一种检测细菌性阴道病方法的建立及临床评价

目的评估一种国内自主建立利用唾液酸酶检测细菌性阴道病（BV）方法的临床应用价值。方法比色法探索研发试剂与酶标准品的最佳反应条件,包括底物溶液的pH值和反应的最适温度及时间。采用研发试剂、BV BLUE、临床现用国产试剂盒对临床标本进行检测,判断研发试剂的临床应用价值。结果研发试剂在pH值6.0-6.2、37℃10 min时与酶标准品达到最佳反应,与BV BLUE相比,检出限相同时研发试剂底物用量仅为BV BLUE的1/2.78。临床实验中,研发试剂与BV BLUE对BV的检测效果差异无统计学意义（P=1.000,Kappa=0.905）,符合率为96%。而国产试剂盒与BV BLUE对BV的检测效果差异有统计学意义（P=0.000,Kappa=0.362）,符合率为65%。结论研发试剂可以达到与BV BLUE相同的检出效果,其快速、方便、可信度高且成本较低,优于国内类似产品,更有利于在临床推广和使用。     

细菌性阴道病实验室诊断方法评价

目的对几种常见的BV诊断试剂盒进行对比实验,选择一种能准确、有效诊断BV的最适试剂盒.方法随机选取我院妇科门诊患者80例,每位患者均一次性留取4份阴道分泌物标本,其中3份分别采用美国产BV Blue快速诊断试剂、国产BV试剂和胺实验试剂进行检测,另一份革兰染色,由经验丰富的技术人员依据Nugent评分标准评分,并结合临床症状对BV确诊.然后对三种试剂盒的检测结果与确诊结果之间的符合率进行比较.结果80例患者,其中40例被确诊为BV.美国产BV Blue快速诊断试剂、国产BV试剂、胺实验试剂与确诊结果的符合率分别为87.5%、65%、70%,美国产BV Blue快速诊断试剂符合率明显高于其他两种(P＜0.05);此外,国产BV试剂和胺实验试剂假阳性率分别为25%、30%,明显高于美国产BV Blue快速诊断试剂(0).结论美国产BV Blue诊断试剂快速、简便,假阳性率低,特异性、敏感性均符合临床要求,值得推广.     

细菌性阴道病实验室诊断方法评价

目的对几种常见的BV诊断试剂盒进行对比实验,选择一种能准确、有效诊断BV的最适试剂盒。方法随机选取我院妇科门诊患者80例,每位患者均一次性留取4份阴道分泌物标本,其中3份分别采用美国产BVBlue快速诊断试剂、国产BV试剂和胺实验试剂进行检测,另一份革兰染色,由经验丰富的技术人员依据Nugent评分标准评分,并结合临床症状对BV确诊。然后对三种试剂盒的检测结果与确诊结果之间的符合率进行比较。结果80例患者,其中40例被确诊为BV。美国产BVBlue快速诊断试剂、国产BV试剂、胺实验试剂与确诊结果的符合率分别为87.5%、65%、70%,美国产BVBlue快速诊断试剂符合率明显高于其他两种(P<0.05);此外,国产BV试剂和胺实验试剂假阳性率分别为25%、30%,明显高于美国产BVBlue快速诊断试剂(0)。结论美国产BVBlue诊断试剂快速、简便,假阳性率低,特异性、敏感性均符合临床要求,值得推广。     

甲胎蛋白化学发光免疫定量检测试剂的研制与临床应用

目的研制肿瘤标志物甲胎蛋白化学发光免疫定量检测试剂并建立检测方法,进行初步的临床应用评价。,方法将甲胎蛋白单抗包被微孔板．以辣根过氧化物酶标记的甲胎蛋白抗体为二抗．结合鲁米诺化学发光底物系统．建立甲胎蛋白化学发光免疫定量检测方法。用甲胎蛋白检测试剂国家参考品分析所建立方法的准确性、灵敏度、稳定性和重复性等试剂性能．并与西门子公司的甲胎蛋白定量检测试剂同时检测临床血清样本350例,比较检测结果。结果所研制的试剂性能符合甲胎蛋白检测试剂国家参考品各项质量标准要求。批内变异系数4．1％。5.2％、批间变异系数4．7％;试剂盒置37℃考核3d,其稳定性良好。临床样本比对检测结果表明,两种方法相关性良好（相关系数r=0．9823,阴性符合率99．5％、阳性符合率98．7％,总符合率为99．1％,Kappa值为0．98,一致性强度为最强）。结论成功研制了快速、特异、敏感和稳定的甲胎蛋白化学发光免疫定量试剂并建立其检测方法适合临床检验推广应用。     

