Geochemical and petrological studies of high sulfur coal and overburden from Makum coalfield (Northeast India) towards understanding and mitigation of acid mine drainage

Opencast coal mining produces trash of soil and rock containing various minerals,that are usually dumped nearby the abandoned sites which causes severe environmental concern including the production of acid mine drainage(AMD)through oxidation pyrite minerals.The current study entailed assessing the potential production of AMD from an opencast coal mining region in Northeast part of India.In order to have a comprehensive overview of the AMD problem in Makum coalfield,the physico-chemical,geochemical,and petrological characteristics of the coal and overburden(OB)samples collected from the Makum coalfield(Northeast India)were thoroughly investigated.The maceral compositions reveal that coal features all three groups of macerals(liptinite,vitrinite,and inertinite),with a high concentration of liptinite indicating the coal of perhydrous,thereby rendering it more reactive.Pyrite(FeS_(2))oxidation kinetics were studied by conducting the aqueous leaching experiments of coal and(OB)samples to interpret the chemical weathering under controlled laboratory conditions of various temperature and time periods,and to replicate the actual mine site leaching.Inductively coupled plasma-optical emission spectroscopy(ICP-OES)was operated to detect the disposal of some precarious elements from coal and OB samples to the leachates during our controlled leaching experiment.The Rare earth element(REE)enrichment in the samples shows the anthropogenic incorporation of the REE in the coal and OB.These experiments reveal the change in conductivity,acid producing tendency,total dissolved solid(TDS),total Iron(Fe)and dissolved Sulfate(SO_(4)^(2−))ions on progress of the leaching experiments.Moreover,the discharge of FeS_(2) via atmospheric oxidation in laboratory condition undergoes a significant growth with the rise of temperature of the reaction systems in the environment and follows pseudo first order kinetics.A bio-remediative strategies is also reported in this paper to mitigate AMD water by employing size-segregated powdered limestone and water hyacinth plant in an indigenously developed site-specific prototype station.Apart from neutralisation of AMD water,this eco-friendly AMD remediation strategy demonstrates a reduction in PHEs concentrations in the treated AMD water.

Organic petrographic and mineralogical composition of the No. 6 coal seam of the Soutpansberg Coalfield, South Africa: Insights into paleovegetation and depositional environment

This study investigates the paleodepositional conditions of the No.6 Seam of the Madzaringwe Formation in Makhado and Voorburg south area of the Soutpansberg Coalfield(Limpopo Province,South Africa)utilizing organic petrography and inorganic geochemical proxies.The coals are predominantly high-volatile bituminous B-A rank with high ash yields(avg.36.1 wt%),characterized by high-vitrinite(~41.5 vol%),moderate-to-high inertinite(9.8 vol%–33.7 vol%)and low liptinite(~2.3 vol%).The distribution of inertinite varies among different coal horizons(from bottom-lower to middle-upper),suggesting differential oxidation conditions and/or paleofire occurrence.Vitrinite-to-inertinite(V/I)ratio,tissue preservation–gelification index(TPI–GI),and groundwater–vegetation index(GWI–VI)plots,indicate that the peat-forming forest-swamp vegetation accumulated under mesotrophic-to-rheotrophic hydrological conditions.The presence of structured macerals(i.e.,telinite,collotelinite,fusinite,and semifusinite)suggests well-preserved plant tissues,whereas framboidal pyrite and sulphur content(0.24 wt%–2.16 wt%)point to brackish-water influence at the peat stage.The coals contain quartz,kaolinite,siderite,muscovite,dolomite,calcite,and pyrite minerals,most of which were likely sourced from felsic igneous rocks.The Al/(Al+Fe+Mn)and(Fe+Mn)/Ti ratios for the studied samples range between 0.24–0.97 and 0.57–70.10,respectively.The ratios,Al–Fe–Mn plot,and presence of massive botryoidal-type pyrite imply some influence of meteoric waters or fluids from hydrothermal activity post-deposition.Moreover,the chemical index of alteration(CIA:98.25–99.67),chemical index of weathering(CIW:92.04–97.66),and A–CN–K ternary diagram suggest inorganic matter suffered strong chemical weathering,indicating warm paleoclimatic conditions during the coal formation.

