ABI7700、7500荧光定量PCR仪性能评价

目的 对美国ABI 7700、7500荧光定量PCR仪的主要性能指标进行评价.方法 按照美国临床实验室标准化委员会(NCCLS)制定的评价标准,对20份标本(HBV-DNA)定量检测,评价两种仪器的精密度、准确性、线性、可比性、灵敏度等指标.结果 精密度:ABI 7700批内变异系数(CV)为3.67%～5.58%,批问为4.46%～6.53%;7500批内CV为4.09%～5.61%,批间为4.73%～6.96%.准确性:与标准质控物比较,相对偏差7700为0.93%,7500为2.97%.线性:ABI 7700 r=0.999,7500 r=0.995.灵敏度:ABI 7700、7500能检测到的最低HBV-DNA浓度均为1000 U/ml.两种仪器的可比性:相关系数为0.994,直线回归方程为.y=1.0694x-0.1372.结论 两种荧光定量PCR仪各种指标性能均良好.     

ABI7500 HBV-DNA检测系统性能评价

目的对ABI7500 HBV-DNA检测系统进行性能评价,确定该系统是否稳定可靠。方法按照美国临床和实验室标准化协会(Clinical Laboratory and Standards Institute,CLSI)系列文件,对ABI7500 HBV-DNA检测系统的精密度、正确度及线性指标进行评价;根据HBV-DNA标准品的阳性检出率判断该检测系统的最低检出限。结果 ABI7500 HBV-DNA检测系统的批内精密度(s批内)分别为0.08和0.06;批间精密度(s批间)分别为0.06和0.12;正确度符合要求;线性分析通过验证实验;最低检出限为1.00×102IU/ml。结论 ABI7500 HBV-DNA检测系统的精密度、正确度、线性、最低检出限性能评价均能满足临床检测要求。     

LightCycler 480Ⅱ型实时荧光定量PCR仪性能评价

目的对Roche LightCycler 480Ⅱ型实时荧光定量PCR仪(Roche 480)主要性能指标进行评价,为该仪器检测结果的可靠性提供依据。方法按照美国临床实验室标准化委员会(CLSI)文件制定的评价标准,分别对40例标准血清和40例临床标本定量检测HBV-DNA,评价其精密度、准确度、灵敏度、线性和可比性。结果精密度:批内变异系数(CV批内)为1.40%～2.10%,批间变异系数(CV批间)1.17%～1.40%,总变异系数(CV)为1.40%～1.83%;准确度:与标准品比较,相对偏差为0.35%～0.41%;灵敏度:对血清HBV-DNA浓度大于或等于4×103IU/mL的标本检出率为100%,对血清HBV-DNA浓度为4×102IU/mL的标本检出率为90%;线性:相关系数为0.999,直线回归方程为Y=1.0073X-0.0487;Roche480和Roche Light-Cycler1.2(Roche1.2)2台PCR仪的可比性:P=0.113,相关系数为0.995,线性比对直线回归方程为Y=0.9230X+0.3397。结论 Roche 480具有良好的精密度、准确度、灵敏度、线性,与Roche1.2检测系统有良好的相关性,能够满足临床需要。     

实时荧光定量PCR检测病毒核酸方法学性能验证程序的探讨

目的探讨实时荧光定量聚合酶链反应（PCR）检测病毒核酸的方法学性能验证程序。方法参考美国国家临床实验室标准化协会（CLSI）颁布的相关文件对实验室开展PCR检测病毒核酸进行方法学性能验证;通过稀释标本直至低于检测下限进行定量检出限验证实验。结果乙型肝炎病毒核酸（HBV-DNA）检测的批内精密度（CV批内）分别为4.28%和2.08%;总精密度（CV总）为4.14%和2.69%;与比对方法回归方程为y=1.1082x-0.5225;线性相关系数为0.9976,回归方程为y=0.9771x-0.0062,线性范围为1.08E3~1.05E8;定量检出限为500IU/mL。丙型肝炎病毒核酸（HCV-RNA）检测的CV批内分别为4.11%和2.63%;CV总为5.15%和3.41%;与比对方法回归方程为y=1.0075x-0.0662;线性相关系数为0.9974,回归方程为y=1.0479x-0.2594,线性范围为1.50E3~2.53E7;定量检出限为1000IU/mL。结论实验室开展PCR检测项目前有必要进行方法学验证,根据实际情况选择实验方案和统计方法可减少人力和财力。     

