Specification for Quality Control in Traditional Chinese Medicine Clinical Trials（GB/T 47336-2026） is the first national standard in the field of clinical research on traditional Chinese medicine （TCM）， aims to address the core issue that the quality shortcomings of current TCM clinical research restrict the transformation of achievements and international recognition. Through the interpretation of the core contents of this standard， including its scope of application， graded quality control system， TCM-specific quality control requirements， implementation and responsible entities， responsibilities of quality control personnel， formulation of quality control plans， critical nodes of quality control， and quality control archive management， it is believed that the promotion and implementation of this standard are of great significance for improving the standard system of TCM clinical research， enhancing research quality， optimizing the quality management model， and promoting the internationalization process of TCM. Meanwhile， the implementation paths for the standard are discussed， including carrying out pilot applications in institutions， establishing publicity， implementation， and training mechanisms， encouraging multi-party collaborative supervision， and setting up implementation feedback mechanisms. On this basis， the challenges that may be encountered during implementation， such as resource input pressure， difficulties in implementing TCM-specific quality control， and a relative shortage of interdisciplinary composite talents， are sorted out， and corresponding strategies are proposed， which can provide references for relevant researchers and practitioners.

ObjectiveTo investigate the expression and prognostic significance of human epidermal growth factor receptor 2 （HER-2）， vascular endothelial growth factor-A （VEGF-A）， and programmed death-ligand 1 （PD-L1） in gallbladder cancer， and to provide a theoretical basis for subsequent research. MethodsA retrospective analysis was performed for the postoperative specimens and clinical data of 55 patients who underwent radical cholecystectomy for gallbladder cancer and had pathologically confirmed gallbladder adenocarcinoma in The Affiliated Hospital of Inner Mongolia Medical University from December 2017 to September 2019. Immunohistochemical staining was used to measure the expression levels of HER-2， VEGF-A， and PD-L1 in cancerous tissue and paracancerous tissue. The association between the expression of these three markers and clinical features were analyzed， as well as their impact on the prognosis of patients. The independent-samples t test was used for comparison of normally distributed continuous data between groups， and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups； the chi-square test was used for comparison of categorical data between groups. The Cox regression model was used to perform the univariate and multivariate analyses of clinical factors. The Kaplan-Meier curve was used to analyze the prognosis of patients， and the Log-rank test was used for comparison. ResultsAmong the 55 patients， 15 patients （27.2%） had a high expression level of HER-2 in cancerous tissue， 23 （41.8%） had a high expression level of VEGF-A， and 18 （32.7%） had a high expression level of PD-L1， with significant differences compared with the paracancerous tissue （all P<0.05）. There was a significant difference in tumor location between the groups with different expression levels of HER-2 （P<0.05）； there were significant differences in maximum tumor diameter， degree of tumor differentiation， tumor location， N stage， peripheral organ invasion， and vascular invasion between the groups with different expression levels of VEGF-A （all P<0.05）； there were significant differences in peripheral organ invasion， vascular invasion， and disease stage between the groups with different expression levels of PD-L1 （all P<0.05）. The multivariate Cox analysis showed that preoperative CA19-9 level and HER-2 expression were independent risk factors for overall survival of patients （P<0.05）， and preoperative CA19-9 level， maximum tumor diameter， N stage， VEGF-A， and PD-L1 were independent influencing factors for progression-free survival of patients （P<0.05）. The Kaplan-Meier analysis showed that there were significant differences in overall survival and progression-free survival between the patients with high HER-2 expression and those with low HER-2 expression （P<0.05）. ConclusionHER-2， VEGF-A， and PD-L1 have an important clinical significance for patients with gallbladder cancer and are potential sites for targeted therapy.

Purpose To investigate the expression of LAMB3 and ITGB4 in esophageal squamous cell carcinoma(ESCC)and analyze their associations with clinicopathological features.Methods Bioinformatics was used to assess the expression of LAMB3 and ITGB4 in pan-cancer and ESCC.Immunohistochemistry was performed to evaluate their expression and distribution in ESCC tissues,and correlations clinicopathological features were analyzed.Follow-up data were collected to construct Kaplan-Meier survival curves,and Cox regression analysis was proformed to determine their prognostic significance.Results Bioinformatics analysis showed that LAMB3 and ITGB4 were highly expressed in ES-CC tissues(P＜0.001).Immunohistochemistry confirmed that both proteins were localized in the cytoplasm and membrane of tumor cells.High LAMB3 expression was significantly associated with poor differentiation(P＜0.001),lymph node metastasis(P=0.015),and T staging(P＜0.001).High ITGB4 expression was significantly correlated with poor differentiation(P=0.004)and advanced T staging(P=0.004).Cox regression analysis identified high ex-pression of LAMB3 and ITGB4 as independent prognostic factors for overall survival[HR=4.97(95％CI:2.73-9.02);HR=2.33(95％CI:1.36-3.99)].Conclusion LAMB3 and ITGB4 are highly expressed in ESCC.High LAMB3 expression is associated with tumor differentiation,lymph node metastasis,and T staging,while high ITGB4 expression is correlated with tumor differentiation and T staging.Patients with high expression of LAMB3 or ITGB4 have poorer overall survival,suggesting that these proteins may serve as prognostic biomarkers for unfavorable outcome in ESCC.