国产化学发光甲功五项试剂盒与雅培试剂对比及临床应用探讨

[目的]将国产化学发光甲功五项试剂盒与雅培试剂进行灵敏度、线性范围、参考值、反应模式、示踪物、底物、分离相等方法和参数,以及临床样本检测对比。[方法]将两组试剂测量334例临床血清样本检测结果进行分析。[结果]国产试剂在临床检测方面与雅培试剂符合良好。[结论]国产化学发光甲功五项试剂盒质量已经达到国外水平。     

两种结核感染T细胞检测试剂盒性能评估

目的评估外周血结核分枝杆菌感染T细胞斑点试验(T-SPOT.TB)两种试剂盒的检测性能。方法以英国Oxford Immunotec公司的T-SPOT.TB产品为参比试剂,以北京同生时代生物技术有限公司生产的TS-SPOT.TB产品为考核试剂。用两种试剂盒同时检测458份血液标本,其中临床标本408份来自金域集团5家连锁检验中心,体检标本50份来自金域体检中心,评估考核试剂与参比试剂的一致性。结果两种试剂的检测结果总一致率为98.03%(Kappa=0.96),其中,广州金域检验中心一致率为96.43%(Kappa=0.93);杭州金域检验中心一致率为97.73%(Kappa=0.95);福州金域检验中心一致率为98.44%(Kappa=0.97);成都金域检验中心一致率为98.75%(Kappa=0.97);沈阳金域检验中心一致率为100.00%(Kappa=1.00);金域体检中心两种试剂检测结果一致率达98.00%。结论国产考核试剂与进口参比试剂检测性能相当,国产试剂成本相对较低,对基层医院广泛开展结核病筛查及预防有较好的应用价值。     

新型乙型肝炎病毒基因分型检测试剂盒的临床评价

目的评价一种新型乙型肝炎病毒基因分型检测(免疫荧光法)试剂的临床性能。方法收集中国人民解放军三○二医院研究对象的血清383例,与血清对应的血浆50例。乙型肝炎病毒A基因型评价采用北京万泰生物药业股份有限公司试剂盒(荧光免疫层析法),基因序列测定为对照方法;乙型肝炎病毒B、C、D基因型评价使用北京万泰生物药业股份有限公司试剂盒(荧光免疫层析法),上海之江生物科技试剂盒(荧光定量PCR法)为对照试剂。验证试剂和对照试剂同时检测同一例标本,若结果不一致,2种方法分别进行复测,结果以复测为准,如仍不一致进行基因测序,以测序结果为准,对结果进行Kappa一致性检验,计算2种方法的检测一致率。另通过验证试剂检测对应的血浆标本,评价验证试剂对血清、血浆标本检测能力的一致性。结果 A基因型验证试剂检出15例,对照方法检出12例,2种方法的符合率为12/15。B基因型验证试剂相对对照试剂的阳性符合率为98.00%(49/50),阴性符合率为99.06%(315/318),总符合率为98.91%(364/368),Kappa值为0.954。C基因型验证试剂相对对照试剂的阳性符合率为98.78%(242/245),阴性符合率为86.99%(107/123),总符合率为94.84%(349/368),Kappa值为0.881。D基因型验证试剂相对对照试剂的阳性符合率为87.50%(7/8),阴性符合率为100.00%(360/360),总符合率为99.73%(367/368),Kappa值为0.932。验证试剂对50例对应的血清/血浆标本检测,结果均为5例乙型肝炎病毒B基因型,44例C基因型,1例未分型。结论该新型试剂盒对乙型肝炎病毒的A、B、C、D型分型效果较好,可用于感染病毒分型的临床检测。     

