Reevaluation on Antioxidant Activity of Tonic Chinese Herbs Pseudostellaria heterophylla

Tonic Chinese herbs Pseudostellaria heterophylla has complex components,which has both medicinal and nutritional effects,and the clinical research on anti-oxidation of P.heterophylla has become a hotspot.By searching domestic and foreign databases,the antioxidant literatures of P.heterophylla were searched,consulted,sorted,classified and analyzed,and systematic reevaluation of antioxidant function was conducted from three aspects of P.heterophylla extract in vitro chemical method,biological method and animal test method according to evaluation criteria for antioxidant activity of traditional Chinese medicine and Meta analysis statistical methods.The results would provide systematic reference for further research and development of P.heterophylla,especially for forage value excavation and development of P.heterophylla in the field of modern animal breeding.

Reevaluation of the Holotype of Odorrana schmackeri Boettger,1892(Amphibia:Anura:Ranidae) and Characterization of One Cryptic Species in O.schmackeri sensu lato through Integrative Approaches

The Odorrana schmackeri sensu la to is a group of cascade frogs that are widely distributed in southern China.However,their taxonomy has long been unresolved and several cryptic species have been reported in the past decade.Previous analyses revealed the existence of three sympatrie species(i.c,O.schmackeri,O.hejiangensis and O.sp2) at the type locality of O.schmackeri(Gaojiayan Town,Yichang City,Hubei Province,China).However,the lack of an original description for the holotype specimen(SMF6241) of O.schmackeri poses a confusing and controversial problem in species nomination within this group.Here,we reevaluate the taxonomic affinities of SMF6241 and examine the distinctness of O.sp2 based on specimens from the type locality.We use integrative approaches that combine morphology with 10 microsatellite loci and bioacoustics.Canonical discriminant analysis of morphological characteristics revealed three distinct groupings(i.e.,O.schmackeri,O.hejiangensis and O.sp2) and attributed SMF6241 to O.schmackeri.Genetic clustering analysis of nuclear DNA also identified three corresponding clusters.In addition,analysis of interspecific variation in morphometrics and acoustics showed divergence between O.sp2 and its sympatric congeners.All lines of evidence from morphological,molecular and bioacoustic approaches suggest the species status of O.sp2,namely Odorrana ichangensis Chen,sp.nov.Overall,this study resolves the taxonomic assignment of the holotype of O.schmackeri and provides an example for species delimitation using integrative approaches.

Lactate reloaded–reevaluation of the importance of lactate monitoring in the management of adult sepsis in the emergency department

For about a quarter of a century,monitoring lactate levels and/or lactate clearance has been an unquestionable cornerstone in sepsis management.The elevated lactate level appeared to be an independent predictor of mortality,and the consequent metabolic acidosis was thought to explain a number of pathophysiological changes seen in septic shock.Recent physiological and clinical findings seem to challenge the adverse role of lactic acidosis in sepsis.Evidence suggests that lactate levels are not necessarily directly proportional to either tissue or cellular hypoxia,and conversely,despite high lactate levels,increased peripheral tissue oxygen pressure can be measured in adult patients with septic shock.According to the most recent understanding of in vitro and in vivo evidence,the elevated lactate level in sepsis might be a normal reaction due to adrenergic stress with potential beneficial/protective physiological effects,as well.On the one hand,burning lactic may help fuel the body during critical illness,but on the other hand,with a slight drop in pH,the body may counteract certain deleterious changes during the dysregulated host response;reduce the chances of reperfusion myocardial injury,and improve tissue oxygenation by shifting the haemoglobin dissociation curve to the right.Understanding the pathophysiological process in sepsis resulting in elevated lactate levels may aid management in an emergency,medicine,and intensive care settings.With more in-depth physiological knowledge,physicians may inevitably surpass normalisation heuristics and deliver personalized rather than protocolised sepsis resuscitation.

Burnout and work-family conflict among nurses during the preparation for reevaluation of a grade A tertiary hospital

Objectives： To gain a better understanding of nurse burnout and work-family conflict for nurses and to help the hospital prepare for hospital grade reevaluation.Methods： This study is a cross-sectional study, and 95 nurses participated. The questionnaires included MBI and Carlson work-family conflict questionnaires, and the data were analyzed using SPSS 17.Results： A total of 71.6% of nurses worked over 8 h per day during the last two months before the reevaluation. The total score of burnout of nurses was 66.84 ± 12.60, and the proportion of heavy work burnout was 44.2%. The personal accomplishment takes the heaviest portion（80.0%）. The total score of work-family conflict is 55.19 ± 9.27. The scores of work-to-family conflict are all higher than that of family-to-work conflict. The time dimension had the highest score.Conclusions： During the preparation period, nurses suffered from a heavy workload and intense job burnout, and many aspects of work-family conflict existed.

