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Aim of the studyDifferent drug modification rules or growth factor support guidance may affect the results in oncology randomised controlled trials. We aimed to estimate the prevalence of unequal rules for dose modification rules or the use of myeloid growth factors in head-to-head registration Food and Drug Administration trials.MethodsThis cross-sectional analysis included all head-to-head registration randomised controlled trials leading to a US Food and Drug Administration approval between 2009 and 2021. Trials examined anti-cancer drugs in the advanced or metastatic setting where a comparison could be made between arms regarding either dose modification rules or myeloid growth factors recommendations. Sixty-two registration trials met inclusion criteria. Information abstracted for each trial included tumour type, setting, phase, and type of sponsor. We assessed, according to pre-specified rules, imbalance in drug modification rules, myeloid growth factors recommendations or both.ResultsWe find 40 of 62 (65%) selected trials have unequal rules for dose medication, granulocyte colony-stimulating factor (G-CSF) use or both. Six trials (10%) had rules favouring the control arm, while 55% of selected trials (34/62) favoured the experimental arm. Among these, 50% (17/34) had unequal drug modification rules, 41% (14/34) had unequal G-CSF rules and 9% contained both (3/34).ConclusionWe find that 55% of trials testing anti-cancer drugs against each other used protocol rules that favoured the experimental arm. This leaves open the question of whether new molecules are truly superior to older molecules or if instead different outcomes are due to more aggressive dosing or growth factor support. Trials should utilise equal rules for dose medication and G-CSF support.

Miguel Turégano-Yedro,1 Eva Trillo-Calvo,2 Fernando Navarro i Ros,3,4 José David Maya-Viejo,5 Cruz González Villaescusa,6,7 Jose Maria Echave Sustaeta,8 Esperanza Doña,9 Bernardino Alcázar Navarrete10,11 1Centro de Salud Casar de Cáceres, Casar de Cáceres, Cáceres, Spain; 2Centro de Salud Campo de Belchite, Belchite, Zaragoza, Spain; 3Centro de Salud Ingeniero J Benlloch, Valencia, Spain; 4Red Investigadores SEMERGEN, Madrid, Spain; 5Unidad de Gestión Clínica de Camas, Distrito Sanitario Aljarafe-Sevilla Norte, Camas, Sevilla, Spain; 6Servicio de Neumología, Hospital Clínico Universitario de Valencia, Valencia, Spain; 7Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain; 8Servicio de Neumología, Hospital Universitario Quironsalud, Universidad Europea de Madrid, Madrid, Spain; 9Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Hospital Regional Universitario de Málaga, Málaga, Spain; 10Servicio de Neumología, Hospital Universitario Virgen de las Nieves, Granada, Spain; 11Instituto de Investigación Biosanitaria, Ibs- Granada, Granada, SpainCorrespondence: Miguel Turégano-Yedro, Centro de Salud Casar de Cáceres, Casar de Cáceres, C/ Barrionuevo Bajo, 49, Casar de Cáceres, Cáceres, 10190, Spain, Tel +34-927291531, Email tureyedro@gmail.comAbstract: COPD is a typical example of chronic disease. As such, treatment adherence tends to be as low as between 30% and 50%, with specific issues in COPD due to the use of inhaled therapies. Decreased adherence in COPD is associated with worse outcomes, with increased risk for exacerbations and long-term mortality. Factors that impact adherence are multiple, some related to patient, some related to clinicians and finally some related to healthcare system. Among clinician factors, prescription of simplified treatment regimens delivered by an inhaler adapted to the patient’s characteristics is crucial. Although it has been observed a huge improvement in the design and usability of inhaler devices for COPD in the last two centuries, there is still a clear gap in this field. Smart inhalers as well as simplified treatment regimens could improve adherence and therefore improve long-term outcomes in COPD.Plain Language Summary: Treatment adherence in COPD is crucial as in many other chronic diseases, with specific issues due to inhaled route, and many factors involved. Low adherence in COPD has been linked to an increased risk of exacerbations and future mortality. Many interventions have been developed to improve treatment adherence in COPD. This review summarizes the current knowledge and future prospects for this important aspect of COPD treatment.Keywords: COPD, inhaled therapies, adherence, persistence, posology

Purpose: To evaluate time-dependent administration of ibuprofen in a lower third molar extraction model. Methods: Eleven patients requiring bilateral surgical removal of lower third molars were recruited and randomized into a blinded crossover randomized controlled trial. For 3 days after surgery, the control group was prescribed ibuprofen 400 mg every 8 h. On the other hand, the experimental group received also ibuprofen 400 mg at breakfast and lunch, replacing the dinner intake with a placebo. Pain measurements (Visual Analog Scale from 0 to 10) were recorded at baseline, 24, 48, and 72 h postoperatively. Facial swelling and trismus were also measured at baseline, 24, and 72 h postoperatively. Results: Postoperative swelling and pain perception did not show significative difference between the control and experimental groups at 24, 48, and 72 h. Trismus was significantly lower in the control group than in the experimental group at 72 h postoperatively (p = 0.008). Rescue medication consumption seemed to be comparable between groups. Conclusion: Eliminating night time ibuprofen might be insignificant for pain control after third molar extraction. [ABSTRACT FROM AUTHOR]