Responses of soil stoichiometry and soil enzyme activities in the different distance around opencast coal mine of the Hulun Buir Grassland of China

The objectives of this study were to explore the changes in soil stoichiometry and enzyme activities at different distances from an opencast coal mine in the Hulun Buir Grassland of China. Four transects were established on north and east sides of the opencast coal mining area, and samples were collected at 50 m, 550 m, and 1550 m from the pit on each transect. Control samples were collected from a grassland station 8 km from the opencast coal mining area that was not disturbed by mining. Four replicate soil samples were collected at each point on the four transects. Soil physicochemical properties and enzyme activities were determined, and correlations between soil properties and stoichiometric ratios and enzyme activities were explored using redundancy analysis. The increase in distance from mining did not significantly affect soil properties, although soil urease activity was significantly lower than that of the control area. Soil properties 1550 m from the mine pit were similar to those at the grassland control. In addition, soil total nitrogen had the greatest effect on soil stoichiometry, and soil total potassium had the greatest effect on soil enzyme activities. Coal dust from opencast mining might be the main factor affecting soil stoichiometry and enzyme activities. The results of this study provide direction for the next step in studying the influence of mining areas on soil properties and processes.

Fuzzy inference system using genetic algorithm and pattern search for predicting roof fall rate in underground coal mines

One of the most dangerous safety hazard in underground coal mines is roof falls during retreat mining.Roof falls may cause life-threatening and non-fatal injuries to miners and impede mining and transportation operations.As a result,a reliable roof fall prediction model is essential to tackle such challenges.Different parameters that substantially impact roof falls are ill-defined and intangible,making this an uncertain and challenging research issue.The National Institute for Occupational Safety and Health assembled a national database of roof performance from 37 coal mines to explore the factors contributing to roof falls.Data acquired for 37 mines is limited due to several restrictions,which increased the likelihood of incompleteness.Fuzzy logic is a technique for coping with ambiguity,incompleteness,and uncertainty.Therefore,In this paper,the fuzzy inference method is presented,which employs a genetic algorithm to create fuzzy rules based on 109 records of roof fall data and pattern search to refine the membership functions of parameters.The performance of the deployed model is evaluated using statistical measures such as the Root-Mean-Square Error,Mean-Absolute-Error,and coefficient of determination(R_(2)).Based on these criteria,the suggested model outperforms the existing models to precisely predict roof fall rates using fewer fuzzy rules.

Advancing respirable coal mine dust source apportionment:a preliminary laboratory exploration of optical microscopy as a novel monitoring tool

Exposure to respirable coal mine dust(RCMD)can cause chronic and debilitating lung diseases.Real-time monitoring capabilities are sought which can enable a better understanding of dust components and sources.In many underground mines,RCMD includes three primary components which can be loosely associated with three major dust sources:coal dust from the coal seam itself,silicates from the surrounding rock strata,and carbonates from the inert‘rock dust’products that are applied to mitigate explosion hazards.A monitor which can reliably partition RCMD between these three components could thus allow source apportionment.And tracking silicates,specifically,could be valuable since the most serious health risks are typically associated with this component-particularly if abundant in crystalline silica.Envisioning a monitoring concept based on field microscopy,and following up on prior research using polarized light,the aim of the current study was to build and test a model to classify respirable-sized particles as either coal,silicates,or carbonates.For model development,composite dust samples were generated in the laboratory by successively depositing dust from high-purity materials onto a sticky transparent substrate,and imaging after each deposition event such that the identity of each particle was known a priori.Model testing followed a similar approach,except that real geologic materials were used as the source for each dust component.Results showed that the model had an overall accuracy of 86.5%,indicating that a field-microscopy based moni-tor could support RCMD source apportionment and silicates tracking in some coal mines.

Synergistic CO_(2) mineralization using coal fly ash and red mud as a composite system

CO_(2) mineralization plays a critical role in the storage and utilization of CO_(2).Coal fly ash(CFA)and red mud(RM)are widely utilized as CO_(2) mineralizers.However,the inert calcium species in CFA limit its carbonation capacity,meanwhile the substantial Ca^(2+)releasing of RM is hindered by a covering layer of calcium carbonate.In this study,CO_(2) mineralization in a composite system of CFA and RM was investigated to enhance the carbonation capacity.Multiple analyzers were employed to characterize the raw materials and resulting mineralization products.The results demonstrated that a synergistic effect existed in the composite system of CFA and RM,resulting in improving CO_(2) mineralization rate and efficiency.The produced calcium carbonate was ectopically attached the surface of CFA in the composite system,thus slowing down its coverage on the surface of RM.This phenomenon facilitated further releasing Ca^(2+)from the internal RM,thereby enhancing CO_(2) mineralization efficiency.Meanwhile,the inclusion of RM significantly improved the alkalinity of the composite system,which not only promoted the dissolution of Ca^(2+)of the inert CaSO_(4)(H_(2)O)_(2) in CFA,but also accelerated CO_(2) mineralization rate.The investigation would be beneficial to CO_(2) mineralization using industrial solid wastes.

