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.Preliminary efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy for advanced temporal bone squamous cell carcinoma
Yu SI ; Yan HUANG ; Dian LIU ; Maojin LIANG ; Wenting DENG ; Yuexin CAI ; Yuebo CHEN ; Yanfang YE ; Li LING ; Zhigang ZHANG ; Suijun CHEN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(11):1399-1406
Objective:To evaluate the safety of neoadjuvant therapy with pembrolizumab combined with 5-fluorouracil (5-FU) and cisplatin in patients with advanced temporal bone squamous cell carcinoma (TBSCC), and its impact on tumor response rate and disease-free survival (DFS).Methods:This prospective, single-arm, open-label clinical study enrolled patients with advanced (Stage Ⅲ/Ⅳ) TBSCC from Sun Yat-sen Memorial Hospital. Patients received 2-3 cycles of neoadjuvant therapy with pembrolizumab, 5-FU, and cisplatin, followed by definitive surgery. Postoperatively, patients received 6 cycles of pembrolizumab combined with radiotherapy. The primary endpoint was the 2-year disease-free survival (DFS) rate. Secondary endpoints included objective response rate (ORR) and safety indicators. Survival analysis was performed using the Kaplan-Meier method. Adverse events (AE) were assessed using the National Cancer Institute′s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Statistical analyses were conducted using SPSS software, version 22.0.Results:From August 2021 to April 2024, 16 patients with advanced TBSCC were enrolled (13 males and 3 females), with a median age of 54 years and a median follow-up time of 2.32 years. Following neoadjuvant therapy, the objective response rate (ORR) was 64.3% (9/14), and the disease control rate (DCR) was 92.9% (13/14). The 2-year DFS rate was 86.6%. Common treatment-related adverse events (TRAE) included leukopenia (56.3%, 9/16), nausea and vomiting (50.0%, 8/16), diarrhea, oral mucositis, and elevated liver function tests (25.0%, 4/16). One patient (6.25%) experienced a grade 3 adverse event.Conclusion:Neoadjuvant pembrolizumab-chemotherapy significantly enhances objective response rate and disease-free survival in advanced TBSCC.
3.Study on key performance of medical ultrasonic probe of third-party repair based on test data
Lei XU ; Jun YAO ; Taotao FAN ; Yinkai CHEN ; Zhigang WANG ; Jiyun LING
China Medical Equipment 2025;22(8):174-176,181
Objective:To conduct performance tests on medical ultrasound probes repaired by the third party,and explore whether the key parameters of the probes of third-party repair can meet the requirements of clinical use for quality.Methods:A total of 79 ultrasound probes that had been repaired by the third party were selected from different medical institutions.The performance tests were conducted on multiple parameters of ultrasound probes of different models and brands in accordance with national technical standards and relevant industry norms.Then,the test results were analyzed,studied and evaluated.Results:The tested results of the temperature rise and the leakage current of the ultrasound probes,which were repaired by the third party,met the national standards.However,in the test for sound power,26.58%of the probes failed to meet the national standards,which outputted sound intensity that was calculated was higher than the specified value.Conclusion:The general performance of the probes that have been repaired by the third party is well,but the quality of the repair is uneven levels,and some indicators do not meet national standards or industry norms,which might lead to occur risks in ultrasound diagnosis of medical institutions.It is recommended to implement regular test for quality and performance of medical ultrasound equipment,and establish a method and system for quality monitoring and re-evaluation after sale of repair for medical ultrasound,so as to ensure the use and safety of the equipment.
