Pub Date : 2017-09-11DOI: 10.4172/2329-6887.1000238
Kyle A. Franco, Tara Higgins
Objectives: To determine the dosage of vancomycin in milligrams/kilogram/day (mg/kg/day) required to achieve a trough value of 10 to 20 micrograms/milliliter (mcg/mL) in pediatric patients with differing types of malignancies. Methods: Retrospective review of pediatric patients with hematologic malignancy, solid tumor, or status post autologous or allogeneic hematopoietic stem cell transplantation (HSCT) receiving at least two doses of intravenous vancomycin with at least one evaluable trough concentration. Primary outcome was the dosage of vancomycin required to achieve first therapeutic trough value. Secondary endpoints included dosage requirement by age, proportion of patients achieving goal, incidence of supratherapeutic trough values and nephrotoxicity. Results: Mean dosage requirements were 72.5 [± 2.3] mg/kg/day among patients with hematologic malignancies, 66.5 [± 3.3] mg/kg/day in patients with solid tumors, and 77.3 [± 4.1] mg/kg/day in HSCT patients (p=0.12). Younger patients required significantly increased daily dosages in order to meet their trough goals in the hematologic malignancy and solid tumor groups (p<0.05). The proportion of patients achieving trough goals was also similar between groups (p=0.5). Supratherapeutic trough values were more common in the solid tumor groups (p<0.05). Nephrotoxicity occurred more frequently in the HSCT group (p<0.05). Conclusion: Vancomycin dosage requirements are similar between pediatric patients with differing categories of malignancies. Patients with solid tumors and HSCT appear to be at higher risk for supratherapeutic trough values, and HSCT patients appear to be at an increased risk for nephrotoxicity.
{"title":"Impact of Malignancy Category on Vancomycin Dosage Requirements inPediatric Oncology Patients","authors":"Kyle A. Franco, Tara Higgins","doi":"10.4172/2329-6887.1000238","DOIUrl":"https://doi.org/10.4172/2329-6887.1000238","url":null,"abstract":"Objectives: To determine the dosage of vancomycin in milligrams/kilogram/day (mg/kg/day) required to achieve \u0000 a trough value of 10 to 20 micrograms/milliliter (mcg/mL) in pediatric patients with differing types of malignancies. \u0000Methods: Retrospective review of pediatric patients with hematologic malignancy, solid tumor, or status post \u0000 autologous or allogeneic hematopoietic stem cell transplantation (HSCT) receiving at least two doses of intravenous \u0000 vancomycin with at least one evaluable trough concentration. Primary outcome was the dosage of vancomycin \u0000 required to achieve first therapeutic trough value. Secondary endpoints included dosage requirement by age, \u0000 proportion of patients achieving goal, incidence of supratherapeutic trough values and nephrotoxicity. \u0000Results: Mean dosage requirements were 72.5 [± 2.3] mg/kg/day among patients with hematologic malignancies, \u0000 66.5 [± 3.3] mg/kg/day in patients with solid tumors, and 77.3 [± 4.1] mg/kg/day in HSCT patients (p=0.12). Younger \u0000 patients required significantly increased daily dosages in order to meet their trough goals in the hematologic \u0000 malignancy and solid tumor groups (p<0.05). The proportion of patients achieving trough goals was also similar \u0000 between groups (p=0.5). Supratherapeutic trough values were more common in the solid tumor groups (p<0.05). \u0000 Nephrotoxicity occurred more frequently in the HSCT group (p<0.05). \u0000Conclusion: Vancomycin dosage requirements are similar between pediatric patients with differing categories of \u0000 malignancies. Patients with solid tumors and HSCT appear to be at higher risk for supratherapeutic trough values, \u0000 and HSCT patients appear to be at an increased risk for nephrotoxicity.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"93 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83586025","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}
Pub Date : 2017-09-07DOI: 10.4172/2329-6887.1000237
Bekri Melka, D. Bisrat, G. NeelaiahBabu
