Objective:To evaluate the clinical efficacy of Rougan Jianpi therapy combined with Mesalazine enema in the treatment of distal ulcerative colitis (DUC) with Ganyu-Pixu syndrome.Methods:This study is a prospective parallel randomized controlled study. From November 2021 to May 2022, 115 patients with DUC in Changshu Hospital Affiliated to Nanjing University of Chinese Medicine were selected and randomly divided into a control group of 58 patients and a study group of 57 patients. The control group was treated with Mesalazine enema, and the study group was treated with Rougan Jianpi Decoction on the basis of the control group. Both groups were treated for 8 weeks. The severity of the disease was evaluated by using the Modified Mayo Scale, and the clinical and endoscopic efficacy was evaluated based on the changes in the score before and after treatment. TCM syndromes were scored from four aspects: abdominal pain, diarrhea, mucopurulent bloody stool, Rectal tenesmus, and anal burning. The quality of life was evaluated by using the IBD Quality of Life Scale (IBDQ). The serum TNF-αand IL-10 level were detected by using ELISA method. The adverse reactions during treatment were observed and recorded.Results:The total effective rate of the study group was 91.23% (52/57), while that of the control group was 79.31% (46/58). The difference between the two groups was no statistically significant ( Z=1.47, P=0.143). The proportion of patients in the study group who achieved clinical response[40.35% (23/57) vs. 51.72% (30/58)] and clinical relief [59.65% (34/57) vs. 43.11% (25/58)] the total proportion were significantly higher than those in the control group [100.00% (57/57) vs. 94.83% (55/58); Z=1.97, P=0.049]. The proportion of patients with endoscopic response [52.63% (30/57) vs. 56.90% (33/58)] and mucosal healing [33.33% (19/57) vs. 17.24% (10/58)] the total proportion in the study group were significantly higher than those in the control group [85.96% (49/57) vs. 74.14% (43/58); Z=2.23, P=0.026]. after treatment, the IBDQ score [(194.3±15.1) vs. (172.6±18.4), t=6.90] in the study group was significantly higher than that of the control group. After treatment, the patient's TCM symptom score: mucopurulent bloody stool [(1.7±0.8) vs. (2.0±0.6), t=2.03], rectal tenesmus [(1.5±0.6) vs. (1.8±0.6), t=2.32] and anal burning [(1.3±0.6) vs. (1.6±0.7), t=2.38] in the control group were significantly lower than those in the control group ( P<0.05). The level of IL-10 [(53.3±8.0) ng/L vs. (49.0±6.7) ng/L, t=3.10] in the study group after treatment was higher than that of the control group ( P<0.01), and TNF-α [(28.3±7.9)ng/L vs. (36.8±8.1)ng/L, t=3.58] was lower than that of the control group ( P<0.01). There were no significant adverse reactions observed during the treatment in both groups. Conclusion:Method of Rougan Jianpi combined with mesalazine enema can improve the clinical symptoms of DUC patients, improve clinical efficacy, and have good safety.

Objective:To clarify the clinicopathological features, prognosis, and recurrence pattern of early-onset gastric cancer (EOGC).Methods:Using data from the gastric cancer database of Zhongshan Hospital, Fudan University, we performed a retrospective, large-scale, real-world study of 5046 patients with gastric cancer who had undergone redical or palliative gastrectomy from January 2013 to December 2018, including 425 patients with EOGC (age ≤45 years) and 4621 controls. All those patients were pathologically confirmed adenocarcinoma with complete follow-up of five years. Residue gastric cancer and patients without complete clinical or follow-up data were excluded. We used a combination of outpatient and telephone follow-up, ending in October 2022 (median duration of follow-up 60 months), and compared the clinicopathological features and prognosis of the two groups.Results:The clinicopathological features of EOGC included female predominance (61.1% [262/425 vs. 26.3% [1217/4621], χ 2=234.215, P<0.001), fewer comorbidities (31.3% [133/425] vs. 58.5% [2703/4621], χ 2=34.378, P<0.001), poorer differentiation (90.6% [385/425] vs. 78.2% [3614/4621], χ 2=30.642, P<0.001), higher proportion of diffuse type (53.9% [229/425] vs. 18.3% [846/4621], χ 2=274.474, P<0.001), higher proportion of T4 stage (44.7% [190/425] vs. 37.5% [1733/4621], χ 2=17.535, P=0.001), more lymph node metastases (60.5% [257/425] vs. 53.9% [2491/4621], χ 2=6.764, P=0.009), and higher proportion of pathological stage III/IV (47.5% [202/425] vs. 42.4% [1959/4621], χ 2=4.093, P=0.043). The 5-year overall survival rates of the EOGC and control groups were 55.1% and 49.1%, respectively. Overall survival was significantly better in the EOGC than in the control group ( P<0.001). According to subgroup analysis, the prognosis of pathological stage I/II/III EOGC was better than that of the control group. Recurrence rates were similar in the two groups, whereas patients with EOGC had a higher proportion of peritoneal recurrence (7.8% [33/425] vs. 3.2% [146/4621], χ 2=23.741, P<0.001) and a lower proportion of distant metastasis (4.9% [21/425] vs. 8.3% [385/4621], χ 2=6.247, P=0.012). Conclusion:EOGC has unique clinicopathological features and recurrence patterns and resectable EOGC has a better prognosis, suggesting that patients with EOGC should be actively treated with the focus on preventing peritoneal recurrence.

