Safety and efficacy of a new recombinant FVIII formulated with sucrose (rFVIII–FS) in patients with haemophilia A: a long-term, multicentre clinical study in Japan

The recombinant full-length FVIII product Kogenate has been reformulated using sucrose (rFVIII-FS) instead of human serum albumin as a stabiliser in purification and formulation. The in vivo recovery, haemostatic efficacy, and safety of rFVIII-FS were investigated in 20 previously treated patients with severe or moderate haemophilia A for > or = 24 weeks. In vivo recoveries of 73.5 +/- 16.3%, 78.4 +/- 16.1%, and 82.8 +/- 23.9% after the initial infusion of 50 IU kg(-1) rFVIII-FS and at weeks 12 and 24, respectively, showed no significant changes over time. A total of 1115 infusions (mean dose 24.1 +/- 8.4 IU kg(-1)) were included in the analysis of haemostatic efficacy. One (80.5%) or two (8.2%) infusions achieved adequate haemostasis in 88.7% of all bleeding episodes, and haemostatic efficacy was judged 'excellent' or 'good' in 749 of 764 episodes (98.0%). The haemostatic efficacy was judged as 'excellent' or 'good' in 924 of 1115 (82.9%) infusions. Twenty-one adverse events were observed in 12 patients in the total 1541 infusions included in the safety analysis. Causality with respect to rFVIII-FS could not be ruled out in three events in one HIV-negative patient: elevated CD4(%), decreased CD8(%), and elevated CD4/CD8 ratio. No FVIII inhibitor development was observed in any patient. ELISA assay testing for antibodies to rFVIII, baby hamster kidney cell (BHK) protein, and murine IgG were all negative. These results show that rFVIII-FS is a safe and effective for long-term treatment of patients with haemophilia A.     

沙苑子化学成分的研究Ⅱ

A new flavonoid glucosidc-rhamnocitrin-3,4′-O-β-D-diglucoside named complanatuside was isolated from the seeds Astragalus complanatus R. Brown. The elucidation of its structure was based on chemical and spectroscopic data.     

Surgical prosthetic approach to sequelae of a case of noma involving half the face

In this study, the authors discuss a prosthetic rehabilitation case resulting from loss of substance due to Noma. The dental prosthesis is made from tinted acrylic resin with a combination of two means of retention. The lower mean of retention is composed of a hook leaning on a handle which has been attached to that end on a metal armature and the upper mean of retention is connected to the bridge of spectacles.     

Cartography of fluoride in the Ivory Coast (partial study)

The authors report on a study done in the C?te d'Ivoire, about the amount of fluoride in drinking water. The cartography of fluoride shows amounts lower than 0.7 ppm. This small amount of fluoride partially explains the increase in the number of dental caries in the C?te d'Ivoire.     

Risk status at discharge and cause of death for postneonatal infant deaths: a total population study

OBJECTIVES: To obtain population-based, clinical information regarding potentially modifiable factors contributing to death during the postneonatal period (28 to 364 days), we examined all postneonatal infant deaths in four areas of the United States to determine: (1) the cause of death from clinical and autopsy data rather than vital statistics, (2) whether death occurred during initial hospitalization or after discharge, and (3) the portion of postneonatal mortality attributable to infants who left the hospital with identified high-risk medical conditions. DESIGN AND SETTING: Retrospective medical record review of all postneonatal infant deaths with birth weights greater than 500 g (total N = 386) born to mothers residing in: (1) the city of Boston (1984 and 1985, N = 55), (2) the city of St Louis and contiguous areas (1985 and 1986, N = 123), (3) San Diego County (1985, N = 112), and (4) the state of Maine (1984 and 1985, N = 96). Deaths were identified using linked birth and death vital statistics, and medical record audits of infants' and mothers' charts were performed. Causes of death were obtained from medical record review in conjunction with autopsy if performed (72%, N = 278), medical record alone (17%, N = 67), or vital statistics if no other source was available (11%, N = 41). The medical conditions at the time of discharge for each infant were reviewed and, if judged to confer an increased risk of morbidity or mortality, were classified as high risk. RESULTS: The causes of death were sudden infant death syndrome (47%, N = 181), congenital conditions (20%, N = 77), prematurity-related conditions (11%, N = 43), infections (9%, N = 34), external causes (including injuries, drownings, ingestions, and burns) (7%, N = 25), and other (6%, N = 23). In 24% of congenital and 25% to 44% of prematurity-related deaths, infection was the acute or associated cause of death. Infants born to black mothers were more likely than those born to white mothers to die during the postneonatal period of all major causes of death (7.3 per 1000 vs 3.0 per 1000). Overall, 18% (N = 68) of deaths occurred to infants who never left the hospital; 79% (N = 305) of the infants were discharged before death; and discharge status was unknown in 3% (N = 13). Eighty-one percent of all infants with prematurity-related postneonatal deaths were never discharged, and of the total infants who were initially discharged, only 1% (N = 4) subsequently died of prematurity-related causes. Of all postneonatal deaths, only 16% (N = 62) left the hospital with identified high-risk medical conditions. CONCLUSIONS: These findings suggest that the etiology of postneonatal mortality is heterogeneous, with significant complexity in attributing specific causes of death and making designations of "preventability." The vast majority of infants who died of prematurity-related postneonatal causes never left the hospital, and only a small percentage of all infants that left the hospital before death were identified as being at high medical risk. Therefore, strategies for further decreasing postneonatal mortality must link high-risk follow-up programs to more comprehensive strategies that address risk throughout pregnancy and early childhood.     

