Y. Potchoo, Mouhoudine Yérima, Tante T. Gnandi, M. Salou, Aboudoulatif Diallo, Batoyema Bakoma, A. Nyansa, M. Prince-david
Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets; 45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets; 44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.
{"title":"Analysis of Adverse Reactions Related to Drugs and Vaccines Received at the National Centre for Pharmacovigilance from 2009 to 2016 in Togo","authors":"Y. Potchoo, Mouhoudine Yérima, Tante T. Gnandi, M. Salou, Aboudoulatif Diallo, Batoyema Bakoma, A. Nyansa, M. Prince-david","doi":"10.4236/pp.2018.98027","DOIUrl":"https://doi.org/10.4236/pp.2018.98027","url":null,"abstract":"Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets; 45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets; 44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90569096","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}
Ryuichiro Hosoya, Ippei Tanaka, R. Ishii‐Nozawa, T. Amino, T. Kamata, Seiichi Hino, H. Kagaya, Y. Uesawa
Background: Hiccups are common somatic side effects of medication. Our previous analysis of the clinical risk factors for hiccups identified chemotherapy as a factor related to hiccup risk. Therefore, in the present study, we investigated the risk factors for hiccups associated with chemotherapy. Methods: We included all patients who received cancer chemotherapy and were hospitalized at the Musashino Red Cross Hospital between April 2014 and December 2014. We investigated patient demographics, physical characteristics, and other clinical factors to identify the risk factors for chemotherapy-induced hiccups (CIH). We conducted univariate and multivariable analysis to compare the CIH group and the non-CIH and determined risk factors of CIH. Results: Hiccups were identified in 48 of 292 patients with an incidence rate of 16.4%. Univariate analysis revealed that the male gender, pain, and nausea and vomiting were related to CIH. It also showed that cisplatin, pemetrexed, gemcitabine, etoposide, dexamethasone, and metoclopramide were related to CIH.A correlation which was found with doses of cisplatin, pemetrexed, gemcitabine, and etoposide. Multivariable analysis identified male gender (OR, 72.69; 95% CI, 6.95 - 757.64), nausea and vomiting (OR, 52.01; 95% CI, 3.93 - 447.13), dexamethasone (OR, 4.55; 95% CI, 1.12 - 16.91), cisplatin (OR, 3.84; 95% CI, 1.52 - 9.70), and etoposide (OR, 3.72; 95% CI, 1.14 - 12.11) as independent risk factors for hiccups. Conclusions: The present study is the first one to report risk factors for the development of CIH. Our results suggest that male gender, having nausea, and the drugs dexamethasone, cisplatin, and etoposide are important risk factors for CIH. These results may assist in elucidation of the underlying mechanisms and guide therapy to reduce hiccup risk.
{"title":"Risk Factors for Cancer Chemotherapy-Induced Hiccups (CIH)","authors":"Ryuichiro Hosoya, Ippei Tanaka, R. Ishii‐Nozawa, T. Amino, T. Kamata, Seiichi Hino, H. Kagaya, Y. Uesawa","doi":"10.4236/PP.2018.98026","DOIUrl":"https://doi.org/10.4236/PP.2018.98026","url":null,"abstract":"Background: Hiccups are common somatic side effects of medication. Our previous analysis of the clinical risk factors for hiccups identified chemotherapy as a factor related to hiccup risk. Therefore, in the present study, we investigated the risk factors for hiccups associated with chemotherapy. Methods: We included all patients who received cancer chemotherapy and were hospitalized at the Musashino Red Cross Hospital between April 2014 and December 2014. We investigated patient demographics, physical characteristics, and other clinical factors to identify the risk factors for chemotherapy-induced hiccups (CIH). We conducted univariate and multivariable analysis to compare the CIH group and the non-CIH and determined risk factors of CIH. Results: Hiccups were identified in 48 of 292 patients with an incidence rate of 16.4%. Univariate analysis revealed that the male gender, pain, and nausea and vomiting were related to CIH. It also showed that cisplatin, pemetrexed, gemcitabine, etoposide, dexamethasone, and metoclopramide were related