The usage of vast amount of synthetic dye causes pollution that disturbs the ecological balance and health hazards for human beings. Indeed there is a growing trend towards the usage of natural colorants of plant origin in various food industries. One of such plant that falls in this category is Bixa orellana (Annatto) whose seed aril extracts are used as a natural food colorants. Aril of seeds of B. orellana was subjected to extraction using three different solvent mixtures (CHCl3/EtOH; CHCl3/Acetone; Hexane/EtOAc) and a base extraction (5% KOH) to yield a reddishorange semi-solid, with percentage yield of 9.02% (w/w; CHCl3/EtOH), 4.90% (w/w; CHCl3/Acetone), 2.98% (w/w; Hexane/EtOAc) and 26.66% (w/w; alkali extraction). The total carotenoids were found to be 3.14% (CHCl3/EtOH), 1.42% (CHCl3/Acetone), 0.51% (Hexane/EtOAc) and 1.76% (Alkali extraction) in the seed extracts. Phytochemical investigation of the CHCl3/EtOH seed extract over silica gel preparative thin layer chromatography led to the isolation of two compounds, of which one compound BO-2 was identified as Bixin by using spectroscopic techniques (UV, IR, MS and NMR). Compound BO-3 was partially characterized. Bixin is one of the most important constituents of the seed, which was gravimetrically determined to be 1.62% (w/w) from the seed. It is important to note that the antioxidant activity of the seed extract was showed a weak free radical scavenging with an IC50 value of 3124.31 μg/ mL, which is about 50 times less than that offered by the standard ascorbic acid (IC50=577.04 μg/mL). The CHCl3/ EtOH seed extract exhibited moderate inhibitory effect against the tested bacterial pathogens at a concentration of 50 mg/mL. The Gram-negative bacterium Escherichia coli was found to be the most susceptible to the seed extract, with zone of inhibition of 14.0 mm (MIC=0.25 mg/mL), while the least antibacterial activity against the Gram-positive bacteria, S. aureus, was observed, with zone of inhibition of 9.2 mm (MIC=1.0 mg/mL). In general, the activity of the tested substances on the tested fungal pathogens were relatively weaker with the exception of seed extract against A. niger, which showed a zone inhibition of 9.2 mm (MIC=12.5 mg/mL). In conclusion, the present findings support the huge potential of B. orellana as a natural food colorant.
大量合成染料的使用造成污染，破坏生态平衡，危害人类健康。事实上，在各种食品工业中，使用植物来源的天然着色剂的趋势正在增长。其中一种属于这一类的植物是红木，它的种子假皮提取物被用作天然的食用色素。采用三种不同的溶剂(CHCl3/EtOH;CHCl3 /丙酮;正己烷/乙酸乙酯)和碱萃取(5% KOH)制得红橙色半固体，产率为9.02% (w/w;CHCl3/EtOH)， 4.90% (w/w;CHCl3/丙酮)，2.98% (w/w;己烷/EtOAc)和26.66% (w/w;碱提取)。类胡萝卜素的总含量分别为3.14% (CHCl3/EtOH)、1.42% (CHCl3/丙酮)、0.51%(己烷/EtOAc)和1.76%(碱提法)。利用硅胶制备薄层色谱对CHCl3/EtOH种子提取物进行植物化学研究，分离得到两个化合物，其中一个化合物BO-2通过光谱技术(紫外、红外、质谱和核磁共振)鉴定为Bixin。对化合物BO-3进行了部分表征。碧新是种子中最重要的成分之一，重量测定其含量为1.62% (w/w)。值得注意的是，该种子提取物显示出较弱的自由基清除能力，IC50值为3124.31 μg/mL，比标准抗坏血酸(IC50=577.04 μg/mL)低约50倍。在浓度为50 mg/mL时，CHCl3/ EtOH种子提取物对细菌病原菌有中等抑制作用。对革兰氏阴性菌大肠杆菌最敏感，抑菌带为14.0 mm (MIC=0.25 mg/mL)，对革兰氏阳性菌金黄色葡萄球菌抑菌带最小，抑菌带为9.2 mm (MIC=1.0 mg/mL)。总体而言，除种子提取物对黑曲霉的抑制作用为9.2 mm (MIC=12.5 mg/mL)外，各物质对真菌病原菌的抑制作用相对较弱。综上所述，目前的研究结果支持了黑螺旋藻作为天然食品着色剂的巨大潜力。
{"title":"Isolation, Characterization and Biological Activities of Food Colorantsfrom Bixa orellana","authors":"Bekri Melka, D. Bisrat, G. NeelaiahBabu","doi":"10.4172/2329-6887.1000237","DOIUrl":"https://doi.org/10.4172/2329-6887.1000237","url":null,"abstract":"The usage of vast amount of synthetic dye causes pollution that disturbs the ecological balance and health hazards for human beings. Indeed there is a growing trend towards the usage of natural colorants of plant origin in various food industries. One of such plant that falls in this category is Bixa orellana (Annatto) whose seed aril extracts are used as a natural food colorants. Aril of seeds of B. orellana was subjected to extraction using three different solvent mixtures (CHCl3/EtOH; CHCl3/Acetone; Hexane/EtOAc) and a base extraction (5% KOH) to yield a reddishorange semi-solid, with percentage yield of 9.02% (w/w; CHCl3/EtOH), 4.90% (w/w; CHCl3/Acetone), 