Drug Usage Safety from Drug Reviews with Hybrid Machine Learning Approach

With the increasing usage of drugs to remedy different diseases,drug safety has become crucial over the past few years.Often medicine from several companies is offered for a single disease that involves the same/similar substances with slightly different formulae.Such diversification is both helpful and danger-ous as such medicine proves to be more effective or shows side effects to different patients.Despite clinical trials,side effects are reported when the medicine is used by the mass public,of which several such experiences are shared on social media platforms.A system capable of analyzing such reviews could be very helpful to assist healthcare professionals and companies for evaluating the safety of drugs after it has been marketed.Sentiment analysis of drug reviews has a large poten-tial for providing valuable insights into these cases.Therefore,this study proposes an approach to perform analysis on the drug safety reviews using lexicon-based and deep learning techniques.A dataset acquired from the‘Drugs.Com’contain-ing reviews of drug-related side effects and reactions,is used for experiments.A lexicon-based approach,Textblob is used to extract the positive,negative or neu-tral sentiment from the review text.Review classification is achieved using a novel hybrid deep learning model of convolutional neural networks and long short-term memory(CNN-LSTM)network.The CNN is used at thefirst level to extract the appropriate features while LSTM is used at the second level.Several well-known machine learning models including logistic regression,random for-est,decision tree,and AdaBoost are evaluated using term frequency-inverse docu-ment frequency(TF-IDF),a bag of words(BoW),feature union of(TF-IDF+BoW),and lexicon-based methods.Performance analysis with machine learning models,long short term memory and convolutional neural network models,and state-of-the-art approaches indicate that the proposed CNN-LSTM model shows superior performance with an 0.96 accuracy.We also performed a statistical sig-nificance T-test to show the significance of the proposed CNN-LSTM model in comparison with other approaches.

High-speed railway and safety: Insights from a bibliometric approach

High-Speed Rail(HSR)systems represent a significant advancement in modern transportation.They offer rapid,efficient,and environmentally friendly alternatives to traditional rail,air travel and road transportation.Even if highspeed trains appeared approximately in the middle of the previous century,several aspects concerning safety remain.This study aims to comprehensively review the scientific literature related to the safety issues of high-speed railways.A bibliometric analysis was carried out utilizing 2358 publications from the last two decades(2004-2023)to understand better the existing research on HSR and safety.Future trends and thematic areas of research are identified and analyzed.Chinese researchers and universities have led the total number of current publications related to the context of HSR safety.While most of the publications come from Chinese institutions,a significant international collaboration can be identified.The main areas of research on HSR and safety can be classified into four main clusters based on the keywords co-occurrence analysis and are related to risk management,structural dynamics and resilience in railway systems,geotechnical engineering and tunnelling and maintenance technologies.Researchers and policymakers can use the results of this study to better understand the dynamics of scientific research in the field of highspeed railways and safety and make decisions about future directions and funding priorities.

Comparison of renal safety of tenofovir and entecavir in patients with chronic hepatitis B: Systematic review with meta-analysis

