1.A retrospective cohort study of the efficacy and safety of oral azvudine versus nirmatrelvir/ritonavir in elderly hospitalized COVID-19 patients aged over 60 years.
Bo YU ; Haiyu WANG ; Guangming LI ; Junyi SUN ; Hong LUO ; Mengzhao YANG ; Yanyang ZHANG ; Ruihan LIU ; Ming CHENG ; Shixi ZHANG ; Guotao LI ; Ling WANG ; Guowu QIAN ; Donghua ZHANG ; Silin LI ; Quancheng KAN ; Jiandong JIANG ; Zhigang REN
Acta Pharmaceutica Sinica B 2025;15(3):1333-1343
Azvudine and nirmatrelvir/ritonavir (Paxlovid) are recommended for COVID-19 treatment in China, but their safety and efficacy in the elderly population are not fully known. In this multicenter, retrospective, cohort study, we identified 5131 elderly hospitalized COVID-19 patients from 32,864 COVID-19 patients admitted to nine hospitals in Henan Province, China, from December 5, 2022, to January 31, 2023. The primary outcome was all-cause death, and the secondary outcome was composite disease progression. Propensity score matching (PSM) was performed to control for confounding factors, including demographics, vaccination status, comorbidities, and laboratory tests. After 2:1 PSM, 1786 elderly patients receiving azvudine and 893 elderly patients receiving Paxlovid were included. Kaplan-Meier and Cox regression analyses revealed that compared with Paxlovid group, azvudine could significantly reduce the risk of all-cause death (log-rank P = 0.002; HR: 0.71, 95% CI: 0.573-0.883, P = 0.002), but there was no difference in composite disease progression (log-rank P = 0.52; HR: 1.05, 95% CI: 0.877-1.260, P = 0.588). Four sensitivity analyses verified the robustness of above results. Subgroup analysis suggested that a greater benefit of azvudine over Paxlovid was observed in elderly patients with primary malignant tumors (P for interaction = 0.005, HR: 0.32, 95% CI: 0.18-0.57) compared to patients without primary malignant tumors. Safety analysis revealed that azvudine treatment had a lower incidence of adverse events and higher lymphocyte levels than Paxlovid treatment. In conclusion, azvudine treatment is not inferior to Paxlovid treatment in terms of all-cause death, composite disease progression and adverse events in elderly hospitalized COVID-19 patients.
2.Role of neoadjuvant rectal score in prognosis and adjuvant chemotherapy decision-making in locally advanced rectal cancer following neoadjuvant short-course radiotherapy and consolidation chemotherapy
Qiang ZENG ; Yuan TANG ; Haitao ZHOU ; Ning LI ; Wenyang LIU ; Silin CHEN ; Shuai LI ; Ningning LU ; Hui FANG ; Shulian WANG ; Yueping LIU ; Yongwen SONG ; Yexiong LI ; Jing JIN
Chinese Journal of Oncology 2024;46(4):335-343
Objectives:To assess the prognostic impact of the neoadjuvant rectal (NAR) score following neoadjuvant short-course radiotherapy and consolidation chemotherapy in locally advanced rectal cancer (LARC), as well as its value in guiding decisions for adjuvant chemotherapy.Methods:Between August 2015 and August 2018, patients were eligible from the STELLAR phase III trial (NCT02533271) who received short-course radiotherapy plus consolidation chemotherapy and for whom the NAR score could be calculated. Based on the NAR score, patients were categorized into low (<8), intermediate (8-16), and high (>16) groups. The Kaplan-Meier method, log rank tests, and multivariate Cox proportional hazard regression models were used to evaluate the impact of the NAR score on disease-free survival (DFS).Results:Out of the 232 patients, 24.1%, 48.7%, and 27.2% had low (56 cases), intermediate (113 cases), and high NAR scores (63 cases), respectively. The median follow-up period was 37 months, with 3-year DFS rates of 87.3%, 68.3%, and 53.4% ( P<0.001) for the low, intermediate, and high NAR score groups. Multivariate analysis demonstrated that the NAR score (intermediate NAR score: HR, 3.10, 95% CI, 1.30-7.37, P=0.011; high NAR scores: HR=5.44, 95% CI, 2.26-13.09, P<0.001), resection status ( HR, 3.00, 95% CI, 1.64-5.52, P<0.001), and adjuvant chemotherapy ( HR, 3.25, 95% CI, 2.01-5.27, P<0.001) were independent prognostic factors for DFS. In patients with R0 resection, the 3-year DFS rates were 97.8% and 78.0% for those with low and intermediate NAR scores who received adjuvant chemotherapy, significantly higher than the 43.2% and 50.6% for those who did not ( P<0.001, P=0.002). There was no significant difference in the 3-year DFS rate (54.2% vs 53.3%, P=0.214) among high NAR score patients, regardless of adjuvant chemotherapy. Conclusions:The NAR score is a robust prognostic indicator in LARC following neoadjuvant short-course radiotherapy and consolidation chemotherapy, with potential implications for subsequent decisions regarding adjuvant chemotherapy. These findings warrant further validation in studies with larger sample sizes.