Study on the Safety and Prevention Technology of Coal Mining under the River in Xingyuan Coal Mine

Coal mining-induced surface subsidence poses significant ecological and infrastructural challenges, necessitating a comprehensive study to ensure safe mining practices, particularly in underwater conditions. This project aims to address the extensive impact of coal mining on the environment, infrastructure, and overall safety, focusing on the Shigong River area above the working face. The study employs qualitative and quantitative analyses, along with on-site engineering measurements, to gather data on crucial parameters such as coal seam characteristics, roof rock lithology, thickness, water resistance, and structural damage degree. The research encompasses a multidisciplinary approach, involving mining, geology, hydrogeology, geophysical exploration, rock mechanics, mine surveying, and computational mathematics. The importance of effective safety measures and prevention techniques is emphasized, laying the foundation for research focused on the Xingyun coal mine. The brief concludes by highlighting the potential economic and social benefits of this project and its contribution to valuable experience for future subsea coal mining.

Crustal structure in the Anyuan Coal Mine and its adjacent areas of Jiangxi Province by P-wave receiver functions

We collected high-quality teleseismic events recorded by 12 broadband seismographs deployed in the Anyuan Coal Mine and its adjacent areas in Pingxiang City,Jiangxi Province for nearly two years.The H-κ-c stacking method was employed to obtain the crustal thickness and Poisson's ratio distribution,then the characteristics of crustal structure below the stations were obtained by using the time-domain linear inversion method.The crustal thickness in the Anyuan Coal Mine and its adjacent areas ranges from approximately 32~35 km,with an average thickness of 33 km,which is consistent with the crustal thickness results in South China from previous studies using the receiver function method.The average Poisson's ratio of the crustal bulk composition in the study area varies between 0.22 and 0.25,which is lower than the global value with a 0.27 average,indicating a predominantly intermediate-acidic or felsic crustal composition.There is a weak negative correlation between Poisson's ratio and crustal thickness estimates in the Anyuan Coal Mine and its adjacent areas,suggesting that the absence of mafic-ultramafic materials in the lower crust is associated with the process of crustal delamination.The velocity inversion results indicate that the crustal structure including three velocity discontinuity interfaces,with the first at a depth of approximately 1.5 km,the second at about 10~15 km,and the third being the Moho.The study also indicates that the results obtained by the H-κ-c stacking method are significantly better than those obtained by the H-κmethod,effectively reducing the standard deviation and dispersion of crustal thickness and vP/vSratio.

Research on the mechanism of rockburst induced by mined coal-rock linkage of sharply inclined coal seams

In recent years,the mining depth of steeply inclined coal seams in the Urumqi mining area has gradually increased.Local deformation of mining coal-rock results in frequent rockbursts.This has become a critical issue that affects the safe mining of deep,steeply inclined coal seams.In this work,we adopt a perspective centered on localized deformation in coal-rock mining and systematically combine theoretical analyses and extensive data mining of voluminous microseismic data.We describe a mechanical model for the urgently inclined mining of both the sandwiched rock pillar and the roof,explaining the mechanical response behavior of key disaster-prone zones within the deep working face,affected by the dynamics of deep mining.By exploring the spatial correlation inherent in extensive microseismic data,we delineate the“time-space”response relationship that governs the dynamic failure of coal-rock during the progression of the sharply inclined working face.The results disclose that(1)the distinctive coal-rock occurrence structure characterized by a“sandwiched rock pillar-B6 roof”constitutes the origin of rockburst in the southern mining area of the Wudong Coal Mine,with both elements presenting different degrees of deformation localization with increasing mining depth.(2)As mining depth increases,the bending deformation and energy accumulation within the rock pillar and roof show nonlinear acceleration.The localized deformation of deep,steeply inclined coal-rock engenders the spatial superposition of squeezing and prying effects in both the strike and dip directions,increasing the energy distribution disparity and stress asymmetry of the“sandwiched rock pillar-B3+6 coal seam-B6 roof”configuration.This makes worse the propensity for frequent dynamic disasters in the working face.(3)The developed high-energy distortion zone“inner-outer”control technology effectively reduces high stress concentration and energy distortion in the surrounding rock.After implementation,the average apparent resistivity in the rock pillar and B6 roof substantially increased by 430%and 300%,respectively,thus guaranteeing the safe and efficient development of steeply inclined coal seams.

