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[This corrects the article DOI: 10.1371/journal.pone.0230215.].

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Abstract The pursuit of quality of life, which has become marked in recent years, has translated into important population health benefits. This study assessed the quality of life of patients with type 2 diabetes (T2DM) who received pharmaceutical care, and their satisfaction with the service provided in community pharmacies. This single blind, randomized controlled clinical trial included 100 patients. The intervention group (N=47) received pharmaceutical care by a clinical pharmacist and the control group (N=42) received standard care. The Quality of Life Diabetes Questionnaire (DQOL) was used to measure all participants´ quality of life at study enrollment and six months later. Satisfaction of the participants in the intervention group was measured using a validated 14-items questionnaire. At the end of the study, participants in the intervention group had a statistically significant improvement in DQOL scores ( -0.62 x 1.57, p < 0.001) and were highly satisfied with the intervention (96% excellent satisfaction scores). Pharmaceutical care practice was associated with high satisfaction and increased quality of life scores in T2DM patients. These results underscore the important role of pharmacists to improve the health of diabetic patients.

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OBJECTIVE: Development and internal validation of a clinical tool for assessment of the risk of adverse drug reactions (ADR) in hospitalized patients. METHODOLOGY: Nested case-control study in an open cohort of all patients admitted to a general hospital. Cases of ADR were matched to two controls. Eighty four patient variables collected at the time of the ADR were analyzed by conditional logistic regression. Multivariate logistic regression with clustering of cases in a random sample of 2/3 of the cases and respective controls, with baseline odds-ratio corrected with an estimate of ADR incidence, was used to obtain regression coefficients for each risk factor and to develop a risk score. The clinical tool was validated in the remaining 1/3 observations. The study was approved by the institution's research ethics committee. RESULTS: In the 8060 hospitalized patients, ADR occurred in 343 (5.31%), who were matched to 686 controls. Fourteen variables were identified as independent risk factors of ADR: female, past history of ADR, heart rate ≥72 bpm, systolic blood pressure≥148 mmHg, diastolic blood pressure <79 mmHg, diabetes mellitus, serum urea ≥ 67 mg/dL, serum sodium ≥141 mmol/L, serum potassium ≥4.9 mmol/L, main diagnosis of neoplasia, prescription of ≥3 ATC class B drugs, prescription of ATC class R drugs, prescription of intravenous drugs and ≥ 6 oral drugs. In the validation sample, the ADR risk tool based on those variables showed sensitivity 61%, specificity 73% and area under the ROC curve 0.73. CONCLUSION: We report a clinical tool for ADR risk stratification in patients hospitalized in general wards based on 14 variables.

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OBJECTIVE: To identify risk factors for potential Drug-Related Problems (DRP) at admission in hospitalized patients. METHODOLOGY: Prospective cohort study conducted in adults patients hospitalized (May 2016 to May 2018) in a general tertiary care hospital in Brazil. Potential DRP were detected by daily review of 100% of electronic medication orders by hospital pharmacists and classified by the Pharmaceutical Care Network Europe classification system (PCNE version 6.2). For the identification of risk factors of potential DRP, backward stepwise logistic regression was used to identify the set of independent predictors among over 120 variables collected in the initial 48 hours after admission in a training set consisting of 2/3 of the study population. The model was validated in the remaining sample. RESULTS: The study population consisted of 1686 patients aged 52.0+/- 18.3 years-old, 51.4% females, with a median length of stay of 3.24 days, and 4.5% in-hospital mortality. The cumulative incidence of potential DRP was 14.5%. Admission for elective surgery and main diagnosis of disease of the circulatory system were associated with reduced risk of DRP (OR 0.41 and 0.57, respectively, p<0.05). The independent risk factors of DRP are heart rate ≥ 80 bpm (OR 1.41, p = 0.05), prescription of more than seven drugs in day 2 (OR 1.63, p = 0.05), prescription in day 1 of drugs of the Anatomical Therapeutic Chemical Code (ATC) class A (alimentary tract and metabolism, OR 2.24, p = 0.003), prescription in day 2 of two or more ATC class A drugs (OR = 3.52, p<0.001), and in day 1 of ATC class J drugs (antiinfectives for systemic use, OR 1.97, p = 0.001). In the validation set, the c-statistic of the predictive model was 0.65, the sensitivity was 56.1% and the specificity was 65.2%. CONCLUSION: This study identified seven independent risk factors of potential DRP in patients hospitalized in a general hospital that have fair predictive performance for utilization in clinical practice.