Objectives:To compare the efficacy of the combination of excimer laser coronary angioplasty(ELCA)and drug-coated balloon(DCB)for in-stent restenosis(ISR)and to evaluate the impact of neointimal tissue characteristics on treatment outcomes. Methods:A total of 96 ISR lesions from 86 patients who underwent optical coherence tomography(OCT)evaluation and DCB with or without ELCA treatment at The First Medical Center of Chinese PLA General Hospital from January 2019 to May 2023 were retrospectively analyzed.ISR lesions were divided into ELCA+DCB group(n=30)and DCB group(n=66).Additionally,ISR lesions were classified as homogeneous and non-heterogeneous patterns based on the OCT characteristics of the neointimal tissue,and the impact on acute lumen gains was compared between different ISR patterns.Acute lumen gain(ΔMLA)was defined as the changes in minimum lumen area before and after the intervention. Results:The ELCA+DCB group had a significantly greater ΔMLA than the DCB group([3.2±0.8]mm2 vs.[2.6±1.4]mm2,P=0.015).Among the ISR with a homogeneous pattern,the ΔMLA of the ELCA+DCB group was significantly greater than that of the DCB group([3.0±0.9]mm2 vs.[2.2±1.1]mm2,P=0.030).There was no significant difference in ΔMLA between the two ISR groups with the non-homogeneous pattern([3.4±0.7]mm2 vs.[3.2±1.5]mm2,P=0.533).There was no death,the rate of target lesion revascularization was similar between the patients with lesions receiving DCB treatment and patients receiving ELCA +DCB treatment(7.4%vs.4.2%,P＞0.05). Conclusions:The combination of ELCA and DCB is an effective strategy for treating ISR,which can achieve greater acute lumen gain compared to DCB treatment alone,especially for the treatment of homogenous ISR pattern characterized by OCT.

Objective To investigate the clinical efficacy and safety of the combination PP(Pemetrexed+Cisplatin)regimen of sindilizumab(Sintilimab)+bevacizumab(Bevacizumab)in advanced non-squamous non-small cell lung cancer(NSCLC)with disease progression after treatment with epidermal growth factor receptor(EGFR)tyrosine kinase inhibitors.Methods Patients with advanced non-squamous NSCLC with disease progression after receiving EGFR tyrosine kinase inhibitor treatment from January 2019 to January 2022 were retrospectively selected from The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine.According to the different treatment modalities,patients were divided into the pemetrexed+cisplatin treatment group(Chemotherapy)group and the pemetrexed+cisplatin+si ndilizumab+bevacizumab treatment(Sintilimab+Bevacizumab)group.Progression-free survival(PFS),overall survival(OS),objective response rate(ORR)and disease control rate(DCR)were compared between the two groups and the occurrence of adverse reactions was assessed.Results A total of 107 patients were enrolled in the study,53 in the Sintilimab+Bevacizumab group and 54 in the Chemotherapy group.The median PFS and median OS were significantly higher in the Sintilimab+Bevacizumab group than in the Chemotherapy group(P＜0.05).The median PFS and median OS in the Sintilimab+Bevacizumab group were significantly higher than in the Chemotherapy group.Bevacizumab group had no statistically significant difference in ORR with Chemotherapy group(P＞0.05),while DCR was significantly higher than Chemotherapy group(P＜0.05).The main adverse reactions were similar in both groups with the most common adverse events being anemia and neutrophils decrease.Conclusion Sintilimab+Bevacizumab combined with PP regimen treatment improved DCR and prolonged PFS and OS in patients with advanced non-squamous NSCLC whose disease progressed after EGFR tyrosine kinase inhibitor treatment.

