Tea consumption has increased due to its beneficial effects. Results from a lab study on the effect of sucrose (5 g per cup, 150 mL) and/or ascorbic acid (2 mL per cup, 150 mL) on dissolved aluminum compounds during t...Tea consumption has increased due to its beneficial effects. Results from a lab study on the effect of sucrose (5 g per cup, 150 mL) and/or ascorbic acid (2 mL per cup, 150 mL) on dissolved aluminum compounds during the infusion of two commercial types of dry tea leaves (black, green) with boiling water (5, 15 min infusion time) are presented. Factors influencing the presence of dissolved aluminum in the infusions of both tea leaves were infusion time and sugar contents, as well as the interaction between ascorbic acid and sucrose (p < 0.05). Aluminum contents found after 15 min of infusion were 0.7 mg L–1 for black tea infusions added with sugar, and 0.69 mg L–1 for green tea added with both sugar and ascorbic acid. Both concentrations are higher than the level accepted in Mexico for drinking water (there is no act concerning tea infusions), that is 0.2 mg L–1.展开更多
AIM:To study the safety and effectiveness associated with accelerated infliximab infusion protocols in patients with inflammatory bowel disease(IBD).METHODS:Original protocols and infusion rates were developed for the...AIM:To study the safety and effectiveness associated with accelerated infliximab infusion protocols in patients with inflammatory bowel disease(IBD).METHODS:Original protocols and infusion rates were developed for the administration of infliximab over 90-min and 60-min.Then the IBD patients on stable maintenance infliximab therapy were offered accelerated infusions.To be eligible for the study,patients needed a minimum of four prior infusions.An initial infusion of 90-min was given to each patient;those tolerating the accelerated infusion were transitioned to a 60-min infusion protocol at their next and all subsequent visits.Any patient having significant infusion reactions would be reverted to the standard 120-min protocol.A change in a patient's dose mandated a single 120-min infusion before accelerated infusions could be administered again.RESULTS:The University of Virginia Medical Center's Institutional Review Board approved this study.Fifty IBD patients treated with infliximab 5mg/kg,7.5mg/kg and 10mg/kg were offered accelerated infusions.Forty-six patients consented to participate in the study.Nineteen(41.3%) were female,five(10.9%) were African American and nine(19.6%) had ulcerative colitis.The mean age was 42.6 years old.Patients under age 18 were excluded.Ten patients used immunosuppressive drugs concurrently out of which six were taking azathioprine,three were taking 6-mercaptopurine and one was taking methotrexate.One of the 46 study patients used corticosteroid therapy for his IBD.Seventeen of the patients used prophylactic medications prior to receiving infusions;six patients received corticosteroids as pre-medication.Four patients had a history of distant transfusion reactions to infliximab.These reactions included shortness of breath,chest tightness,flushing,pruritus and urticaria.These patients all took prophylactic medications before receiving infusions.46 patients(27 males and 19 females) received a total of fifty 90-min infusions and ninety-three 60-min infusions.No infusion reactions were reported.There were no adverse events,including drug-related infections.None of the patients developed cancer of any type during the study timeframe.Total cost savings for administration of the both 90-min and 60-min accelerated infusions compared to standard 120-min infusions was estimated to be $53 632($116 965 vs $63 333,P=0.001).One hundred and eighteen hours were saved in the administration of the accelerated infusions(17 160 min vs 10 080 min,P=0.001).In the study population,overweight females [body mass index(BMI)>25.00kg/m2] were found to have statistically higher BMIs than overweight males(mean BMI 35.07±2.66kg/m2 vs 30.08±0.99kg/m2,P=0.05),finding which is of significance since obesity was described as being one of the risk factors for Crohn's disease.CONCLUSION:We are the first US group to report substantial cost savings,increased safety and patient satisfaction associated with accelerated infliximab infusion.展开更多