Analysis of Ornidazole Injection in Clinical Use at Post-marketing Stage by Centralized Hospital Monitoring System

This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method,and investigate its widespread use in patients,in order to regulate and guide the rational drug use,improve the drug specificity and provide a basis for drug therapy.The study adopts a prospective,multi-center,large sample size,centralized hospital monitoring system.We selected five leading hospitals in Hubei province,and observed the inpatients who received the ornidazole injection from July 1,2015 to October 31,2015.The basic information of patients was recorded,as well as the drug use and adverse events.The statistical analysis was performed based on these data.A total of 4396 individuals were enrolled in this study,most of them were middle-aged female patients and the ornidazole injection was mainly used as prophylactic prior to surgery to prevent the infections,and surgical treatment of anaerobic infections,abdominal infections and pelvic infections.The irrational drug use existed mainly in the prescribing and administration process,including unreasonable dosing frequency,rapid intravenous drip speed and extended duration of drug use.Eleven cases of adverse reactions were collected during the monitoring,incidence rate of adverse reactions was 2.5‰;adverse drug reactions occurred within 30 min.The study results fully reflected the usage of ornidazole injection in the real world.Based on the study,we calculated the adverse reaction incidence of ornidazole and identified the risk factors which may affect the safety of ornidazole injection.Study results strongly recommend that the manufacturers should publish standards for inpatient use and doctors should prescribe with caution accordingly.

How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern.The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine.In this paper,we propose a reappraisal protocol called“precise proprietary Chinese medicine”to precisely i)define the therapeutic aim;ii)design the protocol;iii)control the quality of proprietary Chinese medicine;iv)implement the protocol in the trial;v)study the mechanism-of-action of the proprietary Chinese medicine and vi)describe the indications of the proprietary Chinese medicine.We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

Safety and Efficacy of Combination Therapy with Insulin Glargine and Oral Hypoglycaemic Agents Including DPP-4 Inhibitors in Japanese T2DM Patients: ALOHA 2 Study, a Post-Marketing Surveillance for Lantus^®

Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine (Lantus®) and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4 (DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods: This postmarketing surveillance was a prospective, observational, 24-week study that complied with the pharmaceutical affairs law and the ministerial ordinance of “Good Post-Marketing Study Practice (GPSP)” in Japan. Safety, efficacy and patient-reported outcomes (PROs);patients’ satisfaction with treatment (DTSQs and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630 patients were enrolled. Of the 2,602 patients in the safety analysis population, 161 patients experienced 175 cases of adverse drug reactions, and the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the incidence rate (episodes per patient-year) was 0.019. Basal supported oral therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2 hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL respectively. The mean weight was increased, however the change was +0.50 kg. In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index scores and EQ-VAS scores were significantly improved. Conclusion: Insulin glargine and OADs combination therapy was suggested to be effective and well tolerated. Patients’ satisfaction with treatment and their self-reported health improved in spite of the addition of injections to oral agents. The combination therapy of insulin glargine and OADs including DPP-4 inhibitors is likely to be considered an important therapeutic option in the diabetic patients.

Reevaluating Africa’s Strategic Partnerships

Africa＇s strategic partnerships are aimed at mobilizing the necessary financial and technical support for the implementation of regional and continental programs, including the recently adopted Agenda 2063 and its First lO-Year Implementation Plan. However, although the strategic partnerships have proven relevant in the past, their objectives, scope and modus operandi need to be regularly reviewed in order to make them more balanced, productive and action-oriented.

