval， elevated lipase and amylase； the clinical pharmacists conducted pharmaceutical care and put forward reasonable suggestions. RESULTS The physician adopted the pharmacists’ suggestion， and the patient was discharged after treatment. CONCLUSIONS For the treatment of severe pneumonia caused by C. psittaci， the characteristics of patients， drugs and pathogens should be taken into account to develop individualized anti-infective treatment. Tetracyclines and macrolides have a definite effect on C. psittaci infection， but attention should be paid to the possible ADR caused by drugs in clinical application.

Improvement effects of azithromycin on bronchopulmonary dysplasia in neonatal rats and its mechanism / 中国药房

OBJECTIVE To investigate the improvement effects of azithromycin on bronchopulmonary dysplasia （BPD） in neonatal rats based on hypoxia-inducible factor-1α（HIF-1α）/HIF-2α/vascular endothelial growth factor （VEGF） pathway. METHODS Sixty newborn SD rats were randomly divided into negative control group （NC）， BPD group， azithromycin group and budesonide group （positive control）， with 15 rats in each group. Rats in NC group were given normal breathing air， while rats in other three groups were exposed to high-concentration oxygen for 14 days to establish BPD rat models. After successful modeling， rats in azithromycin group were intraperitoneally injected with azithromycin 200 mg/kg， and rats in budesonide group were atomized with budesonide 1.5 mg/kg once a day for 14 consecutive days， while rats in BPD group and NC group were not treated. Pathological changes of lung tissue， radial alveolar count and mean alveolar intercept of rats were observed in each group. The white blood cell count in bronchoalveolar lavage fluid （BALF） and the levels of tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6）， IL-1β， superoxide dismutase （SOD）， catalase （CAT） and malondialdehyde （MDA） were detected； mRNA and protein expressions of VEGF， HIF-1α， HIF-2α were also detected. RESULTS Compared with NC group， the lung tissue in BPD group was obviously damaged； the white blood cell count， average alveolar intercept and the levels of TNF-α， IL-6， IL-1β and MDA were significantly increased； the radial alveolar count， SOD and CAT levels， the relative expressions of VEGF， HIF-1α， HIF-2α mRNA and protein were significantly decreased （P＜0.05）. Compared with BPD group， the changes of the above indexes in azithromycin group and budesonide group were significantly reversed （P＜0.05）. CONCLUSIONS Azithromycin can obviously improve the symptoms of BPD in rats， reduce inflammation and oxidative stress， and exert lung protection， the mechanism of which may be realized by activating HIF-1α/HIF-2α/VEGF pathway.

Epidemiología y prevalencia de Mycoplasma genitalium y resistencia a azitromicina en el Área Norte de Tenerife, Islas Canarias

Introducción: La infección y resistencia antimicrobiana de Mycoplasma genitalium está infradiagnósticada en nuestra comunidad ya que no es una Enfermedad de Declaración Obligatoria y requiere técnicas de biología molecular, no siempre disponibles. Objetivo: Estudiar la epidemiología y prevalencia de M. genitalium y la tasa de resistencia frente a azitromicina en nuestra Área de Salud. Métodos: Estudio retrospectivo, desde abril de 2019 a julio de 2020, realizado en el Área de Salud del Norte de Tenerife, la cual atiende el Hospital Universitario Canarias. Para el diagnóstico de las infecciones de transmisión sexual (ITS) se utilizó la RT-PCR Allplex™ STI Essential Assay (Seegene, South Korea). Las muestras en las que se detectó M. genitalium fueron congeladas a −80°C para posteriormente realizar estudio de resistencia a azitromicina con la RT-PCR Allplex™ MG y AziR Assay (Seegene, South Korea). Resultados: Se identificaron 111/3.849 (prevalencia de 2,8%) pacientes con M. genitalium, de los cuales la mayoría, 59(53,1%) eran hombres con una mediana de 32 años (15-74) y cuyas muestras procedían principalmente de Atención Primaria: 55 (49,5%). Para la detección de resistencia a azitromicina, de los 111 pacientes solo se pudo analizar las muestras de 79, detectándose resistencia in vitro en 15(18,3%): 10 con A2059G, 4 con A2058G y 1 con ambas. La resistencia a azitromicina fue más frecuente en hombres 12 (15,8%). Discusión y Conclusiones: Con este estudio se pone de manifiesto la importancia de la prevalencia de M. genitalium en nuestro entorno, así como su alta tasa de resistencia a azitromicina por lo que se hace necesario vigilar dicha resistencia en nuestro Área de Salud para su adecuado tratamiento.

Background: Infection and antimicrobial resistance of Mycoplasma genitalium is under-diagnosed in our community as it is not a Notifiable Infectious Disease and requires for its detection molecular biology techniques, which are not always available. Aim: To study the epidemiology and prevalence of M. genitalium and the rate of resistance to azithromycin in our Health Care Area. Methods: We conducted a retrospective study from April 2019 to July 2020 in the Northern Health Care Area of Tenerife, which is attended to the Universitary Hospital Complex of the Canary Islands. The RT-PCR Allplex™ STI Essential Assay (Seegene, South Korea) to diagnose Sexually Transmitted Infections (STI) was used. Samples in which M. genitalium was detected were stored at −80°C for subsequent diagnosis of resistance to azithromycin with the RT-PCR Allplex™ MG and AziR Assay (Seegene, South Korea). Results: Of a total of 111/3,849 (2.8% prevalence) patients diagnosed with M. genitalium, 59 (53.1%) were male with a mean age of 30 (19-61) years and mainly from Primary Care 55 (49.5%). Only 79 samples of the 111 patients could be tested to detect azithromycin resistance, of which 15 (18.3%) were resistant in vitro: 10 with A2059G, 4 with A2058G and 1 with both. Azithromycin resistance was more frequent in men 12 (15.8%) and detected mainly in urine samples 6 (60%). Discussion and Conclusions: This study highlights the prevalence of M. genitalium in our setting as well as the high rate of resistance to azithromycin, making it necessary to detect resistance to azithromycin in M. genitalium for its appropriate treatment in our Health Care Area.

