接骨膏促进骨折愈合的实验研究

目的探讨中草药接骨膏促进大鼠骨折愈合的作用。方法选用健康雄性大鼠40只随机分为4组：正常组、模型组、接骨膏组和治疗组各10只。采用股骨骨缺损的方法复制大鼠骨折模型,连续给药21d。通过X线片检测骨痂和骨小梁的面积、密度和综合强度,并结合骨折愈合组织抗折力试验检测血清碱性磷酸酶活性和钙、磷水平的变化,观察中草药接骨膏对骨折愈合的促进作用。结果与模型组比较,接骨膏组的骨痂和骨小梁的面积、密度和综合强度、骨折愈合组织抗折力,血清碱性磷酸酶活性、钙、磷水平均升高差异均有统计学意义（P〈0.05）。结论接骨膏对促进骨折愈合具有显著的作用。     

郭氏接骨灵对桡骨不完全性骨折家兔血清碱性磷酸酶及骨痂中钙、磷的调节

目的：观察郭氏接骨灵对双侧桡骨中下段不完全性骨折的家兔血清碱性磷酸酶（alkaline phosphatase,AKP）及骨痂中钙（calcium,Ca）、磷（phosphorus,P）的含量的影响,为郭氏接骨灵的开发推广提供理论和实验依据.方法：无菌条件下手术分离家兔双前肢桡骨,以双层钢锯造成双侧桡骨中下段不完全性骨折.造模成功后一周开始用郭氏接骨灵治疗,并于造模后第10天、20天和30天分别测定血清AKP的水平、骨痴中Ca及P的含量.结果：与阳性对照组相比第10天、20天和30天血清的AKP水平明显升高（P＜0.05）.检测第30天骨痴中Ca、P含量,与阳性对照组相比Ca、P含量均明显升高（P＜0.05）.结论：郭氏接骨灵能通过有效调节家兔血清中AKP水平及骨痴中Ca、P的含量而达到促进骨折的修复作用。     

伤科接骨片联合桃红四物汤对胫腓骨骨折的疗效及对骨形态发生蛋白2与成纤维细胞生长因子b的影响

目的 观察伤科接骨片单用及与桃红四物汤联用对胫腓骨骨折患者骨痂生长情况、骨折部位疼痛情况及消肿时间的影响,并探讨其促进骨骼愈合的机制。方法 选择医院收治的胫腓骨骨折患者90例,随机分为A组（对照组）、B组（伤科接骨片组）和C组（伤科接骨片＋桃红四物汤组）,各30例,观察不同时点的骨痂生成情况、疼痛程度及消肿时间,检测血骨形态发生蛋白2（BMP-2）、成纤维细胞生长因子b（bFGF）的含量,并对结果进行分析。结果 治疗4,6,8周的骨痂生长综合评分,B组、C组均高于A组（P〈0.05）;治疗4,6周的骨痂生长综合评分,C组高于B组（P〈0.05）。治疗3,5,7,9 d,B组、C组与A组比较,患者疼痛程度均减轻（P〈0.05）;治疗5,7 d,C组疼痛减轻程度优于B组（P〈0.05）。治疗后B组、C组与A组比较,患者消肿时间更短（P〈0.05）,且C组优于B组（P〈0.05）。治疗2周后,B组、C组血清中BMP-2及bFGF的含量比A组更高（P〈0.05）。结论 伤科接骨片能促进胫腓骨骨折患者骨痂生长,减轻疼痛,缩短消肿时间,发挥促骨骼生长作用,伤科接骨片联合桃红四物汤有协同作用,比伤科接骨片单用效果好,其分子生物学机制是通过增加促骨生长因子BMP-2及bFGF的表达。     

