BACKGROUND: Spicy food consumption has been reported to be inversely associated with mortality from multiple diseases. However, the effect of spicy food intake on the incidence of vascular diseases in the Chinese population remains unclear. This study was conducted to explore this association. METHODS: This study was performed using the large-scale China Kadoorie Biobank (CKB) prospective cohort of 486,335 participants. The primary outcomes were vascular disease, ischemic heart disease (IHD), major coronary events (MCEs), cerebrovascular disease, stroke, and non-stroke cerebrovascular disease. A Cox proportional hazards regression model was used to assess the association between spicy food consumption and incident vascular diseases. Subgroup analysis was also performed to evaluate the heterogeneity of the association between spicy food consumption and the risk of vascular disease stratified by several basic characteristics. In addition, the joint effects of spicy food consumption and the healthy lifestyle score on the risk of vascular disease were also evaluated, and sensitivity analyses were performed to assess the reliability of the association results. RESULTS: During a median follow-up time of 12.1 years, a total of 136,125 patients with vascular disease, 46,689 patients with IHD, 10,097 patients with MCEs, 80,114 patients with cerebrovascular disease, 56,726 patients with stroke, and 40,098 patients with non-stroke cerebrovascular disease were identified. Participants who consumed spicy food 1-2 days/week (hazard ratio [HR] = 0.95, 95% confidence interval [95% CI] = [0.93, 0.97], P <0.001), 3-5 days/week (HR = 0.96, 95% CI = [0.94, 0.99], P = 0.003), and 6-7 days/week (HR = 0.97, 95% CI = [0.95, 0.99], P = 0.002) had a significantly lower risk of vascular disease than those who consumed spicy food less than once a week ( Ptrend <0.001), especially in those who were younger and living in rural areas. Notably, the disease-based subgroup analysis indicated that the inverse associations remained in IHD ( Ptrend = 0.011) and MCEs ( Ptrend = 0.002) risk. Intriguingly, there was an interaction effect between spicy food consumption and the healthy lifestyle score on the risk of IHD ( Pinteraction = 0.037). CONCLUSIONS Our findings support an inverse association between spicy food consumption and vascular disease in the Chinese population, which may provide additional dietary guidance for the prevention of vascular diseases.
Humans ; Male ; Female ; Prospective Studies ; Middle Aged ; Aged ; Vascular Diseases/etiology* ; Risk Factors ; China/epidemiology* ; Adult ; Proportional Hazards Models ; Cerebrovascular Disorders/epidemiology* ; East Asian People

To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.

To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines. Under the dynamic monitoring data of vaccines post-market approval, this research introduces the fundamental principles of maximizing sequential probability ratio test (MaxSPRT) and Bayesian sequential analysis, employing R software. Through an example of dynamic safety monitoring data of vaccines post-market approval, we analyze using the MaxSPRT and Bayesian sequential analysis. The MaxSPRT identified a safety signal in week 4 ( P<0.05), while Bayesian sequential analysis indicated that the 95% highest density interval for the RR value at week 4 is 1.13-3.27, suggesting the first appearance of a safety signal at week 4. The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data, thereby serving as a valuable method for post-market safety surveillance of vaccines.

AIM:To evaluate the application effec-tiveness of a Bayesian mixture model based on the principal stratum strategy for estimating the com-plier average causal effect(CACE)in clinical trials with non-compliance.METHODS:Using a non-infe-riority randomized controlled trial investigating a novel drug for primary type 2 diabetes mellitus(non-inferiority margin:-0.4)as a case study,the primary analysis applied a Bayesian mixture model under the monotonicity assumption to estimate CACE of between-group differences in glycated he-moglobin(HbA1c)changes within the compliant stratum,followed by non-inferiority testing.Sensi-tivity analyses included a Bayesian mixture model relaxing the monotonicity assumption and compar-ing results with per-protocol set(PPS)analysis.RE-SULTS:In the primary analysis,the posterior mean of CACE for HbA1c change in the compliant stratum was 0.081％,with a one-sided 97.5％credible inter-val lower bound of-0.124,exceeding the non-infe-riority margin(-0.4％),supporting the non-inferiori-ty efficacy of the novel drug in the compliant stra-tum(P(H1|Data)=1).Consistent findings were ob-served in PPS analyses(estimated effect:0.136％;one-sided 97.5％credible interval lower bound:-0.069％),further validating methodological robust-ness.CONCLUSION:In clinical trials with noncom-pliance as an intercurrent event,the Bayesian mix-ture model under the principal stratum strategy ef-fectively adjusts for compliance-related bias and yields conservative,robust estimates of causal ef-fects,supporting its value in efficacy evaluation un-der complex compliance scenarios.

