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Braz. j. biol ; 84: e251289, 2024. tab, graf
Article in English | LILACS, VETINDEX | ID: biblio-1355889


Abstract The present research was made to determine the micronuclei and cytotoxic capacity of the antidepressant venlafaxine in an in vivo acute and subchronic assays in mouse. In the first study, we administered once 5, 50, and 250 mg/kg of the drug, and included a negative and a daunorubicin treated group. Observations were daily made during four days. The subchronic assay lasted 5 weeks with daily administration of venlafaxine (1, 5, and 10 mg/kg) plus a negative and an imipramine administered groups. Observations were made each week. In the first assay results showed no micronucleated polychromatic erythrocytes (MNPE) increase, except with the high dose at 72 h. The strongest cytotoxic effect was found with 250 mg/kg at 72 h (a 51% cytotoxic effect in comparison with the mean control level). In the subchronic assay no MNPE increase was found; however, with the highest dose a significant increase of micronucleated normochromatic erythrocytes was observed in the last three weeks (a mean of 51% respect to the mean control value). A cytotoxic effect with the two high doses in the last two weeks was observed (a polychromatic erythrocyte mean decrease of 52% respect to the mean control value). Results suggest caution with venlafaxine.

Resumo A presente pesquisa foi feita para determinar a capacidade micronuclei e citotóxica do antidepressivo venlafaxina em ensaios agudos e subcrônicos in vivo em camundongos. No primeiro estudo, administramos uma vez 5, 50 e 250 mg/kg do medicamento e incluímos um grupo negativo e um grupo tratado com daunorubicina. As observações foram feitas diariamente durante quatro dias. O ensaio subcrônico durou cinco semanas com administração diária de venlafaxina (1, 5, e 10 mg/kg) mais um grupo negativo e um grupo administrado de imipramina. As observações foram feitas a cada semana. No primeiro ensaio, os resultados não mostraram aumento de eritrócitos policromáticos micronucleados (MNPE), exceto com a dose elevada a 72 h. O efeito citotóxico mais forte foi encontrado com 250 mg/kg a 72 h (um efeito citotóxico de 51% em comparação com o nível médio de controle). No ensaio subcrônico não foi encontrado aumento de MNPE; entretanto, com a dose mais alta, um aumento significativo de eritrócitos normocromáticos micronucleados foi observado nas últimas três semanas (média de 51% em relação ao valor médio de controle). Foi observado um efeito citotóxico com as duas altas doses nas últimas duas semanas (uma diminuição média de 52% em relação ao valor médio de controle dos eritrócitos policromáticos). Os resultados sugerem cautela com a venlafaxina.

Animals , Rabbits , DNA Damage , Antineoplastic Agents , Micronucleus Tests , Dose-Response Relationship, Drug , Erythrocytes , Venlafaxine Hydrochloride/toxicity
J. coloproctol. (Rio J., Impr.) ; 42(2): 167-172, Apr.-June 2022. tab
Article in English | LILACS | ID: biblio-1394410


ABSTRACT Background Anal fissure is a common surgical disease that is usually treated conservatively. The golden surgical treatment for anal fissure is lateral internal sphincterotomy, but it may result in multiple complications. Therefore, other treatment methods have recently been introduced, and one of them is the injection of botulinum toxin A (BTA) and fissurectomy. In the present study, we aim to evaluate the effectiveness of the combination of fissurectomy and BTA injection in the treatment of chronic anal fissure by single surgeon. Materials and Methods The present is a non-randomized prospective cohort study conducted by a single surgeon in Saudi Arabia. Our sample was composed of 116 female patients, with mean age of 36.57 ± 11.52 years, who presented to our Surgical Outpatient Clinic with chronic anal fissure between October 2015 and July 2020, and were treated with BTA injection combined with fissurectomy. They were followed up for 1, 2, 3, 4, and 8 weeks, and after one year to evaluate the efficacy and safety of the treatment. The main outcomes analyzed were symptomatic relief, complications, recurrence, and the need for further surgical intervention. Results The treatment with BTA injection combined with fissurectomy was effective and safe in 115 patients (99.1%) at 1 year of follow-up. A total of 5 patients experienced recurrence at 8 weeks, which resolved completely with pharmacological sphincterotomy, and 12 patients experienced minor incontinence, which disappeared later. Conclusion In total, 70 units of BTA injection combined with fissurectomy is a suitable second-line treatment of choice for chronic anal fissure, with a high degree of success and a low rate of major morbidity. (AU)

Humans , Female , Adult , Middle Aged , Aged , Botulinum Toxins, Type A/therapeutic use , Dose-Response Relationship, Drug , Pain, Postoperative , Fecal Incontinence , Fissure in Ano/surgery
Dolor ; 31(73): 26-31, ene. 2021. tab, ilus
Article in Spanish | LILACS | ID: biblio-1362747


Objetivo: El presente trabajo de investigación tuvo como objetivo explorar la eficacia analgésica mediante la comparación de la respuesta analgésica de los parches transdérmicos (PTD) de buprenorfina y fentanilo en dolor oncológico y patrón de uso. Material y Método: Se obtuvieron los datos y variables desde los registros clínicos de pacientes ingresados a la Unidad de Cuidados Paliativos (UCP) del Instituto Nacional del Cáncer (INC) que estaban bajo tratamiento en mayo del 2017. Se incluyó en este estudio a 78 pacientes con PTD, que representan el 13% de los pacientes en control mensual. De estos, 66 estaban bajo tratamiento con buprenorfina y 8 bajo tratamiento con fentanilo. Resultados: Los resultados mostraron que el PTD de buprenorfina se utiliza más frecuentemente que el de fentanilo. El principal motivo de rotación fue dolor no controlado, seguido por imposibilidad de contar con la administración por vía oral. En pacientes con mayores intensidades de dolor somático o visceral se indicó fentanilo y en aquellos con componente neuropático se prefirió el uso de buprenorfina. PTD de fentanilo fue indicado en dosis mayores que buprenorfina, incluso al comparar sus dosis equianalgésicas, siendo la variación de dosis alta para ambos parches: aumentó en promedio 257%. Se logró una mejor respuesta analgésica con buprenorfina, con una variación de intensidad de escala numérica verbal (ENV) de 2,94 y 1,88 puntos de promedio para buprenorfina y fentanilo, respectivamente. Adicionalmente, se presentó mayor reacción local dérmica con fentanilo. Conclusiones: Se evidenció diferencias en patrón de uso y, a diferencia de lo esperado, se obtuvo una mejor eficacia analgésica con buprenorfina. Datos que deben ser corroborados en estudios con mayor número de pacientes bajo tratamiento con fentanilo.

