Genotoxicity research takes an important place in traditional Chinese medicine safety evaluation. Genotoxicity test on traditional Chinese medicine has been paid great attention since 1970s. Currently, the most developed genotoxicity test methods included: bacterial reverse mutation test and mouse lymphoma assay which are used to detect relevant genetic changes, micronucleus test and chromosomal analysis which are used to measure chromosomal aberration, and single cell electrophoresis assay which is used to test DNA damage. This article reviews research progress on genotoxicity of traditional Chinese medicine, evaluation methods of genotoxicity, the problems and solutions on genotoxicity evaluation of traditional Chinese medicine, and new technique used in genotoxicity test.
Animals ; Biomedical Research ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Mutagenicity Tests ; methods

Drug allergy and pseudoallergic reactions are main adverse drug reactions. Allergy is mainly induced by the immunogenicity of drug, drug metabolic products or drug additive. Pseudoallergic reactions may result from the irritation or activation of inflammatory material release. Pre-clinical evaluation of drug allergy and pseudoallergic reactions is included in immunotoxicity evaluation. Now there is no in vivo or in vitro method that could predict all kinds of allergy or pseudoallergic reactions due to the different mechanisms. In the past few years, FDA, SFDA OECD, ICH and WHO have published several guidelines on per-clinical immunotoxicity evaluation, however, no agreement has been reached on allergy and pseudoallergic reactions evaluation. This article reviews the requirements of allergy and pseudoallergic reactions in pre-clinical evaluation.
Drug Hypersensitivity ; diagnosis ; Humans ; Immune System ; drug effects ; Practice Guidelines as Topic

BACKGROUND: With the improvement of medical imaging technology, the visualization of human anatomy has been further developed; the role of three-dimensional (3D) reconstruction in medical treatment is also becoming increasingly prominent. Mimics is the most widely used medical image reconstruction software. Arigin 3D Pro is a recently developed 3D reconstructed medical software system based on 3D printing. OBJECTIVE: To study the accuracy of 3D reconstruction models obtained by using Arigin 3D Pro and Mimics with medical images. METHODS: The image data of liver, spine, knee joint and heart were selected, and the deviations of two software reconstruction models were analyzed based on the 3D model reconstructed by Mimics. Totally 10 cases of skull and 1 case of femoral comminuted fracture image data were selected and reconstructed. Each reconstruction model was measured with 10 groups of feature sizes to evaluate the differences between the two software programs. RESULTS AND CONCLUSION: Arigin 3D Pro and Mimics were used to reconstruct the liver, spine, knee and heart data. The mean ± standard deviation of model deviations were (0.93 ± 1.05), (0.36 ± 0.74), (0.45 ± 0.74), (0.18 ± 0.41) mm. It took 3 minutes and 35 minutes for Arigin 3D Pro and Mimics to reconstruct the liver model respectively, and both software reconstructed other models for less than 1 minute. There was no statistically significant difference between the feature sizes of the two software for the 3D reconstruction models of skull and femoral comminuted fracture data (P > 0.05). The 3D reconstruction model of Arigin 3D Pro is comparable to that of Mimics. For the liver model, the reconstructed time of Arigin 3D Pro is significantly shorter than that of Mimics.

Objective To explore the effective management of inpatients' fall so as to reduce the incidence of inpatients fall.Methods To use the feedforward control of the theories and methods,set up management group to prevent inpatients' fall,conducted specialized training,developed standardized nursing processes,three quality control was carried out in the process of nursing.Results After training,the pass rate of nurses' knowledge about the prevention of inpatients' fall was 92.16％ which was significantly higher than 66.67 ％ before the training ( x2 =20.2681,P ＜ 0.01 ),and the pass rate of patients and families' knowledge of fall prevention was increased from 63.03％ to 85.73％ after training ( x2 =76.8791,P ＜ 0.01 ).After the control,1348 patients without one case of fall,patient satisfaction was significantly improved from original 96.2％ to now 99.6％.Conclusions The feedforward control is effective means to prevent the inpatients' fall and improve the quality of security care.

OBJECTIVETo explore the effect of recombinant human erythropoietin (rhEPO) on expression of brain-derived neurotrophic factor (BDNF) in different brain regions of aging rats.

METHODSForty male SD rats were randomized equally into negative control group, D-galactose group, EPO treatment group, and positive control group. Rat models of subacute aging were established by continuous subcutaneous injection of 5% D-galactose. Immunohistochemical staining was used to analyze the variation of BDNF expressions in different brain regions of the aging rats with different treatments.