3.Role of neoadjuvant rectal score in prognosis and adjuvant chemotherapy decision-making in locally advanced rectal cancer following neoadjuvant short-course radiotherapy and consolidation chemotherapy
Qiang ZENG ; Yuan TANG ; Haitao ZHOU ; Ning LI ; Wenyang LIU ; Silin CHEN ; Shuai LI ; Ningning LU ; Hui FANG ; Shulian WANG ; Yueping LIU ; Yongwen SONG ; Yexiong LI ; Jing JIN
Chinese Journal of Oncology 2024;46(4):335-343
Objectives:To assess the prognostic impact of the neoadjuvant rectal (NAR) score following neoadjuvant short-course radiotherapy and consolidation chemotherapy in locally advanced rectal cancer (LARC), as well as its value in guiding decisions for adjuvant chemotherapy.Methods:Between August 2015 and August 2018, patients were eligible from the STELLAR phase III trial (NCT02533271) who received short-course radiotherapy plus consolidation chemotherapy and for whom the NAR score could be calculated. Based on the NAR score, patients were categorized into low (<8), intermediate (8-16), and high (>16) groups. The Kaplan-Meier method, log rank tests, and multivariate Cox proportional hazard regression models were used to evaluate the impact of the NAR score on disease-free survival (DFS).Results:Out of the 232 patients, 24.1%, 48.7%, and 27.2% had low (56 cases), intermediate (113 cases), and high NAR scores (63 cases), respectively. The median follow-up period was 37 months, with 3-year DFS rates of 87.3%, 68.3%, and 53.4% ( P<0.001) for the low, intermediate, and high NAR score groups. Multivariate analysis demonstrated that the NAR score (intermediate NAR score: HR, 3.10, 95% CI, 1.30-7.37, P=0.011; high NAR scores: HR=5.44, 95% CI, 2.26-13.09, P<0.001), resection status ( HR, 3.00, 95% CI, 1.64-5.52, P<0.001), and adjuvant chemotherapy ( HR, 3.25, 95% CI, 2.01-5.27, P<0.001) were independent prognostic factors for DFS. In patients with R0 resection, the 3-year DFS rates were 97.8% and 78.0% for those with low and intermediate NAR scores who received adjuvant chemotherapy, significantly higher than the 43.2% and 50.6% for those who did not ( P<0.001, P=0.002). There was no significant difference in the 3-year DFS rate (54.2% vs 53.3%, P=0.214) among high NAR score patients, regardless of adjuvant chemotherapy. Conclusions:The NAR score is a robust prognostic indicator in LARC following neoadjuvant short-course radiotherapy and consolidation chemotherapy, with potential implications for subsequent decisions regarding adjuvant chemotherapy. These findings warrant further validation in studies with larger sample sizes.