to CIH.A correlation which was found with doses of cisplatin, pemetrexed, gemcitabine, and etoposide. Multivariable analysis identified male gender (OR, 72.69; 95% CI, 6.95 - 757.64), nausea and vomiting (OR, 52.01; 95% CI, 3.93 - 447.13), dexamethasone (OR, 4.55; 95% CI, 1.12 - 16.91), cisplatin (OR, 3.84; 95% CI, 1.52 - 9.70), and etoposide (OR, 3.72; 95% CI, 1.14 - 12.11) as independent risk factors for hiccups. Conclusions: The present study is the first one to report risk factors for the development of CIH. Our results suggest that male gender, having nausea, and the drugs dexamethasone, cisplatin, and etoposide are important risk factors for CIH. These results may assist in elucidation of the underlying mechanisms and guide therapy to reduce hiccup risk.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80341361","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}
R. Raffa, J. Pergolizzi, R. Taylor, Sanjib Choudhuri, Robert Rodenbeck
The most frequent adverse event in the healthcare delivery system is acquisition of an infection within a healthcare facility. Since infection control measures are known, simple, and low-cost, we examine why the problem of healthcare-associated infections persists. Hundreds of millions of patients each year are affected by a healthcare-associated infection, with negative medical outcome and financial cost. It is a major public health problem even in countries with advanced healthcare systems. This is a bit perplexing, given that hygienic practices have been known and actively promoted. The objective is to address the question: doesn’t the use of disinfection, sterilization, handwashing, and alcohol rubs prevent the spread of pathogenic organisms? We conclude that the persistent high prevalence of nosocomial infections despite known hygienic practices is attributable to two categories of factors: biological and inherent shortcomings of some practices (considered in Part 1), and human factors (considered in Part 2). A new approach is presented in Part 3.
{"title":"Persistence of Healthcare-Associated (Nosocomial) Infections Due to Inadequate Hand Hygiene: Part 1—Biological and Treatment Factors","authors":"R. Raffa, J. Pergolizzi, R. Taylor, Sanjib Choudhuri, Robert Rodenbeck","doi":"10.4236/PP.2018.98023","DOIUrl":"https://doi.org/10.4236/PP.2018.98023","url":null,"abstract":"The most frequent adverse event in the healthcare delivery system is acquisition of an infection within a healthcare facility. Since infection control measures are known, simple, and low-cost, we examine why the problem of healthcare-associated infections persists. Hundreds of millions of patients each year are affected by a healthcare-associated infection, with negative medical outcome and financial cost. It is a major public health problem even in countries with advanced healthcare systems. This is a bit perplexing, given that hygienic practices have been known and actively promoted. The objective is to address the question: doesn’t the use of disinfection, sterilization, handwashing, and alcohol rubs prevent the spread of pathogenic organisms? We conclude that the persistent high prevalence of nosocomial infections despite known hygienic practices is attributable to two categories of factors: biological and inherent shortcomings of some practices (considered in Part 1), and human factors (considered in Part 2). A new approach is presented in Part 3.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85394200","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}
R. Raffa, J. Pergolizzi, R. Taylor, Sanjib Choudhuri, Robert Rodenbeck
Compliance to hand-hygiene guidelines in healthcare facilities remains disappointingly low for a variety of human-factors (HF) reasons. A device HF-engineered for convenient and effective use even under high-workload conditions could contribute to better compliance, and consequently to reduction in healthcare-acquired infections. We present an overview of the efficacy of a passive hand-spray device that uses solubilized ozone—a strong, safe, non-irritant biocide having broad-spectrum antimicrobial properties—on glass surface, pigskin, and synthetic human skin matrix.
