Revista de Ciências Farmacêuticas Básica e Aplicada

Herbal product labels: do they guide rational or irrational use?

Adriany Barreto de Souza — 2022-01-03

Objective: The purpose of this study was to analyze the primary and secondary labels of plantbased medicines. Method: This research has a cross-sectional and descriptive. The procedure consisted of analyzing 100 labels of medicinal plant-based products used by elderly people from (in) Macapá-AP, in 2017. A script was prepared to verify their adequacy to health standards based on the Brazilian legislation (commercial name, botanical nomenclature, active ingredients, concentration, route of administration, age-restricted use, quantity and pharmaceutical form, preservation care, company name, CNPJ - Brazils's companies registration number, composition, SAC, expiration date, manufacture and batch), descriptive analysis of the data was performed (protocol number 38400314.9.0000.0003). Results: Only 4% of the products completely met the analyzed criteria. One of the main problems observed was the absence of a uniform standard of presentation of information on the packaging. About 7% of these products did not present any information besides the popular name of the medicinal plant used, 37% of the packages (or labels) contain statements and images that induce self-medication, errors in use, or references to "natural medicine", besides, transmitting the idea that the product has superior properties to drugs on the market. Conclusions: The results obtained suggest that the packaging of medicinal plant-based products induces the irrational use of medicines due to the lack of adequate information, as well as the presence of inadequate makenting strategies, in accordance with current national legislation.

Zingerone alleviates cadmium-induced nephrotoxicity in rats via its antioxidant and anti-apoptotic properties

Shauq Mumtaz Dawood — 2022-01-17

Objectives: Cadmium is an essential industrial metal and acts as an environmental toxicant that is a major cause of kidney diseases. Hence, we aimed to evaluate the possible nephroprotective effects of zingerone (ZGO), a major flavonoid constituent in ginger (Zingiber officinale) dry roots, against cadmium-induced nephrotoxicity in rats. Methods: In this study, Wistar albino rats [ACUC: HU2020/Z/FMS0120-01] were allocated randomly to 4 groups with seven animals in each group. The control group which received physiological saline; cadmium chloride (CdCl2) treatment group which received CdCl2 at a dose of 6.5 mg/kg intraperitoneally (i.p.) for 7 consecutive days; zingerone treatment group which received 25 mg/kg of zingerone orally for 7 consecutive days and CdCl2(6.5 mg/kg; i.p.)+ZGO (25 mg/kg; p.o.) treatment group which received CdCl2 and ZGO for 7 consecutive days. Results: Co-administration of ZGO along with CdCl2 resulted in a significant reduction in creatinine and urea levels of serum. Additionally, ZGO significantly diminished the tissue levels of Cd concentration, lipid peroxidation, and nitric oxide and significantly recovered the enzymatic and nonenzymatic antioxidant molecules, namely glutathione, total superoxide dismutase, catalase, and glutathione recycling enzymes peroxidase and reductase, in kidney tissue. Furthermore, ZGO treatment prevented the inflammation produced by CdCl2 by restraining the elevation in the level of pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin1beta). Moreover, ZGO improved histopathological alternations in the kidney by preventing apoptosis cascade in kidney tissue by stimulating Bcl-2 and suppressing Bax and caspase-3. Conclusions: Our findings suggest that ZGO has nephroprotective activity in cadmium-induced nephrotoxicity mostly via modulating of oxidant/antioxidant balance, inflammatory response, and apoptosis.

Characterization of occupational exposure to pesticides and its impact on the health of rural women

Carolina Panis — 2022-01-21

Objective: To characterize the profile of occupational exposure to pesticides and its impact on women’s health. Method: This is a prospective and descriptive study with a quantitative approach. The study population included all patients attended at Francisco Beltrao Cancer Hospital (Ceonc) from May 2015 to December 2018 (n=315). The characterization of their exposure profile was obtained through an interview using a form applied by trained researchers contained 60 questions related to women’s pesticide exposure and their health status. The questions referred to past and current occupational pesticide exposure profile, intoxication, and health history from women and their families. All collected data were analyzed in the Statistical Package for the Social Sciences package (SPSS 25.0). Results: A total of 265 individuals (84.2%) have lived some part of their life in the countryside, and 70% were categorized as occupationally exposed to pesticides. Most of them (57%) were directly exposed, mainly by washing pesticide-contaminated clothes and personal protective equipment used in pesticide pulverization without glove protection. Cancer cases in the family were the main disease reported (68.3%). Further, 57% of interviewed women had a breast cancer diagnosis but no significance between breast cancer occurrence and pesticide exposure was observed. Conclusion: The form allowed us to characterize the profile of occupational pesticide exposition in rural women, alerting them to their severe contamination. This approach can be useful to characterize the occupational exposure profiles of rural workers living in other rural regions of Brazil that use pesticides.

