Treprostinil is a relatively new tricyclic prostacyclin analog with a stable str-ucture,extended half-life and improved potency.Currently,treprostinil is indicated by the Food and Drug Administration in the United Sta...Treprostinil is a relatively new tricyclic prostacyclin analog with a stable str-ucture,extended half-life and improved potency.Currently,treprostinil is indicated by the Food and Drug Administration in the United States for the treatment of pulmonary arterial hypertension(group 1 in the pulmonary hy-pertension classification of the World Health Organization).It has a potent vasodilating effect along with the inhibition of platelet aggregation and the attenuation of the inflammatory response in pulmonary and systemic circulation.It is available in the following formulations:Subcutaneous,intravenous,inhaled and oral.Although unknown to many clinicians,several encouraging reports of off-label treprostinil use in the adult population suggest its potential effectiveness in other clinical conditions.Currently under investigation are digital ischemia secondary to systemic sclerosis,chronic limb ischemia,hepatic ischemia-reper-fusion injury and group 3 and 4 pulmonary hypertension.Based on review and analysis of the available literature,this article provides a thorough update on the off-label use of treprostinil in adult patients.展开更多
High-quality scientific research is very important in attempting to effectively control the coronavirus disease 2019(COVID-19)pandemic and ensure people’s health and safety.Chloroquine(CQ)and hydroxychloroquine(HCQ)h...High-quality scientific research is very important in attempting to effectively control the coronavirus disease 2019(COVID-19)pandemic and ensure people’s health and safety.Chloroquine(CQ)and hydroxychloroquine(HCQ)have received much attention.This article comprehensively investigates the ethical review of off-label CQ and HCQ research during the COVID-19 pandemic with regard to strictly abiding by review standards,improving review efficiency,ensuring the rights and interests of subjects and that ethics committees conduct independent reviews,and achieving full ethics supervision of research conducted during an emergency.Research must be both rigorous and prudent to ensure the best outcome,with the maximization of benefits as the core principle.Standardization of the application,implementation and ethical review processes are needed to prevent unnecessary risk.展开更多
Aim: To analyse antibiotic prescriptions in a cohort of extremely low birth weight neonates admitted to Italian level III Neonatal intensive Care Units. Methods: An online questionnaire was used to collect detailed in...Aim: To analyse antibiotic prescriptions in a cohort of extremely low birth weight neonates admitted to Italian level III Neonatal intensive Care Units. Methods: An online questionnaire was used to collect detailed information for each newborn. Antibiotic prescriptions were classified about their license status and compared with British National Formulary for Children (BNFC) and with a practical guide prepared by the Italian Society of Neonatology (ISN). Results: During the study period (May-July 2014) among 93 neonates admitted to 30 Italian Neonatal intensive Care Units, 56 (60%) received at least an antibiotic (92 prescriptions in total). Ampicillin, gentamicin and vancomycin were the antibiotics most commonly used for the prevention/treatment of bacterial infections. 56/92 antibiotic prescriptions (61%) resulted off-label mainly as regards dosing frequency, while 13 prescriptions (14%) regarded antibiotics used in absence of specific indication for newborns (meropenem, imipenem, piperacillin/tazobactam, clindamycin, clarithromycin). 50/56 neonates (89.3%) received at least one off-label antibiotic prescription. Differences have been observed in dosing regimens between current study and recommendations contained in BNFC, while prescriptions adhered more frequently to ISN indications. Conclusions: Our results confirm the high prevalence of off-label antibiotic use in ELBW neonates and underline a better adherence to indications based on clinical practice.展开更多
