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.

According to the theory of cancer toxin pathogenesis， tumors are complex syndromes centered on cancer toxin， characterized by multiple time points and locations， interwoven pathogenic toxins， and a combination of deficiency and excess. Postoperative recurrence of colorectal cancer is a dynamic spatiotemporal process. In this paper， the core pathogenesis of postoperative recurrence of colorectal cancer， namely "deficiency of spleen qi， with damp-heat stasis toxin"， has been discussed based on spatiotemporal evolution of cancer toxin. It is suggested that spleen qi depletion leading to the proliferation of cancer toxin represents the temporal characteristic of postoperative recurrence， while the stasis of damp-heat facilitating the aggregation and spread of cancer toxin refelct its spatial pattern. This paper has constructed a holistic spatiotemporal prevention and treatment strategy according to different stages before and after recurrence. Before recurrence， the focus is on prevention， and it is suggested to rectify the healthy qi and fortify spleen， clear heat and resolve dampness， unblock collaterals and remove toxin. After recurrence， the focus should be on treatment， and the strategy is combating cancer and removing toxin， breaking the blood to eliminate disease， regulating and tonifying the zang-fu （脏腑） organs.

Objective:To investigate the resuscitation effect of sodium bicarbonate Ringer's solution on traumatic hemorrhagic shock in patients.Methods:A randomized controlled trial was conducted on 70 patients with traumatic hemorrhagic shock who were admitted to Yiwu Central Hospital between February 2021 and February 2022. The patients were randomly assigned to a control group ( n = 35) and an observation group ( n = 35) using the random number table method. Both groups received routine treatment. The control group was given adequate resuscitation by intravenous injection of a compound sodium chloride injection, while the observation group received restricted resuscitation with sodium bicarbonate Ringer's solution. Related clinical indicators, coagulation function, lactate levels, hemorheological indicators, and incidence of complications were compared between the two groups. Results:The blood oxygen saturation, shock index, pulse pressure difference, and urine output in the observation group were (76.53 ± 2.56)%, (0.43 ± 0.07), (38.56 ± 6.52) mmHg (1 mmHg = 0.133 kPa), and (35.62 ± 4.21) mL/h, respectively. These values were all superior to those in the control group [(65.32 ± 3.21)%, (1.21 ± 0.13), (23.56 ± 4.23) mmHg, (23.65 ± 5.68) mL/h, t = 16.15, 31.25, 11.42, 10.06, all P < 0.001]. The prothrombin time, fibrinogen, activated partial thromboplastin time, and thrombin time in the observation group were (17.65 ± 0.83) seconds, (1.69 ± 0.89) g/L, (39.68 ± 0.52) seconds, and (17.86 ± 0.74) seconds, respectively. These values were significantly superior to those in the control group [(14.56 ± 0.86) seconds, (1.32 ± 0.23) g/L, (35.26 ± 0.16) seconds, and (16.02 ± 0.05) seconds, t = 15.30, 2.38, 48.06, 14.68, all P < 0.05]. The lactate level in the observation group was significantly lower than that in the control group [(2.24 ± 0.53) mmol/L vs. (2.94 ± 0.78) mmol/L, t = 4.39, P < 0.05]. The platelet cohesion, red blood cell deformability, and blood viscosity in each group were significantly reduced, and these indices in the observation group were superior to those in the control group ( t = 13.71, 5.64, 5.67, all P < 0.001). The incidence of complications in the observation group was significantly lower than that in the control group (8.6% (3/35) vs. 60.0% (21/35), χ2 = 10.08, P < 0.05). Conclusion:Restricted resuscitation with sodium bicarbonate Ringer's solution can improve clinical indicators, coagulation function, and lactate levels in patients with traumatic hemorrhagic shock. It can effectively improve hemodynamic indicators and reduce the incidence of complications. It is worthy of clinical promotion.

