Objective To explore the ideas,methods and pathways for the registration of Chinese medicine prescriptions in overseas countries,to form a strategy for overseas registration of Chinese medicine,and to provide technical support and reference for China's Chinese medicine prescriptions to go abroad.Methods Five representative countries were selected to form corresponding expert teams and exchange platforms for international cooperation.The laws,regulations,rules,standards,specifications and technical guidance documents related to Chinese medicine prescription preparations of the target countries were used as pathway research materials,and the documents were translated directly,naturalized,proofread and diagrammed,and a problem-oriented mechanism for consultation with domestic and international experts was established to form a pathway for overseas registration of Chinese medicine prescription preparations.Results The path for standardization of overseas registration of Chinese medicines was clarified,and the detailed registration paths and corresponding work strategies of Chinese medicines in five countries were formulated with flow charts,tables and explanatory texts.Conclusion By developing standardized registration pathways for traditional Chinese medicine in target countries,reference can be provided for the internationalization of Chinese herbal formula preparations.

International registration of herbal drugs is a necessary prerequisite for the internationalization of Chinese materia medica. North America and European Union occupy an important position in the world herbal drugs market, and their drug administration and quality supervision requirements are relatively complete and progressiveness. By summarizing the definition of herbal drugs in North America and European Union, combing and interpreting the relevant laws, regulations and policy documents, this article constructed the registration path of herbal drugs, and discussed the current status of market registration of herbal drugs in North America and European Union based on the examples of successful marketing of herbal drugs under current application and approval in overseas markets. This article believed that in the future, an internationally matched TCM quality standard evidence system should be built, clinical trials of TCM products in line with international standards should be carried out, standards that are the same or higher than international mainstream GMP should be developed, the registration path of TCM compounds should be explored, and professionals to establish an international registration application team should be recruited to provide theoretical and practical support for China's overseas registration of Chinese TCM products, promote TCM products to enter the world mainstream market, and achieve high-quality development of TCM internationalization.

Objective:To summarize the clinical and electrophysiological characteristics of epilepsy patients with fixation-off sensitivity (FOS).Methods:Using "fixation-off sensitivity" and "epilepsy" as search terms, data were retrieved from the Electroencephalogram Monitoring Center Database of Xijing Hospital, Air Force Military Medical University. Information was collected on epilepsy patients with FOS who were seen at the Xijing Hospital Electroencephalogram Monitoring Center from March 2019 to May 2023. A retrospective analysis of video electroencephalograms and clinical information was conducted, along with follow-up. Single factor analysis and multi-factor Logistic regression analysis were used to analyze the risk factors affecting the prognosis of the patients.Results:A total of 78 patients met the inclusion criteria, including 43 females and 35 males; the age at first epilepsy onset was 12.00 (8.00, 15.25) years. Among these 78 patients, 46 were diagnosed with genetic generalized epilepsy, 11 with self-limited focal epilepy, 9 with familial cortical myoclonic tremor with epilepsy, 7 with developmental and epileptic encephalopathy, 3 with symptomatic epilepsy, and 2 with progressive myoclonic epilepsy. The fixation-off induction trial most commonly triggered seizures in epilepsy with eyelid myoclonia (EEM) patients, with eyelid myoclonia being the most common type of seizure. Twenty-five epilepsy patients with FOS showed a positive photoparoxysmal response, of whom 6 experienced photo-convulsive response. Sixty-eight patients completed follow-up with comprehensive clinical data. At the last follow-up, 45 patients had been free from tonic-clonic seizures for at least one year. A history of febrile seizures ( OR=20.559, 95% CI 2.179-193.997, P=0.008) and cognitive decline ( OR=3.752, 95% CI 1.118-12.588, P=0.032) were identified as risk factors for poor prognosis in epilepsy patients with FOS. The age of first epilepsy onset, the number of anti-seizure medications, and the intermittent photo stimulation trial results had no correlation with prognosis. Conclusions:FOS is more common in female epilepsy patients and can be observed in both generalized and focal epilepsy syndromes. EEM patients are prone to seizures during fixation-off induction trial, and the most common type of seizures is eyelid myoclonus seizure. Patients with epilepsy with FOS who have a history of febrile seizures and cognitive impairment tend to have poor prognosis.

