RESUMEN
BACKGROUND: Non-small-cell lung cancer (NSCLC) is a major health burden in many countries. This review aimed to evaluate the efficacy of traditional herbal medicine (THM) combined with first-line platinum-based chemotherapy (PBCT) for the treatment of advanced NSCLC. METHODS: From inception to April 2021, relevant studies were retrieved from 9 electronic databases. Randomized controlled trials (RCTs) comparing survival outcomes of THMâ+âPBCT treatment with PBCT treatment in patients with advanced NSCLC were reviewed. The risk of bias was evaluated using the Cochrane Risk of Bias Tool. Overall survival, 1-year survival, progression-free survival or time to progression, tumor response rate, and adverse effects were analyzed. RESULTS: Sixteen RCTs comprising 1445 patients were included. The meta-analysis indicated that THMâ+âPBCT treatment, compared to PBCT alone, could improve overall survival (median survival ratioâ=â1.24, 95% confidence intervals [CI] [1.11, 1.39], Pâ<â.001), progression-free survival/time to progression (median survival ratioâ=â1.22, 95% CI [1.09, 1.37], Pâ<â.001), and the 1-year survival rate (risk ratio [RR]â=â1.56, 95% CI [1.31, 1.86], Pâ<â.001). THMâ+âPBCT also led to a higher tumor response rate (RRâ=â1.39, 95% CI [1.22, 1.59], Pâ<â.001) and lower incidence of thrombocytopenia (RRâ=â0.72, 95% CI [0.56, 0.92], Pâ=â.009) and nausea/vomiting (RRâ=â0.35, 95% CI [0.21, 0.57], Pâ<â.001), while there was no significant effect observed on leukopenia (RRâ=â0.68, 95% CI [0.34, 1.36], Pâ=â.27). CONCLUSION: THM, when used in combination with PBCT, might increase survival and the tumor response rate while decreasing the side effects caused by chemotherapy in patients with advanced NSCLC. However, considering the limited methodological qualities of the included trials, more rigorous RCTs are needed.
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Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Quimioterapia/normas , Medicina Tradicional/normas , Platino (Metal)/farmacología , Quimioterapia/métodos , Humanos , Medicina Tradicional/métodos , Platino (Metal)/uso terapéutico , Supervivencia sin Progresión , Análisis de SupervivenciaRESUMEN
PURPOSE: This study aimed to compare the functioning, symptoms, and quality of life (QoL) of patients with breast or colon cancer before and after their first-cycle (FC) chemotherapy. DESIGN: One-group pretest/posttest design. METHOD: The study utilized the standardized Arabic-translated Quality of Life Questionnaire Version 3 from the European Organization for Research and Treatment of Cancer in measuring the functioning, symptoms, and QoL of 120 Saudi patients diagnosed with breast or colon cancer. Dependent t test was used in analyzing the presence of significant differences in mean scores before and after chemotherapy with periods ranging from 14 days to 21 days following the treatment protocol. RESULTS: The findings revealed significant differences in the functioning, symptoms, and QoL among patients with breast or colon cancer before and after FC chemotherapy (p < .001). Baseline scores showed higher physical, role, emotional, cognitive, and social functioning; lesser symptoms; lower financial difficulties; and better overall global health status compared to post-FC chemotherapy. CONCLUSION: Assessing the QoL of patients with breast or colon cancer undergoing FC chemotherapy is essential to establish a holistic care plan in supporting and alleviating the unfavorable effects of chemotherapy and implement patient-centered interventions that aid in the enhancement of their overall QoL.
