老年人血清CRP增高178例与自身生化指标水平相关性分析

目的:探讨老年人血清C反应蛋白(CRP)浓度增高与WBC、DC、ALT、AsT、r-GT、CK、LDH、UA、GLU、ALB、TBIL、TP相关性分析.方法:用胶乳增强免疫比浊法测CRP,全自动血球仪和全自动生化仪测定WBC、DC、ALT、AST、CK、LDH、UA、GLU、TP、ALB、TBIL,分析CRP与WBC、DC、ALT、AST、CK、LDH、UA、GLU、TP、ALB、TBIL的关系.结果:老年人CRP浓度增高与DC、CK、LDH、GLU、WBC、DC差异有显著性(P<0.001),与ALT、AST、UA、TP、ALB、TBIL差异无显著性(p>0.05).结论:老年患者CRP和CK、LDH联合检测有利于对组织损伤和心脑血管疾病的诊断.CRP和GLU联合检测与女性糖尿病有密切联系.CRP和中性粒细胞分类联合检测有助于炎症的判断.     

56例标本溶血对常规生化检验结果影响分析

目的对血清标本溶血后部分生化检验结果的变化情况进行探讨。方法取56例健康人群血液标本,采用全自动生化仪比较在溶血前后丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）、总胆红素（TBIL）、直接胆红素（DBIL）、总胆固肌酸激酶（CK）、总蛋白（TP）、清蛋白（ALB）、乳酸脱氢酶（LDH）,γ-谷胺酰转肽酶（γ-GT）、胆固醇（TC）、三酰甘油（TG）、低密度脂蛋白（LDL）、高密度脂蛋白（HDL）测定值的变化情况,进行统计分析。结果 TBIL、DBIL、ALB、TC、TG、LDL、HDL测定值溶血前后无明显差异;ALT、AST、CK、TP、LDH、γ-GT溶血后测定值明显升高（P〈0.05）,造成溶血的原因主要是采血不规范和采血器械不合格两种。结论在测定血清中ALT、AST、CK、TP、LDH、γ-GT值时应注意标本是否溶血。     

病毒性肝炎患者血清铁代谢指标的临床分析

目的 探讨血清铁代谢指标与病毒性肝炎患者肝脏炎症活动度的关系;乙型肝炎患者与丙型肝炎血清铁代谢指标有无差异。方法 入组135例乙肝患者和31例丙型肝炎患者,收集患者血清铁（SI）、血清铁蛋白（SF）、转铁蛋白（TRF）、总铁结合力（TIBC）并计算转铁蛋白饱和度（TS）,肝功能指标谷丙转氨酶（ALT）、谷草转氨酶（AST）、总胆红素（TBIL）、白蛋白（ALB）。结果 TRF、TIBC与年龄成负相关;SI、SF、TS分别与ALT、AST、TBIL有显著正相关,SF、TS与ALB成显著负相关;TRF、TIBC分别与ALT、AST、TBIL成负相关,与ALB成正相关（r=0.551,P＜0.001）。丙型肝炎患者的SF高于乙型肝炎患者,TRF及TIBC低于乙型肝炎患者（P=0.003）,SI及TS在两组中无显著性差异。结论 血清铁代谢指标与肝脏炎症活动度有显著相关性; 慢性丙型肝炎与慢性乙型肝炎患者相比,铁超载现象明显。     