国产全自动HIV-1核酸定量检测试剂盒的性能评价

目的探讨国产NEPG全自动人类免疫缺陷病毒1型(HIV-1)核酸定量检测试剂[荧光聚合酶链反应(PCR)法](简称国产NEPG HIV-1试剂)临床应用的可行性。方法采用灵敏度/定量参考品评估国产NEPGHIV-1试剂的定值准确性及灵敏度。收集210例临床血液样本,以cobas AmpliPrepcobas TaqManHIV-1 Testv2.0试剂盒(简称进口HIV-1试剂)为参比试剂,评估2种试剂检测结果的一致性。结果低、中、高浓度样本测定结果的绝对偏差分别为0.05、0.08、-0.06,均符合要求(绝对偏差≤±0.5个对数数量级)。国产NEPG HIV-1试剂的灵敏度为50 IU/mL(约30拷贝/mL)。国产NEPG HIV-1试剂与进口HIV-1试剂定性结果的符合率均为100.00%,定性结果一致(Kappa值=1.00)。国产NEPG HIV-1试剂检测HIV-1载量结果与进口HIV-1试剂比较差异无统计学意义(P>0.05),2种试剂的相关性良好(r=0.953),低值样本的相关性也较好(r=0.823)。结论国产NEPG HIV-1试剂的灵敏度和准确性均符合临床要求,定量及定性检测结果与进口HIV-1试剂一致,且相关性良好。     

乙型肝炎表面抗原酶联免疫法检测试剂的性能评价

目的对我室使用国产乙型肝炎表面抗原酶联免疫法（ELISA）检测试剂进行性能评价。方法用ELISA法使用国产试剂检测国家参考品（n=33）、临床科研血清盘（n=40）及临床标本（n=270）,判断其是否符合国家检定标准,并分析其真实性、可靠性和收益指标。结果检测国家参考品的阴性符合率为100%（20/20）,阳性符合率为100%（3/3）,三种亚型的最低检出量均为0.5ng/mL;其真实性指标：灵敏度、特异性、粗一致性和约登指数（Youden）分别为96.88%、99.45%、98.39%和0.96;可靠性指标：变异系数（CV）和Kappa值分别为5.2%和0.96;收益指标：阳性预测值与阴性预测值分别为99.20%和97.84%。结论国产试剂性能评价结果优质,适用于临床标本检测。     

国产和进口试剂盒EB病毒VCA-IgA检测结果比较分析

目的比较进口与国产试剂盒检测EB病毒壳抗原免疫球蛋白A抗体(VCA-IgA)检测结果的诊断效能及符合性。方法采用两种试剂盒对138例鼻咽癌确诊患者和138例体检健康者进行血清VCA-IgA检测,对检测结果进行比较分析。结果国产、进口试剂盒检测VCA-IgA的诊断率分别为88.04%、83.70%;检测结果阳性符合率为94.55%,阴性符合率为75.68%,总符合率为86.96%,Kappa值为0.722。结论两种试剂盒VCA-IgA检测结果具有较高的诊断率与一致性。     

Determination of creatine kinase isoenzyme MB activity in serum using immunological inhibition of creatine kinase M subunit activity. Activity kinetics and diagnostic significance in myocardial infarction.

This is a new method for the determination of creatine kinase isoenzyme MB activity in serum. The method uses direct activity measurement of creatine kinase B subunit activity after blocking of CK-M subunit activity by inhibiting antibodies. The test takes no longer than 15 min. The method yields an intra-serial C.V. of 2.0-12.9%, and a C.V. from day to day of 5.5%. The detection limit is 3.4 U/l creatine kinase MB. In the 95 cases with proven myocardial infarction several types of creatine kinase MB activity kinetics could be determined. The percentage of creatine kinase MB of peak CK-total is 6-25%, with a mean of 11.1%. The amount of creatine kinase MB with respect to total CK activity after reinfarction is higher than the amount after initial infarction.     

