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1.
目的评估4种脂肪酶(Lipase,LPS)检测系统的分析性能。方法方法学评价研究。应用美国临床和实验室标准化协会(CLSI)EP5-A2、EP15-A2、EP7-A2、EP6-A、EP9-A2方法验证4种脂肪酶检测系统的精密度、正确度、抗干扰性、分析测量范围(AMR)、相关及偏差。采用美国病理学家协会(CAP)发放的室间质评物(C-A和C-B)验证不同系统检测LPS正确度。回归分析采用Passing-Bablok检验,回归线性检测采用Cusum方法,相关分析采用Pearson检验,偏差分析应用Bland-Altman曲线。结果 LPS在25-240U/L时,4种检测系统的批内CV均TEa的1/4(9.47%),批间CV均TEa的1/3(12.63%)。正确度验证测定美国CAP室间质评物显示仅A、C系统较为理想,其95%验证区间包含了指定均值,且符合生物学变异设定的总允许误差(TEa:37.88%);回收试验显示除B系统高回收标本外,其它系统均未超出±10%。抗干扰性评估显示Hb≥5g/L时,对B、C系统低水平有10%的正干扰,在15g/L时,对D系统低水平有10%的正干扰;Bil≤600μmol/L时对4种系统均无明显干扰现象;TG≥8mmol/L时,对A、C系统均有10%的负干扰。4种系统AMR上限分别为341、494、529、379U/L。相关分析以选取上述性能较为理想的C系统为参考对象,A、B、D与C系统比较相关性较好,r均0.975(P0.01),Bland-Altman偏差分析显示平均绝对偏差分别为-9.7、-21.7、-21.1U/L,平均相对偏差分别为-10.12%、-11.96%、-13.51%,计算医学决定水平(Xc)时的预期偏差显示在Xc=60U/L时,A、B、D系统均符合生物学变异设定的1/3总允许误差(12.63%),在Xc=180U/L时,B、D系统的允许偏差不在预期偏差的可信区间内且小于可信区间下限,证实B、D系统在Xc=180U/L时与C系统的性能不相当,结果可比性差,不可接受。结论 4种检测系统的性能之间存在差异。  相似文献   

2.
目的探讨并比较常规方法检测血清总胆红素(T-Bil)的正确度的评价方法。方法参照CLSI EP15-A2文件,用常规方法测定有证参考物质、国际参考实验室室间比对计划(RELA)样本、卫生部临床检验中心室间质评样本T-Bil水平,用BioRad Unity实验室室间质评数据分析本实验室与对等组和方法组间的偏移及标准差指数(SDI),与参考方法比对等方案评估常规测量T-Bil的正确度。结果 NIST SRM 909b参考物质、2010~2011年RELA样本、2012年卫生部临检中心第1次室间质评样本测定结果均在可接受范围内。2012年1~6月Unity实验室间质评数据结果偏移及SDI指数均满足要求。与参考方法比对结果相关性好(Y=1.129 9X-5.734 3,r=0.999 8),小于300μmol/L时,偏移可接受;大于300μmol/L时,偏移较大(10%~13%),不可接受。用去离子水稀释5倍使其浓度约达到50~100μmol/L后重测,偏移可接受,满足临床需要。结论 "单点浓度"的正确度评价具有局限性,临床实验室应分析全测量范围内的正确度情况,与参考方法比对是实现常规测量正确度评价的有效方法之一。  相似文献   

3.
目的对速率法测定血浆谷氨酸脱氢酶(GLDH)活性进行方法学评价,以确定其分析性能是否符合临床实验室应用的要求。方法由ADVIA 2400全自动化分析仪和武汉生之源生物科技股份有限公司的GLDH检测试剂组成检测系统,参照CLSI提供的临床检验方法学评价方案EP5-A2、EP 6-A、EP7-A2、EP15-A分别对该检测系统的精密度、线性范围、干扰、正确度等性能进行评价。结果该检测系统的高、低2个GLDH水平的批内CV分别为3.09%和4.88%,总精密度CV分别为3.83%和5.74%;浓度在2.9~155.4U/L的范围内样本,测定结果为线性;干扰物血红蛋白(Hb)=2g/L;三酰甘油(TG)=5.6mmol/L;总胆红素(TB)=342μmol/L;维生素C(Vc)=6g/L时,干扰相对偏差从-1.81%到4.82%不等,对检测结果无明显干扰;正确度验证时偏差≤10.59%。开瓶后30d内试剂吸光度值无明显变化,试剂稳定性良好。结论该GLDH试剂盒的精密度、分析范围、分析特异性、正确度、试剂稳定性等重要指标与试剂盒声明性能指标一致,可以满足临床检测需要。  相似文献   

