Advances in Pharmacoepidemiology and Drug Safety最新文献

{"title":"Statins Cardiovascular Benefits Outweigh their Diabetogenicity: A Direct Comparison between Number Needed to Treat and Number Needed to Harm","authors":"Shimoyama S","doi":"10.4172/2167-1052.1000185","DOIUrl":"https://doi.org/10.4172/2167-1052.1000185","url":null,"abstract":"Backgrounds: Although there are several metaanalyses showing that the risk of new onset diabetes mellitus (NODM) is more increased in statin or higher dose statin users than placebos or lower dose statin users, a small increase in the risk of NODM would be outweighed by the improved cardiovascular outcomes. However, these metaanalyses are accompanied by limitations of the inclusion of the studies with confounders. The aim of this study is to elucidate the risk-benefit balance by investigating the number needed to treat (NNT) and number needed to harm (NNH) in a simultaneous comparison according to the individual trial-based criteria of NODM and cardiovascular events. \u0000Methods: A systematic review of the literature retrieves 6 randomized controlled trials (RCTs) comparing statins vs. placebos and 5 RCTs comparing higher vs. moderate doses of statin. Only RCTs which documented the number of patients who developed DM and who experienced cardiovascular events are included. \u0000Results: NNH is consistently larger than NNT in trials of statin use vs. placebos, or in trials of higher vs. moderate dose. Furthermore, the benefit-risk ratios are consistently greater than 1 in most trial. \u0000Conclusions: These results suggest that the absolute risk of NODM by statin is offset by the benefit for reducing cardiovascular events. The evaluation of an individual trial-based risk-benefit balance could resolve the limitations of previous studies as well as provide further reinforced evidence that the merit of statin use for the purpose of lowdensity lipoprotein cholesterol lowering outweighs the NODM risk.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"317 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2015-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77849717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Indian Pharmacopoeia Commission's Partners for Promoting Public Health","authors":"Kalaiselvan, R. Kumar, Gyanendra Nath Singh","doi":"10.4172/2167-1052.1000181","DOIUrl":"https://doi.org/10.4172/2167-1052.1000181","url":null,"abstract":"In order to promote the awareness and to monitor the adverse drugs reactions, one of the most noteworthy nation-wide programme initiated by IPC on 15th April 2011 under the aegis of Central Drugs Standard Control Organization (CDSCO), is Pharmacovigilance Programme of India (PvPI). IPC is a National Coordination Centre (NCC) for PvPI, meant for protecting the health of the public by assuring medicines safety. PvPI monitors the benefitrisk profile of medicines & generate independent, evidence based recommendations on safety of medicines & support CDSCO for formulating safety related regulatory decisions for medicines. \u0000With a view to establish a centre of excellence for pharmacovigilance in India, NCC-PvPI collaborated with the WHO-Uppsala Monitoring Centre (UMC), Sweden & participating in International Drug Monitoring Programme & now become a significant contributor for the global drug safety database. The WHO country office for India coordinates with NCC-PvPI in terms of providing technical support for organizing training programmes, awareness programmes,meetings and updating PV toolkit etc. \u0000PvPI has been continuously taken several steps for ensuring patient safety and well being of society, in this regards PvPI expanded its patient safety programme to 150 AMCs across the country & also collaborated with different National Health Programme (AEFI, NACO, RNTCP) as it has been always preeminent to established safety and efficacy of medicines used in these NHP(s). As consumers / patients are the important allies for any country's pharmacovigilance programme, PvPI has taken step towards encouraging consumers reporting by the release of medicines side effect reporting form for consumers in different regional languages. \u0000For the last two decades, pharmacovigilance has been gaining an increasing attention. It is now, high time for national authorities, multilateral agencies, nongovernmental organizations, healthcare institutions, pharmaceutical industries & lay public to work together for the effective implementation of PvPI across the country.