Objective: This study aims to explore analgesic efficacy comparisons of buprenorphine and fentanyl transdermal patches (TDP) in cancer pain and it's usage pattern. Material and Method: Data and variables were collected from patient's clinical reports who were admitted in the National Cancer Institute's (NCI) Palliative Care Unit (PCU) and were under treatment with TDP in May 2017. 78 TDP patients were studied and represented 13% of the monthly control patients in the PCU. Of these, 66 were under buprenorphine treatment and 8 under fentanyl treatment. Results: The results showed that buprenorphine TDP is more frequently used than fentanyl TDP, and the main reason for exchange between them was uncontrolled pain, followed by oral administration impossibility. Fentanyl TDP was indicated in patients with higher somatic or visceral pain intensities and Buprenorphine TDP was preferred in patients with neuropathic pain. Fentanyl TDP was indicated in higher doses than buprenorphine, even when comparing its equianalgesic doses, the dose variation was high for both patches throughout the treatment: it increased on average by 257%. A better analgesic response was achieved with buprenorphine, with a variation of intensity of the Verbal Numerical Scale (VNS) of 2.94 and 1.88 average points, for buprenorphine and fentanyl respectively. Additionally, there was a higher local dermal reaction with fentanyl TDP. Conclusions: Differences in usage patterns were evidenced and, unlike what was expected, better analgesic efficacy was obtained with buprenorphine TDP. This data should be corroborated in receiving fentanyl treatment.

Humans , Male , Female , Middle Aged , Buprenorphine/administration & dosage , Fentanyl/administration & dosage , Transdermal Patch , Cancer Pain/drug therapy , Analgesics, Opioid/administration & dosage , Palliative Care/methods , Buprenorphine/therapeutic use , Fentanyl/therapeutic use , Treatment Outcome , Dose-Response Relationship, Drug , Analgesics, Opioid/therapeutic use
Article in English | WPRIM | ID: wpr-921358


To explore interleukin-6 (IL-6) production and characterize lipid accumulation in L02 hepatocytes induced by sodium oleate. L02 hepatocytes were incubated with 0, 37.5, 75, 150, 300, 600, or 1,200 μmol/L sodium oleate for 24 h, and the supernatant was collected to detect the concentration of IL-6. L02 hepatocytes were incubated with 300, 150, 75, or 0 μmol/L sodium oleate for 0-24 h. The supernatant was collected for detection of IL-6 and free fatty acids. L02 hepatocytes treated with 300 μmol/L sodium oleate for 0-24 h were stained with Oil Red O. With extended sodium oleate incubation time, IL-6 levels increased, and free fatty acids decreased. After 24 h incubation, IL-6 levels increased as sodium oleate increased from 37.5 to 300 μmol/L (

Dose-Response Relationship, Drug , Hepatocytes/metabolism , Humans , Interleukin-6/metabolism , Lipid Metabolism , Oleic Acid/administration & dosage , Time Factors
Article in English | WPRIM | ID: wpr-888614


High levels (> 100 ug/L) of arsenic are known to cause lung cancer; however, whether low (≤ 10 ug/L) and medium (10 to 100 ug/L) doses of arsenic will cause lung cancer or other lung diseases, and whether arsenic has dose-dependent or threshold effects, remains unknown. Summarizing the results of previous studies, we infer that low- and medium-concentration arsenic cause lung diseases in a dose-dependent manner. Arsenic trioxide (ATO) is recognized as a chemotherapeutic drug for acute promyelocytic leukemia (APL), also having a significant effect on lung cancer. The anti-lung cancer mechanisms of ATO include inhibition of proliferation, promotion of apoptosis, anti-angiogenesis, and inhibition of tumor metastasis. In this review, we summarized the role of arsenic in lung disease from both pathogenic and therapeutic perspectives. Understanding the paradoxical effects of arsenic in the lungs may provide some ideas for further research on the occurrence and treatment of lung diseases.

Animals , Arsenic/toxicity , Dose-Response Relationship, Drug , Humans , Lung/pathology , Lung Neoplasms/drug therapy , Mice
Article in English | WPRIM | ID: wpr-880354


BACKGROUND@#Periploca aphylla is used by local population and indigenous medicine practitioners as stomachic, tonic, antitumor, antiulcer, and for treatment of inflammatory disorders. The aim of this study was to evaluate antidiabetic effect of the extract of P. aphylla and to investigate antioxidant and hypolipidemic activity in streptozotocin (STZ)-induced diabetic rats.@*METHODS@#The present research was conducted to evaluate the antihyperglycemic potential of methanol extract of P. aphylla (PAM) and subfractions n-hexane (PAH), chloroform (PAC), ethyl acetate (PAE), n-butanol (PAB), and aqueous (PAA) in glucose-overloaded hyperglycemic Sprague-Dawley rats. Based on the efficacy, PAB (200 mg/kg and 400 mg/kg) was tested for its antidiabetic activity in STZ-induced diabetic rats. Diabetes was induced via intraperitoneal injection of STZ (55 mg/kg) in rat. Blood glucose values were taken weekly. HPLC-DAD analysis of PAB was carried out for the presence of various polyphenols.@*RESULTS@#HPLC-DAD analysis of PAB recorded the presence of rutin, catechin, caffeic acid, and myricetin. Oral administration of PAB at doses of 200 and 400 mg/kg for 21 days significantly restored (P < 0.01) body weight (%) and relative liver and relative kidney weight of diabetic rats. Diabetic control rats showed significant elevation (P < 0.01) of AST, ALT, ALP, LDH, total cholesterol, triglycerides, LDL, creatinine, total bilirubin, and BUN while reduced (P < 0.01) level of glucose, total protein, albumin, insulin, and HDL in serum. Count of blood cells and hematological parameters were altered in diabetic rats. Further, glutathione peroxidase, catalase, superoxide dismutase, glutathione reductase, and total soluble protein concentration decreased while concentration of thiobarbituric acid reactive substances and percent DNA damages increased (P < 0.01) in liver and renal tissues of diabetic rats. Histopathological damage scores increased in liver and kidney tissues of diabetic rats. Intake of PAB (400 mg/kg) resulted in significant improvement (P < 0.01) of above parameters, and results were comparable to that of standard drug glibenclamide.@*CONCLUSION@#The result suggests the antihyperglycemic, antioxidant, and anti-inflammatory activities of PAB treatment in STZ-compelled diabetic rat. PAB might be used as new therapeutic agent in diabetic patients to manage diabetes and decrease the complications.

