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RESUMEN Introducción: los medicamentos de alto costo son medicamentos nuevos, altamente específicos y utilizados en condiciones clínicas complejas, como el tratamiento de algunos tipos de cáncer; enfermedades que comprometen el sistema inmunológico, enfermedades inflamatorias o infecciosas. Objetivo: determinar cumplimiento del plan de consumo de los medicamentos de alto costo en la provincia de Matanzas, en el quinquenio 2012-2017. Materiales y métodos: estudio descriptivo, observacional de seguimiento sobre el cumplimiento del plan de consumo de los medicamentos de alto costo, en la población matancera del año 2012 al 2017. Se analizó el universo de medicamentos incluidos en esta categoría, a partir de la base de datos de suministro de medicamentos que emplea la Empresa Comercializadora de Medicamentos. Se identificaron las variables estudiadas. Resultados: en todo el período de estudio se observó un incremento creciente de los medicamentos de alto costo, en el 88,9 % de ellos el consumo ha estado por encima de la planificación realizada por la provincia. Los costos se incrementaron en un 233 % y además en las prescripciones realizadas de estos productos, se encontraron problemas como escaques vacíos, antibióticos sin impresión diagnóstica y omisión de la forma de presentación del medicamento y/o dosis indicada. Conclusiones: el consumo de muchos medicamentos de alto costo fue mayor que la planificación realizada en la provincia de Matanzas, durante el período analizado. Implicó un incremento significativo del presupuesto destinado a estos fines y se detectaron dificultades en el cumplimiento de lo establecido en las prescripciones de dichos medicamentos (AU).
ABSTRACT Introduction: high cost medications (HCM) are new highly specific medications and used in complex clinical conditions as in treatment of some types of cancer, diseases that compromise the immunological system, inflammatory or infections disorders. Objective: to determine the fulfillment of the consumption plan of high-cost medications in the province of Matanzas in the period 2012-2017. Materials and methods: a descriptive, observational, follow up study on the fulfillment of the consumption plan of high-cost medication by the population of Matanzas2012 year to 2017. The universe of drugs included in this category was analyzed on the bases of the drug-supplying database used by the Drug Commercializing Enterprise (ENCOMED in Spanish). The studied variables were identified. Results: it was observed a growing increase of high-cost drugs use during all the period; in 88.9 % of them the consumption has been above the planning made in the province. The costs increased in 233 %, and besides that in the prescriptions made of these drugs there were found problems like empty boxes, antibiotics without diagnostic impression and omissions of the drug presentation forms and/or the prescribed doses. Conclusions: the consumption of many high-cost drugs was higher than the planning made in the province of Matanzas for the analyzed period. It implied a significant increase of the budget destined for these aims and difficulties were found in the fulfillment of the terms for prescribing these drugs (AU).
Subject(s)
Humans , Male , Female , Drug Costs/standards , Drug and Narcotic Control/methods , Pharmacy and Therapeutics Committee/standards , National Drug Policy , Antineoplastic Agents/administration & dosageABSTRACT
The Asiatic pit vipers from the Trimeresurus complex are medically important venomous snakes. These pit vipers are often associated with snakebite that leads to fatal coagulopathy and tissue necrosis. The cytotoxic venoms of Trimeresurus spp.; however, hold great potential for the development of peptide-based anticancer drugs. Methods: This study investigated the cytotoxic effect of the venom from Trimeresurus purpureomaculatus, the mangrove pit viper (also known as shore pit viper) which is native in Malaysia, across a panel of human cancer cell lines from breast, lung, colon and prostate as well as the corresponding normal cell lines of each tissue. Results: The venom exhibited dose-dependent cytotoxic activities on all cell lines tested, with median inhibition concentrations (IC50) ranging from 0.42 to 6.98 µg/mL. The venom has a high selectivity index (SI = 14.54) on breast cancer cell line (MCF7), indicating that it is significantly more cytotoxic toward the cancer than to normal cell lines. Furthermore, the venom was fractionated using C18 reversed-phase high-performance liquid chromatography and the anticancer effect of each protein fraction was examined. Fraction 1 that contains a hydrophilic low molecular weight (approximately 7.5 kDa) protein was found to be the most cytotoxic and selective toward the breast cancer cell line (MCF7). The protein was identified using liquid chromatography-tandem mass spectrometry as a venom disintegrin, termed purpureomaculin in this study. Conclusion: Taken together, the findings revealed the potent and selective cytotoxicity of a disintegrin protein isolated from the Malaysian T. purpureomaculatus venom and suggested its anticancer potential in drug discovery.(AU)
Subject(s)
Animals , Trimeresurus , Disintegrins , Cytotoxicity, Immunologic , Neoplasms , Viper Venoms , Antineoplastic AgentsABSTRACT
The inhibiting mechanisms of brucine to cancer cells included inducing the apoptosis of cancer cells, inhibiting the proliferation of cancer cells, preventing cell adhesion and transfer. This paper reviews the function of brucine and its anti-tumor preparations, and compares the efficacy and adverse reactions between brucine related preparations and traditional drugs to evaluate its anti-tumor effects. Furthermore, more exploration on the inhibiting mechanisms is necessary for the patients to obtain safe and effective drugs.
