术前孕酮预测异位妊娠保守手术治疗预后的价值

目的观察术前血清孕酮水平在预测输卵管妊娠行保守手术后持续性输卵管妊娠穴persistentectopicpreg鄄nancy,PEP雪发生中的价值。方法对确诊为异位妊娠行腹腔镜下输卵管保守手术的住院患者50例,在术前24h内及术后第1、3、7、14天测定血清孕酮穴progesterone,P雪和人绒毛膜促性腺激素穴β-HCG雪水平至正常,用受试者工作特性曲线穴receiveroperatorcharacteris鄄ticcurve熏ROC雪确定用于预测PEP发生的最佳临界点穴bestcriticalpoints雪。结果50例患者中,PEP组9例,未发生持续性异位妊娠穴NonePEP雪组41例。术前PEP组P均值12.28ng/ml,NPEP组P均值6.42ng/ml,经t检验,P<0.05;其中术前血清孕酮>10ng/ml,术后发生PEP的危险性明显升高。结论术前血清孕酮水平对异位妊娠能否行保守手术的决策有一定的参考价值。     

血尿酸与急性心肌梗死预后

目的探讨血尿酸对急性心肌梗死穴AMI雪预后的影响。方法对23例死亡AMI穴死亡组雪患者与23例生存AMI穴对照组雪的患者血尿酸水平、肌酸磷酸激酶、肌钙蛋白T穴cTNT雪、血脂、血糖进行比较分析。结果死亡组血尿酸水平、肌酸磷酸激酶明显高于AMI对照组穴P<0.05雪,两组间cTNT、血脂、血糖无明显差异穴P>0.05雪。结论高尿酸血症与A鄄MI的预后不良有关。     

血清C-反应蛋白和α1-酸性糖蛋白水平评估类风湿性关节炎病情的意义

目的探讨C-反应蛋白穴CRP雪和α1-酸性糖蛋白穴α1-AG雪的检测在类风湿性关节炎穴RA雪活动性评估中的意义。方法用免疫比浊法检测36例活动期患者和23例非活动期患者血清C-反应蛋白和α1-酸性糖蛋白,并与30名正常人相比较。结果活动期患者血清C-反应蛋白和α1-酸性糖蛋白水平明显高于非活动期患者穴P均<0.01雪熏且两组患者血清水平均高于正常对照组穴P均<0.01雪。11例活动期患者治疗后,血清C-反应蛋白和α1-酸性糖蛋白水平明显下降穴P<0.05雪熏但仍高于正常对照组穴P<0.05雪。结论血清C-反应蛋白和α1-酸性糖蛋白的检测对类风湿性关节炎患者活动性评估具有一定的临床应用价值。     

血管紧张素转换酶抑制剂在心肌梗死中的应用研究

肾素-血管紧张素-醛固酮系统穴renin-angiotensin-aldosteronesystem,RAAS雪在人体里发挥着重要作用,且分布广泛。以前这个重要系统的功能都被片面的强调为与内分泌和循环系统有关。但是现代的深入研究已经发现这个系统对人体的应激和修复功能起着十分重要的作用。现已发现RAAS在组织中分布广泛,在心血管系统、脑组织、肾脏等都有丰富的分布。在1970年,BURAN等人发现了血管紧张素在心脏疾病中的重要作用以后,人们重新认识了血管紧张素转换酶穴an鄄giotensinconvertingenzyme,ACE雪,并研制了数种血管紧张素转换酶抑制剂穴angiotensinc…     

抗抑郁药用药频度与金额的跟踪分析

北京回龙观医院是一所大型三级甲等精神病专科医院穴固定床位1369张雪,主要收治精神分裂症、心境障碍等各类精神疾病患者。治疗的主要手段是精神药物,而抗抑郁药是一类主要用于治疗各种抑郁状态的药。因此,分析、评价这类药物在临床上的应用情况,对指导药物的合理应用和研制、开发具有重要的意义。本文采用世界卫生组织穴WHO雪提出的约定日剂量穴De鄄finedDailyDose,DDD雪分析方法[1],对北京回龙观医院1999年～2002年抗抑郁药应用情况进行调查,通过用药频度和金额分析,对各类抗抑郁药物在临床应用的地位进行评价,并预测抗抑郁药的用药趋…     

