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Three leading and competitive commercial products of paracetamol tablets coded as brands A, B and C (A, being the innovator product) in the country were evaluated for their in vitro properties and in vivo comparative bioavailability. The studies included chemical equivalence, hardness, disintegration time, dissolution rate and systemic availability among eight healthy volunteers. The disintegration times were 2.1 min for brand A, 5.7 min for brand B and 36.2 min for brand C. The dissolution rate (T70) were 33.0 min, 74.5 min and 56.5 min for brands A, B and C, respectively. While brand A passed all the in vitro tests as specified in the official monograph, brand B failed only the dissolution rate test and brand C failed both the disintegration and dissolution tests. These significant differences observed among the products after in vitro tests were not reflected in the in vivo availability. While the absorption rate (indicated by tmax) of brand C was significantly faster (i.e. shorter) than those of Brands A and B, the extent of absorption (indicated by AUC) was comparable among the three brands. The relative bioavailabilities (with respect to brand A) were 92 and 91% for brands B and C, respectively indicating that the products were bioequivalent. Comparison of the in vitro and in vivo data suggest that the systemic absorption of paracetamol may not be dissolution--rate limited and that using in vitro dissolution rate studies alone to establish bioequivalency of paracetamol tablets should be done with caution. 相似文献
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RN Shain JM Piper ER Newton ST Perdue R Ramos JD Champion FA Guerra 《Canadian Metallurgical Quarterly》1999,340(2):93-100
Using annual bite-wing radiographs, the incidence and progression of approximal caries (4d-7m) were assessed longitudinally in teenagers and adolescents whose treatment had been based on remineralizing rather than restorative strategies. A closed cohort of 536 children initially was followed from 11 to 22 years of age. The scoring system was: 0 = no visible radiolucency; 1-2 = radiolucency in the enamel up to the enamel-dentin border; 3 = radiolucency with a broken enamel-dentin border but with no obvious progression in the dentin; 4 = radiolucency with obvious spread in the outer half of the dentin, and 5 = radiolucency in the inner half of the dentin. Caries rates were estimated as the number of new lesions/100 tooth surface-years, and the Kaplan-Meier estimate was used to calculate the cumulative survival time of each approximal surface. Three events were used: the transitions from states 0 to 2, 2 to 4 and 3 to 4. The results showed a considerable variation between the surfaces in both caries rates and survival time. For all surfaces combined, the median caries rate from state 0 to 2 was 3.9 new lesions/100 tooth surface-years; from state 2 to 4, the rate was 5.4, and from state 3 to 4 it was 20.3. Of the sound surfaces (state 0), 75% survived 6.3 years without reaching state 2. Given state 2, 75% survived 4.8 years without reaching the outer half of the dentin (state 4), while given a lesion at the enamel-dentin border (state 3), 75% survived 1.3 years without doing the same. The median survival time of lesions from state 3 to 4 was 3.1 years. The group with DMFSappr>1 at the age of 11-12 years had a risk of new approximal enamel lesions (state 0-2) that was 2.5 times greater than that of the group with DMFSappr = 0-1. 相似文献
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SA Gould EE Moore FA Moore JB Haenel JM Burch H Sehgal L Sehgal R DeWoskin GS Moss 《Canadian Metallurgical Quarterly》1997,43(2):325-31; discussion 331-2
We have previously documented the safety of 1 unit (50 gram) of human polymerized hemoglobin (Poly SFH-P) in healthy volunteers. This report describes the first patient trial to assess the therapeutic benefit of Poly SFH-P in acute blood loss. Thirty-nine patients received 1 (n = 14), 2 (n = 2), 3 (n = 15), or 6 (n = 8) units of Poly SFH-P instead of red cells as part of their blood replacement after trauma and urgent surgery. There were no safety issues related to the infusion of Poly SFH-P. The plasma hemoglobin concentration ([Hb]) after the infusion of 6 units (300 gram) of Poly SFH-P was 4.8 +/- 0.8 g/dL (mean +/- SD). Although the red cell [Hb] fell to 2.9 +/- 1.2 g/dL, the total [Hb] was maintained at 7.5 +/- 1.2 g/dL. Poly SFH-P maintained total [Hb], despite the marked fall in red cell [Hb] due to blood loss. The utilization of O2 (extraction ratio) was 27 +/- 16% from the red cells and 37 +/- 13% from the Poly SFH-P. Twenty-three patients (59%) avoided allogeneic transfusions during the first 24 hours after blood loss. Poly SFH-P effectively loads and unloads O2 and maintains total hemoglobin in lieu of red cells after acute blood loss, thereby reducing allogeneic transfusions. Poly SFH-P seems to be a clinically useful blood substitute. 相似文献