4.Protective effect of modified University of Wisconsin preservation solution containing α 2-adrenergic receptor agonists and noble gases on isolated amputated skeletal muscle of rats
Zhengwei XUE ; Zhigang QIN ; Xiangfeng LIU ; Jieyu LI ; Ling JIANG ; Xiao LI ; Jianbo MA ; Guanlei LIU ; Pengfei ZHENG ; Ying TANG ; Peng LI ; Jianteng GU
Chinese Journal of Trauma 2025;41(11):1112-1122
Objective:To develop a modified University of Wisconsin preservation solution (UW solution) containing α 2-adrenergic receptor agonists (dexmedetomidine) and noble gases (argon) and investigate its protective effect on the isolated amputated skeletal muscle of rats. Methods:Sixty male SD rats were selected to establish a hindlimb cold preservation/perfusion model and were divided into blank control group, hypothermic storage group, UW solution perfusion group, and modified UW solution perfusion group using a random number table, with 15 rats in each group. Simultaneously, a cold preservation model of rat skeletal muscle myoblasts (L6 cells) was established and the rats were also divided into four groups in the same way. Animal models were prepared in different ways: In the blank control group, the hindlimbs received no special treatment; In the hypothermic storage group, the amputated hindlimbs were stored in a dry centrifuge tube at 4℃ for 18 hours; In the UW solution perfusion group, the amputated hindlimbs were perfused with UW solution and then stored in a centrifuge tube containing UW solution at 4℃ for 18 hours; In the modified UW solution perfusion group, the amputated hindlimbs were perfused with modified UW solution (containing 0.1 nmol/L dexmedetomidine and 50% volume fraction of argon) and then stored in a centrifuge tube containing the modified UW solution at 4℃ for 18 hours. Cell models were treated as follows: In the blank control group, L6 cells were cultured under standard conditions; In the hypothermic storage group and UW solution group, L6 cells were treated with conventional culture medium or UW solution, stored in argon-filled sealed bags at 4℃ for 8 hours, and then rewarmed and cultured for 6 hours; In the modified UW solution group, L6 cells were treated with the modified solution, stored in argon-filled sealed bags at 4℃ for 8 hours, and then rewarmed and cultured for 6 hours. After sample collection, skeletal muscle morphology, tissue edema and ultrastructure features were assessed by HE staining, wet-to-dry weight ratio, and transmission electron microscopy, respectively. Additionally, L6 cell morphology was examined by light microscopy. L6 cell viability was determined by cell counting kit-8 (CCK-8) assay (expressed as absorbance A value). Expression levels of glutathione peroxidase 4 (GPX4) protein in both skeletal muscle tissue and L6 cells were evaluated by immunofluorescence staining and Western blot, respectively.Results:After 18 hours of in vitro preservation of rat isolated amputated limbs, the following results were obtained: (1) HE staining results showed that the muscle fiber morphology of the modified UW solution perfusion group was close to that of the blank control group. Moreover, the area ratio of skeletal muscle cells in the modified UW solution perfusion group was significantly higher than that in the hypothermic storage group and UW solution perfusion group ( P<0.05). (2) The wet-dry weight ratio results showed that there was no statistically significant difference among the modified UW solution perfusion group, the blank control group and UW solution group ( P>0.05), with significantly lower ratios in all three groups than that in the hypothermic storage group ( P<0.05). (3) Transmission electron microscopy results revealed that the modified UW solution perfusion group showed no statistically significant differences in ultrastructural metrics, including myofiber diameter, sarcomere length, mitochondrial short-axis/long-axis ratio, and mitochondrial cristae count, compared with those in the blank control group ( P>0.05), and performed significantly better than both the hypothermic storage group and UW solution perfusion group ( P<0.05). (4) Morphological observation of L6 cells showed that the cellular morphology was regular in the modified UW solution perfusion group, close to that in the blank control group, while it was severely damaged in the hypothermic storage group. Moreover, the cells were reduced in number and partially damaged in the UW solution group. The sequence of cell viability expressed as absorbance A value was blank control group >modified UW solution perfusion group > UW solution perfusion group > hypothermic storage group, with statistically significant differences among the four groups ( P<0.05). (5) Immunofluorescence staining showed that there was no statistically significant difference in fluorescence intensity of GPX4 protein expression between the modified UW solution perfusion group and blank control group ( P>0.05), while the fluorescence intensity was higher in the modified UW solution perfusion group than that in the hypothermic storage group and UW solution perfusion group ( P<0.05). Western blot analysis showed that the relative expression level of GPX4 in the modified UW solution group was significantly lower than that in the blank control group ( P<0.05), but higher than that in the hypothermic storage group and UW solution perfusion group ( P<0.05). Conclusion:The modified UW solution can stabilize the expression level of GPX4 protein, thereby inhibiting ferroptosis and alleviating cold preservation injury in both rat amputated isolated limb skeletal muscle tissue and L6 cells.
5.Boron neutron capture therapy: A new era in radiotherapy.
Ling ZHOU ; Meng PENG ; Yuming CHEN ; Huanqing LIANG ; Xiumao YIN ; Jieming MO ; Xiaotao HUANG ; Zhigang LIU
Chinese Medical Journal 2025;138(19):2517-2519
6.Study on Suitable Areas and Ecological Characteristics of Lonicera japonica Thunb.Based on MaxEnt Model and GIS
Yaping ZHANG ; Suzhen ZHANG ; Guangzhen WAN ; Mei ZHANG ; Jianglong LI ; Juan CHEN ; Ling JIN ; Zhigang YANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):18-23
Objective To explore the environmental factors affecting the growth of Lonicera japonica Thunb.;To predict the suitable areas of L.japonica in China under current and future climate conditions.Methods Totally 2 553 pieces of L.japonica distribution information and 19 environmental factors were collected.MaxEnt model was used to screen the main environmental factors affecting the growth of L.japonica.Combined with ArcGIS 10.8 software,this article simulated the suitable area of L.japonica in our country under current and future climate conditions.Results The main environmental factors affecting the distribution of L.japonica were the lowest temperature in the coldest month,the average daily temperature range,the precipitation in the wettest quarter and the annual temperature range.Under the current climate conditions,the suitable area of L.japonica in China was about 318.29×104 km2,which was mainly distributed in central and southern China.Under the future climate scenario,the total suitable area would decrease.Conclusion This study predicted distribution of L.japonica resources and ecological suitability areas can provide theoretical basis for its wild cultivation,rational cultivation,and resource protection.