Purpose To investigate the expression of LAMB3 and ITGB4 in esophageal squamous cell carcinoma(ESCC)and analyze their associations with clinicopathological features.Methods Bioinformatics was used to assess the expression of LAMB3 and ITGB4 in pan-cancer and ESCC.Immunohistochemistry was performed to evaluate their expression and distribution in ESCC tissues,and correlations clinicopathological features were analyzed.Follow-up data were collected to construct Kaplan-Meier survival curves,and Cox regression analysis was proformed to determine their prognostic significance.Results Bioinformatics analysis showed that LAMB3 and ITGB4 were highly expressed in ES-CC tissues(P＜0.001).Immunohistochemistry confirmed that both proteins were localized in the cytoplasm and membrane of tumor cells.High LAMB3 expression was significantly associated with poor differentiation(P＜0.001),lymph node metastasis(P=0.015),and T staging(P＜0.001).High ITGB4 expression was significantly correlated with poor differentiation(P=0.004)and advanced T staging(P=0.004).Cox regression analysis identified high ex-pression of LAMB3 and ITGB4 as independent prognostic factors for overall survival[HR=4.97(95％CI:2.73-9.02);HR=2.33(95％CI:1.36-3.99)].Conclusion LAMB3 and ITGB4 are highly expressed in ESCC.High LAMB3 expression is associated with tumor differentiation,lymph node metastasis,and T staging,while high ITGB4 expression is correlated with tumor differentiation and T staging.Patients with high expression of LAMB3 or ITGB4 have poorer overall survival,suggesting that these proteins may serve as prognostic biomarkers for unfavorable outcome in ESCC.

Through the textual research and analysis of the variety， origin， processing， quality evaluation and clinical application of Moslae Herba in ancient and modern literature， its origin of materia medica was clarified. Moslae Herba has experienced variety changes in history. Elsholtzia ciliata was the mainstream variety during and before the Song dynasty， however， during the Ming and Qing dynasties， emerging variety of Mosla chinensis rose to the mainstream status due to its remarkable efficacy and the formation of cultivation， and differentiated into two commodities（wild variety of Qingxiangru and cultivated variety of Jiangxiangru）， cultivated products formed an authentic producing area in Jiangxi. The three varieties coexisted during the Ming and Qing dynasties， and the Elsholtzia varieties were gradually eliminated. Variety changes have caused changes in the functions and indications of drugs. E. ciliata had the effect of clearing heat and was mainly used to treat heatstroke and cholera， while M. chinensis was used for exogenous wind cold and dampness in the summer because of its warm and strong sweating properties， but not for cholera. Traditional Moslae Herba is mainly harvested in the summer and autumn （flowering to fruiting stage） and the above-ground parts are dry in the shade and used as medicine. Modern Qingxiangru is mostly harvested before the flowering period， and Jiangxiangru is harvested after flowering and fruiting in late summer and early autumn. In summary， according to the 2020 edition of Chinese Pharmacopoeia， the dried above-ground parts of Moslae Herba should be selected for Xinjia Xiangruyin in the Catalogue of Ancient Famous Classical Formulas（The First Batch）， mainly the cultivated variety of Jiangxiangru， and the raw products is cut into segments and used as medicine. It is suggested that when applying and developing famous classical formulas containing Moslae Herba at different periods of time today， the origin should be established in conjunction with clinical efficacy.

Through the textual research and analysis of ancient and modern documents of Acanthopanacis Cortex（AC）， this paper combed the variety， origin， harvesting， processing and ancient quality evaluation methods of AC， and clarified the historical context of the mixing of its common counterfeit product（Periplocae Cortex）， in order to provide a basis for the development of famous classical formulas containing AC. AC was first published in Shennong Bencaojing with the name of Wujia， Wujiapi is the name rectification in all dynasties since Leigong Paozhilun. According to the description of inflorescence location and fruit morphology of Wujia in the materia medica， it is judged that the mainstream origin of AC used in previous dynasties was Acanthopanax gracilistylus. Periplocae Cortex was mixed with AC in the period of the Republic of China because it was in line with the "like Lycii Cortex， light， brittle and fragrant". The origin of Wujiapi recorded in past dynasties was concentrated in the middle and lower reaches of the Yangtze River， mainly in Hubei， Henan， Anhui and other places. Since modern times， the traditional quality evaluation of AC has been gradually summarized， with thick skin， white color and fragrant smell as the best. The traditional harvesting and processing of AC involved picking the stems in May and July of the lunar calendar， picking the roots in October， and drying in the shade. In modern times， the roots of AC are harvested， washed， peeled and dried in summer and autumn. In the past dynasties， there were rice wine processing， Euodiae Fructus boiling， ginger juice processing and other methods. In modern times， it is usually cut into thick slices after the cleansing. According to the research results， it is suggested that the root bark of A. gracilistylus should be selected as the origin of AC in famous classical formulas， which should be processed into the medicine according to the specific prescription requirements. In addition， it is suggested to restore the medicinal name of Periplocae Cortex as Yangtao， in order to reduce its chaotic influence on the medicinal use of AC.