Theory,technology and application of grouted bolting in soft rock roadways of deep coal mines

The grouted bolt,combining rock bolting with grouting techniques,provides an effective solution for controlling the surrounding rock in deep soft rock and fractured roadways.It has been extensively applied in numerous deep mining areas characterized by soft rock roadways,where it has demonstrated remarkable control results.This article systematically explores the evolution of grouted bolting,covering its theoretical foundations,design methods,materials,construction processes,monitoring measures,and methods for assessing its effectiveness.The overview encompassed several key elements,delving into anchoring theory and grouting reinforcement theory.The new principle of high pretensioned high-pressure splitting grouted bolting collaborative active control is introduced.A fresh method for dynamic information design is also highlighted.The discussion touches on both conventional grouting rock bolts and cable bolts,as well as innovative grouted rock bolts and cables characterized by their high pretension,strength,and sealing hole pressure.An examination of the merits and demerits of standard inorganic and organic grouting materials versus the new inorganic–organic composite materials,including their specific application conditions,was conducted.Additionally,the article presents various methods and instruments to assess the support effect of grouting rock bolts,cable bolts,and grouting reinforcement.Furthermore,it provides a foundation for understanding the factors influencing decisions on grouted bolting timing,the sequence of grouting,the pressure applied,the volume of grout used,and the strategic arrangement of grouted rock bolts and cable bolts.The application of the high pretensioned high-pressure splitting grouted bolting collaborative control technology in a typical kilometer-deep soft rock mine in China—the soft coal seam and soft rock roadway in the Kouzidong coal mine,Huainan coal mining area,was introduced.Finally,the existing problems in grouted bolting control technology for deep soft rock roadways are analyzed,and the future development trend of grouted bolting control technology is anticipated.

基于FAERS数据库的白消安不良事件信号挖掘与分析

目的 利用美国食品药品管理局不良事件报告系统(FAERS)数据库对白消安的药品不良事件(ADE)进行研究,挖掘潜在的ADE信号,为临床安全用药提供参考。方法 检索FAERS数据库中2004年第1季度至2023年第1季度的数据,通过数据清洗、目标药物名称标准化,获得以白消安为首要怀疑药物的ADE记录。采用报告比值比法、比例报告比值法和综合标准法挖掘白消安ADE信号,并利用信息成分法进行信号强弱判断。以《国际医学用语词典》对ADE进行系统器官分类(SOC),并按照ADE发生频次和信号强度分别排序。结果 共获得20 326份以白消安为首要怀疑药物的ADE报告,涉及患者5 615例,男性患者比例高于女性(40.71%vs.30.74%);年龄小于18岁占31.56%;上报人群主要为医师(33.71%)、其他健康专业人员(24.35%)以及药师(23.86%);上报国家主要为美国(29.69%)、日本(15.78%)、法国(11.79%)。共挖掘出白消安相关ADE信号556个,其中117个ADE信号未被药品说明书收载。556个ADE信号中,发生频次前五位ADE分别为产品用于未经批准的适应证、肝小静脉闭塞症、黏膜炎症、巨细胞病毒感染和移植物抗宿主病;信号强度排名前五位ADE分别为肝小静脉闭塞症、急性移植物抗宿主病、静脉闭塞性疾病、移植物抗宿主病以及慢性移植物抗宿主病。挖掘的ADE信号共累及23个SOC,数量排名前三的SOC分别为感染及侵染类疾病,各类检查,良性、恶性及性质不明的肿瘤(包括囊状和息肉状)。结论 白消安临床应用中,应警惕肝小静脉闭塞症、感染、移植物抗宿主病、神经相关毒性和血栓性微血管病等易造成严重后果的ADE,临床药师协助医师做好ADE的预防方案,提高白消安的使用安全性。

