WS/T403-2012标准对临床生物化学常规项目检测质量控制的检验医学评估

目的：应用WS/T403-2012标准试行评估生化质量控制状态。方法：WS/T403-2012标准中将23项指标按指标等级分为＂优＂、＂中＂、＂低＂和＂低于低等＂四等,其分别与生物学变异质量指标中的＂最佳的＂、＂期望的＂、＂最低的＂允许总误差相近。＂低于低等＂即按目前质量水平设定质量目标。将上述项目分别进行匹配进行比较分析。结果：在参加卫生部室间质评的21项常规检测中,仅肌酸肌酶的σ水平〉6σ,无需进行任何的改进措施;K＋、Na＋、Ca2＋、Mg2＋、尿酸、肌酐、胆固醇、三酰甘油、丙氨酸氨基转移酶、天冬氨酸氨基转移酶、总胆红素、碱性磷酸酶、淀粉酶、乳酸脱氢酶、γ谷氨酰转肽酶,目前尚能基本达到WS/T403-2012标准中所规定的质量水平;而尿素氮、糖、总蛋白、白蛋白、Cl-目前的质量状态还欠理想。结论：对于质量状态还欠理想的项目需采取全面质量控制策略,改善和提高其准确度和/或精密度,确保其质量控制水平符合要求。     

应用六西格玛原理分析临床生化项目的质量水平

目的：用六西格玛（σ）质量管理方法评价罗氏Modular P800全自动生化分析仪检测项目的分析性能,用以指导质量改进。方法收集2013年全国临床实验室生化项目的室间质量评价（EQA）和本实验室室内质控（IQC）数据,用EQA数据评估偏倚（Bias）,IQC数据计算变异系数（CV）水平,依据美国临床实验室改进修正法案（CLIA′88）的允许总误差（TEa）通过公式（TEa－Bias）／CV计算各检测项目的σ值,评价实验室的24项生化检测项目的分析性能;并计算检验项目的质量目标指数（QGI）,查找导致性能不佳的主要原因;根据美国胆固醇教育计划（NCEP）和原卫生部临床检验中心（NCCL ）规定血脂检验项目的 T E a ,分别计算σ值,分析其差距。结果在24个检测项目中,8个检测项目大于6σ水平,占检验项目的33．3％;8个项目在3σ～＜6σ水平,占33．3％;8个项目在3σ水平以下,占33．3％。对于σ＜6的项目,需优先改进正确度的占37．5％,优先改进精密度的占43．8％,既需改进正确度又要改进精密度的占18．8％。根据NCEP和NCCL对血脂的质量要求,总胆固醇、三酰甘油、高密度胆固醇、低密度胆固醇的σ值分别为1．55、3．40、1．36、3．48和1．82、6．34、5．80、9．91。结论6σ质量管理理论是临床实验室管理的重要工具,有助于临床实验室检测项目质量水平的改进。与国外相比,国内对脂类检验项目质量水平的要求差距明显,需进一步提高。     

西格玛度量在临床化学实验室的应用研究

目的: 评价我科常规生化检测项目的质量水平。方法: 收集 2016－01 ～ 2018－01 期间实验室室内质 控数据及 2016 年卫生部常规化学室间质评第 3 次检测项目的室间评价数据，计算变异系数( CV%) 及偏倚 ( biss，BIAS%) 。并依据项目的国家标准和行业标准的总允许误差( TEa%) ，CV%及 BIAS%计算实验室统计项目 的西格玛值，同时绘制西格玛性能评价图，用 6 西格玛( 6σ) 度量评价本室的分析性能。结果: 我科 22 个常规项 目中以国标标准统计，达到 6σ 水平的占68．2%，达到 5－6σ 水平的占 0%，达到 4－5σ 水平的占13．6%，3－4σ 水平 的占9．1%，3σ 以下的占9．1%; 用行标标准统计，达到 6σ 水平的占27．3%，达到 5－6σ 水平的占9．1%，达到 4－5σ 水平的占22．7%，3－4σ 水平的占22．7%，3σ 以下的占18．2%。结论: 我科常规生化检测项目的质量达到高水平， 检验结果可以满足临床需求，但仍有改进空间。     

