Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and preven...Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and prevent the occurrence of drug damage. Runzao Zhiyang Capsule is mainly composed of Radix Polygoni Multiflor, Radix Polygoni Multiflori Preparata, Radix Rehmanniae Recens, Radix Sophorae Flavescentis, Folium Mori and Urtica dentata Hand.-Mazz. It has the functions of nourishing blood, nourishing yin, expelling wind to relieve itching and moistening the intestines to relieve constipation. It is mainly used for skin itching, acne, constipation and other diseases caused by blood deficiency and wind dryness. The large, national SRS database of ADRs needs effective evaluation methods. We reported on the use of Bayesian confidence propagation neural network method(BCPNN) and reporting rate ratio method(PRR) with propensity score to control confounding variables. The tendency score method was used to control the hybrid bias produced by SRS data analysis. After the calculation of PRR and BCPNN, the score of "diarrhea", "rash" and "gastric dysfunction" showed that there was an early warning before and after matching. To sum up, it indicated that diarrhea, rash and gastric dysfunction were early warning signs.展开更多
This paper is concerned with the existence of traveling wave solutions in a reaction-diffusion predator-prey system with Beddington-DeAngelis functional response and a discrete time delay. By introducing a partial qua...This paper is concerned with the existence of traveling wave solutions in a reaction-diffusion predator-prey system with Beddington-DeAngelis functional response and a discrete time delay. By introducing a partial quasi-monotonicity condition and constructing a pair of upper-lower solutions, we establish the existence of traveling wave solutions. Moreover, a numerical simulation is carried out to illustrate the theoretical results.展开更多
Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collectin...Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.展开更多
OBJeCTIve：To systematically evaluate the long-term effect and safety ofXingnao Kaiqiao nee-dling method in ischemic stroke treatment. DATA ReTRIevAL： We retrieved relevant random and semi-random controlled trials th...OBJeCTIve：To systematically evaluate the long-term effect and safety ofXingnao Kaiqiao nee-dling method in ischemic stroke treatment. DATA ReTRIevAL： We retrieved relevant random and semi-random controlled trials that used theXingnao Kaiqiao needling method to treat ischemic stroke compared with various control treatments such as conventional drugs or other acupuncture therapies. Searched databases included China National Knowledge Infrastructure, Weipu Information Resources System, Wanfang Medical Data System, Chinese Biomedical Literature Database, Cochrane Library, and PubMed, from May 2006 to July 2014. SeLeCTION CRITeRIA： Two authors independently conducted literature screening, quality evaluation, and data extraction. The quality of articles was evaluated according to the Cochrane Reviewers’ Handbook 5.1, and the study was carried out using Cochrane system assessment methods. RevMan 5.2 was used for meta-analysis of the included studies. MAIN OUTCOMe MeASUReS： Mortality rate, recurrence rate, and disability rate were observed. ReSULTS：Nine randomized and semi-randomized controlled trials treating 931 cases of ischemic stroke were included in this review. Meta-analysis results showed that there were no sig-niifcant differences in mortality reduction （risk ratio （RR） = 0.58, 95% conifdence interval （CI）： 0.17–1.93,Z = 0.89,P = 0.37） or recurrence rate （RR = 0.55, 95%CI： 0.18–1.70,Z = 1.04,P = 0.30） of ischemic stroke patients between theXingnao Kaiqiao needling and control treatment groups. However, theXingnao Kaiqiao needling method had a tendency towards higher