基于FAERS数据库对塞来昔布不良事件信号的分析

目的基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库,挖掘塞来昔布的不良事件(ADE)信号,为临床安全用药提供参考。方法采用报告比值比法、综合标准法和信息成分法挖掘FAERS数据库2004年第1季度至2022年第4季度的报告数据。结果ADE报告人主要为45岁以上人群,以女性居多,上报国家主要是美国。获得塞来昔布ADE报告37020例,涉及ADE 4068种,挖掘ADE信号406个,经筛选后得到有效信号285个,累及23个系统-器官(SOC)。根据信号强度,排名前5位的信号分别为:食管纤维化、与性活动有关的原发性头痛、脑血管疾病、胃肠道腺癌、心血管障碍。说明书未载明的ADE信号主要有:视网膜静脉血栓形成、失明、健忘、过敏性休克等。结论所得ADE信号基本与说明书一致;信号提示塞来昔布ADE主要集中在心脏疾病、神经系统疾病、免疫系统疾病、胃肠道疾病等;说明书黑框警告心血管血栓事件,胃肠道出血、溃疡和穿孔均有相关ADE信号检出。在使用该药时,除注意患者心脑血管、胃肠道不适症状以外,还应关注患者视网膜病变,并做好相关监护,以保证临床用药的安全。

基于FAERS数据库的喹硫平不良事件信号挖掘与分析

目的基于美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库挖掘喹硫平的药物不良事件(ADE)信号,为该药的临床安全使用提供参考。方法检索FAERS数据库中2004年至2023年共79个季度关于喹硫平的不良反应报告,同时采用报告比值比法、比例报告比值法、贝叶斯置信区间神经网络传播法、多重伽马-泊松收缩估计法,按药物不良事件术语集的首选术语(PT)和系统器官分类(SOC)对纳入的ADE报告进行分类并计算风险信号。结果共收集主要怀疑药物为喹硫平的ADE报告261725份,涉及的患者有68012例,其中以女性(37495份,55.13%)及老年患者(>65岁)(35312份,占51.9%)居多,报告国家以美国为主,结局多为其他严重后果、住院、死亡和危及患者生命。共挖掘出喹硫平阳性风险信号PT 713个,涉及SOC 27个,所得信号基本与药品说明书一致,其中报告数最多的ADE为糖尿病,且信号强度较高。报告数超过500例的ADE中,共挖掘47个阳性风险信号PT,其中横纹肌溶解为说明书中未收载的ADE。喹硫平引起ADE发生的时间不一,常在用药后30 d内或用药一年以上发生。结论临床在使用喹硫平时除应在全程关注药品说明书收录的ADE外,还应警惕说明书未提及的ADE,并且根据性别、年龄等制订个体化的用药监护方案。

基于美国FAERS数据库的利奈唑胺抗结核治疗不良事件分析

目的分析美国FDA不良事件报告系统(FAERS)数据库中利奈唑胺在抗结核治疗中的不良事件(AEs),评估其安全性特征,为临床合理用药提供科学依据。方法提取2016年第1季度至2024年第1季度间与利奈唑胺相关的抗结核治疗不良事件报告。数据经过清洗和预处理,采用报告比值比(ROR)和信息成分法(IC)进行信号挖掘。结果研究共筛选出1135例利奈唑胺相关AEs,主要不良事件类型为住院(18.46%)和死亡(10.99%)。结果显示,利奈唑胺的AEs主要涉及血液及淋巴系统疾病和肝胆系统疾病。常见不良反应包括贫血、周围神经病、视神经病等。此外,发现了一些说明书未提及的不良反应信号,如多发神经病(ROR=75.25,IC_(025)=5.8)、中毒性视神经病(ROR=776.95,IC_(025)=8.86)和耳聋(ROR=14.66,IC_(025)=3.26)。结论本研究表明,利奈唑胺在抗结核治疗中可能伴随一些严重不良反应,建议对长期使用利奈唑胺的患者进行定期的神经系统、眼科和听力检查,为临床合理用药提供更充足的依据。

