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Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.
Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.
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ABSTRACT BACKGROUND: Research on the economic burden of sedentary behavior and abdominal obesity on health expenses associated with cardiovascular diseases is scarce. OBJECTIVE: The objective of this study was to verify whether sedentary behavior, isolated and combined with abdominal obesity, influences the medication expenditure among adults with cardiovascular diseases. DESIGN AND SETTING: This cross-sectional study was conducted in the city of President Prudente, State of São Paulo, Brazil in 2018. METHODS: The study included adults with cardiovascular diseases, aged 30-65 years, who were treated by the Brazilian National Health Services. Sedentary behavior was assessed using a questionnaire. Abdominal obesity was defined by waist circumference. Medication expenditures were verified using the medical records of each patient. RESULTS: The study included a total of 307 adults. Individuals classified in the group with risk factor obesity combined (median [IQ] USD$ 29.39 [45.77]) or isolated (median [IQ] USD$ 27.17 [59.76]) to sedentary behavior had higher medication expenditures than those belonging to the non-obese with low sedentary behavior group (median [IQ] USD$ 13.51 [31.42]) (P = 0.01). The group with combined obesity and sedentary behavior was 2.4 (95%CI = 1.00; 5.79) times more likely to be hypertensive. CONCLUSION: Abdominal obesity was a determining factor for medication expenses, regardless of sedentary behavior, among adults with cardiovascular diseases.
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Resumo A catação de materiais recicláveis é uma ocupação com crescente número de trabalhadores, que encontram nela sustento diante das desigualdades socioeconômicas e do desemprego. Este artigo descreve as estratégias de resistência de mulheres catadoras que fazem parte de uma associação no Nordeste brasileiro, além da forma como elas lidaram com problemas de saúde durante a pandemia de covid-19, especialmente no que se refere aos medicamentos. Utilizamos uma abordagem quantitativa e uma etnográfica, coletando dados sociodemográficos de 13 participantes e dos medicamentos presentes em suas casas, e também realizando observação participante e entrevistas aprofundadas. Em meio à crise sanitária, foram mencionados problemas como o desemprego, as relações de gênero, a violência e os estigmas do trabalho. Se por um lado a pandemia vulnerabilizou ainda mais alguns segmentos populacionais, por outro potencializou estratégias coletivas de enfrentamento. As catadoras e a associação se organizaram para obter insumos e melhorias tanto na sede quanto no bairro. Identificamos 58 unidades de medicamentos, prescritos e obtidos principalmente na Unidade Básica de Saúde. Desses, 27,6% tinham ação sobre o sistema nervoso (analgésicos, psicolépticos e psicoanalépticos) e 17,2% sobre o sistema cardiovascular e sobre o trato alimentar e metabolismo. As catadoras desenvolveram práticas de autoatenção com os medicamentos, destacando o papel central deles no enfrentamento dos problemas de saúde.
Abstract The collection of recyclable materials is an occupation with an increasing number of workers, who find in it a livelihood in a context of socioeconomic inequalities and unemployment. This article describes resistance strategies of women collectors who are part of an association in Northeast Brazil, in addition to describing how they managed health problems during the COVID-19 pandemic, especially regarding medicines. A quantitative and an ethnographic approach were used by collecting data on sociodemographic and medicines present in the homes of 13 participants and conducting participant observation and in-depth interviews. Amid the health crisis, the participants mentioned problems such as unemployment, gender relations, violence, and work stigmas. If, on the one hand, the pandemic has further increased vulnerability for certain population segments, on the other hand, it has enhanced collective resistance strategies. The collectors of the association organized to obtain various materials and benefits both for their headquarters and their neighborhood. We identified 58 units of medicines, prescribed and obtained mainly at the Basic Health Unit. Of these, 27.6% had action on the nervous system (analgesics, psycholeptics, and psychoanaleptics) and 17.2% on the cardiovascular system and on the alimentary tract and metabolism. The collectors developed self-attention practices with the medicines highlighting their central role in facing health problems.
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Background: South African legislation advocates for equitable access to mental healthcare services integrated into general healthcare settings. Mental, neurological, and substance use (MNS) disorders are often comorbid. Pharmacoepidemiology provides indirect evidence of service provision for conditions amenable to medicine treatment. Aim: The study aims to evaluate medicine procurement for MNS disorders at different service levels in the health system. Setting: The Public health sector, Gauteng province formed the setting for the study. Method: A secondary analysis of the Gauteng pharmaceutical database was conducted using Anatomic Therapeutic Chemical (ATC) and defined daily dose (DDD) methodology. Anatomic Therapeutic Chemical classes of medicines for MNS disorders were included. Defined daily doses and costs were calculated per 1000 population served by each facility and service level. Statistical comparisons were made using chi-square testing. Results: General healthcare settings accounted for 90% (R118 638 248) and specialised hospitals for 10% (R13 685 032) of expenditure on medicines for MNS disorders, procuring 94% (n = 49 442 474) and 6% (n = 3 311 528) of DDDs, respectively. Although district clinics procured 60% of DDDs, they procured the least per 1000 population served, whereas district hospitals procured the most. For almost all ATC classes, procurement differed significantly between municipalities at every service level and between specialised hospitals. Conclusion: In Gauteng province, most medicines for MNS disorders are procured by general healthcare services, but access to care may not be equitable. While population coverage at district clinics appears low, district hospitals may experience the greatest care burden. Research regarding quality of care at each service level is recommended. Contribution: This study provides insight into service provision for MNS disorders.