Caracterización de eventos adversos a hidroxicloroquina, ivermectina, azitromicina y tocilizumab en pacientes hospitalizados por COVID-19 en un hospital del Seguro Social de Salud del Perú / Characterization of adverse events to hydroxychloroquine, ivermectin, azithromycin and tocilizumab in patients hospitalized due to COVID-19 in a Peruvian Social Health Insurance hospital

Objetivos. Caracterizar los eventos adversos (EA) asociados a hidroxicloroquina (HQ), azitromicina (AZI), tocilizumab (TOB) e ivermectina (IVM) prescritos como «fuera de etiqueta» en el tratamiento de pacientes hospitalizados por la COVID-19. Materiales y métodos. Se realizó un análisis secundario transversal de la base de datos del sistema de farmacovigilancia del Seguro Social de Salud del Perú (EsSalud) de las notificaciones de EA a HQ, AZI, TOB e IVM provenientes del Hospital Nacional Edgardo Rebagliati Martins de abril a octubre del 2020. Se revisaron las historias clínicas digitales, se estimaron las tasas de reporte de EA y se evaluaron sus características por tipo de fármaco, tiempo de aparición, tipo por órgano-sistema afectado, gravedad y causalidad. Resultados. Se identificaron 154 notificaciones que describen un total de 183 EA posiblemente relacionados con HQ, AZI, TOB e IVM, siendo 8% la tasa de reporte de EA. La mediana de tiempo de aparición de EA fue de 3 días (RIC: 2-5). La mayoría fueron cardiovasculares, destacándose la prolongación del intervalo QT. Se observaron EA hepatobiliares principalmente asociados a TOB. La mayoría de los casos fueron moderados, no obstante, el 10,4% fue grave. Conclusiones. Se identificaron EA potencialmente asociados al uso de HQ, AZI, TOB e IVM contra la COVID-19, siendo los más frecuentes los de tipo cardiovasculares. A pesar de que la AZI, HQ e IVM poseen perfiles conocidos de seguridad, su empleo en la COVID-19 podría incrementar la aparición de EA por los factores de riesgo propios de esta infección. Se sugiere reforzar la vigilancia, especialmente, de TOB.

Objective. To characterize the adverse events (AEs) related to the off-label use of hydroxychloroquine (HQ), azithromycin (AZI), tocilizumab (TOB) and ivermectin (IVM) for the treatment of COVID-19 in hospitalized patients. Materials and Methods. We conducted a secondary cross-sectional analysis of the Peruvian Social Health Insurance (EsSalud) pharmacovigilance system database of AE notifications to HQ, AZI, TOB and IVM in the Edgardo Rebagliati Martins National Hospital from April to October 2020. Information was collected from digital medical records. We estimated AE reporting rates and evaluated their characteristics by drug type, time of occurrence, type by the affected organ-system, severity and causality. Results. We identified 154 notifications describing a total of 183 AE possibly related to HQ, AZI, TOB and IVM; the reporting rate was 8%. The median time of AE occurrence was 3 days (IQR: 2-5). Most were cardiovascular events; prolongation of the QT interval was the most frequent. Hepatobiliary AEs were mainly associated with TOB. Most cases were moderate, however, 10.4% were severe. Conclusions. We found AEs potentially associated with the use of HQ, AZI, TOB and IVM against COVID-19; cardiovascular events were the most frequent. Although AZI, HQ and IVM have known safety profiles, their use against COVID-19 could increase the occurrence of AE due to the risk factors inherent to this infection. Surveillance systems must be improved, especially those for TOB.

Dados de Vida Real sobre o Uso da Hidroxicloroquina ou da Cloroquina Combinadas ou Não à Azitromicina em Pacientes com Covid-19: Uma Análise Retrospectiva no Brasil / Real-Life Data on Hydroxychloroquine or Chloroquine with or Without Azithromycin in COVID-19 Patients: A Retrospective Analysis in Brazil

Resumo Fundamento Apesar da ausência de evidência mostrando benefícios da hidroxicloroquina e da cloroquina combinadas ou não à azitromicina no tratamento da covid-19, esses medicamentos têm sido amplamente prescritos no Brasil. Objetivos Avaliar desfechos, incluindo moralidade hospitalar, alterações eletrocardiográficas, tempo de internação, admissão na unidade de terapia intensiva, e necessidade de diálise e de ventilação mecânica em pacientes hospitalizados com covid-19 que receberam cloroquina ou hidroxicloroquina, e comparar os desfechos entre aqueles pacientes e seus controles pareados. Métodos Estudo multicêntrico retrospectivo do tipo coorte que incluiu pacientes com diagnóstico laboratorial de covid-19 de 37 hospitais no Brasil de março a setembro de 2020. Escore de propensão foi usado para selecionar controles pareados quanto a idade, sexo, comorbidades cardiovasculares, e uso de corticosteroides durante a internação. Um valor de p<0,05 foi considerado estatisticamente significativo. Resultados Dos 7850 pacientes com covid-19, 673 (8,6%) receberam hidroxicloroquina e 67 (0,9%) cloroquina. A idade mediana no grupo de estudo foi 60 (46-71) anos e 59,1% eram mulheres. Durante a internação, 3,2% dos pacientes apresentaram efeitos adversos e 2,2% necessitaram de interromper o tratamento. Alterações eletrocardiográficas foram mais prevalentes no grupo hidroxicloroquina/cloroquina (13,2% vs. 8,2%, p=0,01), e o prolongamento do intervalo QT corrigido foi a principal diferença (3,6% vs. 0,4%, p<0,001). O tempo mediano de internação hospitalar foi maior no grupo usando CQ/HCQ em relação aos controles (9,0 [5,0-18,0] vs. 8,0 [4,0-14,0] dias). Não houve diferenças estatisticamente significativas entre os grupos quanto a admissão na unidade de terapia intensiva (35,1% vs. 32,0%; p=0,282), ventilação mecânica invasiva (27,0% vs. 22,3%; p=0,074) ou mortalidade (18,9% vs. 18,0%; p=0,682). Conclusão Pacientes com covid-19 tratados com cloroquina ou hidroxicloroquina apresentaram maior tempo de internação hospitalar, em comparação aos controles. Não houve diferença em relação a admissão em unidade de terapia intensiva, necessidade de ventilação mecânica e mortalidade hospitalar.