2.98% (w/w; Hexane/EtOAc) and 26.66% (w/w; alkali extraction). The total carotenoids were found to be 3.14% (CHCl3/EtOH), 1.42% (CHCl3/Acetone), 0.51% (Hexane/EtOAc) and 1.76% (Alkali extraction) in the seed extracts. Phytochemical investigation of the CHCl3/EtOH seed extract over silica gel preparative thin layer chromatography led to the isolation of two compounds, of which one compound BO-2 was identified as Bixin by using spectroscopic techniques (UV, IR, MS and NMR). Compound BO-3 was partially characterized. Bixin is one of the most important constituents of the seed, which was gravimetrically determined to be 1.62% (w/w) from the seed. It is important to note that the antioxidant activity of the seed extract was showed a weak free radical scavenging with an IC50 value of 3124.31 μg/ mL, which is about 50 times less than that offered by the standard ascorbic acid (IC50=577.04 μg/mL). The CHCl3/ EtOH seed extract exhibited moderate inhibitory effect against the tested bacterial pathogens at a concentration of 50 mg/mL. The Gram-negative bacterium Escherichia coli was found to be the most susceptible to the seed extract, with zone of inhibition of 14.0 mm (MIC=0.25 mg/mL), while the least antibacterial activity against the Gram-positive bacteria, S. aureus, was observed, with zone of inhibition of 9.2 mm (MIC=1.0 mg/mL). In general, the activity of the tested substances on the tested fungal pathogens were relatively weaker with the exception of seed extract against A. niger, which showed a zone inhibition of 9.2 mm (MIC=12.5 mg/mL). In conclusion, the present findings support the huge potential of B. orellana as a natural food colorant.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"26 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2017-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81245482","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}
Pub Date : 2017-09-05DOI: 10.4172/2329-6887.1000236
R. Tetteh, E. Nartey, M. Lartey, Barbara A. Yankey, A. Mantel‐Teeuwisse, H. Leufkens, F. Acheampong, Alex, E. Dodoo
Antiretroviral Therapy (ART) is effective in reducing morbidity and mortality in patients living with HIV/AIDS (PLWHA). However, Adverse Effects (AEs) to ART pose major problems and threaten adherence to therapy. We evaluated the knowledge and attitudes of patients to ART following routine adherence counselling and education in the Korle Bu Teaching Hospital in Accra, Ghana. This cross-sectional study was conducted by administering a questionnaire on socio-demographics, knowledge of AEs of antiretrovirals and attitude to AEs to 98 patients who were on antiretroviral therapy. A 3-point Likert-scale was used to assess knowledge of AEs of ART and a 5 point Likert-scale to assess attitudes to AEs. Mean rated scores for attitude to AEs were estimated and factor analysis was used to reduce the dimensions of the attitudes observed to identify relevant latent constructs. Sixty one percent of participants were females and most of the participants were aged 35-44 years (35%). Ninety nine percent of participants answered that they had been counselled on unpleasant effects of their medicines and 93% knew that all medicines could cause some unpleasant effects. Concerning attitude, 90% of study participants strongly agreed that they benefit from their medicines and get better taking them (mean rated score=4.87 ± 0.49) whilst 27% strongly agreed that medicines may have side effects (mean rated score=3.12 ± 1.55). Majority of the study participants (74%) strongly disagreed that there was no need to tell their doctor/pharmacist about AEs to antiretrovirals (mean rated score=4.60 ± 0.83). Factor analysis yielded two underlying dimensions (cognitive and behavioural/affective aspects) that described participants’ attitude towards AEs. Study participants rating for participants’ knowledge on AEs was good and exhibited positive attitudes to AEs of ART. Adherence counselling and education provided to PLWHA before initiation of antiretroviral therapy is beneficial and should be continued.