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Neoplasias de la Mama/tratamiento farmacológico , Neoplasias del Colon/tratamiento farmacológico , Quimioterapia/psicología , Calidad de Vida/psicología , Adulto , Quimioterapia/normas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psicometría/instrumentación , Psicometría/métodos , Arabia Saudita , Encuestas y CuestionariosRESUMEN
BACKGROUND: At present, the effect of western-medicine (WM) therapy to treat diabetic peripheral neuropathy (DPN) is limited. Moxibustion is a representative external treatment in traditional Chinese medicine that has been beneficial to DPN. We aim to systematically assess the efficacy and safety of moxibustion in treating DPN, following PRISMA guidelines. METHODS: Eight electronic databases were searched to acquire information on eligible trials published from inception to June 1, 2019. We included randomized controlled trials (RCTs) applying moxibustion therapy with a minimum of 14-days treatment duration for DPN patients compared with placebo, no intervention, or conventional WM interventions. The primary outcomes in our study include the sensory-nerve conduction velocity (SNCV) and motor-nerve conduction velocity (MNCV). We used the Cochrane Collaboration Risk of Bias tool to assess the methodological quality of eligible RCTs. Statistical analyses were conducted using Review Manager 5.3. Risk ratios (RR) and mean differences (MD) were calculated with a 95% confidence interval (CI). The χ test was applied to assess the heterogeneity. RESULTS: In total, 11 RCTs were included that involved 927 DPN patients. Compared with the control group, there was an increase in median MNCV (MDâ=â6.26, 95% CI 2.64-9.89, Zâ=â3.39, Pâ=â.0007) and peroneal MNCV (MDâ=â6.45, 95% CI 5.30-7.61, Pâ<â.00001). There was also an increase in median SNCV (MDâ=â6.64, 95% CI 3.25-10.03, Pâ=â.0001) and peroneal SNCV (MDâ=â3. 57, 95% CI 2.06-5.09, Zâ=â4.63, Pâ<â.00001) in the treatment groups. The treatment groups receiving moxibustion therapy indicated a more significant improvement in total effectiveness rate (RRâ=â0.25, 95% CI 0.18-0.37, Zâ=â7.16, Pâ<â.00001). Toronto Clinical Scoring System indicated a significant decrease in the treatment groups (MDâ=â-2.12, 95% CI -2.82 to 1.43, Pâ<â.00001). Only 1 study reported that treatment groups experienced no adverse reactions. The other 10 studies did not mention adverse events. CONCLUSIONS: Moxibustion therapy may be an effective and safe option for DPN patients but needs to be verified in further rigorous studies.
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Neuropatías Diabéticas/terapia , Medicina Tradicional China/métodos , Moxibustión/métodos , Conducción Nerviosa/efectos de los fármacos , Adulto , Anciano , Estudios de Casos y Controles , Bases de Datos Factuales , Quimioterapia/normas , Duración de la Terapia , Femenino , Humanos , Masculino , Medicina Tradicional China/efectos adversos , Persona de Mediana Edad , Moxibustión/efectos adversos , Conducción Nerviosa/fisiología , Nervio Peroneo/fisiopatología , Placebos/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Seguridad , Resultado del Tratamiento , Mundo OccidentalRESUMEN
We invited eleven experts in their fields to share their insights on the growing threats of antibiotic resistance, and how we, as a community, can address them.
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Antibacterianos/uso terapéutico , Programas de Optimización del Uso de los Antimicrobianos/métodos , Bacterias/efectos de los fármacos , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/microbiología , Farmacorresistencia Bacteriana , Quimioterapia/normas , Utilización de Medicamentos/normas , Infecciones Bacterianas/epidemiología , Terapia Biológica/métodos , Descubrimiento de Drogas/tendencias , Quimioterapia/métodos , Salud Global , Humanos , PrevalenciaRESUMEN
BACKGROUND: Medication use in people with dementia and/or cognitive impairment (PWD/CI) is challenging. As medication experts, pharmacists have an important role in improving care of this vulnerable population. OBJECTIVE: Systematically review evidence for the effectiveness of pharmacist-led interventions on quality use of medicines, quality of life, and health outcomes of PWD/CI. METHODS: A systematic review was conducted using MEDLINE, EMBASE, PsycINFO, Allied and Complementary Medicine (AMED) and Cumulative index to Nursing and Allied Health Literature (CINAHL) databases from conception to 20 March 2017. Full articles published in English were included. Data were synthesized using a narrative approach. RESULTS: Nine studies were eligible for inclusion. All studies were from high-income countries and assessed pharmacist-led medication management services. There was great variability in the content and focus of services described and outcomes reported. Pharmacists were found to provide a number of cognitive services including medication reconciliation, medication review, and medication adherence services. These services were generally effective with regards to improving quality use of medicines and health outcomes for PWD/CI and their caregivers, and for saving costs to the healthcare system. Pharmacist-led medication and dementia consultation services may also improve caregiver understanding of dementia and the different aspects of pharmacotherapy, thus improving medication adherence. CONCLUSION: Emerging evidence suggests that pharmacist-led medication management services for PWD/CI may improve outcomes. Future research should confirm these findings using more robust study designs and explore additional roles that pharmacists could undertake in the pursuit of supporting PWD/CI.