六西格玛质量管理在临床生化检验中的应用

目的 探索六西格玛质量管理在临床生化检验中应用的效果,指导临床生化检验中的质量管理办法和改进。方法 在我院检验科2018年1月至2019年12月的室内质控数据以及参与卫生部临床检验中心室间质评数据,计算不精密度变异系数(CV)、不正确度偏移(Bias),然后计算西格玛值(σ),对于未达到5σ的项目,计算质量目标指数(QGI)。结果 2018—2019年的23个生化检验项目均达到6σ值的为:P、CK、Mg、AST、DBIL、LDH、AMY、TG、CRE、UN;连续2年均未达到3σ值的项目为:Na、ALB;2018年达到6σ值的项目占52.17%,未达到3σ值的项目占17.39%;2019年达到6σ值的项目占56.52%,未达到3σ值的项目占17.39%。未达到5σ值的项目:2018年为8个,2019年为7个,计算QGI值,其中QGI值0.8的2018年为4个,2019年为3个,需优先改进精密度;QGI值1.2的2018年为3个,2019年为2个,需优先改进准确度;QGI值在0.8～1.2之间的2018年为1个,2019年为2个,准确度和精密度均需改进。结论 在临床生化检验中采用六西格玛质量管理法检验各个检验项目的性能,从而有利于设计出个体化的质控管理方案,更好的指导生化检验工作中的质量改进,保证检验结果的准确性。     

1995—2000年临床化学室间质评结果分析

目的：了解我科1995－2000年参加四川省临床化学室间质量评价（EQA）的动态情况，为实验室全面质量管的实施提供科学依据。方法：对6年内的24次室间质评结果进行分析。结果：年平均MVIS和总项平均VIS逐渐降低。结论：通过参加室间质评工作，既增强了实验室技术人员质控意识和开展室内质控工作的责任感，也提高了检验水平和质量。     

23家实验室临床生化室间质评与现场检测结果分析

目的了解实验室临床生化真实的检测水平,调查室间质评成绩的真实性,用现场检测的形式比较与室间质评结果的差异。方法在2012年第一次室间质评活动结束后,对郴州地区23家二级和三级医院进行现场检测,发放5个批号的双盲标本,要求当场回报结果,比较室间质评和现场检测结果的差异。结果现场检测的PT成绩低于室间质评成绩（P〈0.05）。20个检测项目各批号现场检测与室间质评原始数据大多存在统计学意义。结论部分实验室未正确对待室间质评活动,单次室间质评结果不能反映实验室真实水平。     

不同来源允许总误差在临床检测系统不精密度的适用性分析

目的探讨卫生行业标准(WS/T 403-2012临床生物化学检验常规项目分析质量指标)全国临床检验中心EQA-2017计划、国家标准GB/T 20470-2006、美国临床实验室改进修正法案CLIA’88和基于个体内及个体间生物学变异提供的允许总误差(TEa)在临床生化检测系统不精密度的临床适用性验证。提出质量方案,指导质量改进。方法收集2018年6月-2019年5月广东省中医院总院及其4个分院共5家三级医院涉及4个测量系统(罗氏、日立、贝克曼、强生)的白蛋白(ALB)、总蛋白(TP)等22个项目的室内质量控制(IQC)数据。对数据进行分析处理,依据中间(室内)精密度1/3TEa作为判断标准,计算5种允许总误差达到标准的次数,以80%为通过验证,则该水平TEa满足作为该项目推荐TEa的要求。结果 EQA-2017标准的ALB、镁离子(Mg~(2+))、TP、尿素(Urea)项目的总体符合率80%,采用12个月的CV%按检测系统分组统计,其中ALB、Mg~(2+)、TP项目差异有统计学意义(P0.05),Urea在各检测系统间差异无统计学意义(P0.05)。WS/T 403-2012、GB/T 20470-2006和CLIA’88四个标准的中间(室内)精密度1/3TEa的总体符合率均满足要求。而个体生物学变异允许总误差则过于严格,其中ALB、氯离子(Cl~-)、钠离子(Na~+)、钙离子(Ca~(2+))、TP项目的总体符合率0%。结论实验室不同来源的TEa计算出不同的合格率,推荐临床实验室选择行业标准来源TEa或根据自身实验室水平制定合适的允许总误差。     