无源植入类医疗器械上市后安全性评价专家共识

无源植入类医疗器械是不依靠电能或其他能源、借助外科手术器械全部或部分进入人体或自然腔道中的一类医疗器械。加强无源植入类医疗器械上市后的风险评价工作,对于全面提升医疗器械全生命周期监管水平具有十分重要的意义。国家药品监督管理局药品评价中心组织相关专家组成专家组,进行讨论指导后最终形成“无源植入类医疗器械安全性评价”专家共识,通过对国内外医疗器械不良事件监测法规体系及案例进行对比分析,结合我国医疗器械不良事件监测现状,将无源植入类医疗器械的上市后安全性评价分为工作体系和技术指导原则,为开展无源植入类医疗器械上市后安全性评价提供参考依据,促进上市后的医疗器械安全性评价工作规范化。

论茅坤对柳宗元“与故人书”的重估及其影响

在茅坤之前,柳宗元的“与故人书”往往被认为乞哀望援,格调不高,其评价以否定居多。茅坤仕途坎坷,中岁削籍,一腔郁愤,与柳宗元为近,乞哀望援,亦所不免,因而能够揣情度理,拨弃旧见,第一次全面肯定“与故人书”的文学价值。茅坤认为,柳宗元“与故人书”的“沉郁”风格,源自司马迁《报任安书》和杨恽《报孙会宗书》,实系“发愤著书”的产物。他还认为,柳宗元“与故人书”代表了其在古文运动中的最高成就,与此前带有六朝锦色的骈散相兼之作判然有别。这就从中国优秀文学传统的继承和中国散文骈散分流的宏大视角肯定了柳宗元“与故人书”在中国散文史上的重要价值,可以看作柳宗元散文批评的分水岭。清人基本接受了茅坤的新评价,并在此基础上更加深刻、详尽地阐明了柳宗元“与故人书”的审美价值。茅坤对柳宗元“与故人书”的重估是柳文经典化过程中的关捩,对清代柳文地位的提升具有先导意义。

双黄连注射剂不良反应回顾性研究

目的 :了解双黄连注射剂不良反应类型及其发生率 ,探索药物流行病学方法在药品安全性评价中的应用。方法 :采用病历回顾性研究法 ,对北京等 6省市 16家医院 4 382份使用双黄连注射剂的完整住院病历进行调查 ,用SPSS11.5进行统计分析。结果 :双黄连注射剂主要不良反应为变态反应 (发生率 2 .2 4 % ) ,其中以皮疹(1.6 9% )最为常见 ;胃肠道反应 (1.5 1% )以恶心、呕吐、腹痛、腹泻为常见 ;其他不良反应包括发热 (0 .6 4 % )、心脑血管反应 (0 .4 3% )、胸闷心悸 (0 .32 % )。结论 :病历回顾性研究方法适用于药品的安全性研究。双黄连注射剂的常见不良反应应引起临床医生的重视。有必要修改其药品说明书 。

基于问题的教学方法在外科教学中的应用效果系统评价的再评价

目的对已发表文献中基于问题的教学方法(PBL)在外科教学中应用效果的系统评价进行再评价。方法计算机检索The Cochrane Library、PubMed、Web of Science、Embase、CNKI、万方、维普数据库,查找PBL教学方法在外科教学方面的系统评价文献,各数据库检索时限从建库至2021年3月。使用AMSTAR 2量表评价纳入分析文献方法学的质量。结果经过筛选后纳入7篇系统评价文献进行分析,其中2篇中质量文献,1篇低质量文献,4篇极低质量文献。在基础成绩方面,PBL联合老师教授为主的教学方法(LBL)或单纯PBL均优于单纯LBL组,但单纯使用PBL可能存在关键知识遗漏的情况;在实践操作技能和综合成绩方面,PBL联合LBL或单独PBL方法均优于LBL法。结论 PBL在外科教学中不失为一种优质的方法,但同时LBL也具有与PBL互补的作用,两者有机结合可更好地培养外科医学人才。

医疗设备质量再评价的意义及方法

质量再评价是医疗设备质量控制体系的重要组成部分。通过分析我国医疗机构在用医疗设备质量合格率欠佳的现状,提出医疗设备质量控制再评价工作的意义及实施办法,以改善医疗设备质量所存在的不足。从加强医疗设备质量标准、构建技术规范及完善不良事件监测等环节,对建立医疗设备质量再评价体系进行探索和研讨。医疗机构对医疗设备展开质量再评价,对医疗设备的质量控制具有重要价值。

药品上市后的风险管理

目的探讨上市药品风险管理的技术模式,为开展我国药品再评价提供技术参考。方法通过分析、总结国外风险管理模式,探索较为实用的评价方式。结果基本掌握了风险管理技术模式。结论通过风险/效益评价,对药品可采取召回、永久撤市、限制使用、修改说明书等措施。

