阿托伐他汀钙胶囊的人体生物等效性研究

目的评价国产阿托伐他汀钙胶囊与进口阿托伐汀钙片剂(立普妥片)的生物等效性。方法22名男性健康志愿者,采用随机、单剂量、自身交叉对照试验设计,空腹口服国产阿托伐他汀钙胶囊和立普妥片20mg,分别于服药前及服药后各时间点采集血样,用LC/MS/MS法测定血浆中阿托伐他汀的浓度,并计算Cmax、Tmax、T1/2、AUC(0-t)、AUC(0-∞)等相关参数,利用方差分析及双单侧t检验判断2种制剂是否具有生物等效性。结果口服阿托伐他汀钙受试及参比制剂后,血浆中阿托伐他汀的Cmax分别为7.98±3.25、8.47±3.36μg·L-1;Tmax分别为1.37±0.64、1.20±1.01h;T1/2分别为10.64±3.21、10.01±1.81h;AUC(0-t)分别为52.70±13.79、51.83±17.52μg·L-1·h;AUC(0-∞)分别为55.45±14.66、54.09±17.79μg·L-1·h;2组参数均无统计学差异(P>0.05);受试制剂的相对生物利用度为(106.0±23.8)%。结论国产阿托伐他汀钙胶囊与进口立普妥片剂具有生物等效性。     

甲钴胺血清浓度的测定及生物等效性研究

目的　建立血清中甲钴胺的血药浓度测定方法 ,比较国产甲钴胺胶囊和进口甲钴胺片在健康人体内的相对生物等效性。方法　 2 4名男性健康志愿者以标准二阶段交叉设计自身对照试验法 ,分别口服单剂量二种甲钴胺制剂 ,采用微粒子酶免法测定受试者服药后 72h内血清中甲钴胺的浓度。结果　国产和进口甲钴胺主要的药代动力学参数 Tmax　分别为 3.15± 0 .95、3.10± 0 .88h ,Cmax　、AUC(0 -72h) 分别为 :310± 10 6、2 70± 98ng·L-1;5 5 88± 170 6、5 4 0 8± 182 8ng·h-1·L-1,药动学参数间均无统计学差异 (P >0 .0 5 ) ,国产胶囊对进口片剂的相对生物利用度为 10 5 .3%。结论　二种甲钴胺制剂在健康志愿者体内具有生物等效性。     

国产盐酸曲他维林片的动力学和生物等效性研究

目的　观察国产盐酸曲他维林片的生物等效性。方法　 2 0名健康男性志愿者 ,双周期随机交叉口服单剂量 80mg国产和进口盐酸曲他维林片 ,用高效液相紫外检测法测定血浆中曲他维林的浓度。结果　单剂量口服国产盐酸曲他维林片剂和进口盐酸曲他维林片剂后 ,曲他维林的药时曲线下面积AUC的均值分别为 2 2 4 9.82± 6 2 2 .4 3、2 32 8.6 1± 72 3.0 7h·μg·L-1,峰值浓度Cmax　的均值分别为 4 6 9.39± 10 9.92、4 93.6 3± 16 0 .78μg·L-1。结论　双单侧检验表明 ,国产盐酸曲他维林片和进口盐酸曲他维林片AUC、Cmax　均具有生物等效性     

阿奇霉素干混悬剂在健康人体的药代动力学及生物等效性评价

目的研究阿奇霉素干混悬剂在健康人体的药代动力学特征及其生物等效性。方法20名健康志愿受试者,采用标准二阶段交叉设计自身对照试验方法,单剂量口服阿奇霉素试验品和参比品500mg时,以液相色谱-质谱-质谱联用法测定服药后72h内不同时刻的血药浓度,计算主要药动学参数,并采用方差分析和双单侧t检验(1-2α)90%置信区间进行生物等效性评价。结果受试者分别口服阿奇霉素受试品和参比品后,其主要药动学参数Tmax分别为2.30±0.55、2.25±0.53h,Cmax分别为478.4±133.9、562.6±132.9ng.ml-1,T1/2分别为30.1±8.3、32.4±9.4h;用梯形法计算,AUC0-t分别为4 263±1 341、4511±918ng.h.ml-1,AUC0-∞分别为5 233±2 0735、426±1 011ng.h.ml-1。AUC0-t计算,阿奇霉素的相对生物利用度平均为(95.2±21.5)%。结论两种阿奇霉素制剂在健康志愿者体内具有生物等效性。     