efifcacy in mor-tality reduction and recurrence rates. TheXingnao Kaiqiao needling method was signiifcantly better than that of the control treatment in reducing disability rate （RR = 0.51, 95%CI： 0.27–0.98, Z = 2.03,P 〈 0.05）. CONCLUSION：TheXingnao Kaiqiao needling method has a better effect than control treatment in reducing disability rate. The long-term effect ofXingnao Kaiqiao needling against ischemic stroke is better than that of control treatment. However, the limitations of this study limit the strength of the conclusions. Randomized controlled trials with a strict, reasonable design, and multi-center, large-scale samples and follow-up are necessary to draw conclusions aboutXingnao Kaiqiao needling.展开更多
目的分析艾司洛尔不良反应/事件发生特点,为临床安全用药提供参考。方法检索Web of Science、PubMed、Springer Link、中国知网、万方数据、维普网从建库至2023年10月31日中艾司洛尔致不良反应/事件个案报道,进行统计和分析,并基于美国...目的分析艾司洛尔不良反应/事件发生特点,为临床安全用药提供参考。方法检索Web of Science、PubMed、Springer Link、中国知网、万方数据、维普网从建库至2023年10月31日中艾司洛尔致不良反应/事件个案报道,进行统计和分析,并基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据(2004年第1季度至2023年第4季度)进行挖掘验证其一致性。结果文献检索共纳入14篇个案报道,14例患者发生艾司洛尔不良反应/事件;男性10例,女性4例;年龄15~94岁,平均年龄59.79岁;发生时间最短为立即发生,最长9 d;不良反应主要有癫痫发作、谵妄、低钠血症、心脏骤停、严重室性心律失常、多巴酚丁胺应激超声心动图假阳性冠状动脉痉挛等。美国FAERS数据库中艾司洛尔不良事件报告208例,发生不良事件559例次,累及系统--器官分类(SOC)21个;不良事件信号强度排序为:交界异位性心动过速、心搏出量降低、无脉性电活动、外渗、热射病、心室机能障碍、室颤、输液部位渗出、心源性休克、冠状动脉痉挛等,与文献收集的病例报告一致性较高。结论艾司洛尔临床应用广泛,发生的不良反应/事件多为轻微且短暂,但有严重的且说明书未记载的不良反应/事件。建议临床使用时仍需谨慎,对不良反应/事件早期判断、及时停药、尽早给予相关对症处理。展开更多
目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FA...目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。展开更多
基金funded by National Science and Technology Major Project of New Important Drug Creation (2015ZX09501004-001-002)The National Natural Science Foundation of China (81473798):Study on allergic reaction mechanism of Chinese medicine injections with active monitoring and network target monitoring+1 种基金Project of "One Belt, One Road" for Traditional Chinese Medicine of China Academy of Chinese Medical Sciences (GH2017-04)Construction of China-US Major Disease Clinical Research Center (GH2017-04-01)
文摘Spontaneous reporting system(SRS) is an important way to monitor the adverse drug reaction(ADR) and discover the ADR signal for marketed drugs. It can detect adverse reaction signals timely and effectively, and prevent the occurrence of drug damage. Runzao Zhiyang Capsule is mainly composed of Radix Polygoni Multiflor, Radix Polygoni Multiflori Preparata, Radix Rehmanniae Recens, Radix Sophorae Flavescentis, Folium Mori and Urtica dentata Hand.-Mazz. It has the functions of nourishing blood, nourishing yin, expelling wind to relieve itching and moistening the intestines to relieve constipation. It is mainly used for skin itching, acne, constipation and other diseases caused by blood deficiency and wind dryness. The large, national SRS database of ADRs needs effective evaluation methods. We reported on the use of Bayesian confidence propagation neural network method(BCPNN) and reporting rate ratio method(PRR) with propensity score to control confounding variables. The tendency score method was used to control the hybrid bias produced by SRS data analysis. After the calculation of PRR and BCPNN, the score of "diarrhea", "rash" and "gastric dysfunction" showed that there was an early warning before and after matching. To sum up, it indicated that diarrhea, rash and gastric dysfunction were early warning signs.
文摘This paper is concerned with the existence of traveling wave solutions in a reaction-diffusion predator-prey system with Beddington-DeAngelis functional response and a discrete time delay. By introducing a partial quasi-monotonicity condition and constructing a pair of upper-lower solutions, we establish the existence of traveling wave solutions. Moreover, a numerical simulation is carried out to illustrate the theoretical results.