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Molecular target therapy plays an important role in the treatment of malignant tumor.But research and development progress is slow on drugs targeting ovarian cancer.Only bevacizumab and olaparib have been approved for treating ovarian cancer by the FDA or the EMA,and their clinical application is limited.In recent years,there have been more and more reports on molecular tar?get therapy of ovarian cancer.Research advances have been made on novel drugs targeting E3 ubiquitin ligase,VEGF/VEGFR signal?ing pathways,PD-1/PD-L1 signaling pathways,IL-6/IL-6R signaling pathways and macrophage migration-inhibitory factor.This arti?cle briefly summarizes the current progresses in studies of molecular target therapy in ovarian cancer.
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Objetivos: Identificar aquellos factores que impactan en la respuesta terapéutica para alcanzar una segunda remisión (2 RC) en pacientes con leucemia aguda linfobl´stica (LAL) en recaída. Métodos: Estudio observacional y analítico anidado en una cohorte retrospectiva de adultos (>18 años) portadores de LAL que fueron atendidos durante 2008-2014 y que interrumpieron el protocolo HGMLAL07 al detectarse recaída e iniciaron otro esquema. Resultados: Se estudiaron 69 pacientes y el 62,3% (n = 43) correspondía a hombres. La media de edad fue de 29 años. Los regímenes terapéuticos empleados fueron: alta intensidad (55,1%) [Hyper-CVAD (n = 34), IDA-Flag (n = 1), mitoxantrona-DARAC (n = 3) ], moderada intensidad (4,3%) [Esquemas de reinducción (n = 3) ] y tratamiento paliativo de baja intensidad con soporte transfusional (40,6%, n = 28). Solo 19 pacientes (27,5%) integraron una 2 RC. La media de supervivencia fue 120 (2- 575) días y el 29% sobrevivió al año de seguimiento. El uso de un segundo régimen intensivo o moderado no brindó ventaja sobre el esquema conservador (prueba log-Rank, p = 0,812). Ninguna variable demostró valor pronóstico sobre la supervivencia a 1 año. La duración de la primera RC (OR 6,78, p = 0,005, 95% IC: 1,7532-26,2803) y recibir un primer tratamiento intensivo (OR 0,22, p = 0,018, 95% IC: 0,0661-0,7813) fueron variables pronósticas de falla terapéutica para alcanzar la 2 RC. Conclusiones: Poseer una primera RC < 1 año fue un factor de riesgo importante para no integrar una 2 RC. No se identificaron factores pronósticos de supervivencia ni superioridad de alguno de los esquemas de rescate empleados.
