乳酸试剂盒的研制

目的：建立用酶法测定乳酸浓度的试剂盒。方法：乳酸在乳酸脱氢酶的作用下脱氢生成丙酮酸，同时NAD^ 接受H^ 生成NADH，在340nm处测定NADH的吸光度，根据吸光度来计算样品中乳酸的含量。结果：此方法的批内精密度为：n=20,x↑-=1.4095mmol/L,S=0.0239mmol/L,CV=1.79%;批间精密度为：n=20,x↑-=1.4135mmol/L,S=0.0386mmol/L,CV=2.73%；线形范围为：0.5-10.0mmol/L，平均回收率为：98.87%。结论：此方法经济、可靠、灵敏、重复性好，操作简便，既适用于手工操作又适用于全自动分析仪使用。     

白蛋白钴结合力法检测缺血修饰白蛋白的建立与评价

目的：建立缺血修饰白蛋白（ischemia modified albumin,IMA）的检测方法并对其性能进行评价。方法：应用长沙颐康科技开发有限公司生产的IMA试剂盒和日立7600全自动生化分析仪组建白蛋白钴结合力（albumin cobalt binding,ACB）比色分析法检测IMA的分析系统,依据美国临床实验室标准化委员会（NCCLS）EP文件的要求,对该分析系统的线性、回收率、精密度分别做出评价。结果：不同浓度白蛋白与ACB比色分析法检测结果是线性的,回归方程为Y=1.676X＋6.735（r=0.983,P=0.001）;平均回收率为97%;以该分析系统测定低、中、高3种不同水平IMA的重复精密度（CV）分别为3.34%、1.13%、1.67%,中间精密度（CV）分别为3.72%、1.63%、1.88%。结论：ACB比色分析法测定IMA,实验条件的建立较为简单,各项检测指标均能够满足临床实验室管理办法的相关要求,标本和试剂用量少,方便快捷,亦可以进行大量样本的测定,适宜临床常规推广应用。     

肌酸激酶同工酶质量法的优势及其性能评价研究

目的 对北京九强生物技术有限公司肌酸激酶同工酶CKMB 测定试剂盒（胶乳免疫比浊法）进行性能评价。方法 自2019 年5～12 月期间采用东芝2000FR 全自动生化分析仪,检测肌酸激酶同工酶的准确度、精密度、线性范围、空白检测限、最大稀释倍数、临床可报告范围、参考范围进行实验性能验证。统计学方法采用直线相关回归分析。结果 北京九强CKMB 试剂盒的准确度验证中测定值与定值的相对偏差分别为0.62%、-2.89%,批内精密度CV 分别为1.29%、0.67%,批间精密度CV 分别为1.53%、1.14%。线性范围为0.00～218.36 ng/mL,临床可报告范围为0.12～1642.56 ng/mL,随机抽取的20 例健康体检样本的测定结果95%在参考值范围（0.00～5.00 ng/mL）内。结论 该试剂盒的胶乳免疫比浊法测定肌酸激酶同工酶性能符合要求,可满足临床测试要求。     

OLYMPUS AU-600与HITACHI 7180测定AST和GLU的精密度评价

目的:为了更确切的了解全自动生化分析仪OLYMPUSAU-600与HITACHI7180测定精密度的性能。方法:使用广东省临床检验中心提供的2005年省临床检验中质量评价血清(编号200507和200509)分别使用这两种仪器测定AST和GLU各20次,分别计算其均数、标准差和变异系数,从而得出批间精密度和总精密度。结果:OLYMPUSAU-600全自动生化分析仪测定AST和GLU的SWT分别为:0.531,0.049,0.090。ST为:0.567,0.053,0.092。总CV为:1.1%,0.9%,0.6%。HITACHI7180全自动生化分析仪测定AST和GLU的SWT分别为:0.547,0.046,0.088。ST为:0.563,0.056,0.087。总CV为:0.6%,0.4%,0.2%。将测定结果与试剂盒内批内精密度分别做χ2检验,差别均无显著性(P>0.05)。结论:全自动生化分析仪OLYMPUSAU-600在使用一定时间后与HITACHI7180均具有良好的分析精密度,能够满足临床和科研工作需要。     