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OBJECTIVE: To assess the analgesic efficacy of subcutaneous lidocaine and multimodal analgesia for chest tube removal following heart surgery. METHODS: Sixty volunteers were randomly allocated in two groups; 30 participants in the experimental group were given 1% subcutaneous lidocaine, and 30 controls were given a multimodal analgesia regime comprising systemic anti-inflammatory agents and opioids. The intensity and quality of pain and trait and state anxiety were assessed. The association between independent variables and final outcome was assessed by means of the Chi-squared test with Yates' correction and Fisher's exact test. RESULTS: The groups did not exhibit significant difference with respect to the intensity of pain upon chest tube removal (p= 0.47). The most frequent descriptors of pain reported by the participants were pressing, sharp, pricking, burning and unbearable. CONCLUSION: The present study suggests that the analgesic effect of the subcutaneous administration of 1% lidocaine combined with multimodal analgesia is most efficacious.

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Objective: to assess the analgesic efficacy of subcutaneous lidocaine and multimodal analgesia for chest tube removal following heart surgery. Methods: sixty volunteers were randomly allocated in two groups; 30 participants in the experimental group were given 1% subcutaneous lidocaine, and 30 controls were given a multimodal analgesia regime comprising systemic anti-inflammatory agents and opioids. The intensity and quality of pain and trait and state anxiety were assessed. The association between independent variables and final outcome was assessed by means of the Chi-squared test with Yates' correction and Fisher's exact test. Results: the groups did not exhibit significant difference with respect to the intensity of pain upon chest tube removal (p= 0.47). The most frequent descriptors of pain reported by the participants were pressing, sharp, pricking, burning and unbearable. Conclusion: the present study suggests that the analgesic effect of the subcutaneous administration of 1% lidocaine combined with multimodal analgesia is most efficacious.

Objetivo: avaliar a eficiência analgésica de lidocaína subcutânea e analgesia multimodal na remoção do dreno torácico após cirurgia cardíaca. Método: sessenta voluntários foram alocados aleatoriamente em dois grupos; 30 participantes no grupo experimental receberam lidocaína subcutânea 1%, e outros 30 do grupo controle receberam o regime de analgesia multimodal compreendendo agentes anti-inflamatórios e opióides sistêmicos. A intensidade e qualidade da dor e Ansiedade Traço Estado foram avaliados. A associação entre variáveis independentes e desfecho final foi avaliada através do Teste Qui-quadrado com correção de Yates e o Teste exato de Fisher. Resultados: os grupos não apresentaram diferenças significante, no que diz respeito à intensidade da dor na remoção do dreno torácico (p= 0,47). Os descritores de dor mais comuns relatados pelos participantes foram dor: de pressão, aguda, como uma picada, queimar/arder e intolerável. Conclusão: o presente estudo sugere que o efeito analgésico da administração de lidocaína 1% combinada com a analgesia multimodal é mais eficiente.

Objetivo: evaluar la eficacia analgésica de la lidocaína subcutánea y la analgesia multimodal para la remoción del tubo torácico después de la cirugía cardíaca. Métodos: sesenta voluntarios fueron asignados aleatoriamente en dos grupos; 30 participantes en el grupo experimental recibieron lidocaína subcutánea al 1%, y 30 controlos recibieron un régimen de analgesia multimodal que comprende agentes antiinflamatorios sistémicos y opioides. La intensidad y calidad del dolor y rasgo y estado de ansiedad se evaluaron. La asociación entre las variables independientes y el resultado final han sido evaluados por medio de la prueba de Chi-cuadrado con corrección de Yates y la prueba exacta de Fisher. Resultados: los grupos no mostraron diferencias significativas con respecto a la intensidad del dolor después de la retirada del tubo torácico (p= 0,47). Los descriptores de dolor más frecuentes informados por los participantes fueron apretado, agudo, punzante, ardiente e insoportable. Conclusión: el presente estudio sugiere que el efecto analgésico de la administración subcutánea de lidocaína al 1% combinada con la analgesia multimodal es eficaz.