Aims: To identify those factors that affect therapeutic response to achieve a second remission (2 RC) in patients with acute lymphoblastic leukaemia (ALL) in relapse. Methods: Observational, descriptive and analytical study nested in a retrospective cohort of adults (> 18 years-old) ALL carriers treated during the period from 2008 to 2014 that disrupted the HGMLAL07 protocol when relapse was detected and began another therapeutic scheme. Results: The study included 69 patients, of whom 62.3% (n = 43) were males, and the mean age was 29 years-old. The therapeutic regimens used were: high intensity (55.1%) [Hyper-CVAD (n = 34), IDA-Flag (n = 1), mitoxantrone-DARAC (n = 3) ], moderate intensity (4.3%) [Re-induction schemes (n = 3) ], and palliative treatment of low intensity with transfusion support (40.6%, n = 28).Only 19 patients (27.5%) achieved a 2 RC. The median overall survival was 120 (2-575) days, 29% of patients were alive at one year. Using a high or moderate intensity regime as the rescue scheme gave no advantage over the conservative one (log-rank test, P = .812). None of the variables showed prognostic value of survival at one year. The duration of the first RC (OR 6.78, P = .005, 95% CI; 1.75 -26.28) and receiving high intensity treatment (OR 0.22, P = 018, 95% CI: 0.06 -0.78) were predictors of treatment failure to achieve 2 RC. Conclusions: To achieve a first RC < 1 year was an important risk factor for not achieving a 2 RC. No prognostic factors for survival were identified. None of the schemes used for rescue showed superiority.
Subject(s)
Humans , Male , Adult , Prognosis , Antineoplastic Combined Chemotherapy Protocols , Precursor Cell Lymphoblastic Leukemia-Lymphoma , Treatment Failure , SurvivorshipABSTRACT
Objective To investigate the application situation and analyze the main characters and developing tendency of anti‐neoplastic drugs in some hospital .Methods To collect the frequency and the consumption sum of anti‐neoplastic drugs used in this hospital during 2012-2013 .All the data were analyzed with pharmaco‐economic methods .Results Anti‐neoplas‐tic herb drugs occupied the leading position in some hospital .Kang'ai injection occupied the top of consumption sum .Ubenimex capsule occupied the top of DDDS and the bottom of DDC ,most of anti‐neoplastic drugs had DUI nearly 1 .Conclusion The u‐tilization of anti‐neoplastic drugs was basically reasonable ,herb drugs occupied the leading position in this hospital ,and herb drugs played a large role in tumor treatment .
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<b>Introduction</b>: Dermatological disorders are one of the adverse events caused by cancer chemotherapy and are a dose-limiting factor for some anti-neoplastic agents. The severe symptoms associated with these disorders affect the patients’ quality of life (QOL). Early countermeasures for the onset of dermatological disorders associated with anti-neoplastic agent administration might be important.<br><b>Materials and Methods: </b>We analyzed the occurrences of dermatological disorders after administration of an anti-neoplastic agent in the Food and Drug Administration Adverse Event Reporting System (FAERS), and compared the adverse event (AE) reporting ratio of the total reports. In addition, we studied the association between anti-neoplastic agents and dermatological disorders using cluster analysis. Reports for 15 anti-neoplastic agents (4 anti-neoplastic agents and 11 molecular target drugs) were analyzed.<br><b>Results: </b>After excluding duplicate data in FAERS, 6,157,897 reports were analyzed. The number of reports that showed a dermatological disorder was 534,934. The reporting ratio of hand-foot syndrome with sorafenib and capecitabine was 11.20% and 7.05%, respectively.<br><b>Conclusions: </b>We set the cluster number at six; cluster features obtained were as follows: (1) the reporting ratio of hand-foot syndrome was especially high, followed by the reporting ratio of rash, (2) the reporting ratio of rash and erythema was high. Similar anti-neoplastic agents may demonstrate similar occurrence tendencies of AEs and cluster features. Further studies are required to draw conclusions over these findings. Information services based on the feature of each cluster might be useful to improve patient QOL at the clinical site.
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O objetivo do estudo foi descrever a implantação, estruturação e desenvolvimento da prática de auditoria farmacêutica em uma operadora de planos de saúde de Fortaleza (OPS). Trata-se de um estudo descritivo do tipo estudo de caso, em que a unidade de análise foi uma OPS localizada em Fortaleza, capital do estado do Ceará (Brasil). Foram coletados e analisados dados qualitativos e quantitativos que corresponderam ao período de 2007 a 2010. Para a implantação da área de auditoria farmacêutica foi utilizada como primeira estratégia sua formalização na Diretoria de Recursos Médicos Hospitalares e na estrutura organizacional da OPS em janeiro de 2007. Com o reconhecimento do trabalho desenvolvido pela área, a equipe chegou em 2010 com dois farmacêuticos, dois assistentes de farmácia e cinco estagiários. O desenvolvimento da prática de auditoria farmacêutica resultou na exigência de pareceres técnicos para inclusão de medicamentos em tabela definida pela OPS e de solicitação para medicamentos de alto custo e de reserva terapêutica. A intervenção do farmacêutico, em seis meses de experiência, junto a pacientes em uso de antimicrobianos mostrou uma economia de R$ 279.153,80. A gestão de quimioterápicos resultou em uma economia total de R$ 2.502.278,31 para a OPS em 2009. Embora a auditoria farmacêutica envolva uma discussão recente, é preciso desde já, que aspectos relacionados à sua implantação, estruturação e desenvolvimento sejam apoiados, uma vez que essa prática ajuda na descrição e análise de elementos assistenciais e de gestão que envolve pacientes em tratamento farmacológico.