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Disfunción Cognitiva/tratamiento farmacológico , Demencia/tratamiento farmacológico , Quimioterapia , Farmacéuticos , Disfunción Cognitiva/psicología , Demencia/psicología , Quimioterapia/métodos , Quimioterapia/normas , Estado de Salud , Humanos , Mejoramiento de la Calidad/organización & administración , Calidad de la Atención de Salud/organización & administración , Calidad de VidaRESUMEN
PURPOSE: The administration of chemotherapy is a complex task which has many safety issues. Safe administration of chemotherapy by nurses should be evidence-based. The aim of this integrative review was to synthesise the evidence about education and practice requirements for safe administration of chemotherapy by nurses. METHOD: A systematic search of four databases identified 17 studies for inclusion in this review. Key words: Nurse, chemotherapy, cytotoxic drug, administration, safety, education. Data extracted from the studies included author, year, aims, design, sample, outcome measures and findings. After screening the articles, extracting study data and completing a summary table, critical appraisal of the studies was completed using the Mixed Methods Appraisal Tool (MMAT). RESULTS: All the studies focused on strategies to promote patient and nurse safety during nursing administration of chemotherapy. Content analysis identified five themes: governance, process safeguards, communication, interdisciplinary collaboration and education. Key strategies or interventions that increased patient and/or nurse safety identified were standardised computer-generated chemotherapy orders, barcodes, medication safety procedures, education and simulated learning. CONCLUSIONS: This review found low-level evidence exists about the education and safety requirements for nursing administration of chemotherapy. High-level research is needed to assist healthcare services to select evidence-based educational and safety strategies and provide appropriately resourced work environments to support the safe nursing administration of chemotherapy and deliver the best possible patient outcomes.
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Atención a la Salud/normas , Quimioterapia/normas , Personal de Enfermería en Hospital/educación , Enfermería Oncológica/educación , Enfermería Oncológica/normas , Seguridad del Paciente/normas , Adulto , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
Congenital heart disease (CHD) is the most common inborn defect. Due to advances in paediatric care, surgical, and catheter procedures the number of adults with CHD has grown remarkably in recent years. Most of these patients, however, have residua from their original operation/s and require life-long care, many of them are subjected to further haemodynamic and electrophysiological interventions during adulthood. While such re-do surgical or catheter interventions together with device therapy and transplantation play a key therapeutic role, increasingly, adults with CHD require drug therapy for late complications namely heart failure (HF), arrhythmias, pulmonary and systemic hypertension, thromboembolic events, etc. Unlike other cardiovascular areas, drug therapy in adult CHD is based on scarce clinical data and remains largely empiric. Consequently, pharmacological therapies are individualized to ameliorate patients' symptoms and/or degree of haemodynamic impairment. Thus far, recommendations have been difficult to make and formalized guidelines on drug therapy are lacking. We review herewith the rationale, limited evidence and knowledge gaps regarding drug therapy in this growing cardiovascular field and discuss pharmacotherapy options in specific conditions namely HF, arrhythmias, thrombosis, pulmonary arterial hypertension, contraception, and pregnancy.