ObjectiveTo investigate the effect of Dendrobium officinale polysaccharides （DOP） in reversing carbon tetrachloride （CCl₄）-induced hepatic fibrosis （HF） in rats via the Notch signaling pathway and evaluate the therapeutic effect of DOP by ultrasound elastography. MethodFifty-six male SD rats were randomized into normal， model， colchicine （1×10^-4 g·kg^-1）， Fuzheng Huayu powder （0.45 g·kg^-1）， and low-， medium-， and high-dose （0.05， 0.1， 0.2 g·kg^-1） DOP groups （n=8）. The rats in the model group and each treatment group were injected subcutaneously with a mixture of CCl₄-olive oil （2∶3） once every 3 days for 10 weeks. After 6 weeks of modelling， the rats were administrated with corresponding drugs once a day for 4 weeks. Hematoxylin-eosin （HE） staining and Masson staining were employed to observe the pathomorphological changes of the liver tissue. An automatic biochemical analyzer was used to measure the serum levels of alanine aminotransferase （ALT）， aspartate transaminase （AST）， alkaline phosphatase （ALP）， and total bile acids （TBA）. Enzyme-linked immunosorbent assay （ELISA） was employed to measure the serum levels of hyaluronic acid （HA）， laminin （LN）， type Ⅲ precollagen （PC-Ⅲ）， and type Ⅳ collagen （Col-Ⅳ）. The mRNA and protein levels of α-smooth muscle actin （α-SMA）， Notch1， Jagged1， and Hes1 in the liver tissue were determined by Real-time fluorescence quantitative polymerase chain reaction （Real-time PCR） and Western blot， respectively. The Young's modulus （YM） of the rat liver was measured by acoustic radiation force impulse （ARFI） elastography before and after treatment. Then， the correlations of YM with the serum levels of HA， LN， PC-Ⅲ， and Col-Ⅳ and the protein levels of α-SMA and Notch1 signaling pathway-related factors in the liver tissue were analyzed. ResultCompared with the normal group， the model group showed disordered arrangement of liver cell cords， obvious infiltration of inflammatory cells， appearance of a large number of fat vacuoles， and fibrous proliferation， elevated levels of ALT， AST， TBA， ALP， HA， LN， PC-Ⅲ， and Col-Ⅳ in the serum， and up-regulated mRNA and protein levels of α-SMA， Notch1， Jagged1， and Hes1 in the liver tissue （P<0.01）. Compared with the model group， drug interventions alleviated the pseudolobule formation and the collagen deposition in confluent areas. Except that the serum level of ALT in the low-dose DOP group had no significant changes， drug interventions， especially high-dose DOP， lowered the levels of ALT， AST， TBA， ALP， HA， LN， PC-Ⅲ， and Col-Ⅳ in the serum and down-regulated the mRNA and protein levels of α-SMA， Notch1， Jagged1， and Hes1 in the liver tissue （P<0.05， P<0.01）. The results of ARFI and correlation analysis showed that the YM of the liver tissue was increased in the model group （P<0.01） compared with that in the normal group， Compared with the model group， drug interventions decreased YM （P<0.01）. YM was positively correlated with the expression levels of HA， LN， PC-Ⅲ， α-SMA， Notch1， Jagged1， and Hes1s （r=0.754， 0.734， 0.801， 0.885， 0.896， 0.757， and 0.800， respectively， P<0.01）， and it had a moderate correlation with Col-Ⅳ （r=0.688， P<0.01）. ConclusionDOP can reverse HF by down-regulating the Notch1/Jagged1/Hes1 signaling pathway. YM can be used as an indicator in the assessment of the efficacy of DOP against HF.