【Objective】 To analyze the correlation between the expressions of CD10,CA9 and CD133 and the prognosis of patients with metastatic renal clear cell carcinoma (mccRCC) treated with sorafenib or sunitinib. 【Methods】 A total of 80 mccRCC patients who received sorafenib or sunitinib as first-line therapy were retrospectively enrolled. Immunohistochemical staining (IHC) was performed for CD10,CA9 and CD133 in tumor tissue samples to analyze the correlation between the expression of each marker and clinicopathologic variables. Univariate and multivariate Cox proportional risk models were used to analyze prognostic factors of progression free survival (PFS) and overall survival (OS),and Kaplan-Meier survival analysis was performed for CA9 expression and PFS,OS in the treatment subgroups. 【Results】 Altogether 37 patients (46.25%) had PFS,and the median PFS (mPFS) was 24.9 months (95%CI:16.5-33.2 months),while 55 patients (68.75%) died and the median OS (mOS) was 44.2 months (95%CI:14.6-73.7). Low expression of CD10 was correlated with high Fuhrman grade (χ²=6.241,P=0.012),lymph node metastasis (χ²=5.952,P=0.015),and the number of metastatic organs ≥2 (χ²=8.205,P=0.004). Univariate analysis showed that Fuhrman grade,number of metastatic organs and lymph node metastasis were the prognostic factors of PFS (P<0.05),while the number of metastatic organs,lymph node metastasis and CA9 expression were the prognostic factors of OS (P<0.05). Multivariate analysis showed that Fuhrman grade was an independent factor of PFS (HR=2.457,95%CI:1.126-5.365,P=0.024),and the number of metastatic organs was an independent prognostic factor of OS (HR=1.857,95%CI:1.048-3.290,P=0.034). Survival analysis in subgroups showed that high CA9 expression in the sorafenib group was associated with longer OS (HR=0.401,95%CI:0.204-0.787,P=0.008). 【Conclusion】 Low expression of CA9 is an non-independent risk factor for OS,while CD10 and CD133 cannot be used as prognostic factors for mccRCC patients. Since mccRCC patients with low CA9 expression have less survival benefit from sorafenib and sunitinib,they can choose target therapy combined with immunotherapy or dual immunotherapy according to the guidelines to improve prognosis.

With the decline in male fertility in recent years, infertility has become an urgent global problem to be solved. Existing evidence shows that gut microbiota has an important impact on male reproductive health, and gut microbiota disorder can affect spermatogenesis by inducing inflammation, metabolic disorder and endocrine disruption. This paper systematically reviews the relevant research progress in this field, focusing on the impact of gut microbiota disorder on male reproductive ability from the aspects of gut microbiota and spermatogenesis, gut microbiota and sex hormone metabolism, effects of fecal microbiota transplantation and dietary regulation on male reproductive function, and discusses the future research directions of gut micro-biota and male infertility.

Malignant mesothelioma of the tunica vaginalis testis (MMTVT) is a rare tumor. At present, there are still many disputes in its epidemiology, pathogenesis, selection of diagnostic methods, treatment and prognosis. Asbestos exposure, ionizing radiation and chromosome abnormalities are the risk factors of MMTVT. Immunohistochemistry, ultrasonography and electron microscope can be used for the diagnosis and aggressive surgery is the main treatment method. The development of endoscopic surgery, multi-disciplinary treatment (MDT), tumor targeted therapy and immunotherapy will bring more benefits to MMTVT patients.

Objective:To investigate the clinical effect of esophagofundostomy combined with pericardial devascularization in the treatment of upper gastrointestinal hemorrhage caused by portal hypertension.Methods:The clinical data of 108 patients with portal hypertension admitted to the Affiliated Hospital of Inner Mongolia Medical University from Feb 2009 to Feb 2015 were analyzed. Among them 42 patients underwent esophagofundostomy combined with pericardial devascularization as the study group, and 66 patients underwent pericardial devascularization only as the control group. All patients presented with splenomegaly or hypersplenism; the spleen was routinely removed during the operation.Results:The difference of operation time between the study group and the control group was statistically significant [(157±41) min vs. (143±27) min, t=2.81, P<0.05]. The improvement in the esophagogastric varices in the study group within 6 months was significantly better than that in the control group( Z=2.47, P<0.05). In addition, the rebleeding rates of varicose veins within 1, 3 and 5 years in the study group was 2%, 5% and 10%, while that in the control group was 15%, 21% and 26% (χ 2=5.49, 4.27, 4.31, all P<0.05). Conclusions:Esophagofundostomy combined with pericardia devascularization achieves complete devascularization and low rebleeding rate.