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Arritmias Cardíacas/tratamiento farmacológico , Quimioterapia/métodos , Cardiopatías Congénitas/tratamiento farmacológico , Insuficiencia Cardíaca/tratamiento farmacológico , Adulto , Anticoncepción/ética , Anticoncepción/métodos , Quimioterapia/normas , Técnicas Electrofisiológicas Cardíacas/métodos , Femenino , Cardiopatías Congénitas/complicaciones , Cardiopatías Congénitas/fisiopatología , Insuficiencia Cardíaca/fisiopatología , Hemodinámica/efectos de los fármacos , Hemodinámica/fisiología , Humanos , Hipertensión/tratamiento farmacológico , Hipertensión Pulmonar/tratamiento farmacológico , Embarazo , Tromboembolia/tratamiento farmacológicoRESUMEN
Prescribing medications safely and effectively in older adults is a complex process. This review discusses challenges with medication prescribing in older adults and outlines a holistic approach to medication management in older adults. Well-known challenges including the alterations in pharmacokinetics and pharmacodynamics that often occur with aging are discussed. Other classic concerns including polypharmacy, potentially inappropriate medication use, prescribing cascades, suboptimal prescribing, paradoxical harm and unintended consequences of medications, and drug interactions are reviewed. Newer approaches, including deprescribing, pharmacogenomics, and the future potential for senolytic therapy are also discussed. All healthcare providers should consider these challenges when prescribing medications in older adults. Choosing a drug that fits both a patient's pathophysiology and biology, avoiding drugs with significant side effects, titrating doses, and deprescribing are all critical in optimizing medication therapy.
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Envejecimiento/patología , Quimioterapia/métodos , Polifarmacia , Pautas de la Práctica en Medicina , Anciano , Anciano de 80 o más Años , Comorbilidad , Quimioterapia/normas , Humanos , Pautas de la Práctica en Medicina/normas , Pautas de la Práctica en Medicina/tendenciasRESUMEN
Metabolomics is an analytical approach to metabolism and involves quantitative and comparative analysis of low-molecular-weight metabolites in body fluids or cellular/tissues extracts. Owing to its ability to reveal disease-specific metabolic patterns or metabolic changes produced in response to a therapeutic intervention; it is gaining widespread applications virtually in all aspects of biomedical and pharmaceutical research pertaining to human healthcare management. It has also started playing a strategic role in pharmacological and toxicological research for evaluating therapeutic efficacy/safety of promising drug candidates either alone or in conjunction with other omics tools such as genomics, transcriptomics and proteomics. The metabolic profiling capabilities of nuclear magnetic resonance (NMR) spectroscopy along with pattern recognition methods have successfully been applied for identifying a diagnostic panel of biomarkers, evaluating drug efficacy/safety, screening toxicity and disease mechanism. Particularly, the interest in applying NMR-based metabolomics for the assessment of therapeutic efficacy and safety is increasing among drug researchers and drug regulators owing to its nondestructive, non-selective and minimal sample preparation requirement. On top of this, it offers the potential for high-throughput (i.e. >100 samples a day is attainable) and provides highly reproducible results. In this review, we will discuss some of the recent developments related to NMR based metabolomics followed by some recent literature examples to highlight its potential in (a) the evaluation of therapeutic efficacy and safety of lead discovery compounds, (b) monitoring disease status and recovery after treatment and (c) identification and evaluation of biomarkers of systemic/organ-specific toxicity. Additionally, the review will also highlight its role to facilitate clinical trial testing and improve post-approval drug monitoring.
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Evaluación Preclínica de Medicamentos/métodos , Quimioterapia/normas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Espectroscopía de Resonancia Magnética/métodos , Metabolómica/métodos , Animales , Descubrimiento de Drogas , Humanos , Análisis Multivariante , FarmacocinéticaRESUMEN
Differentiated thyroid cancer (DTC) is a rare malignant disease, although its incidence has increased over the last few decades. It derives from follicular thyroid cells. Generally speaking, the prognosis is excellent. If treatment according to the current guidelines is given, cases of recurrence or persistence are rare. DTC requires special expertise by the treating physician. In recent years, new therapeutic options for these patients have become available. For this article we performed a systematic literature review with special focus on the guidelines of the American Thyroid Association, the European Association of Nuclear Medicine, and the German Society of Nuclear Medicine. For DTC, surgery and radioiodine therapy followed by levothyroxine substitution remain the established therapeutic procedures. Even metastasized tumors can be cured this way. However, in rare cases of radioiodine-refractory tumors, additional options are to be discussed. These include strict suppression of thyroid-stimulating hormone (also known as thyrotropin, TSH) and external local radiotherapy. Systemic cytostatic chemotherapy does not play a significant role. Recently, multikinase or tyrosine kinase inhibitors have been approved for the treatment of radioiodine-refractory DTC. Although a benefit for overall survival has not been shown yet, these new drugs can slow down tumor progression. However, they are frequently associated with severe side effects and should be reserved for patients with threatening symptoms only.
