1999～2001年全国治疗药物监测室间质评结果

目的:通过开展室间质量评价活动提高临床实验室的检验结果质量。方法:每年向参加治疗药物监测(TDM)室间质量评价活动的单位发放质控品10个批号,测定项目包括茶碱、地高辛、苯妥英、苯巴比妥、卡马西平和环孢菌素A,实验室用常规方法测定并回报测定结果,经计算机软件对全部结果进行统计分析。结果:2001年参加TDM室间质评的实验室数为48家,测定结果的平均及格率分别为茶碱94.2％、地高辛82.6％、苯妥英83.8％、苯巴比妥88.4％、卡马西平94.2和环孢菌素A92.4％。1999～2001年全国TDM室间质评的年平均及格率分别为78.7％、84.7％和89.3％。不同测定方法的精密度分别为茶碱4.4％～14.2％、地高辛11.5％～21.9％、苯妥英8.5％～29.5％、苯巴比妥8.2％～13.9％、卡马西平10.8％～12.6％和环孢菌素A15.5％～16.6％。结论:多数参加TDM室间质评实验室的测定结果有较好的一致性,及格率逐年上升,但参加TDM室间质评的实验室数占开展TDM的实验室总数的比例较低,在不同的测定方法间还存在较大的差异。     

2014年全国血清治疗药物监测(卡马西平、地高辛、苯妥英、茶碱、丙戊酸)室内质量控制结果分析

目的 调查全国血清治疗药物监测(卡马西平、地高辛、苯妥英、茶碱、丙戊酸)室内质量控制的精密度现状,并与目前所确定的室内质量控制精密度的评价标准进行比较,提出改进措施。方法 采用基于Web方式的室间质量评价(EQA)软件系统,收集2014年2月份参加全国血清治疗药物监测EQA计划的175家实验室的室内质量控制数据,包括当月的和累积的室内质量控制变异系数、质控规则、所使用的方法、仪器、室内质控品的厂家等信息。使用Microsoft Excel 2013和SPSS 13.0对数据进行分析。将EQA范围(地高辛为20%,其余项目为25%)定义为允许总误差(TEa),将1/3TEa和1/4TEa定义为允许不精密度的评价标准,计算这5个项目的室内质量控制变异系数的通过率。血清治疗药物监测项目的允许不精密度评价标准为8.33%(1/3TEa)和6.25%(1/4TEa),地高辛为6.67%(1/3TEa)和5%(1/4TEa)。结果 分别有94家、97家、61家、43家和116家实验室回报了卡马西平、地高辛、苯妥英、茶碱、丙戊酸的室内质控数据。>60%的实验室(63.93%~76.29%)使用伯乐检测系统,只有<40%的实验室(23.71%~36.07%)使用其他检测系统。不同项目间的室内质控变异系数通过率都存在显著统计学差异,卡方值为10.689~19.255,均P<0.05。不同检测系统间,只有丙戊酸在当月和累积不精密度在1/3TEa时的通过率存在显著统计学差异(P<0.05)。结论 通过对当月和累积的室内质控数据的变异系数的监测,并将室内质量控制数据计算的变异系数与相关要求进行比较,可以评价该检测系统的不精密度水平是否满足规定的质量要求。     

对HPLC法测定茶碱血药浓度的改进

目的：使用与日常工作中测定一些常用抗癫痫药物(如：苯妥英钠、卡马西平、苯巴比妥)相同的流动相(甲醇-水1：1)，建立用HPLC法测定茶碱血药浓度的方法，希望在日常治疗药物监测工作中能起到降低成本、提高效率的作用。方法：用二氯甲烷萃取血清中的茶碱，浓集后进样测定，以内标法定量。在室温条件下，使用ELITE C18色谱柱(5μm)，以甲醇-水(1：1)为流动相(流速1．0mL／min)，以咖啡因(0．1g／L)为内标，检测波长275nm。结果：本方法线性范围0．5mg／L～20．0mg/L，相关系数0．9992，检测限0．2mg／L，回收率96％～105％。结论：方法灵敏、简便、准确，适用于对茶碱进行治疗药物监测的需要，在和一些常用抗癫痫药物先后测定时可以有效地降低成本、提高效率。     

抗癫痫药物的血浆浓度测定

作者采用高效液相色谱法同时测定多种抗癞痫药物在人血浆中的浓度。测定药物有朴痫酮、苯巴比妥、苯妥英、卡马西平和10.11一环氧化卡马西平。用于研究抗癫痫药物配伍用药后体内各药物动力学的变化及临床治疗药物的监测工作。色谱条件:ODS-C18柱,紫外检测波长210nm,流动相为甲醇和水的等体积混合溶液,流速为1.0ml/min,内标为苯乙酮。本文采用相对校正因子来控制多批样本测定质量,用t检验判断药物测定的稳定性,证明本法稳定,重复性好,灵敏度高等优点。     