Aim: To understand pharmacological concepts, usefulness for Medical Representatives' sales outcomes, and corporate brand equity outcomes. Background: Teams of medical representatives are deployed by pharmaceutical companies for drug promotion. Pharmaceutical selling is a significant job creator in India - an estimated six lakh plus medical representatives/field personnel are employed in this sector. The Life Sciences Sector Skills Development Council (LSSSDC) has also laid down National Occupational Standards (NOS) for the medical representative job function. The medical representative is a crucial link to the market for pharmaceutical companies involved in drug promotion and making products available. A vital role of the medical representative is to create product presentations by detailing and providing collaterals. In detailing and collateral content, pharmacology talking points are crucial. In this study, we gather feedback through a questionnaire based on a Likert scale from doctors, pharmacists, medical representatives, and field managers (total sample = 1008) regarding the pharmacology talking points. Materials and Methods: The present survey analyzes the influence of pharmacological concepts with doctors, pharmacists, field managers, and medical representatives on sales outcomes. To develop a pharmacological model for product promotion based on the type of product (novel, new and old), niche, and mass me-too brand). Successful pharmaceutical marketing is the key to product and therapy success. Conclusion: This study reiterates the importance of pharmacology in pharmaceutical product promotion and its benefits to the pharmaceutical company for improved corporate image and sales outcomes. [ABSTRACT FROM AUTHOR]

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Presented is a case of subacute illness developing after a bout of nasopharyngitis in a woman of 35 years. The patient was seen early in the development of her condition with symptoms of numbness, coldness, weakness, perspiration, and anxiety. The patient responded well to Arsenicum album and later needed Causticum for the development of new symptoms. [ABSTRACT FROM AUTHOR]

Well-characterized adipose stem cells and chemically defined culture media are important factors that control the production of the cell sheet, used in translational medicine. In this study, we have developed and engineered multilayer adipose stem cell cell sheets (ASCCSs) using chemically defined/serum-free culture media: undifferentiated or differentiated into osteoblasts and chondrocytes. In addition, using the cell sheet transmittance, we estimated the number of cells per cell sheet. Undifferentiated ASCCSs were engineered in 10 days, using serum-free/xeno-free culture media. They were CD29+, CD73+, CD90+, CD105+, HLA-A+, and HLA-DR-. ASCCSs differentiated into chondrocytes and osteoblasts were also engineered using chemically defined and animal-free culture media, in only 14 days. The addition of an ROCK inhibitor improved the chondrocyte cell sheet engineering. The decrease in the cell sheet transmittance rate was higher for the osteoblast cell sheets due to the intracellular Ca2+ accumulation. The estimation of cell number per cell sheet was carried out with the transmittance, which will provide important information for cell sheet posology. In conclusion, three types of ASCCSs were engineered using serum-free, xeno-free culture media, expressing their specific markers. Their transmittance measurement allowed estimating the number of cells per cell sheet, with a non-invasive methodology.

The objective of this study is to design and validate an instrument that allows assessing the probability of adherence in patients who are going to start medical treatment based on a biopsychosocial model. The instrument consisting of three areas was used: pharmacological indications or drug dosage, lifestyle change and social support. For the design and validation of the instrument, the sample consisted of 161 participants, 98 women (60.9%) and 63 men (39.1%), with ages between 18 and 64 years old (M = 26.63; SD = 0.75). For data processing, it was necessary to use the R Studio program and SPSS version 26. The results obtained proved that the test of adherence to medical treatment had a sample adequacy index by KMO of 0.924 and Bartlett's sphericity test of <0.01 which will be carried out by exploratory and confirmatory factor analysis, in addition a reliability of Cronbach's Alpha of 0.94 and of McDonald's Omega of 0.96 were found, being an adequate index for its use. [ABSTRACT FROM AUTHOR]

Abstract Background Furosemide is approved in full term neonates to treat edema associated with congestive heart failure, cirrhosis and renal diseases. It is often administered off-label in premature neonates, to treat respiratory conditions and at doses greater-than-recommended. We conducted a national survey on behalf of the Neonatal Pharmacotherapy Study Group of the Italian Society of Neonatology (SIN), to investigate its use in Italian neonatal intensive care units (NICUs), in conformity with current guidelines. Methods Between December 2016 and June 2017, a 14-item multiple-choice online questionnaire was sent to all NICU directors from the SIN directory. Gestational age, route of administration, posology, indications, referenced guidelines, adverse effects monitoring and the presence of Paediatric Cardiology or Cardiosurgery service on site were assessed. A chi-square test was performed 1) to evaluate differences in the distribution of responses between NICUs administering furosemide at doses higher-than-recommended; 2) to compare the proportion of NICUs administering furosemide at high doses in institutions with versus without a Paediatric Cardiology or Cardiosurgery service. Results The response rate was 50% (57/114). The intravenous and oral routes were chosen primarily; the intravenous administration in single doses predominated over continuous infusion. Its main therapeutic indications were congestive heart failure/overload (94.7%) and oligo-anuria (87.7%) however furosemide was also frequently used for broncopulmonary dysplasia (50.9%) and respiratory distress syndrome and/or transient tachypnea of the newborn (24.6%). In 28/57 NICUs furosemide was administered at doses higher-than-recommended. In most NICUs the same posology was used in term and preterm neonates. Compared to the total sample, a larger proportion of NICUs administering doses greater-than-recommended referenced current literature for reasons to do so (19.3 and 32.1% respectively). The presence of a Paediatric Cardiology or Cardiosurgery service on site did not correlate with the chosen posology. The majority of NICUs performed acoustic test and renal ultrasound for furosemide exposure greater than 2 weeks. Conclusions In Italian NICUs, furosemide is commonly prescribed to term and preterm newborns for label and unlabeled indications. Doses greater-than-recommended are frequently administered. Such use is not necessarily inappropriate. More research is required to assess the efficacy and safety of unlabeled use.