260例乙型病毒性肝炎患者血清标志物与生化指标测定及其意义

目的：观察乙型肝炎病毒不同模式感染的生化指标,了解肝功能损害情况,为临床治疗和判断愈后情况提供依据。方法：以HBsAg（＋）、HBeAg（＋）、HBcAb（＋）（大三阳）和HBsAg（＋）、HBeAb（＋）、HBcAb（＋）（小三阳）两组共260例为测定组,以体检肝功能正常,乙肝标志物测定均为阴性者110例为对照组,进行丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）、碱性磷酸酶（ALP）、r-谷胺酸转移酶（GGT）、总蛋白（TP）、白蛋白（ALB）、胆碱酯酶（CHE）、总胆红素（TBIL）、直接胆红素（DBIL）、总胆汁酸（TBA）10项生化指标的检测。结果：大三阳组ALT、AST、CHE、GGT、TBIL、TP、ALB指标与对照组比较,差异有统计学意义（P〈0．05）,小三阳组TBIL、TP、ALB指标与对照组差异有统计学意义（P〈0．05）,大三阳组与小三阳组ALT、AST、CHE、GGT指标差异有统计学意义（P〈0．05）。结论：大三阳患者ALT、AST、CHE、GGT变化与肝细胞损害有一定关系,对慢性乙肝患者生化指标的检测具有重要意义。     

索拉非尼对肝癌术后早期肝功能及凝血功能影响的临床研究

目的 研究索拉非尼对肝癌术后早期肝功能及凝血功能的影响.方法 经病理确诊为肝癌,术后接受索拉非尼治疗者,共30例,分析不同剂量下、服药前及服药后1个月、3个月时肝功能及凝血功能的变化.结果 不同剂量对血清AST、ALT、TBIL、IBIL、ALB浓度及PT的影响均无统计学意义（P＞0.05）;服药前及服药后1个月时血清AST、ALT、TBIL、IBIL及ALB浓度变化无统计学意义（P＞0.05）,而血清PT变化有统计学意义（P＜0.05）.服药前及服药后3个月时血清TBIL、IBIL及ALB浓度变化无统计学意义（P＞0.05）,而血清AST、ALT浓度及PT变化有统计学意义（P＜0.05）.结论 索拉非尼可引起肝癌术后患者早期转氨酶升高,对早期凝血功能有抑制作用,且均与剂量无关.     

血清标志蛋白对婴儿肝炎综合征诊断及病情评定价值

目的：研究理化指标水平测定对婴儿肝炎综合征病情评定的意义。方法选取2012年9月-2013年9月于该院就诊的婴儿肝炎综合征患儿60例为观察组,另选取30例健康者为对照组,对2组血清总胆固醇（TC）、三酰甘油（TG）、总蛋白（TP）、白蛋白（ALB）、球蛋白（GLB）、总胆红素（TBIL）、直接胆红素（DBIL）、间接胆红素（IBIL）、丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）以及 CMV-IgM 阳性率进行检测。结果观察组 TBIL、DBIL、IBIL、ALT和 AST 水平高于对照组（P ﹤0.05）;患儿的 TC、TG、TP、ALB 和 GLB 与对照组比较差异均无统计学意义（P ﹥0.05）。观察组 GLB 与 TBIL 和 DBIL 呈正相关（P ﹤0.05）;ALB 与 TBIL 和 DBIL 呈负相关（P ﹤0.05）;AST 与 TC 呈正相关（P ﹤0.05）;AST 与 TG、ALB、GLB 无相关性（P ﹥0.05）;ALT 与 ALB、GLB 均无相关性（P ﹥0.05）。结论血清 DBIL、AST、TBIL、ALT、IBIL 水平与婴儿肝炎综合征发病显著相关,用于该病的诊断与病情评定具积极的意义,TP、ALB、GLB 有稍微变化,能够作为肝功异常的指导,而 TG 与 TC 水平与婴儿肝炎综合征无关系。     

溶血对肝功能检验结果影响的分析

目的探讨标本溶血对生化检验结果的影响。方法采用全自动生化分析仪检测62例正常人不溶血和溶血血清中的总胆红素（TBIL）、直接胆红素（DBIL）、总蛋白（TP）、白蛋白（ALB）、谷氨酰转肽酶（GGT）、谷丙转氨酶（ALT）、谷草转氨酶（AST）、碱性磷酸酶（ALP）并进行配对资料秩和检验的统计分析。结果TBIL、DBIL、TP、AST、的值在溶血和非溶血标本之间有非常显著性差异（P〈0.01）;ALB的值在溶血和非溶血标本之间有显著性差异（P〈0.05）的值在组间差异无显著性（P〉0.05）。结论溶血对肝功检验有明显的干扰和影响。     

