OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

AIM:The objective of this study was to investigate the ameliorative effect of Erjing pills(PL)on the functional impairment of the diabetic retinal neurovascular unit(NVU)in rats.METHODS:A diabetic retinopathy(DR)model was established using BN rats,which were then treated with freeze-dried Erjing pills powder.After 12 weeks,various assessments were conducted:retinal thickness was measured using OCT,fundus lesions were evaluated with FFA,and retinal cell structure,arrangement,and layer thickness were analyzed through HE staining.Additionally,transmission electron microscopy was employed to examine ultrastructural changes in retinal ganglion cells(RGCs),and retinal leakage was assessed using EB in vivo perfusion.The expression of ZO-1,a tight junction protein in the retina,was detected via immunohistochemistry,while Western blot analysis quantified the levels of ZO-1,occludin,and claudin-5 proteins in rat retinal tissue.Serum vascular endothelial growth factor(VEGF)levels were measured using an ELISA kit.RESULTS:Results showed that OCT,FFA,HE staining,and transmission electron microscopy indicated a significant reduction in retinal thickness in the MOD group compared to the CON group(P＜0.05).In contrast,the retinal thickness increased in the CDC,PLL,and PLH groups compared to the MOD group,with significant improvement observed in the PLH group(P＜0.05).Additionally,the number of RGCs increased,and sodium fluorescein leakage from fundus mi-crovessels decreased in the CON group relative to the administered groups.Transmission electron microscopy revealed ir-regular deformation of RGC nuclei,mitochondrial reduction and swelling,and organelle loss in the MOD group compared to the CON group.However,the CDC,PLL,and PLH groups demonstrated varying degrees of improvement in cellular layers.EB leakage assay results indicated a significant increase in retinal EB leakage in the MOD group compared to the CON group(P＜0.01).EB leakage was significantly reduced in the CDC group compared to the MOD group(P＜0.01),with some reduction also observed in the PLL and PLH groups(P＜0.05,P＜0.01).Immunohistochemistry and Western blot analyses revealed a significant decrease in the expression of retinal tight junction proteins ZO-1,occludin,and clau-din-5 in the MOD group compared to the CON group(P＜0.05).Protein expression was notably higher in the CDC group compared to the MOD group(P＜0.01),with increases also observed in the PLL and PLH groups(P＜0.05,P＜0.01).ELISA results showed that VEGF levels were significantly higher in the MOD group compared to the CON group(P＜0.01).The CDC,PLL,and PLH groups exhibited varying degrees of reduction in VEGF levels compared to the MOD group(P＜0.05,P＜0.01).CONCLUSION:These findings suggest that PL effectively ameliorates retinal NVU damage in DR rats.

Objective To analyze the risk factors affecting the prognosis of patients with advanced gastric cancer,so as to provide evidence for identifying high-risk populations and guiding clinical treatment.Methods The clinical data of 282 patients with advanced gastric cancer who admitted to Zhoushan Hospital of Traditional Chinese Medicine from January 2017 to December 2021 were retrospectively analyzed.The survival outcome of patients was obtained by telephone follow-up and regular review.Kaplan-Meier method was used to analyze the overall survival(OS).Univariate and multivariate COX regression models were used to analyze the effects of clinical features on OS in patients with advanced gastric cancer.Results The median OS of 282 patients with advanced gastric cancer was 10.0 months.Univariate analysis showed that first-line chemotherapy,traditional Chinese medicine treatment,body mass index(BMI),Karnofsky performance status(KPS)score,hemoglobin(Hb)and albumin(Alb)were significantly correlated with the survival of patients with advanced gastric cancer(P<0.05).Multivariate COX regression models analysis showed that first-line chemotherapy,BMI,KPS score and Alb were independent risk factors affecting the survival of patients with advanced gastric cancer(P<0.05).Conclusion BMI,Alb,KPS score and first-line chemotherapy are independent risk factors for predicting the prognosis of patients with advanced gastric cancer,indicating nutrition management may be an important way to improve the outcome of patients with advanced gastric cancer.