4.
目的利用美国临床实验室标准化委员会(NCCLS)EP9-A2和EP15-A指南对同系列的不同型号的2台全自动生化分析仪进行正确度验证并对不同评价方案进行比较。方法根据NCCLS EP9-A2文件标准,每天选取患者样本8份,浓度尽可能分布于分析检测范围(AMR)的高、中、低内,分别在日本东芝TBA-40FR和日本东芝TBA-120FR上测定钙(Ca)、磷(P)、天门冬氨酸氨基转移酶、乳酸脱氢酶、肌酸激酶、肌酸激酶同工酶、α-羟丁酸脱氢酶(α-HBDH)5种心肌酶谱和Ca、P,不连续测定5d,对结果进行相关分析。根据EP9-A2直线方程计算在某医学决定水平处的预期偏倚和预期偏倚的95%可信区间,并判断偏倚是否可以接受。依据EP15-A标准计算两种方法间的平均偏倚和偏倚的标准差,并判断偏倚或百分比偏倚是否小于厂家声明的偏倚或百分比偏倚。结果除α-HBDH在医学决定水平145U/L处偏倚不可接受,其余各指标测定结果预期偏倚均在要求范围内;应用EP15-A文件时无法查到厂家声明的偏倚或百分比偏倚,不能进行偏倚比较。结论同一实验室同一检测项目存在两种以上检测系统时,应进行方法学比对和偏差评估,判断其临床可接受性,以保证检验结果的可比性;EP15-A简便实用,但在难以获得厂家声明偏倚时,进行正确度的评价应按照EP9-A2文件进行。  相似文献   

5.
目的评价免疫透射比浊法检测尿清蛋白(Alb)的性能,探讨尿Alb/肌酐(Cr)比值(ACR)联合估算肾小球滤过率(e GFR)在2型糖尿病(T2DM)患者肾损伤评价中的诊断价值。方法对免疫透射比浊法检测尿Alb的精密度、正确度、分析测量范围(AMR)、检测限、参考区间进行验证,并分析其与免疫散射比浊法的相关性和偏差。选取220例T2DM住院患者,检测尿Alb、尿Cr、血Cr,计算ACR和e GFR并进行分析。结果尿Alb在11.11~298.76 mg/L范围内批内、批间不精密度均小于厂家声明的标准。正确度验证显示两种诊断系统尿Alb校准品测定结果符合验证要求;CAP室间质评物(U-A、U-B)、校准验证/线性评价物(LN20-B)结果符合CAP校准验证/线性评价误差界限所规定的标准,相对偏倚小于基于生物学变异设定质量规范中的适当允许偏倚(<16.4%)。AMR验证显示尿Alb在5.08~347.93 mg/L范围内线性良好。方法学比对显示透射比浊法与散射比浊法检测尿Alb结果相关性较好,平均绝对偏差为8.6 mg/L,平均相对偏差为14.52%,在医学决定水平处的预期偏差在可接受范围内。220例T2DM患者按照正常Alb、微量Alb、大量Alb尿分组,分别有10.9%、45.7%、66.7%的患者e GFR<60m L·min-1·1.73 m-2;在e GFR≥90 m L·min-1·1.73 m-2的患者中,15.7%有微量Alb尿,7.1%有大量Alb尿。结论免疫透射比浊法检测尿Alb的各项性能指标基本满足实验室要求,联合应用ACR和e GFR有助于评估T2DM患者肾脏损伤状况。  相似文献   

