OBJECTIVE: Exposure to polycyclic aromatic hydrocarbons (PAHs) or metal(loid)s individually has been associated with neural tube defects (NTDs). However, the impacts of PAH and metal(loid) co-exposure and potential interaction effects on NTD risk remain unclear. We conducted a case-control study in China among population with a high prevalence of NTDs to investigate the combined effects of PAH and metal(loid) exposures on the risk of NTD. METHODS: Cases included 80 women who gave birth to offspring with NTDs, whereas controls were 50 women who delivered infants with no congenital malformations. We analyzed the levels of placental PAHs using gas chromatography and mass spectrometry, PAH-DNA adducts with ³²P-post-labeling method, and metal(loid)s with an inductively coupled plasma mass spectrometer. Unconditional logistic regression was employed to estimate the associations between individual exposures and NTDs. Least absolute shrinkage and selection operator (LASSO) penalized regression models were used to select a subset of exposures, while additive interaction models were used to identify interaction effects. RESULTS: In the single-exposure models, we found that eight PAHs, PAH-DNA adducts, and 28 metal(loid)s were associated with NTDs. Pyrene, selenium, molybdenum, cadmium, uranium, and rubidium were selected through LASSO regression and were statistically associated with NTDs in the multiple-exposure models. Women with high levels of pyrene and molybdenum or pyrene and selenium exhibited significantly increased risk of having offspring with NTDs, indicating that these combinations may have synergistic effects on the risk of NTDs. CONCLUSION Our findings suggest that individual PAHs and metal(loid)s, as well as their interactions, may be associated with the risk of NTDs, which warrants further investigation.
Humans ; Neural Tube Defects/chemically induced* ; Polycyclic Aromatic Hydrocarbons/adverse effects* ; Female ; Case-Control Studies ; China/epidemiology* ; Adult ; Pregnancy ; Environmental Pollutants ; Maternal Exposure/adverse effects* ; Metals/toxicity* ; Young Adult ; Risk Factors

Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective:To evaluate the role of nucleotide-binding oligomerization domain-2 (NOD2) in dorsal root ganglion in the development of neuropathic pain (NP) in rats.Methods:Thirty-two adult male SPF Sprague-Dawley rats, weighing 240-260 g, aged 2-3 months, were divided into 4 groups ( n=8 each) using a random number table method: control group (group C), NP group (group S), negative control siRAN group (group N), and NOD2-siRNA group (group R). In N and R groups, 1×10 8 IFU/ml negative control siRNA and NOD2-siRNA 10 μl were intrathecally injected, respectively, once a day for 3 consecutive days.Normal saline 10 μl was intrathecally injected once a day for 3 consecutive days in C and S groups.The model of NP was established using spared nerve injury (SNI) at 2 weeks after intrathecal injection.The mechanical paw withdrawal threshold (MWT) was measured at 1 day before surgery and 1, 3, 7, 10, 14 and 28 days after SNI.Animals were sacrificed after measuring pain threshold on day 28, and the dorsal root ganglions (DRGs) of the lumbar segment (L 4-6) were removed for determination of the expression of NOD2 (by Western blot) and expression of tumor necrosis factor-alpha (TNF-α), interleukin-1beta (IL-1β), IL-6 and NOD2 mRNA (using quantitative real-time polymerase chain reaction). Results:Compared with group C, MWT was significantly decreased at each time point after SNI, and the expression of NOD2 protein and mRNA and TNF-α, IL-1β and IL-6 mRNA in DRGs was up-regulated in group NP ( P<0.01). Compared with group NP, MWT was significantly increased at each time point after SNI, and the expression of NOD2 protein and mRNA and TNF-α, IL-1β and IL-6 mRNA in DRGs was down-regulated in group R ( P<0.01), and no significant change was found in the parameters mentioned above in group N ( P>0.05). Conclusion:The mechanism underlying the development of NP may be related to the up-regulation of NOD2 expression in DRGs, thus further promoting the expression of pro-inflammatory factors in rats.