Abstract Background Despite no evidence showing benefits of hydroxychloroquine and chloroquine with or without azithromycin for COVID-19 treatment, these medications have been largely prescribed in Brazil. Objectives To assess outcomes, including in-hospital mortality, electrocardiographic abnormalities, hospital length-of-stay, admission to the intensive care unit, and need for dialysis and mechanical ventilation, in hospitalized COVID-19 patients who received chloroquine or hydroxychloroquine, and to compare outcomes between those patients and their matched controls. Methods A retrospective multicenter cohort study that included consecutive laboratory-confirmed COVID-19 patients from 37 Brazilian hospitals from March to September 2020. Propensity score was used to select matching controls by age, sex, cardiovascular comorbidities, and in-hospital use of corticosteroid. A p-value <0.05 was considered statistically significant. Results From 7,850 COVID-19 patients, 673 (8.6%) received hydroxychloroquine and 67 (0.9%) chloroquine. The median age in the study group was 60 years (46 - 71) and 59.1% were women. During hospitalization, 3.2% of patients presented side effects and 2.2% required therapy discontinuation. Electrocardiographic abnormalities were more prevalent in the chloroquine/hydroxychloroquine group (13.2% vs. 8.2%, p=0.01), and the long corrected QT interval was the main difference (3.6% vs. 0.4%, p<0.001). The median hospital length of stay was longer in the HCQ/CQ + AZT group than in controls (9.0 [5.0, 18.0] vs. 8.0 [4.0, 14.0] days). There was no statistical differences between groups in intensive care unit admission (35.1% vs. 32.0%; p=0.282), invasive mechanical ventilation support (27.0% vs. 22.3%; p=0.074) or mortality (18.9% vs. 18.0%; p=0.682). Conclusion COVID-19 patients treated with chloroquine or hydroxychloroquine had a longer hospital length of stay, when compared to matched controls. Intensive care unit admission, invasive mechanical ventilation, dialysis and in-hospital mortality were similar.

Preparation of azithromycin-ion exchange resin complexes for taste-masking and controlled drug release / 中国药科大学学报

@#In order to mask the bitterness of azithromycin (AZI) and individually regulate the drug release rate to reduce gastrointestinal irritation, immediate-release AZI-AmberliteTM IRP64/HPC and delayed-release AZI-AmberliteTM IRP69/RS100 were prepared by modifying with hydroxypropyl cellulose (HPC) and Eudragit RS100, respectively, and further combined to achieve controlled release.The drug loading and drug utilization rate of AZI-ion exchange resin complexes were measured; the structure of AZI-ion exchange resin complexes was characterized by differential scanning calorimetry and X-ray diffraction; and the wetting humidity, odor masking effects, in vitro dissolution and release behaviors were determined.The results showed that the formation of AZI-ion exchange resin complexes changed the original crystallization state of the drug, that the 2.5% HPC-modified AZI-AmberliteTM IRP64/HPC and the 0.5% RS100-modified AZI-AmberliteTM IRP69/RS100 demonstrated good taste masking effect, and that their combination in the drug content ratio of 13∶67 achieved the expected drug release behavior, i.e.rapid release of AZI in the first 10 min and smooth release in the later 6 h.These results indicated that the AZI-ion exchange resin complexes prepared by surface modification and their composites could mask the bitterness of AZI and realize the flexible adjustment of drug release rate, which lays the foundation for the research and development of new AZI preparations.

Comparison and improvement of palatability for multisourced oral azithromycin suspension / 药学学报

Azithromycin dry suspension is one of the most commonly used drugs in pediatric clinic, but its taste masking has been difficult to achieve. 5 representative products of azithromycin dry suspension were chose to compare their tastes both using electronic tongue and human sensory evaluation methods, and there existed the differences of bitterness, later bitterness, graininess, and adhesion among these products. Raman micro-imaging was used to determine the difference in taste mainly due to different prescription ingredients and manufacturing techniques. Through mixing the dry suspensions with alkaline mixing solvent, the bad taste of each product was masked after evenly dispersing in the solvent, and their tastes were all close to the taste of the solvent. In the future, it is planned to investigate the stability and bioavailability of the solvent preparations, and then to give the medication suggestion of solvent preparation after ensuring their efficacy.

Efectividad de antimicrobianos como coadyuvantes del raspado y alisado radicular en el tratamiento de la periodontitis del adulto

Fundamento: existen escasos estudios que evalúen la aplicación subgingival de antimicrobianos en el tratamiento de la periodontitis del adulto. Objetivo: evaluar la efectividad de antimicrobianos como coadyuvantes del raspado y alisado radicular en el tratamiento de la periodontitis leve y moderada del adulto. Métodos: estudio cuasiexperimental de intervención terapéutica, realizado en la Clínica Estomatológica de Santiago de Cuba, entre noviembre 2018 y septiembre 2021, sobre 144 pacientes con diagnóstico de periodontitis crónica leve y moderada. Mediante el método probabilístico aleatorio simple, se conformaron tres grupos con 48 integrantes, de forma voluntaria. El grupo control tratado con el raspado y alisado radicular y dos grupos de estudio en que, además, se aplicó una concentración subgingival de tetraciclina y azitromicina, respectivamente. Los pacientes fueron examinados y evaluados a los siete días, al mes y tres meses. Se empleó el análisis de varianza ANOVA para evaluar la igualdad de medias y la prueba ji-cuadrado para la efectividad de curación con un 95 % de confiabilidad. Resultados: hubo reducción de profundidad de sondaje y mayor ganancia de inserción clínica en los tres grupos, pero a favor de los grupos de estudio. Todas las terapias fueron efectivas, pero obtuvo mayor curación el grupo dos (RAR + Tetraciclina) con 97,9 %. Conclusiones: las aplicaciones subgingivales de tetraciclina y azitromicina resultaron efectivas como coadyuvantes del raspado y alisado radicular en el tratamiento de la periodontitis leve y moderada del adulto; con la tetraciclina se logró mayor mejoramiento de parámetros clínicos, disminución de profundidad de sondaje, ganancia de inserción clínica y menor tiempo de curación.