对HPLC法测定茶碱血药浓度的改进

目的 :使用与日常工作中测定一些常用抗癫痫药物 (如 :苯妥英钠、卡马西平、苯巴比妥 )相同的流动相 (甲醇—水 1∶1) [1\〗,建立用HPLC法测定茶碱血药浓度的方法 ,希望在日常治疗药物监测工作中能起到降低成本、提高效率的作用。方法 :用二氯甲烷萃取血清中的茶碱 ,浓集后进样测定 ,以内标法定量。在室温条件下 ,使用ELITEC18色谱柱 (5 μm) ,以甲醇—水 (1∶1)为流动相 (流速 1.0mL/min) ,以咖啡因 (0 .1g/L)为内标 ,检测波长2 75nm。结果 :本方法线性范围 0 .5mg/L～ 2 0 .0mg/L ,相关系数 0 .9992 ,检测限 0 .2mg/L ,回收率 96 %～ 10 5 %。结论 :方法灵敏、简便、准确 ,适用于对茶碱进行治疗药物监测的需要 ,在和一些常用抗癫痫药物先后测定时可以有效地降低成本、提高效率     

反相高压液相色谱法测定人血清苯巴比妥、苯妥英、卡马西平

采用反相高压液相色谱法测定抗癫痫药物苯巴比妥、苯妥英及卡马西平的血清浓度。用苯乙酮作内标,甲醇:水(40/60,V/V)作流动相,流速为0.5ml/min,柱温为60℃,检测波长为216nm。用丙酮沉淀血清蛋白质,离心后直接进样,进样量2μ1。计算待测药物及内标峰高,用内标法测定药物含量。苯巴比妥、苯妥英、卡马西平最低检测限分别为1μg/ml,0.5μg/ml,0.5μg/ml。除氯硝安定干扰卡马西平测定外,安定、丙戊酸、异戊巴比妥、巴比妥、利眠宁、血清内源性物质及药物代谢产物均不影响测定。本法操作简便,精密度及准确性良好。     

冰冻储存对HPLC法测定血清中苯妥英钠、卡马西平的影响

目的：本实验考察了不同时间冰冻储存(-20℃)。对血清中苯妥英钠、卡马西平HPLC色谱图和测定结果的影响。方法：记录经过不同时间冰冻储存的血清的HPLC色谱图、计算血清中苯妥英钠、卡马西平的浓度，考察每个血清5次测定结果之间有无显著性差异。结果：经过不同时间冰冻储存的血清，其HPLC色谱图基本上没有发生变化，血清中苯妥英钠、卡马西平浓度5次测定结果之间无显著性差异。结论：在冰冻条件下储存血清不影响对苯妥英钠、卡马西平的测定。     

冰片对癫痫患者血清及脑脊液卡马西平药物浓度的作用

目的观察冰片对卡马西平血清及脑脊液药物浓度的影响。了解冰片是否促进卡马西平透过血脑屏障的作用。方法采用高效液相色谱法测定癫痫患者合用冰片前后血清及脑脊液卡马西平的药物浓度,观察冰片对其药物浓度的影响。结果合用冰片后平均血清卡马西平药物浓度由原来6．06μg／ml上升到6．21μg／ml。脑脊液平均卡马西平药物浓度由1.24μg／ml上升到1．32μg／ml,脑脊液／血清药物浓度比由20．5％提高到21.2％。结论冰片能促进卡马西平透过血脑屏障,提高卡马西平在中枢神经系统的浓度。     

抗癫痫药物的血清浓度、疗效和不良反应观察

目的：观察癫痫患在长期服用抗癫痫药物期间的血药浓度，疗效和严重的不良反应。方法：采用美国产全自动荧光免疫偏振分析仪和相应的试剂药盒对本市可评价的213例癫痫患进行血药浓度监测，并观察各种抗癫痫药物的疗效和严重不良反应。结果：卡马西平，丙戊酸，苯胺英，苯巴比妥和氯硝西泮分别有95．7％，45．8％，30．4％，80．5％和70．3％例次在有效治疗血药浓度范围中；严重不良反应较少见；卡马西平和丙戊酸疗效较佳，苯妥英疗效较差，结论：卡马西平（除婴儿痉挛外）和丙戊酸宜作为癫痫患的首选药物，血清浓度分别宜控制在6－8μg/ml和60－90μg/ml，苯妥英不宜用于癫痫的治疗。     

375例抗癫痫药物血药浓度监测结果分析

目的 通过对抗癫痫药物血药浓度的监测,为调整药物剂量、评价药物不良反应和保证治疗效果提供依据。方法 采用荧光偏振免疫法及高效液相色谱法对未合并用药的138例服用丙戊酸、151例服用卡马西平、21例服用苯妥英、65例服用苯巴比妥的癫痫患者进行血药浓度监测。结果 丙戊酸、卡马西平、苯妥英和苯巴比妥有效血药浓度范围分别为50-100、4—12、10-20和15-40μg／mL,有效血药浓度范围内的控制率明显高于浓度范围外的控制率。苯妥英和苯巴比妥均有中毒病例发生。结论 血药浓度监测对抗癫痫药物的个体化给药十分必要,应紧密结合临床症状,做到安全、有效用药。     

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.