Pharmacokinetic compartment models are the only models that can extract pharmacokinetic parameters from data collected in clinical studies but their estimates lack accuracy, explanations and physiological significance...Pharmacokinetic compartment models are the only models that can extract pharmacokinetic parameters from data collected in clinical studies but their estimates lack accuracy, explanations and physiological significance. The objective of this work was to develop particular solutions to drug concentration and AUC in the form of mathematical series and Heaviside functions for repetitive intermittent infusions in the one- and two-compartment models, as a function of dose number and total time using differential calculus. It was demonstrated that the central and peripheral compartment volumes determined from regression analysis of the aminoglycoside antibiotic Sisomicin concentration in plasma represent the actual physiological body fluid volumes accessible by the drug. The drug peak time and peak concentration in the peripheral compartment were also calculated as a function of dose number. It is also shown that the time of intercompartmental momentary distribution equilibrium can be used to determine the drug’s apparent volume of distribution within any dosing interval in multi-compartment models. These estimates were used to carry out simulations of plasma drug concentration with time in the one-compartment model. In conclusion, the two-compartment open mammillary pharmacokinetic model was fully explained for the aminoglycoside antibiotic sisomicin through the new concept of the apparent volume of distribution.展开更多
A simple iterative process can be used to generate intravenous drug infusion profiles. It overcomes limitations in deriving compartmental pharmacokinetic models and has application to evaluation of new drugs and to cl...A simple iterative process can be used to generate intravenous drug infusion profiles. It overcomes limitations in deriving compartmental pharmacokinetic models and has application to evaluation of new drugs and to clinical practice.展开更多
Schwann cells are essential for the maintenance and function of motor neurons,axonal networks,and the neuromuscular junction.In amyotrophic lateral sclerosis,where motor neuron function is progressively lost,Schwann c...Schwann cells are essential for the maintenance and function of motor neurons,axonal networks,and the neuromuscular junction.In amyotrophic lateral sclerosis,where motor neuron function is progressively lost,Schwann cell function may also be impaired.Recently,important signaling and potential trophic activities of Schwann cell-derived exosomal vesicles have been reported.This case report describes the treatment of a patient with advanced amyotrophic lateral sclerosis using serial intravenous infusions of allogeneic Schwann cell-derived exosomal vesicles,marking,to our knowledge,the first instance of such treatment.An 81-year-old male patient presented with a 1.5-year history of rapidly progressive amyotrophic lateral sclerosis.After initial diagnosis,the patient underwent a combination of generic riluzole,sodium phenylbutyrate for the treatment of amyotrophic lateral sclerosis,and taurursodiol.The patient volunteered to participate in an FDA-approved single-patient expanded access treatment and received weekly intravenous infusions of allogeneic Schwann cell-derived exosomal vesicles to potentially restore impaired Schwann cell and motor neuron function.We confirmed that