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"2 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2015-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90316091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Direct Consumer Reporting of ADRs to PvPI, a Position Paper of Indian Pharmacopoeia Commission","authors":"M. Kalaivani, Kalaiselvan, K. Dabhi, G. Singh","doi":"10.4172/2167-1052.1000184","DOIUrl":"https://doi.org/10.4172/2167-1052.1000184","url":null,"abstract":"Patients/consumers are end user of medicines and should play important role in reporting the Adverse Drug Reactions (ADRs) to pharmacovigilance system. Consumers can provide detailed first-hand in formation about their experiences with medicines and how these medicines have affected their life. Direct consumer reporting leads to earlier identification and accumulation of signals and may provide neglected details related to psychiatric feelings and quality of life. Consumers may report ADRs due to “over the counter” (OTC) medicines, herbal medicines, and ADRs related to excipients and potential interactions. Direct patient/ consumer reporting will also rectify the under-reporting by patients to physician and will change the attitude related to importance of patient’s experience. NCC-PvPI (National Coordination Centre-Pharmacovigilance Programme of India), IPC (Indian Pharmacopoeia Commission) had launched “Medicines Side Effect Reporting form for Consumer” (blue form) at the National level conference on “Participation of patient/consumer organization in PvPI” on 1st August, 2014, which encourages patient or his/her representative (relative) to report ADRs directly either by submitting the form to the NCC-PvPI or to the nearest AMC (Adverse Drug Reaction Monitoring Centres) under PvPI. Consumers can also reports through toll free helpline number: 1800-180-3024 or email id: pvpi.compat@gmail.com to NCC-PvPI.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"40 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2015-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73170619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antimicrobial (Drug) Resistance","authors":"Rompikuntal Pk, Garlapati S","doi":"10.4172/2167-1052.S2-001","DOIUrl":"https://doi.org/10.4172/2167-1052.S2-001","url":null,"abstract":"","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"34 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82737575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review on Antibiotic Resistance","authors":"E. Crouch, L. Dickes, A. Kahle","doi":"10.4172/2167-1052.1000183","DOIUrl":"https://doi.org/10.4172/2167-1052.1000183","url":null,"abstract":"Antibiotic resistance is the ability of bacteria and other microbes to resist the effects of an antibiotic. A primary characteristic of antibiotics is that they lose their effectiveness over time. In the last twenty years, the number of antibiotic classes and analogues in development has not kept pace with antibiotic resistance. Appropriate use of existing classes of antibiotics could improve the lifespan of these drugs. The side effects of antibiotic resistance include reduced patient outcomes and increasingly potent disease states. New government task forces have been developed to increase the level of research and federal involvement into this growing public health problem.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"46 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2015-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79757492","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In Vitro Antischistosomal Activity and Cytotoxicity of 5-Methoxylated Flavones fom Vochysia divergens, a Flood-Adapted Species from Brazilian Pantanal","authors":"L. P. Pimenta, K. Lc, Rhavena Graziela Liotti, M. Soares, Daniela P. Aguiar, M. Lg, P. F. Oliveira, D. Tavares, Andrade Ml, W. Cunha, P. Pauletti, J. Ah","doi":"10.4172/2167-1052.1000182","DOIUrl":"https://doi.org/10.4172/2167-1052.1000182","url":null,"abstract":"Background: Vochysia divergens is native to the Amazon Basin and considered an invasive species in the Brazilian Pantanal. In this work, the ethanolic extract of V. divergens leaves was chemically investigated and evaluated in vitro against Schistosoma mansoni adult worms together with the isolated compounds. \u0000Methods: The samples were available at concentrations of 12.5, 25, 50 and 100 μM. The parasites were kept for 4 days and monitored every 24 h to evaluate their viability and motor activity comparing with the positive control praziquantel. The cell viability of isolated flavones as determined by XTT assays in V79 cells. \u0000Results: The flavones 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside, 5-methoxy luteolin and 3′,5-dimethoxy luteolin were isolated from V. divergens. Flavone 5-methoxy luteolin caused the death of 25% of male and female adult S. mansoni worms in 24 h at 100 μM and also reduced their motor activity. Flavones 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside and 3′,5-dimethoxy luteolin were able to slightly reduce the motor activity to 25% within 24 \u0000h at 25 μg/mL and 12.5 μg/mL, respectively, but only in male worms. The results were compared with the flavone luteolin. For XTT assay in V79 cells the IC50 values were 1468.4 ± 10.5 μM, 5946.6 ± 25,1 μM, > 7960.8 μM and 270.6 ±9.3 μM for compounds 3′,5-dimethoxy luteolin-7-O-β-glucopyranoside, 5-methoxy luteolin, 3′,5-dimethoxy luteolin and luteolin, respectively. \u0000Conclusion: To the best of our knowledge, flavones 5-methoxy luteolin and 3′,5-dimethoxy luteolin are reported for the first time as constituents of V. divergens and the Vochysiaceae family.