Off-label use is defined by the prescription of a marketed drug outside the conditions described in the summary of product characteristics.In oncology,off-label prescribing of targeted therapies may occur in patients ...Off-label use is defined by the prescription of a marketed drug outside the conditions described in the summary of product characteristics.In oncology,off-label prescribing of targeted therapies may occur in patients with other tumor types expressing the same target.Agents associated to phenotypic approaches such as therapies against the tumoral vasculature(anti-angiogenic drugs) and new immunotherapies(checkpoint inhibitors) also carry the potential of alternative indications or combinations.Off-label use of targeted therapies is little documented and appears to be in the same range than that regarding older drugs with wide variations among agents.When compared with older agents,off-label use of targeted therapies is probably more rational through tumoral genotyping but is faced with a limited clinical support,reimbursement challenges related to the very high pricing and the cost of genotyping or molecular profiling,when applicable.展开更多
目的:以儿童癫痫为研究病种,调研该院门诊儿科患者面临的超说明书用药情况,建立门诊儿科超说明书用药风险获益评估体系。方法:对2021—2022年该院儿科诊断为癫痫的1400例患者的门诊处方进行分析,运用Logistic回归分析推测影响儿童癫痫...目的:以儿童癫痫为研究病种,调研该院门诊儿科患者面临的超说明书用药情况,建立门诊儿科超说明书用药风险获益评估体系。方法:对2021—2022年该院儿科诊断为癫痫的1400例患者的门诊处方进行分析,运用Logistic回归分析推测影响儿童癫痫患者超说明书用药的独立因素,并使用“Benefit and Risk Assessment for Off-label Use”(BRAvO)评估表对托吡酯超说明书用药进行分析。结果:1400例门急诊癫痫患儿中,共有112例超说明书用药。多因素Logistic回归分析结果显示,年龄和用药品种数是癫痫患儿超说明书用药的独立影响因素。运用BRAvO评估表确定了托吡酯在2岁以下儿童使用的有效性,但是未确定具体给药剂量。结论:超说明书用药仍然是门诊儿科患者面临的主要问题,BRAvO评估表可为门诊儿科超说明书用药提供决策,规范儿科超说明书用药,降低超说明书用药风险。展开更多
目的为优化或制定统一的药品说明书外用法专家共识的证据和推荐意见评价方法提供参考。方法检索中国知网、万方数据、维普网、中国生物医学文献数据库、PubMed和Web of Science,纳入各数据库自建库起至2024年8月1日收录的包含证据和推...目的为优化或制定统一的药品说明书外用法专家共识的证据和推荐意见评价方法提供参考。方法检索中国知网、万方数据、维普网、中国生物医学文献数据库、PubMed和Web of Science,纳入各数据库自建库起至2024年8月1日收录的包含证据和推荐意见评价方法的药品说明书外用法中国专家共识,筛选文献并提取资料后进行描述性统计分析。结果与结论最终纳入32篇文献,14篇(43.8%)采用Micromedex的Thomson分级系统,形成推荐意见时仅有7篇(21.9%)考虑了经济性,10篇(31.3%)报告了利益冲突情况,仅2篇(6.3%)有循证医学方法学专家的参与。不同专家共识评价方法中证据来源类型、形成推荐意见时考量的因素、证据和推荐意见分级标准有差异,同一用法在不同专家共识中的证据等级和推荐意见也有差异。建议未来制定共识时应提高对参与共识人员利益冲突的关注度,加强与方法学专家的合作,并尽快制定统一的证据和推荐意见评价方法标准。展开更多
文摘Treprostinil is a relatively new tricyclic prostacyclin analog with a stable str-ucture,extended half-life and improved potency.Currently,treprostinil is indicated by the Food and Drug Administration in the United States for the treatment of pulmonary arterial hypertension(group 1 in the pulmonary hy-pertension classification of the World Health Organization).It has a potent vasodilating effect along with the inhibition of platelet aggregation and the attenuation of the inflammatory response in pulmonary and systemic circulation.It is available in the following formulations:Subcutaneous,intravenous,inhaled and oral.Although unknown to many clinicians,several encouraging reports of off-label treprostinil use in the adult population suggest its potential effectiveness in other clinical conditions.Currently under investigation are digital ischemia secondary to systemic sclerosis,chronic limb ischemia,hepatic ischemia-reper-fusion injury and group 3 and 4 pulmonary hypertension.Based on review and analysis of the available literature,this article provides a thorough update on the off-label use of treprostinil in adult patients.
基金Supported by National Natural Science Foundation of China,No.81900641Peking University Health Center for Combating the Pandemic Programs,No.BMU 2021MX020,and No.BMU 2022MX008.
文摘High-quality scientific research is very important in attempting to effectively control the coronavirus disease 2019(COVID-19)pandemic and ensure people’s health and safety.Chloroquine(CQ)and hydroxychloroquine(HCQ)have received much attention.This article comprehensively investigates the ethical review of off-label CQ and HCQ research during the COVID-19 pandemic with regard to strictly abiding by review standards,improving review efficiency,ensuring the rights and interests of subjects and that ethics committees conduct independent reviews,and achieving full ethics supervision of research conducted during an emergency.Research must be both rigorous and prudent to ensure the best outcome,with the maximization of benefits as the core principle.Standardization of the application,implementation and ethical review processes are needed to prevent unnecessary risk.