cultured Schwann cells obtained from the amyotrophic lateral sclerosis patient via sural nerve biopsy appeared impaired(senescent)and that exposure of the patient’s Schwann cells to allogeneic Schwann cell-derived exosomal vesicles,cultured expanded from a cadaver donor improved their growth capacity in vitro.After a period of observation lasting 10 weeks,during which amyotrophic lateral sclerosis Functional Rating Scale-Revised and pulmonary function were regularly monitored,the patient received weekly consecutive infusions of 1.54×1012(×2),and then consecutive infusions of 7.5×1012(×6)allogeneic Schwann cell-derived exosomal vesicles diluted in 40 mL of Dulbecco’s phosphate-buffered saline.None of the infusions were associated with adverse events such as infusion reactions(allergic or otherwise)or changes in vital signs.Clinical lab serum neurofilament and cytokine levels measured prior to each infusion varied somewhat without a clear trend.A more sensitive in-house assay suggested possible inflammasome activation during the disease course.A trend for clinical stabilization was observed during the infusion period.Our study provides a novel approach to address impaired Schwann cells and possibly motor neuron function in patients with amyotrophic lateral sclerosis using allogeneic Schwann cell-derived exosomal vesicles.Initial findings suggest that this approach is safe.展开更多
A female patient diagnosed with acute myelocytic leukemia M5a （AML-M5a） relapsed 986 days after her allogeneic peripheral blood stem cell transplantation （alIo-PBSCT） from an unrelated male donor with matched huma...A female patient diagnosed with acute myelocytic leukemia M5a （AML-M5a） relapsed 986 days after her allogeneic peripheral blood stem cell transplantation （alIo-PBSCT） from an unrelated male donor with matched human leukocyte antigen （HLA）. Three re-induction chemotherapies were administered, and partial remission was achieved. The patient was given repetitive infusion of cytokine-induced killer （CIK） cells expanded from recipient peripheral mononuclear cells of full donor chimerism due to loss of contact of quondam donor for donor lymphocyte infusion （DLI） and rejection of second transplantation. The patient achieved complete cytogenetical remission. This strategy might overcome the obstacle of donor unavailability and present an appealing new therapeutic alternative to donor-recruited adoptive immunotherapy for relapsed disease at post-transplantation.展开更多
目的总结成人患者安全输注血管活性药物的最佳证据总结,为临床护理工作提供证据支持。方法检索UpToDate、BMJ Best Practice、澳大利亚乔安娜布里格斯研究所循证卫生保健中心数据库、Cochrane Library、美国国立指南库、美国疾病预防与...目的总结成人患者安全输注血管活性药物的最佳证据总结,为临床护理工作提供证据支持。方法检索UpToDate、BMJ Best Practice、澳大利亚乔安娜布里格斯研究所循证卫生保健中心数据库、Cochrane Library、美国国立指南库、美国疾病预防与控制中心、英国国家临床医学研究所指南库、国际指南协作网、CINAHL、Embase、加拿大安大略注册护士协会、英国重症监护协会、美国静脉输液护理学会、PubMed、Web of Science、中国知网、万方数据库、维普网、中华护理学会、中国生物医学文献数据库和医脉通中有关成人患者血管活性药物输注的指南、专家共识、团体标准、系统评价、证据总结和原始研究等证据。检索时限为2013年1月1日-2023年3月10日。由2名具有循证护理研究背景的研究者独立进行文献质量评价及证据筛查,证据汇总后由团队归类综合。结果共纳入12篇文献,从培训与教育、评估、血管通路选择、输注方案、并发症管理5个维度总结了29条证据。结论该研究总结了成人患者血管活性药物输注的最佳证据,可为医务人员提供科学的输注方案,保证患者安全,提高护理质量。展开更多
目的 探讨预防性加温输液在急诊严重创伤患者中的应用效果。方法 选取2022年1月至12月上海市第六人民医院收治的急诊严重创伤患者84例,采用随机数字表法分为对照组(42例)和观察组(42例)。对照组采用常规干预和常规保温措施,观察组在对...目的 探讨预防性加温输液在急诊严重创伤患者中的应用效果。方法 选取2022年1月至12月上海市第六人民医院收治的急诊严重创伤患者84例,采用随机数字表法分为对照组(42例)和观察组(42例)。对照组采用常规干预和常规保温措施,观察组在对照组的基础上进行预防性加温输液。比较两组体温值、凝血指标和酸碱指标变化,28 d存活率,寒战、低体温发生率。结果 两组体温组间、时间点及交互作用比较,差异有统计学意义(P<0.05)。进一步两两比较,组内比较:两组组内各时间点体温值比较,差异无统计学意义(P>0.05);组间比较:观察组入院后4、8、12、24 h体温值高于对照组,差异有统计学意义(P<0.05)。两组TT水平组间、时间点及交互作用比较,差异有统计学意义(P<0.05)。其中,两组入院后24 h TT水平高于入院时,观察组入院6、12、24 h TT水平低于对照组,差异有统计学意义(P<0.05)。两组不同时间FIB水平比较,差异有统计学意义(P<0.05)。其中两组入院后24 h FIB水平低于入院时,差异有统计学意义(P<0.05)。两组不同时间点血乳酸水平比较,差异有统计学意义(P<0.05)。其中两组入院后6、12、24 h血乳酸水平高于入院时,差异有统计学意义(P<0.05)。两组p H值水平组间、时间点比较,差异有统计学意义(P<0.05)。其中两组入院后6、12、24 h p H值水平低于入院时,差异有统计学意义(P<0.05)。观察组寒战、低体温发生率低于对照组,差异有统计学意义(P<0.05)。两组28 d存活率比较,差异无统计学意义(P>0.05)。结论 预防性加温输液可减少寒战和低体温的发生,并改善患者凝血功能。展开更多