Background: there are few studies that evaluate the subgingival application of antimicrobials in adult periodontitis. Objective: to evaluate the effectiveness of antimicrobials as contributing for scaling and root planing in the treatment of mild and moderate periodontitis in adults. Methods: quasi-experimental study of therapeutic intervention, carried out at the Santiago de Cuba Stomatological Clinic, between November 2018 and September 2021, on 144 patients diagnosed with mild and moderate chronic periodontitis. Using the simple random probabilistic method, three groups with 48 members were formed voluntarily. The control group treated with scaling and root planing and two study groups in which, in addition, a subgingival concentration of tetracycline and azithromycin, respectively, was applied. The patients were examined and evaluated at seven days, one month and three months. ANOVA analysis of variance was used to evaluate the equality of means and the chi-square test for the effectiveness of healing with 95% reliability. Results: there was a reduction in probing depth and greater gain in clinical attachment in the three groups, but in favor of the study groups. All therapies were effective, but group two (RAR + Tetracycline) obtained a greater cure with 97.9%. Conclusions: subgingival applications of tetracycline and azithromycin were effective as adjuvants for scaling and root planing in mild and moderate periodontitis in adults; Tetracycline achieved greater improvement in clinical parameters, decreased probing depth, gain in clinical attachment, and shorter healing time.

Effect of periodontal debridement plus systemic azithromycin in subjects with stage III periodontitis: a randomized controlled clinical trial / Efecto del desbridamiento periodontal más azitromicina sistémica en sujetos con periodontitis estadio III: un ensayo clínico controlado aleatorio

Aim: To evaluate the effect of the systemic administration of azi-thromycin (AZM) as an adjunct to non-surgical periodontal therapy (NSPT) on the clinical and microbiological variables of patients with periodontitis. Material and Methods: Eighteen volunteers received NSPT combined with placebo or AZM (500 mg/day) for 3 days (n=9/group). They were monitored clinically for probing pocket depth (PPD), clinical attachment level (CAL), O'Leary index (OI), bleeding on probing (BoP) at baseline and during the first, third and sixth month and microbiologically, at baseline and at 3 and 6 months after therapy, by conventional polymerase chain reaction tests. Results: Fourteen patients completed the study (n=7/group). Differences statistically significant were observed among both groups. The experimental group presented: A PPD mean (p=0.04) significantly lower and PPD reduction (p=0.02), at 6-months post NSPT. Regarding changes (∆), at the third month post NSPT, there was a significant increase in the number of shallow sites (p<0.001) and a decrease in the intermediate sites (p<0.001). In addition, a significant decrease in the mean number of deep sites (p=0.04) was detected at 6 months post treatment. There was also a significant decrease in periodontal index BoP at 1 (p=0.01), 3 (p<0.001) and 6 (p=0.01) months and OI at 3- and 6-months (p<0.001), post treatment. Regarding the presence of periodontal pathogens, no significant differences were observed, intra and inter groups. Conclusion: AZM as an adjuvant to NSPT provides additional beneficial effects for PPD and BoP compared to NSPT alone.

Objetivo: Evaluar el efecto de la administración sistémica de azitromicina (AZM) como coadyuvante de la terapia periodontal no quirúrgica (TPNQ) en las variables clínicas y microbiológicas de pacientes con periodontitis. Material y Métodos: Dieciocho voluntarios recibieron TPNQ combinado con placebo o AZM (500 mg/día) durante 3 días (n=9/grupo). Fueron monitoreados clínicamente para determinar Profundidad de Sondaje del Saco (PSS), Nivel de Inserción Clínica (NIC), Índice de O'Leary (IO), Sangrado al sondaje (SS) al inicio y durante el primer, tercer y sexto mes y microbiológicamente, al inicio y a los 3 y 6 meses después de la terapia, mediante la reacción en cadena de la polimerasa convencional. Resultados: Catorce pacientes completaron el estudio (n=7/grupo). Se observaron diferencias estadísticamente significativas entre ambos grupos. El grupo experimental presentó una media de PSS significativamente menor (p=0,04) y una reducción de PSS (p=0,02), a los 6 meses post TPNQ. En cuanto al delta (∆) pre y post tratamiento, al tercer mes post TPNQ, hubo un aumento significativo en el número de sitios poco profundos (p<0.001) y una disminución en los sitios intermedios (p<0.001). Además, se detectó una disminución significativa en la media de los sitios profundos (p=0.04) a los 6 meses post tratamiento. También hubo una disminución significativa en el índice SS al primer (p=0.01), tercer (p<0. 0 01) y sexto mes (p=0.01) post TPNQ y del IO al tercer y sexto mes (p<0.001), post tratamiento. En cuanto a la presencia de patógenos periodontales, no se observaron diferencias significativas tanto intra como ínter grupos. Conclusión: AZM como adyuvante a TPNQ proporciona efectos benéficos adicionales en la PSS y SS en comparación a TPNQ solo.

Indicación y prescripción de macrólidos en una población colombiana / Study of the indications for macrolide prescriptions in a Colombian population