1-Butanol/chemistry , Administration, Oral , Animals , Diabetes Mellitus, Experimental/drug therapy , Dose-Response Relationship, Drug , Hypoglycemic Agents/chemistry , Male , Periploca/chemistry , Phytochemicals/chemistry , Plant Extracts/chemistry , Rats , Rats, Sprague-Dawley , Streptozocin/adverse effects
Rev. cuba. med ; 59(4): e1388, oct.-dic. 2020. tab
Article in Spanish | LILACS, CUMED | ID: biblio-1144502


Introducción: La obesidad está asociada al uso frecuente de medicación de rescate y padecer asma de mayor gravedad. Los obesos asmáticos tienen menor reactividad bronquial, sin embargo, existe información limitada sobre la magnitud de la reversibilidad aguda al broncodilatador (RAB). Objetivo: Evaluar la magnitud de respuesta aguda al broncodilatador en pacientes asmáticos sobrepesos y obesos. Métodos: Se realizó un estudio descriptivo transversal con 49 pacientes asmáticos sobrepesos y obesos atendidos en consulta externa del Hospital Neumológico Benéfico Jurídico (enero 2017˗ enero 2018) y se constató mediante espirometría la respuesta aguda al broncodilatador. Resultados: Predominó la edad (40-59 años), mayor asociación de padecer asma, poca mejoría con la aplicación del broncodilatador. El sexo femenino (20-59 años) presentó mayor número que el masculino y menor reversibilidad al broncodilatador. Los pacientes con antecedentes patológicos familiares de asma o atopia representaron 73,5 por ciento del total. El 76,5 por ciento de los obesos no presentó mejoría con la aplicación del broncodilatador. Predominó la categoría de gravedad persistente moderada. Conclusiones: El sexo femenino tiene más riesgo de padecer asma y no tener mejoría al aplicar el broncodilatador. Los obesos mayores de 40 años tienen mayor riesgo de no presentar reversibilidad aguda al broncodilatador. Los antecedentes patológicos familiares de asma o atopia y personales de otras enfermedades no predisponen a menor reversibilidad aguda al broncodilatador. La gravedad del asma no influye en la reversibilidad aguda al broncodilatador(AU)

Introduction: Obesity is associated with the frequent use of rescue medication and suffering from more severe asthma. Obese asthmatics have less bronchial reactivity, however, there is limited information on the magnitude of acute bronchodilator reversibility. Objective: To assess the magnitude of the acute response to the bronchodilator in overweight and obese asthmatic patients. Methods: A cross-sectional descriptive study was carried out in 49 overweight and obese asthmatic patients seen in the outpatient clinic at Benéfico Jurídico Pneumologic Hospital from January 2017 to January 2018, and the acute response to bronchodilator was verified by spirometry. Results: Age predominated (40-59 years), greater association of suffering from asthma, and little improvement with the use of bronchodilator. The female sex (20-59 years) showed greater number than the male and less reversibility to bronchodilator. Patients with family pathological history of asthma or atopy represented 73.5 percent of the total. 76.5 percent of the obese did not show improvement with the use of bronchodilator. The category of moderate persistent severity predominated. Conclusions: The female sex has greater risk of suffering from asthma and has no improvement when applying bronchodilator. Obese individuals over 40 years of age have higher risk of not having acute reversibility to the bronchodilator. Family pathological history of asthma or atopy and personal history of other diseases do not predispose to less acute reversibility of bronchodilator. The severity of asthma does not influence acute reversibility to bronchodilator(AU)

Humans , Male , Female , Middle Aged , Bronchodilator Agents/therapeutic use , Dose-Response Relationship, Drug , Obesity/complications , Epidemiology, Descriptive , Cross-Sectional Studies
Rev. chil. pediatr ; 91(5): 684-690, oct. 2020. tab, graf
Article in Spanish | LILACS | ID: biblio-1144266


INTRODUCCIÓN: El primer año de vida es un periodo de riesgo de deficiencia de vitamina D (VD). La administración de 400 UI diarias de VD no tiene una adherencia del 100%, en cambio dosis únicas de 100.000 UI de VD oral son seguras en recién nacidos. OBJETIVO: Comparar el efecto de la suplementación oral de VD en dosis única de 100.000 UI al mes de edad vs dosis diarias de 400 UI sobre las concentraciones séricas de VD, a los 6 meses de vida. SUJETOS Y MÉTODOS: Ensayo clínico aleatorizado, sin enmascaramiento. Se incluyeron 84 lactantes sanos de 1 mes de vida, asignados al azar al grupo de estudio (GE) que recibió una dosis única de VD de 100.000 UI oral o al grupo control (GC), que recibió dosis diarias de VD de 400 UI oral del 1er al 6to mes de vida. A los 6 meses de edad se determinó la concentración sérica de VD. RESULTADOS: 65 lactantes terminaron el estudio, 36 en GE y 29 en GC. No se encontró deficiencia de VD. La insuficiencia de VD fue de 5,5% y 6,8% en el GE y GC, respectivamente. La concentración sérica de VD a los 6 meses de vida, fue de 38,8 ± 5,2 ng/ml y 39,7 ± 6,3 ng/ml para GE y GC, respectivamente (NS). CONCLUSIONES: La suplementación con 100.000 UI de VD única al mes de edad logra concentraciones séricas de VD a los 6 meses de vida, similares a dosis diarias de 400 UI de VD, del 1er al 6to mes.