7.Analysis of influencing factors and construction of risk prediction model for cardio-cerebrovascular complications in patients with type 2 diabetes mellitus
Min RUI ; Jianjie WANG ; Zhigang LING
Adverse Drug Reactions Journal 2025;27(3):162-168
Objective:To understand the influencing factors for cardio-cerebrovascular complications in patients with T2DM and construct a nomogram risk prediction.Methods:The study design was a prospective observational study, and the subjects were selected from hospitalized patients with T2DM admitted to Huangshan City People′s Hospital from May 2022 to April 2023. Data on patients' gender, age, body mass index, alcohol consumption, smoking status, family history of cardio-cerebrovascular diseases, insulin use, duration of diabetes, blood pressure, and routine laboratory test results were collected using the hospital electronic medical record system. At discharge, patients were assessed using the T2DM-Specific Medication Belief Scale (total score range: 10-50), Medication Literacy Assessment Scale (total score range: 0-7), and Morisky Medication Adherence Scale (total score range: 0-8). Patients were followed up by telephone for 6 months after discharge and divided into 2 groups based on the occurrence of cardio-cerebrovascular complications. Logistic regression analysis was performed using SPSS 26.0 software to identify influencing factors for cardio-cerebrovascular complications in T2DM patients. A nomogram prediction model was constructed using R 4.1.0 software, and internal validation of the model was conducted using the Bootstrap method.Results:A total of 294 T2DM patients were included in the analysis. The medication belief score was (32.6±5.6) score, the medication literacy score was (4.2±0.5) score, and the medication adherence score was (6.1±0.8) score. During the 6-month follow-up, a total of 43 patients (14.6%) experienced cardio-cerebrovascular complications, including of coronary heart disease (23 cases), heart failure (12 cases), and stroke (8 cases). Compared to patients without cardio-cerebrovascular complications, patients with complications had higher body mass index, glycosylated hemoglobin A1c (HbA1c), D-dimer, and uric acid levels, as well as lower medication belief scores, medication literacy scores, and medication adherence scores (all P<0.05). Binary logistic regression analysis showed that HbA1c, D-dimer, uric acid, medication belief, medication literacy, and medication adherence were influencing factors for cardio-cerebrovascular complications in T2DM patients. Accordingly, a nomogram prediction model was established. Internal validation results of the model showed that the concordance index was 0.958, the area under the receiver operating characteristic curve was 0.824, and the calibration curve was close to the ideal curve. Conclusions:The current status of medication belief, medication literacy, and medication adherence in T2DM patients was not ideal. High levels of HbA1c, D-dimer, and uric acid, as well as poor medication belief, medication literacy, and medication adherence were risk factors for cardio-cerebrovascular complications in T2DM patients. The nomogram model, which integrated multiple influencing factors, had high value in predicting the risks.
8.Preliminary efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy for advanced temporal bone squamous cell carcinoma
Yu SI ; Yan HUANG ; Dian LIU ; Maojin LIANG ; Wenting DENG ; Yuexin CAI ; Yuebo CHEN ; Yanfang YE ; Li LING ; Zhigang ZHANG ; Suijun CHEN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(11):1399-1406
Objective:To evaluate the safety of neoadjuvant therapy with pembrolizumab combined with 5-fluorouracil (5-FU) and cisplatin in patients with advanced temporal bone squamous cell carcinoma (TBSCC), and its impact on tumor response rate and disease-free survival (DFS).Methods:This prospective, single-arm, open-label clinical study enrolled patients with advanced (Stage Ⅲ/Ⅳ) TBSCC from Sun Yat-sen Memorial Hospital. Patients received 2-3 cycles of neoadjuvant therapy with pembrolizumab, 5-FU, and cisplatin, followed by definitive surgery. Postoperatively, patients received 6 cycles of pembrolizumab combined with radiotherapy. The primary endpoint was the 2-year disease-free survival (DFS) rate. Secondary endpoints included objective response rate (ORR) and safety indicators. Survival analysis was performed using the Kaplan-Meier method. Adverse events (AE) were assessed using the National Cancer Institute′s Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Statistical analyses were conducted using SPSS software, version 22.0.Results:From August 2021 to April 2024, 16 patients with advanced TBSCC were enrolled (13 males and 3 females), with a median age of 54 years and a median follow-up time of 2.32 years. Following neoadjuvant therapy, the objective response rate (ORR) was 64.3% (9/14), and the disease control rate (DCR) was 92.9% (13/14). The 2-year DFS rate was 86.6%. Common treatment-related adverse events (TRAE) included leukopenia (56.3%, 9/16), nausea and vomiting (50.0%, 8/16), diarrhea, oral mucositis, and elevated liver function tests (25.0%, 4/16). One patient (6.25%) experienced a grade 3 adverse event.Conclusion:Neoadjuvant pembrolizumab-chemotherapy significantly enhances objective response rate and disease-free survival in advanced TBSCC.