BACKGROUND Recently, the American Association for the Study of Liver Disease suggested no preference between tenofovir(TDF) and entecavir(ETV) regarding potential long-term risks of renal complications. Over the years, renal safety has become a critical concern in nucleos(t)ide analog-treated patients due to the long-term use of these drugs. However, existing studies do not show significant differences in renal dysfunction between these two drugs. Further, there is a paucity of studies comparing the long-term renal effects of TDF and ETV.AIM To investigate the effects of TDF and ETV on renal function, we performed systematic review and meta-analysis.METHODS Two investigators independently searched the Cochrane Library, MEDLINE, and Embase databases for randomized controlled trials and nonrandomized studies(NRSs) using the keywords 'CHB', 'Tenofovir', and 'Entecavir', and additional references were obtained from the bibliographies of relevant articles published through December 2017. The quality of each study was assessed using the Newcastle-Ottawa scale and the Grading of Recommendations Assessment,Development and Evaluation criteria. The primary outcome was the change in serum creatinine level in the TDF and ETV groups at baseline, 6 mo, 12 mo and24 mo.RESULTSNine NRSs comprising 2263 participants met the inclusion criteria. Changes in creatinine levels were higher in the TDF group than in the ETV group at 6 mo[mean difference(MD) = 0.03 mg/dL;95%CI: 0.02-0.04;I2 = 0%], 12 mo(MD =0.05 mg/dL;95%CI: 0.02-0.08;I2 = 78%), and 24 mo(MD = 0.07 mg/dL;95%CI:0.01-0.13;I2 = 93%). The change in estimated glomerular filtration rate(eGFR) was significantly higher in the TDF group than in the ETV group at 6 mo[standardized mean difference(SMD),-0.22;95%Cl:-0.36--0.08;I2 = 0%], 12 mo(SMD =-0.24;95%Cl:-0.43--0.05;I2 = 50%), and 24 mo(-0.35;95%Cl:-0.61--0.09;I2= 67%).CONCLUSION TDF statistically significantly increased serum creatinine levels and decreased the eGFR in 6-24 mo compared to ETV, with moderate to low quality of evidence.However, the differences are negligible.

No country is an island in regulating food safety:How the WTO monitors Chinese food safety laws through the Trade Policy Review Mechanism(TPRM)

Established within the framework of the World Trade Organization （WTO）, the Trade Policy Review Mechanism （TPRM） reviews periodically the trade policies of all WTO Members. The review includes many aspects of food safety regulation. China＇s trade policy is reviewed every two years. This paper analyses in detail the reviews of China＇s trade policy in 2006, 2008, 2010, 2012 and 2014. It focuses in particular on food safety laws and types of standards, alignment of domestic standards with international standards, the role of different domestic institutions, transparency and notification of food safety measures under the WTO agreements on Sanitary and Phytosanitary Measures （SPS） and on Technical Barriers to Trade （TBTAgreement）, import and export, and geographical indications （GIs）. It concludes that the WTO TPRM can contribute, within its mandate, to reform of Chinese food safety laws and improvement of food safety in China. it notes that China has already undertaken substantial reforms of its system for regulating food safety. It recommends that China should continue to participate actively in the TPRM, follow its own path with regard to alignment and learn selectively from other WTO Members.

Efficacy and safety of early oral feeding in postoperative patients with upper gastrointestinal tumor:A systematic review and metaanalysis

BACKGROUND Early oral feeding(EOF)is an important measure for early recovery of patients with gastrointestinal tumors after surgery,which has emerged as a safe and effective postoperative strategy for improving clinical outcomes.AIM To determine the safety and efficacy of early oral feeding in postoperative patients with upper gastrointestinal tumor.METHODS This meta-analysis was analyzed using Review Manager version 5.3 and Stata version 14.All clinical studies that analyzed efficacy and safety of EOF for postoperative patients with upper gastrointestinal tumor were included.RESULTS Fifteen studies comprising 2100 adult patients met all the inclusion criteria.A significantly lower risk of pneumonia was presented in the EOF compared with TOF group[relative risk(RR)=0.63,95%confidence interval(CI):0.44-0.89,P=0.01].Length of hospital stay was significantly shorter in the EOF group than in the TOF group[weighted mean difference(WMD)=-1.91,95%CI:-2.42 to-1.40;P<0.01].Cost of hospitalization was significantly lower(WMD=-4.16,95%CI:-5.72 to-2.61;P<0.01),and CD4 cell count and CD4/CD8 cell ratio on postoperative day 7 were significantly higher in the EOF group than in the TOF group:CD4 count(WMD=7.17,95%CI:6.48-7.85;P<0.01),CD4/CD8 ratio(WMD=0.29,95%CI:0.23-0.35;P<0.01).There was no significant difference in risk of anastomotic leak and total postoperative complications.CONCLUSION EOF as compared with TOF was associated with lower risk of pneumonia,shorter hospital length of stay,lower cost of hospitalization,and significantly improved postoperative immune function of patients.