The purpose of this study was to describe the implantation, organization and development of pharmaceutical audit in a health insurance provider (HIP) in northeast Brazil. This is a descriptive case study in which the unit of analysis was an HIP located n Fortaleza, capital of Ceará State. Qualitative and quantitative data covering the period from 2007 and 2010 were collected and analyzed. In order to create the pharmaceutical auditing team, the first strategy used was to set up a section in the Hospital Medical Resources Directorate and in the managerial structure of the HIP, in January 2007. With the recognition of the work developed by the section, the team was amplified in 2010 with the arrival of two pharmacists, two pharmacy assistants and five trainees. The development of the practical aspects of pharmaceutical auditing revealed a need for technical opinions on the inclusion of medicines in the table defined by the HIP and requests for authorization in the case of high-cost medicines and those used in reserved therapy. The pharmacists intervention, over a six-month period, in the treatment of patients with antibiotics, yielded savings of R$ 279,153.80. The management of chemotherapy resulted in total savings of R$ 2,502,278.31 for the HIP in 2009. Although pharmaceutical auditing has only come out in recent discussions, there is an immediate need to support actions related to its implantation, organization and development, since this practice helps in describing and analyzing the healthcare and management features that involve patients under pharmacological treatment.
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Medical Audit/methods , Hospital Administration , Cost ControlABSTRACT
BACKGROUND/AIMS: To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). METHODS: Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. RESULTS: In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as 'unlikely' and 'unclassifiable', based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as 'serious' AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. CONCLUSIONS: The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.
Subject(s)
Humans , Male , Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Expert Testimony , Pharmacovigilance , Platinum Compounds , Product Labeling , Protein Kinase Inhibitors , Pyrimidines , Skin , Statistics as Topic , Taxoids , United States Food and Drug AdministrationABSTRACT
BACKGROUND/AIMS: To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). METHODS: Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. RESULTS: In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as 'unlikely' and 'unclassifiable', based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as 'serious' AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. CONCLUSIONS: The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.
Subject(s)
Humans , Male , Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Expert Testimony , Pharmacovigilance , Platinum Compounds , Product Labeling , Protein Kinase Inhibitors , Pyrimidines , Skin , Statistics as Topic , Taxoids , United States Food and Drug AdministrationABSTRACT
Objective:To investigate the safety and efficacy of a modified baseline BEACOPP regimen(bleomycin+etoposide+adriamycin+cyclophosphamide+vincristine+ procarbazine hydrochloride+ prednisone) in the treatment of advanced Hodgkin 's lymphoma (HL). Methods:From March 2006 to September 2008, 22 previously untreated patients with stages Ⅱ(bulky), Ⅲ and Ⅳ HL were treated with a modified baseline BEACOPP regimen. Each patient was scheduled to receive 6 to 8 cycles of BEACOPP with consolidation radiotherapy to bulky (≥5 cm) or residual disease.Results:There were 11 males and 11 females with a median age of 28 years (15 to 61 years old). Twelve patients (54.5%) had nodular sclerosis HL, and 10(45.5%) had mixed cellularity HL. There were 4 patients in stageⅡ, 7 in stage Ⅲ and 11 in stage Ⅳ. Sixteen patients (72.7%) achieved a complete remission (CR) and 5 patients (22.7%) had partial remission (PR). The total effective rate (CR+PR) was 95.5%. Among all kinds of clinical factors International Prognostic Score (IPS) had significant effect on CR rate (P=0.011). The 1-, 2- and 3-year total survival rates were the same (95.5%); the 1-, 2- and 3-year progression-free survival (PFS) rates were 72.7%, 53.1% and 53.1%, respectively;the 1-, 2- and 3-year disease-free survival rates were 85.9%, 76.4% and 76.4%,respectively. Univariate analysis showed that the gender, IPS and whether achieving CR had significant effects on PFS (P<0.05). The main toxic effects were bone marrow depression and liver injury. Three patients (13.6%) had grade Ⅲ drug-induced lung injury. No treatment-related death was observed.Conclusion:The modified baseline BEACOPP regimen was effective and safe for treatment of newly diagnosed patients with advanced HL.
