Investigator initiated trial （IIT） represents a primary format for clinical research in traditional Chinese medicine （TCM）. As key implementation sites for TCM-based IIT targeting malignant tumors， western medicine institutions often face unique challenges in conducting such studies， which limit their feasibility and standardization. This paper reviews the registration status of TCM-based IIT for malignancies conducted in western medical institutions and analyzes key difficulties， including complex project initiation and management processes， limited TCM knowledge and skills among western medicine physicians， and relatively low patient acceptance of TCM. From a practical perspective， the study proposes several optimization strategies. These include improving the review and management mechanisms of TCM-related IIT within western medical institutions， establishing multidisciplinary clinical research teams that integrate TCM and western medicine， and enhancing investigators' training in TCM theory and clinical skills. Additionally， the study suggests standardizing IIT operational procedures， objectifying the collection of TCM diagnostic information， refining subject recruitment methods， and increasing TCM involvement in patient follow-up and management. These investigator-oriented， TCM-featured， and operable strategies aim to promote the high-quality development of TCM-based IIT in western medicine institutions and enhance the clinical application of TCM.

ObjectiveTo investigate the attenuating effect of Dioscoreae Bulbiferae Rhizoma（DBR） processed with Phaseoli Radiati Semen（PRS） juice， and explore the attenuating mechanism based on ferroptosis of the main toxic target organ. MethodSixty male ICR mice were randomly divided into blank group， DBR group， water roasted DBR group（hereinafter referred to as water group）， PRS juice-roasted DBR group 1（DBR-PRS 10∶1， stuffy moistening for 40 min， stir-fried at 130 ℃ for 18 min， hereinafter referred to as group 1）， PRS juice-roasted DBR group 2（DBR-PRS 10∶1， stuffy moistening for 80 min， stir-fried at 100 ℃ for 14 min， hereinafter referred to as group 2）， PRS juice-roasted DBR group 3（DBR-PRS=20∶3， stuffy moistening for 40 min， stir-fried at 160 ℃ for 14 min， hereinafter referred to as group 3）. The raw and processed groups of DBR were gavaged with their corresponding 95% ethanol extract at a dose of 3 g·kg^-1·d^-1， while the blank group was gavaged with an equal volume of 0.5% sodium carboxymethyl cellulose， once a day for 14 consecutive days. Hematoxylin-eosin（HE） staining was used to observe the histopathological changes of mouse liver. Alanine aminotransferase（ALT） and aspartate aminotransferase（AST） levels in serum， as well as malondialdehyde（MDA）， ferrous ions（Fe²⁺）， reduced glutathione（GSH） and superoxide dismutase（SOD） levels in liver tissue were detected by the biochemical detection. Western blot was used to detect the expression of iron key proteins such as ferritin heavy chain 1（FTH1） and glutathione peroxidase 4（GPX4）. ResultHE staining results showed that the liver tissue structure of the blank group was clear， the morphology of hepatocytes was normal， the cytoplasms of hepatocytes in the DBR group and water group were loose and vacuolar， with obvious pathological damages， and the pathologic damages of mice in the group 1-3 were significantly improved. Compared with the blank group， the levels of ALT， AST， MDA and Fe²⁺ in mice from the DBR group were significantly increased（P<0.01）， while GSH and SOD levels were significantly reduced（P<0.01）， and the protein expression levels of FTH1 and GPX4 were significantly decreased（P<0.01）. Compared with the DBR group， the ALT， AST，MDA and Fe²⁺ levels of mice in the group 1-3 were significantly reduced（P<0.05， P<0.01）， the GSH and SOD levels and the protein expression levels of FTH1 and GPX4 were significantly increased（P<0.01）. Compared with the water group， the AST and MDA levels of mice in the group 1-3 were significantly reduced（P<0.05， P<0.01）， the SOD level significantly increased（P<0.05， P<0.01）， the FTH1 protein expression significantly increased（P<0.01）， and the serum ALT level of mice in the group 2-3 significantly reduce（P<0.01）， Fe²⁺ level significantly reduced（P<0.01）， GSH level significantly increased（P<0.05， P<0.01）， and GPX4 protein expression significantly increased（P<0.05， P<0.01）. Among the group 1-3， the group 3 had the best detoxification effect. ConclutionProcessing with PRS juice can reduce the liver injury induced by DBR， and the mechanism may be related to the inhibition of ferroptosis in the liver.