试验相关因素对SD大鼠临床生化学指标的影响

目的研究试验相关因素对SD大鼠临床生化学指标的影响。方法选择SPF级SD大鼠为实验动物,按性别(A)、停食(B)、麻醉剂(C)和动静脉采血(D) 4个因素,根据不同因素交互影响分为24组,采集各组SD大鼠血液标本,测定血清丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、总蛋白(TP)、白蛋白(ALB)、总胆红素(TBIL)、碱性磷酸酶(ALP)、血糖(GLU)、尿素氮(BUN)、肌酐(CREA)、总胆固醇(CHOL)、甘油三酯(TG)和胆碱酯酶(CHE)等指标。结果性别(A)对TP、ALB和BUN无影响,而对其余9项生化指标有明显影响,差异有统计学意义(P0. 05);停食(B)对ALT、AST、TP、ALB、CREA和CHE无影响,而对TBIL、ALP、GLU、BUN、CHOL和TG有明显影响(P0. 05);麻醉剂(C)仅对TBIL无影响,对其他11项生化指标均有影响(P0. 05);动静脉采血(D)对ALP、TP和ALB有明显影响(P0. 05),而其余9项生化指标均无影响。结论 SD大鼠大部分临床生化学指标存在性别、停食、麻醉剂以及动静脉采血差异。     

标本溶血对生化检验结果的影响

目的：分析标本溶血对临床生化检验结果的影响。方法随机选取医院门诊部2013年8月-2014年8月进行体检的60名正常人的血标本作为研究对象,使用全自动生化分析仪进行检测,检测血液标本溶血血清中的胆红素（DBIL）、总胆红素（TBIL）、丙氨酸氨基转移酶（ALT）、清蛋白（ALB）、尿素氮（BUN）、肌酸激酶（CK）、肌酐（Cr）、门冬氨酸氨基转移酶（AST）、乳酸脱氢酶（LDH）、总蛋白（TP）、三酰甘油（TG）、尿酸（UA）等12项生化指标值,并进行临床分析。结果溶血后 TBIL、DBIL、ALT、AST、CK、LDH、TP、ALB 等指标较溶血前均存在明显变化,差异具有统计学意义（P ＜0.05）。结论标本溶血对生化检验有显著影响,因此为尽量避免或减少标本的溶血,医护人员采血时,应规范操作,并对血标本的运送、分离和检测过程严格把关。     

标本溶血对生化检验结果的影响及处理对策

目的分析研究标本溶血对生化检验结果的影响及处理对策。方法随机选择本院2011年8～11月在门诊进行体检的65例正常人的血标本作为研究对象,采用全自动生化分析仪对正常和溶血标本中的15项生化指标含量进行检测。结果研究对象血液的总胆红素（TBIL）、直接胆红素（DBIL）、总蛋白（TP）、清蛋白（ALB）、肌酸激酶（CK）、谷丙转氨酶（ALT）、谷草转氨酶（AST）、乳酸脱氢酶（LDH）、钾（K＋）、葡萄糖（GLU）、尿酸（UA）的值在溶血和不溶血标本中差异有统计学意义（P〈0.05）;三酰甘油（TG）、尿素氮（BUN）、肌酐（Cr）、钙（Ca2＋）的值在溶血和不溶血的标本中差异无统计学意义（P〉0.05）。其中TBIL、DBIL、TP、ALB、CK、ALT、AST、LDH、K＋的值更能说明溶血对血液生化指标有影响（P〈0.01）。结论溶血对较多的生化检验项目有影响,为尽量避免或减少标本的溶血,要求医务工作者采血时规范操作,对血标本的运送、分离和检测过程严格把关,使检验结果更准确可靠。     

Application of recovery tests in the validation of immunoassays for assessing the immunogenicity of B. anthracis PA vaccine.