{"title":"Persistence of Healthcare-Associated (Nosocomial) Infections Due to Inadequate Hand Hygiene: Part 3—Application of Human Factors Engineering to an Ozone Hand Sanitizer","authors":"R. Raffa, J. Pergolizzi, R. Taylor, Sanjib Choudhuri, Robert Rodenbeck","doi":"10.4236/pp.2018.98025","DOIUrl":"https://doi.org/10.4236/pp.2018.98025","url":null,"abstract":"Compliance to hand-hygiene guidelines in healthcare facilities remains disappointingly low for a variety of human-factors (HF) reasons. A device HF-engineered for convenient and effective use even under high-workload conditions could contribute to better compliance, and consequently to reduction in healthcare-acquired infections. We present an overview of the efficacy of a passive hand-spray device that uses solubilized ozone—a strong, safe, non-irritant biocide having broad-spectrum antimicrobial properties—on glass surface, pigskin, and synthetic human skin matrix.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80963326","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}
R. Raffa, J. Pergolizzi, R. Taylor, Sanjib Choudhuri, Robert Rodenbeck
A healthcare-associated infection (defined as an infection acquired within a healthcare facility), such as due to transmission via medical equipment or by healthcare providers is the most frequent adverse event in the healthcare delivery system. But why does the problem persist, when infection control measures are known, simple, and low-cost? We reviewed some biological- and treatment-factors in Part 1, and we now review some human-factors. Healthcare-associated infections are a major public health problem even in advanced healthcare systems. They affect hundreds of millions of patients each year, and are responsible for increased morbidity, mortality, and financial burden. This is perplexing, since good-hygiene practices are known and promoted. Disinfection, sterilization, handwashing, and alcohol rubs should be more effective, but human-factors interfere. The persistent high prevalence of nosocomial infections, despite known hygienic practices, is attributable to two categories of factors: biological and inherent shortcomings of some practices (considered in Part 1), and human factors (considered here). A new approach is considered in Part 3.
{"title":"Persistence of Healthcare-Associated (Nosocomial) Infections Due to Inadequate Hand Hygiene: Part 2—Human Factors","authors":"R. Raffa, J. Pergolizzi, R. Taylor, Sanjib Choudhuri, Robert Rodenbeck","doi":"10.4236/PP.2018.98024","DOIUrl":"https://doi.org/10.4236/PP.2018.98024","url":null,"abstract":"A healthcare-associated infection (defined as an infection acquired within a healthcare facility), such as due to transmission via medical equipment or by healthcare providers is the most frequent adverse event in the healthcare delivery system. But why does the problem persist, when infection control measures are known, simple, and low-cost? We reviewed some biological- and treatment-factors in Part 1, and we now review some human-factors. Healthcare-associated infections are a major public health problem even in advanced healthcare systems. They affect hundreds of millions of patients each year, and are responsible for increased morbidity, mortality, and financial burden. This is perplexing, since good-hygiene practices are known and promoted. Disinfection, sterilization, handwashing, and alcohol rubs should be more effective, but human-factors interfere. The persistent high prevalence of nosocomial infections, despite known hygienic practices, is attributable to two categories of factors: biological and inherent shortcomings of some practices (considered in Part 1), and human factors (considered here). A new approach is considered in Part 3.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81058834","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}
Hyunjin Kim, Shin-Hee Kim, Semi Kim, Jae-Sung Ahn, Ju‐Seop Kang
The goal of our research was to compare the pharmacokinetics and evaluate the bioequivalence of two brands of cephradine 500 mg capsules in 24 normal Korean volunteers. The plasma samples were acquired at 13 time points for 8 h after administration. The concentrations of cephradine in human plasma were measured by a high-performance liquid chromatography (HPLC). Isocratic mobile phase which consisted of acetonitrile, methanol, and 20 mM potassium phosphate (15/5/80, v/v/v, pH 3.48) was used to separate the analytical column cosmosil cholester (250 × 4.6 mm, 3 μm). Analytes were detected in ultraviolet (260 nm). The novel analytical method was described as simple sample preparation, a short retention time (less than 6 min) and making it suitable for use in clinical trials. Pharmacokinetic parameters, such as AUC0-t (20.54 vs 18.42 μg·h/mL), AUC0-infinity (21.22 vs 19.14 μg·h/mL), Cmax (12.69 vs 12.81 μg/mL), Tmax (1.22 vs 0.92 h), half-life (1.02 vs 1.13 h), extrapolation (3.22% vs 3.75%), and Ke (0.73 vs 0.69 h–1) were determined for the reference and test drugs in plasma. Pharmacokinetic parameters with a 90% confidence interval were 87% - 95% for AUC0-t and 91% - 115% for Cmax. They were satisfied within the bioequivalence range 80% - 125% of the KFDA guidelines. Therefore, our HPLC method was well applied in a bioequivalence and pharmacokinetic study of two formulations in normal subjects.