{"title":"Knowledge and Attitudes of HIV Infected Patients on the Adverse Effectsof Antiretroviral Medicines in Ghana","authors":"R. Tetteh, E. Nartey, M. Lartey, Barbara A. Yankey, A. Mantel‐Teeuwisse, H. Leufkens, F. Acheampong, Alex, E. Dodoo","doi":"10.4172/2329-6887.1000236","DOIUrl":"https://doi.org/10.4172/2329-6887.1000236","url":null,"abstract":"Antiretroviral Therapy (ART) is effective in reducing morbidity and mortality in patients living with HIV/AIDS (PLWHA). However, Adverse Effects (AEs) to ART pose major problems and threaten adherence to therapy. We evaluated the knowledge and attitudes of patients to ART following routine adherence counselling and education in the Korle Bu Teaching Hospital in Accra, Ghana. This cross-sectional study was conducted by administering a questionnaire on socio-demographics, knowledge of AEs of antiretrovirals and attitude to AEs to 98 patients who were on antiretroviral therapy. A 3-point Likert-scale was used to assess knowledge of AEs of ART and a 5 point Likert-scale to assess attitudes to AEs. Mean rated scores for attitude to AEs were estimated and factor analysis was used to reduce the dimensions of the attitudes observed to identify relevant latent constructs. Sixty one percent of participants were females and most of the participants were aged 35-44 years (35%). Ninety nine percent of participants answered that they had been counselled on unpleasant effects of their medicines and 93% knew that all medicines could cause some unpleasant effects. Concerning attitude, 90% of study participants strongly agreed that they benefit from their medicines and get better taking them (mean rated score=4.87 ± 0.49) whilst 27% strongly agreed that medicines may have side effects (mean rated score=3.12 ± 1.55). Majority of the study participants (74%) strongly disagreed that there was no need to tell their doctor/pharmacist about AEs to antiretrovirals (mean rated score=4.60 ± 0.83). Factor analysis yielded two underlying dimensions (cognitive and behavioural/affective aspects) that described participants’ attitude towards AEs. Study participants rating for participants’ knowledge on AEs was good and exhibited positive attitudes to AEs of ART. Adherence counselling and education provided to PLWHA before initiation of antiretroviral therapy is beneficial and should be continued.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"3 1","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2017-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86354610","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}
Pub Date : 2017-09-05DOI: 10.4172/2329-6887.1000234
Santhosh Kumar, G. Anusha, Rajyalaxmi, Srinivas, Manoj
The present research was aimed to design, formulate and evaluate Mucoadhesive colon targeted microspheres of Ketoprofen for many advantages especially increased bioavailability and reduction in dosing frequency etc. Ketoprofen is a NSAID, like other drugs in this group reduces pain, inflammation and stiffness in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. In this study an attempt was made to prepare mucoadhesive microspheres of Ketoprofen using the natural polymers designed for oral controlled release. Ketoprofen microspheres were prepared following 32 full factorial designs with varying concentrations of the polymers using sodium alginate and natural polymer such guar gum, xanthan gum by orifice-ionic gelation method. The prepared ketoprofen microspheres were evaluated for surface morphology and particle shape, rheological studies. Micro encapsulation efficiency, swelling index and in vitro drug release studies were done, and compatibility studies. The microspheres were found discrete, spherical and free flowing. The percentage yield ranged from 88% to 96% and encapsulation efficiency was from 86.23% to 94.46%. The particle size was found to be between 400-550 μm. From the in vitro drug release studies the (KPN5) showed 92.12% drug release in 12 hrs and showed better control of drug release. The in vitro release data was treated with mathematical equations, and was concluded that ketoprofen followed zero order release from the microspheres and Peppas model with non-Fickian diffusion Super Case II transport. The results indicate that Enteric coated mucoadhesive colon targeted microspheres of ketoprofen containing xanthan gum; guar gum provides a better option for controlled release action and improved bioavailability.