4.Summary of the best evidence for nutritional management in patients with severe pneumonia
Junjie YOU ; Bo LIU ; Mengling CHEN ; Yushan SHEN ; Silin ZHENG ; Min HUANG
Chinese Journal of Nursing 2024;59(13):1616-1623
Objective To summarize the best evidence of nutrition management in patients with severe pneumonia,aiming to offer evidence-based guidance for clinical healthcare professionals.Methods All evidence on nutrition management in patients with severe pneumonia was retrieved from various databases and websites including BMJ Best Practice,UpToDate,National Guideline Clearinghous(NGC),Guidelines International Network(GIN),Registered Nurses'Association of Ontario(RNAO),National Institute for Health and Care Excellence(NICE),Cochrane Library,OVID,PubMed,Embase,Web of Science,CINAHL,Chinese Medical Journal Full-text Database,CNKI,VIP,Wanfang,CBM,American Society for Parenteral and Enteral Nutrition(ASPEN),European Society for Clinical Nutrition and Metabolism(ESPEN),Society of Critical Care Medicine(SCCM)and European Society of Intensive Care Medicine(ESICM).The retrieved evidence included clinical decisions,guidelines,systematic reviews,expert consensuses and evidence summaries.The search period ranged from January 1st,2012 to December 31st,2022.There were 2 researchers who independently assessed the quality of the included studies and then extracted and summarized the evidence by topic.Results A total of 13 articles were involved,including 3 clinical decisions,4 guidelines,1 systematic review,and 5 expert consensuses.A total of 24 pieces of evidence were summarized across 6 aspects which encompassed team building,nutrition screening and assessment,nutritional requirements,nutrition intervention,nutrition monitoring,and health education.Conclusion The production process of this evidence summary followed standardized procedures,ensuring comprehensive content.Medical professionals should integrate clinical conditions,patient factors,and family preferences to select the most optimal evidence in order to enhance patient prognosis and improve medical quality.
5.Construction of a predictive model for postoperative subsyndromal delirium in elderly patients undergoing abdominal surgery
Shunli CHEN ; Yan LIU ; Jing CHEN ; Lingyu TANG ; Ru SONG ; Luyao CAI ; Silin ZHENG
Chinese Journal of Nursing 2024;59(16):2001-2008
Objective To analyze the influencing factors of postoperative subsyndromal delirium in elderly patients undergoing abdominal surgery,and to develop a nomogram risk prediction model.Methods A convenience sampling method was used to select 497 elderly patients who underwent abdominal surgery in a tertiary hospital in Sichuan Province from February to October 2022.The risk prediction model and nomograms model were constructed using Logistic regression analysis and R software.The area under the subject's working characteristic curve(AUC)and Hosmer-Lemshow test were used to evaluate the discrimination and calibration of the model.Results The results of Logistic regression showed that age(OR=1.066),functional activities(OR=1.143),patient controlled intravenous analgesia(OR=5.811),transanal drainage tube(OR=2.276)and postoperative blood transfusion(OR=4.322)were independent influences on the occurrence of postoperative subsyndromal delirium.The p-values of the prediction model in both the training and validation sets were greater than 0.05;the area under the ROC curves were 0.734 and 0.691;the model was presented in the form of nomogram.Conclusion The prediction model developed in this study has good discrimination and accuracy.It can be used to assist clinical staff in identifying patients at high risk of developing postoperative subsyndromal delirium and provide the reference for developing preventive and intervention measures.