Objectives: The major role of interleukin (IL)-1 in the pathogenesis of hereditary recurrent fever syndromes favored the employment of targeted therapies modulating IL-1 signaling. However the best use of IL1 inhibitors in terms of dosage is difficult to define at present.Methods: In order to better understand the use of IL1 inhibitors in a real-life setting, our study assessed the dosage regimens of French patients with one of the four main hereditary recurrent fever syndromes (Familial Mediterranean Fever (FMF), TNF receptor associated periodic syndrome (TRAPS), cryopyrin associated periodic fever (CAPS) and mevalonate kinase deficiency). The patients were retrieved retrospectively from the JIR cohort, an international platform gathering data of patients with pediatric inflammatory diseases.Results: Forty five patients of the JIR cohort with a hereditary recurrent fever syndrome had received at least once an IL1 inhibitor (anakinra or canakinumab). Of these, 43% received a lower dosage than the one suggested in the product recommendations, regardless of the type of the IL1 inhibitor. Especially patients with FMF and TRAPS seemed to need lower treatment regimens; in our cohort none of the FMF or TRAPS patients received an intensified dose of IL-inhibitor. On-demand treatment with a short half-life IL-1 inhibitor has also been used successfully for some patients with one of these two conditions The standard dose was given to 42% of the patients; whereas an intensified dose of IL-1 inhibitors was given to 15% of the patients (44% of CAPS patients and 17% of mevalonate kinase deficiency patients). In our cohort each individual patient’s need for treatment seemed highly variable, ranging from on demand treatment regimens to intensified dosage maintenance therapies depending on the activity and the severity of the underlying disease.Conclusion: IL-1 inhibitors are a good treatment option for patients with a hereditary recurrent fever syndrome, but the individual need of the dosage of IL-1 inhibitors to control the disease effectively seems highly variable. Severity, activity but also the type of the underlying disease, belong to the parameters underpinning the treat-to-target strategy implemented in an everyday life practice.

Background: Furosemide is approved in full term neonates to treat edema associated with congestive heart failure, cirrhosis and renal diseases. It is often administered off-label in premature neonates, to treat respiratory conditions and at doses greater-than-recommended. We conducted a national survey on behalf of the Neonatal Pharmacotherapy Study Group of the Italian Society of Neonatology (SIN), to investigate its use in Italian neonatal intensive care units (NICUs), in conformity with current guidelines. Methods: Between December 2016 and June 2017, a 14-item multiple-choice online questionnaire was sent to all NICU directors from the SIN directory. Gestational age, route of administration, posology, indications, referenced guidelines, adverse effects monitoring and the presence of Paediatric Cardiology or Cardiosurgery service on site were assessed. A chi-square test was performed 1) to evaluate differences in the distribution of responses between NICUs administering furosemide at doses higher-than-recommended; 2) to compare the proportion of NICUs administering furosemide at high doses in institutions with versus without a Paediatric Cardiology or Cardiosurgery service. Results: The response rate was 50% (57/114). The intravenous and oral routes were chosen primarily; the intravenous administration in single doses predominated over continuous infusion. Its main therapeutic indications were congestive heart failure/overload (94.7%) and oligo-anuria (87.7%) however furosemide was also frequently used for broncopulmonary dysplasia (50.9%) and respiratory distress syndrome and/or transient tachypnea of the newborn (24.6%). In 28/57 NICUs furosemide was administered at doses higher-than-recommended. In most NICUs the same posology was used in term and preterm neonates. Compared to the total sample, a larger proportion of NICUs administering doses greater-than-recommended referenced current literature for reasons to do so (19.3 and 32.1% respectively). The presence of a Paediatric Cardiology or Cardiosurgery service on site did not correlate with the chosen posology. The majority of NICUs performed acoustic test and renal ultrasound for furosemide exposure greater than 2 weeks. Conclusions: In Italian NICUs, furosemide is commonly prescribed to term and preterm newborns for label and unlabeled indications. Doses greater-than-recommended are frequently administered. Such use is not necessarily inappropriate. More research is required to assess the efficacy and safety of unlabeled use. [ABSTRACT FROM AUTHOR]

Objective: According to 2017 records 17.000 people are infected with HIV (human immunodeficiency virus) in Turkey. Drug compliance is one of the most important points in the treatment of the disease. Patient training is very important in HIV / AIDS treatment. This study aimed to evaluate drug compliance in a patient group undergoing training intervention. Methods: The study was conducted as a retrospective analysis of an intervention. Totally, 107 HIV / AIDS patients followed up at the Infectious Diseases and Clinical Microbiology Department of Dicle University Medical Faculty between May-July 2017 were included in the study. Patients who were evaluated as Group 1 received personalized detailed training, the other 25 patients (Group 2) took standard briefing. Patients' drug compliances evaluated by tablet counting method at third and sixth months of treatment. Results: The mean age of 107 patients trained was 28.6 years. Eighty-six (80.4%) of the patients were male. The educational status of the patients, 8,4% (n = 9) were literate, 67,3% (n = 72) studied primary and secondary education, no statistically significant difference was found between the educational status of the patients and drug compliance. (p = 0,159 and p = 0,274, respectively). Regardless of the number of tablets per day, drug compliance was found to be statistically significantly higher in Group 1. (p <0,001) Discussion and Conclusion: In patients with HIV, providing disease-specific training significantly increases drug compliance regardless of the number of tablets and education level. Using of regimens containing fewer tablets increases drug compliance. [ABSTRACT FROM AUTHOR]

ABSTRACT Chloroquine and hydroxychloroquine have shown promising preliminary results and have been discussed as therapeutic options for patients with Covid-19. Despite the lack of robust evidence demonstrating the benefits and justifying the use of one of these drugs, the final decision is the responsibility of the attending physician and should be individualized and shared, whenever possible. This position statement recommends dosage adjustment for these drugs in the context of renal impairment.