Patients’ Role in Their Own Safety—A Systematic Review of Patient Involvement in Safety

It is necessary to evaluate progress in the area of patient safety. However, although there has been an increase in number of quality and safety related studies have increased, the topics of patient involvement and patient safety are not automatically linked. The aim of this systematic review was to identify and evaluate the evidence contributed by studies of patient involvement in the provision of safe care. Inclusion criteria were studies undertaken to promote involvement in safety, covering patients’ attitudes, unsafe and safe care, risk reduction and handover practices during discharge from hospital to primary care. The results revealed three themes: satisfaction with and need for knowledge about healthcare and the health system, sharing responsibility and accountability for safety and the need to overcome language barriers to prevent harm and error. In conclusion, there is an increased focus on the role of the patient in the provision of safe care. Existing evidence is related to medication rather than patients’ capability and willingness to be involved. It is recommended that patient participation in the provision of safe care should be explored in relation to phenomena such as trust, responsibility, shared decision-making and powerlessness. It is also important to investigate the patient’s role with respect to patient rights.

Efficacy and safety of Buyanghuanwu decoction combined with regular western medicine treatment for ischemic stroke convalescence: a systematic review and meta-analysis

Objective: To evaluate the efficacy and safety of Buyanghuanwu (BYHW) decoction for the treatment of ischemic stroke convalescence. Methods: CNKI, Wanfang knowledge service platform, VIP journal database, Chinese biomedical literature database (CBM), Pubmed, the Cochrane Library, Science Citation Index (SCI) and Elsevier SD databases were searched from the origin time to May 2018. Cochrane recommended bias risk assessment method was used to evaluate the bias risk. Review Manager 5.3 was used to perform meta-analysis. Results: A total of 12 studies with a 1246 cases were included in the study. The results of the analysis showed that the efficacy of BYHW decoction combined with western medicine treatment was better than that of control group (OR = 2.88, 95% CI (2.10,3.95), P < 0.001)]. The neurological deficit score in the treatment group was lower than that in the control group, and the difference was statistically significant [MD =-2.84, 95% CI (-3.22,-2.45), P < 0.001]. The scores of daily living ability in the treatment group were higher than those in the control group, and the difference was statistically significant [MD = 8.89, 95% CI (7.61, 10.16), P <0.00001]. In the safety aspect, the results of the study are different, and there was a lack of quantitative indicators to evaluate the objectivity of adverse reactions. Conclusion: BYHW decoction combined with the Western medicine is an effective treatment for the recovery period of cerebral infarction, which can significantly improve the clinical efficacy, improve patients' neurological symptoms and their quality of life.

Effects of using headset-delivered virtual reality in road safety research:A systematic review of empirical studies

To reduce serious crashes,contemporary research leverages opportunities provided by technology.A potentially higher added value to reduce road trauma may be hidden in utilising emerging technologies,such as headset-delivered virtual reality(VR).However,there is no study to analyse the application of such VR in road safety research systematically.Using the PRISMA protocol,our study identified 39 papers presented at conferences or published in scholarly journals.In those sources,we found evidence of VR's applicability in studies involving different road users(drivers,pedestrians,cyclists and passengers).A number of articles were concerned with providing evidence around the potential adverse effects of VR,such as simulator sickness.Other work compared VR with conventional simulators.VR was also contributing to the emerging field of autonomous vehicles.However,few studies leveraged the opportunities that VR presents to positively influence the involved road users'behaviour.Based on our findings,we identified pathways for future research.

Evidence of Linkages between Patient Safety and Person-Centred Care in the Maternity and Obstetric Context—An Integrative Review