5所医院19487例马来酸桂哌齐特用药人群ADR自动监测与评价

目的:通过实施哨点医院多中心ADR信息化重点品种主动监测研究,探讨药物监测与评价规律和相关因素,深化军队药物警戒工作。方法:经过集中培训,按照统一监测条件,利用"住院患者药品不良事件主动监测与评估警示系统",自动监测2016年1–12月期间5所军队哨点医院19 487例马来酸桂哌齐特用药人群数据,系统报警案例经人工逐例分析后上报汇总并统计分析。结果:马来酸桂哌齐特注射液相关血小板减少、血红蛋白减少、白细胞减少、肝损害、肾损害发生率分别为0.20%、0.37%、0.41%、1.37%、0.82%;总发生率3.17%。未见相关性粒细胞缺乏病例。多中心监测结果能反映各医院的用药习惯和真实人群特点,但总体趋同。结论:基于大样本真实世界研究获得的药物上市后安全性再评价结果更具参考意义;基于专项软件开展多中心药物安全性再评价,数据可靠、便捷高效。桂哌齐特注射液工艺改进后,临床用药较为安全。

美国、欧盟、日本药品再评价的法律制度研究及对我国的启示

目的:为我国建立和完善药品再评价制度提供参考。方法:查阅并总结美国、欧盟、日本药品上市后再评价的相关法律制度,分析我国在药品再评价工作方面的不足,并提出完善建议。结果与结论:美国、欧盟、日本均对药品上市后再评价制定了相关法律及制度,还有具体的实施规范和技术支撑计划。美国药品再评价法律制度可分为药品不良反应的监测与报告制度、药品上市后研究制度和药品安全风险主动监测系统;欧盟主要有针对常规上市药品、特殊情况或条件许可药品的监测与评价制度,以及药品再注册制度;日本的再评价法律制度主要由再审查制度和再评价制度等组成。而我国药品再评价工作尚存在体系性不强,立法层面薄弱、可操作性和震慑力不足,药品再评价结果的落实与应用环节未能得到有效衔接,资源未得到有效配置等不足。建议我国可整合已有再评价相关制度,从药品再评价法律制度体系的系统构建、立法层面的建设和规范、再评价法律制度体系的衔接及资源的配置三方面入手,完善我国药品再评价法律制度体系。

3004例乌灵胶囊上市后安全性医院集中监测研究

目的观察乌灵胶囊不良事件(ADE)和不良反应(ADR)发生率、性质和临床表现,为临床安全用药提供依据。方法采用多中心前瞻性、单臂医院集中监测的临床试验,监测2013年6月15日—2015年12月31日12家临床研究中心使用乌灵胶囊且符合伦理要求的患者,记录并分析所有ADR/ADE以及处理情况。结果共纳入患者3004例,其中发生ADE19例,发生率0.63%,发生ADR15例,发生率0.50%。ADR主要集中在消化系统及神经系统,包括食欲减退、口干、恶心、腹泻、胃部不适、心悸、头晕、头痛等症状,尚未发现与ADR/ADE相关的影响因素。结论乌灵胶囊的ADR发生率低,属于偶见,临床应用安全性较高。

从药品不良反应信息通报探究中药注射剂问题及对策

目的从《药品不良反应信息通报》探究中药注射剂临床使用中存在的问题,分析对策减少其不良反应发生。方法对70期《药品不良反应信息通报》所涉及的中药注射剂进行回顾性分析。结果涉及中药注射剂不良反应的通报15期,通报中药注射剂20品次,其中有4种中药注射剂被通报两次。中药注射剂的免疫原性和临床不合理用药是导致中药注射剂不良反应发生的主要原因。结论为保障中药注射剂临床使用的安全性,需要提升中药注射剂品质,开展临床再评价工作,并在临床使用中严格按照规范操作。

关于我国药品上市后评价技术工作的思考

目的探讨今后药品上市后评价工作方向。方法分析和总结以往工作体会。结果我国药品上市后评价工作已初见成效。结论应继续深入开展药品上市后评价工作。

应当重视中药注射剂上市后再评价

中药注射剂是我国特有的中药新剂型,颇具开拓国际市场潜在优势。由于中药注射剂尚存在一系列问题,亟待上市后再评价。笔者重点阐述中药注射剂上市后再评价的主要内容——安全性、有效性、处方组成、制备工艺、质量标准、功能主治和药物经济学,并就再评价的重点品种、主要措施和方法提供参考意见。