Objective To analyze and compare epidemiological characteristics of adult single metatarsal fractures between the east and west areas in China from 2010 through 2011.Methods Thirty-five hospitals in the east area (group A) and 28 hospitals in the west area (group B) participated in this epidemiological investigation of adult single metatarsal fractures treated from January 2010 through December 2011.Data concerning gender,age and fracture location and type were documented and compared between groups A and group B.Results There were 4,779 fractures in group A and 1,708 in group B,accounting for 21.28％ (4,779/22,455) and 26.88％ (1,708/6,354) of the adult foot fractures,and 2.48％ (4,779/192,991) and 2.10％ (1,708/81,143) of all the adult fractures,respectively,showing significant differences between the 2 groups (P ＜ 0.05).The ratio of male to female was 1.21:1 in group A and 1.48:1 in group B,showing a significant difference (x2 =11.768,P =0.001).The median age of group A (43 years) was significantly older than that of group B (40 years) (Z =-6.275,P ＜ 0.001).The proportions of the patients aged from 21 to 30 years (19.02％) and of those aged from 31 to 40 years (18.62％) in group A were significantly lower than those in group B (22.66％ and 21.60％),but the proportion of the patients aged from 51 to 60 years in group A (21.09％) was significantly higher than that in group B (14.64 ％) (P ＜ 0.05).The proportions of type 87-A (40.18％) and type 87-C (5.52％) in group A were significantly lower than those in group B (44.38％ and 8.20％),but the proportion of type 87-B in group A (54.30％) was significantly higher than that in group B (47.42％) (P ＜ 0.05).There was no significant difference between the 2 groups in the distribution of fracture locations (P ＞ 0.05).Conclusions The most common single metatarsal fracture was that of the fifth metatarsal bone and the fractures of proximal metatarsal bone accounted for the largest proportion in both the cast and west areas.The west area had higher proportions of male patients and single metatarsal fracture than the east area.

Objective To compare the epidemiological characteristics of adult single fractures of the cuneiform between the east and west areas in China from 2010 through 2011.Methods Thirty-five hospitals in the east coast area (group A) and 28 hospitals in the west inland area (group B) were selected for this investigation. The data of adult single fracture of the cuneiform treated between January 2010 and De-cember 2011 at the 63 hospitals were collected through the PACS system and medical records inquiry system. The epidemiological characteristics concerning age, gender and fracture classification were compared between the 2 groups. Results A total of 457 adult single fractures of the cuneiform were collected, involving 384 cases in group A and 73 cases in group B. They accounted respectively for 4.38% (384/8,772) and 3.53% (73/2, 068) of the adult tarsal bone fractures in the same period, showing no significant difference (P >0.05), accounted respectively for 1.71% (384/22, 455) and 1.15% (73/6, 354) of the adult foot frac-tures, showing a significant difference (P <0.05), and accounted respectively for 0.20% (384/192,991) and 0.09% (73/81, 143) of all the adult fractures, showing a significant difference (P <0.05). The median age was 39 years in group A (29, 50) and 36 years in group B (25, 45), showing a significant difference (P <0.05). The male to female ratio was 1.61:1 (237/147) for group A and 1.52:1 (44/29) for group B. The peak age range of the fracture for males was from 21 to 30 years old in both groups, and its proportion was 28.69% (68/237) in group A and 38.64% (17/44) in group B. The peak age range of the fracture for females was from 41 to 50 years old in both groups, and its proportion was 26.53% (39/147)in group A and 27.59% (8/29) in group B. All the above comparisons were statistically insignificant (P> 0.05). The proportion of the age group of≥61 years was significantly larger in group A than in group B (P <0.05). The high risk type of the fracture was type 85-A1 in both groups, and its proportion was 61.98% (238/384) in group A and 52.05% (38/73) in group B. The proportion of type 85-B1 was significantly larger in group B than in group A (P <0.05). Conclusions Adult single fractures of the cuneiform were more common in young and male patients. The proportion of elderly patients (≥61 years old) was significantly larger in the east area. The high risk type of the fracture was simple fracture involving the medial cuneiform bone (type 85-A) in both areas. The proportion of the comminuted fracture of the medial cuneiform (type 85-B1) was significantly larger in the west area.