{"title":"Design and Evaluation of a Controlled Release Drug Delivery System forManagement of Rheumatism","authors":"Santhosh Kumar, G. Anusha, Rajyalaxmi, Srinivas, Manoj","doi":"10.4172/2329-6887.1000234","DOIUrl":"https://doi.org/10.4172/2329-6887.1000234","url":null,"abstract":"The present research was aimed to design, formulate and evaluate Mucoadhesive colon targeted microspheres of Ketoprofen for many advantages especially increased bioavailability and reduction in dosing frequency etc. Ketoprofen is a NSAID, like other drugs in this group reduces pain, inflammation and stiffness in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. In this study an attempt was made to prepare mucoadhesive microspheres of Ketoprofen using the natural polymers designed for oral controlled release. \u0000Ketoprofen microspheres were prepared following 32 full factorial designs with varying concentrations of the polymers using sodium alginate and natural polymer such guar gum, xanthan gum by orifice-ionic gelation method. The prepared ketoprofen microspheres were evaluated for surface morphology and particle shape, rheological studies. Micro encapsulation efficiency, swelling index and in vitro drug release studies were done, and compatibility studies. The microspheres were found discrete, spherical and free flowing. \u0000The percentage yield ranged from 88% to 96% and encapsulation efficiency was from 86.23% to 94.46%. The particle size was found to be between 400-550 μm. From the in vitro drug release studies the (KPN5) showed 92.12% drug release in 12 hrs and showed better control of drug release. The in vitro release data was treated with mathematical equations, and was concluded that ketoprofen followed zero order release from the microspheres and Peppas model with non-Fickian diffusion Super Case II transport. The results indicate that Enteric coated mucoadhesive colon targeted microspheres of ketoprofen containing xanthan gum; guar gum provides a better option for controlled release action and improved bioavailability.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"58 1","pages":"1-17"},"PeriodicalIF":0.0,"publicationDate":"2017-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73075522","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}
Pub Date : 2017-08-28DOI: 10.4172/2329-6887.1000235
Dina O Abdulazima, Mona M Salemb, M. Hassanc, Ahmed Abdoc, Esam Rashadc, U. Din
Background: Loin pain is frequently not associated with any urinary abnormality. Musculoskeletal abnormalities are not uncommon as alternative cause of flank pain. Osteomalacia of the ribs was infrequently encountered as the cause of flank pain. Vitamin D deficiently has been reported as common problem worldwide with special predilection to Middle East area. Objective: In this study, we looked for vitamin D deficiency in patients with flank pain associated with tenderness over the tips of the lowermost ribs. Cases and methods: Out of 783 patients presenting with unilateral or bilateral flank pain to a single center over a period of 3 years, 316 did not have a definite urologic cause (group B). One hundred eighty seven of these patients had distinct tenderness over the costal margin (groupB1) that could not be explained by history and radiology. All patients of group B were tested for serum level of 25(OH) vitamin D. Results: Very low serum level of 25(OH) vitamin D was detected in all cases of group B1 and in only in only 26.4% of the remaining cases of group B (group B2). Relief of flank pain was noticed within 2 months in 55.1% of vitamin D deficient cases. Conclusion: In patients presenting with flank pain, the existence of tenderness of the last ribs instead of the renal angle proper should alert to a possible cause in the rib cage. Estimation of serum vitamin D level should be performed in these cases.