文摘Tea consumption has increased due to its beneficial effects. Results from a lab study on the effect of sucrose (5 g per cup, 150 mL) and/or ascorbic acid (2 mL per cup, 150 mL) on dissolved aluminum compounds during the infusion of two commercial types of dry tea leaves (black, green) with boiling water (5, 15 min infusion time) are presented. Factors influencing the presence of dissolved aluminum in the infusions of both tea leaves were infusion time and sugar contents, as well as the interaction between ascorbic acid and sucrose (p < 0.05). Aluminum contents found after 15 min of infusion were 0.7 mg L–1 for black tea infusions added with sugar, and 0.69 mg L–1 for green tea added with both sugar and ascorbic acid. Both concentrations are higher than the level accepted in Mexico for drinking water (there is no act concerning tea infusions), that is 0.2 mg L–1.
文摘AIM:To study the safety and effectiveness associated with accelerated infliximab infusion protocols in patients with inflammatory bowel disease(IBD).METHODS:Original protocols and infusion rates were developed for the administration of infliximab over 90-min and 60-min.Then the IBD patients on stable maintenance infliximab therapy were offered accelerated infusions.To be eligible for the study,patients needed a minimum of four prior infusions.An initial infusion of 90-min was given to each patient;those tolerating the accelerated infusion were transitioned to a 60-min infusion protocol at their next and all subsequent visits.Any patient having significant infusion reactions would be reverted to the standard 120-min protocol.A change in a patient's dose mandated a single 120-min infusion before accelerated infusions could be administered again.RESULTS:The University of Virginia Medical Center's Institutional Review Board approved this study.Fifty IBD patients treated with infliximab 5mg/kg,7.5mg/kg and 10mg/kg were offered accelerated infusions.Forty-six patients consented to participate in the study.Nineteen(41.3%) were female,five(10.9%) were African American and nine(19.6%) had ulcerative colitis.The mean age was 42.6 years old.Patients under age 18 were excluded.Ten patients used immunosuppressive drugs concurrently out of which six were taking azathioprine,three were taking 6-mercaptopurine and one was taking methotrexate.One of the 46 study patients used corticosteroid therapy for his IBD.Seventeen of the patients used prophylactic medications prior to receiving infusions;six patients received corticosteroids as pre-medication.Four patients had a history of distant transfusion reactions to infliximab.These reactions included shortness of breath,chest tightness,flushing,pruritus and urticaria.These patients all took prophylactic medications before receiving infusions.46 patients(27 males and 19 females) received a total of fifty 90-min infusions and ninety-three 60-min infusions.No infusion reactions were reported.There were no adverse events,including drug-related infections.None of the patients developed cancer of any type during the study timeframe.Total cost savings for administration of the both 90-min and 60-min accelerated infusions compared to standard 120-min infusions was estimated to be $53 632($116 965 vs $63 333,P=0.001).One hundred and eighteen hours were saved in the administration of the accelerated infusions(17 160 min vs 10 080 min,P=0.001).In the study population,overweight females [body mass index(BMI)>25.00kg/m2] were found to have statistically higher BMIs than overweight males(mean BMI 35.07±2.66kg/m2 vs 30.08±0.99kg/m2,P=0.05),finding which is of significance since obesity was described as being one of the risk factors for Crohn's disease.CONCLUSION:We are the first US group to report substantial cost savings,increased safety and patient satisfaction associated with accelerated infliximab infusion.