Introducción. El uso inadecuado de antibióticos se asocia con aumento de la resistencia antimicrobiana, mayores costos de atención médica, más efectos adversos y peores resultados clínicos. Objetivo. Determinar los patrones de prescripción y las indicaciones aprobadas y no aprobadas para macrólidos en un grupo de pacientes en Colombia. Materiales y métodos. Se hizo un estudio de corte transversal sobre las indicaciones de uso de macrólidos en pacientes ambulatorios a partir de una base de datos de dispensación de medicamentos de 8,5 millones, aproximadamente, de personas afiliadas al sistema de salud de Colombia. Se consideraron variables sociodemográficas, farmacológicas y clínicas. Resultados. Se encontraron 9.344 pacientes que habían recibido prescripción de macrólidos; su mediana de edad era de 40,1 años (rango intercuartílico: 27,1-53,3 años) y el 58,3 % correspondía a mujeres. El macrólido más prescrito fue la azitromicina (38,8 %) y los usos más frecuentes fueron el tratamiento de la infección por Helicobacter pylori (15,9 %) y la neumonía (15,8 %). El 31,3 % de las prescripciones correspondía a indicaciones no aprobadas, destacándose el resfriado común (7,8 %), la Covid-19 (4,0 %) y la bronquitis aguda (3,5 %). La residencia en la región Caribe (OR=1,17; IC95% 1,05-1,31), las prescripciones odontológicas (OR=2,75; IC95% 1,91-3,96), las comorbilidades respiratorias crónicas (OR=1,30; IC95% 1,08-1,56), y la prescripción de eritromicina (OR=3,66; IC95% 3,24-4,14) o azitromicina (OR=2,15; IC95% 1,92 2,41), se asociaron con una mayor probabilidad de recibir macrólidos para indicaciones no aprobadas, en tanto que tener entre 18 y 64 años (OR=0,81; IC95% 0,71-0,93), 65 o más años (OR=0,77; IC95% 0,63-0,94) y residir en Bogotá-Cundinamarca (OR=0,74; IC95% 0,65 0,85) reducían dicho riesgo. Conclusiones. La mayoría de los pacientes recibieron macrólidos para infecciones del sistema respiratorio; la eritromicina y la azitromicina se prescribieron en indicaciones no aprobadas en menores de 18 años y en quienes presentaban enfermedades respiratorias crónicas.

Introduction: The inappropriate use of antibiotics is associated with a greater risk for antimicrobial resistance, high health care costs, adverse events, and worse clinical outcomes. Objective: To determine the prescription patterns and approved and nonapproved indications for macrolides in a group of patients from Colombia. Materials and methods: This was a cross-sectional study on the indications for the use of macrolides in outpatients registered in a drug-dispensing database of approximately 8.5 million people affiliated with the Colombian health system. Sociodemographic, pharmacological, and clinical variables were considered. Results: A total of 9.344 patients had received a macrolide prescription; their median age was 40.1 years (interquartile range: 27.1-53.3 years) and 58.3% were women. The most commonly prescribed macrolide was azithromycin (38.8%) most frequently for Helicobacter pylori infection (15.9%) and pneumonia treatment (15.8%). A total of 31.3% of the prescriptions were used for unapproved indications: common cold (7.8%), COVID-19 (4.0%), and acute bronchitis (3.5%). Residence in the Caribbean region (OR=1.17; 95%CI 1.05-1.31), dental prescriptions (OR=2.75; 95%CI 1.91-3.96), presence of chronic respiratory comorbidities (OR=1.30; 95%CI 1.08-1.56), and prescription of erythromycin (OR=3.66; 95%CI 3.24-4.14) or azithromycin (OR=2.15; 95%CI 1,92-2.41) were associated with a higher probability of macrolide use for unapproved indications while being 18-64 years old (OR=0.81; 95%CI 0.71-0.93) or 65 years or older (OR=0.77; 95%CI 0.63-0.94) and residing in Bogotá-Cundinamarca (OR=0.74; 95%CI 0.65-0.85) were associated with reduced risk. Conclusions: Most patients received macrolides for respiratory tract infections; erythromycin and azithromycin were used for unapproved indications in people under 18 years of age and those with chronic respiratory diseases.

Chlamydia infection resembling ulcerative colitis: case report / Infecção por clamídia lembrando retocolite ulcerativa: relato de caso

Introduction: The diagnosis of ulcerative colitis is relatively complex because the symptoms are similar to those seen in several other diseases. Objective: To report a case of rectal chlamydial infection whose initial symptoms resembled ulcerative colitis. Case report: A 50-year-old male patient presented with diarrhea, blood and mucus in the stools, and an ulcer in the rectum. The histopathological exam pointed to chronic, unspecified inflammation. After a broad serological screening, with Immunoglobulin M positive for Chlamydia and a high titer of immunoglobulin G, the patient was treated with antibiotics and is clinically cured. Later, he remained Immunoglobulin M positive, but the titers of immunoglobulin G lowered considerably. Chlamydia has been shown to live in the gut microbiota, which could explain the case. Conclusion: It is important to search for chlamydial infection as a differential diagnosis of ulcerative colitis.

Introdução: A retocolite ulcerativa é uma condição clínica de diagnóstico relativamente complexo, uma vez que apresenta sinais e sintomas comuns a muitas outras doenças. Objetivo: Relatar um caso de infecção anorretal por clamídia, cujos sintomas iniciais se pareciam com os de retocolite ulcerativa. Relato de caso: Paciente de 50 anos, do sexo masculino, apresentou-se com diarreia, muco e sangue nas fezes, e úlcera no canal anorretal. O exame histopatológico mostrou um processo inflamatório crônico e inespecífico, então procedeu-se a amplo rastreamento sorológico, que revelou Imunoglobulina M positivo para clamídia e altos títulos de Imunoglobulina G. O paciente foi tratado com antibióticos e encontra-se clinicamente curado. No seguimento, permanece com Imunoglobulina M positivo, mas os títulos de Imunoglobulina G decresceram consideravelmente. Bactérias do gênero Chlamydia têm sido reportadas como parte da microbiota intestinal, o que poderia explicar tal comportamento sorológico. Conclusão: É importante rastrear por clamídia como diagnóstico diferencial das suspeitas de retocolite ulcerativa

Advances in epidemiology and mechanism of azithromycin resistance in Salmonella / 国际儿科学杂志

Salmonella are important food-borne infectious bacteria causing gastroenteritis, enteric fever, bloodstream infection and focal extraintestinal infection and other salmonellosis.It is a major global public health problem.Antibiotics play an important role in the prevention and treatment of salmonellosis.With the emergence of resistance to traditional first-line drugs for the treatment of salmonellosis, azithromycin has become one of the commonly used antibiotics.However, studies have reported azithromycin resistant Salmonella strains, and azithromycin resistance in Salmonella is becoming more common and increasing year by year.Enhanced activity of active efflux pump, destruction of lactone ring structure, methylation of ribosome, carrying ICE_erm42 gene may be related mechanisms of drug resistance.The discovery, monitoring and in-depth study of azithromycin resistance in Salmonella play an important role in the rational use of antibiotics and delaying the trend of resistance.This article reviews the research progress on the epidemiology and related mechanisms of azithromycin resistance in Salmonella.