INTRODUCTION: Infants are a group at risk of vitamin D (VD) deficiency. The administration of 400 IU of VD per day during the first year of life does not achieve 100% adherence. A single dose of 100,000 IU of oral VD is safe in newborns. OBJECTIVE: To compare the effect of oral administration of VD between a single dose of 100,000 IU at one month of age vs daily doses of 400 IU on serum concentrations of VD, at 6 months of age. SUBJECTS AND METHOD: Randomized clinical trial, without masking. 84 healthy infants were included at 1 month of age, randomized to the study group (SG) receiving a single oral dose of 100,000 IU or to the control group (CG), who received daily oral doses of VD of 400 IU from the 1st to the 6th month of life. At 6 months of life, the serum concentration of VD was determined. RESULTS: 65 infants completed the study, 36 in SG and 29 in CG. No VD deficiency was found. VD insufficient was 5.5% and 6.8% in the SG and CG, respectively. The serum concentration of VD at six months of age was 38.8 ± 5.2 ng/ml and 39.7 ± 6.3 ng/ml for the SG and CG, respectively (NS). CONCLUSIONS: Supplementation of 100,000 IU of VD at one month age achieves serum concentrations of VD at 6 months of life similar to the administration of daily doses of 400 IU of VD from the 1st to the 6th month.

Humans , Male , Female , Infant , Vitamin D/administration & dosage , Vitamin D Deficiency/prevention & control , Vitamins/administration & dosage , Dietary Supplements , Vitamin D/analogs & derivatives , Vitamin D/blood , Vitamin D/therapeutic use , Vitamin D Deficiency/diagnosis , Vitamin D Deficiency/blood , Vitamins/therapeutic use , Drug Administration Schedule , Biomarkers/blood , Nutritional Status , Administration, Oral , Follow-Up Studies , Treatment Outcome , Dose-Response Relationship, Drug
Rev. bras. ter. intensiva ; 32(3): 391-397, jul.-set. 2020. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1138519


RESUMO Objetivo: Investigar a efetividade da vancomicina contra Gram-positivos com concentração inibitória mínima de 1mg/L em pacientes pediátricos com base na razão entre área sob a curva e concentração inibitória mínima > 400. Métodos: População de 22 pacientes pediátricos (13 meninos) internados no centro de terapia intensiva pediátrica, com função renal preservada, que foram distribuídos em dois grupos (G1 < 7 anos e G2 ≥ 7 anos). Após a quarta dose de vancomicina (10 - 15mg/kg a cada 6 horas), duas amostras de sangue foram colhidas (terceira e quinta horas), seguidas da dosagem sérica por imunoensaios para investigação da farmacocinética e da cobertura do antimicrobiano. Resultados: Não se registrou diferença entre os grupos com relação à dose, ao nível de vale ou ainda na área sob a curva. A cobertura contra Gram-positivos com concentração inibitória mínima de 1mg/L ocorreu em apenas 46% dos pacientes em ambos os grupos. A farmacocinética se mostrou alterada nos dois grupos diante dos valores de referência, mas a diferença entre grupos foi registrada pelo aumento da depuração total corporal e pelo encurtamento da meia-vida biológica, mais pronunciados nos pacientes mais novos. Conclusão: A dose empírica mínima de 60mg/kg ao dia deve ser prescrita ao paciente pediátrico de unidade de terapia intensiva com função renal preservada. A utilização da razão entre área sob a curva e concentração inibitória mínima na avaliação da cobertura da vancomicina é recomendada para se atingir o desfecho desejado, uma vez que a farmacocinética está alterada nesses pacientes, podendo impactar na efetividade do antimicrobiano.

Abstract Objective: To investigate the vancomycin effectiveness against gram-positive pathogens with the minimum inhibitory concentration of 1mg/L in pediatric patients based on the area under the curve and the minimum inhibitory concentration ratio > 400. Methods: A population of 22 pediatric patients (13 boys) admitted to the pediatric intensive care unit with preserved renal function was stratified in two groups (G1 < 7 years and G2 ≥ 7 years). After the fourth dose administered of vancomycin (10 - 15mg/kg every 6 hours) was administered, two blood samples were collected (third and fifth hours), followed by serum measurement by immunoassays to investigate the pharmacokinetics and antimicrobial coverage. Results: There was no difference between the groups regarding dose, trough level or area under the curve. Coverage against gram-positive pathogens with a minimum inhibitory concentration of 1mg/L occurred in only 46% of patients in both groups. The pharmacokinetics in both groups were altered relative to the reference values, and the groups differed in regard to increased total body clearance and shortening of the biological half-life, which were more pronounced in younger patients. Conclusion: A minimum empirical dose of 60mg/kg per day should be prescribed for pediatric patients in intensive care units with preserved renal function. The use of the ratio between the area under the curve and minimum inhibitory concentration in the evaluation of vancomycin coverage is recommended to achieve the desired outcome, since the pharmacokinetics are altered in these patients, which may impact the effectiveness of the antimicrobial.

Humans , Male , Infant , Child, Preschool , Child , Adolescent , Vancomycin/administration & dosage , Gram-Positive Bacterial Infections/drug therapy , Gram-Positive Bacteria/drug effects , Anti-Bacterial Agents/administration & dosage , Vancomycin/pharmacology , Vancomycin/pharmacokinetics , Intensive Care Units, Pediatric , Microbial Sensitivity Tests , Pilot Projects , Age Factors , Area Under Curve , Dose-Response Relationship, Drug , Half-Life
Rev. bras. anestesiol ; 70(4): 311-317, July-Aug. 2020. tab, graf
Article in English, Portuguese | LILACS | ID: biblio-1137208


Abstract Background: Tranexamic acid was studied in four different dosage regimens and their efficacy was compared for perioperative blood loss reduction, blood transfusion requirements and deep vein thrombosis (DVT) complication. Methods: Two hundred patients undergoing major orthopedic procedures were divided into five groups containing 40 patients each: Placebo, low dose (bolus 10 mg kg-1), low dose + maintenance (bolus 10 mg kg-1 + maintenance 1 mg kg-1 hr-1), high dose (bolus 30 mg kg-1) and high dose + maintenance (bolus 30 mg kg-1 + maintenance 3 mg kg-1 hr-1). Surgical blood loss was measured intraoperatively and drains collection in the first 24 hours postoperatively. Blood transfusion was done when hematocrit falls less than 25%. DVT screening was done in the postoperative period. Results: The intraoperative blood loss was 440 ± 207.54 mL in the placebo group, 412.5 ± 208.21 mL in the low dose group, 290 ± 149.6 ml in the low dose plus maintenance group, 332.5 ± 162.33 mL in the high dose group and 240.7 ± 88.15 mL in the high dose maintenance group (p < 0.001). The reduction in postoperative blood loss in the drain for first 24 hours was 80 ± 44.44 mL in the placebo group, 89.88 ± 44.87 mL in the low dose group, 56.7 ± 29.12 mL in the low dose plus maintenance group, 77.9 ± 35.74 mL in the high dose group and 46.7 ± 19.9 mL in the high dose maintenance group (p < 0.001). DVT was not encountered in any patient. Conclusion: Tranexamic acid was most effective in reducing surgical blood loss and blood transfusion requirements in a low dose + maintenance group.