文摘Pharmacokinetic compartment models are the only models that can extract pharmacokinetic parameters from data collected in clinical studies but their estimates lack accuracy, explanations and physiological significance. The objective of this work was to develop particular solutions to drug concentration and AUC in the form of mathematical series and Heaviside functions for repetitive intermittent infusions in the one- and two-compartment models, as a function of dose number and total time using differential calculus. It was demonstrated that the central and peripheral compartment volumes determined from regression analysis of the aminoglycoside antibiotic Sisomicin concentration in plasma represent the actual physiological body fluid volumes accessible by the drug. The drug peak time and peak concentration in the peripheral compartment were also calculated as a function of dose number. It is also shown that the time of intercompartmental momentary distribution equilibrium can be used to determine the drug’s apparent volume of distribution within any dosing interval in multi-compartment models. These estimates were used to carry out simulations of plasma drug concentration with time in the one-compartment model. In conclusion, the two-compartment open mammillary pharmacokinetic model was fully explained for the aminoglycoside antibiotic sisomicin through the new concept of the apparent volume of distribution.
文摘A simple iterative process can be used to generate intravenous drug infusion profiles. It overcomes limitations in deriving compartmental pharmacokinetic models and has application to evaluation of new drugs and to clinical practice.
基金support from the Miami Project to Cure Paralysis,the Buoniconti Fund,and the Interdisciplinary Stem Cell Institute(to AK,WDD,JDG,and ADL)the unconditional support of Dean Henri Ford of the Leonard M.Miller School of Medicine at the University of Miami.
文摘Schwann cells are essential for the maintenance and function of motor neurons,axonal networks,and the neuromuscular junction.In amyotrophic lateral sclerosis,where motor neuron function is progressively lost,Schwann cell function may also be impaired.Recently,important signaling and potential trophic activities of Schwann cell-derived exosomal vesicles have been reported.This case report describes the treatment of a patient with advanced amyotrophic lateral sclerosis using serial intravenous infusions of allogeneic Schwann cell-derived exosomal vesicles,marking,to our knowledge,the first instance of such treatment.An 81-year-old male patient presented with a 1.5-year history of rapidly progressive amyotrophic lateral sclerosis.After initial diagnosis,the patient underwent a combination of generic riluzole,sodium phenylbutyrate for the treatment of amyotrophic lateral sclerosis,and taurursodiol.The patient volunteered to participate in an FDA-approved single-patient expanded access treatment and received weekly intravenous infusions of allogeneic Schwann cell-derived exosomal vesicles to potentially restore impaired Schwann cell and motor neuron function.We confirmed that cultured Schwann cells obtained from the amyotrophic lateral sclerosis patient via sural nerve biopsy appeared impaired(senescent)and that exposure of the patient’s Schwann cells to allogeneic Schwann cell-derived exosomal vesicles,cultured expanded from a cadaver donor improved their growth capacity in vitro.After a period of observation lasting 10 weeks,during which amyotrophic lateral sclerosis Functional Rating Scale-Revised and pulmonary function were regularly monitored,the patient received weekly consecutive infusions of 1.54×1012(×2),and then consecutive infusions of 7.5×1012(×6)allogeneic Schwann cell-derived exosomal vesicles diluted in 40 mL of Dulbecco’s phosphate-buffered saline.None of the infusions were associated with adverse events such as infusion reactions(allergic or otherwise)or changes in vital signs.Clinical lab serum neurofilament and cytokine levels measured prior to each infusion varied somewhat without a clear trend.A more sensitive in-house assay suggested possible inflammasome activation during the disease course.A trend for clinical stabilization was observed during the infusion period.Our study provides a novel approach to address impaired Schwann cells and possibly motor neuron function in patients with amyotrophic lateral sclerosis using allogeneic Schwann cell-derived exosomal vesicles.Initial findings suggest that this approach is safe.