Monitoring plasmatic concentrations of efavirenz for prediction of clinical outcomes in people living with HIV

Thaís Lorenna Souza Sales — 2022-04-19

Objective: To assess the ability of efavirenz plasma concentrations to predict clinical outcomes. Methods: This is a cross-sectional study in people living with HIV on efavirenz antiretroviral therapy. The ROC curve (Receiver Operating Characteristic) analysis was carried out in order to verify the variation in sensitivity and specificity between the efavirenz plasma concentration and the other variables of interest in the study. The study was approved by the Human Research Ethics Committee of the University of São João del-Rei, Central-West Dona Lindu Campus, as per CAAE 41775015.3.0000.5545. Results: Among the 108 patients included in the study, the median age was 54.5 years (IQ25%: 41.0; IQ75%: 63.0). The efavirenz plasma concentration was not able to predict outcomes such as viral suppression (AUC: 0.525; CI95%: 0.334 - 0.716; p = 0.803), immune response (AUC: 0.501; CI95%: 0.390 - 0.612; p = 0.982), presence of adverse events (1 adverse event - AUC: 0.326: CI95%: 0.156 - 0.497; p = 0.103) / ≥ 4 adverse events – AUC = 0.432; CI95%: 0.323 - 0.542; p = 0.232) and adherence (AUC = 0.537; CI95%: 0.423 - 0.651; p = 0.520). Conclusions: More studies are needed to estimate the relationship between clinical outcomes and efavirenz plasma concentrations in current clinical protocols. Therefore, the accumulation of evidence on the subject is essential to identify the feasibility of therapeutic monitoring of antiretrovirals for the purpose of optimizing parameters such as efficacy, safety and adherence.

Assessment of a clinical pharmaceutical service for hypertensive and/or diabetic patients in a primary healthcare center

Paulo Yuri Milen Firmino — 2022-05-25

Objectives: The present study aimed to assess the short- and long-term outcomes of a clinical service provided by a pharmacist structured in a primary healthcare center (PHC) in Fortaleza, Ceará, Brazil. Methods: A longitudinal-type study was conducted. Data were collected from pharmacotherapy follow-up (PTF) records from the Pharmaceutical Care Unit of the PHC Dr. Anastácio Magalhães. The PTF was provided to patients diagnosed with hypertension and/or diabetes mellitus. Two groups were formed: records of patients who intended to undergo six months or more of PTF (PTF group) and those who opted not to go through with it after the first session (control). In addition, new blood pressure and glucose measurements were obtained after invitation by phone call at least six months after the completion of the PTF to assess maintenance of the benefits gained. The control patients were invited for this new data collection as well for comparison purposes. Research Ethics Committee approval protocol no. 329.717. Results: A total of 224 patients were considered, 109 in the complete PTF group and 115 in the control group, where the following main results were obtained: systolic pressure (mean ± SD) went from 139.43±20.6 to 128.31±16.03 mmHg; diastolic pressure, from 82.45±11.44 to 77.68±9.21 mmHg; blood glucose, from151.78±75.8 to 121.39±47.56 mg/dL; and cardiovascular risk, from 21.59±9.42 to 18.95±9.06%. In comparison, the control group did not show significant changes on the above parameters. In the post-PTF analysis, the benefits gained tended to be maintained even at least six months after its conclusion. Conclusions: Thus, the findings of the present study suggest that the provision of the clinical pharmaceutical service assessed at the primary healthcare level offers benefits to patients who attended it for at least six months. Furthermore, the data also suggest that these benefits are maintained in the long term.

Vitamin D in patients with Hashimoto's disease: a systematic review and meta-analysis

Josiane Marlei Muller Fernandes dos Santos — 2021-11-29

One of the most common thyroid dysfunctions is Hashimoto's disease (HD), characterized by the production of specific antibodies against thyroid gland antigens (Anti-Tg and Anti-TPO). Recent studies have suggested that vitamin D supplementation, associated with levothyroxine, may contribute to the control of this autoimmune disease. However, secondary studies on this topic, such as systematic reviews and meta-analyses, are still scarce. Thus, the present study aimed to evaluate the efficacy and safety of vitamin D in patients with HD through a systematic review with meta-analysis. Randomized clinical trials were selected on the Pubmed, Scopus, and Web of Science databases. Studies comparing groups of HD patients supplemented with vitamin D and non-supplemented HD patients were included. The following outcomes were considered: TSH, T3, T4, Anti-Tg, Anti-TPO, and adverse drug reactions. The risk of bias was performed according to the Cochrane recommendations (RoB v. 2.0), and the quality of evidence was evaluated by the GRADE system. A total of 766 studies were identified in the databases, of which 7 met the eligibility criteria. None of the studies indicated the occurrence of adverse reactions with vitamin D supplementation in any administered dosage. Supplemented patients had a significant reduction in serum TSH levels compared to the control group (mean difference = -0.180 (95% CI [-0.316 to -0.045]), p = 0.009), suggesting that thyroid function was more controlled in the intervention group. However, for the other outcomes, no statistically significant differences were observed between the groups. Additionally, most of included articles (n=5/7) had some concerns or high risk of bias, and the quality of evidence revealed a moderate confidence for almost all outcomes; so the results must be interpreted with caution. Thus, more consistent, and robust clinical trials need to be carried out to confirm the efficacy of vitamin D supplementation in patients with HD.