In the quantitative assessment of polyclonal serum antibodies, the complex composition and characteristics of the analyte population (serum antibodies) restricts the capability of constructing appropriately defined calibration standards. This fact limits the application of the conservative recovery tests to the validation of immunoassays aimed at determining serum antibody levels. The present report describes a modification of recovery tests that overcomes this impediment. The modified approach is based on a dilution analysis system, where a given immune serum is serially diluted in normal serum and the antibody titers in each of the derived diluted samples are then determined. Expected sample titers (calculated on the basis of the relevant dilution factors) are plotted against the respective observed results, and the resulting recovery curve is then examined by means of a regression analysis, according to the standard rules of the conservative recovery analysis. This approach was tried with two immunoassay systems, Enzyme Linked Immunosorbent Assay (ELISA) and Neutralizing Antibodies (NtAb) immunoassays, aimed at assessing the immunogenicity in guinea pigs of B. anthracis protective antigen (PA) vaccine. In a series of feasibility studies using a recovery simulation model (dilutions made in the immunoassay diluent, rather than in normal serum) the average recovery levels in ELISA and NtAb immunoassays were 0.99 +/- 0.011 and 1.02 +/- 0.04 respectively, and the 99% confidence intervals contained the target 100% value. Regression lines were proved to be linear demonstrating R > 0.97 in all cases. The 99% confidence intervals around the observed slopes and intercepts always contained the corresponding target values 1 and 0. The relative standard deviation (RSD) in the ELISA and NtAb immunoassays was found to be 0.01 and 0.025 respectively. All of the above experimental results were not affected by the serum antibody titer, or by day-to-day variations embodied in these immunoassay systems. When true recovery tests were applied to the above immunoassays, essentially identical results were obtained. In both assays the correlation coefficients were in the range of 0.96-1, recoveries were found to be in the range of 0.90-1.06, and RSD values were in the range of 0.02-0.025. All the recovery deviations from the target value of 1 were not statistically significant. The hitherto observed experimental findings illustrate the capability of the dilution analysis system to allow the application of recovery tests to the validation of quantitative immunoassays, which are based on the procedure of serum titrations.     

生化分析系统淀粉酶测定结果的偏倚评估

目的 探讨不同生化分析系统检测血清淀粉酶(Amy)结果偏倚.方法 先检测三台仪器重复性及线性分析后,再以强生V350干式生化仪测定结果作为比较方法的测定值(X),以我院7170A全自动生化分析仪测定结果作为实验方法的测定值(Y),对46例测定结果进行相关分析及偏倚的评估.结果 各检测系统测定Amy的精密度变异系数均小于10%,3个不同牛化分析系统新鲜血清淀粉酶测定结果相关系数均大于0.975,可靠性系数为0.9856.两台7170A生化分析仪测定46例血清Amy在3个医学决定水平(50,120,200 U/L)处相对偏差分别为39.08%、8.95%、0.34%和40.58%、10.39%、1.76%.结论 不同生化分析系统血清Amy检测结果存在偏倚.其相对偏差在医学决定水平50 U/L时,临床不可接受;而在120和200 U/L时,临床可接受.     

Analytic performance of two automated nonpretreatment digoxin immunoassays

The analytic performance of two automated nonpretreatment digoxin methods, AxSYM Digoxin II and Vitros digoxin immunoassays, was assessed. Both assays had analytic sensitivities of less than 0.2 microg/L, were linear from digoxin concentrations of 0.5 to 4.0 microg/L, and showed acceptable precision, with a maximum total coefficient of variation (CV) of 8.9% and 6.4% for the AxSYM and Vitros, respectively. Comparison of the two methods using samples from patients receiving digoxin gave the following relationship: Vitros = 0.91 x AxSYM + 0.23 (r = 0.97, Sy,x = 0.12). Digoxinlike immunoreactive factor (DLIF) crossreactivity was examined in specimens from patients who had hepatic disease, renal insufficiency, had undergone cardiac surgery, and in neonatal cord blood samples. Minimal crossreactivity was observed for most samples and the average crossreactivity for each group of samples was comparable for the two methods. The recovery of digoxin added to samples from each group of DLIF was similar, except for that from cord blood samples, for which recovery was significantly lower with the AxSYM method. Titration of a digoxin-spiked serum pool with digoxin-immune Fab showed a similar decrease in the measured digoxin concentration for both methods. Overall, the analytic performance characteristics of these two methods were comparable.     