LTR real‐time PCR for HIV‐1 DNA quantitation in blood cells for early diagnosis in infants born to seropositive mothers treated in HAART area (ANRS CO 01)

HIV‐1 diagnosis in babies born to seropositive mothers is one of the challenges of HIV epidemics in children. A simple, rapid protocol was developed for quantifying HIV‐1 DNA in whole blood samples and was used in the ANRS French pediatric cohort in conditions of prevention of mother‐to‐child transmission. A quantitative HIV‐1 DNA protocol (LTR real‐time PCR) requiring small blood volumes was developed. First, analytical reproducibility was evaluated on 172 samples. Results obtained on blood cell pellets and Ficoll‐Hypaque separated mononuclear cells were compared in 48 adult HIV‐1 samples. Second, the protocol was applied to HIV‐1 diagnosis in infants in parallel with plasma HIV‐RNA quantitation. This prospective study was performed in children born between May 2005 and April 2007 included in the ANRS cohort. The assay showed good reproducibility. The 95% detection cut‐off value was 6 copies/PCR, that is, 40 copies/10⁶ leukocytes. HIV‐DNA levels in whole blood were highly correlated with those obtained after Ficoll‐Hypaque separation (r = 0.900, P < 0.0001). A total of 3,002 specimens from 1,135 infants were tested. The specificity of HIV‐DNA and HIV‐RNA assays was 100%. HIV‐1 infection was diagnosed in nine infants before age 60 days. HIV‐DNA levels were low, underlining the need for sensitive assays when highly active antiretroviral therapy (HAART) has been given. The performances of this HIV‐DNA assay showed that it is adapted to early diagnosis in children. The results were equivalent to those of HIV‐RNA assay. HIV‐DNA may be used even in masked primary infection in newborns whose mothers have received HAART. J. Med. Virol. 81:217–223, 2009. © 2008 Wiley‐Liss, Inc.     

Positioning women's and children's health in African union policy-making: a policy analysis

Background  

With limited time to achieve the Millennium Development Goals, progress towards improving women's and children's health needs to be accelerated. With Africa accounting for over half of the world's maternal and child deaths, the African Union (AU) has a critical role in prioritizing related policies and catalysing required investments and action. In this paper, the authors assess the evolution of African Union policies related to women's and children's health, and analyze how these policies are prioritized and framed.     

The aging face in Black Africans]

The face is the part of the human body that most reflects external marks of time. The change of this region concerns the body support as well as the musculo-cutaneous surface. In this survey, we have described its evolution during the life, in the Black African, particularly on the esthetical plane.     

The identification of a complex A/G/I/J recombinant HIV type 1 virus in various West African countries

In this sequence note we describe the full-length genome sequence of an HIV-1 isolate originating from the west African country of Mali. The phylogenetic tree analysis from the near full-length genome shows that the 95ML84 strain forms a separate cluster, supported by 100% of the bootstrap values, with the previously described A/G/J/? mosaic virus BFP90 from Burkina Faso. Additional analysis showed that throughout the genome the lowest diversity was seen between the 95ML84 and the BFP90 viruses, and bootscan analysis showed a similar complex genomic structure. In addition to the initial report describing the BFP90 virus as an A/G/J/? recombinant, our data show that for the BFP90 and 95ML84 strains the unclassified region corresponds to subtype I. The A/G/I/J BFP90 and 95ML84 strains represent the fifth and most complex circulating recombinant form of HIV-1 detected so far, and our data show its presence in various West African countries. Subtype I and J sequences, initially considered rare, seem to have broadened their geographical spread by way of these recombinant forms.