Objectives: Information on the use of medicinal products should be particularly clear and un-ambiguous, including the information on dosing for children. Age groups of children in patient information leaflets are sometimes described with a "gap" (eg, 2-4 years, 5-12 years) or without a gap (2-4 years, 4-12 years). The first style is based on the view that person's age is a discrete variable and the second style is based on continuous understanding of person's age. The aim of this 3-language study was to test if these 2 styles are comprehensive. Methods: We presented a dosing chapter from patient information leaflet to 274 volunteers and asked them what dose they would use for a child whose age is on the border between the two age intervals. Results: We found that all commonly used styles are ambiguous. On average, 10% to 20% of people understand the instructions differently than the majority. Conclusions: A need exists to develop a new, unambiguous style to present this information and prevent suboptimal dosing of drug with a lack of efficacy or additional risks of adverse effects. [ABSTRACT FROM AUTHOR]

Objectives: The study is aimed to assess whether the information contained in standard pharmacology, endocrinology, and diabetology textbooks regarding timings of administration, frequency and dose of various insulins is adequate and also to see whether the information contained in these texts is concordant with product inserts. Materials and Methods: Four standard textbooks of pharmacology, two of diabetology and three of endocrinology were assessed for the published information regarding dose, timing, and frequency of insulin administration. The product inserts of commonly available insulins in India were also studied for the same. Results: Various omissions and disparities could be seen in the coverage of insulins in standard textbooks. Posology information about premixed insulins and basal insulins have been omitted by the majority of the textbooks. Details about dose, frequency and timings of ultra-short acting insulins have also not been covered by all textbooks. Some discrepancies regarding prescribing information was also noted in product inserts, especially in case of newer insulins. Conclusions: Thus, this article stresses upon the need of a uniform source of information for providing adequate and standardized knowledge regarding timing, frequency, and dose of insulins.

Résumé Objectif Rechercher des facteurs expliquant les différences de consommation de concentrés plaquettaires (CP) entre les régions Lorraine-Champagne (LOCH) et Alsace (ALSA). Matériel et méthodes Il s’agit d’une enquête non interventionnelle, prospective, réalisée pendant 30 jours en 2015 dans les services de réanimation, chirurgie cardiovasculaire et oncohématologie de 8 établissements de LOCH et ALSA. Un questionnaire de renseignements clinico-biologiques était adossé aux ordonnances de produits sanguins labiles (PSL) et rempli à chaque prescription de CP. Résultats Au total, 290 patients, à l’origine de 1093 prescriptions et 1093 délivrances de CP, ont été analysés. Le contexte prétransfusionnel (poids des patients, transfusion préventive/curative, urgence vitale, recours à une numération prétransfusionnelle) est homogène. Quatre-vingt-trois pour-cent des prescriptions sont exprimées en quantité de produit actif (QPA) en LOCH vs 22 % en ALSA. L’intervalle moyen entre 2 transfusions est de 2,9 jours en ALSA vs 4,9 jours en LOCH. La QPA moyenne/délivrance est plus élevée en ALSA (5,6.1011 vs 4,0.1011 en LOCH). Les QPA délivrées ont été comparées aux recommandations AFSSaPS de 2003, en vigueur au moment de l’étude. Vingt-sept pour-cent des QPA délivrées sont dans l’intervalle recommandé en LOCH, vs 49 % en ALSA. LOCH se démarque par 63 % de QPA, inférieures à 0,5.1011 plaquettes/7 Kg liées à la délivrance systématique d’un seul CP, y compris pour les poids > 80 Kg. Vingt-deux pour-cent des délivrances en ALSA sont supérieures à 0,7.1011 plaquettes/7 Kg, majoritairement liées à la délivrance simultanée d’un deuxième CP. Conclusion Cette étude identifie des disparités de pratiques de prescription et de délivrance entre LOCH et ALSA, qui peuvent expliquer les niveaux respectifs de cessions de CP. Abstract Objectives To find explanations for the observed differences of platelets concentrates (PC) deliveries between 2 French regions, Lorraine-Champagne (LOCH) and Alsace (ALSA). Methods This is a non-interventional prospective study, performed during 30 days in 2015 in intensive care, cardiovascular surgery and onco-hematological wards of 8 LOCH and ALSA hospitals. Questionnaires listing clinical and biological parameters were attached to the prescription forms and filled in at each PC prescription. Results In all, 290 patients, 1093 prescriptions and 1093 deliveries of PC were analyzed. The pre-transfusional context (patient weight, prophylactic or curative situation, pre-transfusional platelet count) were homogenous. The phasing of the prescription forms wording had a direct impact on the doses’ formulation : 100 % of the LOCH forms were expressed in platelet quantity (PQ), vs 22 % in ALSA. The mean interval between 2 transfusions was 2.9 days in ALSA vs 4.9 days in LOCH. The mean PQ/delivery was higher in ALSA (5.6.1011 vs 4.0.1011 in LOCH). The delivered PQs were compared to the 2003 French recommendations that were in force in 2015. Twenty-seven percent of the LOCH delivered PQs were in the recommended interval, vs Forty-nine percent in ALSA. Due to the systematic delivery of a single PC unit, including weights > 80 Kg, LOCH presented 63 % insufficient PQ deliveries. Twenty-two percent of the deliveries in ALSA were over the recommended interval, mostly linked with the simultaneous delivery of a second PC. Conclusion This study identifies disparities in terms of prescription and delivery between LOCH and ALSA, which may explain their respective PC consumption levels. [ABSTRACT FROM AUTHOR]