ObjectiveTo explore the effect of mentality-controlling on local microcirculation of acupuncture at Hegu （LI 4）. MethodsForty healthy subjects were randomly divided into simple acupuncture group and mentality-controlling acupuncture group， with 20 cases in each group. The simple acupuncture group was acupunctured at Hegu （LI 4） on the right hand of the patient. In mentality-controlling acupuncture group， an audio clip was played to guide the participants to control their mentality when needle retention for 5 min after performing acupuncture twirling mani-pulation. The microcirculatory blood perfusion units （MBPU） was captured and compared between groups of participants using laser speckle contrast imaging （LSCI） for 5 mins in each of the four stages， state before acupuncture （R1）， after needle insertion （A1）， after needle twirling （A2） and after needle withdrawal （R2）. The participants' feelings such as relaxation， concentration， drowsiness， energy flow at acupoints were compared between groups， and the adverse reactions were recorded. ResultsThe MBPU values of R1， A1， A2 and R2 stages in mentality-controlling acupuncture group were 67.92±18.40 PU， 168.13±46.03 PU， 144.19±44.40 PU， 159.73±65.21 PU， respectively. The simple acupuncture group were 79.85 （66.80， 99.40）PU， 193.31 （173.15， 224.80）PU， 147.68 （128.12， 198.30）PU， 158.09 （126.05， 207.59）PU respectively. There was a statistically significant difference in MBPU between groups of the four stages （P＜0.01）. Among them， the MBPU in the A1 stage of both groups was significantly larger than that in the R1 stage， the MBPU in the A2 stage significantly smaller than that in the A1 stage， and the MBPU in the R2 stage was significantly larger than that in the R1 stage （P＜0.01）. MBPU in the R2 stage of the mentality-controlling acupuncture group was larger than that in the A2 stage （P＜0.05）. The difference of MBPU between A2 and A1 in mentality-controlling acupuncture group was significantly smaller than that in the simple acupuncture group， and the difference was statistically significant （t = 3.79， P＜0.01）. In mentality-controlling acupuncture group， 18 participants felt relaxed （90%）， 15 concentrated （75%）， 3 felt sleepy （15%）， and 14 felt energy flow at acupoints （70%）； while in the simple acupuncture group， 13 participants felt relaxed and sleepy （65%）， 6 concentrated and 6 felt energy flow at acupoints （30%）. The number of participants with concentration and energy flow at acupoints in mentality-controlling acupuncture group was higher than that in the simple acupuncture group， and the number felt sleepy was lower than that in the simple acupuncture group （P＜0.05）. No needle fainting， needle site infection， local haematoma and any other adverse reactions were found in both groups. ConclusionAcupuncture could affect the changes of local microcirculation， and controlling mentality during acupuncture can slow the rate of MBPU reduction and enhance the post-acupuncture effect with a favourable safety profile.

Objective:To clarify the clinicopathological features, prognosis, and recurrence pattern of early-onset gastric cancer (EOGC).Methods:Using data from the gastric cancer database of Zhongshan Hospital, Fudan University, we performed a retrospective, large-scale, real-world study of 5046 patients with gastric cancer who had undergone redical or palliative gastrectomy from January 2013 to December 2018, including 425 patients with EOGC (age ≤45 years) and 4621 controls. All those patients were pathologically confirmed adenocarcinoma with complete follow-up of five years. Residue gastric cancer and patients without complete clinical or follow-up data were excluded. We used a combination of outpatient and telephone follow-up, ending in October 2022 (median duration of follow-up 60 months), and compared the clinicopathological features and prognosis of the two groups.Results:The clinicopathological features of EOGC included female predominance (61.1% [262/425 vs. 26.3% [1217/4621], χ 2=234.215, P<0.001), fewer comorbidities (31.3% [133/425] vs. 58.5% [2703/4621], χ 2=34.378, P<0.001), poorer differentiation (90.6% [385/425] vs. 78.2% [3614/4621], χ 2=30.642, P<0.001), higher proportion of diffuse type (53.9% [229/425] vs. 18.3% [846/4621], χ 2=274.474, P<0.001), higher proportion of T4 stage (44.7% [190/425] vs. 37.5% [1733/4621], χ 2=17.535, P=0.001), more lymph node metastases (60.5% [257/425] vs. 53.9% [2491/4621], χ 2=6.764, P=0.009), and higher proportion of pathological stage III/IV (47.5% [202/425] vs. 42.4% [1959/4621], χ 2=4.093, P=0.043). The 5-year overall survival rates of the EOGC and control groups were 55.1% and 49.1%, respectively. Overall survival was significantly better in the EOGC than in the control group ( P<0.001). According to subgroup analysis, the prognosis of pathological stage I/II/III EOGC was better than that of the control group. Recurrence rates were similar in the two groups, whereas patients with EOGC had a higher proportion of peritoneal recurrence (7.8% [33/425] vs. 3.2% [146/4621], χ 2=23.741, P<0.001) and a lower proportion of distant metastasis (4.9% [21/425] vs. 8.3% [385/4621], χ 2=6.247, P=0.012). Conclusion:EOGC has unique clinicopathological features and recurrence patterns and resectable EOGC has a better prognosis, suggesting that patients with EOGC should be actively treated with the focus on preventing peritoneal recurrence.

Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)is the main pathogen that causes COVID-19,which is fast-mutating and highly transmissible.The infection has led to a global epidemic.As the main preventive and control measure,vaccination plays a critical role in fighting a-gainst COVID-19.Although a large number of epitope-based and mucosal vaccines have been stud-ied,few peptide epitope vaccines targeting the mucosa and their functional evaluation have been re-ported.In this study,we used SARS-CoV-2 structural protein M peptide epitope predicted by the IEDB database as an antigenic target to design the MS-3S gene containing 3 050 and 1 229 signal peptides and DCpep optimized for insertion into MS2 phage coat proteins.The expression plasmid pSIP:MS-3S was constructed by cloning the PCR fragments seamlessly and was transformed into Lactiplantibacillus plantarum 18 to obtain the recombinant bacterium LP18:MS-3S.Expression conditions such as induction time,inducer concentration,rotational speed and initial pH were opti-mized.The intranasal immunization experiments were performed to examine the vaccine efficacy.The results showed that the 916 bp-long target gene MS-3S modified and optimized was amplified and used to successfully construct the recombinant bacterial strain LP18:MS-3S.The optimal con-ditions for recombinant protein expression were obtained and verified by Western blot,flow cy-tometry,immunofluorescence and other detection methods.The optimal expression conditions were determined as follows:induction time was 4 h with 100 pg/L of SppIP as the optimal induction concentration.Antibody-specific for the epitope was verified by ELISA experiments in serum,alve-olar lavage fluid and fecal dilutions of mice.In summary,a recombinant bacterial strain expressing the epitope antigen of the SARS-CoV-2 M protein peptide was constructed.The obtained protein can induce the body to produce humoral and mucosal immunity,which lays the foundation for the development of a vaccine candidate for the mucosal immunity of COVID-19.

Purpose To investigate the expression status of GNL3 in gastric cancer,and to explore the role of GNL3 in tumor proliferation,invasion and migration.Methods The ex-pression of GNL3 mRNA in gastric cancer tissues was analyzed by searching database.The expression of GNL3 protein in 51 gastric cancer tissues and 51 adjacent non-tumor tissues was de-tected by immunohistochemistry(IHC)SP method.The correla-tion between GNL3 protein expression and gastric cancer clinical pathological features was analyzed by x2 test.The expression of GNL3 in gastric cancer cells was silenced by transfection of sh-RNA,and the silencing efficiency was verified by Western blot.The effect of silencing GNL3 on the proliferation of gastric cancer cells was examined by CCK-8,colony formation and EdU stai-ning.In addition,wound-healing assay and Transwell assay were performed to detect the effect of GNL3 silencing on cell invasion and migration.Results SangerBox and UALCAN database re-trieval showed that the expression of GNL3 mRNA was signifi-cantly increased in gastric cancer tissues(P＜0.01).IHC stai-ning showed that the positive expression rate of GNL3 protein in gastric cancer tissues was 96.1％,and the high expression rate was 78.4％,which was significantly higher than that in adjacent non-tumor tissues(74.5％,51.0％,P＜0.01).Moreover,the high expression of GNL3 was significantly correlated with lymph node metastasis in gastric cancer patients(x2=4.933,P=0.026).CCK-8,colony formation and EdU staining showed that GNL3 silencing inhibited the proliferation of gastric cancer cell SGC-7901.The wound-healing and Transwell assay showed that GNL3 silencing inhibited the migration and invasion of gastric cancer cell.Conclusion The GNL3 protein is highly expressed in gastric cancer tissues,and closely related to the proliferation,migration and invasion of gastric cancer cells.