Epilepsy with eyelid myoclonia (EEM), also known as Jeavons syndrome, is a type of genetic generalized epilepsy officially recognized by the International League Against Epilepsy. The clinical characteristics of EEM include eyelid myoclonia, eye closure sensitivity, and photosensitivity, typically manifesting in childhood with a higher prevalence in female patients. The prognosis of EEM is poor, and seizures are difficult to fully control even with standardized drug treatment. The electroencephalogram of EEM often shows fast interictal multiple spike-wave complexes, which can be induced by eye closure or photic stimulation. Functional magnetic resonance imaging and other studies have found that EEM is associated with brain network abnormalities, particularly the key role of the central medial thalamic nucleus in the regulation of cortical excitability. Genetic research has found that EEM may be related to variations in genes such as CHD2, SYNGAP1, NEXMIF, RORB, and GABRA1.

Introduces the regulatory requirements of the Natural and Over-the-Counter Health Products Administration on the quality of natural health products, and adopts the literature research method to translate and interpret Health Canada's "Guidelines for the Quality of Natural Health Products" on the quality management and quality control of natural health products. Policy documents, from the perspective of stakeholders, provide requirements for the detection methods and standards of natural health products, such as characterization, identification experiments, component content, pollutants and impurity content detection, etc. To achieve natural health Quality management and quality control in the whole process of product production. Familiar with and understand the requirements for the quality management of natural health products in Canada will help to promote the legal and compliant management of product quality in the production process of Traditional Chinese Medicine (TCM) products after registration in Canada, and promote the production and sustainable development of TCM products. At the same time, it provides a reference for further improving my country's drug quality management system normative system documents, and assists the effective connection between the registration-related standards of Chinese patent medicines and international standards.

In the nucleus, chromatin is folded into hierarchical architecture that is tightly linked to various nuclear functions. However, the underlying molecular mechanisms that confer these archi-tectures remain incompletely understood. Here, we investigated the functional roles of H3 lysine 9 dimethylation (H3K9me2), one of the abundant histone modifications, in three-dimensional (3D) genome organization. Unlike in mouse embryonic stem cells, inhibition of methyltransferases G9a and GLP in differentiated cells eliminated H3K9me2 predominantly at A-type (active) genomic compartments, and the level of residual H3K9me2 modifications was strongly associated with B-type (inactive) genomic compartments. Furthermore, chemical inhibition of G9a/GLP in mouse hepatocytes led to decreased chromatin-nuclear lamina interactions mainly at G9a/GLP-sensitive regions, increased degree of genomic compartmentalization, and up-regulation of hundreds of genes that were associated with alterations of the 3D chromatin. Collectively, our data demonstrated essential roles of H3K9me2 in 3D genome organization.

Objective: To explore the efficacy and safety of converting from traditional calcineurin inhibitor-based immunosuppressive regimen to sirolimus plus low-dose calcineurin inhibitor after kidney transplantation from expanded criteria donors. Methods: For this prospective, open-label, non-randomized controlled clinical trial, 15 recipients of initial transplant from expanded criteria donors received sirolimus plus low-dose calcineurin inhibitor regimen 3 months after transplantation during June 2017 and March 2018. The follow-up period was over 1 year. The allograft survival time, changes in blood creatinine and glomerular filtration rate before and after conversion (0, 1, 3, 6, 12 months), changes in urinary protein before and after conversion, incidence of acute rejection after conversion, BK virus or cytomegalovirus infection and sirolimus-related complications were observed. Results: Renal functions of all 15 patients improved after conversion and 1-year allograft survival rate was 100% (15/15). Serum creatinine decreased markedly and glomerular filtration rate increased significantly at 1 month and 3 months after conversion (P<0.05). BK viruria was detected in 5 patients before conversion. After conversion, BK virus turned into negative in 3 patients within 3 months and viral load also decreased in another 2 patients. After conversion, only 2 patients (13.3%) developed de novo proteinuria. Eight patients (53.3%) developed de novo hypertriglyceridemia responding well to medications. None of them experienced acute rejection during follow-ups. Conclusions Sirolimus plus low-dose calcineurin inhibitor is a safe and effective maintenance immunosuppressive regimen for recipients of kidneys from expanded criteria donors, especially for those with abnormal renal function during recovery. But it cannot completely replace the traditional immunosuppressive regimen. Individualized treatment should be chosen properly for recipients.

