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WORKSHOP ON THE SOURCES, QUANTIFICATION AND HEALTH IMPLICATIONS OF BIOAEROSOLS WORKSHOP REPORT 关于生物气溶胶的来源、量化和健康影响的讲习班报告
Pub Date : 2014-10-28 DOI: 10.3844/AJPTSP.2014.189.199
K. Exley, S. Robertson, F. Pope, R. Harrison, T. Gant
Scientists, health care professionals and the gener al public have all raised concerns about the potent ial health impact natural and manmade sources bioaerosols. In response in september 2012 the Natural Environmental Research Council and public health England jointly funded a workshop to review the ‘sources, quantification and health implications of bioaerosols’. The organising committee for the wor kshop identified five priority areas-(1) bioaerosol ident ification and quantification methodology, (2) bioae rosol sources, (3) health effects of bioaerosols, (4) ext reme events, risk assessment and mediation and (5) bioaerosol dispersion and modelling. The primary purpose was to bring together experts to report on re cent research and identify research gaps where increased knowledge would improve risk understanding and public health. This report summarises the presentat ions, the main discussion points and key conclusion s that emerged during the workshop.
科学家、卫生保健专业人员和普通公众都对天然和人为来源的生物气溶胶对健康的潜在影响表示担忧。作为回应,2012年9月,自然环境研究委员会和英国公共卫生部联合资助了一个讲习班,审查"生物气溶胶的来源、量化和健康影响"。研讨会组委会确定了五个优先领域——(1)生物气溶胶识别和量化方法,(2)生物气溶胶来源,(3)生物气溶胶对健康的影响,(4)极端事件,风险评估和调解,以及(5)生物气溶胶扩散和建模。主要目的是召集专家就最近的研究报告并确定研究差距,在这些差距中,知识的增加将改善对风险的了解和公共卫生。本报告总结了研讨会期间的演讲、主要讨论点和主要结论。
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引用次数: 2
ANTIBIOTIC RESISTANCE: A FRIGHTENING HEALTH DILEMMA 抗生素耐药性:一个可怕的健康困境
Pub Date : 2014-09-26 DOI: 10.3844/AJPTSP.2014.174.176
R. Tiwari, K. Dhama
The discovery of antibiotics, being the wonderful amiable pillars of chemotherapy, was a revolutioniz ed turning point in human history. With the discovery of antibiotic drug Penicillin in 1928, Sir Alexander Flemming explored the role of microbial products in counteracting the pathogenic effects of microorgani sms. Before 1940, antibiotics were magical drugs used as growth promoters, during the processing, storage an d transportation of food products to check secondary contaminations and for the treatment of various bac terial ailments (Byarugaba, 2004). However, very frequent, inappropriate and irrational use of antibiotics aga inst various microorganisms had a continuous survival pressure as a warning to their life and this pressu re forced them to express various resistance genes in equilibrium with environment to support the rise of antibiotic resistance to counteract antimicrobial approaches and to develop antibiotic resistance, in deed (Soulsby, 2005; Zhang et al ., 2006).