Sales of "COVID kit" drugs and adverse drug reactions reported by the Brazilian Health Regulatory Agency / Vendas de "kit-COVID" e reações adversas a esses medicamentos relatadas pela Agência Nacional de Vigilância Sanitária / Ventas de medicamentos del "kit-COVID" y reacciones adversas a los medicamentos notificadas por la Agencia Nacional de Vigilancia Sanitaria

Off-label use of azithromycin, hydroxychloroquine, and ivermectin (the "COVID kit") has been suggested for COVID-19 treatment in Brazil without clinical or scientific evidence of efficacy. These drugs have known adverse drug reactions (ADR). This study aimed to analyze if the sales of drugs in the "COVID kit" are correlated to the reported number of ADR after the COVID-19 pandemic began. Data was obtained from the Brazilian Health Regulatory Agency (Anvisa) website on reported sales and ADRs for azithromycin, hydroxychloroquine, and ivermectin for all Brazilian states. The period from March 2019 to February 2020 (before the pandemic) was compared to that from March 2020 to February 2021 (during the pandemic). Trend adjustment was performed for time series data and cross-correlation analysis to investigate correlation between sales and ADR within the same month (lag 0) and in the following months (lag 1 and lag 2). Spearman's correlation coefficient was used to assess the magnitude of the correlations. After the pandemic onset, sales of all investigated drugs increased significantly (69.75% for azithromycin, 10,856,481.39% for hydroxychloroquine, and 12,291,129.32% for ivermectin). ADR levels of all medications but azithromycin were zero before the pandemic, but increased after its onset. Cross-correlation analysis was significant in lag 1 for all drugs nationwide. Spearman's correlation was moderate for azithromycin and hydroxychloroquine but absent for ivermectin. Data must be interpreted cautiously since no active search for ADR was performed. Our results show that the increased and indiscriminate use of "COVID kit" during the pandemic correlates to an increased occurrence of ADRs.

No Brasil, o uso off label de azitromicina, hidroxicloroquina e ivermectina (o "kit-COVID") foi sugerido para tratar COVID-19 sem que tivéssemos evidências clínicas ou científicas de sua eficácia. Estas drogas têm causado reações adversas (RA) em quem as tomam. Este estudo almejou analisar se a venda dos medicamentos que compõem o "kit-COVID" correlaciona-se com o número relatado de RAs após o início da pandemia da COVID-19. Os dados sobre vendas e RA associados a azitromicina, hidroxicloroquina e ivermectina foram obtidos no site da Agência Nacional de Vigilância Sanitária (Anvisa) para todos os estados brasileiros. Comparamos o período entre março de 2019 e fevereiro de 2020 (antes da pandemia) ao de março de 2020 a fevereiro de 2021 (durante a pandemia). Ajustamos tendências para os dados de séries temporais e as análises de correlação cruzada para investigar a correlação entre vendas e RA em um mesmo mês (lag 0) e nos seguintes (lag 1 e 2). O coeficiente de correlação de Spearman foi utilizado para avaliar a magnitude das correlações. Após o início da pandemia, as vendas de todos os medicamentos investigados aumentaram significativamente (69,75% para azitromicina, 10.856.481,39% para hidroxicloroquina e 12.291.129,32% para ivermectina). Os níveis de RAs de todos os medicamentos (com exceção de azitromicina) eram zero antes da pandemia mas aumentaram após seu início. A análise de correlação cruzada foi significativa no lag 1 para todas as drogas em todo o país. A correlação de Spearman foi moderada para azitromicina e hidroxicloroquina, mas ausente para ivermectina. Os dados devem ser interpretados com cautela, uma vez que não realizamos uma busca ativa por RA. Nossos resultados mostram que o uso aumentado e indiscriminado do "kit-COVID" durante a pandemia se correlaciona com uma ocorrência aumentada de RAs.

Se ha sugerido el uso fuera de lo establecido de azitromicina, hidroxicloroquina e ivermectina (el "kit-COVID") para el tratamiento de la COVID-19 en Brasil sin evidencia clínica o científica de su eficacia. Estos medicamentos tienen reacciones adversas (RAM) conocidas. Este estudio pretendía analizar si las ventas de medicamentos del "kit-COVID" están correlacionadas con el número de reacciones adversas notificadas tras el inicio de la pandemia de COVID-19. Los datos se obtuvieron del sitio web de la Agencia Nacional de Vigilancia Sanitaria (Anvisa) sobre las ventas y las RAM notificadas para la azitromicina, la hidroxicloroquina y la ivermectina para todos los estados brasileños. Se comparó el periodo de marzo de 2019 a febrero de 2020 (antes de la pandemia) con el de marzo de 2020 a febrero de 2021 (durante la pandemia). Se realizó un ajuste de tendencia para los datos de las series de tiempo y un análisis de correlación cruzada para investigar la correlación entre las ventas y la RAM dentro del mismo mes (lag 0) y en los meses siguientes (lag 1 y lag 2). Se utilizó el coeficiente de correlación de Spearman para evaluar la magnitud de las correlaciones. Tras el inicio de la pandemia, las ventas de todos los medicamentos investigados aumentaron significativamente (69,75% para la azitromicina, 10.856.481,39% para la hidroxicloroquina y 12.291.129,32% para la ivermectina). Los niveles de RAM de todos los medicamentos, excepto la azitromicina, eran nulos antes de la pandemia, pero aumentaron tras su inicio. El análisis de correlación cruzada fue significativo en el lag 1 para todos los medicamentos a nivel nacional. La correlación de Spearman fue moderada para la azitromicina y la hidroxicloroquina, pero no para la ivermectina. Los datos deben interpretarse con cautela, ya que no se realizó una búsqueda activa de RAM. Nuestros resultados muestran que el uso creciente e indiscriminado del "kit-COVID" durante la pandemia se correlaciona con una mayor aparición de las RAM.