本研究的目的是比较两种品牌头孢拉定500 mg胶囊在24名正常韩国志愿者体内的药代动力学和生物等效性。在给药后8小时的13个时间点采集血浆样本。采用高效液相色谱法测定了人血浆中头孢拉定的浓度。采用乙腈、甲醇、20 mM磷酸钾(15/5/80,v/v/v, pH 3.48)等容流动相分离分析柱cosmosil cholester (250 × 4.6 mM, 3 μm)。分析物用紫外(260 nm)检测。新的分析方法被描述为简单的样品制备，保留时间短(小于6分钟)，使其适合用于临床试验。测定参比药和试验药血浆中AUC0-t (20.54 vs 18.42 μg·h/mL)、AUC0-infinity (21.22 vs 19.14 μg·h/mL)、Cmax (12.69 vs 12.81 μg/mL)、Tmax (1.22 vs 0.92 h)、半衰期(1.02 vs 1.13 h)、外推率(3.22% vs 3.75%)、Ke (0.73 vs 0.69 h - 1)等药代动力学参数。AUC0-t的药代动力学参数为87% ~ 95%，Cmax的药代动力学参数为91% ~ 115%，置信区间为90%。它们在KFDA指南的80% - 125%的生物等效性范围内得到满足。因此，我们的高效液相色谱法可以很好地应用于两种制剂在正常人体内的生物等效性和药代动力学研究。
{"title":"Clinical Pharmacokinetic and Bioequivalence Studies of Two Brands of Cephradine in Healthy Korean Using HPLC Method","authors":"Hyunjin Kim, Shin-Hee Kim, Semi Kim, Jae-Sung Ahn, Ju‐Seop Kang","doi":"10.4236/PP.2018.97022","DOIUrl":"https://doi.org/10.4236/PP.2018.97022","url":null,"abstract":"The goal of our research was to compare the pharmacokinetics and evaluate the bioequivalence of two brands of cephradine 500 mg capsules in 24 normal Korean volunteers. The plasma samples were acquired at 13 time points for 8 h after administration. The concentrations of cephradine in human plasma were measured by a high-performance liquid chromatography (HPLC). Isocratic mobile phase which consisted of acetonitrile, methanol, and 20 mM potassium phosphate (15/5/80, v/v/v, pH 3.48) was used to separate the analytical column cosmosil cholester (250 × 4.6 mm, 3 μm). Analytes were detected in ultraviolet (260 nm). The novel analytical method was described as simple sample preparation, a short retention time (less than 6 min) and making it suitable for use in clinical trials. Pharmacokinetic parameters, such as AUC0-t (20.54 vs 18.42 μg·h/mL), AUC0-infinity (21.22 vs 19.14 μg·h/mL), Cmax (12.69 vs 12.81 μg/mL), Tmax (1.22 vs 0.92 h), half-life (1.02 vs 1.13 h), extrapolation (3.22% vs 3.75%), and Ke (0.73 vs 0.69 h–1) were determined for the reference and test drugs in plasma. Pharmacokinetic parameters with a 90% confidence interval were 87% - 95% for AUC0-t and 91% - 115% for Cmax. They were satisfied within the bioequivalence range 80% - 125% of the KFDA guidelines. Therefore, our HPLC method was well applied in a bioequivalence and pharmacokinetic study of two formulations in normal subjects.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75172128","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}
Diuretics are efficaciously used in management of various clinical emergencies like hypertension, heart failure, cirrhosis, hypercalciuria, hematuria and nephrotic syndrome. Cymbopogon jwarancusa is an aromatic perennial grass used in both traditional and Unani system of medicine to eradicate diseases like colds, seasonal fever, asthma, tuberculosis, rheumatic pain, back pain, toothache and nervous disorders. C. jwarancusa essential oils are used in perfumery, soap, detergents, medicines and pharmaceutical industry. Monoterpenes and sesquiterpenes constitute the highest composition in essential oil of C. jwarancusa. The present was designed to compare the diuretic activity of C. jwarancusa after single and multi-doses. Furosemide (20 mg/kg) was used as reference drug and 10% DMSO was used as vehicle. Diuretic activity was noticed by measuring urine volume and calculating diuretic and Lipchitz values. Maximum diuretic response was observed at 500 mg/kg of extract after both single and multi-dose administration. On basis of results it may be concluded that C. jwarancusa may be used as diuretic agent.