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Mental Health , Costs and Cost AnalysisABSTRACT
ObjectiveTo construct the evidence body for revision of safety information on package inserts of Chinese patent medicines in post-marketing by taking Xiaoke'an capsules as an example， so as to provide reference for the revision of instructions of Chinese patent medicines in post-marketing. MethodThe construction of the evidence body was guided by the theory of traditional Chinese medicine（TCM） and the Technical Guiding Principles for Revision of Safety Information Items in Instructions for TCMs After Marketing， and 8 categories and 25 specific items were taken as the main body of the evidence body， and information inclusion， integration， screening and improvement were carried out， then expert demonstrations were conducted， and finally modifications were made based on the opinions of the Center for Drug Evaluation to complete the revision of the safety information in the instructions of Xiaoke'an capsules. Result［Adverse reactions］ of Xiaoke'an capsules was revised to "monitoring data show that the following adverse reactions can be seen with this product：individual hypoglycemic reaction reports". ［Contraindications］ was revised to "contraindicated for those allergic to this product and its ingredients". ［Precautions］ was revised to "（1）pregnant women should use with caution， （2）elderly people should consult a physician， （3）people with spleen deficiency and dampness， spleen and stomach deficiency and cold， or those who eat less and have diarrhea should use with caution， （4）this product contains ginseng， should not be taken at the same time with TCM prescriptions or patent medicines containing veratrum and Wulingzhi， （5）pay attention to monitoring blood sugar during medication， （6）if any other discomfort occurs during medication， you should seek medical attention in time". The warning was revised to "use with caution by pregnant women， and pay attention to regular monitoring of blood sugar". ConclusionIn accordance with the content and process of the evidence body for the revision of safety information in the instructions， the revision of the safety information in the instructions of Xiaoke'an capsules has been completed， providing a strong basis for the rational and safe use of medication in the clinic.
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ObjectiveTo investigate the functions and characteristics of traditional Chinese medicine （TCM） from plant skin and their Chinese patent medicines and explore the related laws of the medicinal tissue， property， taste， efficacy， and clinical application， so as to strengthen the theory of identifying symptoms for qualities and provide references for the development and utilization of TCM from plant skin and their Chinese patent medicines. MethodBy reviewing the 2020 edition of the Chinese Pharmacopoeia and some local pharmacopeias， TCM from plant skin and their Chinese patent medicines were screened out， and the characteristics， functions， and precautions of TCM from plant skin and their Chinese patent medicines were summarized. Statistical analysis was carried out with Excel. ResultA total of 62 TCM from plant skin were found， mainly distributed in one kingdom， three phyla， and 31 families. In terms of the family genus， Rutaceae>Leguminosae>Cucurbitaceae. In terms of the medicinal tissue， bark>root bark>fruit bark>seed bark. In terms of property and taste， warm>cold>plain>cool>hot， and bitter>sweet=pungent>acidic. In terms of meridians， lung>liver>spleen>heart>colorectal>kidney>stomach=bladder. In terms of TCM classification， most of them belong to the category of heat-clearing medicines. There were 485 types of Chinese patent medicines from plant skin， with the most Chinese patent medicines containing Citri Reticulatae Pericarpium. Among the forms of administration， pills were the most predominant. In terms of the tastes of the medicines， bitter and sweet flavors predominated. In terms of functions， medicines for strengthening the body resistance were the most. For the precautions， contraindications during pregnancy were the most common. ConclusionThere is a correlation among medicinal tissue， property， taste， efficacy， and clinical application of TCM from plant skin. It is also necessary to pay attention to the contraindications of the medicines and rationally choose TCM from plant skin and their Chinese patent medicines under the guidance of TCM theory based on syndrome differentiation and treatment.