Resumo Justificativa: O ácido tranexâmico foi avaliado em quatro esquemas com diferentes posologias, comparando-se a eficácia de cada esquema quanto a redução na perda sanguínea perioperatória, necessidade de transfusão sanguínea e ocorrência de Trombose Venosa Profunda (TVP). Método: Duzentos pacientes submetidos a procedimentos ortopédicos de grande porte foram divididos em cinco grupos de 40 pacientes de acordo com o esquema de administração de ácido tranexâmico: grupo placebo, grupo baixa dose (bolus de 10, grupo baixa dose e manutenção (bolus de 10 + manutenção de 1, grupo alta dose (bolus de 30, e grupo alta dose e manutenção (bolus de 30 + manutenção de 3 A perda sanguínea cirúrgica foi medida no intraoperatório. Além disso, nas primeiras 24 horas pós-operatórias, foi medido o volume de sangue coletado no dreno. Era realizada transfusão de sangue se o valor do hematócrito fosse inferior a 25%. Foi realizada avaliação quanto à ocorrência de TVP no pós-operatório. Resultados: A perda sanguínea intraoperatória foi de 440 ± 207,54 mL no grupo placebo, 412,5 ± 208,21 mL no grupo baixa dose, 290 ± 149,6 mL no grupo baixa dose e manutenção, 332,5 ± 162,33 mL no grupo alta dose, e 240,7 ± 88,15 mL no grupo alta dose e manutenção (p < 0,001). A redução na perda sanguínea pós-operatória pelo dreno nas primeiras 24 horas foi de 80 ± 44,44 mL no grupo placebo; 89,88 ± 44,87 mL no grupo baixa dose, 56,7 ± 29,12 mL no grupo baixa dose e dose de manutenção, 77,9 ± 35,74 mL no grupo alta dose e 46,7 ± 19,9 mL no grupo alta dose e manutenção (p < 0,001). TVP não foi observada em nenhum paciente. Conclusão: O ácido tranexâmico administrado em baixa dose combinado à manutenção foi mais eficaz em reduzir a perda sanguínea cirúrgica e a necessidade de transfusão de sangue.

Tranexamic Acid/administration & dosage , Blood Loss, Surgical/prevention & control , Orthopedic Procedures/methods , Antifibrinolytic Agents/administration & dosage , Blood Transfusion/statistics & numerical data , Drug Administration Schedule , Double-Blind Method , Prospective Studies , Postoperative Hemorrhage/prevention & control , Dose-Response Relationship, Drug , Middle Aged
Rev. cuba. med ; 59(2): e1358, abr.-jun. 2020. tab
Article in Spanish | LILACS, CUMED | ID: biblio-1139049


Introducción: El cáncer de pulmón constituye una de las principales causas de muerte en Cuba. La mayoría de los enfermos acuden al servicio de salud en etapa avanzada de la enfermedad, la poliquimioterapia es uno de los tratamientos utilizados. Objetivos: Evaluar la respuesta al tratamiento con cisplatino-etopósido vs cisplatino-paclitaxel, en pacientes con carcinoma no microcítico en estadios avanzado de la enfermedad. Métodos: Se realizó un estudio descriptivo, prospectivo, en 40 pacientes diagnosticados con carcinoma no microcítico en estado avanzado de la enfermedad, que fueron asignados de forma aleatoria a uno de los dos grupos de tratamiento de cisplatino + etopósido (n=20) y cisplatino + paclitaxel (n=20) en el Hospital Neumológico Benéfico Jurídico en el período comprendido desde enero de 2017 a septiembre de 2018. Resultados: Predominaron pacientes del sexo masculino entre 50 a 69 años de edad, 37,5 por ciento en estadio IV. En 72,5 por ciento de los pacientes se encontró una respuesta clínica al tratamiento, en la modalidad de cisplatino + etopósido 70 por ciento y en cisplatino + paclitaxel 75 por ciento respectivamente. Se observó un porcentaje similar de respuesta objetiva antitumoral, 32,5 por ciento de los pacientes tuvieron una reducción parcial de la lesión tumoral, mientras que en otro 32,5 por ciento se observó estabilidad de la enfermedad. Por el contrario, en 35 por ciento restante hubo progresión de la enfermedad. Conclusiones: Se concluye que ambas modalidades tienen una efectividad similar en la evolución clínico-radiológica de los enfermos de carcinoma no microcítico en etapa avanzada(AU)

Introduction: Lung cancer constitutes one of the main causes of death in Cuba. Most of the patients come to the health service at an advanced stage of the disease. Polychemotherapy is one of the treatments used. Objectives: To assess the response to treatment with cisplatin-etoposide vs. cisplatin-paclitaxel, in patients with advanced non-small cell carcinoma. Methods: A descriptive, prospective study was conducted in 40 patients diagnosed with advanced non-small cell carcinoma. They were randomly assigned to one of the two treatment groups: cisplatin + etoposide (n = 20) and cisplatin. + paclitaxel (n = 20) at the Pneumologic Hospital from January 2017 to September 2018. Results: Male patients predominated, ages ranged between 50 and 69 years, 37.5 percent were in stage IV. Clinical response to treatment was found in 72.5 percent of patients, that is, 70 percent in the modality of cisplatin + etoposide and 75 percent in cisplatin + paclitaxel. Similar percentage of objective antitumor response was observed, that is, 32.5 percent of the patients had partial reduction of the tumor lesion, while disease stability was observed in 32.5 percent . In contrast, in the remaining 35.0 percent , disease progression was observed. Conclusions: Both modalities are concluded to have similar effectiveness in the clinical-radiological evolution of persons suffering from non-microcytic carcinoma in advanced stage(AU)

Humans , Male , Female , Carcinoma, Non-Small-Cell Lung/drug therapy , Drug Therapy, Combination/methods , Epidemiology, Descriptive , Prospective Studies , Carcinoma, Non-Small-Cell Lung/mortality , Cuba , Dose-Response Relationship, Drug
Gac. méd. Méx ; 156(3): 218-224, may.-jun. 2020. tab, graf
Article in English, Spanish | LILACS | ID: biblio-1249897