Dissociable correlates of two classes of retrieval processing in prefrontal cortex

Although substantial evidence suggests that the prefrontal cortex (PFC) implements processes that are critical for accurate episodic memory judgments, the specific roles of different PFC subregions remain unclear. Here, we used event-related functional magnetic resonance imaging to distinguish between prefrontal activity related to operations that (1) influence processing of retrieval cues based on current task demands, or (2) are involved in monitoring the outputs of retrieval. Fourteen participants studied auditory words spoken by a male or female speaker and completed memory tests in which the stimuli were unstudied foil words and studied words spoken by either the same speaker at study, or the alternate speaker. On "general" test trials, participants were to determine whether each word was studied, regardless of the voice of the speaker, whereas on "specific" test trials, participants were to additionally distinguish between studied words that were spoken in the same voice or a different voice at study. Thus, on specific test trials, participants were explicitly required to attend to voice information in order to evaluate each test item. Anterior (right BA 10), dorsolateral prefrontal (right BA 46), and inferior frontal (bilateral BA 47/12) regions were more active during specific than during general trials. Activation in anterior and dorsolateral PFC was enhanced during specific test trials even in response to unstudied items, suggesting that activation in these regions was related to the differential processing of retrieval cues in the two tasks. In contrast, differences between specific and general test trials in inferior frontal regions (bilateral BA 47/12) were seen only for studied items, suggesting a role for these regions in post-retrieval monitoring processes. Results from this study are consistent with the idea that different PFC subregions implement distinct, but complementary processes that collectively support accurate episodic memory judgments.     

俯卧位通气对高海拔地区肺复张治疗无效急性呼吸窘迫综合征患者氧合的影响

目的 探讨俯卧位通气对高海拔地区肺复张术(RM)治疗无效急性呼吸窘迫综合征(ARDS)患者的治疗作用.方法 从海拔2260m的地区医院筛选RM治疗无效的41例ARDS患者[平均氧合指数( PaO2/FiO2)较RM前升高＜20％视为RM无效],依不同病因分为肺内源性ARDS组(ARDSp组)和肺外源性ARDS组(ARDSexp组),每组再按信封法随机分为俯卧位组和仰卧位组,即ARDSp俯卧位组(11例)、ARDSp仰卧位组(9例)、ARDSexp俯卧位组(10例)、ARDSexp仰卧位组(11例).在通气前及通气1、2、3、4h监测动脉血氧分压( PaO2)、PaO2/FiO2、静态顺应性(Cst)、气道阻力(Raw)的变化.结果 通气lh时,ARDSexp俯卧位组PaO2/FiO2( mm Hg,l mm Hg=0.133 kPa)即较通气前显著升高(157.4±40.6比129.3±48.7,P＜0.05),并随通气时间延长呈持续增高趋势,4h达峰值(219.1 ±41.1);且ARDSexp俯卧位组通气3h内PaO2/FiO2较其他3组显著增高,另3组间则差异无统计学意义.ARDSp俯卧位组、ARDSexp俯卧位组通气4h时PaO2/FiO2均较相应仰卧位组显著增高(208.8±39.7比127.4±47.1,219.1±41.1比124.9±50.8,均P＜0.05).4组通气前后Cst无显著改变,各组间差异也无统计学意义.ARDSp俯卧位组通气4h时Raw(cmH2O·L-1·s-1)较通气前显著降低(6.8±1.7比10.7±1.8,P＜0.05),且明显低于其他3组;其他3组各时间点Raw组内及组间比较差异均无统计学意义.结论 俯卧位通气作为ARDS机械通气重要策略之一,可以改善RM无效高原ARDS患者的氧合,为抢救患者赢得宝贵的时间.     