抗生素的发现,作为化疗的美妙而又亲切的支柱,是人类历史上一个革命性的转折点。随着1928年抗生素青霉素的发现,亚历山大·弗莱明爵士探索了微生物产物在对抗微生物致病作用方面的作用。在1940年之前,抗生素是一种神奇的药物,在食品的加工、储存和运输过程中用作生长促进剂,用于检查二次污染和治疗各种肠道疾病(Byarugaba, 2004年)。然而,对各种微生物非常频繁、不适当和不合理地使用抗生素,对它们的生命产生了持续的生存压力,这种压力迫使它们与环境平衡地表达各种耐药基因,以支持抗生素耐药性的上升,从而抵消抗菌素方法,并实际上产生抗生素耐药性(Soulsby, 2005;Zhang等人,2006)。
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引用次数: 8
PROTECTIVE ROLE OF VITAMIN C AND GREEN TEA EXTRACT ON MALATHION-INDUCED HEPATOTOXICITY AND NEPHROTOXICITY IN RATS 维生素c和绿茶提取物对马拉硫磷所致大鼠肝、肾毒性的保护作用
Pub Date : 2014-07-22 DOI: 10.3844/AJPTSP.2014.177.188
Rabab R Elzoghby, Ahlam F. Hamoda, A. Abdel-Fatah, Mona M. Farouk
The present study was designed to determine the mod ulating effect of green tea and vitamin C against adverse effects of malathion. Animals were divided into four groups 5 rats /group). Group one was used as a control. Group two given malathion (50 mg /kg/day; 1/50 of the LD50 for four weeks). Group three and Group four were given malathion (50 mg/kg/day; 1/50 of the LD50 for four weeks) plus vitamin C (200 mg/kg/day) and plus green tea (36 mg/kg/day) respectively. At the end of the fourth week, the malathion-treated group had significantly lower Red Blood Cell count (RBCs), Hemoglobin concentration (Hb), Packed Cell Volume (PCV%) and leucocytes (WBCs) than the control group. Compared to the control group, the malathion-treate d group had significantly higher serum Alkaline Phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), lactate dehydrogenase (LDH), urea, creatinine and uric acid levels than the control group. The malathion treated rats also had significantly lower serum tot al protein, albumin and globulin levels than the control group, but the malathion plus vitamin C and malathion plus green tea groups did not differ from the control group in terms of these parameters . Moreover, concomitant vitamin C and green tea treatment significantly normalized, at least partia lly, all of the other hematological and biochemical parameters that were altered by malathion. Liver ti ssue homogenate in malathion treated group had lower Glutathione (GSH), Glutathione Peroxidase (GSH-PX) and Superoxide Dismutase (SOD) levels accompanied with higher level of Malondialdehyde (MDA) than the control group. Histopathological studies revealed that the malathion-treated, malath ion plus vitamin C and malathion plus green tea treated groups exhibited histopathological changes in liver and kidney tissues, although some pathological features were only observed in the mal athion-treated group. Thus, vitamin C and green tea can reduce malathion hepatotoxicity and nephrptoxic ity.
本研究旨在确定绿茶和维生素C对马拉硫磷不良反应的调节作用。动物分为4组(5只/组)。第一组为对照组。第二组给予马拉硫磷50 mg /kg/d;LD50的1/50,持续四周)。第3组和第4组给予马拉硫磷(50 mg/kg/d;LD50的1/50,持续四周)加维生素C(200毫克/公斤/天)和加绿茶(36毫克/公斤/天)。第4周结束时,马拉硫磷治疗组的红细胞计数(rbc)、血红蛋白浓度(Hb)、堆积细胞体积(PCV%)和白细胞(wbc)均显著低于对照组。与对照组相比,马拉硫磷治疗组血清碱性磷酸酶(ALP)、丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、乳酸脱氢酶(LDH)、尿素、肌酐和尿酸水平均显著高于对照组。马拉硫磷处理的大鼠血清总蛋白、白蛋白和球蛋白水平也明显低于对照组,但马拉硫磷加维生素C组和马拉硫磷加绿茶组在这些参数方面与对照组没有差异。此外,同时服用维生素C和绿茶显著地使马拉硫磷改变的所有其他血液学和生化参数正常化,至少部分正常化。与对照组相比,malathion处理组肝组织匀浆中谷胱甘肽(GSH)、谷胱甘肽过氧化物酶(GSH- px)和超氧化物歧化酶(SOD)水平较低,丙二醛(MDA)水平较高。组织病理学研究发现,马拉硫磷处理组、马拉硫磷+维生素C处理组和马拉硫磷+绿茶处理组的肝脏和肾脏组织均出现了组织病理学变化,而一些病理特征仅在马拉硫磷处理组出现。因此,维生素C和绿茶可以降低马拉硫磷的肝毒性和肾毒性。
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引用次数: 40
THE INFLUENCE OF PERSONALITY ACCENTUATION ON DRUG ADDICTION AMONG STUDENTS 人格强调对学生吸毒成瘾的影响
Pub Date : 2014-06-27 DOI: 10.3844/AJPTSP.2014.168.173
Elena A. Cheverikina, A. V. Leifa, N. A. Kora, Juliya V. Badalyan, E. Burdukovskaya, E. Pavlova