阿莫西林克拉维酸钾复合制剂生物等效性研究

目的　进行国产阿莫西林克拉维酸钾分散片生物等效性研究。方法　 18名健康男性志愿者交叉口服受试和参比制剂 6 2 5mg(其中阿莫西林 5 0 0mg ,克拉维酸钾 12 5mg) ,采用微生物学方法测定血浆中药物浓度。结果　受试及参比制剂的主要药动学参数分别为 :阿莫西林 Tmax　分别为 1.0 5 6± 0 .2 73、1.2 4 1± 0 .396h ,C max　分别为 5 .36 9± 1.12 4、5 .2 13± 0 .90 3μg·ml-1,AUC0 -6分别为 10 .36 9± 1.776、10 .36 2± 1.370 μg·h·ml-1,T1/2ke　　分别为 1.0 83± 0 .16 6、1.10 1± 0 .2 12h。克拉维酸钾Tmax　分别为1.0 84± 0 .2 92、1.2 87± 0 .2 84h ,Cmax　分别为 2 .796± 0 .878、2 .74 2± 0 .892 μg·ml-1,AUC0 -6分别为 6 .6 18± 2 .15 9、6 .793± 2 .2 74 μg·h·ml-1,T1/2ke　　分别为 1.2 0 7± 0 .16 5、1.2 6 1± 0 .2 0 1h。结论　经统计分析结果显示两制剂为生物等效制剂     

多潘立酮片人体药代动力学和生物等效性

目的研究多潘立酮片(湖南威特)在健康人体内的相对生物利用度和生物等效性,为新药报批及其临床应用提供依据。方法18名健康受试者采用随机双交叉试验方法,单剂量口服受试及参比制剂20 mg,用HPLC法测定给药后不同时间的血药浓度,计算主要药代动力学参数。结果受试制剂多潘立酮片(湖南威特)的T1/2:(9.31±1.60)h、Cmax:(27.2±2.5)μg/L、Tmax:(0.76±0.20)h、AUC0-t:(142.5±24.4)μg.h/L;参比制剂多潘立酮片(西安杨森)T1/2:(8.72±1.39)h、Cmax:(28.1±3.9)μg/L、Tmax:(0.78±0.21)h、AUC0-t:(140.9±27.3)μg.h/L。以AUC0-t计算,与参比制剂相比受试制剂中多潘立酮的平均相对生物利用度为(101.6%±5.1%)。结论两制剂生物等效。     

黄杨宁分散片人体生物利用度和生物等效性研究

目的:在中国健康成年男性志愿者中比较研究黄杨宁分散片与黄杨宁片的相对生物利用度,评价二者的生物等效性.方法:20名健康男性志愿者随机交叉单剂量口服黄杨宁分散片与黄杨宁片3 mg,采用高效液相-质谱-质谱法分别测定血浆中环维黄杨星D的浓度,计算其药代动力学参数,评价这两种制剂的生物等效性.结果:受试制剂及参比制剂环维黄杨星D的Cmax分别为(90.17±45.19)和(99.95±50.06) ng/L,Tmax分别为(5.3±4.1)和(4.9±3.9) h,t1/2分别为(51.45±33.40)和(39.70±20.59) h;AUC0-tn分别为(3 625.79±1 619.20)和(3 608.21±1 320.07) ng·L-1·h,AUC0-∞分别为(4 459.28±1 965.11)和(4 113.58±1 560.08)ng·L-1·h,试验制剂黄杨宁分散片的相对生物利用度F0-tn, F0-∞分别为(102.03±22.79 )%, (109.94±28.08 )%.统计学分析显示,药代动力学参数AUC、Cmax、Tmax等的差异无显著性.结论:受试制剂和参比制剂具有生物等效性.     

快速崩解阿莫西林片的人体相对生物利用度研究

8名男性健康志愿者交叉单剂量一次口服被试制剂和参比制剂阿莫西林 5 0 0mg ,用微生物法测定其血药浓度 ,用 3P87程序进行拟合计算药代动力学参数 ,NDST程序对AUC、Tmax、Cmax和T1/2 的实测值进行生物等效性检验。其结果分别为 :AUC(2 1.39± 3.81) μg/ (ml·h)和 (19.2 4± 4.2 2 ) μg/ (ml·h) ;Tmax(1.94± 0 .73)h和 (1.94± 0 .72 )h ;Cmax(7.5 9± 1.70 ) μg/ml和 (7.2 1± 1.94) μg/ml;T1/2 (1.47± 0 .45 )h和 (1.31± 0 .18)h。其主要动力学参数经配对t检验差异无显著性意义 (P >0 .0 5 )。说明受试与参比制剂具有完全生物等效性 ,生物利用度为 (113.0± 17.2 ) %     

马来酸依那普利片的人体生物等效性研究

目的考察两种马来酸依那普利片的相对生物利用度,评价两者的生物等效性。方法采用双周期自身随机交叉试验设计。20名健康男性志愿者单剂量口服受试制剂或参比制剂,血药浓度采用高效液相色谱-串联质谱测定。结果受试制剂及参比制剂马来酸依那普利实测平均血药峰浓度Cmax分别为（32.74±9.01）、（35.48±11.44）μg.L-1;实测平均达峰时间Tmax分别为（0.76±0.17）、（0.87±0.17）h;受试制剂及参比制剂t1/2分别为（2.52±2.95）、（3.10±5.79）h;AUC（0-48h）平均值分别为（59.22±20.46）、（64.43±23.42）mg·h·L-1;AUC（0-∞）平均值分别为（60.01±20.39）、（65.09±23.43）mg·h·L-1;以AUC计算,受试制剂的相对生物利用度为（97.8±34.1）%。结论受试制剂和参比制剂具有生物等效性。     