Objective:To analyze the variations of serum lymphocyte subsets, immunoglobulins, and complement levels in patients with cheilitis, and to explore the associations between the changes in serum immune levels and the onset of cheilitis.Methods:A retrospective analysis was conducted on 153 patients with cheilitis who visited the Department of Stomatology, The First Affiliated Hospital of Zhengzhou University from January 2017 to December 2023. They were compared with 50 healthy individuals who visited the physical examination department during the same period. The changes of serum lymphocyte subsets, immunoglobulins, and complement levels in patients with cheilitis were analyzed. Main detection indicators as the percentage of total T lymphocytes (T%), helper/inducer T lymphocytes (CD4 +T%), absolute numbers of total T lymphocytes (T#), absolute numbers of helper/inducer T lymphocytes (CD4 +T#), percentage of natural killer cells (NK%), absolute numbers of B lymphocytes (B#), immunoglobulins IgG, IgM and complement C3, C4 were included. Multivariate logistic regression was used to explore the relationship between serum lymphocyte subsets, immunoglobulins, complement levels and cheilitis. Subgroup analysis was further conducted on patients with cheilitis based on gender, age, cheilitis type and severity. Results:The levels of T% [69.54% (64.41%, 75.14%)], CD4 +T% [(35.09±7.10)%], T# [1 328.00 (1 054.00, 1 560.50)], and CD4 +T# [653.00 (505.00, 831.50)] in the cheilitis group were significantly lower than those in the control group respectively [72.33% (69.41%, 75.47%), (39.07±5.84)%, 1 483.50 (1 245.75, 1 805.25), 769.00 (687.25, 933.00), with the corresponding statistical test results of Z=-2.64, P=0.008; t=3.58, P<0.001; Z=-2.80, P=0.005; Z=-3.80, P<0.001]. The level of NK% [16.21% (12.16%, 21.29%)] was significantly higher in the cheilitis group compared to the control group [14.61% (10.97%, 17.87%)] ( Z=-2.28, P=0.023). IgG [12.29 (10.77, 13.73) g/L] and IgM levels [1.18 (0.86, 1.58) g/L] were significantly higher in the cheilitis group than in the control group respectively [11.52 (10.16, 12.91) g/L, 0.99 (0.77, 1.26) g/L] ( Z=-2.24, P=0.025; Z=-2.10, P=0.036), while complement C3 [(1.09±0.17) g/L] and C4 levels [0.23 (0.19, 0.28) g/L] were significantly lower in the cheilitis group compared to the control [(1.18±0.17) g/L, 0.31(0.24, 0.35) g/L] ( t=3.10, P=0.002; Z=-4.79, P<0.001). Logistic regression analysis showed that elevated IgG ( P=0.021), decreased C4 ( P<0.001), decreased CD4 +T% ( P=0.003), and decreased T# ( P=0.035) were independent influencing factors for the occurrence of cheilitis. The rate of abnormal lymphocyte immune analysis in the cheilitis group [68.0% (104/153)] was significantly higher than that in the control group [24.0% (12/50)] (χ 2=29.76, P<0.001). The rate of abnormal immunoglobulin and complement detection in the cheilitis group [41.8% (64/153)] was significantly higher than that in the control group [4.0% (2/50)] (χ 2=24.58, P<0.001). The rate of detection abnormalities in female patients with cheilitis [51.5% (53/103)] was significantly higher than in male ones [22.0% (11/50)] (χ 2=12.00, P=0.001). Patients with granulomatous cheilitis had significantly lower levels of T# [1 136.50 (663.75, 1 310.50)] and B# [162.50 (104.00, 225.50)] compared to those with chronic cheilitis [1 366.00 (1 063.03, 1 602.00), 202.48 (148.00, 298.00)] ( Z=-2.35, P=0.019; Z=-2.16, P=0.031). Conclusions:Patients with cheilitis exhibit a certain degree of imbalance on cellular immunity, humoral immunity, and innate immunity, which may be related to the onset of cheilitis.