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ObjectiveThe relevant laws among the biological characteristics， medicinal parts， growth environment， and medicinal properties and efficacy of traditional Chinese medicines （TCM） from fungi were excavated， so as to strengthen the theory of distinguishing symptoms for quality and provide a reference for the development and utilization of TCM from fungi. MethodThe medicinal parts， meridians for properties and tastes， heterotrophic mode， and efficacy of commonly used TCM from fungi were summarized. By consulting the Compendium of Materia Medica， Shennong Materia Medica， Flora of China， and literature， the TCM from fungi indexed in the 2020 edition of the Chinese Pharmacopoeia and some local pharmacopeias were checked. ResultA total of 28 common TCM from fungi were selected. Different TCMs from fungi have different meridians for properties and tastes， medicinal parts， habits， and growth environments. The relevant information was counted. Among the four properties， plain>cold>warm. Among the five tastes， sweet>bitter>light>pungent=salty. In terms of medicinal parts， fruiting body>sclerotia>complex>spermia=outer skin=other. In terms of meridians， lung>liver=heart>spleen=kidney>stomach. In terms of habits， parasitism>saprophysis>symbiosis=facultative parasitism=facultative saprophysis. ConclusionTCM from fungi are mainly parasitic and saprophytic， and the plain property and sweet taste the most. The meridians are mostly lung， heart， and liver. Nourishment and diuresis are the main efficacy. There is a certain correlation between the color， habit， medicinal parts， and growth environment of TCM from fungi and their properties， tastes， and efficacy， providing comprehensive literature reference and theoretical basis for their in-depth research， clinical use， and resource development.
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ObjectiveTo investigate the correlation among the botanical characteristics， biological characteristics， chemical composition， and medicinal properties and efficacy of traditional Chinese medicines （TCM） from latex-containing plants， so as to strengthen the theory of "identifying symptoms for qualities" and provide a reference for the development and utilization of the latex-containing plant resources. MethodStatistics on the meridians for properties and tastes， efficacy， medicinal parts， family and genus， and chemical components of TCM from latex-containing plants were carried out. A total of 53 TCM from latex-containing plants included in the 2020 edition of the Chinese Pharmacopoeia were screened by mining the Chinese Botanical Journal， Chinese Materia Medica， Dictionary of Traditional Chinese Medicines， and related literature. In addition， their meridians for properties and tastes， medicinal parts， chemical components， and TCM classifications were summarized and statistically analyzed by using Excel 2013 and ChiPlot 2023.3.31 software. ResultIt was found that latex-containing plants were mainly distributed in one kingdom， one phylum， two classes， and 20 families， and most of the TCM from latex-containing plants belonged to Dicotyledonaceae under Angiosperms. In terms of properties and tastes， plain>cold>warm>cool>hot and bitter>pungent>sweet>sour>salty. In terms of meridians， liver>lung>kidney>spleen=large intestine=stomach>heart>bladder=gallbladder=small intestines. In terms of medicinal parts， roots （root， rhizomes， tuberous root， and root bark）>resin>seed>whole herb （whole herb and above-ground part）>stem （stem and branch）>fruit>leaf>flower=skin. In terms of research on chemical components， they were mostly glycosides. In terms of TCM classification， they were mostly medicines for activating blood circulation and removing blood stasis. ConclusionThe TCM from latex-containing plants is mainly plain， with a uniform warm and cold distribution. The tastes are mainly bitter and pungent， and the major meridians are the liver and lung. The roots and resins are mainly used as medicines. The components mostly contain glycosides， alkaloids， and volatile oils， and most of them are medicines for activating blood circulation and removing blood stasis， as well as for removing heat and toxins. There is a certain degree of correlation among the growth habits， medicinal parts， chemical components， and the properties， tastes， and efficacy of the TCM from latex-containing plants. It may provide a reference for resource development and utilization of TCM from latex-containing plants.
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Ferroptosis， a new form of programmed cell death different from apoptosis， necrosis， and autophagy， is closely associated with a variety of physiological and pathological processes. Iron-mediated accumulation of reactive oxygen species is the main inducement of ferroptosis， the mechanism of which is related to intracellular lipid metabolism， iron metabolism， and antioxidant defense pathways. Multiple signaling axes and regulators jointly regulate the occurrence and disruption of ferroptosis. Studies have demonstrated that ferroptosis regulates the growth and proliferation of tumor cells. Inducing ferroptosis in tumor cells can control the growth， metastasis， and multi-drug resistance of tumors. Therefore， the effect and mechanism of ferroptosis on tumor cells have become a hot topic in anti-cancer research. As the research advances， a variety of ferroptosis inducers has been used in the clinical chemotherapy for cancers and demonstrate significant efficacy. Accordingly， the development of ferroptosis-inducing anticancer drugs has become a new research direction for tumor treatment. Some active ingredients such as lycorine， oleanolic acid， dihydroartemisinin， pseudolaric acid B， and ophiopogonin B of Chinese medicines can induce ferroptosis in tumor cells via lipid metabolism， iron metabolism， system Xc-， and GPX4/GSH to regulate the development of tumors， demonstrating a promising prospect in clinical treatment. Based on the theory of the mechanism of ferroptosis， this paper reviews the research progress in ferroptosis induced by active ingredients of Chinese medicines in tumor cells and describes the metabolic regulatory network of ferroptosis from signaling pathways and regulatory factors， providing new strategies for applying active ingredients of Chinese medicines in the treatment of tumors.