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The aim of this work was to evaluate how an aqueous micellar system containing Amphotericin B (AmB) and sodium deoxycholate (DOC) can be rebuilt after heating treatment. Also, a review of the literature on the physicochemical and biological properties of this new system was conducted. Heated (AmB-DOC-H) and unheated (AmB-DOC) micelles were then diluted at four different concentrations (50 mg · L(-1), 5 mg · L(-1), 0.5 mg · L(-1), and 0.05 mg · L(-1)) to perform physicochemical studies and a pharmacotoxicity assay, in which two cell models were used for the in vitro experiments: red blood cells (RBC) from human donors and Candida parapsilosis (Cp). While potassium (K(+)) and hemoglobin leakage from RBC were the parameters used to evaluate acute and chronic toxicity, respectively, the efficacy of AmB-DOC and AmB-DOC-H were assessed by K(+) leakage and cell survival rate from Cp. The spectral study revealed a slight change in the AmB-DOC aggregate peak from 327 nm to 323 nm, which is the peak for AmB-DOC-H. Although AmB-DOC and AmB-DOC-H exhibited different behavior for hemoglobin leakage, AmB-DOC produced higher leakage than AmB-DOC-H at high concentrations (from 5 mg · L(-1)). For K(+) leakage, both AmB-DOC and AmB-DOC-H showed a similar profile for both cell models, RBC and Cp (P < 0.05). AmB-DOC-H and AmB-DOC also revealed a similar profile of activity against Cp with an equivalent survival rate. In short, AmB-DOC-H showed much less toxicity than AmB-DOC, but remained as active as AmB-DOC against fungal cells. The results highlight the importance of this new procedure as a simple, inexpensive, and safe way to produce a new kind of micelle system for the treatment of systemic fungal infections.

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Although many authors have reported several beneficial effects ascribed to xylan, such as inhibitory action on mutagenicity activity, antiphlogistic effects, and mitogenic and comitogenic activities, few papers have investigated a systematic study on the technological properties of this polymer. The aim of the present work was to evaluate xylan as a promise raw material for the pharmaceutical industry. The water-insoluble xylan samples were extracted from corn cobs following several steps. The obtained powered sample was analyzed by infrared and RMN spectroscopy, and characterized regarding their particle size, bulk and tap densities, compressibility index, compactability, Hausner ratio, and angle of repose. According to the results, infrared and RMN spectroscopy were shown to be able to evaluate the xylan structural conformation and composition, respectively. In addition, rheological data demonstrated that xylan powder obtained from corn cobs may be characterized as a material with low density and very cohesive flow properties.

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The aim of this work was to develop an in vitro experimental protocol for the evaluation of toxicity and efficacy of an amphotericin B (AmB) micelle system, Fungizone, which was previously diluted with a lipid based emulsion for parenteral use, named Lipofundin LCT/MCT-20%. Two cell models were used for the experiments: Red Blood Cells (RBC) from human donnors and Candida tropicalis (Ct). These models were used to perform the toxicity and activity of the Fungizone/ Lipofundin admixture (AmB-LP) and the Fungizone (AmB-M) alone. While potassium (K+) and hemoglobin leakage from RBC were the parameters used to evaluate the acute and chronic toxicity, respectively, the efficacy of AmB-LP and AmB-M were assessed by K+ leakage or cell survival rate (CSR) from Ct. The results show that the toxicity of AmB-LP to RBC was concentration dependent concerning the K+ leakage; while at high concentrations, 5 and 50 mg x mL(-1), the leakage was 50.91 +/- 2.09% and 95.71 +/- 0.64%, respectively, at a concentration of 0.5 mg x mL(-1) this value was 17.16 +/- 1.57% and the value tended to zero for the lowest concentration studied, 0.05 mg x mL(-1). Surprisingly, AmB-LP induced very low hemoglobin leakage for all concentrations studied. At the highest concentration, 50 mg x mL(-1), this value was around 3%. When the cell model was Ct, the results changed completely. Not only high concentrations of AmB-LP, but also lower ones were able to induce a K+ permeability of around 100%. The CSR parameter showed an inverse correlation with the concentration; high values, between 50 and 5 mg x mL(-1), resulted in a CSR of around 8%. On the other hand, for lower concentration values, 0.05 and 0.5 mg x mL(-1), this one was around 80%. The same profile of activity against Ct was found for AmB-M. Only a small variation was found for the K+ leakage at 0.05 mg x mL(-1) that presented a value of 96.99 +/- 2.53%. However, AmB-M seemed to be much more toxic than AmB-LP. Its induction of hemoglobin leakage started at 0.5 mg x mL(-1) and reached the 100% at 5 mg x mL(-1). K+ leakage results were worse. The intermediate concentrations of study, 0.5 and 5 mg x mL(-1), presented a significant increase compared to AmB-LP. All together these results reveal that the activity of AmB is not only concentration dependent, but also depends on the drug carrier in which this compound was inserted. The AmB-LP preparation showed the same efficacy as AmB-M, but with a low toxicity. Therefore, AmB-LP presented a higher therapeutic index that permits the administration of high concentration of AmB without revealing side effects. However, the simple mixture of two complex pharmaceutical entities, as micelles and emulsions, should be analyzed carefully to assure that physicochemical stability is not reduced and thereby cause a different biodistribution in vivo.