Objective To assess the prognostic significance of serum cystatin C(CysC)in combination with bedside renal ultrasound for patients diagnosed with sepsis-induced acute kidney injury(AKI).Methods The study cohort comprised 134 patients with sepsis-induced AKI who were admitted to our hospital between October 2019 and October 2023.Based on the 30 day prognosis,the patients were categorized into a survival group(n=93)and a death group(n=41).Collected clinical data included gender,age,heart rate,underlying diseases,treat-ment modalities,duration of hospital stay,basic biochemical indicators,and Acute Physiology and Chronic Health Evaluation Ⅱ(APACHEⅡ)scores.Renal function markers such as serum creatinine(SCr),blood urea nitrogen(BUN),and cystatin C levels were measured;renal blood flow resistance index(RI)was assessed using bedside routine ultrasound.Cox regression analysis was employed to evaluate factors influencing poor prognosis in patients with sepsis-induced AKI while analyzing the prognostic assessment value of combining cystatin C with bedside renal ultrasound through ROC curves.Results The death group exhibited significantly higher APACHEⅡ scores,SCr,BUN,CysC levels,and RI(all P<0.05)compared to the survival group.Cox regression analysis revealed that both CysC levels and RI were significant prognostic indicators(P<0.05).ROC curve analysis demonstrated that the combined assessment of CysC levels and RI yielded a high diagnostic accuracy of 97.5%in predicting outcomes for patients with sepsis-induced AKI.Conclusion CysC levels and bedside renal ultrasound can serve as prognostic indicators for patients with sepsis-induced acute kidney injury(AKI),thereby guiding clinical treatment.

Hypertension heightens the risk of cardiovascular and renal complications in individuals with type 2 diabetes mellitus. Optimal blood pressure (BP) management is crucial for preventing these complications. This review consolidates evidence from clinical trials and major BP management guidelines to shed light on key aspects of hypertension management in diabetes. It addresses BP thresholds to initiate antihypertensive treatment, optimal BP control targets, recommended first-line antihypertensive edications, and BP monitoring plan for the prevention of chronic complications in type 2 diabetes.

Objective To investigate the effect of glaucocalyxin A(GLA)on neuroinflammation and the HMGB1-RAGE signaling pathway in rats with Alzheimer disease(AD).Methods Rats were given intracerebroventricular injec-tion of Aβ1-42 solution to establish a model of AD,and then the rats were randomly divided into sham-operation group,model group,donepezil group,low-dose GLA group and high-dose GLA group,and high GLA+HMGB1 group,with 15 rats in each group.The Morris water maze test was used to assess the learning and memory abilities of rats;HE staining was used to observe the pathological and morphological changes of hippocampal tissue;ELISA was used to measure the lev-els of tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),and interleukin-1β(IL-1β)in hippocampal tissue;immu-nofluorescence assay was used to measure the expression of the microglia marker protein Iba-1 and the astrocyte marker protein GFAP;Western blotting was used to measure the expression of HMGB1-RAGE pathway-related proteins in hippo-campal tissue.Results Compared with the sham-operation group,the model group had significant increases in escape la-tency,the content of TNF-α/IL-6/IL-1β,the positive expression area of Iba-1 and GFAP proteins,and the expression lev-els of HMGB1,RAGE,TLR4,and p-NF-κB p65/NF-κB p65(P<0.05),as well as significant reductions in the time spent in the target quadrant and the number of platform crossings(P<0.05).Compared with the model group,the low-and high-dose GLA groups had significant reductions in escape latency,the content of TNF-α/IL-6/IL-1β,the positive ex-pression area of Iba-1 and GFAP proteins,and the expression levels of HMGB1,RAGE,TLR4,and p-NF-κB p65/NF-κB p65(P<0.05),as well as significant increases in the time spent in the target quadrant and the number of platform crossings(P<0.05),and there were no significant differences between the high-dose GLA group and the donepezil group(P>0.05).Further supplementation experiments using HMGB1 recombinant protein showed that the inhibitory effect of GLA on neuroinflammation was reversed,with a sig-nificant increase in the level of RAGE(P<0.05).Conclusion GLA can alleviate neuroinflammation in AD rats by inhibiting the HMGB1-RAGE signaling pathway.