9.Analysis of influencing factors and construction of risk prediction model for cardio-cerebrovascular complications in patients with type 2 diabetes mellitus
Min RUI ; Jianjie WANG ; Zhigang LING
Adverse Drug Reactions Journal 2025;27(3):162-168
Objective:To understand the influencing factors for cardio-cerebrovascular complications in patients with T2DM and construct a nomogram risk prediction.Methods:The study design was a prospective observational study, and the subjects were selected from hospitalized patients with T2DM admitted to Huangshan City People′s Hospital from May 2022 to April 2023. Data on patients' gender, age, body mass index, alcohol consumption, smoking status, family history of cardio-cerebrovascular diseases, insulin use, duration of diabetes, blood pressure, and routine laboratory test results were collected using the hospital electronic medical record system. At discharge, patients were assessed using the T2DM-Specific Medication Belief Scale (total score range: 10-50), Medication Literacy Assessment Scale (total score range: 0-7), and Morisky Medication Adherence Scale (total score range: 0-8). Patients were followed up by telephone for 6 months after discharge and divided into 2 groups based on the occurrence of cardio-cerebrovascular complications. Logistic regression analysis was performed using SPSS 26.0 software to identify influencing factors for cardio-cerebrovascular complications in T2DM patients. A nomogram prediction model was constructed using R 4.1.0 software, and internal validation of the model was conducted using the Bootstrap method.Results:A total of 294 T2DM patients were included in the analysis. The medication belief score was (32.6±5.6) score, the medication literacy score was (4.2±0.5) score, and the medication adherence score was (6.1±0.8) score. During the 6-month follow-up, a total of 43 patients (14.6%) experienced cardio-cerebrovascular complications, including of coronary heart disease (23 cases), heart failure (12 cases), and stroke (8 cases). Compared to patients without cardio-cerebrovascular complications, patients with complications had higher body mass index, glycosylated hemoglobin A1c (HbA1c), D-dimer, and uric acid levels, as well as lower medication belief scores, medication literacy scores, and medication adherence scores (all P<0.05). Binary logistic regression analysis showed that HbA1c, D-dimer, uric acid, medication belief, medication literacy, and medication adherence were influencing factors for cardio-cerebrovascular complications in T2DM patients. Accordingly, a nomogram prediction model was established. Internal validation results of the model showed that the concordance index was 0.958, the area under the receiver operating characteristic curve was 0.824, and the calibration curve was close to the ideal curve. Conclusions:The current status of medication belief, medication literacy, and medication adherence in T2DM patients was not ideal. High levels of HbA1c, D-dimer, and uric acid, as well as poor medication belief, medication literacy, and medication adherence were risk factors for cardio-cerebrovascular complications in T2DM patients. The nomogram model, which integrated multiple influencing factors, had high value in predicting the risks.
10.Study on key performance of medical ultrasonic probe of third-party repair based on test data
Lei XU ; Jun YAO ; Taotao FAN ; Yinkai CHEN ; Zhigang WANG ; Jiyun LING
China Medical Equipment 2025;22(8):174-176,181
Objective:To conduct performance tests on medical ultrasound probes repaired by the third party,and explore whether the key parameters of the probes of third-party repair can meet the requirements of clinical use for quality.Methods:A total of 79 ultrasound probes that had been repaired by the third party were selected from different medical institutions.The performance tests were conducted on multiple parameters of ultrasound probes of different models and brands in accordance with national technical standards and relevant industry norms.Then,the test results were analyzed,studied and evaluated.Results:The tested results of the temperature rise and the leakage current of the ultrasound probes,which were repaired by the third party,met the national standards.However,in the test for sound power,26.58%of the probes failed to meet the national standards,which outputted sound intensity that was calculated was higher than the specified value.Conclusion:The general performance of the probes that have been repaired by the third party is well,but the quality of the repair is uneven levels,and some indicators do not meet national standards or industry norms,which might lead to occur risks in ultrasound diagnosis of medical institutions.It is recommended to implement regular test for quality and performance of medical ultrasound equipment,and establish a method and system for quality monitoring and re-evaluation after sale of repair for medical ultrasound,so as to ensure the use and safety of the equipment.

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