基因变构人白细胞介素-2克隆构建和原核表达

目的构建基因变构IL-2穴88N→R雪的重组克隆熏并将其在原核系统中进行高效表达,为研究基因变构IL-2穴88N→R雪的生物学活性奠定基础。方法分离人体T细胞经PHA刺激活化后,提取细胞的RNA为模板,逆转录构建cDNA文库,经套式PCR扩增出编码IL-2的基因,插入T-A载体后获得编码天然IL-2的克隆,核苷酸测序证实成功后,自行设计含有突变位点的引物,利用重组PCR技术,进行定点诱变构建基因变构IL-2穴88N→R雪的重组克隆熏DNA测序确认变构成功。将改构后的IL-2基因重组于原核pGEX-4T-2质粒上,转化宿主菌E.coli.DH5α中,经IPTG诱导后表达IL-2变构体,表达产物经SDS-PAGE电泳分析。结果获得了人类天然IL-2的编码基因克隆和基因变构IL-2的编码基因克隆,并将变构IL-2穴88N→R雪在大肠杆菌中获得了高效表达。结论IL-2基因的成功定点变构及其在原核生物中获得稳定高效的表达,为进一步在真核细胞中表达以及研究制备低毒、高效的新型基因变构IL-2药物奠定基础。     

人肝脏再生增强因子cDNA的克隆、表达及产物活性鉴定

目的通过对人源肝脏再生增强因子穴Augmenterofliverregeneration熏ALR雪cDNA进行克隆、表达及表达产物活性的初步鉴定,为基因工程大量制备重组hALR穴humanAugmenterofliverregeneration熏ALR雪及其临床应用提供资料。方法提取人胎肝总RNA,通过RT-PCR获得全长hALRcDNA,构建原核融合表达质粒pGEX-4T-3/hALRcDNA,转化大肠杆菌诱导表达融合蛋白。MTT法及小鼠CCl4肝衰竭模型检测重组hALR的生物学活性。结果测序证实克隆得到的hALR序列完全正确。SDS-PAGE检测表达产物分子量约41kD,与融合蛋白GST-hALR的预期分子量相吻合。MTT比色结果为21.9ng/mlhALR对Hep3B细胞系的促增殖作用显著高于对照组(P<0.05)。体内活性检测结果表明hALR能显著提高CCl4诱导肝功能衰竭动物的存活率(χ2=3.923熏P<0.05)。结论重组hALR的制备过程简单易行,可通过基因工程方法大量生产。活性检测表明hALR具有促肝细胞增殖和肝功能修复的作用。     

中药粉剂外敷减少宫颈环形电切术后出血的临床疗效评价

宫颈环形电切术穴loopelectro-surgicalexcisionprocedureLEEP雪于上世纪90年代开始广泛应用于宫颈疾病的诊断与治疗熏在妇科领域中深受欢迎。本研究以减少LEEP术后出血量熏减轻患者痛苦熏促进宫颈愈合为目的熏短期观察疗效满意熏现报道如下。1. 资料与方法1.1病例来源及分组研究对象为2003年3月至2004年7月在黑龙江中医药大学附属第一医院阴道镜门诊就诊的患者。经宫颈细胞学检查(TCT)、阴道镜及宫颈活组织检查初步诊断为各种宫颈疾病的患者共80例,使用LEEP治疗,其中宫颈糜烂Ⅲ度54例,宫颈息肉7例,宫颈肥大并腺囊肿6例,宫颈肥大并宫…     

糖基化白蛋白液中糖含量的不同定量方法比较

目的探讨测定糖基化白蛋白反应液中葡萄糖含量的适宜方法。方法对3熏5-二硝基水杨酸法、邻甲苯胺法和苯酚-硫酸法三种不同测定糖含量方法进行研究比较。结果3熏5-二硝基水杨酸法、邻甲苯胺法、苯酚-硫酸法测定糖的线性范围分别为:2.5×10-5～3.0×10-4mol/L,3.0×10-5～3.0×10-4mol/L,2.5×10-5～2.5×10-4mol/L;直线回归方程为:y=0.01780x-0.05400穴r=0.9991雪,y=0.006029x+0.004286穴r=0.9988雪,y=0.01554x-0.001905穴r=0.9994雪;摩尔吸光系数为:6.5×103L/mol·cm,2.4×102L/mol·cm,2.4×104L/mol·cm;回收率分别为:101.9%～108.0%,92.3%～109.1%,94.3%～104.5%。结论苯酚-硫酸法具有操作简便、准确、灵敏、快速、显色后颜色稳定等优点,适用于测定糖基化白蛋白样品中的糖含量。     