基于FAERS数据库对酒精使用障碍治疗药品不良事件信号的挖掘与评价

目的基于美国FDA不良事件(adverse drug event,ADE)报告数据库(FDA adverse event reporting system,FAERS)对临床常用的酒精使用障碍治疗药品的ADE信号进行挖掘和分析,为临床合理用药提供参考。方法采用报告比值比法、比例报告比法和贝叶斯可信区间递进神经网络法,对11种临床常用治疗药品(苯二氮䓬类药物:阿普唑仑、地西泮、劳拉西泮、奥沙西泮;非苯二氮䓬类药物:阿坎酸、巴氯芬、戒酒硫、加巴喷丁、纳曲酮、普瑞巴林、托吡酯)的ADE信号进行挖掘分析,利用《监管活动医学词典》术语集进行系统器官归类。结果共收集到11种药品治疗酒精使用障碍的ADE报告14945份,发现阳性信号737个、说明书未记载的高频信号68个,其中阳性信号涉及24个系统器官归类,主要集中在精神病类疾病、神经系统疾病、全身性疾病及给药部位反应和各类损伤、中毒及操作并发症。结论常用酒精使用障碍治疗药品的ADE信号具有差异性,临床使用时,应根据患者情况实现个体化给药,提高用药安全性。

基于FAERS的哌拉西林他唑巴坦不良事件信号挖掘与分析

目的挖掘哌拉西林他唑巴坦(TZP)的药品不良事件(ADE)信号,促进临床合理、安全用药。方法采用比例失衡法对美国食品药品管理局不良事件报告系统(FAERS)自建库至2024年3月所有TZP ADE报告进行信号挖掘,分析报告病例的基本情况及不良反应相关信息。结果共提取得到主要怀疑药物涉及ADE报告数为20620513条,TZP为主要怀疑药物涉及ADE报告数为6489条。共挖掘ADE信号543个,涉及25个器官/系统分类(SOC),二次筛选最终检测出ADE信号数43个,其中新的ADE信号17个,ADE信号涉及SOC分类的数量排名前5为分别是皮肤及皮下组织类疾病、全身性疾病及给药部位各种反应、各类检查、感染及侵染类疾病、血液及淋巴系统疾病;ADE信号数排名前5位的首选术语分别为皮疹、发热、急性肾损伤、瘙痒、血小板减少症。青霉素类药物在血液及淋巴系统疾病存在多种不良反应信号,TZP导致血小板减少病例数最多,苯唑西林导致粒细胞缺乏关联强度比例报告比值比最高;TZP导致白细胞减少疗程中位数为11.00 d,累积剂量中位数为148.50 g;该药导致粒细胞缺乏疗程中位数为14.00 d,累积剂量中位数为216.00 g;该药导致血小板减少症疗程中位数为7.00d,累积剂量中位数为87.00 g。结论用药期间需密切关注皮肤及皮下组织类疾病相关不良反应,可能较胃肠道系统疾病更多;临床大剂量或长疗程应用TZP时可导致多个系统发生不良反应,尤其需密切关注血液及淋巴系统疾病相关不良反应,避免发生严重不良反应。

基于FAERS数据库对奥瑞利珠单抗不良事件信号的挖掘与分析

目的基于FDA不良事件报告系统(FAERS)数据库,挖掘奥瑞利珠单抗的药品不良事件(adverse drug event,ADE)信号,为其临床合理安全使用提供参考。方法利用OpenVigil 2.1工具从FAERS数据库收集奥瑞利珠单抗的不良事件报告,筛选后采用比例报告比值法和报告比值比法对ADE信号进行挖掘,统计报告患者的性别、年龄、国别等基本信息,对新的ADE信号进行分析。结果以奥瑞利珠单抗为主要怀疑药物有17081份不良事件报告,女性占比较高(10363例,60.63%);年龄主要集中在40~65岁;上报年份主要集中在2022年和2023年;报告国家以美国和加拿大居多。共挖掘到ADE信号446个,涉及系统器官分类12个,主要集中在血液淋巴系统疾病、全身性疾病及给药部位各种反应、免疫系统疾病、感染及侵染性疾病和各类检查等方面。说明书尚未记录的ADE信号有白蛋白-球蛋白比率增加、脊柱磁共振成像异常、脑深核高信号、无张力膀胱和母体妊娠前暴露。结论所得ADE信号基本与说明书一致,脊柱磁共振成像异常提示脊柱可能存在病变,部分患者有可能因无张力膀胱,出现排尿困难的情况。妊娠期及哺乳期用药的安全性仍需进一步临床观察。