RESULTSSignificant brain region-specific differences in BDNF expression were found among the rats in different groups. Compared with those in the negative control group, the numbers of BDNF-positive cells in the hippocampal CA1 region, CA3 region, dentate gyrus (DG) and frontal cortex were all decreased obviously in D-galactose group (P<0.05) but increased in both EPO group and the positive control group (P<0.05) without significant differences between the latter two groups. In the rats in the same group, the number of BDNF-positive cells varied markedly in different brain regions (P<0.05), and the expression level of BDNF was the highest in the frontal cortex followed by the hippocampal CA3 region and the dentate gyrus, and was the lowest in the hippocampal CA1 region.

CONCLUSIONTreatment with rhEPO enhances the expression of BDNF in rat neural cells, suggesting that rhEPO may protect the nervous system from aging by regulating the BDNF pathway.

Aging ; Animals ; Brain-Derived Neurotrophic Factor ; metabolism ; CA1 Region, Hippocampal ; metabolism ; CA3 Region, Hippocampal ; metabolism ; Dentate Gyrus ; metabolism ; Erythropoietin ; pharmacology ; Frontal Lobe ; metabolism ; Galactose ; Humans ; Male ; Neurons ; drug effects ; metabolism ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Recombinant Proteins ; pharmacology

OBJECTIVETo investigate the characteristics of microglial activation of hippocampus in experimental epileptic rats.

METHODSMorphological changes and proliferation of OX-42 positive cells were compared at different time points after status of epilepticus (SE) in lithium-pilocarpine induced epileptic rats.

RESULTSOX-42 positive cells were activated after SE, which increased to a peak at 3-7 d and in a relatively stable state at 7-14 d; then gradually decreased after 14d and returned to slightly higher level than previously at 21 d.

CONCLUSIONInflammatory injury, microglial activation and cell proliferation are closely related after seizures, microglial activation may be an important mechanism in the inflammatory injury of epilepsy.

Animals ; Cell Proliferation ; Disease Models, Animal ; Hippocampus ; cytology ; pathology ; Male ; Microglia ; pathology ; Rats ; Rats, Sprague-Dawley ; Status Epilepticus ; pathology

OBJECTIVETo observe the distribution of hypoxia inducible factor-1alpha (HIF-1alpha) in different brain regions in aged rats and investigate the role of HIF-1alpha in the aging process of the nervous system.

METHODSThe Nissl bodies and HIF-1alpha expression in different brain regions were observed in rats aged 3 and 30 months using Nissl staining and immunohistochemical method, respectively.

RESULTSIn the 30-month-old rats, the neural cells in 4 different brain regions presented with large cell body and loose alignment, containing reduced Nissl bodies in the cytoplasm. Compared with the 3-month-old rats, the aged rats showed greater number of HIF-1alpha-positive cells in the brain (P < 0.01), and the number varied significantly between the different brain regions (P < 0.01). The CA3 region contained the greatest number of positive cells, which were fewer in the motor cortex and cerebellum.

CONCLUSIONThe capacity for protein synthesis in the neural cells is weakened but the expression of HIF-1alpha increased in aged rats, suggesting the important role that HIF-1alpha may play in the aging process of the nervous system, especially in hypomnesis.

Aging ; metabolism ; Animals ; Brain ; metabolism ; Hypoxia-Inducible Factor 1, alpha Subunit ; biosynthesis ; Male ; Rats ; Rats, Sprague-Dawley

Objective To compare the clinical features between cryptogenic stoke(CS)with and without right-to-left shunt(RLS)so as to determine whether shunt severity determined by control-enhanced transcranial Doppler(c-TCD)is correlated with the risk of paradoxical embolism(RoPE)score.Methods We made a retrospective analysis of clinical characteristics of 138 CS patients with and without RLS admitted to our department between January 2014 and November 2016.For patients documented by c-TCD,we evaluated whether there was a correlation between RLS severity and RoPE score. RLS was diagnosed by c-TCD and contrast-enhanced transthoracic echocardiography(c-TTE).We compared every modality for detecting RLS with and without Valsalva maneuver.For patients found with RLS in c-TCD and c-TTE,we judged whether there was an agreement in grading RLS between two modalities.Results For patients with CS,shunt severity by c-TCD was positively correlated with RoPE score(r= 0.26,P= 0.05).The clinical features were different between CS patients with RLS and without RLS.Compared with the positive results of c-TCD and c-TTE at rest,the positive rate was higher in Valsalva maneuver,respectively(P＜0.01).There was a moderate agreement between shunt grades identified by the two techniques(Kappa=0.428).Conclusion There is a positive correlation between RoPE score and RLS severity determined by c-TCD in CS patients.Valsalva maneuver can significantly increase the positive rate of RLS detected by c-TCD and c-TTE.