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ObjectiveTo study the characteristics of imprinting template of flavonoid clusters in four Chinese medicines attributed to the lung meridian， and to establish an in vitro experimental approach for the study of the attribution of Chinese medicines to the lung meridian. MethodBased on 13 Chinese medicines， including Xanthii Fructus， Houttuyniae Herba， Fagopyri Dibotryis Rhizoma， Belamcandae Rhizoma and so on， which only belong to the lung meridian in Chinese Materia Medica（the 13th Five-Year planning textbook of general higher education）， we identified four representative Chinese medicines， namely Houttuyniae Herba， Fagopyri Dibotryis Rhizoma， Belamcandae Rhizoma and Mori Cortex， and set up their fingerprints by high performance liquid chromatography（HPLC） and calculated the molecular connectivity indices of various components in the four Chinese medicines， the similarity to their mean value was calculated by included angle cosine method， so as to establish the quantitative relationship of construction versus imprinting ability， and to determine the order of each component in the lung meridian. A total of 7 reference substances， including chlorogenic acid， rutin， quercetin， isoquercitrin， hyperoside， epicatechin， and iridin， were selected to validate the overall conformational relationships of flavonoids of the model， as well as its predictive ability. ResultHouttuyniae Herba， Fagopyri Dibotryis Rhizoma， Belamcandae Rhizoma and Mori Cortex contained a total of 437 chemical components with an average molecular connectivity index similarity of 0.995 6. The four Chinese medicines contained a total of 204 flavonoids with an average molecular connectivity index similarity of 0.978 0， which was second only to the alkaloids with 0.985 1. The retention time（tR） of the 7 reference substances showed a good conformational relationship with the similarity of the molecular connectivity index（tR=831.4×S-790.3， r=0.861 4， P<0.01）， which was applicable to the in vitro attribution study of the position， similarity， and relative similarity with tR of the cluster of 98.04% of flavonoids. Accordingly， the 1st position was kuwanon D， with a similarity of molecular connectivity index of 0.987 7 and a tR of 30.88 min， the 200th position was chlorogenic acid， with a similarity of molecular connectivity index of 0.958 2 and a tR of 6.36 min. The total first-order moment of the four Chinese medicines calculated by total statistical moment method of fingerprint was 24.26 min， ranked 21， which could characterize 99.19% of the whole， and the total first-order moment of the total peak area of the 7 reference substances in the four Chinese medicines was 20.00 min， with a rank of 46， which could characterize 98.68% of the whole. ConclusionFlavonoid clusters are suitable probes for the characterization of imprinting template for the study of the lung meridian， which can be established a quantitative imprinting method for meridian tropism of Chinese medicines in vitro.
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The mild-natured and bitter-flavored traditional Chinese medicines (MB-TCMs) are an important class of TCMs that have been widely used in clinical practice and recognized as safe long-term treatments for chronic diseases. However, as an important class of TCMs, the panorama of pharmacological effects and the mechanisms of MB-TCMs have not been systemically reviewed. Compelling studies have shown that gut microbiota can mediate the therapeutic activity of TCMs and help to elucidate the core principles of TCM medicinal theory. In this systematic review, we found that MB-TCMs commonly participated in the modulation of metabolic syndrome, intestinal inflammation, nervous system disease and cardiovascular system disease in association with promoting the growth of beneficial bacteria Bacteroides, Akkermansia, Lactobacillus, Bifidobacterium, Roseburia as well as inhibiting the proliferation of harmful bacteria Helicobacter, Enterococcus, Desulfovibrio and Escherichia-Shigella. These alterations, correspondingly, enhance the generation of protective metabolites, mainly including short-chain fatty acids (SCFAs), bile acid (BAs), 5-hydroxytryptamine (5-HT), indole and gamma-aminobutyric acid (GABA), and inhibit the generation of harmful metabolites, such as proinflammatory factors trimethylamine oxide (TAMO) and lipopolysaccharide (LPS), to further exert multiplicative effects for the maintenance of human health through several different signaling pathways. Altogether, this present review has attempted to comprehensively summarize the relationship between MB-TCMs and gut microbiota by establishing the TCMs-gut microbiota-metabolite-signaling pathway-diseases axis, which may provide new insight into the study of TCM medicinal theories and their clinical applications.
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Traditional Chinese medicines (TCMs) possess a rich historical background, unique theoretical framework, remarkable therapeutic efficacy, and abundant resources. However, the modernization and internationalization of TCMs have faced significant obstacles due to their diverse ingredients and unknown mechanisms. To gain deeper insights into the phytochemicals and ensure the quality control of TCMs, there is an urgent need to enhance analytical techniques. Currently, two-dimensional (2D) chromatography, which incorporates two independent separation mechanisms, demonstrates superior separation capabilities compared to the traditional one-dimensional (1D) separation system when analyzing TCMs samples. Over the past decade, new techniques have been continuously developed to gain actionable insights from complex samples. This review presents the recent advancements in the application of multidimensional chromatography for the quality evaluation of TCMs, encompassing 2D-gas chromatography (GC), 2D-liquid chromatography (LC), as well as emerging three-dimensional (3D)-GC, 3D-LC, and their associated data-processing approaches. These studies highlight the promising potential of multidimensional chromatographic separation for future phytochemical analysis. Nevertheless, the increased separation capability has resulted in higher-order data sets and greater demands for data-processing tools. Considering that multidimensional chromatography is still a relatively nascent research field, further hardware enhancements and the implementation of chemometric methods are necessary to foster its robust development.