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"24 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2015-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85579615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacoepidemiology and Drug Safety Concept: Indian Scenario","authors":"Patil Js","doi":"10.4172/2167-1052.1000E130","DOIUrl":"https://doi.org/10.4172/2167-1052.1000E130","url":null,"abstract":"The concept of Pharmacoepidemiology was come in existence in late seventies. It is a specialty which links both clinical pharmacology and epidemiology. This specialty ply important role in measurement of success or failure of drug therapy based on various factors which affect use of drugs by the community. In Indian scenario research in pharmacology an important medical specialty has suffered due to many reasons. Shortage of financial support from the administration of many medical colleges, difficulty in procuring and maintaining experimental animals or patients/healthy volunteers are the few reasons have literally pushed many researchers to choose pharmacoepidemiology as their area of research. It doesn’t mean that Indian pharmacologists are really having research interest in this sub specialty. It is more for reasons of convenience rather than that of genuine interest.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80099719","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Chemotherapy for Primary Adenocarcinoma of the Urinary Bladder: Case Report","authors":"W. Xu, B. Yu, T. Xu, Z. Xu, H. Cai, Q. Zou","doi":"10.4172/2167-1052.1000180","DOIUrl":"https://doi.org/10.4172/2167-1052.1000180","url":null,"abstract":"A 71-year-old man was admitted to the hospital because of frequent micturition, urgency of urination and vesical tenesmus for one month. For the recent one week, the symptoms above aggravated gradually, accompanied with indisposition and distention of lower abdomen. Cystoscopic examination revealed that the blister lesions which were transparent protruded into the hanging and lateral wall of the bladder. The pathological biopsy showed it was adenocarcinomas of the urinary bladder. The patient was treated with GC plus S-1 chemotherapy with a regular follow-up. The progress of the disease was evaluated according to the standard of curative effect of RECIST. Traditionally, GC is considered as first-line chemotherapy for urothilial cell carcinoma. In this study, we researched the efficacy of GC plus S-1 combination chemotherapy in the study.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"63 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2015-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79872387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developmental Expression of Calcium Activated Chloride Ion Channels Anoctamin 5 in Mouse Skeletal Muscle","authors":"Hai-yan Song, Yi-Min Zhang, Hui Lian, Li Zhou, Yue-Min Tian, Jin-Xia Zhu","doi":"10.4172/2167-1052.1000179","DOIUrl":"https://doi.org/10.4172/2167-1052.1000179","url":null,"abstract":"Anoctamin 5 (Ano5), also named TMEM16E, belongs to the Anoctamin gene family. The mutations in the \u0000Ano5 gene cause Limb-girdle muscular dystrophy (LGMD) 2L type and Miyoshi muscular dystrophy (MMD3). Both patients showed sarcolemmal lesions. The studies showed that TMEM16E mRNA expressed in the somites during embryogenesis, particularly in the myotomal cells, and also in the muscle myotome-derived progenitor cells. However, no report has been done to examine Ano5 expression during mouse skeletal muscle development. In the present study, we investigated the distribution and quantification of Ano5 in the skeletal muscles of mice during their development, with the methods of immunofluorescence, Reverse transcription-polymerase chain reaction (RT-PCR) \u0000and Western blot analyses. The results indicated that Ano5 mRNA and protein are expressed in skeletal muscle of the mouse from 1 day to 6 months, but with development and aging, the expression of Ano5 reduced gradually. Taken together, our results demonstrate that Ano5 expression level decreased throughout development and aging, and this may explain why the musculardystrophy syndrome of Ano5 mutant patients only starts during the later stage of their lives.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"33 1","pages":"136-140"},"PeriodicalIF":0.0,"publicationDate":"2015-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76272535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-Induced Pulmonary Edema and Acute Respiratory Distress Syndrome in Children","authors":"P. Magon","doi":"10.4172/2167-1052.1000178","DOIUrl":"https://doi.org/10.4172/2167-1052.1000178","url":null,"abstract":"Non-cardiogenic pulmonary edema, and to a lesser extent, Acute Respiratory Distress Syndrome (ARDS) are common clinical manifestations of drug-induced lung diseases. Clinical features and radiographic appearances are generally indistinguishable from other causes of pulmonary edema and ARDS. Typical manifestations include dyspnoea, chest discomfort, tachypnoea, and hypoxemia. Chest radiographs commonly reveal interstitial and alveolar filling infiltrates without cardiomegaly. The laboratory results are usually nonspecific. We illustrate potential aetiologies relating to ARDS and the recognition of mucolytic drug use as one of the pathophysiologic factors of ARDS.","PeriodicalId":7385,"journal":{"name":"Advances in Pharmacoepidemiology and Drug Safety","volume":"105 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2015-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80811464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}