{"title":"Vitamin D Deficiency: The Unrecognized Cause of Flank Pain","authors":"Dina O Abdulazima, Mona M Salemb, M. Hassanc, Ahmed Abdoc, Esam Rashadc, U. Din","doi":"10.4172/2329-6887.1000235","DOIUrl":"https://doi.org/10.4172/2329-6887.1000235","url":null,"abstract":"Background: Loin pain is frequently not associated with any urinary abnormality. Musculoskeletal abnormalities \u0000 are not uncommon as alternative cause of flank pain. Osteomalacia of the ribs was infrequently encountered as the \u0000 cause of flank pain. Vitamin D deficiently has been reported as common problem worldwide with special predilection \u0000 to Middle East area. \u0000Objective: In this study, we looked for vitamin D deficiency in patients with flank pain associated with tenderness \u0000 over the tips of the lowermost ribs. \u0000Cases and methods: Out of 783 patients presenting with unilateral or bilateral flank pain to a single center over \u0000 a period of 3 years, 316 did not have a definite urologic cause (group B). One hundred eighty seven of these \u0000 patients had distinct tenderness over the costal margin (groupB1) that could not be explained by history and radiology. All patients of group B were tested for serum level of 25(OH) vitamin D. \u0000Results: Very low serum level of 25(OH) vitamin D was detected in all cases of group B1 and in only in only \u0000 26.4% of the remaining cases of group B (group B2). Relief of flank pain was noticed within 2 months in 55.1% of \u0000 vitamin D deficient cases. \u0000Conclusion: In patients presenting with flank pain, the existence of tenderness of the last ribs instead of the \u0000 renal angle proper should alert to a possible cause in the rib cage. Estimation of serum vitamin D level should be \u0000 performed in these cases.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"76 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2017-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83833276","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}
Pub Date : 2017-08-10DOI: 10.4172/2329-6887.1000233
Béla E. Tóth, I. Takács, L. Szekeres, Boglárka Szabó, Bence Bakos, P. Lakatos
Introduction: The primary objective of the study was to assess the safety and the efficacy of a “Slower Loading” dose of 30,000 IU vitamin D3 supplementation administered in a weekly schedule for 12 weeks in vitamin D deficient patients compared to the daily equivalent dose of 1000 IU/day regimens in a clinical trial. Methods: This open label, randomized, controlled, multicenter clinical trial was performed during the spring and summer period enrolling adult subjects with 25O HD levels <20 ng/ml. In a sub-study presented here, subjects were randomized into two treatment groups using 30,0000 IU Vitamin D3 film tablets either in weekly (WD30K group, daily dose equivalent of 4286 IU/day) or a standard dose for maintenance treatment in a daily administration (SDD1K group, 1000 IU/day). Subjects in a control group received a similar 30,0000 IU Vitamin D3 film tablets in a once-permonth schedule (MD30K), dosing schedule for 12 weeks, (an equivalent to 1000 IU/day). The assessment of efficacy made by the changes in 25O HD and PTH levels in a throughout 12 weeks. Routine laboratory tests, serum and urinary calcium served for laboratory-safety assessments in every 4 weeks throughout the duration of the study. Results: The baseline values of 25O HD at in group (WD30K, SDD1K and MD30K) were in similar range: 13.7 ± 3.7 ng/mL, 13.48 ± 3.9 ng/mL and 13.1 ± 4.3 ng/mL, respectively. A daily dose of 1000 IU for 12 weeks was effective in restoration of 25O HD values to above 20 ng/mL (50 nmol/L), however the median of the group failed to attain the 30 ng/mL (75 nmol/L) threshold. Dose-response was statistically different in the 4286 IU/day group compared to a 1000 IU/daily dose (p 30 ng/ml): 91% vs. 10% of subjects in after 8 weeks with 30,000 IU/wk and 1000 IU/d doses and 95% vs. 24% by end of the 12 weeks of treatment. The treatment-related increment potential was in a range of 2.26-2.92 ng/week for the weekly 30K dosing group compared to 1.32-1.70 ng/week for the 1000 IU/day standard maintenance dose group after 8 weeks. Treatment with 30,000 IU doses of Vitamin D3 in a weekly administration for 12 weeks did not abolish serum calcium levels. No difference in frequency of laboratory adverse events and other safety parameters was observed compared to lower maintenance doses or to control group. Conclusion: The safety of weekly loading oral doses of 30,000 IU vitamin D3 tablets was demonstrated and efficacy compared to the maintenance treatment with a daily dose equivalent of 1000 IU/d, in a daily or in monthly schedule in vitamin D deficient, adult population. Weekly administration of 30,000 IU loading dose for 12 weeks does not raise safety concern, but provides an effective tool for normalization of 25O HD levels to the desirable level of >30ng/mL in deficient patients.