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ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine （CPM） with internationally recognized tools the appraisal of guidelines for research and evaluation （AGEREE） Ⅱ and reporting items for practice guidelines in healthcare （RIGHT）， thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI， VIP， Wanfang and Sinomed were searched for CPM guidelines， as well as medlive.cn， websites of China Association of Chinese Medicine and Chinese Medical Association， and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools， and consistency tests were performed using Interclass Correlation Coefficient， and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally， 140 CPM guidelines were included， of which 51 were disease-oriented and 89 were drug-oriented， all of which were issued by China. For 51 disease-oriented CPM guidelines， the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity， and the lowest was 26.80% for application； for 89 drug-oriented CPM guidelines， the highest average score was 55.62% for scope and purpose， and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist， the highest reporting rate was 68.26% for background， and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines； the highest reporting rate was 61.31% for background， and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ （rigour of development， clarity of presentation， editorial independence）， as well as four domains of RIGHT checklist （basic information， evidence， funding and declaration and management of interests， and other areas）. ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist， and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines， thereby guiding the clinical use of CPM in a better way.
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Fibrosis， a tumor-like lesion between benign tissue and malignant tumor， mostly occurs in the liver， kidney， heart， lung， bone marrow and other organs and tissues. It can affect almost every organ and eventually induce multiple organ failure and cancers， seriously endangering human life. It will be of great importance to prevent cancer if the disease can be opportunely blocked in the fibrotic stage. The pathogenesis of fibrosis is still not completely clear. It is of great clinical significance to study the occurrence， development， and mechanism of fibrosis as well as to screen new therapeutic targets. Enhancer of zeste homolog 2 （EZH2） is mainly located in the nucleus and involved in the formation of the polycomb repressive complex 2. EZH2 is a methyltransferase which makes the lysine on position 27 of histone H3 （H3K27me3） undergo trimethyl modification induces gene silencing through classical or nonclassical actions， so as to inhibit or activate transcription. EZH2 plays a critical role in cell growth， proliferation， differentiation， and apoptosis， which is regulated by different targets and signaling pathways. EZH2 regulates the transformation of myofibroblasts and participates in the fibrosis of multiple organs. Recent studies have shown that EZH2 plays a role in fibrosis-related pathophysiological processes such as epithelial-mesenchymal transition， oxidative stress， and inflammation. EZH2 as the target of fibrosis， EZH2 inhibitors， and EZH2-related traditional Chinese medicine （TCM） formula and active compounds have gradually become hot research directions. EZH2 may be a powerful target for organ fibrosis. Exploring the structure， function， and distribution of EZH2， the role of EZH2 in fibrosis， the EZH2 inhibitors， and TCM formulas and active components targeting EZH2 has great meanings. This paper reviews the research progress in EZH2 and fibrosis， providing new ideas for the diagnosis， treatment， and drug development of fibrosis.
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Objetivo: Analisar os efeitos benéficos do uso da tecnologia digital no envelhecimento ativo, considerando o contexto pós-pandemia Sars-Cov-2-covid-19. Além disso, pretende-se identificar as vantagens e desvantagens do uso dessas tecnologias pelas pessoas idosas no mundo contemporâneo. Método: estudo descritivo, tipo análise teórico reflexiva, desenvolvido a partir de duas questões norteadoras relacionados à temática, subsidiado por levantamento bibliográfico, considerando publicações pertinentes à temática, disponíveis nas bases de dados do Portal Regional da BVS, Portal de Periódicos Capes, SciELO e Pubmeb. por meio dos descritores controlados DECS /MeSH. Resultados: as TIC's estão desempenhando um papel crucial na vida das pessoas idosas, melhorando a comunicação, promovendo a saúde, facilitando o aprendizado e proporcionando um acesso mais fácil à informação e aos cuidados médicos. Conclusão: a tecnologia digital é um mecanismo auxiliador no envelhecimento ativo; quando bem implementado pode trazer mais vantagens do que desvantagens.(AU)