6.
目的探讨宁波美康公司生产的血清铁检测试剂盒和美国Beckman Coulter公司生产的血清铁检测试剂盒的性能差异。方法依据美国临床和实验室标准协会(CLSI)标准文件EP15-A2对血清铁检测试剂盒进行精密度和正确度评价;依据EP6-A文件进行线性范围评价;依据EP9-A2文件进行方法学比较。结果宁波美康公司试剂盒:高、低浓度的批内不精密度(CV)分别为1.56%和1.51%,总不精密度分别为1.83%和2.19%;原卫生部临床检验中心2份室间质评物的检测结果与靶值比较,相对偏倚分别为-4.67%和-5.83%,线性良好(r=0.999 9)。Beckman Coulter公司试剂盒:高、低浓度的批内不精密度分别为0.89%和1.55%,总不精密度分别为2.26%和2.25%;原卫生部临床检验中心2份室间质评物的检测结果与靶值比较,相对偏倚分别为-3.11%和-3.33%,线性良好(r=0.999 9)。结论两种血清铁检测试剂盒的性能指标均能满足临床检测需求,国产的宁波美康血清铁试剂盒与原装试剂盒检测结果具有相关性良好,国产试剂盒可以在临床上得到更广泛地应用。  相似文献   

7.
目的评价稀释凝血酶时间(d TT)试验用于检测血浆达比加群水平的性能,观察其是否能满足临床实验室检测需求。方法参考美国临床和实验室标准化协会(CLSI)EP15-A2、EP6-A、EP7-A及C-24文件对d TT试验检测血浆达比加群水平的精密度、正确度、分析测量范围、携带污染率、抗生物干扰进行评价,并观察血浆样品的稳定性。结果 d TT试验检测血浆达比加群水平的日内、日间变异系数(CV)均符合厂家声明的CV;3个水平美国病理学家协会(CAP)能力验证计划物质达比加群浓度与靶值的相对偏差均10%;在30.92~249.13 ng/m L范围内d TT试验检测达比加群水平结果呈线性分布;携带污染率为-0.84%;Hb≤3 g/L、三酰甘油≤873 mg/d L、肝素≤2.2 IU/m L、FDP≤29 mg/L对d TT试验检测达比加群水平无影响;血浆样品在常温保存不宜超过4 h,4℃不宜超过4 d,-20℃不宜超过1个月,-80℃条件下可以存放半年。结论 d TT试验检测达比加群浓度的精密度、正确度、分析测量范围、携带污染率、抗生物干扰能力基本符合实验室要求。血浆样品稳定性满足临床要求。  相似文献   

8.
王萌  刘明  郭健 《临床检验杂志》2013,31(6):401-405
目的对肌氨酸氧化酶法检测尿肌氨酸进行方法学性能评价,初步估计尿肌氨酸的生物参考值。方法参考CLSI EP5-A2、EP17-A、EP6-A、C28-A3等文件,评价肌氨酸氧化酶法检测尿肌氨酸的重复性、空白限(limits of blank,LoB)、检测限(limitsof detection,LoD)、定量限(limits of quantitation,LoQ)、线性范围、回收率和生物参考值。结果肌氨酸氧化酶法检测2.0μmol/L肌氨酸溶液、2.9μmol/L新鲜尿液样本,总不精密度均14.0%;肌氨酸氧化酶法检测5.0、10.0μmol/L肌氨酸溶液及6.4、9.8μmol/L新鲜尿液样本,总不精密度均10.0%。肌氨酸氧化酶法检测尿肌氨酸的LoB约为0.35μmol/L;肌氨酸溶液的LoD、LoQ分别为1.1、1.9μmol/L,新鲜尿样本分别为1.2、2.0μmol/L;线性范围为2.0~125.6μmol/L;回收率为65.3%~90.5%。健康人群尿肌氨酸的生物参考值为0.01~0.06μmol/g肌酐。结论肌氨酸氧化酶方法检测尿肌氨酸的精密度、检测限、线性范围等可满足临床实验室的要求,但仍需在校准品基质方面有所改进以提高准确度。  相似文献   