6.Causal relationship between gastroesophageal reflux disease and chronic obstructive pulmonary disease based on Mendelian randomization analysis
Bo LIU ; Junjie YOU ; Silin ZHENG ; Min HUANG
Journal of Clinical Medicine in Practice 2024;28(1):113-117
Objective To analyze the causal relationship between gastroesophageal reflux disease (GERD) and chronic obstructive pulmonary disease (COPD) based on the bidirectional two-sample Mendelian randomization (MR). Methods Genetic variation information of GERD and COPD was obtained from Genome-Wide Association Studies (GWAS) and used as instrumental variables. Inverse variance-weighted (IVW), weighted median and MR-Egger methods were used for MR analysis, and sensitivity analysis was performed to validate the robustness of the results. Results A significant positive correlation was observed between genetically predicted GERD and the incidence risk of COPD, but there was no statistical association between COPD and the incidence risk of GERD. Positive IVW result showed that the odds ratio (
7.Diagnostic and prognostic value of bone marrow biopsy in patients with extranodal NK/T-cell lymphoma based on PET-CT staging
Hao ZHENG ; Yong YANG ; Yanyan QIU ; Siqin LIAO ; Cheng HUANG ; Guiqing SHI ; Ruizhi ZHAO ; Tianlan TANG ; Shunyuan WANG ; Silin CHEN ; Tingbo LIU ; Benhua XU
Chinese Journal of Radiation Oncology 2023;32(4):313-318
Objective:To analyze the diagnostic and prognostic value of routine bone marrow examination in patients with extranodal NK/T-cell lymphoma (ENKTCL) based on PET-CT staging.Methods:Clinical data of 186 patients who received bone marrow biopsy and bone marrow aspiration in Fujian Medical University Union Hospital from 2013 to 2021 were retrospectively analyzed. All patients were divided into bone marrow biopsy + bone marrow aspiration group ( n=186) and PET-CT + bone marrow biopsy group ( n=139). The sensitivity, specificity, positive and negative predictive values were compared between two groups. The data were analyzed and plotted. Survival analysis was performed using Kaplan-Meier method and log-rank test. Results:In the whole cohort, 45 patients were positive for bone marrow biopsy, and 30 of them were positive for bone marrow aspiration. A total of 141 patients who were negative for bone marrow biopsy also achieved negative results for bone marrow aspiration. A total of 139 patients completed PET-CT staging and bone marrow biopsy. And 30 patients were diagnosed with positive bone marrow by PET-CT, in which 22 of them were confirmed positive by bone marrow biopsy. Among 109 patients diagnosed with negative bone marrow by PET-CT, 5 of them were confirmed positive by bone marrow biopsy. All these cases were classified as stage Ⅳ due to distant metastases. PET-CT had a diagnostic sensitivity of 81.5%, a specificity of 92.9%, a positive predictive value of 73.3%, and a negative predictive value of 95.4%. Among early stage (Ⅰ-Ⅱ stage) patients diagnosed with PET-CT, all of them were negative for bone marrow biopsy (the negative predictive value was 100%). In stage Ⅳ patients ( n=55), the 1-year overall survival of patients with bone marrow involvement by bone marrow biopsy or PET-CT ( n=35) compared with their counterparts with the involvement of other organs ( n=20) was 28.7% vs.42.0% ( P=0.13), and 1-year progression free survival rates was 23.2% vs. 23.3% in ( P=0.94). Conclusions:Routine bone marrow biopsy does not change the original staging of patients with early stage ENKTCL based on PET-CT staging. Advanced stage patients with positive bone marrow biopsy tend to obtain worse prognosis, indicating that bone marrow biopsy still has certain value.