{"title":"Safety and Efficacy of Weekly 30,000 IU Vitamin D Supplementation as aSlower Loading Dose Administration Compared to a Daily MaintenanceSchedule in Deficient Patients: A Randomized, Controlled Clinical Trial","authors":"Béla E. Tóth, I. Takács, L. Szekeres, Boglárka Szabó, Bence Bakos, P. Lakatos","doi":"10.4172/2329-6887.1000233","DOIUrl":"https://doi.org/10.4172/2329-6887.1000233","url":null,"abstract":"Introduction: The primary objective of the study was to assess the safety and the efficacy of a “Slower Loading” dose of 30,000 IU vitamin D3 supplementation administered in a weekly schedule for 12 weeks in vitamin D deficient patients compared to the daily equivalent dose of 1000 IU/day regimens in a clinical trial. \u0000Methods: This open label, randomized, controlled, multicenter clinical trial was performed during the spring and summer period enrolling adult subjects with 25O HD levels <20 ng/ml. In a sub-study presented here, subjects were randomized into two treatment groups using 30,0000 IU Vitamin D3 film tablets either in weekly (WD30K group, daily dose equivalent of 4286 IU/day) or a standard dose for maintenance treatment in a daily administration (SDD1K group, 1000 IU/day). Subjects in a control group received a similar 30,0000 IU Vitamin D3 film tablets in a once-permonth schedule (MD30K), dosing schedule for 12 weeks, (an equivalent to 1000 IU/day). The assessment of efficacy made by the changes in 25O HD and PTH levels in a throughout 12 weeks. Routine laboratory tests, serum and urinary calcium served for laboratory-safety assessments in every 4 weeks throughout the duration of the study. \u0000Results: The baseline values of 25O HD at in group (WD30K, SDD1K and MD30K) were in similar range: 13.7 ± 3.7 ng/mL, 13.48 ± 3.9 ng/mL and 13.1 ± 4.3 ng/mL, respectively. A daily dose of 1000 IU for 12 weeks was effective in restoration of 25O HD values to above 20 ng/mL (50 nmol/L), however the median of the group failed to attain the 30 ng/mL (75 nmol/L) threshold. Dose-response was statistically different in the 4286 IU/day group compared to a 1000 IU/daily dose (p 30 ng/ml): 91% vs. 10% of subjects in after 8 weeks with 30,000 IU/wk and 1000 IU/d doses and 95% vs. 24% by end of the 12 weeks of treatment. The treatment-related increment potential was in a range of 2.26-2.92 ng/week for the weekly 30K dosing group compared to 1.32-1.70 ng/week for the 1000 IU/day standard maintenance dose group after 8 weeks. \u0000Treatment with 30,000 IU doses of Vitamin D3 in a weekly administration for 12 weeks did not abolish serum calcium levels. No difference in frequency of laboratory adverse events and other safety parameters was observed compared to lower maintenance doses or to control group. \u0000Conclusion: The safety of weekly loading oral doses of 30,000 IU vitamin D3 tablets was demonstrated and efficacy compared to the maintenance treatment with a daily dose equivalent of 1000 IU/d, in a daily or in monthly schedule in vitamin D deficient, adult population. Weekly administration of 30,000 IU loading dose for 12 weeks does not raise safety concern, but provides an effective tool for normalization of 25O HD levels to the desirable level of >30ng/mL in deficient patients.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"22 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2017-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80011506","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}
Pub Date : 2017-08-04DOI: 10.4172/2329-6887.1000232
K. Sanghavi, M. Someshwari, Rajan, P. Seenivasan
Based on the above subjective and objective evidence, diagnosis was made as SLE, seizure with hepatitis. Patient was treated with Ranitidine 150 mg, Lamivudine 100 mg, Azathioprine 100 mg, Methotrexate 7.5 mg, Hydroxychloroquine 200 mg and Phenytoin 50 mg. Patient was taking azathioprine and phenytoin for past 5 months. Based on clinical suspicion of azathioprine and phenytoin induced hepatitis, drug was withdrawn and treatment started with Cyclosporine 100 mg and Chlorpromazine 50 mg with Nitrazepam 5 mg. A gradual reduction in symptoms and liver profile were observed.
