己酮可可碱缓释胶囊在家兔体内的药动学研究

目的:研究己酮可可碱缓释胶囊在家兔体内的药动学与生物利用度.方法:10只健康家兔随机分为两组,每组5只,单剂量分别给予己酮可可碱肠溶片和缓释胶囊200mg,采用高效液相色谱法测定其血药浓度,比较己酮可可碱肠溶片和缓释胶囊的生物利用度与药动学参数的差异.结果:给药后,血药浓度变化符合一室模型,己酮可可碱肠溶片和缓释胶囊的T1/2分别为(1.608±0.534)h和(4.187±0.617)h;肠溶片的AUC0～∞、Cmax和Tmax分别为(2018.59±161.70)ng/ml/h、383.39ng/ml、1.012h;缓释胶囊的AUC0～∞、Cmax和Tmax分别为(2338.6±241.70)ng/ml/h、177.61ng/ml、3.37h.以肠溶片为参比制剂,缓释胶囊的生物利用度为110.81%.结论:己酮可可碱缓释胶囊在家兔体内表现出较好的缓释特性,其生物利用度明显高于肠溶片.     

格列齐特胶囊人体生物等效性研究

目的 :采用高效液相色谱法测定格列齐特的血药浓度 ,进行两种格列齐特胶囊人体生物等效性比较研究。方法 :12位健康男性受试者采用自身交叉给药方案 ,分别单剂量口服 80mg试验品或对照品。结果 :试验品的主要药代动力学参数分别为AUC0～ 36=(10 0 .19± 10 .34) μg/ (ml·h) ,Cmax=(6 .5 9± 0 .5 9) μg/ml,Tpeak=(4 .33± 1.0 7)h ;对照品的参数分别为AUC0～ 36=(10 3 .41± 9.2 5 ) μg/ (ml·h) ,Cmax=(6 .75± 0 .6 0 ) μg/ml,Tpeak=(4 .5 8± 1.0 8)h ,两制剂的AUC0～ 36、Cmax及Tpeak均无显著性差异。试验品相对于对照品的生物利用度为 (96 .99± 6 .6 2 ) %。结论 :两制剂体内过程相仿 ,具有生物等效性     

尼莫地平在健康人体内的药动学和相对生物利用度

目的 :研究尼莫地平在健康人体内的药动学和相对生物利用度。方法 :8名健康受试者单剂量随机交叉口服尼莫地平标准参比制剂和待测制剂 1 2 0mg,采用HPLC法测定用药后不同时间的血药浓度。结果 :2种制剂的体内过程均符合一房室开放模型 ,AUC分别为 (1 4 3.1± 9.9) μg·h·L-1 和 (1 37.0± 7.3) μg·h·L-1 ,Cmax分别为 (83.1±7.4 ) μg·L-1 和 (80 .8± 4 .6 ) μg·L-1 ,Tmax分别为 (1 .0 0± 0 .0 0 )h和 (1 .0 6± 0 .1 7)h。待测制剂的相对生物利用度为 (96 .0± 5 .9) %。经双向单侧t检验证明 ,2种制剂的AUC、Cmax相比 ,差异均无统计学意义。结论 :2种制剂具有生物等效性。     

格列吡嗪片在健康人体内的药物动力学及相对生物利用度

目的 :研究格列吡嗪片在健康人体的药物动力学及相对生物利用度。方法 :9名健康受试者单剂量随机交叉口服格列吡嗪片参比制剂和被试制剂 5mg ,采用HPLC法测定用药后不同时间的血药浓度。 结果 :2种制剂的体内过程均符合一房室开放模型 ,Tmax分别为 (3 .67± 0 .50 )h和 (3 .33± 0 .50 )h。Cmax分别为 (391± 37) μg·L- 1和 (40 0± 35) μg·L- 1 ,AUC分别为 (2 .46± 0 .39) μg·h·L- 1 和 (2 .2 3± 0 .88) μg·h·L- 1 ,被试制剂的相对生物利用度为 (1 0 2 .9± 1 5 .7) %。结论 :用NDST软件对两种制剂的AUC、Cmax、Tmax进行双单侧t检验 ,证明两种制剂具有生物等效性。     

盐酸氟桂利嗪胶囊人体相对生物利用度研究

目的:研究盐酸氟桂利嗪胶囊在正常人体内的药代动力学与相对生物利用度.方法:采用HPLC法测定18名健康男性志愿者随机自身交叉单剂量po20mg金花盐酸氟桂利嗪胶囊和杨森盐酸氟桂利嗪胶囊后的血药浓度,计算两者的药代动力学参数及相对生物利用度,并以AUC(0～24),Tmax,Cmax为指标,用方差分析、单双侧t检验及(1-2a)置信区间法分析金花胶囊与杨森胶囊的生物等效性.结果:金花与杨森盐酸氟桂利嗪胶囊的药-时曲线符合po吸收一房室模型.AUC(0～24)分别为(391.28±170.77)ng@h/L与(407.18±174.25)ng@h/L;Tmax分别为(2.89±0.44)h与(2.97±0.47)h;Cmax分别为(62.70±21.67)ng/ml与(56.15±15.71)ng/ml;统计学检验结果表明AUC(0～24),Tmax,Cmax均无显著性差异(P＞0.05).结论:金花盐酸氟桂利嗪胶囊对杨森盐酸氟桂利嗪胶囊的相对生物利用度为(96.10±14.07)%,金花与杨森两种盐酸氟桂利嗪胶囊具有生物等效性.     

