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 observe the effect of acupuncture at "pelvic floor six needles" for mild to moderate female stress urinary incontinence (SUI). METHODS: A total of 60 patients with mild to moderate female SUI were randomly divided into an observation group and a control group, 30 cases each group. The control group received Kegel exercise. The observation group received acupuncture at "pelvic floor six needles" on the basis of the treatment as the control group, bilateral Zhongliao (BL33), Zhibian (BL54), Huiyang (BL35), Shuidao (ST28), Dahe (KI12) and Guanyuan (CV4) were selected, once every other day, 3 times a week, 4 weeks as a course of treatment, a total of 2 courses were required. Before treatment and after 4, 8 weeks of treatment, urine leakage in 1 hour, International Consultation on Incontinence questionnaire short form (ICI-Q-SF) score, and incontinence quality of life questionnaire (I-QOL) score were observed in the two groups, and the clinical efficacy was evaluated. RESULTS: After 8 weeks of treatment, urine leakage in 1 hour and ICI-Q-SF scores in both groups were decreased compared with those before treatment (P<0.05), and urine leakage in 1 hour and ICI-Q-SF score in the observation group were lower than those in the control group (P<0.05). After 4, 8 weeks of treatment, I-QOL scores were increased compared with those before treatment in both groups (P<0.05), and the I-QOL scores in the observation group were higher than those in the control group (P<0.01, P<0.001). The total effective rate of the observation group was 93.3% (28/30), which was higher than 73.3% (22/30) in the control group (P<0.05). CONCLUSION Acupuncture at "pelvic floor six needles" could improve the clinical symptoms and quality of life in patients with mild to moderate female SUI to a certain degree.
Humans ; Female ; Acupuncture Therapy/instrumentation* ; Urinary Incontinence, Stress/physiopathology* ; Middle Aged ; Adult ; Exercise Therapy ; Acupuncture Points ; Pelvic Floor/physiopathology* ; Aged ; Treatment Outcome ; Quality of Life

OBJECTIVE: To evaluate the effects of acupuncture at Hegu (LI4), Taichong (LR3) and Sanyinjiao (SP6) on pain, anxiety, intrapartum blood loss, labor stage, and neonatal outcomes in primiparas. METHODS: One hundred primiparas were randomly divided into an acupuncture group (50 cases, 1 case was eliminated) and a control group (50 cases). The conventional obstetrical nursing was given in the control group. On the basis of the intervention in the control group, acupuncture was applied at bilateral Hegu (LI4), Taichong (LR3) and Sanyinjiao (SP6) in the acupuncture group. The delivery mode and labor stage, the scores of visual analogue scale (VAS) for uterine contraction pain and Hamilton anxiety scale (HAMA) before and after acupuncture, the intrapartum/postpartum blood loss and massive hemorrhage, as well as the neonatal Apgar score after 1, 5, and 10 min of birth, were compared in the two groups. RESULTS: The cesarean section rate was 4.1% (2/49) in the acupuncture group, which was superior to 10.0% (5/50) in the control group (P<0.05). In the acupuncture group, the time of latent phase of 2-cm cervical dilation, active phase, first and second stages of labor, and total labor stage was shorter than that in the control group (P<0.001), the intrapartum blood loss and massive hemorrhage rate were lower than those in the control group (P<0.001, P<0.05). After acupuncture, the VAS and HAMA scores were decreased compared with those before acupuncture in the acupuncture group (P<0.001), the VAS and HAMA scores were increased compared with those before acupuncture in the control group (P<0.001). In the acupuncture group, the VAS and HAMA scores after acupuncture were lower than those in the control group (P<0.001), the changes of the VAS and HAMA scores before and after acupuncture were larger than those in the control group (P<0.001). There were no statistical differences in neonatal Apgar scores between the two groups (P>0.05). CONCLUSION Acupuncture at Hegu (LI4), Taichong (LR3) and Sanyinjiao (SP6) can effectively alleviate the pain and anxiety, shorten the labor stage, reduce the intrapartum blood loss and incidence rate of massive hemorrhage, and promote spontaneous delivery, thereby enhancing maternal comfort and safety in primiparas.
Humans ; Female ; Pregnancy ; Acupuncture Points ; Acupuncture Therapy ; Adult ; Young Adult ; Labor, Obstetric ; Parity

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.

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.

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 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.

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.

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.