Objective To investigate the changes in the levels of serum high-sensitivity C-reactive protein(hs-CRP)and soluble fms-like tyrosine kinase-1(sFlt-1)in hypertensive disorder of pregnancy(HDP)patients with fetal growth restriction(FGR),and to evaluate their predictive value for FGR.Methods A total of 137 HDP patients admitted to the Obstetrics De-partment of Ganzhou Maternal and Child Health Hospital from December 2021 to May 2023 were selected as the study subjects.According to whether their fetuses had growth restriction,they were divided into the restricted group(n=46)and the non-re-stricted group(n=91).The general information and serum levels of hs-CRP and sFlt-1 were collected and analyzed.Multiple lo-gistic regression analysis was used to identify the influencing factors for fetal growth restriction in HDP patients,and receiver oper-ating characteristic(ROC)curve was plotted to evaluate the predictive value of serum hs-CRP and sFlt-1 levels for fetal growth restriction in HDP patients.Results Univariate analysis showed that the serum levels of folic acid(FA),vitamin B12(VitB12),and placental growth factor(PIGF)in the restricted group were lower than those in the non-restricted group,while the serum lev-els of hs-CRP and sFlt-1 were higher than those in the non-restricted group,with statistically significant differences(P＜0.05).Multivariate analysis showed that serum hs-CRP,sFlt-1,and PIGF levels were independent risk factors for fetal growth restriction in HDP patients.The H-L test of the model showedx2=7.014,P=0.535,indicating a good fit.The area under the ROC curve(AUC)was 0.932,with a 95％CI of 0.889-0.975(P＜0.05),a sensitivity of 93.50％,and a specificity of 89.00％.Conclusion Serum hs-CRP and sFlt-1 levels are upregulated in HDP patients with fetal growth restriction,indicating their good predictive value for the occurrence of fetal growth restriction.

The Wnt signaling pathway plays an important role in maintaining liver homeostasis and liver regeneration.In healthy livers,the Wnt signaling pathway is mostly inactive,but it is continuously overactivated during cell renewal or regeneration processes,as well as in certain pathological conditions,diseases,precancerous states,and cancers.Persistent liver cell injury often leads to chronic liver diseases such as liver fibrosis,liver cirrhosis,and liver cancer.This article summarizes the basic structural features of the Wnt signaling pathway and analyzes its important role in the pathological progression of various liver diseases,so as to provide new ideas for the prevention and treatment of liver diseases in clinical practice.

Objective To investigate the effects of α7 nicotinic acetylcholine receptor (α7nAChR) on CD11b, IL-1β, IL-18 and TNF-α in acute respiratory distress syndrome (ARDS) mice. Methods A total of 40 healthy and clean male Balb/C mice (6 weeks old) were randomly divided into normal group (N group), normal saline control group (NS group), ARDS group (A group), and ARDS mice treated with nicotinic acetylcholine receptor agonist after bilateral cervical vagotomy group (J group), with 10 mice in each group. The right lung structure of mice in each group was observed by hematoxylin-eosin (HE) staining, the lung tissue wet weight/body weight ratio (LWW/DW ratio) was detected, and the percentage of CD11b in the alveolar lavage fluid of mice was detected by flow cytometry. Real-time fluorescence quantitative polymerase chain reaction (RT-qPCR) was used to detect the expression of IL-1β mRNA, IL-18 mRNA and TNF-α mRNA in left lung tissue. Serum IL-18 was determined by enzyme-linked immunosorbent assay (ELISA) and double antibody sandwich method. Results HE staining of the right lung of mice in group N and NS showed normal structure, while the lung interstitial of mice in group A showed a large number of inflammatory cells infiltrated, alveolar wall thickened, alveolar structure destroyed and alveolar cavity fused. The alveolar structure of mice in group J was intact, with a little damage and alveolar cavity. The percentage of CD11b in alveolar lavage fluid in group A was higher than that in the other three groups, and the difference was statistically significant compared with group N, NS and J, respectively (P<0.05). The expressions of IL-1β mRNA, IL-18 mRNA and TNF-α mRNA in the left lung of mice in group J were statistically significant compared with those in group N, NS and A (P<0.05), and the serum IL-18 level of mice in group A was higher than that in the other three groups, and the differences were statistically significant compared with groups N, NS and J, respectively (P<0.05). Conclusions Activation of α7nAChR can directly inhibit the release of CD11b in lung tissue and reduce the accumulation of inflammatory factors. Simultaneously, it can also directly inhibit the expression of IL-β1 mRNA, IL-18 mRNA and TNF-α mRNA in lung tissue and the release of IL-18, thus inhibiting the inflammatory response of ARDS and alleviating the pathological changes of ARDS.