Purpose: The purpose of this study was to evaluate the efficacy and safety of red ginseng oil (RXGIN) in men with lower urinary tract symptoms. Materials and Methods: Men aged between 40 and 75 years with a total International Prostate Symptom Score (IPSS) of 8 to 19 points were recruited from April 2020 to December 2020. Subjects were randomly assigned to either the RXGIN group or the control group in a 1:1 ratio and received either RXGIN or placebo daily for 12 weeks. For the primary outcome, changes in IPSS scores at 6 and 12 weeks from baseline were analyzed. The secondary outcomes were changes in International Index of Erectile Function (IIEF), maximum urinary flow rate, and post-void residual volume at weeks 6 and 12 compared to baseline. Urine analysis and blood tests were additionally performed for safety assessment. Results: A total of 88 subjects (RXGIN group, 46; control group, 42) completed the study. The total IPSS and IPSS subscores (residual urine sensation, frequency, intermittency, urgency, weak stream, straining, nocturia, and quality of life) were significantly improved in the RXGIN group compared to the control group at weeks 6 and 12. Total IIEF and sexual desire were significantly improved in the RXGIN group at week 6 and week 12, respectively, but there were no significant changes in the level of serum testosterone or dihydrotestosterone. The serum prostate-specific antigen showed significant decrease at weeks 12. No serious adverse events leading to discontinuation of the study drug were observed in the RXGIN group. Conclusions Red ginseng oil (RXGIN) appears to be safe and effective in improving lower urinary tract symptoms in men and may also improve some aspects of sexual function.

Objective:To evaluate the efficacy of first-line tyrosine kinase inhibitors (TKI) plus immune checkpoint inhibitors (ICI) in metastatic fumarate hydratase-deficient renal cell carcinoma (FH-deficient RCC).Methods:The data of 87 metastatic FH-deficient RCC patients from West China Hospital ( n=44), Renji Hospital ( n=27) and Sun Yat-sen University Cancer Center (n=16) from Mar 2019 to Aug 2022 were retrospectively analyzed. The median age was 37(30, 47) years, the male to female ratio was 1.9∶1. The median size of tumor was 7.5(5.0, 10.0) cm. Sixty-one patients (70.1%) had germline FH mutations, and 26 patients (29.9%) had somatic FH mutations. Forty-nine patients (56.3%) metastasis disease at initial diagnosis, and 38 patients (43.7%) had metachronous metastasis. The most common site of metastasis was lymph node (41/87, 47.1%), followed by bone (33/87, 37.9%), liver (22/87, 25.3%), and lung (14/87, 16.1%). Fifteen patients (17.2%) had weak expression of FH protein and 59 patients (67.8%) had positive PD-L1 expression. The most common treatments were sintilimab plus axitinib (52/87, 59.8%), followed by pembrolizumab plus cabozantinib (7/87, 8.0%), tirelizumab plus axitinib (6/87, 6.9%), pembrolizumab plus axitinib (5/87, 5.7%), and toripalimab plus axitinib (4/87, 4.6%). Thirteen patients (13/87, 14.9%) received other ICI plus TKI combination treatments. Statistical analysis was conducted using R 4.2.3 software. Kaplan Meier survival curve was used to evaluate survival data, and log-rank test was used to compare differences between treatment groups. Results:The overall objective response rate (ORR) and disease control rate (DCR) of first-line TKI + ICI were 39.1% and 89.7%, respectively. The median progression-free survival (PFS) and overall survival (OS) were 16.5 months and 71.0 months, respectively. For first-line sintilimab plus axitinib, the ORR and DCR were 44.2% and 92.3%, respectively. The median PFS was 17.3 months and the median OS was not reached for this combination treatment. The efficacy of first-line tirelizumab plus axitinib was inferior to other treatment strategies (median PFS: 4.0 vs. 16.6 months, P<0.001; median OS: 22.0 vs. 71.0 months, P=0.043). Subgroup analyses further showed that the efficacy of ICI+ TKI combination therapy was consistent in patients with different clinicopathologic and genomic features. However, patients with liver metastasis had shorter OS than those without liver metastasis (median OS: 26.3 vs. 71.0 months, P=0.021). Conclusion:First-line TKI + ICI is effective for metastatic FH-deficient RCC and can significantly prolong the survival of the patients.