Methotrexate (MTX) is a remarkable drug with a key role in the management of rheumatoid arthritis (RA) at every stage of its evolution. Its attributes include good overall efficacy for signs and symptoms, inhibition of structural damage and preservation of function with acceptable and manageable safety, a large dose-titratable range, options for either an oral or parenteral route of administration, and currently unrivalled cost-effectiveness. It has a place as a monotherapy and also as an anchor drug that can be safely used in combination with other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or used concomitantly with biological DMARDs or targeted synthetic DMARDs. MTX is not without potential issues regarding toxicity, notably hepatotoxicity and bone marrow toxicity, as well as tolerability problems for some, but not all, patients. But many of these issues can be mitigated or managed. In the face of a welcome expansion in available targeted therapies for the treatment of RA, MTX looks set to remain at the foundation of pharmacotherapy for the majority of people living with RA and other inflammatory rheumatic diseases. In this article, we provide an evidence-based discussion as to how to achieve the best outcomes with this versatile drug in the context of a treat-to-target strategy for the management of RA.

BACKGROUND: The use of topical antifungal agents in the treatment of onychomycosis is of great value in clinical practice as there are different limitations regarding the use of systemic treatment. OBJECTIVE: To evaluate the efficacy and safety of a nail lacquer formulation containing ciclopirox 8% in two different posologies: the traditional regimen (3/2/1) and a regimen of weekly use. METHODS: A blind, randomized, comparative trial which included 41 patients divided into 02 groups, with Group I using the nail lacquer once weekly and Group II using the traditional regimen (3/2/1). Both groups applied the medication for 06 months. RESULTS: The species most frequently found in groups I and II were Trichophyton rubrum (55% and 61.9%) and Trichophyton mentagrophytes (30% and 19%). There was a tendency to a higher level of treatment resistance by T. mentagrophytes infection in both groups, without any predilection for sex, age, proportion of the nail affected at the beginning of the study, duration of the clinical disease and quantity of nails affected per person. Both groups had significant levels of mycological cure, clinical response and therapeutic success and there was no statistically significant difference between groups I and II (p >0.05). CONCLUSION: The nail lacquer containing ciclopirox 8% was equally effective at a weekly dose when compared to the traditional dosing (3/2/1), allowing a more comfortable regimen.FUNDAMENTOS: A utilização de antifúngicos tópicos na terapêutica da onicomicose é de grande valor na prática clínica, visto que há diferentes limitações ao uso das opções terapêuticas sistêmicas. OBJETIVO: Avaliar comparativamente a eficácia e a segurança de uma formulação de esmalte de ciclopirox a 8% em dois diferentes esquemas posológicos: o esquema tradicional (3/2/1) e um esquema posológico de uso semanal. MÉTODOS: Foi realizado um estudo cego, comparativo e randomizado que incluiu 41 pacientes, divididos em dois grupos, sendo o grupo I submetido ao esquema posológico de uma vez por semana e o grupo II submetido ao esquema posológico tradicional (3/2/1). Os grupos utilizaram a medicação por 180 dias. RESULTADOS: As espécies mais frequentemente encontradas nos grupos I e II foram Trichophyton rubrum (55% e 61,9%) e Trichophyton mentagrophytes (30% e 19%). Houve tendência de maior resistência ao tratamento pelo T. mentagrophytes nos dois grupos estudados, sem predileção por sexo, idade, proporção de acometimento ungueal inicial, tempo de evolução do quadro ou número de unhas acometidas por indivíduo. Ambas as modalidades apresentaram índices significativos de cura micológica, resposta clínica e sucesso terapêutico, e não houve diferença estatisticamente significante entre os grupos I e II (p > 0,05). CONCLUSÃO: O esmalte contendo ciclopirox a 8% mostrou-se igualmente eficaz na posologia de uma vez por semana quando comparada à posologia tradicional (3/2/1), permitindo um esquema posológico mais confortável.

Los antioxidantes y en particular el selenio parenteral parecen vincularse con una reducción significativa de la mortalidad en los pacientes críticos con Síndrome de Respuesta Inflamatoria Sistémica (SRIS). Actualmente, el selenio parenteral es considerado la piedra angular dentro de la estrategia de tratamiento antioxidante en los pacientes críticos. En los últimos años, diferentes estudios clínicos han evaluado el impacto clínico del uso de selenio intravenoso (selenito) aportado como monoterapia o asociado a otros micronutrientes antioxidantes ("cócteles antioxidantes"). Sin embargo, los resultados de estos estudios no han sido concluyentes. En la actualidad existe una mejor comprensión sobre la farmacocinética y farmacodinamia del selenio intravenoso, siendo reconocido el efecto pro-oxidante del bolo intravenoso inicial así como el efecto antioxidante de la infusión continua. Sin embargo, la dosis óptima y el tiempo de suplementación de selenio no han sido aun definidos planteándose la existencia de una posible sinergia entre selenio y glutamina parenteral. Esta revisión analiza la evidencia actual sobre la suplementación de selenio en pacientes críticos con SRIS. El uso de altas dosis de selenio por vía parenteral (bolo inicial e infusión continua) parece ser una estrategia segura y efectiva en optimizar los niveles séricos de selenio y la actividad de ciertas selenoenzimas antioxidantes tales como la Glutatión Peroxidasa y la Selenoproteína P. Sin embargo, son necesarios nuevos estudios sobre la posología y farmacocinética del selenio en pacientes críticos. Estas pesquisas deberían demostrar un beneficio definitivo del uso de selenio sobre end point clínicos de relevancia.High dose intravenous selenium may be associated with a significant reduction in mortality among critically ill patients with systemic inflammation. Currently, parenteral selenium as sodium selenite seems to be a cornerstone of the antioxidant defence in the critically ill. So far, several clinical trials have evaluated the effects of selenium in monotherapy or as part of a multi-micronutrient approach, on relevant clinical end points for critically ill patients. Nonetheless, the results from these studies have sometimes been contradictory. We now have a better understanding of the pharmacokinetics of the initial and transient pro-oxidant effect of an intravenous bolus followed by the antioxidant effect of continuous infusion, which seems efficacious and safe among critically ill patients. Clinical confirmation of the potentially advantageous synergism between selenium and glutamine may soon be forthcoming but the most appropriate and the optimum time of supplementation remains undetermined. Short-term intravenous selenite (bolus injection plus continuous infusion) has shown to be safe and capable of optimizing serum selenium and antioxidant selenoenzymes activities. However, additional dose-ranging trials are necessary to elucidate an optimal and safe posology with confirmed pharmacokinetic profiles before more definitive phase III trials can be conducted.