Digital imaging among medical facilities

The Department of Veterans Affairs (VA) in the USA operates a network of 172 medical centres which all utilize a hospital information system (HIS) which has been developed and is currently maintained by the VA. During the past several years, an image management and communication module has been developed, installed and clinically utilized at the Washington DC and Maryland VA Medical Centres. This image management and communication system, referred to as the decentralized hospital computer program (DHCP) imaging system, is fully integrated with a commercial picture archiving and communication system (PACS). The system is utilized to capture, archive, and display all images generated within the hospital including radiology, nuclear medicine, pathology, endoscopy, bronchoscopy, and dermatology, intraoperative photographs, ECG data, and a limited number of paper documents. The ultimate goal of the project is to have all patient text and image data available at any clinical workstation to any authorized user anywhere within the network of medical centres. Clinical requirements for an imaging workstation include ease of use, rapid and reliable access to the complete set of patient information, and images which are of acceptable quality to meet the requirements of the user and the subspecialty. Patient confidentiality and data security must be safeguarded at all times. Integration of the images with the remainder of the patient's database was found to be critical to the success of the project. The experience at the Washington and Maryland facilities suggests that an imaging system that is successfully integrated with a hospital information system can provide substantial clinical and economic benefits both within and among medical centres. Clinical acceptance and utilization of the system has been excellent, particularly in diagnostic radiology where DHCP Imaging has been interfaced to a commercial PAC system. Based upon this initial experience, the VA has begun to deploy the system throughout its large network of medical centres.     

Myocardial elastography at both high temporal and spatial resolution for the detection of infarcts

Myocardial elastography is a novel method for noninvasively assessing regional myocardial function, with the advantages of high spatial and temporal resolution and high signal-to-noise ratio (SNR). In this paper, in-vivo experiments were performed in anesthetized normal and infarcted mice (one day after left anterior descending coronary artery [LAD] ligation) using a high-resolution (30 MHz) ultrasound system (Vevo 770, VisualSonics Inc., Toronto, ON, Canada). Radiofrequency (RF) signals of the left ventricle (LV) in longitudinal (long-axis) view and the associated electrocardiogram (ECG) were simultaneously acquired. Using a retrospective ECG gating technique, 2-D full field-of-view RF frames were acquired at an extremely high frame rate (8 kHz) that resulted in high-quality incremental displacement and strain estimation of the myocardium. The incremental results were further accumulated to obtain the cumulative displacements and strains. Two-dimensional and M-mode displacement images and strain images (elastograms), as well as displacement and strain profiles as a function of time, were compared between normal and infarcted mice. Incremental results clearly depicted cardiac events including LV contraction, LV relaxation and isovolumetric phases in both normal and infarcted mice, and also evidently indicated reduced motion and deformation in the infarcted myocardium. The elastograms indicated that the infarcted regions underwent thinning during systole rather than thickening, as in the normal case. The cumulative elastograms were found to have higher elastographic SNR (SNR(e)) than the incremental elastograms (e.g., 10.6 vs. 4.7 in a normal myocardium, and 6.0 vs. 2.4 in an infarcted myocardium). Finally, preliminary statistical results from nine normal (m = 9) and seven infarcted (n = 7) mice indicated the capability of the cumulative strain in differentiating infracted from normal myocardia. In conclusion, myocardial elastography could provide regional strain information at simultaneously high temporal (>/=0.125 ms) and spatial ( approximately 55 microm) resolution as well as high precision ( approximately 0.05 microm displacement). This technique was thus capable of accurately characterizing normal myocardial function throughout an entire cardiac cycle, at the same high resolution, and detecting and localizing myocardial infarction in vivo.     

Clinical Pharmacokinetics of Morphine

Morphine, the most widely used mu-opioid analgesic for acute and chronic pain, is the standard against which new analgesics are measured. A thorough understanding of the pharmacokinetics of morphine is required in order to safely and effectively use this analgesic in a wide variety of patients with different levels of organ function. A MEDLINE search was conducted to identify literature published between 1966 and January 2002 relevant to the pharmacokinetics of morphine. These publications were reviewed and the literature summarized regarding unique and clinically important elements of morphine disposition relative to its parenteral administration (including intravenous, intramuscular, subcutaneous, epidural and intrathecal administration), absorption profile (immediate release, controlled release, and sublingual/buccal, and rectal administration), distribution, and its metabolism/ excretion. Special populations, including infants, elderly, and those with renal/liver failure, have a unique morphine pharmacokinetic profile that must be taken into account in order to maximize analgesic efficacy and reduce the risk of adverse events.