意大利LIAISON全自动化学发光分析仪性能评价

目的：对LIAISON进行性能验证。方法：通过对不同浓度的血清标本进行检测,进行分析系统的精密度、线性范围、准确度、携带污染率及参考范围等指标进行测试。结果：批内精密度CV〈6％,批间精密度CV〈10％,携带污染率〈1％,回收率95～108％。结论：LIAISON仪器测定结果灵敏度高,特异性好,稳定性强,检测范围宽,有良好的准确性和重复性,适合应用于临床。     

甲型肝炎病毒IgM抗体酶免试剂盒临床应用评价

目的采用酶联免疫方法对准备新引进的和实验室现使用的两种甲型肝炎病毒(HAV)IgM抗体酶免试剂盒进行临床应用准确性和精密度评价。方法采用卫生部临检中心已明确预期阴、阳结果的HAV—IgM抗体质控血清，进行HAV—IgM抗体酶免试剂盒临床应用准确性评价；用含量2NCU／ml的定值血清进行批内和批间精密度评价；并对134例患者血清同时检测．对比分析。结果待评价的和现使用的HAV—IgM抗体酶免试剂盒检测质控血清符合率均为98％，批内精密度CV为9．09％和8．27％．批间精密度CV为15．17％和16．31％。均可以接受。结论所评价的HAV—IgM抗体酶免试剂盒其灵敏度、特异性、总符合率均较高．与现使用的试剂盒基本一致。     

胶乳免疫比浊法测定血清铁蛋白的方法学评价

目的 对胶乳免疫比浊法定量测定血清铁蛋白(FER)进行方法学评价.方法 参照美国临床实验室标准化协会(CLSI)推荐的评价方法,对胶乳免疫比浊法测定血清FER的精密度、回收实验、线性范围等进行评价.结果 胶乳免疫比浊法测定血清FER的批内、日间变异系数(CV)均<5.0%,精密度良好;FER浓度在25~500 ng/mL范围内,检测线性良好;比对实验:两种厂家的试剂盒测定FER结果相关性良好(r2=0.9907,n=40),检测结果基本一致(P>0.05);回收率为96.20%~102.43%;40例健康体检者样本的检测值均在待验证区间之内.结论 胶乳免疫比浊法用于定量检测人血清FER水平,测定结果准确可靠,操作简便、快速,能直接在全自动生化分析仪上使用,适用于临床样本检测.     

化学发光法与放射免疫法检测血清FT3、TF4及TSH的比较

目的：对化学发光法（CLIA）与放射免疫法（RIA）两种方法测定血清游离三碘甲状腺原氨酸（FT3）、游离甲状腺素（FT4）及促甲状腺激素（TSH）浓度进行比较。方法：分别采用CLIA和RIA平行测定66份临床送检标本并进行线性实验、回收实验、对比实验和精密度实验。结果：两种方法的相关性良好(r=0.995），无显著差异（P＞0．05），回收率均接近100％，但CLIA的批间CV％及批内CV％均低于RIA。结论：CLIA的精密度和重复性均优于RIA。     

免疫抑制法直接测定血清高密度脂蛋白胆固醇试剂盒的评价

目的 :评价免疫抑制法直接测定血清高密度脂蛋白胆固醇 (HDL -C)试剂盒是否符合临床应用要求。方法 :将免疫抑制法与磷钨酸———镁法 (PTA)和选择性抑制法进行比较 ,并分析其线性范围、精密度、准确度和干扰因素。结果 :免疫抑制法 (Y)与PTA法 (X1)的回归方程为Y =0 .993X1 0 .2 1 3,r =0 .981 ;与选择性抑制法 (X2 )的回归方程为Y =1 .0 1X2 0 .1 77) ,r =0 .971 ;Y与X1、X2 所测得的均值无显著差异 (P >0 .0 5 ) ;HDL -C浓度在 0 5 1～ 2 .5 5mmol/L范围内线性良好。对高、中、低血清标本进行精密度测定 ,批内CV值分别为 1 35 %、1 6 7%和 2 0 1 % ,日间CV值分别为 2 78%、3 1 4%和 3 43%。回收率为 97 8%～ 1 0 0 .9% ,平均回收率为 99 2 %。胆红素 ( <2 5 0 μmol/L)、血红蛋白 ( <5 g/L) ,抗坏血酸 ( <2 0 0 μmol/L)、TG( <1 0mmol/L)不干扰测定。 结论 :日本和光公司生产的免疫抑制法直接测定血清HDL -C试剂盒符合临床应用要求 ,可用于自动化分析     