AIM:The objective of this study was to investigate the ameliorative effect of Erjing pills(PL)on the functional impairment of the diabetic retinal neurovascular unit(NVU)in rats.METHODS:A diabetic retinopathy(DR)model was established using BN rats,which were then treated with freeze-dried Erjing pills powder.After 12 weeks,various assessments were conducted:retinal thickness was measured using OCT,fundus lesions were evaluated with FFA,and retinal cell structure,arrangement,and layer thickness were analyzed through HE staining.Additionally,transmission electron microscopy was employed to examine ultrastructural changes in retinal ganglion cells(RGCs),and retinal leakage was assessed using EB in vivo perfusion.The expression of ZO-1,a tight junction protein in the retina,was detected via immunohistochemistry,while Western blot analysis quantified the levels of ZO-1,occludin,and claudin-5 proteins in rat retinal tissue.Serum vascular endothelial growth factor(VEGF)levels were measured using an ELISA kit.RESULTS:Results showed that OCT,FFA,HE staining,and transmission electron microscopy indicated a significant reduction in retinal thickness in the MOD group compared to the CON group(P＜0.05).In contrast,the retinal thickness increased in the CDC,PLL,and PLH groups compared to the MOD group,with significant improvement observed in the PLH group(P＜0.05).Additionally,the number of RGCs increased,and sodium fluorescein leakage from fundus mi-crovessels decreased in the CON group relative to the administered groups.Transmission electron microscopy revealed ir-regular deformation of RGC nuclei,mitochondrial reduction and swelling,and organelle loss in the MOD group compared to the CON group.However,the CDC,PLL,and PLH groups demonstrated varying degrees of improvement in cellular layers.EB leakage assay results indicated a significant increase in retinal EB leakage in the MOD group compared to the CON group(P＜0.01).EB leakage was significantly reduced in the CDC group compared to the MOD group(P＜0.01),with some reduction also observed in the PLL and PLH groups(P＜0.05,P＜0.01).Immunohistochemistry and Western blot analyses revealed a significant decrease in the expression of retinal tight junction proteins ZO-1,occludin,and clau-din-5 in the MOD group compared to the CON group(P＜0.05).Protein expression was notably higher in the CDC group compared to the MOD group(P＜0.01),with increases also observed in the PLL and PLH groups(P＜0.05,P＜0.01).ELISA results showed that VEGF levels were significantly higher in the MOD group compared to the CON group(P＜0.01).The CDC,PLL,and PLH groups exhibited varying degrees of reduction in VEGF levels compared to the MOD group(P＜0.05,P＜0.01).CONCLUSION:These findings suggest that PL effectively ameliorates retinal NVU damage in DR rats.

Pulmonary blast injury has become the main type of trauma in modern warfare, characterized by externally mild injuries but internally severe injuries, rapid disease progression, and a high rate of early death. The injury is complicated in clinical practice, often with multiple and compound injuries. Currently, there is a lack of effective protective materials, accurate injury detection instrument and portable monitoring and transportation equipment, standardized clinical treatment guidelines in various medical centers, and evidence-based guidelines at home and abroad, resulting in a high mortality in clinlcal practice. Therefore, the Trauma Branch of Chinese Medical Association and the Editorial Committee of Chinese Journal of Trauma organized military and civilian experts in related fields such as thoracic surgery and traumatic surgery to jointly develop the Clinical treatment guideline for pulmonary blast injury ( version 2023) by combining evidence for effectiveness and clinical first-line treatment experience. This guideline provided 16 recommended opinions surrounding definition, characteristics, pre-hospital diagnosis and treatment, and in-hospital treatment of pulmonary blast injury, hoping to provide a basis for the clinical treatment in hospitals at different levels.