Interacciones farmacocinéticas de la azitromicina e implicación clínica / Pharmacokinetic interactions of azithromycin and clinical implication

Introducción: El síndrome respiratorio agudo grave (por la COVID-19) es en la actualidad la primera causa de muerte en el Perú, por lo que se requiere de fármacos eficaces y seguros para mitigar la enfermedad. Se realizó una búsqueda bibliográfica en SciELO y PubMed/ Medline; se seleccionaron 37 de 58 artículos sobre el tema. Objetivos: Revisar e integrar la información sobre las interacciones farmacocinéticas de la azitromicina que se prescriben en el tratamiento ambulatorio de la COVID-19 en el Perú, y evaluar su implicación clínica. Desarrollo: La azitromicina es usada en la COVID-19, por su actividad antiinflamatoria, al inhibir a las interleucinas (IL1, 6, 8 y TNF-α), y a las moléculas de adhesión intracelular 1 (ICAM1); y por inducir la producción de interferón tipo I (IFN-α, IFN-β) y III (IFN-λ) en células de pacientes con enfermedad pulmonar obstructiva crónica. Los estudios de tres brazos, aleatorizado y abierto, indican que la azitromicina no genera cambios en los parámetros farmacocinéticos de la ivermectina, sildenafilo, rupatadina y desloratadina; los estudios de un solo centro, abierto, sin ayuno y de dos períodos, evidencian que la azitromicina influye en los parámetros farmacocinéticos de venetoclax y de los psicotrópicos. Conclusiones: Basado en la evidencia de los estudios clínicos revisados e integrados, se concluye que estas son limitadas y de poca relevancia clínica, sin embargo, se propone usar el antibiótico bajo el criterio científico del médico, para evitar las interacciones farmacocinéticas y las reacciones adversas de los fármacos(AU)

Introduction: The severe acute respiratory syndrome (due to COVID-19) is currently the leading cause of death in Peru, so effective and safe drugs are required to mitigate the disease. A bibliographic search was carried out in SciELO and PubMed/Medline; 37 of 58 articles on the topic were selected. Objectives: Review and integrate the information on the pharmacokinetic interactions of azithromycin that are prescribed in the outpatient treatment of COVID-19 in Peru, and evaluate their clinical implication. Development: Azithromycin is used in COVID-19, due to its anti-inflammatory activity, by inhibiting interleukins (IL1, 6, 8 and TNF-α), and intracellular adhesion molecules 1 (ICAM1); and by inducing the production of type I interferon (IFN-α, IFN-β) and III (IFN-λ) in cells of patients with chronic obstructive pulmonary disease. The three-arm, randomized and open-label studies indicate that azithromycin does not cause changes in the pharmacokinetic parameters of ivermectin, sildenafil, rupatadine, and desloratadine; single-center, open-label, non-fasting, and two-period studies show that azithromycin influences the pharmacokinetic parameters of venetoclax and psychotropics. Conclusions: Based on the evidence from the reviewed and integrated clinical studies, it is concluded that these are limited and of little clinical relevance, however, it is proposed to use the antibiotic under the scientific criteria of the doctor, to avoid pharmacokinetic interactions and adverse reactions of drugs(AU)

The impact of hydroxychloroquine and azithromycin on the corrected qt interval in patients with the novel Coronavirus disease 2019

SUMMARY OBJECTIVE: With the coronavirus disease 2019 (COVID-19) continuing to spread all over the world, although there is no specific treatment until now, hydroxychloroquine and azithromycin have been reported to be effective in recent studies. Although long-term use of hydroxychloroquine and azithromycin has been reported to cause QT prolongation and malign arrhythmia, there is not enough data about the effect of short-term use on arrhythmia. Therefore, this study aims to assess the effect of hydroxychloroquine alone and hydroxychloroquine + azithromycin on corrected QT (QTc). METHODS: A baseline electrocardiogram and on-treatment baseline electrocardiogram were retrospectively collected in COVID-19 patients who received hydroxychloroquine and/or azithromycin. The QTc interval was calculated, and the baseline and peak QTc intervals were compared. In addition, the peak QTc intervals of monotherapy and combination therapy were compared. RESULTS: Of the 155 patients included, 102 (65.8%) patients were using hydroxychloroquine, and 53 (34.2%) patients were using hydroxychloroquine + azithromycin combination. The use of both hydroxychloroquine alone and hydroxychloroquine + azithromycin combined therapy significantly prolonged the QTc, and the QTc interval was significantly longer in patients receiving combination therapy. QTc prolongation caused early termination in both groups, 5 (4.9%) patients in the monotherapy group and 6 (11.3%) patients in the combination therapy group. CONCLUSION: In this study, patients who received hydroxychloroquine for the treatment of COVID-19 were at high risk of QTc prolongation, and concurrent treatment with azithromycin was associated with greater changes in QTc.

Mortalidad por hidroxicloroquina y azitromicina en pacientes con COVID-19 en ventilación mecánica de una unidad de cuidados intensivos de Lima

Objetivo : Estimar la mortalidad relacionada a hidroxicloroquina y azitromicina en pacientes con Covid-19 en ventilación mecánica de una unidad de cuidados intensivos. Material y métodos : Cohorte analítica retrospectiva. Se incluyeron 105 pacientes con Covid-19 en ventilación mecánica invasiva que ingresaron con el diagnóstico de Insuficiencia Respiratoria Aguda a la unidad de cuidados intensivos del Hospital Cayetano Heredia durante el año 2020. Resultados : La mortalidad global fue 38 %; el 79 % fueron varones, la edad media fue 50±13 años, el 65 % no tuvo comorbilidades; al ingreso la puntuación en la escala APACHE II fue 12±6 puntos y en la escala SOFA 5±3 puntos; el 30 % recibió hidroxicloroquina, el 32 % azitromicina y 32 % la combinación de los mismos. La mortalidad fue significativamente mayor en pacientes que recibieron hidroxicloroquina (p=0.001), azitromicina (p=0.03), y la combinación hidroxicloroquina más azitromicina (p=0.001). Sin embargo, en la regresión de Cox se evidenció que los pacientes que fallecieron tuvieron mayor probabilidad de exposición a hidroxicloroquina (p=0.001) (HR: 21, IC: 3.4-131.3), no ocurrió lo mismo con azitromicina (p=0.22) (HR: 0.43, IC: 0.11-1.6). Conclusión : La mortalidad en los pacientes con Covid-19 en ventilación mecánica invasiva fue significadamente mayor en pacientes que recibieron hidroxicloroquina.