动态浊度法测定尿液中内毒素含量及临床应用

目的：建立尿液中内毒素的测定方法并探讨该方法在临床上的应用。方法：对比不同的尿液前处理方法，用动态浊度法测定尿中内毒素含量。用已建立的方法考察泌尿系统疾病患者尿度中内毒素的含量，并与尿液细菌培养结果进行对比。结果：采用KT—200血处理液以10倍浓度稀释尿液为尿液前处理方法。以该方法则定了10例泌尿系统疾病患者尿液中的内毒素含量，且与尿液细菌培养结果一致。结论：本法适用于泌尿系统疾病患者尿液中内毒素的测定；与尿液细菌培养结果一致且具有快速、简便及价廉的优点。     

注射用泮托拉唑钠使用过程中质量稳定性的探讨

目的:考察注射用泮托拉唑钠使用过程中质量稳定性。方法:用pH计法测定溶解和稀释后的泮托拉唑钠pH值的变化,同时测定溶液中不溶性微粒的变化及观察颜色的变化。结果:注射用泮托拉唑钠与0.9%氯化钠注射液溶解和稀释,5 h内溶液较稳定,用其他输液溶解和稀释溶液均不太稳定,不溶性微粒均有显著增加(P<0.05)),pH有明显下降,颜色有加深的现象。结论:注射用泮托拉唑钠最好用0.9%氯化钠注射液溶解和稀释且即配即用。     

Stability, potency, and preservative effectiveness of epoetin alfa after addition of a bacteriostatic diluent.

The stability, potency, and preservative effectiveness of two dilutions of epoetin alfa containing a bacteriostatic diluent were studied. Epoetin alfa 10,000 units/mL in single-use vials was diluted 1:1 and 1:1.5 with bacteriostatic 0.9% sodium chloride injection. USP tests of preservative effectiveness were performed on samples from two batches each of the 1:1 and the 1:1.5 dilutions. Appearance assessment, Western blot analysis, radioimmunoassay, and bioassay were used to determine the stability or potency of samples from three batches of each dilution that were stored at 5 degrees C or at 30 degrees C for 12 weeks. Both batches of the 1:1.5 dilution (epoetin alfa 4,000 units/mL with 0.54% benzyl alcohol) met the USP criteria for preserved solutions, while one batch of the 1:1 dilution (epoetin alfa 5,000 units/mL with 0.45% benzyl alcohol) did not. Epoetin alfa 10,000 units/mL diluted either 1:1 or 1:1.5 with bacteriostatic 0.9% sodium chloride injection and stored at 5 degrees C or at 30 degrees C remained stable and potent for 12 weeks. The addition of 1.5 mL of bacteriostatic 0.9% sodium chloride injection to a vial containing 1 mL of epoetin alfa 10,000 units/mL makes a solution of epoetin alfa 4,000 units/mL that meets the USP criteria for preservative effectiveness and remains stable and potent for 12 weeks at 5 degrees C.     