9.
目的对AU2700全自动生化仪检测钾(K)、丙氨酸氨基转移酶(ALT)、肌酐(CREA)的主要分析性能进行验证。方法参照美国临床和实验室标准化委员会(NCCLS)及美国临床和实验室标准协会(CLSI)的评价方案(EP15-A2、EP6-A、EP7-A2)和卫生行业标准(WS/T 403-2012)的要求对K、ALT、CREA的精密度、正确度、线性范围、干扰现象及参考区间进行性能验证。结果 K、ALT和CREA批内精密度(Sr)均小于厂家声明的批内精密度,批内变异系数(CV)小于1/4Tea;室内精密度(Sl)均小于厂家声明的室内精密度,室内CV小于1/3Tea;正确度良好,所有同组实验室均值均落于置信区间内;线性回归方程的斜率在0.999~1.014,R2均≥0.95;K、ALT、CREA的临床可报告范围分别为1~80mmol/L、1~6 000U/L、8.84~212 160μmol/L;干扰物[总胆红素(TBIL)、三酰甘油(TG)、血红蛋白(Hb)]对K、ALT、CREA的检测均无明显干扰,但Hb≥5g/L对K有干扰;这3项指标的参考区间验证结果均在该实验室引用的参考区间内。结论 AU2700全自动生化仪对K、ALT及CREA的检测性能达到要求,能满足临床需要。  相似文献   

10.
目的评价常规检测系统测定血清碱性磷酸酶(ALP)的正确度。方法以国际临床化学联合会(IFCC)参考方法和两种常规检测系统(简称A法、B法)同时测定20份新鲜单人份血清样品。按美国临床实验室标准化协会(CLSI)EP9-A2文件评价两种常规检测系统测定结果的正确度,并用改良Bland-Altman图形分析法进行验证,评价常规检测系统与参考方法测定结果的一致性,综合判断常规检测系统的测定结果。按CLSI EP14-A2文件评价A、B两种方法校准品的基质效应。结果 A法、B法与IFCC参考方法测定结果的直线回归方程分别为YA=0.982 9XIFCC+0.010 8,YB=0.938 3XIFCC+0.012 9,平均偏倚分别为-1.1%、-5.5%。A法和B法检测结果的相关方程为YB=0.955 2XA+0.001 36,R2=0.997 6。A法和B法的校准品均存在基质效应,其中A法校准品的基质效应更明显。结论 A法与IFCC参考方法正确度性能一致,B法与IFCC参考方法正确度性能不一致。  相似文献   

11.
This is a new method for the determination of creatine kinase isoenzyme MB activity in serum. The method uses direct activity measurement of creatine kinase B subunit activity after blocking of CK-M subunit activity by inhibiting antibodies. The test takes no longer than 15 min. The method yields an intra-serial C.V. of 2.0-12.9%, and a C.V. from day to day of 5.5%. The detection limit is 3.4 U/l creatine kinase MB. In the 95 cases with proven myocardial infarction several types of creatine kinase MB activity kinetics could be determined. The percentage of creatine kinase MB of peak CK-total is 6-25%, with a mean of 11.1%. The amount of creatine kinase MB with respect to total CK activity after reinfarction is higher than the amount after initial infarction.  相似文献   

12.
Ranganath C  Heller AS  Wilding EL 《NeuroImage》2007,35(4):1663-1673
Although substantial evidence suggests that the prefrontal cortex (PFC) implements processes that are critical for accurate episodic memory judgments, the specific roles of different PFC subregions remain unclear. Here, we used event-related functional magnetic resonance imaging to distinguish between prefrontal activity related to operations that (1) influence processing of retrieval cues based on current task demands, or (2) are involved in monitoring the outputs of retrieval. Fourteen participants studied auditory words spoken by a male or female speaker and completed memory tests in which the stimuli were unstudied foil words and studied words spoken by either the same speaker at study, or the alternate speaker. On "general" test trials, participants were to determine whether each word was studied, regardless of the voice of the speaker, whereas on "specific" test trials, participants were to additionally distinguish between studied words that were spoken in the same voice or a different voice at study. Thus, on specific test trials, participants were explicitly required to attend to voice information in order to evaluate each test item. Anterior (right BA 10), dorsolateral prefrontal (right BA 46), and inferior frontal (bilateral BA 47/12) regions were more active during specific than during general trials. Activation in anterior and dorsolateral PFC was enhanced during specific test trials even in response to unstudied items, suggesting that activation in these regions was related to the differential processing of retrieval cues in the two tasks. In contrast, differences between specific and general test trials in inferior frontal regions (bilateral BA 47/12) were seen only for studied items, suggesting a role for these regions in post-retrieval monitoring processes. Results from this study are consistent with the idea that different PFC subregions implement distinct, but complementary processes that collectively support accurate episodic memory judgments.  相似文献   