Objective: To explore the changes of the peripheral invariant natural killer T (iNKT) cells in patients with human immunodeficiency virus (HIV) infection. Methods: A total of 101 patients with HIV infection including 52 asymptomatic patients and 49 acquired immunodeficiency syndrome (AIDS) patients were enrolled in the study from June 2016 to July 2017. Flow cytometry was used to detect iNKT cells, CD4⁺ T cells and CD8⁺ T cells, and the relationship among them and HIV RNA was studied. At same time, 12 healthy persons were enrolled as control group. T test or variance analysis, rank sum test, Chi-square test and Fisher exact test were used for statistical analysis. Results: In HIV infected asymptomatic patients, AIDS patients and healthy controls, iNKT cells were 0.135% (0.066%, 0.228%), 0.058% (0.034%, 0.100%) and 0.385% (0.205%, 0.600%), respectively, and the difference was statistical significant (Z=40.113, P<0.01). CD4⁺ T cell counts in the three groups were (340.82±119.26) cells/μL, (72.73±61.84) cells/μL and (555.17±229.43) cells/μL, respectively, and the difference was statistical significant (t=113.79, P<0.01); CD8⁺ T cell counts in the three groups were (842.29±423.68) cells/μL, (540.43±257.85) cells/μL and (875.92±516.45) cells/μL, respectively, and the difference was statistical significant (t=9.423, P<0.01). Ratios of CD4⁺ /CD8⁺ T cells in the three groups were 0.490 (0.240, 0.695), 0.120 (0.030, 0.210) and 0.600 (0.475, 0.895), respectively, and the difference was statistical significant (Z=53.603, P<0.01). iNKT cell counts in patients with or without hepatitis B virus infection, pneumocystis pneumonia, oral mold infection, treponema pallidum, latent tuberculosis or EB virus infection were not significantly different (Z=0.244, 2.325, 2.393, 0.168, 1.183 and 0.454, respectively, all P>0.05). There were correlations between iNKT cells and CD4⁺ T cells, CD4⁺ /CD8⁺ T cells (r=0.513 and 0.261, respectively, both P<0.05), and no relationship was found between iNKT cells and CD8⁺ T cells (r=0.155, P=0.126). In HIV infected asymptomatic patients and AIDS patients, iNKT cells was not associated with HIV RNA (r=-0.113 and -0.111, respectively, both P>0.05). Conclusions The level of peripheral iNKT cells in HIV infected patients decreases with the disease progression. To certain extent, iNKT cells can reflect the severity of immune damaging in HIV infected patients.

Objective To compare and analyze the epidemiological features of adult patients with distal femoral fracture between the east and west areas in China from 2010 to 2011.Methods The data of adult patients with distal femoral fracture treated from January 2010 through December 2011 in 63 hospitals were collected through the PACS system and case reports checking system.The data from 35 hospitals in the east area were classified as group A and those from 28 hospitals in the west area as group B.The analytic items included gender,age and AO classification.Results A total of 2,523 adult distal femoral fractures were collected,involving i,544 males and 979 females,with a male to female ratio of 1.58:1.The adult femoral fractures predominated in an age range from 41 to 50 years (18.94％) and their high-risk type was 33-A (50.18％).In group A of 1,650 cases,there were 1,027 males and 623 females,with a male to female ratio of 1.65:1 and a median age of 48 years;in group B of 873 cases,there were 517 males and 356 females,with a male to female ratio of 1.45:1 and a median age of 45 years.There were no significant differences in the age distribution and gender proportion between groups A and B (P ＞ 0.05).The age distribution showed that the peak ranges were from 31 to 60 years in both groups.The proportion of type 33-A was the most and that of type 33-B the least in both groups.The proportion of type 33-A in group B (53.49％) was significantly higher than in group A (48.42％) while that of type 33-B in group B (16.84％) was significantly lower than in group A (21.39％) (P ＜ O.05).Conclusions Adult distal femoral fractures were common in middle-aged males and their high-risk type was 33-A.Their peak age was from 31 to 60 years in both east and west areas in China.They were more common in men.The predominant fracture type was 33-A in both areas.The east area witnessed a significant higher proportion of type 33-B and a significant lower proportion of type 33-A than the west area.