组合式可变应力接骨板固定对实验性山羊股骨骨折愈合影响的研究

摘要：目的 探讨组合式可变应力接骨板固定对实验性山羊股骨骨折愈合的影响。方法 健康成年山羊30只,普通环境下饲养,制作山羊右下肢股骨骨折动物模型,随机分为组合式可变应力接骨板组（实验组）、普通直型接骨 板组（对照组）,每组15只。分别于手术后4周、8周、12周处死山羊,取股骨断端组织进行组织病理学观察。测量2组钢板下面骨皮质厚度及髓腔直径的变化,评估钢板的应力遮挡效应;测量2组骨折断端骨痂中骨小梁密度,评估骨折愈合情况;通过2组的破骨细胞计数,评估骨折愈合过程中骨痂改建情况。结果 4周时,2组的骨皮质厚度与髓腔直径比较差异无统计学意义,实验组4周、8周、12周骨皮质及髓腔直径无明显变化。对照组在治疗8周、12周骨髓腔直径大于实验组,而骨皮质厚度值低于实验组,提示对照组钢板存在应力遮挡效应,实验组钢板未见明显的应力遮挡效应造成的骨质厚度丢失。与对照组相比,实验组4周、8周的骨痂中骨小梁密度较高,差异有统计学意义,实验组较对照组成骨快;与对照组相比,实验组8周的骨小梁周边的破骨细胞计数增多,12周时实验组破骨细胞计数明显低于对照组,差异均有统计学意义。实验组的骨痂改建出现较早,12周时实验组骨痂改建基本结束。结论 组合式可变应力接骨板可促进骨痂的生成,加快骨痂的改建,促进骨折愈合。     

接骨膏促进大鼠骨折愈合机制的初步研究

摘 要 目的：探讨接骨膏在促进骨折愈合过程中与血生化指标及降钙素基因相关肽（CGRP）表达的关系。方法: 将胫骨骨折模型建立成功的大鼠随机分为5组：空白对照组、模型对照组、阳性对照组、接骨膏低剂量（L,1 g·mL^-1,以生药材计）组和高剂量（H,2 g·mL^-1,以生药材计）组,每组60只。空白对照组和模型对照组给予2 ml生理盐水,阳性对照组给予2 ml续断骨伤合剂浓缩液,接骨膏L组和H组分别给予2 ml低浓度和高浓度浓缩液,均灌胃给药,qd,连续给药28 d。骨折后第7,14,21,28天取血样本和骨痂标本,进行血生化指标检测、HE染色和免疫组织化学染色,骨折标本行数字化X射线（DR）摄片。结果: 与模型对照组比较,接骨膏H组的血清钙磷离子浓度乘积在14,21 d显著升高,血清AKP在14~28 d显著升高,差异有统计学意义 (P<0.05)。骨折21 d内接骨膏H组CGRP表达程度与模型对照组比较显著增强 ,差异有统计学意义 (P<0.05)。接骨膏H组与阳性对照组比较,差异无统计学意义(P＞0.05)。结论: 接骨膏可以通过提高骨折愈合中血清AKP的活性、升高钙磷乘积以及调控神经肽CGRP活性的机制,达到促进骨折愈合的目的。     

接骨宝对骨折愈合过程中转化生长因子-β1表达的影响

目的通过观察转化生长因子-β1（TGF-β1）在骨折修复过程中的表达及分布情况,探讨接骨宝促进骨折愈合的机制。方法制作48只兔桡骨骨折模型,随机分为接骨宝低剂量组、高剂量组及对照组,术后1天接骨宝组即喂服接骨宝,对照组喂服白开水。分别于术后2周、5周取样,随后进行组织学及TGF-β1免疫组化染色观察。结果术后2周接骨宝高低剂量组的TGF-β1表达呈强阳性染色,对照组软骨细胞等有着色,但明显浅于两个用药组;术后5周,接骨宝高低剂量组的TGF—β1表达阳性染色,但此时染色较术前2周组明显减弱,而对照组TGF-β1呈阳性的细胞类别较多,但着色较浅。接骨宝组与对照纽的TGF—β1表达比较有差异（P〈0．05）。组织学显示接骨宝高低剂量组骨折愈合的效果优于对照组。结论接骨宝能调节骨折愈合过程中TGF-β1的合成和分泌,促进骨组织TCF-β1早期大量的的表达,进而调节成骨细胞、软骨细胞的分化,而当软骨细胞成熟并转化为骨细胞时,它们的表达趋向于减少,提示其缩短了骨折愈合的进程,促进了骨折的愈合。     

