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。     

利巴韦林片在健康人体的药动学及生物等效性

目的研究利巴韦林片在健康人体的药代动力学特征及其相对生物等效性。方法24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,分别单剂量口服2种利巴韦林片,采用液相色谱-串联质谱法测定受试者服药后72h内血浆中利巴韦林的浓度。结果受试品和参比品利巴韦林主要的药代动力学参数Tmax分别为3.55±3.06、2.84±2.89h,Cmax分别为:214.12±89.21、223.89±116.83μg·L-1;AUC(0-72h)为5252.63±1896.66、5239.36±2708.07μg·h·L-1,受试品的相对生物利用度为110.5%。结论2种利巴韦林制剂在健康志愿者体内具有生物等效性。     

国产盐酸西替利嗪胶囊的人体药代动力学及相对生物利用度

目的 :研究国产盐酸西替利嗪胶囊的人体药代动力学和相对生物利用度。方法 :选择 2 1名男性健康志愿者 ,采用反相高效液相色谱法 ,以紫外 2 2 9nm为检测波长 ,测定了单剂量 (2 0mg)口服国产盐酸西替利嗪胶囊和进口盐酸西替利嗪片在人体内的西替利嗪浓度。结果 :盐酸西替利嗪的体内动态过程呈一级吸收的二房室开放模型 ,国产胶囊和进口片的Cmax分别为 (678 81± 10 4 5 9)和 (661 5 2± 12 0 64 ) 1ng·ml-1,Tmax分别为 (1 15± 0 5 3 )和 (1 0 9± 0 3 8)h ,t1/ 2 β分别为 (7 64±2 73 )和 (9 40± 5 2 3 )h ,MRT分别为 (7 2 6± 0 5 8)和 (7 3 6± 0 44 )h ,AUC0→ 2 5分别为 (460 1 2 4± 73 9 11)和 (4840 46±93 7 0 9)ng .h .ml 1,AUC0→∞ 分别为 (5 12 9 5 9± 776 2 1)和 (5 43 2 78± 10 2 3 99)ng .h .ml 1。结论 :国产盐酸西替利嗪胶囊的相对生物利用度为 (96 3 2± 12 0 5 ) % ;选择AUC、Cmax进行方差分析和双单侧t检验 ,结果表明国产胶囊和进口片两种制剂具有生物等效性     

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。     

氯雷他定胶囊和片剂的药动学及相对生物利用度

目的　研究氯雷他定胶囊与片剂的人体药动学和生物等效性。方法　选择 2 0名健康男性志愿者 ,随机交叉口服单剂量 (4 0mg)氯雷他定胶囊或片剂两种制剂 ,采用HPLC法测定血清中氯雷他定的浓度。结果　口服氯雷他定胶囊及片剂的Cmax分别为 (34.5± 1 5 .1 )ng·ml-1 和 (33.7± 1 5 .6 )ng·ml-1 ;Tmax　分别为 (1 .2± 0 .4 )h和 (1 .3± 0 .4 )h ;T1 / 2 β　分别为 (4 .3± 1 .2 )h和 (4 .5± 1 .4 )h ;AUC0 -2 4分别为 (99.1± 4 0 .2 )ng·h·ml-1 和 (99.6± 4 3.9)ng·h·ml-1 ;AUC0 -∞ 分别为 (1 0 4 .0± 39.2 )ng·h·ml-1 和 (1 0 5 .1± 4 3.4 )ng·h·ml-1 ;氯雷他定胶囊对片剂的相对生物利度为 (98.9± 31 .7) %。结论　氯雷他定胶囊和片剂具有生物等效性     

富马酸比索洛尔片剂人体药代动力学及相对生物利用度

目的　比较国产与进口富马酸比索洛尔片剂的人体药代动力学及两药的相对生物利用度。方法　受试者自身交叉口服同等剂量的国产与进口富马酸比索洛尔片剂 ,HPLC内标定量方法测定血药浓度 ,3P87计算机程序处理药代数据。结果　两种片剂的体内过程均符合一级吸收二室模型 ,国产片剂的主要药代动力学参数 T1/ 2α、T1/ 2 β、Cmax、Tmax和AUC0 -36分别为 1.32h、7.42h、49.6 0ng·ml-1、2 .5 4h和 489.49ng·ml-1·h-1;进口片剂的主要药代动力学参数T1/ 2α、T1/ 2 β、Cmax、Tmax和AUC0 -36分别为 1.31h、7.94h、48.5 3ng·ml-1、2 .5 7h和 5 2 0 .82ng·ml-1·h-1。结论　相对生物利用度为 95 .31%。经统计学分析两种片剂具有生物等效性     