Resumen Introducción: La cardiotoxicidad es una reacción adversa asociada al uso de antraciclinas. Objetivo: Estimar los factores asociados al desarrollo de cardiotoxicidad por antraciclinas en pacientes pediátricos supervivientes de cáncer. Método: Cohorte retroprolectiva de niños con diagnóstico de cáncer tratados con antraciclinas. Se realizó determinación ecocardiográfica basal de la fracción de expulsión (FEVi0) antes del inicio del tratamiento y a los 12 meses (FEVi1). Del expediente se obtuvieron las características demográficas y el tratamiento. Se realizó un modelo de regresión logística múltiple (RLM); la FEVi1 < 50 % fue la variable dependiente, que se ajustó por las principales variables confusoras. Resultados: Se incluyeron 65 pacientes, 36.9 % fue del sexo femenino y 56.8 % presentó un tumor sólido. La FEVi0 fue de 74.79 ± 7.3 % y la FEVi1, de 67.96 ± 6.7 % (p = 0.001); 60 % desarrolló cardiotoxicidad. En la RLM solo la dosis acumulada > 430 mg se asoció a cardiotoxicidad (p = 0.001). Conclusiones: En los niños mexicanos se debe evitar una dosis acumulada > 430 mg de antraciclinas para evitar la cardiotoxicidad.

Abstract Introduction Cardiotoxicity is an adverse reaction associated with the use of anthracyclines. Objective: To estimate the factors associated with the development of anthracycline cardiotoxicity in pediatric patients surviving cancer. Method: Retro-prolective cohort of children diagnosed with cancer and treated with anthracyclines. Baseline echocardiographic determination of ejection fraction (LVEF0) was carried out before the start of treatment and again at 12 months (LVEF1). Demographic characteristics and treatment were obtained from the medical record. A multiple logistic regression (MLR) model was constructed; LVEF1 < 50 % was the dependent variable, which was adjusted for the main confounding variables. Results: Sixty-five patients were included, out of which 36.9 % were females and 56.8 % had a solid tumor. LVEF0 was 74.79 ± 7.3 % and LVEF1, 67.96 ± 6.7 % (p = 0.001); 60 % developed cardiotoxicity. In the MLR, only a cumulative dose > 430 mg was associated with cardiotoxicity (p = 0.001). Conclusions: In Mexican children, an anthracycline cumulative dose > 430 mg should be avoided in order to prevent cardiotoxicity.

Humans , Male , Female , Child, Preschool , Child , Anthracyclines/adverse effects , Cardiotoxicity/epidemiology , Neoplasms/drug therapy , Stroke Volume , Risk Factors , Cohort Studies , Ventricular Function, Left , Anthracyclines/administration & dosage , Dose-Response Relationship, Drug , Cardiotoxicity/etiology , Cancer Survivors , Mexico
J. health med. sci. (Print) ; 6(1): 21-27, ene.-mar. 2020. tab, ilus
Article in Spanish | LILACS | ID: biblio-1096529


El cáncer de mama es una de las patologías más frecuentes a nivel mundial y en el Ecuador ocupa un sitio importante dentro de la mortalidad; en pacientes con tumores de estadios avanzados la quimioterapia neodyuvante es el procedimiento indicado para lograr una reducción tumoral satisfactoria. El objetivo fue determinar la respuesta clínica y patológica en pacientes con cáncer de mama tratadas con quimioterapia neoadyuvante según cada subtipo molecular, atendidos en el hospital "Teodoro Maldonado Carbo" en el período 2015 a 2017. Se hizo uso de un diseño no experimental, transversal de tipo correlacional. Pacientes con cáncer de mama que recibieron neoadyuvancia, en su mayoría con quimioterapia basada en antraciclinas y taxanos. Se clasificó a las pacientes por sus subtipos moleculares, los mismos se obtuvieron en base a las características inmunohistoquímicas de los reportes de patología que constan en el sistema AS-400. Se comprobó la respuesta clínica al tratamiento usando los Criterios RECIST 1.1. Como resultado los 171 pacientes fueron analizados. La edad promedio de las pacientes fue 55 13 años de edad; el 25% fueron luminal B (HER+), 24% luminal B (HER-), 22% triple negativo, 18% HER2+ y 12% luminal A; el 52% de las pacientes tuvieron estadio III de la enfermedad; el 75% (129) de las pacientes fue realizada una mastectomía radical modificada. Se pudo concluir que la respuesta patológica completa en pacientes con tratamiento neoadyuvante se relaciona con los subtipos moleculares y esto es estadísticamente significativo. Además, se evidenció las mayores tasas de respuesta patológica completa en los grupos moleculares de HER2+ y triple negativo.

Breast cancer is one of the most frequent pathologies worldwide and in Ecuador it occupies an important place in mortality. In patients with advanced stage tumors, the neo-adjuvant chemotherapy is the indicated procedure to achieve a satisfactory tumor reduction. The aim was to determine the clinical and pathological response in patients with breast cancer treated with neoadjuvant chemotherapy according to each molecular subtype, treated at the "Teodoro Maldonado Carbo" hospital in the period 2015 to 2017. We used a non-experimental, crosssectional type design. Patients with breast cancer who received neoadjuvant, mostly with chemotherapy based on anthracyclines and taxanes. The patients were classified by their molecular subtypes, they were obtained based on the immunohistochemical characteristics of the pathology reports that appear in the AS-400 system. The clinical response to treatment was checked using the RECIST 1.1 Criteria. As a result, a sum of 171 patients were analyzed. The average age of the patients was 55 + 13 years old; 25% were luminal B (Her +), 24% luminal B (Her-), 22% triple negative, 18% Her2 + and 12% luminal A; 52% of the patients had stage III of the disease; 75% (129) of the patients underwent a modified radical mastectomy. As a conclusion, the complete pathological response in patients with neoadjuvant treatment is related to molecular subtypes and this is statistically significant. Also, the highest rates of complete pathological response in the molecular groups of Her2 + and triple negative were evident.