8.Long-term outcomes of watch&wait (W&W) after neoadjuvant treatment in patients with rectal cancer
Ying ZHAO ; Yuan TANG ; Wenyang LIU ; Ning LI ; Silin CHEN ; Jinming SHI ; Huiying MA ; Qiang ZENG ; Yongwen SONG ; Shulian WANG ; Yueping LIU ; Hui FANG ; Ningning LU ; Yu TANG ; Shunan QI ; Yong YANG ; Bo CHEN ; Yexiong LI ; Jing JIN
Chinese Journal of Radiation Oncology 2022;31(3):253-259
Objective:To compare the outcomes of watch&wait (W&W) strategy in patients with locally advanced rectal cancer who achieved complete clinical response (cCR) after neoadjuvant therapy, with those who obtained pathological complete response (pCR) after total mesorectal excision (TME).Methods:This is a retrospective cohort analysis study. Patients histologically proven with locally advanced rectal adenocarcinoma (stage Ⅱ-Ⅲ) who had received neoadjuvant chemotherapy were eligible between January 2014 and December 2019. In whom we included patients who had cCR offered management with W&W strategy after completing neoadjuvant therapy and follow-up ≥1 year (W&W group), and patients who did not have cCR but pCR after TME (pCR group). The primary endpoints were 3-year and 5-year overall survival (OS), colostomy-free survival (CFS), disease-free survival (DFS), non-local regrowth disease-free survival (NR-DFS), and organ preservation rate. Kaplan-Meier analysis was used for survival analysis and log-rank test was performed. For comparative analysis, we also derived one-to-one paired cohorts of W&W versus pCR using propensity-score matching (PSM).Results:A total of 118 patients were enrolled, 49 of whom had cCR and managed by W&W, 69 had pCR, with a median follow-up period of 49.5 months (12.1-79.9 months). No difference was observed in the 3-year OS (97.1% vs. 96.7%) and 5-year OS (93.8% vs. 90.9%, P=0.696) between the W&W and pCR groups. Patients managed by W&W had significantly better 3-year and 5-year CFS (89.1% vs. 43.5%, P<0.001), better 3-year DFS (83.6% vs. 97.0%) and 5-year DFS (83.6% vs. 91.2%, P=0.047) compared with those achieving pCR. The 3-year NR-DFS (95.9% vs. 97.0%) and 5-year NR-DFS (92.8% vs. 97.0%, P=0.407) did not significantly differ between the W&W and pCR groups. Local regeneration occurred in six cases, and 87.7% of patients had successful rectum preservation in the W&W group. In the PSM analysis (34 patients in each group), absolutely better CFS (90.1% vs. 26.5%, P<0.001) was noted in the W&W group. A median interval of 17.5 weeks was observed for achieving cCR, while only 23.9% of patients achieved cCR within 5 to 12 weeks from radiation completion. Patients with short-course sequential chemoradiotherapy achieved cCR significantly later when compared with those with long-course concurrent chemoradiotherapy (19.0 vs. 9.8 weeks, P<0.001). Conclusions:The oncological outcomes of W&W strategy in patients with locally advanced rectal cancer are safe and effective, significantly improving the quality of life. Longer interval for cCR evaluation may improve rectal organ preservation rate.
9.Expression of fructose bisphosphate aldolase A in bone marrow of patients with acute myeloid leukemia and its influence on prognosis
Ping MA ; Liang TIAN ; Lihuan SHI ; Jianwen ZHOU ; Yanna MAO ; Wei LIU ; Yongyan HE ; Silin GAN ; Hui SUN
Journal of Leukemia & Lymphoma 2022;31(11):664-668
Objective:To explore the expression of fructose bisphosphate aldolase A (ALDOA) in the bone marrow of patients with acute myeloid leukemia (AML) and the correlation with clinical features and prognosis.Methods:The bone marrow samples of 90 newly diagnosed AML (non-acute promyelocytic leukemia) patients and 18 allogeneic hematopoietic stem cell transplantation donors who were treated from January 2013 to December 2015 in the First Affiliated Hospital of Zhengzhou University and the Children's Hospital Affiliated to Zhengzhou University were collected. The relative expression level of ALDOA mRNA in bone marrow samples was detected by using real-time quantitative polymerase chain reaction (qRT-PCR). Clinical data of these patients were retrospectively analyzed, and the patients were divided into continuous complete remission (CR) group and refractory recurrent (RR) group according to the clinical response and follow-up results. The differences of the relative expression level of ALDOA mRNA between AML group and the normal control group, CR group and RR group were analyzed. Univariate and multivariate Cox regression risk model were used for analysis of factors influencing prognosis of AML patients.Results:The relative expression level of ALDOA mRNA in AML group was higher than that in normal control group [(5.71±0.44) vs. (1.10±0.08), t = 4.74, P<0.001]. The relative expression level of ALDOA mRNA in the RR group was higher than that in the CR group [(6.69±0.67) vs. (4.30±0.36) , t = 2.79, P < 0.001]. In addition, there were statistically significant differences in the proportion of patients with ALDOA mRNA high expression and those with ALDOA mRNA low expression stratified by the number of white blood cell, the proportion of bone marrow blasts and whether complete remission could be achieved or not after 1 course of induction therapy (all P < 0.05). Overall survival in patients with ALDOA high expression was worse than that in patients with ALDOA low expression ( χ2 = 5.59, P = 0.018). Multivariate analysis showed that white blood cell count, prognosis stratification, whether complete remission could be achieved or not after 1 course of induction therapy and ALDOA expression were the independent prognostic factors for the death of AML patients (all P < 0.05). Conclusions:ALDOA may play an important role in the development and progression of AML, and the expression level of ALDOA in the bone marrow can be used as an index for the prognosis assessment of AML patients and may be a potential therapeutic target for AML.