AIM:To evaluate the application effec-tiveness of a Bayesian mixture model based on the principal stratum strategy for estimating the com-plier average causal effect(CACE)in clinical trials with non-compliance.METHODS:Using a non-infe-riority randomized controlled trial investigating a novel drug for primary type 2 diabetes mellitus(non-inferiority margin:-0.4)as a case study,the primary analysis applied a Bayesian mixture model under the monotonicity assumption to estimate CACE of between-group differences in glycated he-moglobin(HbA1c)changes within the compliant stratum,followed by non-inferiority testing.Sensi-tivity analyses included a Bayesian mixture model relaxing the monotonicity assumption and compar-ing results with per-protocol set(PPS)analysis.RE-SULTS:In the primary analysis,the posterior mean of CACE for HbA1c change in the compliant stratum was 0.081％,with a one-sided 97.5％credible inter-val lower bound of-0.124,exceeding the non-infe-riority margin(-0.4％),supporting the non-inferiori-ty efficacy of the novel drug in the compliant stra-tum(P(H1|Data)=1).Consistent findings were ob-served in PPS analyses(estimated effect:0.136％;one-sided 97.5％credible interval lower bound:-0.069％),further validating methodological robust-ness.CONCLUSION:In clinical trials with noncom-pliance as an intercurrent event,the Bayesian mix-ture model under the principal stratum strategy ef-fectively adjusts for compliance-related bias and yields conservative,robust estimates of causal ef-fects,supporting its value in efficacy evaluation un-der complex compliance scenarios.

Objective To make the cost-effectiveness analysis of pembrolizumab and platinum chemotherapy as the first-line treatment for advanced non-small cell lung cancer(NSCLC)in the population with tumor proportion score(TPS)≥1%of PD-L1,and provide some reference for the clinical use and future price negotiation of pembrolizumab.Methods Based on Pubmed database,the published RCT literatures of pembrolizumab were analyzed,and the survival data were extracted,combined with the treatment plan of a tertiary hospital,the Markov model were established to simulate the cost and health effectiveness of patients for twenty years,and the stability of the model was tested by one-way sensitivity analysis and probability sensitivity analysis.Results Twenty years later,the cost-effectiveness ratio of pembrolizumab group and chemotherapy group was ￥58 517.60/quality adjusted life month(QALM)and ￥41 213.08/QALM.Compared with the chemotherapy group,the incremental cost effective ratio(ICER)was ￥104 485.36/QALM.Conclusion When the willingness to pay(WTP)value was ￥30 902/QALM,the pembrolizumab therapy was not more cost-effective advantages than platinum chemotherapy,and the sensitivity analysis showed that the results of the model were relatively stable.

The anterior cruciate ligament (ACL) injury is a common sports injury that has a significant impact on knee function and patients′ mobility. With the popularity of national fitness campaign in China, the incidence of ACL injury is increasing year by year. Currently, there still lacks clinical standards or guidelines on how to choose appropriate treatment methods, surgical plans and rehabilitation protocols for ACL injury. In order to timely reflect the new treatment concept of ACL injury, standardize its diagnosis and treatment and improve the curative effect, the Sports Medicine Society of Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Trauma organized domestic orthopedic and sports medicine experts to formulate the "clinical evidence-based guideline for the diagnosis and treatment of anterior cruciate ligament injury (2022 version)" based on the level of evidence-based medicine and in compliance with the principle of scientificity, practicability and advancement. The present guideline includes 12 recommendations for the diagnosis, treatment and rehabilitation of ACL injury in order to provide guidance and assistance for the clinical diagnosis and treatment of ACL injury in China.