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FA Ventura 《Canadian Metallurgical Quarterly》1996,9(7-9):241-245
The increased incidence of Imported Tropical Diseases in Portugal is correlated to a recent higher standard of living, influence of media and a consequent expansion of tourism, and above all to the close relationship existing between Portugal and Africa. The number and pathology (parasitic diarrhoeas, protozoal and helminthic infections) of in-patients with Tropical Diseases at the Unidade de Doen?as Infecciosas, Parasitárias e de Medicina Tropical (UDIP-MT) were described, with special emphasis on Malaria (155 in-patients during the period from 1989 to 1993) and on Sleeping Sickness, where Eflornitin (DFMO) was for the first time used in Portugal. Finally, the impact of HIV epidemic on incidence and different clinical presentations of parasitic and other tropical pathology was also evaluated. 相似文献
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FA Manning N Bondaji CR Harman O Casiro S Menticoglou I Morrison DJ Berck 《Canadian Metallurgical Quarterly》1998,178(4):696-706
OBJECTIVE: The intent of this comparative clinical study was fourfold: (1) to determine the incidence of cerebral palsy in a large obstetric population, (2) to compare the incidence of cerebral palsy in patients at high risk referred for and managed according to the fetal biophysical profile score result with the incidence among unreferred and untested patients, (3) to determine the relationship, if any, between the last fetal biophysical profile score and the incidence of cerebral palsy, and (4) to categorize cases of cerebral palsy according to the clinical parameters and the probable time and nature of the damaging insult. STUDY DESIGN: In this retrospective 5-year comparative study (1987 to 1991) the incidence of cerebral palsy was determined by analysis of International Classification of Diseases, Ninth Revision, -coded related medical services. The clinical records were then sought and reviewed in index cases and obstetric, neonatal, and postnatal clinical data were abstracted. Cross-correlation with partial registries was done to confirm completeness of capture of index cases. The population of referred high-risk patients who received serial fetal biophysical profile scoring and were managed according to test results was determined by review of a prospective computer-stored database and by review of patient log books. The population of untested patients was calculated as the residual of total cases minus tested cases. The rate of cerebral palsy for all patients and for the tested and untested population was calculated and compared. The tested and untested perinates were compared for birth age, weight, and assigned timing or etiology of cerebral palsy. In the tested population the distribution of test results by last recorded biophysical profile score was determined and the relationship between the last test result and cerebral palsy and predictive accuracy parameters of the fetal biophysical profile score were calculated. RESULTS: The incidence of cerebral palsy among the 84,947 live births was 3.68 per 1000 live births (313 cases). The rate of cerebral palsy in the 26,290 referred high-risk tested patients was 1.33 per 1000 (35 cases) compared with a rate of 4.74 per 1000 live births in the 58,657 untested mixed low-risk/high-risk patients (278 cases). These differences were highly significant. A significant declining trend in the annual incidence of cerebral palsy was observed in the total population and the untested population, whereas the rate in the tested population remained relatively constant over the 5-year study interval. The differences in the cerebral palsy rate between the tested and untested population were not related to differences in gestational age, birth weight, or assigned timing or etiology category. In the tested population the relationship between the incidence of cerebral palsy and the last test fetal biophysical profile score was inverse, exponential, and highly significant. CONCLUSIONS: Antepartum assessment by fetal biophysical profile scoring is associated with a significant reduction in the incidence of cerebral palsy compared with untested patients. The relationship between the last test score and the incidence of cerebral palsy is inverse and exponential, suggesting that antenatal asphyxia is an important and potentially avoidable cause of cerebral palsy. 相似文献
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