婴幼儿轮状病毒肠炎合并肠外器官损害

目的探讨轮状病毒肠炎合并肠外器官的损害情况及与脱水严重程度的关系。方法对216例轮状病毒肠炎合并各系统损害的78例病历进行回顾性分析。结果78例合并有肠外各系统器官损害中,呼吸系统损害占首位为45例穴57.7%雪,其它依次为心肌32例穴41%雪、肝脏8例穴10.3%雪、神经系统6例穴7.8%雪,经对症治疗,1～3周均恢复正常。轻度出现肠外器官损害60例穴76.9%雪,重度脱水出现18例穴23.1%雪,经统计学处理,不同程度脱水肠外器官损害发生率比较,无显著性差异穴P>0.05雪。结论轮状病毒肠炎可合并肠外多系统损害,其发生率与脱水严重程度呈非正相关。     

ASTM and ASME-BPE Standards--Complying with the Needs of the Pharmaceutical Industry

Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and standards and then modifying them in order to meet the more stringent requirements of the Food and Drug Administration (FDA). In 1997 the American Society of Mechanical Engineers (ASME) published the first Bioprocessing Equipment (BPE) Standard. Through harmonization efforts this relatively new standard has brought together, scrutinized, and refined industry accepted methodologies together with FDA compliance requirements, and has established an American National Standard that provides a comprehensive set of standards that are integral to the pharmaceutical industry. This article describes various American National Standards, including those developed and published by the American Society for Testing and Materials (ASTM), and how they apply to the pharmaceutical industry. It goes on to discuss the harmonization effort that takes place between the various standards developers in an attempt to prevent conflicts and omissions between the many standards. Also included are examples of tables and figures taken from the ASME-BPE Standard. These examples provide the reader with insight to the relevant content of the ASME-BPE Standard. LAY ABSTRACT: Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry standards directed at the needs and requirements of the pharmaceutical industry. Prior to that time it was a patchwork effort at resourcing and adopting nonpharmaceutical-related codes and standards and then modifying them in order to meet the more stringent requirements of the Food and Drug Administration (FDA). In 1997 the American Society of Mechanical Engineers (ASME) published the first Bioprocessing Equipment (BPE) Standard. In its initial development and ongoing maintenance it works with other American National Standards developers to harmonize the many standards associated with the design, engineering, and construction of bioprocessing facilities. This harmonization effort has established a comprehensive set of standards for the betterment of the pharmaceutical industry at large. This effort is, and will remain, very important as technology, along with new and improved product and processes, evolve into the future.     

The development and regulation of occupational exposure limits in Singapore

Singapore is an island republic in South East Asia with a workforce of about 2.1 million including 0.7 million employed in the manufacturing industry. Singapore's industry is diversified and the main growth sectors include microelectronics, chemical, petrochemical, pharmaceutical, and biomedical sectors. Exposure to chemical hazards is one of the main occupational health problems in the manufacturing sectors. The main roles of government in the protection of workers against safety and health hazards are to set standards and provide a proper infrastructure for industry to self-regulate. The occupation safety and health laws must provide adequate protection of workforce but must not disadvantage local industry in this globally competitive economy. To ensure a level playing field, Singapore's occupational exposure standards are benchmarked against those established in the developed countries. These standards are reviewed regularly to ensure they are realistic and relevant in tandem with worldwide trends. Industry and stakeholders are consulted before any new standards are introduced. In enforcing the laws relating to exposure standards, legal and administrative procedures are followed to ensure fairness and to prevent abuse.     

国产保健食品质量标准现状概述

目的综述国产保健食品质量标准的制定及进展。方法通过对国产保健食品质量标准现状的分析,就加强我国保健食品质量标准化建设提出几点建议。结果与结论我国保健食品质量标准已经取得了较大的进步,但必须建立、执行自己的国家标准或行业标准。     

中药标准物质的发展现状与展望

目的介绍中药标准物质的发展过程、现状和存在的问题以及今后的发展趋势。方法总结目前中药标准物质的发展过程,分析、探究其发展趋势。结果中药标准物质取得了一些可喜的成就,还存在一些技术及供应方面的问题。结论中药标准物质的发展离不开中药标准的提高,二者相互促进,对于中药的产业化、现代化具有重要的意义。     

我国化妆品标准及其效力研究

目的:系统分析我国化妆品标准现状,为进一步加强化妆品标准体系建设提供参考,为探索不同实施效力的化妆品标准间相互协调,以适应我国化妆品安全生产、经营、监管提供思路.方法:从化妆品定义出发,分析现有法规与标准之间、标准与标准之间的关系,对标准在实施过程中产生的问题进行剖析.结果 与结论:现有的化妆品标准之间存在对同一事项规...     

Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

The continued globalization of pharmaceutics has increased the demand for companies to know and understand the regulations that exist across the globe. One hurdle facing pharmaceutical and biotechnology companies developing new drug candidates is interpreting the current regulatory guidance documents and industry publications associated with bioanalytical method validation (BMV) from each of the different agencies throughout the world. The objective of this commentary is to provide our opinions on the best practices for reference standards and key reagents, such as metabolites and internal standards used in the support of regulated bioanalysis based on a review of current regulatory guidance documents and industry white papers for BMV.     

医疗器械标准在中美医疗器械监管领域的实践和发展思考

目的：为医疗器械标准在医疗器械监管领域的应用和发展提供参考。方法：总结我国医疗器械标准的分类及应用要求、标准符合性评价方面关于检验报告和检验机构资质的要求;对比美国标准体系下的医疗器械认可推荐性共识标准机制及其对医疗器械检验实验室的要求,并介绍了美国食品药品管理局在有关标准符合性评估方面的合格评定计划;总结分析两国监管的异同,提出未来医疗器械监管发展中标准与专利融合的必要性。结果与结论：中美两国在医疗器械标准监管的管理模式上有诸多不同,但本质上也有许多相似之处。我国医疗器械领域标准的监管在未来的发展中应着眼于提升产业核心竞争力,广泛采用国际标准和发达国家的先进标准,并重视对先进技术和专利的吸纳以及向国际标准的转化,以期提升器械监管水平,促进我国医疗器械行业的高水平发展。     

不同包装形式基础输液生产质量内控标准调查研究

目的：考查不同包装形式基础输液的生产质量内控标准。方法：通过调研问卷调查7家基础输液生产企业关于细菌内毒素、不溶性微粒、漏液率、组合盖穿刺落屑的企业标准，并与国家标准/行业标准进行对照。结果：不同包装形式基础输液在细菌内毒素、不溶性微粒、漏液率、胶塞穿刺落屑四个方面的生产质量标准较国家标准/行业标准均有不同程度的提高。结论：生产企业的内控标准均较国家标准/行业标准更为严格，各类材料和包装形式的基础输液产品在保证临床用药安全、便捷等方面发挥了重要作用，建议将不同包装形式的技术、材料成本与药品安全性、使用便捷性挂钩，这对鼓励创新、促进公平竞争十分重要。     

Radiology and endoscopy in acute upper gastrointestinal bleeding.

Of 112 patients admitted with acute upper gastrointestinal bleeding, the presumed bleeding site was detected in 61-5% of cases by radiology and in 57% of cases on endoscopy. Thirty-one patients who had barium-meal examination were operated on and the surgical and radiological findings agreed in 26 (84%). Twenty-three patients who had endoscopy were operated on and the surgical and endoscopic findings agreed in 15 (65%). In 10 cases radiology detected a lesion not identified on endoscopy and in nine endoscopy detected a lesion not seen at radiology. We suggest that when there are two potential sources of bleeding radiology as well as endoscopy can detect the actively bleeding lesion. The supplementary nature of radiology and endoscopy is emphasised and we conclude that both methods should be used if there is any doubt at the initial radiological or endoscopic examination about the source of the bleeding.     

Foreign Particles Testing in Orally Inhaled and Nasal Drug Products

No Heading The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) presents this paper in order to contribute to public discussion regarding best approaches to foreign particles testing in orally inhaled and nasal drug products (OINDPs) and to help facilitate development of consensus views on this subject. We performed a comprehensive review of industry experience and best practices regarding foreign particles testing in OINDPs, reviewed current guidances and techniques, and considered health and safety perspectives. We also conducted and assessed results of an industry survey on U.S. Food and Drug Administration requirements for foreign particles testing. We provide here a result of our review and survey: a summary of industry best practices for testing and controlling foreign particles in OINDPs and proposals for developmental characterization and quality control strategies for foreign particles. We believe that clear consensus-based recommendations and standards for foreign particles testing and control in OINDPs are needed. The proposals contained in this paper could provide a starting point for developing such consensus recommendations and standards.