Objective: To analyze the related factors of postoperative complications after laparoscopic assisted D2 radical resection for advanced gastric cancer. Methods: From August 2015 to July 2017, 80 patients with advanced gastric cancer admitted to the First Hospital of Jiaxing were selected.All the patients were treated with laparoscopic-assisted D2 radical resection, and the risk factors related to postoperative complications were analyzed by logistic regression analysis model. Results: There were 33 cases (41.25%) with postoperative system complications, 19 cases (23.75%) with complications of level Ⅱ and above; 15 cases (18.75%) with postoperative local complications, among them 12 cases (15.00%) appeared level Ⅱ and above local complications.The number of concomitant diseases and age were related risk factors for systemic complications in patients with advanced gastric cancer after laparoscopic D2 radical resection (OR=1.982, 95%CI: 2.183-34.405, OR=6.587, 95%CI: 1.738-23.495, all P<0.05). The preoperative neoadjuvant chemotherapy, reconstruction method and age were the risk factors for local complications in patients with advanced gastric cancer after laparoscopic D2 radical resection (OR=8.273, 95%CI: 4.982-35.394, OR=12.304, 95%CI: 2.384-88.921, OR=6.365, 95%CI: 2.183-21.384, all P<0.05). Conclusion Treatment of advanced gastric cancer patients with laparoscopic D2 radical mastectomy, attention should be paid to control the patients' age, preoperative neoadjuvant chemotherapy, reconstruction mode, associated disease and other related risk factors.In order to ensure the safety of patients and to avoid postoperative complications.

Objective To investigate the short-term outcome of vascularized supraclavicular lymph nodes flap transplantation to treat the lower extremity lymphedema.Methods From June,2014 to June,2016,6 cases of stage Ⅱ-Ⅲ lower extremity lymphedema received vascularized supraclavicular lymph nodes flap transplantation in this study.Flap size ranged from 2.5 cm×8.0 cm to 3.5 cm×10.0 cm.The anterior tibial artery and accompanying vein were detached for anastomosis.Results One case suffered flap necrosis and then received lymphatic-venous anastomosis instead;2 cases suffered vascular crisis and partial flap necrosis,but transplanted lymph node survived and the wound were closed with skin graft.The other 3 flaps survived without any complication.Follow-up time ranged from 0.5 to 2.0 years.The affected limb circumference and the incidence of lymphangitis decreased significandy,with no complications observed in donor site.Conclusion Using vascularized supraclavicular lymph nodes flap transplantation to treat lower limb lymphedema,it has satisfactory short-term outcome and no obvious complications.It is a promising treatment choice for patients with lower extremity lymphedema in the early and mid stage.

This study was aimed to examine the effect of Shaoyao Tang (SYT) on the treatment of dextran sulfate sodium (DSS)-induced experimental colitis in mice via targeting the Notch signaling pathway.The mice were equally and randomly divided into the normal control group (control),model group (DSS),DSS + SYT group (17.8 g· kg-1),n=10.Mice were administered with 3.5％ DSS for 7 days for the model establishment.And then,SYT was given to the model group on the second day after the induction of colitis with DSS for 7 days.The effects were studied by the disease activity index (DAI),histological analysis by HE staining,myeloperoxidase (MPO) activity.ELISA was used to measure secretion of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) in the colon tissues.The expression of mRNA and protein of Notch-1,Hes-1,Math-1 and Mucin-2 (Muc-2) were detected using real-time PCR and immunohistochemistry.The results showed that compared with the model group,SYT attenuated symptoms of colitis by decreasing DAI score,histopathologic score and MPO activity,as well as increasing the colon length.SYT treatment also inhibited the production of IL-6 and TNF-a in colon tissues of mice.Furthermore,SYT significantly blocked the expression of mRNA and protein of Notch-1 and Hes-1,but increased the expression of Math-1 and Muc-2.It was concluded that SYT exerted the anti-inflammatory activity in mice model of DSS-induced colitis by inhibiting the Notch signaling pathway.