{"title":"Diuretic Effect of Cymbopogon jwarancusa after Single and Multiple Doses in Rats","authors":"Sarah Khan, S. Afroz, R. Khan","doi":"10.4236/pp.2018.97019","DOIUrl":"https://doi.org/10.4236/pp.2018.97019","url":null,"abstract":"Diuretics are \u0000efficaciously used in management of various clinical emergencies like hypertension, \u0000heart failure, cirrhosis, hypercalciuria, hematuria and nephrotic syndrome. Cymbopogon jwarancusa is an aromatic \u0000perennial grass used in both traditional and Unani system of medicine to \u0000eradicate diseases like colds, seasonal fever, asthma, tuberculosis, rheumatic \u0000pain, back pain, toothache and nervous disorders. C. jwarancusa essential oils are used in perfumery, soap, \u0000detergents, medicines and pharmaceutical industry. Monoterpenes and \u0000sesquiterpenes constitute the highest composition in essential oil of C. jwarancusa. The present was designed \u0000to compare the diuretic activity of C. \u0000jwarancusa after single and multi-doses. Furosemide (20 mg/kg) was used as \u0000reference drug and 10% DMSO was used as vehicle. Diuretic activity was noticed \u0000by measuring urine volume and calculating diuretic and Lipchitz values. Maximum \u0000diuretic response was observed at 500 mg/kg of extract after both single and \u0000multi-dose administration. On basis of results it may be concluded that C. jwarancusa may be used as diuretic agent.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85538328","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}
Hideyuki Suga, Yuichi Ichimura, Satomi Otsuka, K. Sugaya, M. Oda, H. Saitoh
Indoxyl sulfate (IS) is a typical uremic toxin that extensively accumulates in the plasma of patients with seriously impaired renal function. This study seeks to clarify whether IS exerts a potent modulating effect on the hepatic transport of pravastatin, which is a substrate of both organic anion transporting peptides (OATPs) and multidrug resistance-associated protein (Mrp) 2 in rats. When IS is administered intravenously to the normal rats at a dose of 120 μmol/kg; plasma IS levels are approximately 600 μM after 2 min and 100 μM after 120 min. In rats with acute renal failure (ARF) induced by cisplatin, the area under the curve (AUC) was more than 2.5-fold greater compared with that in the normal rats, indicating that IS accumulates in ARF rats. Intravenously administered pravastatin almost disappeared from the plasma by 60 min post-administration and approximately 55% of dose was excreted in the bile within 60 min. This result suggested that pravastatin was efficiently taken up from the sinusoid into hepatocytes via rat OATPs on the sinusoidal membrane and preferentially transported in the bile mediated by Mrp2 on the canalicular membrane. IS administered intravenously at a dose of 120 μmol/kg caused neither an increase in plasma pravastatin levels nor a decrease in its biliary excretion. In conclusion, the present results demonstrate that single intravenous administration of IS does not interfere with the hepatic transport of pravastatin directly in vivo, which is at variance with the results of previous in vitro studies.