飞测Ⅱ型免疫荧光检测仪检测C-反应蛋白性能验证

目的验证飞测Ⅱ型免疫荧光检测仪检测C-反应蛋白的性能。方法参考美国临床和实验室标准化协会CLSI文件,并结合工作实际情况,以C-反应蛋白作为验证指标,对该仪器精密度、准确度、线性、可比性、稳定性、抗干扰能力进行验证。结果 C-反应蛋白3个浓度水平的批内精密度分别为高值CV4.46%,中值CV3.32%,低值CV6.47%;批间精密度分别为高值CV7.51%,中值CV5.89%,低值CV10.66%,结果均在仪器说明书范围内。准确度验证偏差分别为12.90%和13.95%,均在仪器允许偏差范围内。线性回归方程Y=0.958 X+2.897,相关系数r=0.998,与厂商承诺范围接近。与日本OlympusAU400散射比浊法对比实验检测结果相关性良好,回归方程Y=1.021 X-1.214,r=0.982,两法差异无显著性(P0.05)。稳定性实验表明全血标本在缓冲液中保存30min内结果稳定性良好,CV值2.35%。黄疸和血脂干扰物对测试结果影响较小,平均影响度均5%在可接受范围内。结论飞测Ⅱ型免疫荧光检测仪检测C-反应蛋白的性能符合厂商声明的性能指标。同时该仪器具有操作简单、检测速度快、精密度好、准确度较高、可比性好、抗干扰能力强,临床和患者易接受等优点,适合在临床实验室推广应用。     

HBV-DNA定量检测试剂盒性能验证

目的验证和评价一种新采购的HBV-DNA定量检测试剂盒的分析性能。方法依据美国临床和实验室标准化协会颁布的EP系列文件和《医学实验室质量和能力认可准则》相关文件对试剂盒的精密度、正确度、线性范围、检测下限和不同检测试剂的一致性进行性能评价。结果试剂盒的低值和中值的批内精密度CV为3.2%、3.4%,总精密度CV为4.6%、3.7%;正确度符合要求;线性回归方程为Y=0.958 X+0.355,r2=0.999,P0.001,线性范围为(1.48×103~1.48×108)U/mL;检测下限为500 U/mL;与原有检测试剂之间结果无差异。结论新试剂盒的性能符合厂家声明,能够应用于临床工作。     

均相酶免疫法与胶乳增强免疫比浊法检测甘胆酸的方法学比较

目的对均相酶免疫法和胶乳增强免疫比浊法检测甘胆酸(CG)进行方法学比对,为临床实验室选择合适的检测方法提供参考。方法对2种方法的阳性率、试剂盒批内精密度、线性范围分别进行比较,再分别用2种方法检测248例临床标本,对结果进行统计分析。结果均相酶免疫法和胶乳增强免疫比浊法检测CG的阳性率分别为53.23%和51.21%,阳性符合率为97.58%;批内精密度实验中高值血清变异系数(CV)分别为1.13%和2.65%,低值血清CV分别为3.52%和7.51%;线性评价试验中,均相酶免疫法线性回归方程为Y=1.068 2X+0.421 6,相关系数(r)=0.995 7;胶乳增强免疫比浊法线性回归方程为Y=1.016 1X+0.875 2,r=0.997 7。2种方法临床标本检测结果回归方程Y=1.156X+0.543,决定系数(R2)=0.98。结论 2种检测方法具有良好的一致性,其测定结果准确、稳定、可靠,能满足临床检测需求;但均相酶免疫法检测稳定性显著优于胶乳增强免疫比浊法。     