13.
目的 探讨俯卧位通气对高海拔地区肺复张术(RM)治疗无效急性呼吸窘迫综合征(ARDS)患者的治疗作用.方法 从海拔2260m的地区医院筛选RM治疗无效的41例ARDS患者[平均氧合指数( PaO2/FiO2)较RM前升高<20%视为RM无效],依不同病因分为肺内源性ARDS组(ARDSp组)和肺外源性ARDS组(ARDSexp组),每组再按信封法随机分为俯卧位组和仰卧位组,即ARDSp俯卧位组(11例)、ARDSp仰卧位组(9例)、ARDSexp俯卧位组(10例)、ARDSexp仰卧位组(11例).在通气前及通气1、2、3、4h监测动脉血氧分压( PaO2)、PaO2/FiO2、静态顺应性(Cst)、气道阻力(Raw)的变化.结果 通气lh时,ARDSexp俯卧位组PaO2/FiO2( mm Hg,l mm Hg=0.133 kPa)即较通气前显著升高(157.4±40.6比129.3±48.7,P<0.05),并随通气时间延长呈持续增高趋势,4h达峰值(219.1 ±41.1);且ARDSexp俯卧位组通气3h内PaO2/FiO2较其他3组显著增高,另3组间则差异无统计学意义.ARDSp俯卧位组、ARDSexp俯卧位组通气4h时PaO2/FiO2均较相应仰卧位组显著增高(208.8±39.7比127.4±47.1,219.1±41.1比124.9±50.8,均P<0.05).4组通气前后Cst无显著改变,各组间差异也无统计学意义.ARDSp俯卧位组通气4h时Raw(cmH2O·L-1·s-1)较通气前显著降低(6.8±1.7比10.7±1.8,P<0.05),且明显低于其他3组;其他3组各时间点Raw组内及组间比较差异均无统计学意义.结论 俯卧位通气作为ARDS机械通气重要策略之一,可以改善RM无效高原ARDS患者的氧合,为抢救患者赢得宝贵的时间.  相似文献   

14.
The Department of Veterans Affairs (VA) in the USA operates a network of 172 medical centres which all utilize a hospital information system (HIS) which has been developed and is currently maintained by the VA. During the past several years, an image management and communication module has been developed, installed and clinically utilized at the Washington DC and Maryland VA Medical Centres. This image management and communication system, referred to as the decentralized hospital computer program (DHCP) imaging system, is fully integrated with a commercial picture archiving and communication system (PACS). The system is utilized to capture, archive, and display all images generated within the hospital including radiology, nuclear medicine, pathology, endoscopy, bronchoscopy, and dermatology, intraoperative photographs, ECG data, and a limited number of paper documents. The ultimate goal of the project is to have all patient text and image data available at any clinical workstation to any authorized user anywhere within the network of medical centres. Clinical requirements for an imaging workstation include ease of use, rapid and reliable access to the complete set of patient information, and images which are of acceptable quality to meet the requirements of the user and the subspecialty. Patient confidentiality and data security must be safeguarded at all times. Integration of the images with the remainder of the patient's database was found to be critical to the success of the project. The experience at the Washington and Maryland facilities suggests that an imaging system that is successfully integrated with a hospital information system can provide substantial clinical and economic benefits both within and among medical centres. Clinical acceptance and utilization of the system has been excellent, particularly in diagnostic radiology where DHCP Imaging has been interfaced to a commercial PAC system. Based upon this initial experience, the VA has begun to deploy the system throughout its large network of medical centres.  相似文献   