南蛇藤乙醇提取物对大鼠骨创伤愈合的影响

目的研究南蛇藤乙醇提取物对大鼠骨创伤模型愈合的影响,为临床用药提供理论和实验依据。方法40只SD大鼠随机分为假手术组、模型组、阳性药组、南蛇藤乙醇提取物高剂量组和低剂量组。复制大鼠骨创伤模型,除假手术组外,各组大鼠每天1次给药,连续给药45d。给药期间观察大鼠的一般状况、伤肢活动和伤口愈合情况。末次给药后2h处死大鼠,采血分离血清,测定血清中钙、磷浓度和碱性磷酸酶水平。取股骨照骨痂X光片,分析骨痂骨密度,用折力仪测定骨痂抗折强度。结果骨创伤大鼠股骨骨痂密度、抗折力、血清钙磷含量、碱性磷酸酶水平均降低,而阳性药和高剂量南蛇藤乙醇提取物能增加血清钙、磷含量和碱性磷酸酶水平,提高骨创伤大鼠骨痂密度和抗折力（P〈0．05或P〈0．01）。结论南蛇藤乙醇提取物能有效促进大鼠骨创伤愈合。     

阿仑膦酸钠对骨折愈合的影响

目的 研究阿仑膦酸钠对骨折愈合的影响。方法 48只日本大耳白兔随机分为对照组和实验组各24只。48只大白兔建立单侧尺桡骨骨折模型并夹板固定，实验组犬白兔给予0．05％阿仑膦酸钠溶液2mL。于实验第2，3，4和6周分别取实验组和对照组大白兔各4只，取骨折标本分别摄X线片、测定骨密度及行常规病理切片检查，观察骨痂生长情况、骨痂的骨密度的区别及常规病理切片的变化。结果实验组与对照组比较骨折端骨痂的骨密度降低，差异有显著性（P〈0．05），骨痂塑形减慢，骨折线消失延迟。结论 阿仑膦酸钠对骨折愈合有抑制作用。     

接骨方剂1号对踝关节骨折愈合作用的临床研究

目的研究我院自制中药制剂接骨方剂1号对踝关节骨折愈合作用的影响。方法将98例踝关节骨折患者随机分为两组,治疗组(49例)每日给予口服接骨方剂1号,对照组(49例)每日给予口服碳酸钙D颗粒,12周后进行疗效评定。结果治疗组骨痂生长程度好于对照组。结论接骨方剂1号通过促进骨痂生长,加速新骨生成。从而对骨折愈合产生促进作用。     

愈骨疗伤方醇提物和水提物的药效学研究简

目的：比较愈骨疗伤方（Yuguliaoshang recipe,YGLS）醇提物和水提物促进骨折愈合的作用.方法：提取工艺分为水提工艺和醇提工艺.将60只家兔随机分为10个组：对照组,模型组,YGLS醇提取物低、中、高剂量（0.16、0.32、0.64 g/kg醇提取粉末）组,水提取物低、中、高剂量（0.26、0.53、1.06 g/kg水提取粉末）组,伤科接骨片（0.4 g/kg）组和麝香接骨胶囊（0.4 g/kg）组,每组6只.除对照组外,其余9组,均进行骨缺损模型制作,并给予相应的药物治疗.给药30 d后,测定血清碱性磷酸酶活性和血清钙、磷浓度,对骨缺损部位进行X线检查,病理学检查.结果：从X线片可见,中、高剂量醇提和水提组家兔骨痂填满缺损,骨折线随骨痂骨性愈合而消失,与模型组相比,有显著差异（P＜0.05）.从病理学检查可见,醇提的高剂量组和水提的高剂量组,骨小梁普遍较模型组增粗,骨小梁相互连接,有髓腔通过,各剂量醇提和水提物均能在一定程度上促进骨折愈合.与模型组比较,醇提和水提的中剂量组家兔血清碱性磷酸酶活性显著升高（P＜0.05）;水提高剂量组家兔血清钙磷离子浓度乘积明显升高（P＜0.05）,醇提高剂量组家兔血清碱性磷酸酶活性、钙离子浓度、磷离子浓度及钙磷离子浓度乘积也升高（P＜0.05）.结论：YGLS水提物和醇提物均有促进骨折愈合的作用.     