To identify character accentuation students who are prone to addiction will allow to adjust their socialization process during the training period in order to increase its effectiveness, as well as it will contribute to the creation of effective psycho-educational programs aimed at reducing the level of their addiction to drugs. Objective: To identify the influence of experimental character accentuation susceptibility to drug addiction among students. The study is based on concept of accented personalities by K. Leonhard and typology of accented personalities by A.E. Lichko. Psychological testing was as an empirical research method. Data processing was performed using the Statistical Package for Social Sciences (SPSS) v.17. It was found out that the students of higher education compared to students of secondary vocational education had susceptibility to drug addiction associated with less accentuation of character. This can be explained by the fact that those who are going to the universities to study are more socially adapted, they have a higher level of self-control and self-discipline, able by virtue of age and education to control outbursts of emotions and behavior. The findings of the study data will allow to adjust psycho-educational programs aimed at reducing the propensity to addiction among students based on character accentuation detected among students of higher and vocational education.
识别成瘾倾向学生的性格特征,有助于在训练期间调整其社会化过程,以提高其有效性,并有助于制定有效的心理教育计划,以降低其吸毒成瘾程度。目的:探讨实验性格加重对学生药物依赖易感性的影响。本研究以K. Leonhard的重音人格概念和A.E. Lichko的重音人格类型学为基础。心理测试是一种实证研究方法。使用社会科学统计软件包(SPSS) v.17进行数据处理。研究发现,与中职学生相比,高等教育学生对药物成瘾的易感性较低,且个性的强调程度较低。这可以解释为,那些去大学学习的人更适应社会,他们有更高的自我控制和自律水平,能够凭借年龄和教育来控制情绪和行为的爆发。研究数据的发现将有助于调整心理教育计划,以减少基于在高等和职业教育学生中发现的性格突出的学生成瘾倾向。
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引用次数: 1
THE IMPACT OF ANTIOXIDANTS ON INFLAMMATION AND OXIDATIVE STRESS MARKERS IN OSTEOARTHRITIS RAT MODEL: SCANNING ELECTRON MICROSCOPE INSIGHTS 抗氧化剂对骨关节炎大鼠模型炎症和氧化应激标志物的影响:扫描电镜观察
Pub Date : 2014-05-19 DOI: 10.3844/AJPTSP.2014.157.167
E. H. A. Heidar, FareedF Al Faya, W. N. Hassan, R. Eid, M. Haidara
Osteoarthritis (OA) is characterized by degradation of matrix and destruction of articular cartilage. Articular chondrocytes are solely responsible for t he production and maintenance of the extracellular matrix. Therefore, chondrocyte disruption is implic ated in cartilage degeneration. Numerous studies have shown that antioxidant treatments are promisin g therapeutics in cases of OA. This study was designedto examine whether vitamin E protects rat a rticular chondrocytes against increased inflammatory markers and oxidative stress and preve nts cartilage destruction in mono-iodoacetateinduced osteoarthritis rat model. Data showed that osteoarthritis group showed a significant increase in inflammatory markers, Tumor Necrosis Factor-α (TNF-α) (38±1 ng/mL), Interlukin-6 (IL-6) (253±15 ng/mL) and oxidative stress marker, Super Oxide Dis mutase (SOD) (14±1 ng/mL) compared to control (18±1 ng/mL), (121+/-23 ng/mL) and (8±1 ng/mL) respectively. Opposite trend was found when animals were treated with vitamin E where TNF-α (27±2 ng/mL) and SOD (10±1 ng/mL) declined significantly. Electro-microscopic examination docu mented the above results and showed improvement of knee joint after administration of v itamin E. This study supported the notion that OA is a multi factorial complication, caused by inflam mation and increased oxidative stress. Administration of vitamin E decreased the markers o f inflammation and oxidative stress as well asimproved ultra-structure of the knee jointin acut e OA animal model. However, further work id needed to validate reliability in human patients su ffering from osteoarthritis.