Aim: To evaluate the Package inserts (PIs) for presentation, accuracy, completeness of clinical information and grade them according to the scores obtained. Material and Methods: An observational study conducted by the Department of Pharmacology, Sri Devaraj Urs Medical College from March to August 2014. PIs were analyzed for five leaflet characteristics and for 25 criteria listed by the Indian Drug and Cosmetic Rules, 1945. Each criteria was scored for presence of information as '1', absence as '0'. Total score of >20 was graded as 'A', 10-20 as 'B' and <10 as 'C'. Data was expressed as percentage. Results: Three hundred and sixty three PIs were analyzed. Considering the quality and texture, 80.2% were categorized as good and 19.8% as bad. All PIs were legible. Generic names were used in 99.2%. Content of active ingredients, indication for use were listed in 96.9% and 99.2% respectively. Posology details were mentioned in 97.2% and contraindications were given in 91.5% PIs. Undesirable effects were listed in 92.6%. Manufacturer's name and address was provided in 88.1%. PI with grade A, B and C were 10.2%, 83.8% and 6.1% respectively. Conclusion: Majority of the PIs were of grade B which suggests that most of the relevant information was mentioned except few criteria. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this communication is to assess whether the information about the management of thyrotoxicosis and thyrotoxic crisis as given in standard endocrinology, thyroidology and pharmacology textbooks is similar and concordant with each other. Methods: Three standard textbooks of endocrinology, one of diabetology and four of pharmacology were assessed for the published information regarding treatment of thyrotoxicosis and thyrotoxic crisis. Attention was given to the drugs used, their dose and prescribing frequency. Results: Various omissions and contradictions were found in the coverage of drugs used for thyrotoxicosis treatment in standard textbooks. Information about carbimazole, radio contrast media, cholestyramine, and lithium is missing in many of these texts. There were certain discrepancies in the doses of the drugs as is given in different textbooks. This is especially true in case of methimazole, propylthiouracil, and dexamethasone. Conclusions: This article stresses upon the need of homogeneity in different textbooks for providing adequate and accurate knowledge to physicians and students regarding frequency and dose of the drugs used in treatment of thyrotoxicosis and thyrotoxic crisis. [ABSTRACT FROM AUTHOR]

The present study was conducted to evaluate the utilization of Clark's, Salisbury and Penna's rules and the Body Surface Area (BSA) formula for calculation of pediatric drug dosage, as well as their reliability and viability in the clinical use. These rules are frequently cited in the literature, but much controversy still exists with regards to their use. The pediatric drug dosage was calculated by utilization of the aforementioned rules and using the drugs Paracetamol, Dipyrone, Diclofenac Potassium, Nimesulide, Amoxicillin and Erythromycin, widely employed in Pediatric Dentistry. Weight and body surface areas were considered of children with ages between 1 and 12 years old as well as the dosage for the adult. The pediatric dosages achieved were compared to the predetermined dosages in mg kg-1 herein-named standard dosages. The results were submitted to the parametric test ANOVA and to the Tukey test (pO presente estudo foi realizado com a finalidade de avaliar as fórmulas de Clark, Salisbury, Área da Superfície Corpórea (ASC) e Penna, quanto a sua confiabilidade e viabilidade de uso clínico para o cálculo de doses medicamentosas infantis, uma vez que tais fórmulas são freqüentemente citadas na literatura, mas muita controvérsia ainda existe com relação ao seu uso. As doses infantis foram calculadas utilizando as fórmulas descritas e os medicamentos Paracetamol, Dipirona, Diclofenaco de Potássio, Nimesulida, Amoxicilina e Eritromicina, largamente usados na clínica odontopediátrica. Foram considerados parâmetros como o peso e área da superfície corpórea de crianças com idades entre 1 e 12 anos e a dose para o adulto. As doses obtidas foram comparadas às doses em mg/kg consideradas como padrão de referência para os medicamentos. Os resultados foram submetidos ao teste paramétrico ANOVA e de Tukey (P

Objectives: The study is aimed to assess whether the information contained in standard pharmacology, endocrinology, and diabetology textbooks regarding timings of administration, frequency and dose of various insulins is adequate and also to see whether the information contained in these texts is concordant with product inserts. Materials and Methods: Four standard textbooks of pharmacology, two of diabetology and three of endocrinology were assessed for the published information regarding dose, timing, and frequency of insulin administration. The product inserts of commonly available insulins in India were also studied for the same. Results: Various omissions and disparities could be seen in the coverage of insulins in standard textbooks. Posology information about premixed insulins and basal insulins have been omitted by the majority of the textbooks. Details about dose, frequency and timings of ultra-short acting insulins have also not been covered by all textbooks. Some discrepancies regarding prescribing information was also noted in product inserts, especially in case of newer insulins. Conclusions: Thus, this article stresses upon the need of a uniform source of information for providing adequate and standardized knowledge regarding timing, frequency, and dose of insulins. [ABSTRACT FROM AUTHOR]