国产复方氨酚氢可酮片人体生物等效性研究

目的:评价国产与进口复方氨酚氢可酮片的生物等效性.方法:20名健康男性志愿者随机交叉单剂量口服国产或进口复方氨酚氢可酮片2片,采用高效液相色谱-紫外法和高效液相-质谱-质谱法分别测定血浆中对乙酰氨基酚和重酒石酸氢可酮的浓度.结果:国产与进口复方氨酚氢可酮片剂中对乙酰氨基酚的Cmax分别为(15.18±4.14)和(15.35±5.24)mg/L,Tmax分别为(0.56±0.35)和(0.57±0.41)h,t1/2分别为(2.21±0.56)和(2.32±0.82)h;AUC0-tn分别为(37.07±7.44)和(36.55±9.38)mg·L-1·h,AUC0-∞分别为(39.51±7.58)和(39.59±9.73)mg·L-1·h,国产制剂的相对生物利用度为(107.72±34.94)%.国产与进口复方氨酚氢可酮片剂中重酒石酸氢可酮的Cmax分别为(30.24±7.11)和(27.89±6.26)μg/L,Tmax分别为(0.90±0.40)和(1.03±0.56)h,t1/2分别为(6.05±0.75)和(6.35±1.19)h,AUC0-tn分别为(189.39±40.39)和(183.19±48.74)μg·L-1·h,AUC0-∞分别为(201.81±44.88)和(197.43±53.83)μg·L-1·h,国产制剂的相对生物利用度为(105.74±17.27)%.结论:国产复方氨酚氢可酮片与进口复方氨酚氢可酮片具有生物等效性.     

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     

法莫替丁口溶片的人体药代动力学及相对生物利用度研究

目的　比较法莫替丁口溶片和普通市售片的人体内药代动力学及相对生物利用度。方法　 8名健康志愿者单剂量口含法莫替丁口溶片和口服法莫替丁普通市售片后 ,用高效液相色谱法测定血药浓度 ,进行口溶片与普通市售片的药代动力学和生物利用度研究。结果　两剂型血药浓度有显著差异 ,口溶片为 :AUC =(115 9.2 4± 391.49)ng·h·ml-1,Cmax　 =(2 13.97±78.90 )ng·ml-1,Tmax　 =(1.5 0± 0 .36 )h ,市售片的药动学参数为 :AUC =(719.5 3± 379.17)ng·ml-1,Cmax　 =(131.78± 6 7.5 3)ng·ml-1,Tmax　 =(2 .75± 0 .37)h ,口溶片与普通片的AUC的差异有统计学意义 (P <0 .0 1) ,相对生物利用度为 16 1.11%。结论　该研究制备的口溶片能显著提高法莫替丁的生物利用度     

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。     

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.     

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.     

Do Balance Board Training Programs Reduce the Risk of Ankle Sprains in Athletes?

Introduction Ankle sprains are the most common musculo-skeletal injury that occurs in athletes,particularly in sports that require jumping and landing on one foot such as soccer,and basketball(1-4).These injuries often result in significant time loss from participation,long-term disability,and have a major impact on health care costs and resources(5-8).     

High Intensity Interval Training:New Insights

KEY POINTS ·High-intensity interval training(HIT)is characterized by repeated sessions of relatively brief，intermittent exercise.often performed with an“a11 out”effort or at an intensity close to that which elicits peak oxygen uptake(i.e.，≥90%of VO2 peak).     

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.     