骨关节炎(OA)的特点是基质降解和关节软骨破坏。关节软骨细胞单独负责细胞外基质的产生和维持。因此,软骨细胞破坏与软骨变性有关。大量研究表明,抗氧化治疗是OA病例中有希望的治疗方法。本研究旨在研究维生素E是否能保护大鼠软骨细胞免受炎症标志物和氧化应激增加的影响,并防止单碘乙酸诱导的骨关节炎模型大鼠软骨破坏。数据显示,骨关节炎组炎症标志物肿瘤坏死因子-α (TNF-α)(38±1 ng/mL)、白细胞介素-6 (IL-6)(253±15 ng/mL)和氧化应激标志物超氧化物歧化酶(SOD)(14±1 ng/mL)分别较对照组(18±1 ng/mL)、(121+/-23 ng/mL)和(8±1 ng/mL)显著升高。维生素E组则相反,TNF-α(27±2 ng/mL)和SOD(10±1 ng/mL)明显下降。电镜检查证实了上述结果,并显示服用维生素e后膝关节得到改善。这项研究支持了OA是一种多因素并发症的观点,由炎症和氧化应激增加引起。在急性关节炎动物模型中,维生素E可降低炎症和氧化应激标志物,改善膝关节超微结构。然而,需要进一步的工作来验证在患有骨关节炎的人类患者中的可靠性。
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引用次数: 7
ANTIOPHIDIAN ACTIVITY OF BROSIMUM GUIANENSE (AUBL) HUBER 桂花溴的抗蛇毒活性
Pub Date : 2014-05-13 DOI: 10.3844/AJPTSP.2014.148.156
J. A. H. M. Bittencourt, Nayana Keyla Seabra de Oliveira, M. Cabral, J. R. Ribeiro, S. V. C. Henriques, Leide C. S. Picanço, Cleydson B. R. Santos, D. Stien, J. Carvalho, J. Silva
Snakebites envenomations are a problem public health in worldwide due to the high rates of morbidity and mortality. The Bothrops venom causes local tissue damage and inflammation is one of the most important events that occur. At present, effective treatment for snakebites is serum therapy with antivenom, which neutralizes systemic alterations but does not prevent local damage that can cause disabilities. Many plants are used in popular medicine to treat these accidents but few attempts have been made to investigate the scientific validity of these assertions. In Amazon region, indigenous and local people use the macerated bark of Brosimum guinanensis applied in the form of cataplasm, on the site of snakebite. This study aimed to analyze the ability of the Brosimum guianensis aqueous extract in the neutralization several effects induced by Bothrops atrox snake venom to investigate the scientific validity of folk medicine informations by means of controlled experiments. Our results showed that Brosimum guianensis aqueous extract was not effective to inhibit oedema, peritonitis, coagulant, myotoxic, phospholipase A2 activity (indirect hemolytic method) induced by B. atrox venom, but was able to inhibited significantly hemorrhagic and nociceptive activities. These results support a potential effect of this extract as a compounds source for biotechonological application and synthesis of new drugs with therapeutic purpose.