Humans , Female , Middle Aged , Breast Neoplasms/drug therapy , Chemotherapy, Adjuvant , Anthracyclines/therapeutic use , Taxoids/therapeutic use , Breast Neoplasms/classification , Breast Neoplasms/pathology , Cross-Sectional Studies , Dose-Response Relationship, Drug , Drug Therapy, Combination
Arq. bras. cardiol ; 114(2): 295-303, Feb. 2020. tab, graf
Article in English | LILACS | ID: biblio-1088850


Abstract Background: Cigarette smoking is usually associated with hypertension and may modify vasoconstrictor response. Objective: The present study aimed to analyze and compare the interaction of passive cigarette smoking and hypertension on epinephrine and felypressin blood pressure effects after intravascular injection. Method: 45-day male Wistar rats had the main left renal artery partially constricted and the right kidney removed (1K1C model). Rats were placed in the chamber for exposition to passive cigarette smoking (10 cigarettes) during 10 min (6 days a week). Hypertensive rats received atenolol (90 mg/kg/day) by gavage for two weeks. Hypotensive and hypertensive response, response duration and heart rate were recorded from direct blood pressure values. The significance level was 5%. Results: Passive cigarette smoking increased maximal hypertensive response to epinephrine in normotensive and 1K1C-atenolol treated rats and to felypressin only in 1K1C-atenolol treated rats; it also reduced epinephrine hypotensive response. Epinephrine increased heart rate in normotensive and hypertensive passive smokers or non-smoker rats. Comparing the two vasoconstrictors, epinephrine showed greater hypertensive response in normotensive smokers, 1K1C-atenolol treated smokers and non-smokers. However, in normotensive-nonsmoker rats, felypressin showed a greater and longer hypertensive effect. Conclusions: Our results suggest that passive cigarette smoking may reduce epinephrine vasodilation and increase hypertensive response when compared to felypressin. Therefore, felypressin may be safe for hypertensive patients to avoid tachycardia and atenolol interaction, but for normotensive and non-smoker patients, epinephrine may be safer than felypressin.

Resumo Fundamento: O tabagismo geralmente está associado à hipertensão e pode modificar a resposta vasoconstritora. Objetivo: O presente estudo teve como objetivo analisar e comparar a interação do tabagismo passivo e hipertensão sobre os efeitos da epinefrina e felipressina na pressão arterial após injeção intravascular. Métodos: Ratos Wistar machos de 45 dias tiveram a artéria renal principal esquerda parcialmente obstruída e o rim direito removido (modelo 1K1C). Os ratos foram colocados na câmara para exposição ao tabagismo passivo (10 cigarros) durante 10 minutos (6 dias por semana). Ratos hipertensos receberam atenolol (90 mg/kg/dia) por gavagem durante duas semanas. A resposta hipotensora e hipertensiva, a duração da resposta e a frequência cardíaca foram registradas a partir da medida dos valores diretos da pressão arterial. O nível de significância foi de 5%. Resultados: O tabagismo passivo aumentou a resposta hipertensiva máxima à epinefrina em ratos normotensos e ratos 1K1C tratados com atenolol e à felipressina apenas em ratos 1K1C tratados com atenolol; também reduziu a resposta hipotensiva à epinefrina. A epinefrina aumentou a frequência cardíaca em ratos fumantes passivos ou não-fumantes, normotensos e hipertensos. Comparando os dois vasoconstritores, a epinefrina apresentou maior resposta hipertensiva em fumantes normotensos, ratos 1K1C fumantes e não fumantes tratados com atenolol. No entanto, em ratos normotensos e não fumantes, a felipressina apresentou um efeito hipertensivo maior e mais prolongado. Conclusões: Nossos resultados sugerem que o tabagismo passivo pode reduzir a vasodilatação da epinefrina e aumentar a resposta hipertensiva quando comparado à felipressina. Portanto, a felipressina pode ser segura para pacientes hipertensos, com o objetivo de evitar a interação entre taquicardia e atenolol, mas para pacientes normotensos e não-fumantes, a epinefrina pode ser mais segura que a felipressina.

Animals , Male , Atenolol/pharmacology , Tobacco Smoke Pollution/adverse effects , Blood Pressure/drug effects , Epinephrine/pharmacology , Felypressin/pharmacology , Antihypertensive Agents/pharmacology , Time Factors , Vasoconstrictor Agents/pharmacology , Vasodilation/drug effects , Rats, Wistar , Dose-Response Relationship, Drug , Drug Interactions , Heart Rate/drug effects , Hypertension/drug therapy , Hypotension
Einstein (Säo Paulo) ; 18: eRW5055, 2020. tab, graf
Article in English | LILACS | ID: biblio-1056057


ABSTRACT The objective of the present study was to assess the efficacy of different doses, times for infusion of the first dose, intervals of administration of subsequent doses, and number of epinephrine doses in the survival of children and adolescents who went into cardiorespiratory arrest. It is a review study with data from the PubMedⓇ/MEDLINEⓇdatabase. The search was for articles published from January 1st, 2000 to February 10, 2019, with a sample of patients aged under 18 years, published in English, Portuguese and Spanish. We found 222 articles, of which 16 met the inclusion criteria of the study. The first dose should be given as soon as possible. The standard dose (0.01mg/kg) has a better outcome when compared to the higher dose (0.1mg/kg). There is an iⓇverse relation between the number of epinephrine doses and survival. The interval currently recommended between doses has lower survival when compared to larger intervals. The dosage recommended by the American Heart Association presents a better outcome for survival, but the interval between doses and the maximum number of doses should be better assessed.

RESUMO O objetivo deste estudo foi avaliar a eficácia de diferentes doses, tempos para infusão da primeira dose, intervalos de administração de doses subsequentes e número de doses de epinefrina na sobrevida de crianças e adolescentes que sofreram parada cardiorrespiratória. Trata-se de estudo de revisão, cujas buscas foram feitas na base de dados PubMedⓇ /MEDLINEⓇ. Foram selecionados artigos publicados de 1° de janeiro de 2000 até 10 de fevereiro de 2019, realizados em menores de 18 anos de idade, publicados em inglês, português e espanhol. Foram encontrados 222 artigos, dos quais 16 atenderam os critérios de inclusão no estudo. A primeira dose deve ser aplicada o mais rápido possível. A dose padrão (0,01mg/kg) apresenta melhor desfecho quando comparada à dose alta (0,1mg/kg). Houve relação inversa entre número de doses de epinefrina e sobrevida. O intervalo entre doses recomendado atualmente apresenta menor sobrevida quando comparado a intervalos maiores. A dose recomendada pela American Heart Association apresenta melhor desfecho para sobrevida, porém o intervalo entre doses e o número máximo de doses devem ser melhor avaliados.