10.Diagnostic value of combined detection of p16 and human papillomavirus typing in cervical intraepithelial neoplasia
Haifeng GAO ; Silin LI ; Yang LIU ; Fen QIAO
Cancer Research and Clinic 2021;33(6):423-427
Objective:To explore the application value of combined detection of p16 and human papillomavirus (HPV) typing in the diagnosis of cervical intraepithelial neoplasia (CIN).Methods:A total of 8 346 patients aged between 25 years old and 65 years old at Baoji Central Hospital of Shaanxi Province from February 2019 to February 2020 were selected. There were 2 882 patients with cervical lesions diagnosed by colposcopy biopsy. Patients were divided into the different groups based on the age range, and then the condition of HPV infection in all age groups was analyzed. Taking biopsy as the gold standard and according to the pathological results, the detection rate of p16 and HPV typing and the diagnostic value of the single and combined detection in CIN were also analyzed.Results:The age group with the highest positive rate of p16 and HPV was 31-40 years old [47.42% (1 014/2 427) and 36.84% (894/2 427), respectively], followed by 41-50 years old group [30.15% (907/2 942) and 28.11% (827/2 942)], and there were statistically significant differences in positive rate of p16 and HPV in all age groups (all P < 0.05). Among 2 882 patient with cervical lesions diagnosed by pathological examination, there were 2 572 cases (89.24%) of p16 positive, and 2 169 cases (75.26%) of HPV positive. With the disease progression of cervical lesions, the positive rate of p16 and HPV was gradually increased, and the positive rate of p16 of inflammation, CINⅠ, CINⅡ, CIN Ⅲ, cervical squamous cell carcinoma (SCC) was 11.68% (23/197), 94. 85% (1 105/1 165), 93.57% (771/824), 96.76% (538/556), 96.43% (135/140), respectively; the positive rate of HPV was 17.77% (35/197), 77.60% (904/1 165), 80.22% (661/824), 80.40% (447/556), 87.14% (122/140), respectively, and HPV infection was mostly HPV16/18 infection type with the disease progression of cervical lesions. The sensitivity, specificity, positive predictive value and negative predictive value in detecting CIN of HPV was 75.26%, 81.13%, 67.78% and 86.14%, respectively; the sensitivity, specificity, positive predictive value and negative predictive value in detecting CIN of p16 was 89.24%, 84.74%, 75.51% and 93.72%, respectively; the diagnostic efficacy of p16 was higher than that of HPV in detecting CIN, and the difference was statistically significant ( P < 0.05). The sensitivity, specificity, positive predictive value and negative predictive value of HPV combined with p16 in detecting CIN was 94.10%, 91.33%, 85.12%, 96.71%, which were higher compared with those of single detection (all P < 0.05). Conclusions:HPV infection mainly occurs in women aged 31-40 years old followed by 41-50 years old, and the infected population of CIN tends to be younger. p16 is superior to HPV in detecting the diagnostic efficacy of CIN; combined detection of p16 and HPV can increase the sensitivity and specificity, reduce the rate of misdiagnosis, and can play a key clinical value in early diagnosis and treatment of CIN.


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