利用实验室质控数据评定血常规项目测量不确定度研究

目的：探讨利用室内质量控制（internal quality control,IQC）和室间质量评价（external quality assessment,EQA）数据评定血常规项目测量不确定度。方法：收集南通大学附属医院检验科2014年～2016年累积30个月白细胞计数（WBC）、红细胞计数（RBC）、血红蛋白浓度（HGB）和血小板计数（PLT）等4个项目IQC在控数据以及2015年卫生部（和江苏省）临检中心EQA回报结果,采用自上而下方法评定4个血常规项目的测量不确定度。结果：利用IQC数据结合国家EQA数据评定的相对合成标准不确定度（% uc）分别为2.62、2.34、1.96和4.59;利用IQC数据结合江苏省EQA数据评定的% uc分别为2.59、1.40、1.58和3.97,均小于按中华人民共和国卫生行业标准WS/T 406-2012《临床血液学检验常规项目分析质量要求》设置的目标不确定度。结论：采用实验室的质控数据可较方便地反映XE-2100五分类全自动血细胞分析仪WBC、RBC、HGB和PLT等4个项目测量不确定度,具有一定临床应用价值。     

克山病治疗原则与疗效判定标准（WS／T314—2009）发布

现发布《克山病治疗原则与疗效判定标准》为推荐性行业标准。其编号和名称如下：WS／T314-2009克山病治疗原则与疗效判定标准（代替WS／T77—1996，WS／T209—2001）该标准于2009年12月1日起实施。自实施之日起，WS／T77—1996，WS／T209—2001废止。     

探讨生物学变异在临床化学检验的质量规范设定和结果评价中的应用

目的探讨分析生物学变异在临床化学检验的质量规范设定和在结果评价中的应用价值。方法对总胆红素、总蛋白、尿素、肌酐、清蛋白、三酰甘油、葡萄糖等23个生化项目,根据其室内质控、生物学数据以及两次室间质评,计算其实际变异系数、实际总误差、实际偏差和参考变化值。结果 23个生化项目经过临床化学检查,达到最佳CV质量规范要求的占9项,适当水平要求的项目占11项,最低水平要求项目占2项,大于CV质量规范要求的项目占1项,在不同差值概率中的参考变化值不同。结论把质量规范作为生物变异学的评价标准,能够对各个生化项目进行更为全面客观的分析,利于临床对检验结果的解读。     

Value of D-Dimers in patients with acute aortic dissection

Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P ＜ 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (＞0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P ＜0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P ＜ 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD.     

Research of combined liver-kidney transplantation model in rats

Objective： To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods： SD rats served as both donors and recipients. 4℃ sodium lactate Ringer＇s was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava （IVC） inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results： Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion： This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment.     

BLOOD PRESSURE CHANGE WITH AGE IN SALT-SENSITIVE TEENAGERS

Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P＜ 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P＜ 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure.     

安心颗粒对急诊经皮冠状动脉介入术后生活质量影响的研究

目的：评价使用安心颗粒对急诊经皮冠状动脉介入术（PPCI）术后生活质量的影响.方法：将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组（术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次）和对照组（仅接受基础药物治疗）.所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表（MIDAS）、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果：入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异（P＞0.05）;出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低（P＜0.05）;组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低（P＜0.05）.两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血（P＞0.05）.两组发生轻度血小板减少症的患者数比较无差异（P＞0.05）.结论：PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险.     

The comparative studies of the influences of Urapidil and Nicardipine on sino-atrial node function, atrio-ventricular node function and hemodynamics

Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P＜0.01);the MAP decreased(P＜0.01)and the HR increased drastically(P＜0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients.     

Expression of OPGmRNA and ODFmRNA in the patients of hip fracture due to osteoporosis

Objective：To investigate the gene expression of osteoprotegerin（OPG） and osteoclast differentiation factor（ODF） in the bone tissue of patients with hip fracture due to osteoporosis. Methods：OPGmRNA and ODFmRNA in the bone tissue in 50 cases of osteoporosis sufferers（over 50 years old） with hip fracture（Observer Group） and 30 cases of hip facture sufferers with no osteoporosis（Control group） were analyzed with the Semi-Quantitative RT-PCR method. Results：The mRNA expressed of ODF, OPG were both high in the patients with hip fracture. In the control group, the expression of OPG mRNA was observed, while the expression of ODF mRNA was very slight. Conclusion：Aged patients contained all signals including OPG, ODF that are essential for inducing osteoclastogenesis and promoting bone resorption.     