Objective:To observe the expression, correlation and significance of chemokine (C-X-C motif) ligand 12 (CXCL12) and chemokine (C-X-C motif) receptor 4 (CXCR4) in endometrium and myometrium of adenomyosis.Methods:Totally 38 patients were selected in this study, who underwent hysterectomy for adenomyosis at Beijing Obstetrics and Gynecology Hospital from October 2017 to December 2018 as the adenomyosis group, and, in the same period, selected 31 patients with cervical intraepithelial neoplasia Ⅲ or cervical cancer undergoing hysterectomy served as control group. The expression levels of mRNA and protein for CXCL12, CXCR4 in the endometrium and myometrium of the two groups were detected by immunohistochemistry and real-time PCR.Results:(1) The protein levels of CXCL12 and CXCR4 in endometrium in uterus with adenomyosis (0.229±0.025 and 0.226±0.016) were significantly higher than those in endometrium in uterus without adenomyosis (0.153±0.018 and 0.178±0.026); compared with each other, the differences were statistically significant (all P<0.05). And the expressions of CXCL12 and CXCR4 proteins in uterine myometrium of adenomyosis were 0.222±0.045 and 0.126±0.058, respectively, which were higher than those in the control group (0.091±0.029 and 0.099±0.020); compared with each other, the differences were statistically significant (all P<0.05). (2) The expression levels of CXCL12 and CXCR4 mRNA in endometrium of patients with adenomyosis were 6.31±0.12 and 8.49±0.21, respectively, which were higher than those in the control group (1.23±0.10 and 1.36±0.13); compared with each other, the differences were statistically significant (all P<0.05). Moreover, the expression levels of CXCL12 and CXCR4 mRNA in myometrium of patients with adenomyosis were 9.11±0.12 and 8.45±0.16, respectively, which were higher than those in the control group (1.18±0.08 and 1.46±0.13); compared with each other, the differences were statistically significant (all P<0.05). (3) In endometrium and myometrium of uterus with adenomyosis, CXCL12 and CXCR4 mRNA expression levels were positively associated ( r=0.478, 0.542, all P<0.05). Conclusions:The levels of CXCL12 and CXCR4 in the endometrium and myometrium of adenomyosis are increased and positively correlated. The two chemokine may be involved in the development of adenomyosis.

In the past ten years, the research and application of microbiome has continued to increase. The microbiome has gradually become the research focus in the fields of life science, environmental science, and medicine. Meanwhile, many countries and organizations around the world are launching their own microbiome projects and conducting a multi-faceted layout, striving to gain a strategic position in this promising field. In addition, whether it is scientific research or industrial applications, there has been a climax of research and a wave of investment and financing, accordingly, products and services related to the microbiome are constantly emerging. However, due to the rapid development of microbiome sequencing and analysis related technologies and methods, the research and application from various countries have not yet unified on the standards of technology, programs, and data. Domestic industry participants also have insufficient understanding of the microbiome. New methods, technologies, and theories have not yet been fully accepted and used. In addition, some of the existing standards and guidelines are too general with poor practicality. This not only causes obstacles in the integration of scientific research data and waste of resources, but also gives related companies unfair competition opportunity. More importantly, China still lacks national standards related to the microbiome, and the national microbiome project is still in the process of preparation. In this context, the experts and practitioners of the microbiome worked together and developed the consensus of experts. It can not only guide domestic scientific research and industrial institutions to regulate the production, learning and research of the microbiome, the application can also provide reference technical basis for the relevant national functional departments, protect the scale and standardized corporate company's interests, strengthen industry self-discipline, avoid unregulated enterprises from disrupting the market, and ultimately promote the benign development of microbiome-related industries.
China ; Consensus ; Humans ; Industry ; Microbiota

Animals ; Cells, Cultured ; Gastrointestinal Tract ; metabolism ; Neuroglia ; metabolism ; Neurons ; metabolism ; Peptide Fragments ; metabolism ; Peptides ; metabolism ; Proteins ; metabolism ; Rats

Objective To investigate the expression of GFAP in rat hypothalamus after acute heat stress. Methods The rats were caged in a experimental incubator for 60 minutes,the temperature within the incubator was adjusted to 24℃,34℃,38.5℃ or 42℃,the humidity was 60%.Single anti-GFAP immunohistochemical(ABC) method and anti-Fos and GFAP double immunohistochemical method were used to observe the expression of GFAP in hypothalamus in different ambient temperatures after heat stress. Results The GFAP-positive cells were rare in hypothalamus at 24℃,however it was increased in many nuclei(anterior hypothalamic area,paraventricular nucleus,arcuate nucleus,suprachiasmatic nucleus and supraoptic nucleus)at 34℃ and peaked when ambient temperature was 38.5℃,and then decreased.However,Fos/GFAP-IR double labelled astrocytes were observed at 42℃.Conclusion Astrocytes participate in the pathophysiological process of heat stress.