OBJECTIVEInfants less than 35 weeks of gestational age are susceptible to peri-/intraventricular hemorrhage (PIVH). This may be due in part to low concentrations of vitamin K-dependent coagulation factors. This study was conducted to determine the umbilical cord blood activities of vitamin K-dependent coagulation factors II, VII, IX and X in premature infants to understand whether preterm infants have absence status of these factors the changes of theses factors' activities in premature infants' umbilical blood after vitamin K(1) was given to mothers antenatally and the preventing effectiveness of PIVH after maternal antenatal supplement of vitamin K(1).

METHODSPregnant women in preterm labor at less than 35 weeks of gestational age were randomly selected to receive antenatal vitamin K(1) intramuscular or intravenous injections 10 mg per day for 2 to 7 days (vitamin K(1) group), or no vitamin K(1) treatment (control group). Dexamethone was antenatally given to both groups of pregnant women routinely. Vitamin K(1) group had 44 infants and the control group had 133 infants. During the same period, thirty full-term neonates' cord blood samples were obtained to determine theses factors to compare with those from the premature infants. The cranial ultrasound was performed by a same physician to understand whether the neonates were complicated with PIVH and its severity.

RESULTSThe levels of vitamin K-dependent coagulation factors in umbilical blood in control group were significantly lower than those in full-term infants' cord blood (P < 0.05). However, in vitamin K(1) group, supplement of vitamin K(1) antenatally could significantly increase activities of factors II, VII and X in preterm infants' cord blood (P < 0.05). The total occurrence rates of PIVH in vitamin K(1) group and control group were 31.8% and 52.6%, respectively, (P = 0.017), and the frequency of severe PIVH in vitamin K(1) group and control group was 2.3% and 12.0%, respectively (P = 0.057).

CONCLUSIONPreterm infants have absence status of vitamin K-dependent coagulation factors. Administration of vitamin K(1) to pregnant women at less than 35 weeks of gestational age resulted in significantly improved activities of vitamin K-dependent coagulation factors II, VII, and X, and a significantly decreased frequency of PIVH and less severe hemorrhage in preterm infants.

Blood Coagulation Factors ; analysis ; Cerebral Hemorrhage ; blood ; prevention & control ; Female ; Fetal Blood ; chemistry ; Humans ; Infant, Newborn ; Infant, Premature ; blood ; Infant, Premature, Diseases ; blood ; prevention & control ; Pregnancy ; Vitamin K 1 ; administration & dosage ; therapeutic use

Pseudoallergic reactions occured after the first administration of patients, and the pathogenic mechanisms of them were different from the allergic reactions which needed excitation after antigen sensitization. To provide a basis for evaluation, clinical use and drug development of pseudoallergic reactions, the models were established by two kinds of Chinese herbal injections (CHI) both on different strain or gender mice. With the use of ICR, Kunming, BALB/C, C57 mice, pseudoallergic tests of two CHI were conducted to compare the sensitivity of four strains mice, and compared the differences in male and female animals. Test substances contain 0.8% Evans blue (EB) were intravenously injected into different strain and gender mice. Scores of ear blue staining and quantitation of ear EB exudation were the parameters for pseudoallergic reaction. Results of strain difference indicated that both CHI A and B could cause severe pseudoallergic reactions indicated by obvious vascular hyperpermeability on ICR mice. The pseudoallergic reactions in ICR mice are more obvious under the the same dose of injection, which stated the sensibility of ICR mice. And the reactions of KM mice and BALB/C mice were slightly reduced which compared to ICR mice, even alomost nothing on C57 mice. Comparison results of gender difference showed that one CHI was not have significant difference in male and female animals, but male animals were more susceptible than females on another CHI. Therefore, ICR mice were preferable experimental strain on the model of pseudoallergic reactions induced by CHI A and B. Because of female animals were easily influenced by estrous cycle, the pseudoallergic reactions induced by CHI A and B select and use male mice befittingly.
Animals ; Drug Hypersensitivity ; etiology ; Drugs, Chinese Herbal ; adverse effects ; Female ; Injections ; Male ; Mice ; Mice, Inbred BALB C ; Mice, Inbred ICR ; Sex Characteristics ; Species Specificity