Background::Coronavirus disease 2019 (COVID-19) has potential risks for both clinically worsening pulmonary hypertension (PH) and increasing mortality. However, the data regarding the protective role of vaccination in this population are still lacking. This study aimed to assess the safety of approved vaccination for patients with PH.Methods::In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) were enrolled from October 2021 to April 2022. The primary outcome was the composite of PH-related major adverse events. We used an inverse probability weighting (IPW) approach to control for possible confounding factors in the baseline characteristics of patients.Results::In total, 706 patients with PH participated in this study (mean age, 40.3 years; mean duration after diagnosis of PH, 8.2 years). All patients received standardized treatment for PH in accordance with guidelines for the diagnosis and treatment of PH in China. Among them, 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. None of the participants were infected with COVID-19 during our study period. Overall, 398 patients received inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine, whereas 30 received recombinant protein subunit vaccine. After adjusting for baseline covariates using the IPW approach, the odds of any adverse events due to PH in the vaccinated group did not statistically significantly increase (27/428 [6.3%] vs. 24/278 [8.6%], odds ratio = 0.72, P = 0.302). Approximately half of the vaccinated patients reported at least one post-vaccination side effects, most of which were mild, including pain at the injection site (159/428, 37.1%), fever (11/428, 2.6%), and fatigue (26/428, 6.1%). Conclusions::COVID-19 vaccination did not significantly augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.

BACKGROUND: Limited data are available on the changes in the quality of care for ST elevation myocardial infarction (STEMI) during China's health system reform from 2009 to 2020. This study aimed to assess the changes in care processes and outcome for STEMI patients in Henan province of central China between 2011 and 2018. METHODS: We compared the data from the Henan STEMI survey conducted in 2011-2012 ( n = 1548, a cross-sectional study) and the Henan STEMI registry in 2016-2018 ( n = 4748, a multicenter, prospective observational study). Changes in care processes and in-hospital mortality were determined. Process of care measures included reperfusion therapies, aspirin, P2Y12 antagonists, β-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statins. Therapy use was analyzed among patients who were considered ideal candidates for treatment. RESULTS: STEMI patients in 2016-2018 were younger (median age: 63.1 vs . 63.8 years) with a lower proportion of women (24.4% [1156/4748] vs . 28.2% [437/1548]) than in 2011-2012. The composite use rate for guideline-recommended treatments increased significantly from 2011 to 2018 (60.9% [5424/8901] vs . 82.7% [22,439/27,129], P <0.001). The proportion of patients treated by reperfusion within 12 h increased from 44.1% (546/1237) to 78.4% (2698/3440) ( P <0.001) with a prolonged median onset-to-first medical contact time (from 144 min to 210 min, P <0.001). The use of antiplatelet agents, statins, and β-blockers increased significantly. The risk of in-hospital mortality significantly decreased over time (6.1% [95/1548] vs . 4.2% [198/4748], odds ratio [OR]: 0.67, 95% confidence interval [CI]: 0.50-0.88, P = 0.005) after adjustment. CONCLUSIONS Gradual implementation of the guideline-recommended treatments in STEMI patients from 2011 to 2018 has been associated with decreased in-hospital mortality. However, gaps persist between clinical practice and guideline recommendation. Public awareness, reperfusion strategies, and construction of chest pain centers need to be further underscored in central China.
Humans ; Female ; Middle Aged ; ST Elevation Myocardial Infarction/drug therapy* ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use* ; Cross-Sectional Studies ; Aspirin/therapeutic use* ; Platelet Aggregation Inhibitors/therapeutic use* ; Adrenergic beta-Antagonists/therapeutic use* ; Hospital Mortality ; Registries ; Treatment Outcome ; Percutaneous Coronary Intervention