IMS-972电解质分析仪性能评价

目的对IMS-972电解质分析仪性能进行评价。方法通过分析钾离子(K~+)、钠离子(Na~+)、氯离子(Cl-)的检测精密度、准确度、线性范围及参考区间等对IMS-972电解质分析仪性能进行评价。结果 IMS-972电解质分析仪检测K~+正常水平与病理水平的批内精密度变异系数(CV)分别为0.38%和0.66%,批间精密度CV分别为0.39%和0.95%;Na~+正常水平与病理水平的批内精密度CV分别为0.14%和0.22%,批间精密度CV分别0.31%和0.45%;Cl-正常水平与病理水平的批内精密度CV分别为0.60%和0.93%,批间精密度CV分别为0.51%和1.54%,均满足美国《临床实验室改进法案修正案》(CLIA′88)标准。准确度检测结果在室间质评的允许范围。线性:K~+Y=0.989 7 X~+0.490 0,R~2=0.997 4;Na~+Y=0.996 7 X-1.584 8,R~2=0.999 2;Cl-Y=0.996 9 X~+0.294 3,R2=1.000 0。可报告范围:K~+1.97~20.44mmol/L,Na~+28.80~195.95mmol/L,Cl-13.20~164.54mmol/L。生物参考区间验证通过。结论验证方案可操作性和实用性强,IMS-972电解质分析仪检测电解质项目在精密度、准确度、线性范围等方面均达到了生物化学检验实验室的要求,可用于临床标本检测。     

基于Pre-NAT全自动核酸检测系统的HBV-DNA超敏检测试剂方法学性能验证

目的对基于Pre-NAT全自动核酸检测系统的HBV-DNA超敏检测试剂进行方法学性能验证。方法参考美国国家临床实验室标准化协会(CLSI)颁布的相关文件,分别选用HBV国家标准品、室内质控品、临床高/低值及阴性样本,对基于PreNAT全自动检测系统的HBV-DNA超敏检测试剂进行准确性、灵敏度、线性范围、精密度及特异性的评估;并与基于手工提取的HBV-DNA普通定量检测试剂进行比对。结果 HBV-DNA超敏检测试剂的准确性能够通过国家标准品标准;室内质控品批间精密度CV为2.01%;临床高值、低值样本的批内精密度CV分别为3.21%、5.26%;检测下限为20 IU/m L,高于HBVDNA普通检测试剂(100 IU/m L);对丙型肝炎、戊型肝炎、巨细胞、风疹、单纯疱疹等病毒核酸无交叉反应性;HBV-DNA超敏检测试剂与HBV-DNA普通检测试剂检测结果呈高度相关性(r=0.987,P0.05),回归方程为Y=0.911X+0.215;配对t检验显示两者差异有统计学意义(t=3.765,P0.05)。结论 HBV-DNA超敏检测试剂有较好的准确性、精密性、特异性、灵敏度、线性范围,其基于全自动核酸检测系统可广泛应用于临床。     

罗氏全自动电化学发光免疫分析仪检测白细胞介素-6的方法学评价

目的 评价罗氏Cobas E602全自动电化学发光免疫分析仪模块定量检测白细胞介素-6(IL-6)的分析性能。方法 对罗氏全自动电化学发光免疫分析仪定量检测IL-6的准确度、精密度和线性进行验证,并进行交叉污染率评估实验。结果 经不同批次校准品检测,测定值与靶值的相对偏差为-3.01%～3.84%。批内变异系数(CV)为1.84%～2.80%,批间CV为0.67%～1.43%,检测的准确度和精密度均符合性能标准。IL-6检测回归分析呈一次线性,线性回归方程为y=1.008 1x-1.000 9(R²=0.999 96,P<0.05)。IL-6检测的交叉污染率为0.077%。结论 罗氏Cobas E602全自动电化学发光免疫分析仪对IL-6检测性能的验证结果与仪器生产厂家提供的说明基本一致,符合临床实验室检验的要求,可用于临床标本测定。     

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.     

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.     