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Adenocarcinoma/terapia , Quimioterapia/normas , Radioterapia/normas , Neoplasias de la Tiroides/terapia , Adenocarcinoma/clasificación , Adenocarcinoma/diagnóstico , Adenocarcinoma/epidemiología , Adenocarcinoma Folicular/terapia , Carcinoma Papilar/terapia , Inhibidores Enzimáticos/uso terapéutico , Humanos , Radioisótopos de Yodo/normas , Radioisótopos de Yodo/uso terapéutico , Metástasis de la Neoplasia , Síndrome de Noonan/terapia , Pronóstico , Proteínas Tirosina Quinasas/efectos de los fármacos , Proteínas Tirosina Quinasas/efectos de la radiación , Radioterapia Adyuvante , Cáncer Papilar Tiroideo , Hormonas Tiroideas , Neoplasias de la Tiroides/clasificación , Neoplasias de la Tiroides/diagnóstico , Neoplasias de la Tiroides/epidemiología , Nódulo Tiroideo/diagnóstico , Tirotropina/uso terapéutico , Tiroxina/uso terapéuticoAsunto(s)
Quimioterapia/normas , Fatiga/tratamiento farmacológico , Lavandula/química , Aceites Volátiles/uso terapéutico , Dolor/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Educación Médica Continua , Femenino , Humanos , Masculino , Persona de Mediana EdadAsunto(s)
Quimioterapia/normas , Fatiga/tratamiento farmacológico , Lavandula/química , Aceites Volátiles/uso terapéutico , Dolor/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Educación Médica Continua , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
Poor adherence to treatment regimens has long been recognized as a substantial roadblock to achieving better outcomes for patients. Non-adherence to medications affects the quality and length of life and has been associated with negative health outcomes and increasing healthcare costs. The problem of non-adherence is particularly troublesome in older patients who are affected by multiple chronic diseases and for this reason receive multiple treatments. To date, no single intervention strategy has been shown to be effective in improving adherence across all patients, conditions, and settings. Between September and October 2014, a group of experts in geriatrics, pharmacology, epidemiology, and public health applied a modified RAND appropriateness method to reach a consensus on the possible best interventions to improve adherence in older individuals. Seven interventions were identified, classified based on their target (patient, therapy, and public health/society): (1) Comprehensive Geriatric Assessment, (2) patient (and caregiver) education to improve patient empowerment, (3) optimization of treatment, (4) use of adherence aids, (5) physician and other healthcare professionals' education, (6) adherence assessment, (7) facilitating access to medicine by service integration. For each intervention, experts assessed (a) target population, (b) health professionals potentially involved in the intervention, (c) strategies/instruments needed for implementation, and (d) time of the intervention. Interventions that target adherence must combine different approaches targeting the complex aspects of older adults in a holistic approach. Tackling non-adherence, with its complexity, requires a multi-stakeholder patient-centred approach acting in a defined framework of interactions in which the different players may provide different services but are integrated with one another.
Asunto(s)
Envejecimiento , Consenso , Quimioterapia/métodos , Evaluación Geriátrica , Cumplimiento de la Medicación/estadística & datos numéricos , Atención Dirigida al Paciente , Anciano , Anciano de 80 o más Años , Envejecimiento/psicología , Quimioterapia/normas , Quimioterapia/estadística & datos numéricos , Quimioterapia/tendencias , Educación Profesional/organización & administración , Personal de Salud/educación , Humanos , Italia , Persona de Mediana Edad , Educación del Paciente como Asunto/organización & administración , Atención Dirigida al Paciente/métodos , Atención Dirigida al Paciente/normas , Atención Dirigida al Paciente/tendenciasRESUMEN
In 2010, the Clinical and Laboratory Standards Institute (CLSI) lowered the MIC breakpoints for many beta-lactam antibiotics to enhance detection of known resistance amongEnterobacteriaceae The decision to implement these new breakpoints, including the changes announced in both 2010 and 2014, can have a significant impact on both microbiology laboratories and antimicrobial stewardship programs. In this commentary, we discuss the changes and how implementation of these updated CLSI breakpoints requires partnership between antimicrobial stewardship programs and the microbiology laboratory, including data on the impact that the changes had on antibiotic usage at our own institution.