A study in 2010 reported that administration of 2 g of O. sanctum leaves for 30 days to laboratory male albino rabbits showed adverse effect on sperm count and male hormones. The dose and duration at which this testing was reported was commented upon as being high. It is learnt that basis this publication a few European regulators have imposed restrictions on usage of O. sanctum. Recognizing the need for evaluation, a review has been made of the posological considerations related to decision on dose of a drug in pharmaceuticals (drug development stages) and in Ayurvedic science as part of history of use and current usage. Specifically, we report the dose range as per documented tradition, marketed products containing O. sanctum as an ingredient and current clinical practice. Greater consultation is suggested before deciding the studies on Ayurvedic herbs. Regulatory action of banning use of O. sanctum needs a review and may need to be replaced with an advisory. [ABSTRACT FROM AUTHOR]

Posology concerns science and system of dosage. Conventionally the dosage systems of measurement are the apothecaries' and metric systems and the dosage calculation for each individual patient has been suggested according to several available methods, namely Clark's Rule, Fried's Rule, Young's Rule, body surface area, or mg/kg, etc. There are many factors affect the availability of a drug to its site of action in the body, and their relation to the time course of drug action and variation in each drug response with or without the other drugs taken simultaneously. The correct dosage requires meticulous and accurate calculation. In busy offices, some may feel the dosage calculation is tedious. This article reviews the conventional methods of dosage calculations and the allergy tests, followed by describing a simple way to determine the proper dosage for each patient by simplifying the Clark's concept based on the body weight and verify the Optimum dosage with Bi-Digital O-Ring Test minimize the adverse drug reactions and to increase safety for drug administration. [ABSTRACT FROM AUTHOR]

Aim of the Study: Different drug modification rules or growth factor support guidance may affect the results in oncology randomised controlled trials. We aimed to estimate the prevalence of unequal rules for dose modification rules or the use of myeloid growth factors in head-to-head registration Food and Drug Administration trials., Methods: This cross-sectional analysis included all head-to-head registration randomised controlled trials leading to a US Food and Drug Administration approval between 2009 and 2021. Trials examined anti-cancer drugs in the advanced or metastatic setting where a comparison could be made between arms regarding either dose modification rules or myeloid growth factors recommendations. Sixty-two registration trials met inclusion criteria. Information abstracted for each trial included tumour type, setting, phase, and type of sponsor. We assessed, according to pre-specified rules, imbalance in drug modification rules, myeloid growth factors recommendations or both., Results: We find 40 of 62 (65%) selected trials have unequal rules for dose medication, granulocyte colony-stimulating factor (G-CSF) use or both. Six trials (10%) had rules favouring the control arm, while 55% of selected trials (34/62) favoured the experimental arm. Among these, 50% (17/34) had unequal drug modification rules, 41% (14/34) had unequal G-CSF rules and 9% contained both (3/34)., Conclusion: We find that 55% of trials testing anti-cancer drugs against each other used protocol rules that favoured the experimental arm. This leaves open the question of whether new molecules are truly superior to older molecules or if instead different outcomes are due to more aggressive dosing or growth factor support. Trials should utilise equal rules for dose medication and G-CSF support., Competing Interests: Conflict of interest statement Vinay Prasad's Disclosures: Research funding: Arnold Ventures; Royalties: Johns Hopkins Press, Medscape; Honoraria: Grand Rounds/lectures from universities, medical centres, non-profits and professional societies; Consulting: UnitedHealthcare; Speaking fees: Evicore; Other: Plenary Session podcast has Patreon backers. All other authors have no financial nor non-financial conflicts of interest to report., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Higher-risk myelodysplastic syndromes (MDS) are aggressive disorders with rapid progression to AML and short survival. Azacitidine has shown unprecedented survival advantage in these patients but its treatment schedule involves daily hospital administrations for 7 days every 4 weeks. Due to patient and staffing constraints, we have treated 50 patients with a 5-day dose-intensified (500 mg/m total monthly dose divided in 5 days) azacitidine schedule in our center. The regimen was well tolerated, with Grade 3/4 adverse events seen in 24 % patients and only two discontinuations due to toxicity. The response rate was similar to that reported with the 7-day schedule: 16 % complete remissions, 32 % partial remissions, and 62 % transfusion independence. The median survival was 19.2 months from diagnosis. In addition, this regimen reduced hospital visits by 28 % and drug use by 30 %. Our results demonstrate the safety and efficacy of a dose-intensified 5-day regimen. [ABSTRACT FROM AUTHOR]

Well-characterized adipose stem cells and chemically defined culture media are important factors that control the production of the cell sheet, used in translational medicine. In this study, we have developed and engineered multilayer adipose stem cell cell sheets (ASCCSs) using chemically defined/serum-free culture media: undifferentiated or differentiated into osteoblasts and chondrocytes. In addition, using the cell sheet transmittance, we estimated the number of cells per cell sheet. Undifferentiated ASCCSs were engineered in 10 days, using serum-free/xeno-free culture media. They were CD29 + , CD73 + , CD90 + , CD105+, HLA-A+, and HLA-DR-. ASCCSs differentiated into chondrocytes and osteoblasts were also engineered using chemically defined and animal-free culture media, in only 14 days. The addition of an ROCK inhibitor improved the chondrocyte cell sheet engineering. The decrease in the cell sheet transmittance rate was higher for the osteoblast cell sheets due to the intracellular Ca 2+ accumulation. The estimation of cell number per cell sheet was carried out with the transmittance, which will provide important information for cell sheet posology. In conclusion, three types of ASCCSs were engineered using serum-free, xeno-free culture media, expressing their specific markers. Their transmittance measurement allowed estimating the number of cells per cell sheet, with a non-invasive methodology., Competing Interests: Authors LV, YN, and JOl are employed by Emmaus Life Sciences, Inc. and HN, JOc were employed by Emmaus Life Sciences, Inc. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Ochiai, Villanueva, Niihara, Niihara and Oliva.)