Determination of Indomethacin Crystallinity in the Presence of Excipients Using Diffuse Reflectance Near-Infrared Spectroscopy

Studies were conducted to investigate the use of near-infrared spectroscopy for determining the crystallinity of indomethacin in multi-component physical mixtures. Three calibration sets of amorphous/crystalline indomethacin physical mixtures were prepared over the composition range of 0–100% crystallinity. Each of the three calibration sets was diluted step-wise with increasing amounts of a single excipient (Avicel, α-lactose monohydrate, or sodium chloride). Near-infrared spectra were obtained after each round of dilutions using diffuse reflectance sampling on samples contained in glass vials. After a second derivative transformation, standard curves were constructed by plotting percent indomethacin crystallinity against the ratio of responses at two wavelengths. At dilution levels up to 75% Avicel or lactose, the calibration models demonstrated high coefficients of determination and low standard errors. Dilution with sodium chloride did not produce comparable results and it was necessary to use partial least-squares regression to achieve a similar level of error. These findings were confirmed with separate validation sets. An investigation of instrument error showed that the impact of instrument variability on quantification generally increased as a function of the dilution level.     

Determination of indomethacin crystallinity in the presence of excipients using diffuse reflectance near-infrared spectroscopy.

Studies were conducted to investigate the use of near-infrared spectroscopy for determining the crystallinity of indomethacin in multi-component physical mixtures. Three calibration sets of amorphous/crystalline indomethacin physical mixtures were prepared over the composition range of 0-100% crystallinity. Each of the three calibration sets was diluted step-wise with increasing amounts of a single excipient (Avicel, alpha-lactose monohydrate, or sodium chloride). Near-infrared spectra were obtained after each round of dilutions using diffuse reflectance sampling on samples contained in glass vials. After a second derivative transformation, standard curves were constructed by plotting percent indomethacin crystallinity against the ratio of responses at two wavelengths. At dilution levels up to 75% Avicel or lactose, the calibration models demonstrated high coefficients of determination and low standard errors. Dilution with sodium chloride did not produce comparable results and it was necessary to use partial least-squares regression to achieve a similar level of error. These findings were confirmed with separate validation sets. An investigation of instrument error showed that the impact of instrument variability on quantification generally increased as a function of the dilution level.     

An assessment of the accuracy of electrolyte concentrations in neonatal parenteral nutrition

Over a six‐week period in January and February 2002, 2ml samples were removed from all neonatal PN bags dispensed Samples were submitted for analysis of sodium, potassium and magnesium in triplicate by the hospital's clinical chemistry department using a Vitros Codac 950AT, dry slide, automated analyser Only 19.3, 7.1 and 30.4 per cent of measured sodium, potassium and magnesium concentrations respectively deviated by £5 per cent from stated bag concentrations The results indicate that it is possible that some electrolyte concentrations included in neonatal PN vary significantly from stated values     

室内临床生化不同检测体系间检测结果的可比性及偏倚评估

目的对临床生化内部三种不同检测体系Cobas6000,Hitachi7600及Vitros350（干化学）间相同项目的测定结果进行可比性及偏倚评估分析,为实验室认可及标准化提供实验数据。方法参考美国临床和实验室标准化委员会（CLSI）的EP9A2文R2﹤0.95,并有5项ALT、AST、ALP、Crea、Ca方法间偏倚超出允许误差范围。结论不同检测体系间存在一定偏差,特别是干化学与湿化学之间主要指标差异显著,相对偏差大于30%。当同一项目在2个或以上的检测系统件,以Hitachi7600作为参比方法,Cobas6000和 Vitros350作为待评方法,对相同项目结果进行线性回归分析、并计算医学决定水平处的方法间偏差,以美国临床实验室修正法规（CLIA88）规定的室间质评允许误差范围的1/2为标准,判断偏倚的临床可接受性。结果 Cobas6000与Hitachi7600间相同检测项目40项,其中4项：钙、镁、氯和二氧化碳相关系数R2﹤0.95,并有7项：ALT、AST、ALP、ADA、β2MG、Phos及Lac方法间偏倚超出允许误差范围;Hitachi7600与Vitros350相同项目16项,其中3项：ALB、Na＋、CL＋相关系数测试时,应定期进行结果可比性及偏倚评估,判断临床可接受性,必要时分别建立参考值系统,以满足临床需求。