Objective: To analyze the beneficial effects of digital technology usage in active aging, considering the post-Sars-Cov-2-covid-19 pandemic context. Additionally, the aim is to identify the advantages and disadvantages of older individuals using these technologies in the contemporary world. Method: A descriptive study, specifically a theoretical reflective analysis, developed based on two guiding questions related to the theme. The study was supported by a literature review, considering publications relevant to the topic available in the databases of the Regional Portal of BVS, Capes Periodicals Portal, SciELO, and Pubmeb, using controlled descriptors such as DECS/MeSH. Results: Information and communication technologies (ICTs) are playing a crucial role in the lives of older individuals, enhancing communication, promoting health, facilitating learning, and providing easier access to information and medical care. Conclusion: Digital technology serves as an auxiliary mechanism in active aging; when well implemented, it can bring more advantages than disadvantages.(AU)
Objetivo: Analizar los efectos beneficiosos del uso de la tecnología digital en el envejecimiento activo, considerando el contexto post-pandemia de Sars-Cov-2-covid-19. Además, se pretende identificar las ventajas y desventajas del uso de estas tecnologías por parte de las personas mayores em mundo contemporáneo. Método: Estudio descriptivo, tipo análisis teórico reflexivo, desarrollado a partir de dos preguntas orientadoras relacionadas con el tema, respaldado por revisión bibliográfica que considera publicaciones pertinentes disponibles en las bases de datos del Portal Regional de BVS, Portal de Periódicos Capes, SciELO y Pubmeb, mediante descriptores controlados DECS/MeSH. Resultados: tecnologías de la información y la comunicación (TIC) desempeñan un papel crucial en la vida de las personas mayores, mejorando la comunicación, promoviendo la salud, facilitando aprendizaje y proporcionando acceso fácil a información y atención médica. Conclusión: La tecnología digital es un mecanismo auxiliar en el envejecimiento activo cuando se implementa adecuadamente puede aportar más ventajas que desventajas.(AU)
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Humans , Aged , Aged, 80 and over , Medical Informatics Applications , Aged , Information Technology , Access to Essential Medicines and Health TechnologiesABSTRACT
Colombia depende de la importación de medicamentos, así como de gran parte de los materiales (principios activos y excipientes) requeridos para su elaboración; problemática que genera consecuencias sanitarias y macroeconómicas, las cuales se agudizan en el contexto de desindustrialización nacional y de disrupción tecnológica. De esta manera, se acepta que la disponibilidad y acceso a medicamentos y otras tecnologías sanitarias esenciales son un requisito fundamental para alcanzar la autonomía sanitaria de un país. Por lo tanto, resulta imprescindible coordinar esfuerzos entre diversos sectores sociales para desarrollar una agenda pública enfocada a la creación de condiciones que fortalezcan las capacidades científicas y tecnológicas de la industria farmacéutica local, y con ello, mejorar el suministro farmacéutico del país. En el presente documento se presentan conceptos teóricos y prácticos que deberían ser considerados en la definición y materialización de una política pública encaminada a fortalecer la industria farmacéutica y favorecer la autonomía sanitaria de Colombia.
Colombia has a notorious dependency on the importation of medicines, as well as a large part of the materials (active ingredients and excipients) required for their manufacture. This problem generates health and macroeconomic consequences, which are exacerbated in the context of national deindustrialization and technological disruption. In this way, it is accepted that the availability and access to medicines and other essential health technologies are a fundamental requirement to achieve the health autonomy of a country. Therefore, it is crucial to coordinate efforts between several social sectors to develop a public agenda focused on creating conditions that allow strengthening the scientific and technological capabilities of the local pharmaceutical industry, thereby, improving the country's pharmaceutical supply. This document presents conceptual and practical topics that should be considered to defining and materializing a public policy aimed at strengthening the local pharmaceutical industry and favoring Colombia's sanitary autonomy.
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RESUMO O cenário tecnológico no campo da saúde é um fato alarmante, mormente no contexto provocado pela Covid-19. Nessa conjuntura, a Fundação Oswaldo Cruz, por meio da Unidade de Bio-Manguinhos, e o Butantan foram protagonistas para o acesso universal, dialogando com estratégicas internacionais. No adensamento da discussão estratégica para Instituições Públicas de Produção e Inovação em Saúde (Ippis), o uso de diretrizes da Avaliação de Tecnologias em Saúde destaca-se como via de mudança paradigmática para a introdução de tecnologias no Sistema Único de Saúde (SUS) alinhada à visão de inovação de futuro em saúde consonante às demandas nacionais. Este artigo, desenvolvido metodologicamente mediante pesquisas descritiva qualitativa, bibliográfica, documental e trabalho de campo, buscou traçar simetrias e assimetrias baseado nas experiências coletadas em empresa farmacêutica global e instituição de referência nacional pública do campo de incorporação tecnológica em saúde. Como resultados, são explicitados pontos-chave para o fortalecimento técnico e político do Complexo Econômico-Industrial da Saúde, por meio da revisão organizacional das Ippis quanto a aspectos de inovação e de gestão, culminado na promoção de melhorias na Política de ciência, tecnologia e inovação em resposta ao desafio da sustentabilidade, efetividade e acesso no SUS.