OBJECTIVETo investigate the association between maternal serum neutrophil-lymphocyte ratio (NLR) and placental inflammatory response (PIR) in late pregnancy.

METHODSWe retrospectively analyzed the clinical and follow-up data of 478 pregnant women undergoing routine prenatal examination and delivery in our hospital in the year 2016. According to the placental pathological results, the women were divided into PIR group (238 cases) and control group (240 cases). The levels of serum inflammatory makers including leukocytes, neutrophils, lymphocytes, C-reactive protein (CRP) and NLR were compared between the two groups to analyze the association of these markers with PIR. Multivariate analysis was performed to identify the independent risk factors of PIR. Logistic regression model was established and the area under the receiver operating characteristic curve (ROC) was used for analyzing the prognostic value of these makers in late pregnancy.

RESULTSThe areas under the curve (AUC) of leukocytes, neutrophils, lymphocytes, CRP and NLR were 0.698 (95%: 0.485-0.766), 0.716 (95%: 0.453-0.783), 0.329 (95%: 0.228-0.431), 0.725 (95%: 0.677-0.765) and 0.801 (95%: 0.742-0.856), respectively. After adjusting the confounders, multivariate logistic regression analysis showed that preterm labor (OR=2.446, 95%: 1.003-4.590), premature rupture of membranes (OR=2.304, 95%: 1.049-4.161), NLR > 7 (OR=3.268, 95%: 2.071-6.920), and CRP > 15 mg/L (OR=2.137, 95%: 1.412-8.236) were independent risk factors for PIR.

CONCLUSIONSAn increased NLR in late pregnancy can serve as an effective indicator for predicting the risk of PIR.

Objective:To establish two differential gene expression profiles of qi-deficiency and blood stasis syndrome before or after safflower injection treatment by using gene chip technology;compared and analyzed to ensure the effective genes that are responsible for the therapeutic effects of safflower injection against qi-deficiency and blood stasis syndrome in rats.Furthermore,speculated the effect mechanism of the therapeutic genes.Methods:Fifteen SD rats were randomly divided into 3 groups (n=5):control group,model group,and medication group.Qi-deficiency and blood stasis model was established by subjecting the rats to hunger and fatigue for two weeks.After a week of the modeling,safflower injection (100 mg/kg/d) was administered daily via the tail vein for 7 days in medication group,and the rats in model group were injected with saline of the same volume.Control group received normal feeding.At the end of the experiment,rats were killed and whole blood was collected to evaluate the blood stream change and extract mRNAs in blood samples.Qualified mRNAs were reverse transcribed into cDNA which was then used in gene chip hybridization.The genes regulated by safflower injection were determined by the fluorescence signal and the functional mechanisms of safflower injection were confirmed by further querying genealogy databases and reviewing literatures.Results:After two weeks of the modeling,the whole blood viscosity under various shear rates was significantly increased in the model rats which showed faint,blood stasis and weight loss,indicating that the model is made successfully.The increased whole blood viscosity and qi-deficiency and blood stasis syndrome were obviously reversed by safflower injection treatment.Compared with the control group,252 genes up-regulated while 54 genes down-regulated in model group;compared with the model group,196 genes up-regulated while 32 genes down-regulated.Among these,16 differentially expressed genes were involved in inflammation and immune response.Conclusions:Safflower injection was effective in treating qi deficiency and blood stasis syndrome,which was achieved by regulating inflammation related genes.