The aim was to evaluate the current state of knowledge pertaining to patient safety and its link to person-centred care. The international relevance of patient safety has expanded, as have the models of person-centred care. Inspired by this new trend, we collated and summarized the literature for evidence of the two topics. The study was guided by Russell, Whittemore and Knafl’s integrative review framework. An electronic database search was conducted for relevant articles from 2005 to 2016. This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The structure and process of the evaluation of the evidence are described and the findings interpreted by means of a thematic synthesis. One theme emerged: trustful, safe communication in the relationship between the patient, family members and healthcare professionals and two domains;safety culture and multidisciplinary capacity building. The dominant dimension in the safety culture domain is respectful communication, which implies sharing experiences that lead to a sense of control during labour and birth and is related to the women’s feeling of personal capacity. The dominant dimensions in the multidisciplinary capacity building domain are collaborative teamwork, coordination and risk management, knowledge sharing and patient-centred communication. In conclusion, to enhance patient safety, it is necessary to develop patient-focused, evidence-based skills and guidelines as well as a supportive organization. Due to their interaction with patients, midwives’ communication competence on the part of midwives is essential for supporting the birth and fulfilling the women’s needs and expectations.

护士用药安全管理实践现状与思考

用药安全管理是患者安全管理的重要内容。护士作为患者用药的最终执行者,其用药安全管理水平对于保证住院患者的治疗安全至关重要。文章回顾了国内外用药安全管理与实践现状,总结我国护士在用药安全管理实践中取得的进展与成效,为进一步推动住院患者用药安全水平的提升提供参考。

高速公路风险防控设施应用研究综述与展望

高速公路风险防控设施的合理应用能够显著降低交通运行风险。本文首先针对高速公路风险防控设施的研究现状进行了回顾与总结,将高速公路风险防控设施划分为非电气化防控设施和电气化防控设施。其次,归纳了高速公路非电气化和电气化防控设施在风险防控中的作用以及研究中的关键问题,讨论了不同电气化风险防控设施的应用场景及其效用。然后,对由电气化设施构成的风险防控系统在多种典型场景中的应用效果进行了分析。最后,对高速公路风险防控设施应用综述结果及未来发展情况进行了总结。文献综述结果表明,高速公路风险防控设施和系统在不同场景中均能起到积极的效果;非电气化防控设施受限于自身物理特性,在应对动态信息发布和主动性、针对性风险防控上存在一定的不足;电气化风险防控设施以及风险防控系统的应用越来越广泛,对交通拥堵、不良天气等交通风险的防控愈加完善。同时,日渐成熟的车路协同技术和不断发展的智慧公路系统也是未来保障高速公路交通安全的重要一环。本文的研究成果可在一定程度上为今后高速公路风险防控设施的选型、设置及应用提供一定的借鉴。

他汀类药物仿制药与原研药的疗效和安全性比较的系统评价

目的:系统评价他汀类药物仿制药与原研药在真实世界中的疗效和安全性,为临床用药选择提供循证依据。方法:计算机检索the Cochrane Library、MEDLINE、Embase、中国知网、中国生物医学文献服务系统、维普数据库和万方数据库,并查阅所获文献所附参考文献,收集他汀类药物仿制药与原研药的观察性研究(暴露组患者使用他汀类药物仿制药或原研药换为仿制药;非暴露组患者使用他汀类药物原研药),检索时限均为数据库建库至2023年7月。对符合纳入标准的研究进行资料提取后,采用纽卡斯尔-渥太华量表进行质量评价;运用RevMan 5.4统计软件进行Meta分析,同时进行描述性分析。结果:共纳入14项研究,其中3项为历史对照研究,11项为队列研究。Meta分析结果显示,仿制药与原研药总体主要不良心血管事件(MACE)发生率的差异无统计学意义(HR=1.07,95%CI=0.98~1.18,P=0.14),但氟伐他汀亚组分析结果提示仿制药的总体MACE发生率显著高于原研药;仿制药的总体全因死亡率显著高于原研药,但随访期为12个月的亚组分析结果显示差异无统计学意义(P>0.05);两组患者脑卒中住院率、不良反应发生率的差异均无统计学意义(P>0.05)。“换药”研究设计的定性描述结果表明,2项回顾性队列研究中,原研药换为仿制药组患者的总胆固醇、三酰甘油、低密度脂蛋白胆固醇水平降低程度与未换药组的差异无统计学意义(P>0.05);3项历史对照研究中,将原研药转换为仿制药并不会降低患者的疗效,然而原研药升高高密度脂蛋白胆固醇的效果显著优于仿制药。结论:他汀类药物的仿制药与原研药在临床疗效和安全性方面未见明显差异。