15.
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17.
Myocardial elastography is a novel method for noninvasively assessing regional myocardial function, with the advantages of high spatial and temporal resolution and high signal-to-noise ratio (SNR). In this paper, in-vivo experiments were performed in anesthetized normal and infarcted mice (one day after left anterior descending coronary artery [LAD] ligation) using a high-resolution (30 MHz) ultrasound system (Vevo 770, VisualSonics Inc., Toronto, ON, Canada). Radiofrequency (RF) signals of the left ventricle (LV) in longitudinal (long-axis) view and the associated electrocardiogram (ECG) were simultaneously acquired. Using a retrospective ECG gating technique, 2-D full field-of-view RF frames were acquired at an extremely high frame rate (8 kHz) that resulted in high-quality incremental displacement and strain estimation of the myocardium. The incremental results were further accumulated to obtain the cumulative displacements and strains. Two-dimensional and M-mode displacement images and strain images (elastograms), as well as displacement and strain profiles as a function of time, were compared between normal and infarcted mice. Incremental results clearly depicted cardiac events including LV contraction, LV relaxation and isovolumetric phases in both normal and infarcted mice, and also evidently indicated reduced motion and deformation in the infarcted myocardium. The elastograms indicated that the infarcted regions underwent thinning during systole rather than thickening, as in the normal case. The cumulative elastograms were found to have higher elastographic SNR (SNR(e)) than the incremental elastograms (e.g., 10.6 vs. 4.7 in a normal myocardium, and 6.0 vs. 2.4 in an infarcted myocardium). Finally, preliminary statistical results from nine normal (m = 9) and seven infarcted (n = 7) mice indicated the capability of the cumulative strain in differentiating infracted from normal myocardia. In conclusion, myocardial elastography could provide regional strain information at simultaneously high temporal (>/=0.125 ms) and spatial ( approximately 55 microm) resolution as well as high precision ( approximately 0.05 microm displacement). This technique was thus capable of accurately characterizing normal myocardial function throughout an entire cardiac cycle, at the same high resolution, and detecting and localizing myocardial infarction in vivo.  相似文献   

18.
Objective: To identify patterns of nonfatal and fatal penetrating trauma among children and adults in New Mexico using ED and medical examiner data.
Methods: The authors retrospectively sampled in 5-year intervals all victims of penetrating trauma who presented to either the state Level-1 trauma center or the state medical examiner from a 16-year period (1978–1993). Rates of nonfatal and fatal firearm and stabbing injury were compared for children and adults.
Results: Rates of nonfatal injury were similar (firearm, 34.3 per 100,000 person-years; stabbing, 35.1). However, rates of fatal injury were significantly different (firearm, 21.9; stabbing, 2.7; relative risk: 8.2; 95% confidence interval: 5.4, 12.5). From 1978 to 1993, nonfatal injury rates increased for children (p = 0.0043) and adults (p < 0.0001), while fatal penetrating injury remained constant. The increase in nonfatal injury in children resulted from increased firearm injury rates. In adults, both stabbing and firearm nonfatal injury rates increased.
Conclusions: Nonfatal injury data suggest that nonfatal violence has increased; fatal injury data suggest that violent death rates have remained constant. Injury patterns vary by age, mechanism of trauma, and data source. These results suggest that ED and medical examiner data differ and that both are needed to guide injury prevention programs.  相似文献   

19.
Delineating the Concept of Hope   总被引:2,自引:0,他引:2  
  相似文献   

20.
目的 探讨手转胎头术失败的原因与分娩结局.方法 选择2008年1月至2010年12月于我院住院分娩的持续性枕横位、枕后位产妇198例,根据行手转胎头术后结果分为成功组126例、失败组72例.比较两组分娩结局,对比分析失败原因.结果 失败组胎儿体质量≥3500 g的发生率[76.4%(55/72)]明显高于成功组[31.7%(40/126)],差异有统计学意义(x2=30.177,P=0.001)、失败组宫缩乏力发生率[58.3%(42/72)]高于成功组[38.1% (48/126)],差异有统计学意义(x2=7.569,P=0.006)、失败组骨盆临界或轻度狭窄发生率[38.9% (28/72)]高于成功组[23.8%(30/126)],差异有统计学意义(x2 =5.030,P=0.002)、失败组手转胎头时机不当(宫口开大<6 cm、胎头位于坐骨棘上及宫口开大8~10 cm、胎头位于坐骨棘下≥2 cm)发生率[61.1%(44/72)]高于成功组[38.9%(49/126)],差异有统计学意义(x2=9.084,P=0.003).失败组母儿并发症(产后出血、产褥病率、胎儿窘迫、新生儿窒息)发生率高于成功组(x2 =9.586,P=0.002、x2=9.334,P=0.002、x2=5.910,P=0.015、x2=5.240,P=0.022)、失败组剖宫产发生率[72.2%(52/72)]明显高于成功组[34.1 %(43/126),x2=26.641,P=0.001)].结论 手转胎头术能使难产变顺产,降低剖宫产率,减少母儿并发症,但须积极预防、处理导致手转胎头术失败的原因,对矫正失败后继续矫正及试产应慎重.  相似文献   

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