免疫透射比浊法与干化学法测定血清白蛋白的方法学比较及偏倚评估

目的通过评估免疫透射比浊法与干化学法测定ALB的偏倚,探讨两种方法检测ALB结果间的偏差是否在允许的范围,保证检测结果的可比性。方法依据NCCLS标准化文件EP9-A2[1],每天取临床样本8份,分别用免疫透射比浊法与干化学法进行双份测定,共测定5d,去除离群点,计算相关系数及预期偏差,以CLIA’88规定的室间质评（ALB＋10%）允许误差的1/2作为方法比较结果系统误差的允许限值,进行偏倚的评估。结果干化学法与免疫透射比浊法比较,r2=0.934,在医学决定水平20g/L,35g/L,52g/L时,干化学法的预期相对偏倚分别10.4%,6.8%,3.2%,在Xc=20g/L及Xc=35g/L时,两种方法存在统计学差异。结论以免疫透射比浊法作为比较方法,干化学法测定ALB的结果存在正偏差,测定结果的偏差随着ALB浓度的减低而增大,在低浓度时差异更显著,两者相关性差。因此,实验室内使用不同分析方法检测同一分析物时,建议对各方法进行方法学比较及偏倚评估,明确方法间的差异,并建立各方法的参考范围,特别是建立不同方法在不同医学决定水平浓度的参考值,以保证检测结果的可比性。     

全自动生化仪免疫比浊法检测血清白蛋白的方法学评价

目的使用免疫比浊法对血清白蛋白（ALB）测定的方法学进行评价。方法根据美国临床实验室标准化委员会（NCCLS）的标准,对免疫比浊法测定血清白蛋白的精密度、线性范围、回收率及准确性等指标进行测试．同时与溴甲酚绿法进行相关性的比较。结果精密度批内CV〈4．0,批间CV〈5．0。ALB线性范围可达5-89g／L,平均回收率为102.3％;抗干扰性强,当Hb≤50g／L,胆红素≤400μmol／L,TG≤23．0mmol／L时对测定无影响：与溴甲酚绿法对比,直线回归方程Y=1．05X＋5．56（Y：免疫比浊法：X：溴甲酚绿法）,相关系数r=0．926,提示两种方法有良好的相关性。结论免疫比浊法检测血清白蛋白是较为理想的新方法,完全能满足临床需要。     

雅培i2000SR和BeckmanDX1800全自动化学发光仪测定AFP、CEA水平的可比性研究

目的探讨雅培i2000SR和BeckmanDXl800全自动化学发光仪检测甲胎蛋白（AFP）和癌胚抗原（CEA）结果的可比性、偏倚评估及临床可接受程度。方法根据美国临床实验室标准化委员会（NCCLS）EP9-A2文件的要求，收集40例患者不同浓度的新鲜血清，分别在两台仪器上进行AFP、CEA测定，共得到40组数据。以雅培i2000SR化学发光仪为比较方法，BeckmanDXl800作为实验方法，对检测结果进行方法比对和偏倚评估。结果AFP和CEA两个项目的检验结果在两台仪器上的相关性较好，相关系数r均〉0．99，AFP和CEA在医学决定水平上的预期偏倚均可接受，AFP和CEA在两台化学发光仪上的检测结果具有较好的一致性。结论当同一实验室出现不同仪器检测相同检验项目时，应进行方法比对和偏差评估，以保证检验结果的可比性。     