{"title":"A Case Report of Azathioprine and Phenytoin Induced Hepatitis","authors":"K. Sanghavi, M. Someshwari, Rajan, P. Seenivasan","doi":"10.4172/2329-6887.1000232","DOIUrl":"https://doi.org/10.4172/2329-6887.1000232","url":null,"abstract":"Based on the above subjective and objective evidence, diagnosis was made as SLE, seizure with hepatitis. Patient was treated with Ranitidine 150 mg, Lamivudine 100 mg, Azathioprine 100 mg, Methotrexate 7.5 mg, Hydroxychloroquine 200 mg and Phenytoin 50 mg. Patient was taking azathioprine and phenytoin for past 5 months. Based on clinical suspicion of azathioprine and phenytoin induced hepatitis, drug was withdrawn and treatment started with Cyclosporine 100 mg and Chlorpromazine 50 mg with Nitrazepam 5 mg. A gradual reduction in symptoms and liver profile were observed.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"56 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78416378","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}
Pub Date : 2017-07-27DOI: 10.4172/2329-6887-C1-026
A. H. Stahl
{"title":"The fundamentals and importance of accurate medical review","authors":"A. H. Stahl","doi":"10.4172/2329-6887-C1-026","DOIUrl":"https://doi.org/10.4172/2329-6887-C1-026","url":null,"abstract":"","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"46 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85985098","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}
Pub Date : 2017-07-13DOI: 10.4172/2329-6887.1000E171
B. Rayaprolu
Packaging of parenteral formulations is a critical step in the product development process and most commonly achieved by using a glass container due to its relative inertness. Historically, the pharmaceutical market has utilized glass vials made from borosilicate and soda lime glass as preferred storage of pharmaceutical preparations. A potential issue with glass containers is glass delamination. Glass delamination results from surface degradation and subsequent glass chipping which is observed visually as glass flakes or lamella within the drug product solution. Though clinical relevance of visual particulate, including glass lamella, is difficult to ascertain, glass delamination should be taken seriously as any foreign particulate injected may be hazardous. The issue of glass delamination has caused several pharmaceutical manufacturers to voluntarily recall their drug products. As glass delamination might take multiple years to develop, pharmaceutical companies struggle to identify potential risky drug products in the early stages of development process and may be severely impacted due to occurrence while marketing. Financial burdens, both direct and indirect, may accrue if the drug product is actively marketed and subsequently recalled. Hence, the Food and Drug Administration recommends conducting stability studies of the pharmaceutical drug product with the intended packaging components. Glass manufacturers are also conducting new techniques and statistical control testing to determine the delamination propensity of the glass vials [1].
{"title":"Glass Delamination in Parenterals: A Brief Overview","authors":"B. Rayaprolu","doi":"10.4172/2329-6887.1000E171","DOIUrl":"https://doi.org/10.4172/2329-6887.1000E171","url":null,"abstract":"Packaging of parenteral formulations is a critical step in the product development process and most commonly achieved by using a glass container due to its relative inertness. Historically, the pharmaceutical market has utilized glass vials made from borosilicate and soda lime glass as preferred storage of pharmaceutical preparations. A potential issue with glass containers is glass delamination. Glass delamination results from surface degradation and subsequent glass chipping which is observed visually as glass flakes or lamella within the drug product solution. Though clinical relevance of visual particulate, including glass lamella, is difficult to ascertain, glass delamination should be taken seriously as any foreign particulate injected may be hazardous. The issue of glass delamination has caused several pharmaceutical manufacturers to voluntarily recall their drug products. As glass delamination might take multiple years to develop, pharmaceutical companies struggle to identify potential risky drug products in the early stages of development process and may be severely impacted due to occurrence while marketing. Financial burdens, both direct and indirect, may accrue if the drug product is actively marketed and subsequently recalled. Hence, the Food and Drug Administration recommends conducting stability studies of the pharmaceutical drug product with the intended packaging components. Glass manufacturers are also conducting new techniques and statistical control testing to determine the delamination propensity of the glass vials [1].","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"122 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88009452","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}
Pub Date : 2017-06-29DOI: 10.4172/2329-6887.1000e170
G. Elhassan, Sana Hashmi, S. A. Farhana, K. Qureshi, R. Khan
Volume 5 • Issue 3 • 1000e170 J Pharmacovigil, an open access journal ISSN: 2329-6887 Pharmacists’ roles in pharmacogenetics have remained as poorly defined, and have a little or negligible role to play in their own field and is expected to continue like this in the future as well. However, in actual clinical set up, practitioners whose training and practices involve clinical monitoring of drug treatment, pharmacists are in a valuable position to help them define the role of pharmacogenetics in the eventual outcome of the pharmacotherapy.
{"title":"Role of Pharmacists in Pharmacogenomics","authors":"G. Elhassan, Sana Hashmi, S. A. Farhana, K. Qureshi, R. Khan","doi":"10.4172/2329-6887.1000e170","DOIUrl":"https://doi.org/10.4172/2329-6887.1000e170","url":null,"abstract":"Volume 5 • Issue 3 • 1000e170 J Pharmacovigil, an open access journal ISSN: 2329-6887 Pharmacists’ roles in pharmacogenetics have remained as poorly defined, and have a little or negligible role to play in their own field and is expected to continue like this in the future as well. However, in actual clinical set up, practitioners whose training and practices involve clinical monitoring of drug treatment, pharmacists are in a valuable position to help them define the role of pharmacogenetics in the eventual outcome of the pharmacotherapy.","PeriodicalId":16958,"journal":{"name":"Journal of Pharmacovigilance","volume":"1 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77867027","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：