蛇咬伤是一个全球性的公共卫生问题,其发病率和死亡率都很高。Bothrops毒液引起局部组织损伤和炎症是最重要的事件之一。目前,对蛇咬伤的有效治疗是抗蛇毒血清疗法,它可以中和全身的变化,但不能防止可能导致残疾的局部损伤。在大众医学中,许多植物被用来治疗这些事故,但很少有人试图调查这些说法的科学有效性。在亚马逊地区,土著人和当地人使用浸渍过的桂树树皮,在蛇咬伤的地方涂上膏药。本研究旨在通过对照实验,分析桂竹水提物对蛇毒多种作用的中和作用,探讨民间医药信息的科学有效性。结果表明,桂酸Brosimum guianensis水提物对atrox B.毒液诱导的水肿、腹膜炎、凝血、肌毒、磷脂酶A2活性(间接溶血法)没有明显的抑制作用,但对出血和伤害活性有明显的抑制作用。这些结果支持该提取物作为生物技术应用和具有治疗目的的新药物合成的化合物来源的潜在作用。
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引用次数: 7
Effect of Combined Fenofibrate and Nicotinamide on Oxidative Stress and Inflammatory Cytokines Involved in Cisplatin-Induced Nephrotoxicity in Rats 非诺贝特联合烟酰胺对大鼠顺铂肾毒性氧化应激和炎症细胞因子的影响
Pub Date : 2014-04-01 DOI: 10.3844/AJPTSP.2014.206.222
O. M. A. Allah, A. El-Din, Fouad El Debakey
Cisplatin (Cis) is an anticancer drug, which is accompanied with major side effects including nephrotoxicity. The current study was performed to assess the possible prophylactic effects of fenofibrate (FEN), Nicotinamide (NAM) and their combination on oxidative stress and inflammatory cytokines associated with cisplatin-induced renal damage. Rats were randomly divided into seven groups (8 each) as follows; control group; FEN group (100 mg/kg/day p.o.); NAM group (200 mg/kg/day p.o.); FEN and NAM were administered for eight days. Cis group (7 mg/kg i.p. as a single dose on day five); FEN + Cis group; NAM + Cis group and FEN + NAM + Cis group. Urine, blood and kidneys were taken out for biochemical and histopathological analysis and scoring. Oxidative stress induced by Cis was evidenced by significant elevation in renal Malondialdehyde (MDA) level acompanied by significant decrease in Superoxide Dismutase (SOD) and Glutathione Peroxidase (GPx) in kidney tissues. Moreover, Cis produced significant increase in kidney Tumor Necrosis Factor-I± (TNF-I±) and Interleukin-6 (IL-6), the proinflammatory cytokines and significant decrease in Interleukin-10 (IL-10), the anti-inflammatory cytokine. However, administration of either FEN or NAM attenuated cisplatin-induced increased oxidative stress and inflammation in the kidney of rats, associated with improvement of the impaired renal function and histopathological changes, but their combination was found to be more effective in protection against cisplatin-induced renal damage than each drug alone. In conclusion, FEN and NAM combination protected the kidney tissue against cisplatin-induced nephrotoxicity through their antioxidant and anti-inflammatory activities.