Developmental validation of the PowerPlex(®) ESI 16 and PowerPlex(®) ESI 17 Systems: STR multiplexes for the new European standard

In response to the ENFSI and EDNAP groups’ call for new STR multiplexes for Europe, Promega^® developed a suite of four new DNA profiling kits. This paper describes the developmental validation study performed on the PowerPlex^® ESI 16 (European Standard Investigator 16) and the PowerPlex^® ESI 17 Systems. The PowerPlex^® ESI 16 System combines the 11 loci compatible with the UK National DNA Database^®, contained within the AmpFlSTR^® SGM Plus^® PCR Amplification Kit, with five additional loci: D2S441, D10S1248, D22S1045, D1S1656 and D12S391. The multiplex was designed to reduce the amplicon size of the loci found in the AmpFlSTR^® SGM Plus^® kit. This design facilitates increased robustness and amplification success for the loci used in the national DNA databases created in many countries, when analyzing degraded DNA samples. The PowerPlex^® ESI 17 System amplifies the same loci as the PowerPlex^® ESI 16 System, but with the addition of a primer pair for the SE33 locus. Tests were designed to address the developmental validation guidelines issued by the Scientific Working Group on DNA Analysis Methods (SWGDAM), and those of the DNA Advisory Board (DAB). Samples processed include DNA mixtures, PCR reactions spiked with inhibitors, a sensitivity series, and 306 United Kingdom donor samples to determine concordance with data generated with the AmpFlSTR^® SGM Plus^® kit. Allele frequencies from 242 white Caucasian samples collected in the United Kingdom are also presented. The PowerPlex^® ESI 16 and ESI 17 Systems are robust and sensitive tools, suitable for the analysis of forensic DNA samples. Full profiles were routinely observed with 62.5 pg of a fully heterozygous single source DNA template. This high level of sensitivity was found to impact on mixture analyses, where 54–86% of unique minor contributor alleles were routinely observed in a 1:19 mixture ratio. Improved sensitivity combined with the robustness afforded by smaller amplicons has substantially improved the quantity of data obtained from degraded samples, and the improved chemistry confers exceptional tolerance to high levels of laboratory prepared inhibitors.     

Bronchial stump fistula :treatment with covered retrievable hinged metallic stents-preliminary clinical experience

Objective To evaluate the preliminaily clinical efficacy and retrievability of a retrievable hinged covered metallic stent in the treatment of the bronchial stump fistula （BSF）. Methods Between April 2003 and March 2005, 8 patients with bronchial stump fistula after pneumonectomy or lobectomy were treated with two types （A and B） of retrievable hinged covered metallic stents. Type A stent was placed in 6 patients and type B in 2 under fluoroscopic guidance. The stent was removed with a retrieval set when BSF was healed or complications occurred. Results Stent placement in the bronchial tree was technically successful in all patients, without procedure-related complications. Immediate closure of the BSF was achieved in all patients after the procedure. Stents were removed from all patients but one. Removal of the stents was difficult in two patients due to tissue hyperplasia. Patients were followed up for 6 - 21 months. Placement of the stents remained stable in all patients except one due to severe cough. Permanent closure of BSF was achieved in 7 （87.5%） of 8 patients. Conclusion Use of a retrievable hinged covered expandable metallic stent is a simple, safe, and effective procedure for closure of the BSF. Retrieval of the stent seems to be feasible. （J Intervent Radiol, 2007, 16： 253-257）     

Prevalence and severity of hip and groin pain in sub‐elite male football: a cross‐sectional cohort study of 695 players

The purpose of this study was twofold: (a) to investigate the prevalence of hip and groin pain in sub‐elite male adult football in Denmark and (b) to explore the association between prevalence and duration of hip and groin pain in the previous season with the Copenhagen Hip and Groin Outcome Score (HAGOS) in the beginning of the new season. In total 695 respondents from 40 teams (Division 1–4) were included. Players completed in the beginning of the new season (July–Sept 2011) a self‐reported paper questionnaire on hip and/or groin pain during the previous season and HAGOS. In total 49% (95% CI: 45–52%) reported hip and/or groin pain during the previous season. Of these, 31% (95% CI: 26–36%) reported pain for >6 weeks. Players with the longest duration of pain during the previous season had the lowest HAGOS scores, when assessed at the beginning of the new season, P < 0.001. This study documents that half of sub‐elite male adult football players report pain in the hip and/or groin during a football season. The football players with the longest duration of pain in previous season displayed the lowest HAGOS scores in the beginning of the new season.