[Overview of CDISC standard and implementation in China].

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.

[A pilot study for health effects of the sand climate on exposed population in Inner Mongolia of China].

OBJECTIVE: To assess the relationship between sand climate and the health effects of the population. METHODS: 1362 students from 2 primary schools and 2618 adults were investigated in Baotou City by the questionnaires in sand climates. Meanwhile, the concentrations of SO2, , NO2, CO and PM10 were also monitored during the sand climate. RESULTS: The highest incidence rates of the related respiratory diseases and symptoms were found at the day when the sand climates broke out, and lower incidence rates were found after the breakout day. The concentrations of PM10 increased obviously in the sand climates, and then decreased rapidly. A positive relationship was observed between the concentration of PM10 and the incidence rate of cough and acute irritate symptoms in the exposed population. CONCLUSION: (1) The health effects of the sand climates may be acute without delayed action. (2) The concentrations of PM10 increased significantly in sand climates and may be positively associated with the incidence rate of the cough and acute irritate symptoms of the exposed population.

Distribution characteristics of rare earth elements in children's scalp hair from a rare earths mining area in southern China.

In order to demonstrate the validity of using scalp hair rare earth elements (REEs) content as a biomarker of human REEs exposure, data were collected on REEs exposure levels from children aged 11-15 years old and living in an ion-adsorptive type light REEs (LREEs) mining and surrounding areas in southern China. Sixty scalp hair samples were analyzed by ICP-MS for 16 REEs (La Lu, Y and Sc). Sixteen REEs contents in the samples from the mining area (e.g., range: La: 0.14-6.93 microg/g; Nd: 0.09-5.27 microg/g; Gd: 12.2-645.6ng/g; Lu: 0.2-13.3 ng/g; Y: 0.03-1.27 microg/g; Sc: 0.05-0.30 microg/g) were significantly higher than those from the reference area (range: La: 0.04-0.40 microg/g; Nd: 0.04-0.32 microg/g; Gd: 8.3-64.6 ng/g; Lu: 0.4-3.3ng/g; Y: 0.03-0.29 microg/g; Sc: 0.11-0.36 microg/g) and even much higher than those published in the literature. The distribution pattern of REEs in scalp hair from the mining area was very similar to that of REEs in the mine and the atmosphere shrouding that area. In conclusion, the scalp hair REEs contents may indicate not only quantitatively but also qualitatively (distribution pattern) the absorption of REEs from environmental exposure into human body. The children living in this mining area should be regarded as a high-risk group with REEs (especially LREEs) exposure, and their health status should be examined from a REEs health risk assessment perspective.

[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].

OBJECTIVE: 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. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.