顺铂(Cis)是一种抗癌药物,其主要副作用包括肾毒性。本研究旨在评估非诺贝特(FEN)、烟酰胺(NAM)及其联合用药对顺铂所致肾损伤相关的氧化应激和炎症细胞因子的预防作用。将大鼠随机分为7组,每组8只,方法如下:对照组;FEN组(100mg /kg/day p.o.);NAM组(每天200 mg/kg);FEN和NAM给药8天。顺式组(第5天单次给药7 mg/kg);FEN + Cis组;NAM + Cis组和FEN + NAM + Cis组。取尿、血、肾进行生化、组织病理学分析及评分。Cis诱导的氧化应激表现为肾脏组织中丙二醛(MDA)水平显著升高,超氧化物歧化酶(SOD)和谷胱甘肽过氧化物酶(GPx)显著降低。此外,顺式脂肪酸显著升高了肾肿瘤坏死因子-1±(TNF-I±)和促炎细胞因子白介素-6 (IL-6),显著降低了抗炎细胞因子白介素-10 (IL-10)。然而,FEN或NAM均可减轻顺铂诱导的大鼠肾脏氧化应激和炎症的增加,与肾功能受损和组织病理学改变的改善有关,但它们的联合被发现比单独使用每种药物更有效地保护顺铂诱导的肾脏损伤。综上所述,FEN和NAM联合使用可通过抗氧化和抗炎作用保护肾组织免受顺铂所致的肾毒性。
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引用次数: 1
Anti-Inflammatory, Analgesic and Antioxidant Activities of Allophylus Cobbe Leaves 异叶菜叶的抗炎、镇痛和抗氧化活性
Pub Date : 2014-04-01 DOI: 10.3844/AJPTSP.2014.223.231
P. Jain, M. Hossain, K. Fatema, M. Hossain, Kafil Uddin Mazumder, Hemayet Hossain, M. A. Alam, H. Reza
Allophylus cobbe L. Raeuschel (Family-Sapindaceae) is a medicinal plant used traditionally for the treatment of various health risks like pain, inflammation, ulcers and wounds in Bangladesh. This study determined the polyphenolic compounds and evaluated the analgesic, anti-inflammatory and antioxidant effects of the ethanol extract of Allophylus cobbe leaves. High Performance Liquid Chromatography (HPLC) analysis was used to determine the polyphenolic compounds present in the extract. The analgesic activity was evaluated by hot plate and acetic acid induced writhing in mice at two different doses of 250 and 500 mg kg-1 body weight. The extract was also investigated for the anti-inflammatory effect on rats at above mentioned doses using carrageenan induced rat paw edema method. The antioxidant potential of the extract was determined in terms of radical scavenging ability of the stable 1, 1-Diphenyl-2-Picrylhydrazyl (DPPH) free radical. Preliminary phytochemical analysis revealed the presence of alkaloids, flavonoids, tannins and glycosides in the extract. High Performance Liquid Chromatography (HPLC) analysis also confirmed the presence of polyphenolic compounds such as (+)-catechin hydrate, (–)-epicatechin, caffeic acid, p-coumaric acid and quercetin. The extract increased the licking time of hind paw when placed on a hot plate by 35.31% at 250 mg kg-1 dose which is comparable to the increase shown by diclofenac sodium (42.73%) at the 3rd h of study in hot plate test. Moreover, the extract also showed good analgesic effect in acetic acid induced writhing test. The percent inhibition of writhing response by the extract was 85.96 and 78.07% at 250 and 500 mg kg-1 doses respectively while that of the standard drug was 66.67%. Furthermore, the extract also reduced carrageenan induced paw edema formation; the most prominent inhibition was found to be 58.88% (250 mg kg-1) at the 3rd h of study. The DPPH radical scavenging activity of the extract increased markedly with increasing concentrations. At a concentration of 200 µg mL-1, the scavenging activity of the ethanol extract (91.53% inhibition) was comparable to that of the standard ascorbic acid (99.3% inhibition). Our results suggest that Allophylus cobbe extract possesses significant antinociceptive, anti-inflammatory and free radical scavenging activities which may justify the folkloric use of the plant in several communities for conditions such as colic, fever, inflammatory rheumatic pains and other oxidative stress associated disorders.