{"title":"Limited Effect of Intravenously Administered Indoxyl Sulfate, a Uremic Toxin, on the Hepatic Transport of Pravastatin in Normal Rats","authors":"Hideyuki Suga, Yuichi Ichimura, Satomi Otsuka, K. Sugaya, M. Oda, H. Saitoh","doi":"10.4236/pp.2018.97021","DOIUrl":"https://doi.org/10.4236/pp.2018.97021","url":null,"abstract":"Indoxyl \u0000sulfate (IS) is a typical uremic toxin that extensively accumulates in the \u0000plasma of patients with seriously impaired renal function. This study seeks to clarify whether IS exerts a potent modulating effect on the hepatic \u0000transport of pravastatin, which is a substrate of both organic anion \u0000transporting peptides (OATPs) and multidrug resistance-associated protein (Mrp) \u00002 in rats. When IS is administered intravenously to the normal rats at a dose of 120 μmol/kg; plasma \u0000IS levels are approximately 600 μM after 2 min and 100 μM after 120 min. In rats with \u0000acute renal failure (ARF) induced by cisplatin, the area under the curve (AUC) \u0000was more than 2.5-fold greater compared with that in the normal rats, indicating \u0000that IS accumulates in ARF rats. Intravenously administered pravastatin almost \u0000disappeared from the plasma by 60 min post-administration and approximately 55% \u0000of dose was excreted in the bile within 60 min. This result suggested that \u0000pravastatin was efficiently taken up from the sinusoid into hepatocytes via rat \u0000OATPs on the sinusoidal membrane and preferentially transported in the bile \u0000mediated by Mrp2 on the canalicular membrane. IS administered intravenously at \u0000a dose of 120 μmol/kg caused neither an increase in plasma pravastatin levels \u0000nor a decrease in its biliary excretion. In conclusion, the present results \u0000demonstrate that single intravenous administration of IS does not interfere \u0000with the hepatic transport of pravastatin directly in vivo, which is at variance with the results of previous in vitro studies.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81481112","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}
Bernhard Langer, Michael Kieper, S. Laube, J. Schramm, Sophia J. Weber, Alexander Werwath
Aim: As the primary aim of this study, we analysed whether the quality of advice provided by pharmacies in the period between 2014 (baseline study) and 2017 (follow-up study) could actually be increased using a single written performance feedback given to each pharmacy in 2014. The secondary aim of the follow-up examination was to analyse whether the quality of advice differed depending on the professional group providing the advice. Methodology: To ensure the least possible distortion in the comparison between the baseline and the follow-up studies, the study design used for the follow-up examination in 2017 was not changed compared to the baseline examination in 2014. The data for the follow-up examination were therefore collected using the simulated patient method in all 21 pharmacies in a city in the north-east of Germany. Three female and two male test buyers used four different scenarios for self-medication of acute diarrhoea in all of the pharmacies (a total of 84 test purchases). Results: There were significant differences between the overall results from the baseline study (2014) and the follow-up study (2017) (Wilcoxon signed rank test; z = –2.065, p = 0.039, r = 0.225). In the overall average, the pharmacies in 2017 achieved only 2.7 (30%) of 9 possible points whereas in 2014 they achieved 3.3 (37%). The quality of advice between the professional groups did not show any significant differences (Kruskal-Wallis test: χ2(2) = 1.946; p = 0.378, r = 0.027). Conclusions: The quality of advice for acute diarrhoea in adults declined over time. A written performance feedback intended to improve the quality proved ineffective. Interventions with a far greater impact are required to achieve an improvement in the quality of advice provided.