ABSTRACT The technological scenario in the field of health is an alarming fact, especially in the context caused by COVID-19. In this context, the Oswaldo Cruz Foundation, through the Bio-Manguinhos Unit, and the Butantan Institute were protagonists for universal access, dialoguing with international strategies. In the strategic discussion for Public Institutions of Production and Innovation in Health (IPPIS), the use of guidelines of the Technological Assessment in Health stands out as a way of paradigmatic change for the introduction of technologies in the Unified Health System (SUS) in line with the vision of future innovation in health in accordance with national demands. This article, methodologically developed through qualitative descriptive research, bibliographical, documentary and field work, sought to trace symmetries and asymmetries based on the experiences collected in a global pharmaceutical company and a public national reference institution in the field of technological incorporation in health. As a result, key points are explained for the technical and political strengthening of the Health Economic-Industrial Complex, through the organizational review of the IPPIS regarding innovation and management aspects, culminating in the promotion of improvements in the science, technology and innovation policy in response to the challenge of sustainability, effectiveness and access in the SUS.
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Resumen Introducción : Conocer las características del mercado farmacéutico permite obtener información sensible para entender la oferta, la demanda y el acceso de la pobla ción a los medicamentos. Con el objetivo de aportar da tos primarios respecto a la comercialización de fármacos en Argentina, se desarrolló la siguiente investigación. Métodos : Se trata de un estudio descriptivo cuanti tativo-cualitativo transversal del mercado farmacéutico argentino, tomando en cuenta 30 años de información oficial aportada por la Agencia Reguladora Nacional (ANMAT). Resultados : Se identificaron 216 laboratorios (182 nacionales) productores/importadores de medicamentos, 53 distribuidores y 479 droguerías (establecimientos de distribución de medicamentos al por mayor). Se detectó una alta concentración de la comercialización, agrupán dose el 90% de la misma, en solo 5 intermediarios. En el país existen actualmente 6670 productos/certificados, cantidad que fluctuó a lo largo de los últimos 30 años. Seis laboratorios son dueños de entre 116 y 208 certifica dos. El 84% de estos productos provienen de laboratorios nacionales, 5002 son monofármacos, mientras que el 83% se comercializa bajo un nombre de fantasía. Las tres principales indicaciones a las que se destina el registro de medicamentos en la Argentina son enfermedades del aparato digestivo, sistema nervioso, e infecciosas; el 58% es comercializado como formulaciones orales. Discusión : el presente trabajo muestra que el mer cado farmacéutico argentino tiene una participación mayoritaria de capitales nacionales, existiendo gran concentración en pocas empresas productoras y distri buidoras. Los productos son mayormente monodrogas comercializadas en forma oral y ofrecidas por su nombre de fantasía.
Abstract Introduction : Knowing the characteristics of the phar maceutical market allows obtaining sensitive informa tion to understand the supply, demand and access of the population to medicines. In order to provide primary data regarding the marketing of drugs in Argentina, the following research was performed. Method : This is a cross-sectional quantitative-quali tative descriptive study of the Argentine pharmaceutical market, taking into account 30 years of official information provided by the National Regulatory Agency (ANMAT). Results : Two hundred and sixteen laboratories (182 national) drug producers/importers, 53 distributors and 479 drugstores (wholesale drug distribution establishments) were identified. A high concentration of market ing was detected, grouping 90% in only 5 intermediaries. There are currently 6670 products/certificates in the country, an amount that fluctuated over the last 30 years. Six laboratories are owners of between 116 and 208 certificates; 84% of these products come from na tional laboratories, 5002 are mono-drugs, while 83% are marketed under a fancy name. The three main indica tions for which the registration of drugs in Argentina is intended are diseases of digestive system, nervous system and infectious diseases; 58% of the marketed products consist of oral formulations. Discussion : Based on data provided by this study, it is possible to assert that the Argentinian pharmaceutical market has a majority share of national capital, with a great concentration in a few pharmaceutical companies and distributors. The products are mostly available as non-combined drugs, in their oral form, and available by their brand names.
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Objetivo: caracterizar o acesso aos medicamentos anti-hipertensivos pelas pessoas com hipertensão arterial atendidas em uma unidade ambulatorial. Metodologia: estudo descritivo, quantitativo, desenvolvido com 103 pessoas com hipertensão arterial em uso de anti-hipertensivos. Os dados foram coletados por meio de questionário com perguntas sociodemográficas, sobre tratamento e acesso aos medicamentos anti-hipertensivos. Utilizou-se a estatística descritiva e teste qui-quadrado de Pearson ou exato de Fisher para análise dos dados. Resultados: Predominou a faixa etária de 50-69 (68,9%), sexo feminino (85,4%) e raça/cor autodeclarada preta (46,6%). Quanto ao acesso aos anti-hipertensivos, 70,9% relataram ter acesso gratuito, 60,2% os obtêm nas unidades de saúde, 65,7% não referiram dificuldades na aquisição e 86,4% que tinham acesso total. Todos os participantes que tinham dificuldade econômica também tinham dificuldade de acesso aos anti-hipertensivos. Verificou-se associação significativa entre a dificuldade de acesso aos anti-hipertensivos com forma de acesso (total ou parcial), quantidade de drogas e disponibilidade do medicamento nas farmácias (p<0,005). Conclusão: observou-se que, embora a maioria dos participantes do estudo não encontre dificuldades para obtenção dos anti-hipertensivos nas farmácias das unidades básicas de saúde, ainda assim, existe uma parcela da população sem acesso total aos anti-hipertensivos de forma gratuita, sendo essencial melhorias dos programas de fornecimento de medicamentos.