基于FAERS数据库的米诺环素不良事件信号挖掘研究

目的挖掘米诺环素的药品不良事件(ADE)信号,为临床安全用药提供参考。方法联合报告比值比法、比例报告比值法、综合标准法和贝叶斯置信度递进神经网络法,对美国食品药品管理局不良事件报告系统(FAERS)数据库中2004年一季度至2023年四季度上报的米诺环素ADE报告进行数据挖掘,全面分析ADE信号分布、信号强度、性别及年龄差异、死亡病例情况,并基于标准国际医学用语词典(MedDRA)分析查询(SMQ)检索超敏性ADE并进行深入分析。结果共筛选出米诺环素ADE16871例次,阳性ADE信号364个,涉及27个系统/器官分类(SOC),主要为全身性疾病及给药部位各种反应、皮肤及皮下组织类疾病、各类神经系统疾病等,ADE例数排序前列的强信号分别为药物反应伴嗜酸粒细胞增多和全身性症状(DRESS)、结节性多动脉炎和特发性颅内压增高。与其他药物相比,米诺环素致特发性颅内压增高患者中女性构成比较高(P<0.05)。挖掘到8岁以下儿童ADE 29例次,涉及10个SOC。全部ADE中死亡206例,涉及相关ADE 1046例次。超敏性ADE 1565例次,超敏性SMQ层级下获得首选语信号88个,其中DRESS、荨麻疹、抗中性粒细胞胞浆抗体阳性血管炎和面部水肿上报例次高且信号较强。结论米诺环素临床使用中需警惕超敏性及自身免疫性疾病导致严重ADE的风险,女性患者尤其需关注头痛、视力下降等特发性颅内压增高的相关症状,必要时可行眼科监测。应加强米诺环素在8岁以下儿童中的用药监护及ADE收集。

基于FAERS的儿童奥司他韦不良事件信号挖掘与分析

目的 为临床安全使用奥司他韦提供参考。方法 检索美国食品和药物管理局不良事件报告系统(FAERS)数据库中2004年第1季度至2023年第1季度以奥司他韦为首要怀疑药物、发生于0~17岁患儿的药品不良事件(ADE)报告,采用报告比值比(ROR)法、比例报告比值比(PRR)法进行信号挖掘,采用《国际医学用语词典》中的首选语(PT)及系统器官分类(SOC)进行编码和归类。结果 共挖掘到奥司他韦相关ADE报告3 100份,检测到阳性信号76个,主要集中在精神病类(34个)、各类神经系统疾病(13个)、胃肠系统疾病(7个)、全身性疾病及给药部位各种反应(6个)、免疫系统疾病(3个)等12个SOC。发生频次排前20位的ADE有幻觉(455次)、异常行为(428次)、呕吐(410次)、谵妄(120次)、意识模糊状态(111次)等,信号强度排前20位的ADE仍以精神病类、各类神经系统疾病、胃肠系统疾病为主。发生频次和信号强度均排前20位的ADE有尖叫、恐惧、睡惊症,药品说明书中均未提及。结论 患儿临床应用奥司他韦时,应关注精神疾病、神经系统和胃肠道系统,以及皮肤和眼部的ADE。

基于FAERS数据库的依达拉奉不良事件信号挖掘

目的:挖掘美国食品药品监督管理局不良事件报告系统(FDA Adeverse Event Reporting System,FAERS)数据库中依达拉奉不良事件的相关临床报告,分析其在临床治疗中的安全性和有效性,为依达拉奉在临床中的应用提供参考。方法:从FAERS数据库中收集2017年4月—2022年12月有关依达拉奉不良事件的相关临床报告,并采用报告比值比(reporting odds ratio,ROR)法以及国际上常用ADE信号检测比例报告(proportional reportingratio,PRR)对数据进行分析。结果:共收集4367份报告,涉及全身性疾病及给药部位各种反应(43.46%)、各类神经系统疾病(13.28%)以及呼吸系统、胸及纵隔疾病(6.69%)等13类系统/器官分类项。其中,药物无效、患者疾病进展以及病情恶化的预警报告分别为239份、227份和125份,肌萎缩侧索硬化信号强度较高(PRR=1269.58),这些不良事件均未出现在说明书中。结论:依达拉奉相关报告反映出其在临床治疗中存在药效不理想的情况。因此,在依达拉奉的临床应用中,除了密切关注患者可能出现说明书包含的不良事件之外,还需根据患者实际情况采用联合用药的策略,保证临床干预的有效性。