Extractive spectrophotometric methods for the determination of oxomemazine hydrochloride in bulk and pharmaceutical formulations using bromocresol green, bromocresol purple and bromophenol blue

Three simple, sensitive and accurate spectrophotometric methods have been developed for the determination of oxomemazine hydrochloride in bulk and pharmaceutical formulations. These methods are based on the formation of yellow ion-pair complexes between the examined drug and bromocresol green (BCG), bromocresol purple (BCP), and bromophenol blue (BPB) as sulphophthalein dyes in acetate-HCl buffer of pH 3.6, 3.4, and 4.0, respectively. The formed complexes were extracted with dichloromethane and measured at 405 nm for all three systems. The best conditions of the reactions were studied and optimized. Beer's law was obeyed in the concentration ranges 2.0-12, 2.0-13, and 2.0-14 microg mL(-1) with molar absorptivities of 3.2 x 10(4), 3.7 x 10(4), and 3.1 x 10(4) L mol(-1) cm(-1) for the BCG, BCP, and BPB methods, respectively. Sandell's sensitivity, correlation coefficient, detection and quantification limits are also calculated. The proposed methods have been applied successfully for the analysis of the drug in pure form and in its dosage forms. No interference was observed from common pharmaceutical excipients. Statistical comparison of the results with those obtained by HPLC method shows excellent agreement and indicates no significant difference in accuracy and precision.     

澳甲酚绿比色法测定洗必泰栓的含量

酸性染料与洗必泰生成有色络合物,可以进行比色分析。筛选结果表明:溴甲酚绿优于甲橙。在 pH5.7的条件下,洗必泰与溴甲酚绿形成黄色络合物,溶于氯仿中于410nm 处有最大吸收值。线性范围为2.5—30μg/ml。洗必泰栓剂可以加入乙醇除去基质干扰后测定。方法快速、准确,适于常规分析。     

Spectrophotometric determination of peptic ulcer sulfur-containing drugs in bulk form and in tablets

Two spectrophotometric procedures are suggested for the determination of three irreversible proton pump inhibitors, rabeprazole (RAB), omeprazole (OMP) and pantoprazole (PAN) in pure form and in different pharmaceutical formulations. The first method is based on the oxidation of RAB and PAN with potassium iodate in an acidic medium followed by extracting the liberated iodine with cyclohexane and measurement at λ = 520 nm. Beer's law is valid in the concentration ranges from 10-400 and 5-400 μg ml(-1) for RAB and PAN, respectively. The apparent molar absorptivities of the resulting coloured product were found to be 1.34 × 10(3) and 1.64 × 10(3) l.mol(-1). cm(-1) for RAB and PAN, respectively. The second method is based on the interaction of the basic drugs, OMP, RAB and PAN, in 1,2-dichloroethane with bromophenol blue (BPB), bromocresol green (BCG) and bromocresol purple (BCP) in the same solvent to produce stable coloured ion pairs with maximum absorbance at 385-405 nm. Regression analysis of Beer's plots showed good correlation in the concentration ranges 10-60, 10-60 and 5-40 μg ml(-1) for OMP, 10-150, 10-150 and 10-60 μg ml(-1) for RAB and 10-250, 10-150 and 10-100 μg ml(-1) for PAN with BPB, BCG and BCP reagents, respectively. The limits of detection are 0.46-7.69 μg ml(-1) and limits of quantitation range between 1.52-8.53 μg ml(-1). The optimum assay conditions were investigated and the recovery of the drugs from their dosage forms ranged from 99.33% to 100.5%. Intraday relative standard deviations (RSD) were 0.029-1.397% and the correlation coefficients ranged from 0.9992 to 1. The two methods can be applied successfully for the determination of these drugs in tablets. The results of analysis were validated statistically through recovery studies.     

