Overview of CDISC standard and implementation in China / 药学学报

CDISC standard has become a set of global data standards that can be used in clinical study, covering the full life cycle of clinical researches. After nearly 20 years of development and continuous version upgrades, CDISC standard can improve the quality and efficiency of clinical research and drug review, and to facilitate all stakeholders involved in researches to exchange the study data and communicate the outcomes. CDISC standard has been or is to be adopted as standard format in data submission by multiple regulatory authorities, and more widely implemented by the global pharmaceutical community. CDISC standard is gradually adopted in China. The feasibility and roadmap of CDISC standard as the Chinese data submission format requirements are undergoing exploration and piloting further.

Relationship of the hair content of rare earth elements in young children aged 0 to 3 years to that in their mothers living in a rare earth mining area of Jiangxi / 中华预防医学杂志

<p><b>OBJECTIVE</b>To study the relationship of hair content of rare earth elements (REEs) in the young children aged 0 - 3 years to that in their mothers living in a rare earth mining area of Jiangxi Province.</p><p><b>METHODS</b>Content of five kinds of REEs, i.e., lanthanum (La), cerium (Ce), praseodymium (Pr), neodymium (Nd) and samarium (Sm) were determined for the hair-root samples collected from 71 young children and 62 of their mothers by inductively coupled plasma source mass spectrometry (ICP-MS).</p><p><b>RESULTS</b>The mean hair content of REEs (e.g., La) was the highest (2,202.90 ng/g) in the young children living in the place nearest to the REE mining area, next (471.72 ng/g) was in those nearer to the REE mining area, and the lowest (97.37 ng/g) was in those in the control area. And, the hair content of REEs in the mothers was the same as that in their children, i.e, the mean content of La was the highest (1,510.21 ng/g) in high-exposure area, next (241.63 ng/g) was that in the low-exposure area, and the lowest (59.15 ng/g) was that in the control area, with P < 0.001. Pair-comparison analysis for the means showed that the average hair level of five kinds of REEs in the young children was two times high as their mothers' (P < 0.001). For example, the hair level of La was 533.83 ng/g in the young children and 279.78 ng/g in their mothers, respectively. Simple linear regression analysis showed that there was a significant correlation between the hair levels of each kind of REEs in the young children and those in their mothers, with a correlation coefficient of more than 0.75, e.g., that of La was 0.878 (P < 0.01).</p><p><b>CONCLUSIONS</b>The hair level of REEs can be used as a bio-marker to reflect body's level of exposure to REEs. The hair level of REEs in young children and their mothers decreased with the increase of the distance from their home to rare earth mining area. Young children living in the area with REEs mining may be the high-exposure population, and their hair level of REEs was significantly higher than that in their mothers and more attention should be paid to them.</p>

Distribution Pattern of Rare Earth Elements in Hair Samples of Young Children Aged 0-3yrs in Rare Earth Ore Area / 环境与健康杂志

Objective To study the distribution pattern of rare earth elements (REEs) in hair of young children. Methods REEs level and distribution pattern in hair of young children aged 0～30 months in RE ore area were studied. All the lanthanide elements were determined with inductively coupled plasma mass spectrometer (ICP_MS) in 20 hair samples of young children aged 0_3yrs, 10 samples from RE ore area and 10 samples as controls from Xunwu county, Jiangxi, China. Results 15 kinds of REEs in each sample were all detected. There were significant differences between higher children's hair REEs levels of RE ore area and those lower levels of control site (P

Relationship Between Dust Storms and Acute Impacts in Baotou City / 环境与健康杂志

Objective To make it clear whether dust storms may produce same acute adverse impacts on community population. Methods 2 primary schools in Baotou City were selected. During the period of dust storm in March of 2004 an investigation among 918 pupils from third to fifth grades and 1 770 parents of them was conducted by questionnaires. Meanwhile the concentrations of PM2.5 were also determined. Results On the day of dust storms developed the concentrations of PM2.5 obviously increased (212.9 ?g/m3)then decreased rapidly(