CEMB HCL为色原的酶法测定血清肌酐试剂盒的评价

目的：评价以N-（2-carboxyethy）-N-ethyl-m-toluidine盐酸盐（CEMB HCL）为色原的酶法肌酐（Cre）试剂盒的灵敏度和显色稳定性。方法：采用CEMB HCL为色原酶法测定血清Cre,并对精密度、线性范围、干扰因素及相关性进行分析。结果：精密度批内变异系数（CV）为1.27%~4.33%,线性达13 472μmol/L,r=0.985。上海市临床检验中心质控血清测定偏差值≤1.02%,当胆红素≤684μmol/L、血红蛋白≤5 g/L、维生素C（抗坏血酸）≤200 mg/L、乳糜≤3 000时对本法无干扰。结论：采用CEMB HCL为色原的酶法测定血清肌酐的方法特异性好,灵敏度高,结果准确,有一定推广价值。     

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.     

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.     

Electro-Acupuncture Combined with the Trigger Point Needle-Embedding for Treatment of Primary Trigeminal Neuralgia in 31 Cases

In recent years, the author of this essay has applied electro-acupuncture combined with the trigger point needle-embedding for treatment of primary trigeminal neuralgia in 31 cases, yielding satis- factory results as reported in the following.     

Investigation of Matrix Metalloproteinase -1, 2 and tissue inhibitor of matrix metalloproteinases-1 in Endometriosis

Objective： To explore the role of matrix metalloproteinase-1,2 （MMP-1, MMP-2） and tissue inhibitor of matrix metalloproteinases-1 （TIMP-1） in endometriosis. Methods： The eutopic and ectopic endometria from 40 subjects suffering from endometriosis and regular.endometria from 40 subjects （excluding endometriosis） were collected and examined by in situ hybridization technology and western blot assay. Results： Both expressions of MMP-1 and -2 were stronger in ectopic endometrium and eutopic endometrium than in normal endometrium. On the contrary, the expression of TIMP-1 in ectopic endometrium and eutopic endometrium was lower. The differences were significant （P 〈 0.01 ）. Moreover, there was no relationship among the expressions of MMP-1, 2 and TIMP-1 in ectopic endometrium. Conclusion： The expressions of MMP-1, 2 and TIMP-1 lose balance and lack of periodic changes in ectopic endometrium , which explains the biological invasive behavior of endometriosis. It was suggested-that regulating the balance between the MMPs and TIMP-1 should be an ideal therapeutic target to endometriosis.     

Shi Da-zhuo (史大卓) —An outstanding cardiologist of integrative medicine

Prof. SHI Da-zhuo, Ph.D., male, was born on March 20, 1960. Prof. SHI entered the Ph.D. program in 1990 at the China Academy of Chinese Medical Sciences under the supervision of Prof. CHEN Ke-ji, majoring in the treatment of cardiovascular diseases. After receiving his Ph.D. degree in 1993, Prof. SHI started working at the Cardiovascular Center in Xiyuan Hospital affiliated to China Academy of Chinese Medical sciences.     

Persist in and Carry Forward the Integrative Medical Research——Speech at the 6th National General Congress of Chinese Association of Integrative Medicine by Academician CHEN Zhu,Minister of Ministry of Health

The 6th National General Congress of Chinese Association of Integrative Medicine （CALM） was convened at 19-20, April 2008 in Beijing. Academician CHEN Zhu, the minister of Ministry of Health indicated at the congress that the integration of Chinese and Western medicine is very well in keeping with the situation of our country and the general rule of development in medical science; and as a good integration of Chinese medicine and Western medicine, it is mutually beneficial and advantageous to both of them. Seeing the creativity shown in integrative medical investigation in theoretic and methodological sides, we should and must persist in and develop it.