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Healthcare workers are exposed to a variety of chemical agents used in many different areas and purposes. The chemicals could cause health problems to healthcare workers using them. Glutaraldehyde is a kind of disinfectant and used for endoscopes, catheters, and many kinds of operating apparatus. It may cause allergic contact dermatitis. Formaldehyde is another disinfectant and can be used for fixing tissues. Formaldehyde was classified to a Group 1 carcinogen by IARC and it may cause lung or nasal cancer. Ethylene Oxide gas is the most popular disinfectant these days and may be applied to many health care sets or linens. EO gas may cause allergic contact dermatitis and breast cancer or leukemia. It is also classified as Group 1 carcinogen despite limited evidence for human cancers. Anesthetics are related to genotoxicities, sister chromatid exchange, and might be related to spontaneous abortion, stillbirth or birth defects. Some of the anti-neoplastic drugs such as Busulfan, Chlorambucil, cyclophosphamide, melphalan are Group 1 carcinogens. They could cause nausea, pruritus, or decreasing leukocytes or platelets. Other miscellaneous chemical agents are heavy metals such as elementary mercury or lead and organic solvents such as toluene, xylene and acetone. Although some of these chemical agents including EO gas have occasionally exceeded to permissible level, air levels of most above chemicals in Korean hospitals were relatively low. However, we have to make every effort to reduce the exposure level of these chemicals.
Subject(s)
Female , Humans , Pregnancy , Abortion, Spontaneous , Acetone , Anesthetics , Bedding and Linens , Blood Platelets , Breast Neoplasms , Busulfan , Carcinogens , Catheters , Chlorambucil , Congenital Abnormalities , Cyclophosphamide , Delivery of Health Care , Dermatitis, Allergic Contact , Endoscopes , Ethylene Oxide , Ethylenes , Formaldehyde , Glutaral , Leukemia , Leukocytes , Lung , Melphalan , Metals, Heavy , Nausea , Nose Neoplasms , Pruritus , Sister Chromatid Exchange , Solvents , Stillbirth , Toluene , XylenesABSTRACT
Objective To investigate the effect of chemotherapy drugs on the expression of carci-noembryonic antigen (CEA) in the gastric tissue with precancerous lesions in ectopie cancer. Methods There were 45 cases of cancer patients (precancerous lesions group), the pathological biopsy showed that there were atypical hyperplasia or intestinal metaplasia by gastroscope before chemotherapy. Gastruscope was done before chemotherapy and after six cycles of chemotherapy. Gastric tissue was taken respectively in the same site. The expression of CEA was measured in the gastric tissue. Normal gastric tissue taken from 10 cases of cancer patients was served as control. Compared respectively the expression of CEA in the gastric tissue in control group and precancerous lesions group, in precancerous lesions group between before and after treatment. Results CEA expression in the gastric tissue was (27.76±9.67), (3.32±0.60)μg/L in precancerous lesions group and control group respectively, there was significant difference between two groups(P<0.05). CEA expression in the gastric tissue was (27.76±9.67), (26.60±10.80)μg/L before and after treatment in precancerous lesions group respectively, P<0.05. CEA expression in the gastric tissue before treatment was (23.11±4.11), (17.10±1.66)μg/L, after treatment was (21.11±5.66), (15.10±3.31)μg/L in the mild to moderate atypical hyperplasia, mild to moderate intestinal metaplasia respectively, there was significant difference between before and after treatment in the mild to moderate precancerous lesions. There was no significant difference between before and after treatment in the severe precancerous lesions. Conclusions Chemotherapy drugs can significantly reduce the expression of CEA in the gastric tis-sue in the mild to moderate precancerous lesions. The results suggests that mild to moderate precancerous lesions can be reversed.