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Antibacterianos/farmacología , Antibacterianos/uso terapéutico , Infecciones por Enterobacteriaceae/tratamiento farmacológico , Infecciones por Enterobacteriaceae/microbiología , Enterobacteriaceae/efectos de los fármacos , Pruebas de Sensibilidad Microbiana/normas , Quimioterapia/métodos , Quimioterapia/normas , Utilización de Medicamentos/normas , Humanos , beta-Lactamas/farmacología , beta-Lactamas/uso terapéuticoRESUMEN
OBJECTIVE: To describe the practical aspects of the use of the most commonly prescribed drugs during the postpartum period, the dietetic measures and the management of breast-feeding in case of addictive behaviors. METHODS: Review of the literature between 1972 and May 2015 from the databases Medline, Google Scholar, Cochrane Library, and international recommendations of learned societies. RESULTS: The precaution to stop breast-feeding when drugs are necessary is not justified in many situations (professional consensus). Aspirin at antiaggregant dose is allowed during breast-feeding while high doses are not recommended; NSAIDs with short half-life can be used (professional consensus). Precautions are needed in cases of use of morphonics (professional consensus). There is no justification to delay the initiation of breast-feeding in case of locoregional or general analgesia or for caesarean section. Antibiotic treatment does not justify discontinuing breast-feeding (professional consensus). Anxiolytics of the class of antihistaminic sedating H1 such as hydroxyzine (Atarax®) should not be prescribed in case of breast-feeding (professional consensus). Imaging does not justify to stop breast-feeding (professional consensus). Tobacco consumption is discouraged but is not a contraindication to breast-feed (professional consensus). It is recommended to avoid the consumption of alcohol (professional consensus). In case of occasional and moderate consumption of alcohol, delaying breast-feeding for a minimum of two hours is recommended (professional consensus). Cocaine consumption is a contraindication of breast-feeding (professional agreement), and breast-feeding is not recommended in case of cannabis use (professional consensus). CONCLUSION: Few drug treatments are not compatible with breast-feeding that can be continued in most of the cases.
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Lactancia Materna , Dietética , Quimioterapia/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Trastornos Relacionados con Sustancias , Lactancia Materna/métodos , Dietética/normas , Quimioterapia/normas , Femenino , Humanos , Recién Nacido , Preparaciones Farmacéuticas/administración & dosificación , Periodo Posparto/fisiología , Pautas de la Práctica en Medicina/normas , Pautas de la Práctica en Medicina/estadística & datos numéricos , Embarazo , Trastornos Relacionados con Sustancias/tratamiento farmacológico , Trastornos Relacionados con Sustancias/epidemiologíaRESUMEN
The stable and controllable quality of decoction pieces is an important factor to ensure the efficacy of clinical medicine. Considering the dilemma that the existing standardization of processing mode cannot effectively eliminate the variability of quality raw ingredients, and ensure the stability between different batches, we first propose a new strategy for Chinese medicine processing technologies that coupled with individuation processed and cybernetics. In order to explain this thinking, an individual study case about different grades aconite is provided. We hope this strategy could better serve for clinical medicine, and promote the inheritance and innovation of Chinese medicine processing skills and theories.
