国产与进口盐酸氨溴索片的人体生物等效性研究

目的评价国产与进口盐酸氨溴索片的生物等效性。　方法 9名健康男性志愿者随机交叉 ,自身对照口服单剂量国产与进口盐酸氨溴索片各 90mg后 ,进行生物等效性研究。服药间隔为 1周。采用反相高效液相色谱法测定血药浓度并用 3p87程序对试验数据进行处理。　结果国产与进口盐酸氨溴索片的AUC分别为 2 34 0 .42± 44 8.0 4和 2 36 3.5 5± 44 8.86ng·h/ml;Cmax分别为 2 11.76± 70 .71ng/ml和 2 2 6 .5 3± 34 .5 9ng/ml;tmax分别为 2 .2 2± 1.6 5和 1.82± 0 .8h ;t1/ 2ke分别为 6 .0 8± 1.0 2h和 6 .2 7± 0 .6 6h。方差分析表明两种片剂各参数之间无显著性差异 (P >0 .0 5 ) ,双单侧t检验表明二者具有生物等效性。国产片的相对生物利用度为 (99.5 6± 10 .6 5 ) % (以AUC0 -2 4 计算 )。　结论国产与进口盐酸氨溴索片具有生物等效性。     

盐酸西替利嗪片的人体药代动力学研究

目的用进口盐酸西替利嗪片(A)为对照品,评价片剂B的相对生物利用度和生物等效.方法采用随机交叉分组试验设计,1 0名健康成年男性受试者分别口服单剂量20mg测试品和对照品,采用HPLC法测定人血清中药物浓度进行生物等效性的研究.结果对照品和测试品的tmax分别为(1.72 ±0.39)/h和(1.65±0.55)/h,cmax分别为(6.13±121.7)ng/ml和(597±119 .8)n g/ml,AUC0-24分别为(2855.1±528.3)h/(ng.ml)和(3016.4±702.8)h/(ng.ml), t1/2分别为(11.5±2.7)h和(12.0±2.9)h;片剂B相对A的平均生物利用度为(100.2±7. 4)%.结论测试片剂B与对照片剂A具生物等效性.     

盐酸西替利嗪片的人体药代动力学研究

目的　用进口盐酸西替利嗪片 ( A)为对照品 ,评价片剂 B的相对生物利用度和生物等效。方法　 采用随机交叉分组试验设计 ,1 0名健康成年男性受试者分别口服单剂量 2 0 mg测试品和对照品 ,采用HPLC法测定人血清中药物浓度进行生物等效性的研究。结果　对照品和测试品的 tmax分别为 ( 1 .72±0 .39) /h和 ( 1 .65± 0 .5 5 ) /h,cmax分别为 ( 6.1 3± 1 2 1 .7) ng/ml和 ( 5 97± 1 1 9.8) ng/ml,AUC0 - 2 4分别为( 2 85 5 .1± 5 2 8.3) h/( ng.ml)和 ( 30 1 6.4± 70 2 .8) h/( ng.ml) ,t1 /2分别为 ( 1 1 .5± 2 .7) h和 ( 1 2 .0± 2 .9) h;片剂 B相对 A的平均生物利用度为 ( 1 0 0 .2± 7.4) %。结论　测试片剂 B与对照片剂 A具生物等效性     

国产与进口盐酸氨溴索片的人体生物等效性研究

目的评价国产与进口盐酸氨溴索片的生物等效性.方法9名健康男性志愿者随机交叉,自身对照口服单剂量国产与进口盐酸氨溴索片各90mg后,进行生物等效性研究.服药间隔为1周.采用反相高效液相色谱法测定血药浓度并用3p87程序对试验数据进行处理.结果国产与进口盐酸氨溴索片的AUC分别为2340.42±448.04和2363.55±448.86ng@h/ml;Cmax分别为211.76±70.71ng/ml和226.53±34.59ng/ml;tmax分别为2.22±1.65和1.82±0.8h;t1/2ke分别为6.08±1.02h和6.27±0.66h.方差分析表明两种片剂各参数之间无显著性差异(P＞0.05),双单侧t检验表明二者具有生物等效性.国产片的相对生物利用度为(99.56±10.65)%(以AUC0-24计算).结论国产与进口盐酸氨溴索片具有生物等效性.     

阿奇霉素片的相对生物利用度和生物等效性

目的:考察阿奇霉素片人体相对生物利用度及生物等效性。方法:22名健康男性志愿者,采用交叉给药方案,分别单剂量口服20mg受试阿奇霉素片和参比阿奇霉素片,用液相色谱-串联质谱法测定血浆中阿奇霉素浓度,进行人体相对生物利用度和生物等效性评价。结果:单次口服20mg受试阿奇霉素片和参比阿奇霉素片后,达峰时间Tmax分别为(2.0±1.4)h和(1.8±0.6)h;峰值血药浓度Cmax分别为(584.27±258.93)ng/ml和(523.27±186.53)ng/ml;t1/2分别为(47.64±10.38)h和(51.96±12.49)h;药时曲线下面积采用梯形法计算,AUC0→t分别为(3532.26±1311.69)和(3500.10±1229.70)ng.h/ml,AUC0→∞分别为(3986.30±1443.53)ng.h/ml和(4015.14±1426.56)ng.h/ml。结论:国产阿奇霉素片的相对生物利用度为(104.3±27.8%),主要参数的双单侧t检验,结果显示两种制剂为生物等效制剂。     