Efficacy and safety of immunotherapies for the treatment of high-grade gliomas: a systematic review and meta-analysis

Edilaine Tiburcio da Silva — 2022-03-18

Background/Aim: High-grade gliomas are aggressive brain neoplasms usually refractory to treatment. Recently new treatment approaches have emerged, including immunotherapies. Hence, the aim of the present study was to evaluate the efficacy and safety of immunotherapies in adult patients with high-grade gliomas. Methods: Searches were performed in three databases for relevant studies published until December 2020. Title and abstract screening, full-text review, data extraction, and risk of bias assessment were performed independently by two reviewers. Risk of bias assessment was performed according to the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). Meta-analyses were performed with Review Manager software (version 5.4.1), using risk ratio and 95% confidence intervals as measure of effect, the Mantel-Haenszel method, and random effects models. The quality of evidence assessment was conducted according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: Nineteen studies were included in the systematic review, of which 15 reported comparable data for meta-analyses. The outcomes assessed in the meta-analyses were overall survival (OS) and progression-free survival (PFS), with subgroups at 6, 12, and more than 12 months. No statistical differences were observed between immunotherapy and conventional treatment, except for the OS subgroup over 12 months. The certainty on the evidence was moderate. Conclusion: There was no evidence of an additional benefit of immunotherapy compared to standard treatment in the synthesis of results from clinical trials. Further high-quality clinical trials are needed to improve the quality of evidence concerning immunotherapies for the treatment of high-grade gliomas.

A pilot integrated qualification program to improve medication use in a long-term care facility: a hybrid effectiveness-implementation study

Felipe Augusto dos Santos Oliveira Lima — 2022-02-24

Objective: to describe the implementation and to assess the effectiveness of a pilot integrated qualification program to improve the medication use in a long-term care facility (LTCF). Methods: This was a type 1 hybrid effectiveness-implementation study. A pilot integrated qualification program to improve the medication use in a LTCF was carried out by implementing a new drug distribution system and a comprehensive medication management (CMM) service according to the following four steps: I) implementation of the drug distribution system followed by the evaluation of the health team’s opinion; II) prescription review with the identification of potential drug therapy problems (PDTPs); III) provision of the CMM service according to the framework of Pharmaceutical Care practice within one year; and, IV) evaluation of the effectiveness of the program through the comparison of clinical and laboratory parameters (blood pressure, glycated hemoglobin and lipid fractions) using the t-test or Wilcoxon signed-rank test. Results: In step I, the distribution system was fully outsourced to a company that furnished all solid oral dosage forms in individual boxes containing a plastic coil with multiple envelopes for 30 days. In step II, 180 PDTPs were identified, and all patients presented with at least one of them. In step III, after the first assessment of the CMM Service, 43 actual drug therapy problems (DTPs) were identified. After one year of service provision, 96 DTPs were identified and 75.8% of them were resolved (n=72). In step IV, a statistically significant difference was observed between the initial and final minimum and maximum systolic and diastolic blood pressure (p<0,05). Conclusions: The pilot integrated qualification program had a positive impact on the clinical parameters. The global population is rapidly aging, making this type of study important to exemplify a multifaceted strategy to improve the quality of drug therapy for institutionalized patients.

Tamarind seed polysaccharide (TSP) uses in ophthalmic drug delivery

Matheus Augusto de Castro — 2021-12-16

At present, ophthalmic drug delivery remains a major challenge, given the eye's prot ective structure and susceptibility to irritation, resulting in poor patient adherence. In order to overcome these constraints, new formulations are continually being developed. The inclusion of Galactoxyloglucan (Tamarind seed polysaccharide (TSP) in such formulations, a natural substance extracted from the seeds of Tamarindus indica, has shown great potential due to its physico - chemical properties, high biocompatibility and safety profile. Such properties, have led to its use in formulations for the treatment of dry eye disease, glaucoma, and bacterial keratitis, as well as in dilating eye drops used in eye examinations. In this article, we highlight the most recent TSP - based ophthalmologic formulations, which indicate that this polymer is a strong candidate to reduce adverse effects, improve patient tolerability and drug bioavailability.

Administration of chloroquine and hydroxychloroquine through feeding tubes: that was then and this is now

Mariana Martins Gonzaga Nascimento — 2022-01-03