Objective : To estimate mortality rates associated with hydroxichloroquine and azithromycin use in Covid-19 patients undergoing mechanical ventilation in an intensive care unit in Lima. Material and methods : This is a retrospective analytical cohort. One hundred and five patients with Covid-19 undergoing invasive mechanical ventilation who were admitted with a diagnosis of acute respiratory insufficiency to the intensive care unit of Cayetano Heredia Hospital in Lima during 2020. Results : The overall mortality rate was 38%. Most patients (79%) were male, their mean age was 50 ± 13 years, two thirds (65%) did not have comorbidities; APACHE II and SOFA scores were 12 ± 6 points and 5 ± 3 points, respectively. Thirty percent of all patients received hydroxichloroquine, 32% received azithromycin, and 32% received both drugs. Mortality was significantly higher in those patients who received hydroxichloroquine (p= 0.001), azithromycin (p= 0.03), and the combination of hydroxichloroquine and azithromycin (p= 0.001). However, when a Cox regression analysis was performed, it was evidenced that deceased patients were more likely to have been exposed to hydroxichloroquine (p= 0.001) (HR: 21, CI: 3.4-131.3), but this was not the case with azithromycin (p= 0.22) (HR: 0.43, CI: 0.11-1.6). Conclusion : Mortality in Covid-19 patients undergoing invasive mechanical ventilation was higher in those who received hydroxichloroquine.

Effects of Chloroquine and Hydroxychloroquine on the Cardiovascular System - Limitations for Use in the Treatment of COVID-19

Abstract Chloroquine (CQ) and Hydroxychloroquine (HCQ) are antimalarial drugs, with anti-inflammatory properties that justify their use in the treatment of systemic lupus erythematosus and rheumatic diseases. A pandemic caused by the new coronavirus led the entire world's scientific community to look for drugs already available on the market, capable of exercising beneficial actions in the fight against the disease. Preliminary studies in patients, as well as in vitro studies, suggested possible therapeutic effects associated with the use of HCQ and CQ in the treatment of COVID-19. Despite controversies over the effects of these drugs in combating the "cytokine storm" associated with COVID and the dismal of results in different clinical trials in Brazil, their use has been encouraged and several ongoing investigative studies are underway. In addition to the possible beneficial effects on the prognosis of patients with SARS-CoV-2, such drugs include varied effects on the cardiovascular system, ranging from positive developments related to their vasodilator properties to potential negative effects, such as cardiotoxicity. This work presents the main effects exerted by these drugs on the cardiovascular system, in order to contribute to a scientific discussion about the repurposing of these drugs in the context of COVID-19.

A Randomised Study Comparing the Efficacy of Low-Dose Oral Azithromycin versus Doxycycline in Combination with Topical Benzoyl Peroxide in the Treatment of Moderate to Severe Acne Vulgaris

Background@#Acne vulgaris is a common chronic inflammatory skin disease. Long term therapy involving antibiotics warrants for drug with a long half-life to increase compliance of patients. @*Methods@#A twelve-week prospective randomized study was performed on 40 subjects with moderate to severe facial acne to compare the efficacy of oral azithromycin with oral doxycycline. Thirty-six subjects completed the study. Subjects in azithromycin group received azithromycin 250mg three times a week plus topical benzoyl peroxide 5% (BPO), whereas subjects in doxycycline group received doxycycline 100mg daily plus topical BPO 5%. Efficacy evaluation included treatment success rate (Comprehensive Acne Severity Score /CASS of 0 or 1 or improvement of two grades from baseline) and lesion counts.@*Results@#Treatment was successful in 94.4% of subjects in azithromycin group, compared to 88.9% in doxycycline group (p=1.000) at week 12.However, percentage of clear or almost clear by CASS was higher in the doxycycline group ( 83.3% vs 66.7%; p= 0.443).Percentage reduction of inflammatory lesion counts in azithromycin and doxycycline group following treatment for 12 weeks were 78.3% and 85.3% (p=0.133) respectively, whereas for non-inflammatory lesion counts were 77.7% and 78.8% (p=0.852) respectively. Nausea was reported in 77.8% at week 6 and 66.7% at week 12 in doxycycline group, but none in azithromycin group. There were no significant differences in incidence of diarrhoea and abdominal pain.@*Conclusion@#Azithromycin 250mg three times a week plus topical BPO 5% is as effective as doxycycline 100mg daily plus topical BPO 5%.

Hydroxychloroquine with azithromycin in patients hospitalized for mild and moderate COVID-19

ABSTRACT Objectives: To assess the efficacy of hydroxychloroquine in combination with azithromycin in terms of clinical and biochemical outcomes in adult patients with COVID-19 hospitalized for acute respiratory distress syndrome (ARDS), and to describe the occurrence of adverse events. Method: Retrospective comparative study, based in a quaternary private hospital in Rio de Janeiro, Brazil, involving 193 adult patients hospitalized for mild and moderate COVID-19 related ARSD, analyzing treatment efficacy based on clinical and biochemical outcomes. Results: The active group comprised 101 (52.3%) patients using hydroxychloroquine associated with azithromycin and the control group 92 (47.7%) patients who did not take these medications. Median age was 59 (47-70) in the active group and 65 (47−77) in the control group (p < 0.05). Patients in the control group had greater extent of pulmonary involvement on baseline chest CT scans (p < 0.05). All other baseline variables (BMI, comorbidities, previous use of medications and biochemical assessments) were similar between groups. In the medication group, 25% (25 out of 101) were admitted to the ICU, compared to 21% (19 out of 92) in the control group (p > 0.05). No difference in mortality, duration of non-invasive oxygen use or duration of hospitalization was seen between groups. The therapeutic regimen was well tolerated, with only eight (7.9%) patients presenting gastrointestinal symptoms and eight (7.9%) patients withdrawn treatment due to QTc prolongation. Conclusions: Patients treated with hydroxychloroquine combined with azithromycin and the control group had similar clinical outcomes. This therapeutic regimen was considered ineffective in hospitalized patients with mild to moderate COVID-19 related ARDS and was associated with few non-severe adverse events.