目的:作为本研究的主要目的，我们分析了2014年(基线研究)至2017年(后续研究)期间药房提供的建议质量是否可以通过2014年向每家药房提供的单一书面绩效反馈来实际提高。随访检查的第二个目的是分析建议的质量是否因提供建议的专业团体而异。方法学:为确保基线研究与随访研究比较中尽可能少的失真，2017年随访研究采用的研究设计与2014年基线研究相比没有改变。因此，后续检查的数据是在德国东北部一个城市的所有21家药店中使用模拟患者方法收集的。三名女性和两名男性测试购买者在所有药房使用四种不同的方案自行治疗急性腹泻(总共购买了84次测试)。结果:基线研究(2014年)与随访研究(2017年)的总体结果存在显著差异(Wilcoxon sign rank检验;Z = -2.065, p = 0.039, r = 0.225)。整体平均而言，药房在2017年仅获得2.7分(30%)，而2014年则达到3.3分(37%)。各专业群体的咨询质量差异无统计学意义(Kruskal-Wallis检验:χ2(2) = 1.946;P = 0.378, r = 0.027)。结论:成人急性腹泻的建议质量随着时间的推移而下降。一份旨在提高质量的书面绩效反馈被证明无效。要提高所提供咨询的质量，就需要具有更大影响的干预措施。
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J. Nussberger, A. Dubach, A. Turpeinen, H. Vapaatalo
This placebo-controlled, double-blind, cross-over intervention with twelve normotensive healthy volunteers tested the effects of milk products containing either 5 or 50 mg of ACE1-inhibitory lactotripeptides (isolecine-proline-proline, Ile-Pro-Pro, and valine-proline-proline, Val-Pro-Pro) and placebo milk drink (with similar taste) on plasma bradykinin levels. The subjects consumed one of the three test products in a random order, double-blinded, and four-week trial. On the first day (day 1) and on the last day (day 29) i.e. after four weeks’ treatment with one of the products, the acute effect with the same single dose was assayed. Other markers of the renin-angiotensin-aldosterone system (RAAS) were measured from plasma four times on the same days when we also assessed daytime urinary excretion of biomarkers of endothelial function. Neither acute nor prolonged administration of the ACE-1 inhibiting peptide drinks significantly lowered blood pressure of the normotensive subjects. The most important finding was the dose-dependent, and linear increase in plasma bradykinin concentrations after acute dosing on the first day; it was nearly statistically significant also on the day 29 (p 0.06). Other indicators of RAAS or endothelial function did not differ from those of placebo after the acute or prolonged treatments. Our results suggest that even weak inhibitors of ACE-1, such as the lactotripeptides Ile-Pro-Pro and Val-Pro-Pro, are able to diminish the breakdown of bradykinin and therefore increase plasma bradykinin levels. This may partly explain the blood pressure lowering and vasodilatory effects of lactotripeptides, shown by us earlier in mildly hypertensive subjects.
{"title":"Lactotripeptides Inhibiting ACE1 Elevate the Plasma Bradykinin Concentration Acutely in a Placebo-Controlled, Double-Blind, Cross-Over, 4-Week Trial in Healthy Volunteers","authors":"J. Nussberger, A. Dubach, A. Turpeinen, H. Vapaatalo","doi":"10.4236/PP.2018.97017","DOIUrl":"https://doi.org/10.4236/PP.2018.97017","url":null,"abstract":"This placebo-controlled, double-blind, cross-over \u0000intervention with twelve normotensive healthy volunteers tested the effects of \u0000milk products containing either 5 or 50 mg \u0000of ACE1-inhibitory lactotripeptides (isolecine-proline-proline, Ile-Pro-Pro, and valine-proline-proline, \u0000Val-Pro-Pro) and placebo milk drink (with similar taste) on plasma bradykinin \u0000levels. The subjects consumed one of the three test products in a random order, \u0000double-blinded, and four-week trial. On the \u0000first day (day 1) and on the last day (day 29) i.e. after four weeks’ treatment with one of \u0000the products, the acute effect with the same single dose was assayed. Other \u0000markers of the renin-angiotensin-aldosterone system (RAAS) were measured from \u0000plasma four times on the same days when we also assessed daytime urinary \u0000excretion of biomarkers of endothelial function. Neither acute nor prolonged \u0000administration of the ACE-1 inhibiting peptide drinks significantly lowered \u0000blood pressure of the normotensive subjects. The most important finding was the \u0000dose-dependent, and linear increase in plasma \u0000bradykinin concentrations after acute dosing on the first day; it was nearly \u0000statistically significant also on the day 29 (p 0.06). Other indicators of RAAS or endothelial function did not differ \u0000from those of placebo after the acute or prolonged treatments. Our results \u0000suggest that even weak inhibitors of ACE-1, such as the lactotripeptides \u0000Ile-Pro-Pro and Val-Pro-Pro, are able to diminish the breakdown of bradykinin \u0000and therefore increase plasma bradykinin levels. This may partly explain the \u0000blood pressure lowering and vasodilatory effects of lactotripeptides, shown by \u0000us earlier in mildly hypertensive subjects.","PeriodicalId":19875,"journal":{"name":"Pharmacology & Pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2018-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91284761","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}
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