在孟加拉国,异叶属植物(皂荚科)是一种药用植物,传统上用于治疗疼痛、炎症、溃疡和伤口等各种健康风险。本研究测定了异叶草叶乙醇提取物中多酚类化合物的含量,并对其镇痛、抗炎和抗氧化作用进行了评价。采用高效液相色谱法测定提取物中多酚类化合物的含量。以250和500 mg kg-1体重的小鼠为实验对象,采用热板法和醋酸扭体法评价其镇痛作用。采用角叉菜胶诱导大鼠足部水肿的方法,研究了上述剂量下提取物对大鼠的抗炎作用。通过对稳定的1,1 -二苯基-2-苦味酰肼(DPPH)自由基的清除能力来确定提取物的抗氧化潜力。初步植物化学分析显示,提取物中含有生物碱、黄酮类化合物、单宁和苷类化合物。高效液相色谱(HPLC)分析也证实了多酚类化合物的存在,如(+)-水合儿茶素、()-表儿茶素、咖啡酸、对香豆酸和槲皮素。250 mg kg-1剂量下,双氯芬酸钠在热板试验研究第3 h时的增加率为42.73%,使后爪舔食时间增加35.31%。在醋酸扭体实验中也表现出良好的镇痛作用。在250 mg kg-1和500 mg kg-1剂量下,提取物对扭体反应的抑制率分别为85.96%和78.07%,而标准药的抑制率为66.67%。此外,该提取物还能减少卡拉胶诱导的足跖水肿的形成;实验第3 h时,抑制率为58.88% (250 mg kg-1)。提取物对DPPH自由基的清除能力随浓度的增加而显著增强。在浓度为200 µg mL-1时,乙醇提取物的清除活性(91.53%的抑制)与标准抗坏血酸相当(99.3%的抑制)。我们的研究结果表明,异叶草提取物具有显著的抗炎、抗炎和自由基清除活性,这可能证明了在一些社区中使用该植物治疗绞痛、发烧、炎症性风湿痛和其他氧化应激相关疾病的理由。
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引用次数: 4
Neutrophil Extracellular Traps as Therapeutic Targets for Inflammatory Disease 中性粒细胞胞外陷阱作为炎症性疾病的治疗靶点
Pub Date : 2014-04-01 DOI: 10.3844/AJPTSP.2014.200.202
R. Koenen
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引用次数: 1
Impact of Quantitative Pharmacology on Drug Development 定量药理学对药物开发的影响
Pub Date : 2014-04-01 DOI: 10.3844/AJPTSP.2014.203.205
A. Ruiz-Garcia, K. Parivar
The success of drug development rests over two well defined pillars, a good understanding of the drug’s clinical pharmacology and the appropriate target population for whom the clinical use is intended. The label for human prescription drugs requires a good understanding of the pharmacological effects (pharmacodynamics or PD) and the mechanism of action of the drug as well as detailed information of the drug’s Pharmacokinetics (PK): Absorption, distribution, metabolism and excretion (FDA, 2014). The understanding of the PK characteristics and PD effects (desired or adverse) will provide educated recommendations about the effective dose, dosing regimen, potential drug-drug interactions and hence contraindications and warnings. Further, the influence of demographic factors on the PK and PD attributes (e.g., age, sex, race, hepatic or renal impairment) need to be well understood to provide the appropriate guidance to patients and caregivers for patients in specific populations (pediatric, geriatric, organ impairment, pregnancy, etc). In summary, a very extensive portion of the label covers clinical pharmacology topics, the following label sections are mainly supported by clinical pharmacology knowledge collected throughout the course of drug development:
药物开发的成功取决于两个明确的支柱,对药物临床药理学的良好理解和临床使用的适当目标人群。人用处方药的标签需要很好地理解药物的药理作用(药效学或PD)和作用机制,以及药物的药代动力学(PK)的详细信息:吸收、分布、代谢和排泄(FDA, 2014)。了解PK特性和PD效应(期望的或不良的)将为有效剂量、给药方案、潜在的药物-药物相互作用以及禁忌症和警告提供有根据的建议。此外,需要充分了解人口统计学因素对PK和PD属性的影响(例如,年龄、性别、种族、肝脏或肾脏损害),以便为特定人群(儿科、老年、器官损害、妊娠等)的患者和护理人员提供适当的指导。综上所述,标签的很大一部分涵盖了临床药理学主题,以下标签部分主要由药物开发过程中收集的临床药理学知识提供支持:
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引用次数: 0
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American Journal of Pharmacology and Toxicology
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