手转胎头术失败的原因与分娩结局临床分析

目的 探讨手转胎头术失败的原因与分娩结局.方法 选择2008年1月至2010年12月于我院住院分娩的持续性枕横位、枕后位产妇198例,根据行手转胎头术后结果分为成功组126例、失败组72例.比较两组分娩结局,对比分析失败原因.结果 失败组胎儿体质量≥3500 g的发生率[76.4％(55/72)]明显高于成功组[31.7％(40/126)],差异有统计学意义(x2=30.177,P=0.001)、失败组宫缩乏力发生率[58.3％(42/72)]高于成功组[38.1％ (48/126)],差异有统计学意义(x2=7.569,P=0.006)、失败组骨盆临界或轻度狭窄发生率[38.9％ (28/72)]高于成功组[23.8％(30/126)],差异有统计学意义(x2 =5.030,P=0.002)、失败组手转胎头时机不当(宫口开大＜6 cm、胎头位于坐骨棘上及宫口开大8～10 cm、胎头位于坐骨棘下≥2 cm)发生率[61.1％(44/72)]高于成功组[38.9％(49/126)],差异有统计学意义(x2=9.084,P=0.003).失败组母儿并发症(产后出血、产褥病率、胎儿窘迫、新生儿窒息)发生率高于成功组(x2 =9.586,P=0.002、x2=9.334,P=0.002、x2=5.910,P=0.015、x2=5.240,P=0.022)、失败组剖宫产发生率[72.2％(52/72)]明显高于成功组[34.1 ％(43/126),x2=26.641,P=0.001)].结论 手转胎头术能使难产变顺产,降低剖宫产率,减少母儿并发症,但须积极预防、处理导致手转胎头术失败的原因,对矫正失败后继续矫正及试产应慎重.     

Evidence-Based Pain Management and Palliative Care in Issue Four for 2009 of The Cochrane Library

ABSTRACT

The Cochrane Library of Systematic Reviews is published quarterly. Issue 4 for 2009 contains 4027 complete reviews, 1906 protocols for reviews in production, and 11447 one-page summaries of systematic reviews published in the general medical literature. In addition, there are citations of 600,000 randomized controlled trials, and 12,200 cited papers in the Cochrane methodology register. The health technology assessment database contains over 7500 citations. This edition of the Library contains 90 new reviews, of which 19 have potential relevance for practitioners in pain and palliative medicine.     

Wie zuverlässig sind Angaben zu nichtentzündlichen ausgedehnten Schmerzen?

ZusammenfassungFragestellung Es wurde geprüft, wie sich der Differenziertheitsgrad zweier Schmerzmessmethoden auf Angaben zur Ausgedehntheit klinischer Schmerzen auswirkt. Zugleich wurde der Referenzzeitraum variiert, über den die Patienten berichten sollten.Methode Erfasst wurde der Einfluss zu Lasten der Befragungsdifferenziertheit durch den Vergleich zweier Körperschema-Bildvorlagen. Drei Referenzzeiträume (Schmerz aktuell, letzte Woche, letztes halbes Jahr) wurden vorgegeben.Ergebnisse Patienten mit ausgedehnten Schmerzen gaben bei differenzierter Befragung um so mehr Schmerzen an, je weiter die Schmerzen zurück lagen und je größer der Berichtszeitraum war. Patienten mit gelenknahen Schmerzen gaben bei hoch differenzierter Befragung weniger ausgedehnte Schmerzen in der Vergangenheit an als bei globaler Einschätzung. Patienten mit Rückenschmerzen berichteten bei differenzierter Befragung zum aktuellen Schmerz über weniger ausgedehnte Schmerzen als bei globaler Befragung.Schlussfolgerung Die Angaben zur Schmerzausdehnung variieren vor allem bei Patienten mit ausgedehnten Schmerzen in Abhängigkeit von der Differenziertheit der Befragung. In diesen Fällen ist die Wahrscheinlichkeit erhöht, dass sich die Beschwerdesymptomatik zumindest teilweise erst in der Reaktion auf die situativen Befragungsbedingungen konstituiert und daher nicht auf andere Befragungsbedingungen generalisiert werden kann.