The clinicopathological and immuohistochemical analysis of solid-pseudopapillary tumor of the pancreas： report of 9 cases

Objective：To investigate the clinical features, pathological characteristics and immunophenotype of solid-pseudopapillary tumor of the pancreas（SPTP）. Methods：Nine surgically treated cases of SPTP were retrospectively reviewed. Hematoxylin and Eosin（HE） staining and immunohistochemical staining were used to analyze all cases, and the general clinical data was collected. Results：Six patients were asymptomatic except for a palpable mass. Two patients complained of vague-epigastric pain. One patient appeared jaundice. The tumor was encapsulated and solid tissues alternately with cystic tissues. Histologically, the histological structure of solid portion was pseudopapillary with a fibrovascular core. Tumor cells were uniform and medium-sized which were arranged in sheets ets or nests or pseudopapillary patterns. Immunohistochemical studies demonstrated that SPTP proved positive in vimentin（9/9 cases）, AAT（9/9 cases）, NSE（9/9 cases）, ACT（7/9 cases）, CK20（2/9 cases）, CgA（1/9 cases）, S-100（3/gcases）, PR（4/gcases）, Syn（3/9 cases） and CD56（5/9cases）, negative in CEA and ER. Conclusion：SPTP is a tumor predominantly occurring in young women frequently without special symptoms. This tumor has various characteristical histological patterns with different immunophenotype.     

Dynamic Changes in Serum Estradiol and Progesterone levels in Patients of Premenstrual Syndrome with Adverse Flow of Liver-qi

Objective:To probe into the influence of changes of ovarian hormones on the pathogenesis of the specific sub-type premenstrual syndrome(PMS)and reveal partial microcosmic mechanisms of adverse flow of liver-qi.Methods:Estradiol(E2)and progesterone(P)levels in serum were determined at different phases of menstrual cycle by radioimmunoassay.Results:In the group of PMS with adverse flow of liver-qi.the secretive peak value Of E2 and P at the follicular phase significantly decreased,and the secretive peak value at the luteal phase did not come into being.Conclusions:Low E2 and P secretive peak at the follicular phase and absence of secretive peak at the luteal phase is one of the microcosmic mechanisms of PMS with adverse flow of liver-qi.One of the pathophysiologic mechanisms of specific sub-type PMS is probably the continuous low level of E2and P.     

Real-time Three-dimensional Echocardiography in Assessment of Left Ventricular and Right Ventricular Volumes

Real-time three-dimensional echocardiography (RT3DE)is a new ultrasound technique that enables dynamic threedimensional visualization and quantification of the heart in real time. Investigation of feasibility and methodology of RT3DE in determining left ventricular (LV) and right ventricular (RV) volumes, RT3DE was performed in 35 normal adults using Philips SONOS 7500 system with a 2-4 MHz matrix array transducer. The 60°×60° "pyramid" volume database was obtained and analyzed on a TomTec echo workstation. Both LV and RV volumes were calculated with four 3DE methods (i.e. apical 2, 4, 8, and 16-plane) through manually tracing ventricular endocardial borders in end diastole and end systole. Stroke volumes were then calculated. LV volume was also measured by 2DE Simpson's rule using GE VIVID 7 ultrasound machine.     

SCREENING FOR A 21-CHROMOSOME ABNORMALITY IN PREIMPLANTED EMBRYOS OF ELDERLY WOMEN

Increasing maternal age is the only etiological factor unequivocally linked to Down's syndrome in humans. The occurrence rate of newborns with Down's syndrome is about 1/220 in women over 35 years old. However, the occurrence rate in embryos fertilized in vitro, of the elder woman is unclear. Using FISH we screened the number of chromosome 21 in preimplanted embryos of 5 elderly women (average age, 38.4 years) to study the feasibility and necessity of screening trisomy 21 in embryos in patients over 35 years old at the in vitro fertilization (IVF) center.