罗红霉素氨溴索分散片在健康人体的药代动力学

目的:建立同时测定人血浆中罗红霉素和盐酸氨溴索的液相色谱-串联质谱联用法(LC-MS/MS),研究健康受试者口服罗红霉素盐酸氨溴索分散片(每片含罗红霉素150 mg?盐酸氨溴索30 mg)后的人体药代动力学?方法:12名健康受试者单剂量口服罗红霉素盐酸氨溴索分散片后72 h内间隔取血,用LC-MS/MS测定血浆样品药时过程,用DAS数据处理软件计算主要药代动力学参数?结果:罗红霉素的主要药动学参数Cmax,Tmax,t1/2z,MRT,AUC0-τ,CLz/F和Vz/F分别为(6.99±1.55)μg/ml,(2.04±0.94)h,(13.30±2.56)h,(14.31±2.51)h,(84.56±26.20)h·μg/ml,(1.88± 0.51)L/h和(35.06±8.68)L;盐酸氨溴索的分别为(53.91±22.41)ng/ml,(1.96±0.66)h,(8.24±2.01)h,(7.96±0.47)h,(447.98.±138.95)h·ng/ml,(61.85±14.79)L/h和(724.42±214.86)L?结论:血浆样品中罗红霉素和盐酸氨溴索同时测定LC-MS/MS法专属性强,灵敏度适宜?适用于罗红霉素盐酸氨溴索分散片药代动力学研究?     

法莫替丁散剂和片剂的药代动力学及其生物等效性评价

目的:比较法莫替丁（famotidine,Fam）散剂和片剂的生物利用度和药代动力学。方法：10例健康志愿者分别单剂口服Fam散剂或片剂40mg,用反相高效液相色谱法测定血药和尿药浓度。结果：Fam散剂和片剂体内过程均符合开放性一室模型;散剂的相对生物利用度为103％。Fam散剂和片剂的tmax,cmax,t1/2k和AUC分别为(1.91±0.44),(2.54±0.40)h;(99.4±37.6),(87.0±29.5)ng/ml;(3.21±0.67),(2.49±0.56)h;(627±100),(607±177)h.ng/ml。结论：两种剂型的体内吸收和峰浓度无显著性差异(P>0.05),具有生物等效性;达峰时间具有明显的差异(P<0.05)。     

格列吡嗪胶囊的相对生物利用度和生物等效性

目的:考察格列吡嗪胶囊人体相对生物利用度及生物等效性。方法:20名健康男性志愿者,采用交叉给药方案,分别单剂量口服5.0mg受试格列吡嗪胶囊和参比格列吡嗪胶囊,用液相色谱-串联质谱法测定血浆中格列吡嗪浓度,进行人体相对生物利用度和生物等效性评价。结果:单次口服5.0mg受试格列吡嗪胶囊和参比格列吡嗪胶囊后,达峰时间(Tmax)分别为(2.1±0.5)h和(2.2±1.1)h;峰值血药浓度(Cmax)分别为(298.95±105.66)ng/ml和±281.55±68.84)ng/ml;半衰期(t1/2)分别为(4.14±1.33)h和(3.80±1.28)h;药时曲线下面积采用梯形法计算,AUC0-t分别为(1565.89±659.41)ng·h/ml和(1580.13±465.43)ng·h/ml,AUC0-∞分别为(1649.53±704.58)ng·h/ml和(1644.15±478.92)ng·h/ml。结论:受试格列吡嗪胶囊的相对生物利用度为(98.3±19.3)%,主要参数的双、单侧t检验,结果显示两种制剂为生物等效制剂。     

尼莫地平片剂的人体生物利用度研究

目的 :研究尼莫地平片剂在健康人体内的药代动力学及相对生物利用度。方法 :8名健康男性志愿者随机自身交叉单剂量口服尼莫地平和尼莫通120mg后 ,采用高效液相色谱法测定血浆中尼莫地平的浓度。结果 :两药均符合口服一级吸收一房室开放模型 ,尼莫地平和尼莫通主要药动学参数 :Tmax分别为(0.90±0.28)h和(1.07±0.16)h,Cmax分别为(61.5±32.0)ng/ml和(39.7±10.1)ng/ml,AUC分别为(151.7±61.2)ng·h/ml和160.7±59.3ng·h/ml。各参数间均无显著性差异 (P>0.05)。结论 :尼莫地平对尼莫通的相对生物利用度为(93.77 %±11.62) %,经统计学分析后认为两药体内生物等效性相同。     

盐酸曲马多泡腾颗粒的人体生物等效性研究

目的:研究两种盐酸曲马多制剂的人体相对生物利用度,评价其生物等效性。方法:18名健康男性志愿者按照两制剂两周期的随机交叉试验设计,分别单剂量口服参比制剂(盐酸曲马多片)和受试制剂(盐酸曲马多泡腾颗粒),剂量均为100mg,采用液相色谱-荧光检测法测定人血清中曲马多的浓度,用DAS软件计算各药代动力学参数并进行生物等效性统计分析。结果:参比制剂和受试制剂的主要药动学参数:Cmax分别为(353±84)ng/ml和(365±67)ng/ml;tmax分别为(1.8±0.7)h和(2.0±0.4)h;AUC0-36h分别为(2975±829)ng.ml-1.h-1和(3362±1145)ng.ml-1.h-1;AUC0-∞分别为(3217±926)ng.ml-1.h-1和(3709±1298)ng.ml-1.h-1;t1/2分别为(7.2±1.9)h和(7.6±1.6)h。两制剂的Cmaxt、max、AUC0-36h和AUC0-∞均无显著性差异,双单侧t检验结果表明受试制剂Cmax的90%置信区间落在在参比制剂的70%~143%范围内,受试制剂AUC的90%置信区间均落在在参比制剂的80%~125%范围内,受试制剂的相对生物利用度为(113.1±23.2)%。结论:两制剂具有生物等效性。     

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.