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PURPOSE: Amphotericin B (AmB), an antifungal agent that presents a broad spectrum of activity, remains the gold standard in the antifungal therapy. However, sometimes the high level of toxicity forbids its clinical use. The aim of this work was to evaluate and compare the efficacy and toxicity in vitro of Fungizon (AmB-D) and two new different AmB formulations. METHODS: three products were studied: Fungizon, and two Fungizon /Lipofundin admixtures, which were diluted through two methods: in the first one, Fungizon was previously diluted with water for injection and then, in Lipofundin (AmB-DAL); the second method consisted of a primary dilution of AmB-D as a powder in the referred emulsion (AmB-DL). For the in vitro assay, two cell models were used: Red Blood Cells (RBC) from human donors and Candida tropicallis (Ct). The in vitro evaluation (K+ leakage, hemoglobin leakage and cell survival rate-CSR) was performed at four AmB concentrations (from 50 to 0.05 mg x L(-1)). RESULTS: The results showed that the action of AmB was not only concentration dependent, but also cellular type and vehicle kind dependent. At AmB concentrations of 50 mg x L(-1), although the hemoglobin leakage for AmB-D was almost complete (99.51), for AmB-DAL and AmB-DL this value tended to zero. The p = 0.000 showed that AmB-D was significantly more hemolytic. CONCLUSION: The Fungizon-Lipofundin admixtures seem to be the more valuable AmB carrier systems due to their best therapeutic index presented.

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OBJETIVO: A anfotericina B é um agente antifúngico de largo espectro bastante empregado na terapia antifúngica. Entretanto, esta molécula apresenta um alto nível de toxicidade que, na maioria das vezes, impede o seu uso contínuo na terapêutica médica. O objetivo deste artigo foi comparar a eficácia e a toxicidade in vitro do Fungizon™ (AmB-D) e de dois sistemas carreadores de AmB. MÉTODOS: Três produtos foram avaliados: o Fungizon™ , e dois sistemas oriundos da mistura entre o Fungizon™ e o Lipofundin™ , uma emulsão de uso parenteral. Tais sistemas foram obtidos por duas técnicas: Na primeira diluiu-se previamanete o Fungizon™ com água para injetáveis e em seguida inseriu-se o Lipofundin™ (AmB-DAL); o segundo método consistiu na diluíção extemporânea do Fungizon™ com a referida emulsão (AmB-DL). Dois modelos celulares foram empregados no estudo: os eritrócitos (RBC) oriundos de doadores humanos e a Candida tropicalis (Ct). A avaliação in vitro (liberação de K+ e hemoglobina, e o índice de sobrevivência celular-CSR) foi realizado com quatro concentrações de AmB (entre 50 e 0.05mg.L-1). RESULTADOS: Os resultados demonstram que a ação da AmB não só foi dependente da concentração como também variou de acordo com o modelo celular e o veículo que diluiu o Fungizon™ . Nas concentrações de 50 mg.L-1, apesar da liberação de hemoglobina ser quase que total para AmB-D (99.51), para a AmB-DAL e AmB-DL este valor tendeu a zero. Um p = 0.000 demonstrou que AmB-D foi significativamente mais hemolítico. CONCLUSÃO: A mistura Fungizon™ -Lipofundin™ aparenta ser um bom sistema para carrear a AmB tendo em vista seu elevado índice terapêutico demonstrado.

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