ObjectiveTo explore the mechanism of Jiawei Wendantang in preventing and treating diabetic atherosclerosis by observing the effect of this prescription on the nuclear factor-κB / NOD-like receptor protein 3（NF-κB/NLRP3） pathway and related inflammatory cytokines in rat model of diabetic atherosclerosis. MethodFifty-four SPF-grade rats were randomized into blank， model， atorvastatin （0.9 mg·kg^-1·d^-1）， and high-， medium-， low-dose （18.2， 9.1， 4.55 g·kg^-1·d^-1， respectively） Jiawei Wendantang groups. The rats in other groups except the blank group were modeled for diabetic atherosclerosis by intraperitoneal injection of streptozotocin and feeding with a high-sugar high-fat diet， and those in the blank group were injected with an equal dose of citric acid buffer and fed with a regular diet. The drug administration lasted for 4 weeks， and the blood glucose level in the tail vein was measured every 6 days. After the last administration， the rats were anesthetized for sample collection. Enzyme-linked immunosorbent assay was employed to measure the serum levels of interleukin-18 （IL-18）， C-reactive protein （CRP）， tumor necrosis factor-α （TNF-α）， and intercellular adhesion molecule-1 （ICAM-1）. Western blot was employed to determine the relative protein levels of NF-κB p65， NLRP3， and ICAM-1 in the abdominal aorta. Real-time quantitative polymerase chain reaction was employed to determine the mRNA levels of NLRP3 and interleukin-1β （IL-1β） in the abdominal aorta. The pathological changes in the thoracic aorta were observed by hematoxylin-eosin staining. ResultCompared with the blank group， the model group showed elevated levels of IL-18， CRP， TNF-α， and ICAM-1 in the serum and blood glucose （P<0.05， P<0.01）， up-regulated protein levels of NF-κB p65， NLRP3， and ICAM-1 （P<0.01）， and up-regulated mRNA levels of NLRP3 and IL-1β （P<0.05）. Compared with model group， Jiawei Wendantang lowered the levels of IL-18， CRP， TNF-α， ICAM-1 and blood glucose （P<0.05， P<0.01）， down-regulated the protein levels of NF-κB p65， NLRP3， and ICAM-1 （P<0.01）， and down-regulated the mRNA levels of NLRP3 and IL-1β （P<0.05， P<0.01）. Moreover， Jiawei Wendantang alleviated the pathological injuries in the thoracic aorta. ConclusionJiawei Wendantang may modulate the NF-κB/NLRP3 signaling pathway to reduce the release and adhesion of inflammatory cytokines and regulate the blood glucose level to treat diabetic atherosclerosis.

Arsenic, as a toxic substance that can affect human health, can cause various neurological disorders, including cognitive impairment, when excessive. Relevant epidemiological surveys and animal experimental studies have shown that exposure to arsenic can not only cause intellectual impairment and peripheral neuropathy in humans, but also lead to abnormal behavior in humans and animals. However, so far, the mechanism of arsenic induced damage to the nervous system is still unclear. Peroxisome proliferator activated receptor γ auxiliary activation factor 1α (PGC-1α), as a nuclear transcription coactivator, can interact with transcription factors or other coactivators and plays a role in biological processes such as mitochondrial biogenesis and energy metabolism. PGC-1α, by activating mitochondrial biogenesis, affecting energy metabolism, activating oxidative stress regulatory factors [catalase (CAT), glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), etc.], mitigates the damage to the central nervous system (CNS), peripheral nervous system (PNS), and blood-brain barrier (BBB) caused by arsenic. This article summarize the research progress of arsenic-induced neurological injury and the mechanism of PGC-1α's role in arsenic-induced neurological injury to provide a theoretical basis for further prevention and treatment of neurological diseases caused by arsenic.