头孢拉定胶囊人体药代动力学和生物等效性

目的研究头孢拉定胶囊在健康人体内的相对生物利用度和生物等效性,为新药报批及其临床应用提供依据。方法20名健康受试者随机双交叉试验方法,单剂量口服受试及参比制剂500 mg,用HPLC法测定给药后不同时间的血药浓度,计算主要药代动力学参数。结果口服头孢拉定胶囊受试制剂和参比制剂后的主要药动学参数:T1/2分别为0.841±0.165和0.842±0.213 h;Cm ax分别为(15.922±2.584)和(15.922±2.584)mg/L;Tm ax分别为(1.225±0.197)和(1.225±0.242)h;AUC0-t分别为(25.399±5.806)和(26.159±5.989)mg/(L.h)。以AUC0-t计算,与参比制剂相比受试制剂中头孢拉定的平均相对生物利用度为(97.4±7.0)%。结论两制剂生物等效。     

Knee injury and Osteoarthritis Outcome Score (KOOS) - validation of a Swedish version

The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self-administered instrument measuring outcome after knee injury at impairment, disability, and handicap level in five subscales. Reliability, validity, and responsiveness of a Swedish version was assessed in 142 patients who underwent arthroscopy because of injury to the menisci, anterior cruciate ligament, or cartilage of the knee. The clinimetric properties were found to be good and comparable to the American version of the KOOS. Comparison to the Short Form-36 and the Lysholm knee scoring scale revealed expected correlations and construct validity. Item by item, symptoms and functional limitations were compared between diagnostic groups. High responsiveness was found three months after arthroscopic partial meniscectomy for all subscales but Activities of Daily Living.     

Endovascular management of carotid-cavernous fistulas

Objective To investigate endovascular treatment of traumatic direct carotid-cavernous fistulas （CCF） and their complications such as pseudoaneurysms. Methods： Over a five-year period, 22 patients with traumatic direct CCFs were treated endovascularly in our institution. Thirteen patients were treated once with the result of CCF occluded, 8 twice and 1 three times. Treatment modalities included balloon occlusion of the CCF, sacrifice of the ipsilateral internal carotid artery with detachable balloon, coll embolization of the cavernous sinus and secondary pseudoaneurysms, and covered-stem management of the pseudoaneurysms. Results All the direct CCFs were successfully managed endovascularly. Four patients developed a pseudoaneurysm after the occlusion of the CCF with an incidence of pseudoaneurysm formation of 18.2% （4/22）. A total number of 8 patients experienced permanent occlusion of the ICA with a rate of ICA occlusion reaching 36.4% （8/22）. Followed up through telephone consultation from 6 months to 5 years, all did well with no recurrence of CCF symptoms and signs. Conclusion Traumatic direct CCFs can be successfully managed with endovascular means. The pseudoaneurysms secondary to the occlusion of the CCFs can be occluded with stent-assisted coiling and implantation of covered stents.     

The role of interventional radiology in trauma

Introduction Interventional Radiology has evolved into a specialty having enormous input into the care of the traumatized patient.In all hospitals,regardless of size,the Interventional Radiologist must consider their relationships with the trauma service in order to     

Diagnóstico ecográfico del neumotórax

The ultrasonographic diagnosis of pneumothorax is based on the analysis of artifacts. It is possible to confirm or rule out pneumothorax by combining the following signs: lung sliding, the A and B lines, and the lung point. One fundamental advantage of lung ultrasonography is its easy access in any critical situation, especially in patients in the intensive care unit. For this reason, chest ultrasonography can be used as an alternative to plain-film X-rays and computed tomography in critical patients and in patients with normal plain films in whom pneumothorax is strongly suspected, as well as to evaluate the extent of the pneumothorax and monitor its evolution.     

Carbohydrate Supplementation during Exercise: Does It Help? How Much is Too Much?

KEY POINTS· Carbohydrate intake during exercise can delay the onset of fatigue and improve performance of prolonged exercise as well as exercise of shorter duration and greater intensity (e.g., continuous exercise lasting about 1h and intermittent high-intensity exercise), but the mechanisms by which performance is improved are different.     

The acutely limping child

Acute limping may be the result of multiple pathologies in children. The differential diagnosis varies based on the age of the child. Irrespective of age, the initial imaging work-up includes AP and frog leg radiographs of the pelvis and ultrasound; MRI may sometimes be helpful. In children less than 3 years, infections and trauma are most frequent. MRI is the imaging modality of choice when osteomyelitis is clinically suspected. Between the ages of 3 and 10 years, transient synovitis of the hip and Legg-Calvé-Perthes disease are main considerations but infection, inflammation and focal bony lesions are also considered. In children over 10 years, slipped capital femoral epiphysis also is considered.