文摘A female patient diagnosed with acute myelocytic leukemia M5a （AML-M5a） relapsed 986 days after her allogeneic peripheral blood stem cell transplantation （alIo-PBSCT） from an unrelated male donor with matched human leukocyte antigen （HLA）. Three re-induction chemotherapies were administered, and partial remission was achieved. The patient was given repetitive infusion of cytokine-induced killer （CIK） cells expanded from recipient peripheral mononuclear cells of full donor chimerism due to loss of contact of quondam donor for donor lymphocyte infusion （DLI） and rejection of second transplantation. The patient achieved complete cytogenetical remission. This strategy might overcome the obstacle of donor unavailability and present an appealing new therapeutic alternative to donor-recruited adoptive immunotherapy for relapsed disease at post-transplantation.
文摘目的总结成人患者安全输注血管活性药物的最佳证据总结,为临床护理工作提供证据支持。方法检索UpToDate、BMJ Best Practice、澳大利亚乔安娜布里格斯研究所循证卫生保健中心数据库、Cochrane Library、美国国立指南库、美国疾病预防与控制中心、英国国家临床医学研究所指南库、国际指南协作网、CINAHL、Embase、加拿大安大略注册护士协会、英国重症监护协会、美国静脉输液护理学会、PubMed、Web of Science、中国知网、万方数据库、维普网、中华护理学会、中国生物医学文献数据库和医脉通中有关成人患者血管活性药物输注的指南、专家共识、团体标准、系统评价、证据总结和原始研究等证据。检索时限为2013年1月1日-2023年3月10日。由2名具有循证护理研究背景的研究者独立进行文献质量评价及证据筛查,证据汇总后由团队归类综合。结果共纳入12篇文献,从培训与教育、评估、血管通路选择、输注方案、并发症管理5个维度总结了29条证据。结论该研究总结了成人患者血管活性药物输注的最佳证据,可为医务人员提供科学的输注方案,保证患者安全,提高护理质量。
文摘目的 探讨预防性加温输液在急诊严重创伤患者中的应用效果。方法 选取2022年1月至12月上海市第六人民医院收治的急诊严重创伤患者84例,采用随机数字表法分为对照组(42例)和观察组(42例)。对照组采用常规干预和常规保温措施,观察组在对照组的基础上进行预防性加温输液。比较两组体温值、凝血指标和酸碱指标变化,28 d存活率,寒战、低体温发生率。结果 两组体温组间、时间点及交互作用比较,差异有统计学意义(P<0.05)。进一步两两比较,组内比较:两组组内各时间点体温值比较,差异无统计学意义(P>0.05);组间比较:观察组入院后4、8、12、24 h体温值高于对照组,差异有统计学意义(P<0.05)。两组TT水平组间、时间点及交互作用比较,差异有统计学意义(P<0.05)。其中,两组入院后24 h TT水平高于入院时,观察组入院6、12、24 h TT水平低于对照组,差异有统计学意义(P<0.05)。两组不同时间FIB水平比较,差异有统计学意义(P<0.05)。其中两组入院后24 h FIB水平低于入院时,差异有统计学意义(P<0.05)。两组不同时间点血乳酸水平比较,差异有统计学意义(P<0.05)。其中两组入院后6、12、24 h血乳酸水平高于入院时,差异有统计学意义(P<0.05)。两组p H值水平组间、时间点比较,差异有统计学意义(P<0.05)。其中两组入院后6、12、24 h p H值水平低于入院时,差异有统计学意义(P<0.05)。观察组寒战、低体温发生率低于对照组,差异有统计学意义(P<0.05)。两组28 d存活率比较,差异无统计学意义(P>0.05)。结论 预防性加温输液可减少寒战和低体温的发生,并改善患者凝血功能。