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。     

CEDIA sirolimus assay compared with HPLC-MS/MS and HPLC-UV in transplant recipient specimens

The role of the therapeutic drug monitoring laboratory in support of immunosuppressant drug therapy is well established, and the introduction of sirolimus (SRL) is a new direction in this field. The lack of an immunoassay for several years has restricted the availability of SRL assay services. The recent availability of a CEDIA SRL assay has the potential to improve this situation. The present communication has compared the CEDIA SRL method with 2 established chromatographic methods, HPLC-UV and HPLC-MS/MS. The CEDIA method, run on a Hitachi 917 analyzer, showed acceptable validation criteria with within-assay precision of 9.1% and 3.3%, and bias of 17.1% and 5.8%, at SRL concentrations of 5.0 microg/L and 20 microg/L, respectively. The corresponding between-run precision values were 11.5% and 3.3% and bias of 7.1% and 2.9% at 5.0 microg/L and 20 microg/L, respectively. The lower limit of quantification was found to be 3.0 microg/L. A series of 96 EDTA whole-blood samples predominantly from renal transplant recipients were assayed by the 3 methods for comparison. It was found that the CEDIA method showed a Deming regression line of CEDIA=1.20xHPLC-MS/MS-0.07 (r=0.934, SEE=.47), with a mean bias of 20.4%. Serial blood samples from 8 patients included in this evaluation showed that the CEDIA method reflected the clinical fluctuations in the chromatographic methods, albeit with the variable bias noted. The CEDIA method on the H917 analyzer is therefore a useful adjunct to SRL dosage individualization in renal transplant recipients.     

EVALUATION OF NONISOTOPIC ALTERNATIVES FOR HORMONE DETERMINATION IN TOXICOLOGY STUDIES

Assessment of the endocrine function in toxicology studies implies hormone determination in a number of animal species. Radioimmunoassay (RIA) constitutes the most widely used methodology for this purpose. RIA, however, presents important disadvantages inherent in the use of radiosotopes. In an attempt to look for nonisotopic alternatives to animal hormone dosage, two commercial, nonisotopic assays for the direct measurement of total human thyroxine concentration were compared with an RIA used routinely in our laboratory. Total thyroxine (T 4) in the miniature pig was the parameter chosen for this comparison study. Several protocols, using identical miniature-pig samples, were used to compare stability, precision, sensitivity, accuracy, and bias. Precision and sensitivity studies determined the useful detection range for RIA, enzyme immunoassay (EIA), and luminescent immunoassay (LIA), which were 0.95-9.50 mug/dL, 2.70-13.00 mug/dL, and 0.45-20 mug/dL, respectively. Matrix-effect studies showed that only LIA was influenced by EDTA plasma, and that the other methods were not sensitive to the different matrix tested. Lot-to-lot differences in the EIA method were significantly greater than those with the other methods. The radioimmunoassay and the automated luminescent technique gave the best results in this evaluation study. The general application of the LIA method in veterinary endocrinology remains dependent on the further development of commercial detection kits.     

生物素亲和素系统在ECP的实验效能

目的:评估生物素亲和素系统检测嗜酸性粒细胞阳离子蛋白(ECP)双抗夹心ELISA试验中的应用。方法:建立直接包被抗体的检测法、先包被生物素的检测法和先包被亲和素的检测法,比较3种方法的灵敏度、不准确度和变异度,并用3种方法检测皮肤病患者和正常对照人群的ECP水平。结果:直接包被抗体的ECP检测法线性范围为2.5~200μg/L,灵敏度为2.75μg/L,不准确度为11.5%;先包被生物素的检测法线性范围为2.5~500μg/L,灵敏度为2.61μg/L,不准确度为10.9%;先包被亲和素的检测法线性范围为2.5~500μg/L,灵敏度2.68μg/L,不准确度为11.9%;3种方法的重复性差异无统计学意义;先包被亲和素的检测法最稳定,直接包被抗体的检测法次之,先包被生物素的检测法最不稳定;3种方法及ADL双抗夹心检测试剂盒检测患者及正常对照者血清ECP水平,差异无统计学意义。结论:生物素亲和素包被可提高实验的灵敏度、线性范围,减少抗体用量,节约抗体包被时间。