格列齐特胶囊人体药代动力学及相对生物利用度研究

目的 :对重庆力司特制药有限公司研制的格列齐特胶囊 (LSGL)与陕西丰禾制药有限公司生产的格列齐特胶囊(FHGL)进行人体相对生物等效性研究。方法 :2 0名健康男性志愿受试者随机交叉单剂量口服 80mgLSGL或FHGL ,用高效液相色谱法测定血浆中格列齐特 (GL)浓度 ,经 3P97生物利用度和生物等效性计算程序处理拟合。结果 :LSGL或FHGL体内药时曲线符合一室模型 ,LSGL或FHGL的Cmax分别为 4 .5 0± 0 .83和 4 .5 4± 1.0 4 μg/ml;Tmax分别为 4 .0 5± 0 .89和 4 .0 5± 0 .76h ;AUC(0～T) 分别为 80 .30± 2 6 .87,82 .5 9± 2 6 .2 0 μg·h·ml-1;相对生物利用度为 97.2 3+12 .5 8%。结论 :经方差分析和单双侧t检验 ,表明LSGL或FHGL具有生物等效性。     

LC-MS法评价两种硫普罗宁片的人体生物等效性

目的:建立LC-MS法测定人血中硫普罗宁的药物浓度,并对2种制剂进行生物等效性评价。方法:20例健康受试者单剂量交叉口服400 mg硫普罗宁供试制剂或参比制剂后,采用LC-MS测定人血中不同时间点硫普罗宁的浓度,计算其药代动力学参数和相对生物利用度,评价两制剂的生物等效性。结果:硫普罗宁供试制剂和参比制剂主要药代动力学参数如下:Cmax分别为(2.31±0.64)、(2.33±0.83) μg/ml,AUC0-15分别为(6.70±1.57)、(6.68±1.53) μg·h·ml-1,Tmax分别为(3.1±0.7)、(3.7±0.6) h,t1/2分别为(3.08±0.86)、(2.90±0.84) h。本方法在0.04～10.0 μg/ml浓度范围内线性关系良好。最低定量浓度为0.04 μg/ml,两制剂主要药动学参数经统计学检验无显著性差异。结论:本方法简单、快速、准确,2种制剂具有生物等效性。     

雷贝拉唑在健康志愿者体内的药动学及生物利用度研究

目的:研究健康志愿者单次口服和静脉输注雷贝拉唑20 mg后药动学特征及生物利用度?方法:20名男性健康志愿者,随机分成2组?第1周期分别接受单剂量静脉输注20 mg(输注时间30 min)和单次口服给药(2片,10 mg/片);经7 d清洗期后,2组志愿者接受交叉给药?结果:雷贝拉唑静脉给药后药动学参数如下:t1/2为(62.4 ± 10.7)min,Cmax为(1 308.6 ± 266.4) ng/ml,总清除率为(0.21 ± 0.05)L/min,AUC0-τ和AUC0-∞分别为(99.6 ± 21.9) mg·min/L和 (102.4 ± 23.3) mg·min/L?口服给药后t1/2为(64.2 ± 15.5)min,Cmax为(508.3 ± 180.2) ng/ml,Tmax为229.5 min,Cl为(0.31 ± 0.10)L/min,AUC0-τ和AUC0-∞ 分别为(69.5 ± 20.0) mg·min/L和 (70.6 ± 20.2) mg·min/L?结论:雷贝拉唑在健康志愿者体内的生物利用度为70.1%,雷贝拉唑口服给药的总清除率显著大于静脉给药时的总清除率(P < 0.01)?     

格列吡嗪胶囊人体药动学及相对生物利用度的研究

目的研究格列吡嗪胶囊人体药物代谢动力学及相对生物利用度.方法用HPLC法测定10名受试者单剂量交叉口服5mg格列吡嗪胶囊和片剂后的血药浓度,MC-PKP药动学程序拟合,得药动学参数,计算胶囊剂的相对生物利用度(F).结果胶囊剂的Cmax为(456±60)ng/ml、Tmax为(2.9 5±0.6)h、AUC为(2335±180)h*ng/ml.以上参数经双单侧t检验等统计分析,与片剂比无显著差异.F值为(103±4)%.结论格列吡嗪(2.95±0.6)h血药浓度达高峰,峰浓度为(456±60 )ng/ml.且胶囊与片剂为生物等效制剂.     

口服左旋氧氟沙星在呼吸道感染患者中的药动学研究

目的 :口服左旋氧氟沙星在下呼吸道感染患者中的药代动力学研究。　 方法 :8例肺部感染的住院患者 ,单剂量口服左旋氧氟沙星片 30 0 mg后分别测定不同时间血和尿中左旋氧氟沙星浓度。用高效液相色谱法荧光检测。药时数据用 3p87计算机程序拟合求算药动学参数。　 结果 :单剂量口服 30 0 mg左旋氧氟沙星片后的主要参数为 :Cmax 3.32± 0 .4 1μg/ ml,t1/ 2 5.58± 1.86h,Tmax 2 .17± 0 .69h,AUC0 -∞ 2 3.34± 3.0 9μg/ ( ml· h)。 2 4 h尿中累积排出量 2 4 9.8± 2 4 .2 1mg,占给药剂量的 83.3%。　 结论 :左旋氧氟沙星在呼吸道感染患者中的药代动力学参数与氧氟沙星基本一致     

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.     

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.     

Scientific principles and rigorous processes should be followed in developing clinical guidelines for therapeutic interventions of integrative medicine

A clinical guideline for the therapeutic interventions of integrative medicine may be defined as a written document which states a series of recommendations on therapeutic interventions of integrative medicine for a special disease or condition. The guideline may provide assistance to medical professionals in making clinical decisions aimed at improving the clinical outcome of patients and reducing the costs of medical care（~＇4~. Recommendations issued by a guideline should be based on the best available evidence in both Western and Chinese medicine. For fulfilling this purpose, the development of clinical guidelines for therapeutic interventions in the field of integrative medicine should follow scientific principles and undergo a rigorous processes.