文摘Aim: To analyse antibiotic prescriptions in a cohort of extremely low birth weight neonates admitted to Italian level III Neonatal intensive Care Units. Methods: An online questionnaire was used to collect detailed information for each newborn. Antibiotic prescriptions were classified about their license status and compared with British National Formulary for Children (BNFC) and with a practical guide prepared by the Italian Society of Neonatology (ISN). Results: During the study period (May-July 2014) among 93 neonates admitted to 30 Italian Neonatal intensive Care Units, 56 (60%) received at least an antibiotic (92 prescriptions in total). Ampicillin, gentamicin and vancomycin were the antibiotics most commonly used for the prevention/treatment of bacterial infections. 56/92 antibiotic prescriptions (61%) resulted off-label mainly as regards dosing frequency, while 13 prescriptions (14%) regarded antibiotics used in absence of specific indication for newborns (meropenem, imipenem, piperacillin/tazobactam, clindamycin, clarithromycin). 50/56 neonates (89.3%) received at least one off-label antibiotic prescription. Differences have been observed in dosing regimens between current study and recommendations contained in BNFC, while prescriptions adhered more frequently to ISN indications. Conclusions: Our results confirm the high prevalence of off-label antibiotic use in ELBW neonates and underline a better adherence to indications based on clinical practice.
文摘Off-label use is defined by the prescription of a marketed drug outside the conditions described in the summary of product characteristics.In oncology,off-label prescribing of targeted therapies may occur in patients with other tumor types expressing the same target.Agents associated to phenotypic approaches such as therapies against the tumoral vasculature(anti-angiogenic drugs) and new immunotherapies(checkpoint inhibitors) also carry the potential of alternative indications or combinations.Off-label use of targeted therapies is little documented and appears to be in the same range than that regarding older drugs with wide variations among agents.When compared with older agents,off-label use of targeted therapies is probably more rational through tumoral genotyping but is faced with a limited clinical support,reimbursement challenges related to the very high pricing and the cost of genotyping or molecular profiling,when applicable.
文摘目的:以儿童癫痫为研究病种,调研该院门诊儿科患者面临的超说明书用药情况,建立门诊儿科超说明书用药风险获益评估体系。方法:对2021—2022年该院儿科诊断为癫痫的1400例患者的门诊处方进行分析,运用Logistic回归分析推测影响儿童癫痫患者超说明书用药的独立因素,并使用“Benefit and Risk Assessment for Off-label Use”(BRAvO)评估表对托吡酯超说明书用药进行分析。结果:1400例门急诊癫痫患儿中,共有112例超说明书用药。多因素Logistic回归分析结果显示,年龄和用药品种数是癫痫患儿超说明书用药的独立影响因素。运用BRAvO评估表确定了托吡酯在2岁以下儿童使用的有效性,但是未确定具体给药剂量。结论:超说明书用药仍然是门诊儿科患者面临的主要问题,BRAvO评估表可为门诊儿科超说明书用药提供决策,规范儿科超说明书用药,降低超说明书用药风险。
文摘目的为优化或制定统一的药品说明书外用法专家共识的证据和推荐意见评价方法提供参考。方法检索中国知网、万方数据、维普网、中国生物医学文献数据库、PubMed和Web of Science,纳入各数据库自建库起至2024年8月1日收录的包含证据和推荐意见评价方法的药品说明书外用法中国专家共识,筛选文献并提取资料后进行描述性统计分析。结果与结论最终纳入32篇文献,14篇(43.8%)采用Micromedex的Thomson分级系统,形成推荐意见时仅有7篇(21.9%)考虑了经济性,10篇(31.3%)报告了利益冲突情况,仅2篇(6.3%)有循证医学方法学专家的参与。不同专家共识评价方法中证据来源类型、形成推荐意见时考量的因素、证据和推荐意见分级标准有差异,同一用法在不同专家共识中的证据等级和推荐意见也有差异。建议未来制定共识时应提高对参与共识人员利益冲突的关注度,加强与方法学专家的合作,并尽快制定统一的证据和推荐意见评价方法标准。