Objective:To understand the electrocardiogram and echocardiography examination results of population in key areas of unexplained sudden death in Yunnan Province (referred to as Yunnan sudden death).Methods:From 2014 to 2022, electrocardiogram examination was performed on population (including same incident cases, relatives of the cases, villagers of the affected villages, and control individuals) in key areas of Yunnan sudden death from May to October each year. Echocardiography examination was performed on relatives of the cases and villagers of the affected villages, and the types of electrocardiogram and echocardiography changes were sorted out and analyzed.Results:Electrocardiogram examination was conducted on 1 same incident case, 241 relatives of the cases, 464 villagers of the affected villages, and 99 control individuals, respectively. The types of electrocardiogram changes in the same incident case were Q-T interval prolongation and sinus tachycardia. A total of 17 types of electrocardiogram changes were detected in the relatives of the cases, mainly including sinus arrhythmia (12.45%, 30/241), sinus bradycardia (11.20%, 27/241), and left axis deviation (8.30%, 20/241). A total of 21 types of electrocardiogram changes were detected in the villagers of the affected villages, mainly including left axis deviation (9.48%, 44/464), sinus bradycardia (8.19%, 38/464), and T-wave abnormalities (7.76%, 36/464). A total of 10 types of electrocardiogram changes were detected in the control individuals, mainly including sinus arrhythmia (12.12%, 12/99), T-wave abnormalities (9.09%, 9/99), and sinus bradycardia (7.07%, 7/99). Echocardiography examination was conducted on 49 relatives of the cases and 365 villagers of the affected villages, respectively. A total of 12 types of echocardiography changes were detected in the relatives of the cases, mainly including tricuspid regurgitation (18.37%, 9/49), decreased right ventricular diastolic function (8.16%, 4/49), aortic regurgitation (6.12%, 3/49), and atrial septal defect (6.12%, 3/49). A total of 15 types of echocardiography changes were detected in the villagers of the affected villages, mainly including tricuspid regurgitation (8.77%, 32/365), aortic regurgitation (6.85%, 25/365), and decreased left ventricular diastolic function (6.58%, 24/365).Conclusion:There are many types of changes in electrocardiogram and echocardiography in the population of key areas of Yunnan sudden death.

【Objective】 To explore the effectiveness of intraovarian injection of platelet-rich plasma(PRP) in the treatment of patients with diminished ovarian reserve(DOR), aiming to provide new diagnostic and therapeutic ideas for the treatment. 【Methods】 A total of 22 patients with DOR who underwent autologous PRP ovarian injection at the Reproductive Medical and Genetic Center of Qinzhou Maternal and Child Health Hospital from January 2021 to December 2023 were collected. Among them, 12 patients underwent assisted reproductive technology for pregnancy. The patient′s anti-Müllerian hormone (AMH), antral follicle count (AFC), basal follicle-stimulating hormone (FSH), basal luteinizing hormone (LH) and basal estradiol (E2) levels were observed. 【Results】 The levels of AMH, AFC, basal FSH, basal LH and basal E2 in 22 patients improved after treatment compared with those before treatment. Of the 12 patients who received assisted reproduction, 2 had IVF cycle canceled due to poor ovarian reaction. Ten patients obtained embryos, of which 5 obtained high-quality embryos. 【Conclusion】 Intraovarian injection of autologous PRP can effectively improve ovarian reserve function in patients with DOR.

【Objective】 To evaluate the quality of laboratory testing using anti-HIV ELISA quality monitoring indicators and continuously improve laboratory testing capabilities. 【Methods】 The data of our blood testing laboratory from July 1, 2020 to December 31, 2022 using laboratory quality monitoring indicators were analyzed, including the reaction sample size and reaction rate of initial test and the reaction sample size and compliance rate of retest. The indoor quality control data of two anti HIV ELISA reagents (Xinchuang and Wantai) during the above time period were collected. A line chart or scatter box chart was drawn to monitor the long-term trends and identify the reasons. Inter-laboratory capability comparison and evaluation with the data from the quality monitoring index evaluation report of the National Health Commission′s Clinical Inspection Center and the National Blood Station Blood Testing Laboratory during the same period was conducted. 【Results】 From July 1, 2020 to December 31, 2022, the initial reaction rates of Xinchuang and Wantai anti HIV ELISA reagents were 0.052% and 0.080%, respectively (P<0.05), and the retest compliance rates were 43.97% and 73.39%, respectively (P<0.001). The linear mean trend of the retest compliance rate of innovative reagents is close to the national average retest compliance rate of the same group, while the retest compliance rate of Wantai reagents is higher than the national average retest compliance rate of the same group reagents. The usage rates of the two reagents are lower than the national average for the same group of reagents. The average dispersion of indoor quality control values between different batches of innovative reagents is greater than that of Wantai reagents, but the dispersion of indoor quality control CV between different batches of reagents is similar. 【Conclusion】 Longitudinal analysis of long-term testing data in our laboratory through laboratory quality monitoring indicators and horizontal comparison of laboratories with the same reagents nationwide are able to promptly identify problems in the laboratory, therefore help correct the problems and continuously improve the laboratory′s quality management system, further enhancing the laboratory′s testing capabilities.