护士心理社会安全氛围的研究进展

护士作为医疗卫生领域数量最为庞大的专业人员,在“健康中国”事业发展中发挥着重要作用。随着我国人口老龄化加剧,护理人员短缺问题日益凸显,临床护士的工作压力也越来越大,这对其身心健康和护理工作质量造成了严重影响。心理社会安全氛围(psychosocial safety climate,PSC)可以为护理人员提供各类资源,缓解高压力工作对其心理健康造成的损害,有利于提高护理人员的工作投入水平。本文从护士PSC的概念、相关理论、评估工具、结局变量及干预措施等方面进行综述,并提出相应建议和对策,为探索构建系统化干预方案提供依据,以期提高护士PSC水平,促进护理队伍的建设与发展。

食欲素受体拮抗剂类抗失眠药物的研究进展

随着现代社会生活节奏的加快,失眠的患病率逐渐增加,长期失眠会严重影响个人的工作和生活。目前临床常用的改善失眠症状的药物主要为镇静催眠药。作为新一代抗失眠药物,食欲素受体拮抗剂可以增加睡眠各阶段的持续时间、减弱觉醒信号从而抑制清醒状态而非诱导镇静,从而可以有效避免传统镇静催眠药物的一些缺点。本研究对食欲素受体拮抗剂中3个明星药物suvorexant、lemborexant、daridorexant的有效性和安全性进展进行综述,以期为治疗失眠提供参考。

注射用尖吻蝮蛇血凝酶在手术创面止血中的有效性及安全性的系统评价

目的:系统评价注射用尖吻蝮蛇血凝酶在手术创面止血中的有效性及安全性。方法:计算机检索PubMed、the Cochrane Library、Embase、中国知网、万方数据库和中国生物医学文献数据库,检索时间为建库至2023年3月,收集注射用尖吻蝮蛇血凝酶用于手术创面止血的随机对照试验(RCT,研究组干预措施为注射用尖吻蝮蛇血凝酶,对照组为安慰剂或空白对照),中文数据库中限定期刊为中国科技论文核心期刊,英文数据库中不限制期刊。由2名研究者对文献进行筛选、提取及偏倚风险评估,使用RevMan 5.3软件进行Meta分析。结果:共纳入19项RCT研究,包括1 384例患者,其中研究组患者716例,对照组患者668例。Meta分析结果显示,有效性方面,研究组方案降低术中出血量(MD=-65.71,95%CI=-81.99~-49.43,P<0.000 01)、缩短止血时间(MD=-27.25,95%CI=-36.73~-17.77,P<0.000 01)的效果优于对照组,差异均有统计学意义;在安全性方面,与对照组比较,研究组患者24 h后纤维蛋白原水平有一定的降低趋势,24 h后凝血酶原时间有一定的缩短趋势,但差异均无统计学意义(P>0.05)。结论:现有证据表明,注射用尖吻蝮蛇血凝酶针对手术创面止血具有良好的效果及安全性。因当前所掌握的研究数据在数量和质量方面存在限制,因此,需要未来开展更多高质量的RCT研究进一步验证上述结论。