Objective: to characterize access to antihypertensive drugs by patients with arterial hypertension treated at an ambulatory unit. Methodology: descriptive, quantitative study, developed with a group of 103 people with arterial hypertension currently using antihypertensive drugs. The data were collected through a questionnaire with sociodemographic questions, with respect to treatment and access to antihypertensive drugs. Descriptive statistics and Pearson's chi-square test or Fisher's exact test were used for data analysis. Results: the age group 50-69 (68.9%), female (85.4%) and black self-declared race (46.6%) predominated. Regarding access to antihypertensive drugs, 70.9% reported having free access, 60.2% obtained them at health units, 65.7% did not mention difficulties in acquiring them and 86.4% that had full access. All participants who had economic difficulties also had difficulty accessing antihypertensive drugs. It was identified a significant association between difficulty in accessing antihypertensive drugs and the means of access (total or partial), quantity of drugs and availability of the drug in pharmacies (p<0.005). Conclusion: it was observed that, that most of the study participants did not find it difficult to obtain antihypertensive drugs in the pharmacies of basic health units, notwithstanding, there is a portion of the population without full access to antihypertensive drugs free of charge, improvements in drug supply programs are essential.
Subject(s)
Humans , Female , Middle Aged , Aged , Health Centers , Academic Medical Centers , Medication Adherence , Access to Essential Medicines and Health Technologies , Hypertension , Antihypertensive Agents , Epidemiology, Descriptive , Evaluation Studies as TopicABSTRACT
Patients with rare diseases frequently face unmet medical needs due to the high costs, lengthy development times, and slow approval processes for new treatments. This case study discusses innovative access alternatives for rare diseases in Brazil, focusing on early access to pabinafusp-alfa for mucopolysaccharidosis type II (MPS-II), a rare genetic lysosomal storage disease characterized by a deficiency of the enzyme iduronate-2-sulfatase. From September 2018 to March 2023, 20 Brazilian MPS-II patients received pabinafusp-alfa through a clinical research protocol. This enzyme replacement therapy (ERT) crosses the blood-brain barrier to address central nervous system manifestations unmet by existing treatments. Patients' participation in the clinical study resulted in an estimated BRL 65 million in cost savings for the public healthcare system compared to conventional ERT with idursulfase-alfa and potentially better clinical outcomes. The case study underscores the importance of innovative mechanisms in addressing patients' medical needs. Early access alternatives include: a) clinical study access, with execution/development aligned with healthcare managers and linked to future access strategies; b) regulatory-level risk-sharing, considering effectiveness uncertainties and the possibility of market withdrawal and/or reimbursement in case of negative results; and c) drug pre-delivery, with payment contingent on positive phase III clinical study outcomes. Although public-private partnerships in clinical research are underused, they could benefit all stakeholders by accelerating drug development, facilitating early patient access to innovative medicines, and generating healthcare system savings, particularly for rare diseases.
Pacientes com doenças raras frequentemente enfrentam necessidades médicas não atendidas devido aos altos custos, longos tempos de desenvolvimento e processos de aprovação lentos para novos tratamentos. Este estudo de caso discute alternativas inovadoras de acesso para doenças raras no Brasil, com foco no acesso precoce ao alfapabinafuspe para mucopolissacaridose tipo II (MPS-II), uma doença lisossômica de armazenamento genético rara, caracterizada por uma deficiência da enzima iduronato-2-sulfatase. De setembro de 2018 a março de 2023, 20 pacientes brasileiros com MPS-II receberam alfapabinafuspe por meio de pesquisa clínica. Essa terapia de reposição enzimática (TRE) atravessa a barreira hematoencefálica para tratar manifestações do sistema nervoso central não atendidas pelos tratamentos existentes. A participação dos pacientes no estudo clínico resultou em uma economia estimada de 65 milhões de reais para o sistema público de saúde, em comparação com a TRE convencional com idursulfase alfa, além de potencialmente melhores resultados clínicos. O estudo de caso destaca a importância de mecanismos inovadores no atendimento das necessidades médicas dos pacientes. As alternativas de acesso precoce incluem: a) acesso por meio de estudos clínicos, com execução/desenvolvimento alinhada aos gestores de saúde e vinculada a estratégias futuras de acesso; b) compartilhamento de risco em nível regulatório, considerando as incertezas de eficácia e a possibilidade de retirada do mercado e reembolso em caso de resultados negativos; e c) pré-entrega do medicamento, com pagamento condicionado aos resultados positivos do estudo clínico de fase III. Embora as parcerias público-privadas em pesquisa clínica sejam subutilizadas, elas poderiam beneficiar todas as partes interessadas ao acelerar o desenvolvimento de medicamentos, facilitar o acesso precoce dos pacientes a medicamentos inovadores e gerar economias para o sistema de saúde, especialmente para doenças raras.