Objective To compare and analyze the epidemiological features of Colles fractures between Eastern and Western China from 2010 to 2011.Methods The data of patients with Colles fracture treated from January 2010 to December 2011 in 63 hospitals in Eastern and Western China were analyzed retrospectively.The patients from the 35 hospitals in Eastern China were defined as group A and those from the 28 hospitals in Western China as group B.The 2 groups were analyzed and compared in terms of gender,age and laterality.Results A total of 9,255 Colles fractures were collected.The total male/female ratio was 0.82:1.Their ages ranged from 1 to 110 years,with a median age of 51 years.The Colles fractures predominated in an age range from 51 to 60 years.There were 5,006 left sides and 4,249 right sides.There were 5,639 Colles fractures in group A,accounted for 2.55％ of the total body fractures and 22.09％ of the distal ultra-radius fractures.There were 3,616 Colles fractures in group B,accounted for 3.98％ of the total body fractures and 37.55％ of the distal ultra-radius fractures.The male/female ratio was 0.72:1 in group A and 0.99:1 in group B.The median age was 54 years (from 1 to 110 years) for group A and 45 years (from 1 to 99 years) for group B.There were significant differences between the 2 groups in all the above items (P ＜0.05).The largest proportion of age group was from 51 to 60 years and the smallest proportion of age group was ≥81 years for both groups.The proportions of age groups from 1 to 10 years,from 51 to 60 years,from 61 to 70 years,from 71 to 80 years and ≥81 years in group A were larger than in group B while those from 11 to 20 years,from 21 to 30 years,from 31 to 40 years and from 41 to 50 years in group A were smaller than in group B.There were significant differences between the 2 groups in all the proportions of age group (P ＜0.05).The Colles fractures predominated on the left side in both groups,showing no significant difference between the 2 groups (P ＞ 0.05).Conclusions The Colles fractures from 2010 to 2011 predominated in the elderly and female patients in China.The proportions of Colles fractures in all body fractures and distal ultra-radius fractures in Eastern China were lower than those in Western China.There were significant differences in gender and age proportions between the 2 areas.Eastern China had a larger proportion of female patients and a higher median age than Western China.

Objective To investigate the relationship between human leukocyte antigen-G( HLA-G) gene Exon 8 14 bp deletion polymorphism and the pathogenesis of severe pre-eclampsia.Methods Forty-two pregnant women with severe pre-eclampsia,who admitted to the Third Affiliated Hospital of Zhengzhou University from October 2008 to February 2009,and their newborns were chosen as the severe pre-eclampsia group.Another 45 healthy gravidas at the third trimester and their newborns were chosen as the control.All gravidas in both groups were Han Nationality.HLA-G Exon 8 genotyping was detected by PCR in both groups and the allele frequencies and genotype frequencies were compared between the two groups.The genotype frequencies of maternal-neonatal pairs were also analyzed.Results ( 1 ) In the severe pre-eclampsia group,14% of the maternal-neonatal pairs were homozygote of 14 bp deletion,and significantly higher frequency 33% (15/45) was found in the control group (P =0.038).(2) No significant difference was found in the allele frequencies and genotype frequencies of HLA-G 14 bp deletion polymorphism among all the mothers between the two groups (P >0.05).(3) The + 14 bp and-14 bp allele frequencies of HLA-G 14 bp deletion polymorphism in newborns in the severe pre-eclampsia group were 44% (37/84) and56% (47/84),respectively,and 30% (27/90) and 70% (63/90) in the control group.Although there was no significant difference between the two groups,but differences in trends was identified (χ2= 3.678 P = 0.055) ; The genotype (-14 bp/-14 bp) frequency of neonates in the severe pre-eclampsia group showed no difference compared with that in the control group[29% (12/42) vs 49% (22/45)],but differences in trends was also found (P =0.052).Conclusions HLA-G 14 bp deletion polymorphism is associated with the susceptibility of severe pre-eclampsia in Chinese Han nationality.Maternal-fetal genotype pairs of-14 bp/-14 bp may have reduced risk of severe pre-eclampsia.