Humans , Male , Female , Child , Adolescent , Epinephrine/administration & dosage , Adrenergic alpha-Agonists/administration & dosage , Heart Arrest/drug therapy , Time Factors , Dose-Response Relationship, Drug , Heart Arrest/mortality
Medwave ; 20(7): e7996, 2020.
Article in English, Spanish | LILACS | ID: biblio-1122647


Se sabe que la amiodarona, un potente antiarrítmico, causa toxicidad pulmonar. La neumonitis intersticial crónica es la presentación más común. Sin embargo, la toxicidad pulmonar aguda es rara y provoca una mayor mortalidad. Se presenta un paciente de 61 años con fibrilación auricular persistente que, tras tratamiento por un mes con amiodarona vía oral a dosis baja de impregnación de 400 miligramos al día, desarrolló toxicidad pulmonar aguda secundaria al antiarrítmico confirmada por radiografía y tomografía. Su caso tuvo resolución después de la suspensión del fármaco y tratamiento con esteroides.

Amiodarone, considered a potent antiarrhythmic, is known to cause pulmonary toxicity. Chronic interstitial pneumonitis is the most common presentation. However, acute pulmonary toxicity is rare and has a higher case fatality rate. We present a 61-year-old patient with persistent atrial fibrillation who, after a one-month treatment with oral amiodarone at a low dose impregnation of 400 mg/day, develops acute pulmonary toxicity, with radiographic and tomographic resolution after antiarrhythmic suspension and steroid treatment.

Humans , Male , Middle Aged , Amiodarone/adverse effects , Lung Diseases/chemically induced , Anti-Arrhythmia Agents/adverse effects , Atrial Fibrillation/drug therapy , Acute Disease , Dose-Response Relationship, Drug , Amiodarone/administration & dosage , Anti-Arrhythmia Agents/administration & dosage
Article in English | WPRIM | ID: wpr-828999


Objective@#To verify the health advisory for short-term exposure to phenol.@*Methods@#The method of this validation experiment was the same as the US Environmental Protection Agency (EPA) methodology for toxicology experiments used to determine phenol drinking water equivalent level (DWEL). Pregnant female Sprague-Dawley rats were administered phenol in distilled water by gavage at daily doses of 15, 30, 60, 120, and 240 mg/kg body weight (b.w.) from implantation (the 6th day post-mating) to the day prior to the scheduled caesarean section (the 20th day of pregnancy). The following information was recorded: general behavior; body weight; number of corpus luteum, live birth, fetus, stillbirth, and implantation; fetal gender; body weight; body length; tail length; and abnormalities and pathomorphological changes in the dams.@*Results@#In the 60 mg/kg b.w. dose group, the mortality of pregnant rats increased with increasing doses, suggesting maternal toxicity. Fetal and placental weights decreased as phenol dose increased from 30 mg/kg b.w., and were significantly different compared those in the vehicle control group, which suggested developmental toxicity in the fetuses. However, the phenol-exposed groups showed no significant change in other parameters compared with the vehicle control group ( > 0.05).@*Conclusion@#Despite using the same method as the US EPA, a different NOEAL of 15 mg/(kg·d) was obtained in this study.

Animals , Dose-Response Relationship, Drug , Environmental Pollutants , Toxicity , Female , Fetal Development , Phenol , Toxicity , Pregnancy , Rats , Rats, Sprague-Dawley , Toxicity Tests, Acute
Article in Chinese | WPRIM | ID: wpr-828315


OBJECTIVE@#To compare the accuracy of five warfarin-dosing algorithms and warfarin stable dose model (2.5 mg/day) for Shandong population.@*METHODS@#One hundred and twenty five patients who achieved stable warfarin dose were enrolled. Clinical and genetic data were used to evaluate the value of each algorithm by calculating the percentage of patients whose predicted warfarin dose was within 20% of the actual stable therapeutic dose and mean absolute error (MAE).@*RESULTS@#The frequency of patients with CYP2C9*1/*1, CYP2C9*1/*3 and CYP2C9*1/*2 genotype was 92.00%, 7.20%, 0.80%, respectively. That of VKORC1-1639 AA, AG and GG genotype was 82.40%, 15.20%, 2.40%, respectively. CYP4F2*1/*1, *1/*3, *3/*3 genotype was 50.40%, 39.20%, 10.40%, respectively. With the same genotypes for other loci, patients who carried at least one VKORC1-16398G mutant allele had increased warfarin stable daily dose compared with VKORC1-1639AA. Compared with CYP4F2*1/*1, those carrying at least one CYP4F2*3 mutant allele had warfarin stable daily dose increased by 5.9%-13.00%. The percentage of ideal prediction calculated from IWPC model (59.20%), Huang model (57.60%) and Ohno model (52.80%) were higher than others. The MAE were 0.35 (95%CI: 0.11-0.49), 0.15 (95%CI: 0.10-0.32), 0.39 (95%CI: 0.12-0.51), respectively.@*CONCLUSION@#The polymorphisms of CYP2C9, VKORC1 and CYP4F2 genes can influence the stable dose of warfarin in Shandong population. IWPC algorithm is suitable for guiding the use of warfarin in this population.

Anticoagulants , Aryl Hydrocarbon Hydroxylases , Cytochrome P-450 CYP2C9 , Genetics , Cytochrome P450 Family 4 , Genetics , Dose-Response Relationship, Drug , Genotype , Humans , Models, Theoretical , Polymorphism, Genetic , Vitamin K Epoxide Reductases , Genetics , Warfarin
Article in English | WPRIM | ID: wpr-827441


OBJECTIVES@#To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.@*METHODS@#A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.@*RESULTS@#An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).@*CONCLUSIONS@#Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at ).

Administration, Inhalation , Adult , China , Coronavirus Infections , Diagnosis , Drug Therapy , Mortality , Dose-Response Relationship, Drug , Drug Administration Schedule , Drugs, Chinese Herbal , Female , Follow-Up Studies , Humans , Integrative Medicine , Interferon-alpha , Lopinavir , Male , Middle Aged , Pandemics , Pneumonia, Viral , Diagnosis , Drug Therapy , Mortality , Risk Assessment , Severe Acute Respiratory Syndrome , Diagnosis , Drug Therapy , Mortality , Severity of Illness Index , Survival Rate