In this, the fifth in a series of articles on practice-related aspects of pharmacology, drug therapy and applied nursing pharmacology, we will continue to focus on the role of the nursing practitioner in administering prescribed medication to patients in their care. Specific consideration will now be given to the importance of posology, including the timing of drug dosages and the impact of ward routine. Furthermore, some attention will also be given to the stocking and maintenance of drugs on the emergency trolley. This series uses excerpts and diagrams with permission from the 2nd edition of Pharmacology in Clinical Practice: Application Made Easy for Nurses and Allied Health Professionals, and is compiled and expanded upon by the author. [ABSTRACT FROM AUTHOR]

The article presents abstracts of papers presented at the 39th European Society of Clinical Pharmacy (ESCP) European Symposium on Clinical Pharmacy and the 3th Société Française de Pharmacie Clinique (SFPC) Congress: Clinical Pharmacy at the Front Line of Innovations in Lyon, France, including "Hallucinations Due to Therapeutic Doses of Ertapenem," "Carboplatin Dosage in Overweight Patient: Case Report" and "Severe Hypokalemia Associated With Flucloxacillin."

High dose intravenous selenium may be associated with a significant reduction in mortality among critically ill patients with systemic inflammation. Currently, parenteral selenium as sodium selenite seems to be a cornerstone of the antioxidant defense in the critically ill. So far, several clinical trials have evaluated the effects of selenium in monotherapy or as part of a multi-micronutrient approach, on relevant clinical end points for critically ill patients. Nonetheless, the results from these studies have sometimes been contradictory. We now have a better understanding of the pharmacokinetics of the initial and transient pro-oxidant effect of an intravenous bolus followed by the antioxidant effect of continuous infusion, which seems efficacious and safe among critically ill patients. Clinical confirmation of the potentially advantageous synergism between selenium and glutamine may soon be forthcoming but the most appropriate and the optimum time of supplementation remains undetermined. Short-term intravenous selenite (bolus injection plus continuous infusion) has shown to be safe and capable of optimizing serum selenium and antioxidant selenoenzymes activities. However, additional dose-ranging trials are necessary to elucidate an optimal and safe posology with confirmed pharmacokinetic profiles before more definitive phase III trials can be conducted. [ABSTRACT FROM AUTHOR]

Résumé De nombreux médicaments sont utilisés sans que leur concentration sanguine soit surveillée, le plus souvent parce que celle-ci peut varier de façon importante sans affecter l’effet clinique attendu. Cependant, pour un groupe restreint de substances, qui nécessitent un suivi thérapeutique pharmacologique précis, l’absence de contrôle n’est pas sans conséquence. Summary Many drugs are used without their blood concentration being monitored, usually because this can vary significantly without affecting the expected clinical effect. However, for a restricted group of substances which require specific therapeutic drug monitoring, the lack of control is not without consequence. [ABSTRACT FROM AUTHOR]

A 64 year old woman developed symptomatic disease consistent with Covid-19 although testing was not available. Close follow up of the patient revealed the necessity for frequent repetition of the homeopathic medication even after improvement had set it in order to prevent relapse. Due to the severity of the symptoms and her age, it is quite probable that the severe form of Covid-19 was prevented by homeopathic treatment. [ABSTRACT FROM AUTHOR]

Summary Objective: Although the elimination half-life of most glucocorticoids is short, they are usually administered once daily, or even on alternate days. Our hypothesis was that this practice might compromise the immunosuppressive effect of those drugs during the second part of the administration interval. Methods: Eight healthy male volunteers were randomly assigned to receive intravenous methylprednisolone either 32 mg in the morning, or 16 mg in the morning and 16 mg in the evening in a cross-over design. Methylprednisolone concentrations were determined in plasma by high-pressure liquid chromatography. The total number of CD3+ lymphocytes, and CD4+ and CD8+ T-cell subpopulations was measured in blood. The suppression of these cells was used as a surrogate parameter for the immunosuppressive response, and expressed as reduction of the area under the effect time curve (AUETC). Possible adverse effects on blood pressure, glucose, insulin, and endogenous cortisol levels were monitored. Results: There were no significant differences in methylprednisolone half-life (2&bdot;2 ± 0&bdot;4 h), clearance (575 ± 113 mL/min), volume of distribution (106 ± 22 l), concentration producing the half-maximum effect on CD4+ T-cells (1&bdot;5 ± 0&bdot;7 ng/mL), and Hill-coefficient (1&bdot;2 ± 0&bdot;1), after single or divided dose. However, the total 24 h effect area (AUETC) of lymphocytes, and mainly CD4+ T-cells was significantly more suppressed (P = 0&bdot;008) with the divided dosage regimen than after the single dose (8422 ± 2163 vs. 11 545 ± 3020 h cells/μ L). The surrogate markers for adverse events were not different, except for cortisol. Conclusion: Within a 24-h interval, two dose fractions of methylprednisolone produce a stronger and more sustained immunosuppressive response than one single bolus dose. [ABSTRACT FROM AUTHOR]