文摘Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.
基金financially supported by grants from Hebei Province Engineering Talent Cultivation Project and Hebei Province Science and Technology Research and Development Projects,No.11276103D-35
文摘OBJeCTIve：To systematically evaluate the long-term effect and safety ofXingnao Kaiqiao nee-dling method in ischemic stroke treatment. DATA ReTRIevAL： We retrieved relevant random and semi-random controlled trials that used theXingnao Kaiqiao needling method to treat ischemic stroke compared with various control treatments such as conventional drugs or other acupuncture therapies. Searched databases included China National Knowledge Infrastructure, Weipu Information Resources System, Wanfang Medical Data System, Chinese Biomedical Literature Database, Cochrane Library, and PubMed, from May 2006 to July 2014. SeLeCTION CRITeRIA： Two authors independently conducted literature screening, quality evaluation, and data extraction. The quality of articles was evaluated according to the Cochrane Reviewers’ Handbook 5.1, and the study was carried out using Cochrane system assessment methods. RevMan 5.2 was used for meta-analysis of the included studies. MAIN OUTCOMe MeASUReS： Mortality rate, recurrence rate, and disability rate were observed. ReSULTS：Nine randomized and semi-randomized controlled trials treating 931 cases of ischemic stroke were included in this review. Meta-analysis results showed that there were no sig-niifcant differences in mortality reduction （risk ratio （RR） = 0.58, 95% conifdence interval （CI）： 0.17–1.93,Z = 0.89,P = 0.37） or recurrence rate （RR = 0.55, 95%CI： 0.18–1.70,Z = 1.04,P = 0.30） of ischemic stroke patients between theXingnao Kaiqiao needling and control treatment groups. However, theXingnao Kaiqiao needling method had a tendency towards higher efifcacy in mor-tality reduction and recurrence rates. TheXingnao Kaiqiao needling method was signiifcantly better than that of the control treatment in reducing disability rate （RR = 0.51, 95%CI： 0.27–0.98, Z = 2.03,P 〈 0.05）. CONCLUSION：TheXingnao Kaiqiao needling method has a better effect than control treatment in reducing disability rate. The long-term effect ofXingnao Kaiqiao needling against ischemic stroke is better than that of control treatment. However, the limitations of this study limit the strength of the conclusions. Randomized controlled trials with a strict, reasonable design, and multi-center, large-scale samples and follow-up are necessary to draw conclusions aboutXingnao Kaiqiao needling.
文摘目的分析艾司洛尔不良反应/事件发生特点,为临床安全用药提供参考。方法检索Web of Science、PubMed、Springer Link、中国知网、万方数据、维普网从建库至2023年10月31日中艾司洛尔致不良反应/事件个案报道,进行统计和分析,并基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据(2004年第1季度至2023年第4季度)进行挖掘验证其一致性。结果文献检索共纳入14篇个案报道,14例患者发生艾司洛尔不良反应/事件;男性10例,女性4例;年龄15~94岁,平均年龄59.79岁;发生时间最短为立即发生,最长9 d;不良反应主要有癫痫发作、谵妄、低钠血症、心脏骤停、严重室性心律失常、多巴酚丁胺应激超声心动图假阳性冠状动脉痉挛等。美国FAERS数据库中艾司洛尔不良事件报告208例,发生不良事件559例次,累及系统--器官分类(SOC)21个;不良事件信号强度排序为:交界异位性心动过速、心搏出量降低、无脉性电活动、外渗、热射病、心室机能障碍、室颤、输液部位渗出、心源性休克、冠状动脉痉挛等,与文献收集的病例报告一致性较高。结论艾司洛尔临床应用广泛,发生的不良反应/事件多为轻微且短暂,但有严重的且说明书未记载的不良反应/事件。建议临床使用时仍需谨慎,对不良反应/事件早期判断、及时停药、尽早给予相关对症处理。
文摘目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。