唑来膦酸用于儿童代谢性骨疾病有效性和安全性的系统评价

目的:系统评价唑来膦酸治疗儿童代谢性骨疾病的有效性和安全性。方法:计算机检索PubMed、the Cochrane Library、EMBase、中国知网、维普和万方数据库、ClinicalTrials和Cochrane Central Registry of Controlled Trials、International Clinical Trials Registry Platform。检索时限均从建库起至2021年12月。收集唑来膦酸治疗儿童代谢性骨疾病的随机对照试验(RCT)、病例系列研究和病例报告。RCT、病例系列研究和病例报告的质量评价分别采用Cochrane偏倚风险评价手册和澳大利亚JBI质量评价工具。采用RevMan 5.3软件对RCT进行Meta分析,其他研究进行描述性分析。结果:共纳入研究16项,其中4项为RCT、2项为病例系列研究、10项为病例报告,未检索到关于儿童的队列研究和病例对照研究。Meta分析结果显示,试验组与对照组有效性结局指标腰椎骨密度评分比较差异有统计学意义(MD=0.45,95%CI 0.06~0.84,P=0.02)。对于安全性结局指标,唑来膦酸与安慰剂(RR=1.14,95%CI 0.82~1.60,P=0.44)、其他双膦酸盐(帕米膦酸钠和阿仑膦酸钠,RR=1.33,95%CI 0.53~3.35,P=0.55)比较差异无统计学意义。试验组与对照组在神经系统、消化系统、一般病情和用药部位及骨骼和结缔组织的不良事件发生率相当;唑来膦酸与其他双膦酸盐在神经系统、消化系统、骨骼肌和结缔组织及骨折的不良事件发生率相当。试验组患儿严重不良事件发生率与对照组比较差异无统计学意义(RR=2.59,95%CI 0.54~12.50,P=0.24)。结论:唑来膦酸可有效治疗儿童骨代谢疾病;唑来膦酸与安慰剂、其他双膦酸盐药物的总体不良事件发生率、严重不良事件发生率相当,尤其是在神经系统、消化系统及骨骼和结缔组织中的不良事件发生率相当。

声发射法检测输气管道泄漏的研究综述

声发射法检测管道泄漏是目前的热点方法,研究涉及泄漏信号的产生与传播、信号拾取与处理、基于信号的智能识别与定位等。通过介绍声发射检测定位原理及一些基本规律,详细分析小波分析、局域均值分解、经验模态分解、变分模态分解在处理泄漏信号时的优劣,探讨人工智能在处理管道泄漏声发射信号中的应用,总结管道泄漏的模态研究、相关试验研究,来理清基于声发射的管道泄漏检测现状及展望未来发展。

门诊中药饮片处方点评及合理用药研究

在临床用药过程中,处方点评是十分重要的环节,结合处方点评结果,能够准确判断用药的合理性与安全性,对预防不合理用药有积极的影响。基于此,本研究围绕临床用药管理展开讨论,分析不合理用药的发生原因及危害性,探讨处方点评的相关措施及应用效果。

基于对同情用药认知现状的调研探索在我国开展同情用药研究的思考

目的:根据中美同情用药经验,调研临床试验从业人员的认知和理解现状,对细化和完善我国同情用药制度体系提出建议,从而更好地满足患者的临床需求。方法:使用自愿抽样、方便抽样等非概率抽样方法,基于现有中美同情用药经验,就同情用药的适用条件、申请和审查主体、患者安全管理、审批流程等方面,对临床试验从业人员的认知和理解进行问卷调查。结果:共收集740份有效问卷。调研结果显示,我国临床试验从业人员对我国同情用药的认知程度有待提高。相关企业和机构人员对我国同情用药的认知与理解存在共性和差异。共性主要体现在对同情用药适用人群、“是否可以向药品监管部门提出同情用药申请”的审查主体、严重不良事件报告义务的承担方、同情用药开展地点以及收费问题的认知等方面。差异主要体现在同情用药的药品条件、申请主体、同情用药期间发生不良事件的补偿或赔偿承担方、美国食品药品监督管理局针对紧急情况下单个患者协议和非紧急情况下中等规模患者同情用药的审批流程等方面。结论:现阶段,我国临床试验从业人员对同情用药的了解不足。不同角色的临床试验从业人员对我国同情用药的药品条件、申请和审查主体、患者安全管理以及审批流程等方面的理解差异较大。因此,鼓励加强同情用药相关政策宣传工作,引导更多满足条件的企业开展同情用药计划,让更多潜在患者获益,同时建议针对理解差异较大的内容进一步明确、细化和完善。

护理缺失研究进展

护理缺失是指护理行为的缺失,其存在必然导致护理质量降低,影响患者安全。本文就护理缺失的概念、理论模型、主要缺失内容、测评工具、不良影响及相关干预措施进行阐述,并对未来研究提出建议和展望,以期引起国内护理工作者和管理者的重视,为相关研究的开展提供借鉴和参考。