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Química Farmacéutica/normas , Cibernética/normas , Medicamentos Herbarios Chinos/química , Química Farmacéutica/métodos , Quimioterapia/normas , Medicamentos Herbarios Chinos/normas , Medicamentos Herbarios Chinos/toxicidad , Humanos , Control de CalidadRESUMEN
In the face of diminishing therapeutic options for the treatment of infections caused by multidrug-resistant, Gram-negative bacteria, clinicians are increasingly using colistin and polymyxin B. These antibiotics became available clinically in the 1950s, when understanding of antimicrobial pharmacology and regulatory requirements for approval of drugs was substantially less than today. At the 1st International Conference on Polymyxins in Prato, Italy, 2013, participants discussed a set of key objectives that were developed to explore the factors affecting the safe and effective use of polymyxins, identify the gaps in knowledge, and set priorities for future research. Participants identified several factors that affect the optimum use of polymyxins, including: confusion caused by several different conventions used to describe doses of colistin; an absence of appropriate pharmacopoeial standards for polymyxins; outdated and diverse product information; and uncertainties about susceptibility testing and breakpoints. High-priority areas for research included: better definition of the effectiveness of polymyxin-based combination therapy compared with monotherapy via well designed, randomised controlled trials; examination of the relative merits of colistin versus polymyxin B for various types of infection; investigation of pharmacokinetics in special patient populations; and definition of the role of nebulised polymyxins alone or in combination with intravenous polymyxins for the treatment of pneumonia. The key areas identified provide a roadmap for action regarding the continued use of polymyxins, and are intended to help with the effective and safe use of these important, last-line antibiotics.
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Antibacterianos/uso terapéutico , Colistina/uso terapéutico , Infecciones por Bacterias Gramnegativas/tratamiento farmacológico , Polimixina B/uso terapéutico , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Antibacterianos/farmacología , Ensayos Clínicos como Asunto , Colistina/administración & dosificación , Colistina/efectos adversos , Colistina/farmacología , Quimioterapia/métodos , Quimioterapia/normas , Humanos , Italia , Pruebas de Sensibilidad Microbiana/normas , Polimixina B/administración & dosificación , Polimixina B/efectos adversos , Polimixina B/farmacología , Resultado del TratamientoRESUMEN
The purpose of this investigation was to describe the effect of antibacterial stewardship and evaluate the trends and correlation of antibacterial resistance and usage from 2009 to 2013 in a tertiary-care teaching hospital in northwest China. Antibacterial usage was expressed as defined daily doses per 100 patients per day (DDDs/100 PDs). Hospital-wide population-level data and time series analysis were used to evaluate the trends and determine associations between antibacterial exposure and acquisition of resistance. Yearly consumption of overall antibacterials significantly decreased from 66.54 to 28.08 DDDs/100 PDs (ß = -10.504, p < 0.01). The resistant rates of the five most frequently isolated species (including Escherichia coli, Acinetobacter baumannii, Staphylococcus aureus, Pseudomonas aeruginosa, and Klebsiella pneumoniae) significantly decreased or remained stable, and none of them showed a statistically significant upward trend. The medical quality indicators got better or remained stable. Autoregressive integrated moving average (ARIMA) models demonstrated that the monthly resistance rate of P. aeruginosa to imipenem was strongly correlated with antipseudomonal carbapenems usage (ß = 34.94, p < 0.001), as did the correlation of P. aeruginosa to meropenem with antipseudomonal third-generation cephalosporins usage (ß = 32.76, p < 0.01) and K. pneumoniae to amikacin with aminoglycosides usage (ß = 22.01, p < 0.001). The decreased antibacterial use paralleled the improved bacterial resistance without deteriorating medical quality indicators during antimicrobial stewardship. It also suggests that optimum antibiotic use is necessary to alleviate the threat posed by resistant microorganisms at the hospital level.
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Antibacterianos/uso terapéutico , Bacterias/efectos de los fármacos , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/microbiología , Farmacorresistencia Bacteriana , Quimioterapia/normas , Utilización de Medicamentos/normas , Bacterias/aislamiento & purificación , Infecciones Bacterianas/epidemiología , China , Prescripciones de Medicamentos/normas , Quimioterapia/métodos , Política de Salud , Hospitales de Enseñanza , Humanos , Pruebas de Sensibilidad Microbiana , Política Organizacional , Prevalencia , Centros de Atención Terciaria , Factores de TiempoRESUMEN
Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.