1.Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study.
Yuanchao ZHU ; Fei ZHAO ; Yubing ZHU ; Xingang LI ; Deshi DONG ; Bolin ZHU ; Jianchun LI ; Xin HU ; Zinan ZHAO ; Wenfeng XU ; Yang JV ; Dandan WANG ; Yingming ZHENG ; Yiwen DONG ; Lu LI ; Shilei YANG ; Zhiyuan TENG ; Ling LU ; Jingwei ZHU ; Linzhe DU ; Yunxin LIU ; Lechuan JIA ; Qiujv ZHANG ; Hui MA ; Ana ZHAO ; Hongliu JIANG ; Xin XU ; Jinli WANG ; Xuping QIAN ; Wei ZHANG ; Tingting ZHENG ; Chunxia YANG ; Xuguang CHEN ; Kun LIU ; Huanhuan JIANG ; Dongxiang QU ; Jia SONG ; Hua CHENG ; Wenfang SUN ; Hanqiu ZHAN ; Xiao LI ; Yafeng WANG ; Aixia WANG ; Li LIU ; Lihua YANG ; Nan ZHANG ; Shumin CHEN ; Jingjing MA ; Wei LIU ; Xiaoxiang DU ; Meiqin ZHENG ; Liyan WAN ; Guangqing DU ; Hangmei LIU ; Pengfei JIN
Acta Pharmaceutica Sinica B 2025;15(1):123-132
Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T NANC), time to symptom improvement (T SI), and time of hospital stay (T HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.
2.A questionnaire survey and analysis on the current situation of forensic ethics practice and educational needs
Wenjie LUO ; Tiantian PAN ; Shiyue LI ; Mengjun ZHAN ; Lirong QIU ; Yuchi ZHOU ; Xin CHEN ; Fei FAN ; Zhenhua DENG
Chinese Medical Ethics 2025;38(3):378-384
ObjectiveTo explore the current situation of forensic ethics practice and education by designing a questionnaire on forensic ethics, with a view to exploring the path of forensic ethics education construction. MethodsA total of 667 valid questionnaires were collected using the online survey method, basically covering various regions across the country and all sub-specialties of forensic medicine. Descriptive analysis was used to analyze the relevant data. ResultsMost practitioners had relevant ethical reflections in the process of forensic practice. 69.12% of the respondents indicated that they had studied the relevant rules, but approximately half stated that there were no corresponding ethical norms or standard operating manuals. The specific behaviors violating ethics in different units were diverse. 23.04% of the respondents reported that they had encountered unethical behaviors, but only 4.9% of them reported such violations. In terms of forensic ethics education, 87.75% of the respondents believed that there were issues with the current model of forensic ethics education. Meanwhile, the respondents showed a high degree of recognition for receiving forensic ethics education, with 84.15% of respondents expressing willingness to participate in relevant courses. More than half of respondents were willing to participate in forensic ethics education during undergraduate studies, new employee training, and regular post-employment training. ConclusionCurrently, there is a problem of ethical neglect in forensic work in China. Combining ethics courses with professional courses at the practitioner training stage and providing regular training at the practice stage are effective measures to popularize forensic ethics knowledge, enhance ethical awareness, and improve the quality of practice.
3.Cleansing skin wound by irrigation with tap water replacing normal saline
Gaoxing LUO ; Rixing ZHAN ; Zhiqiang YUAN ; Huapei SONG ; Fei XIANG ; Siyuan MA ; Haisheng LI ; Wei QIAN ; Jianglin TAN ; Yizhi PENG
Chinese Journal of Burns 2025;41(3):201-205
Wound cleansing is an essential step in skin wound management. It can prevent local infection and optimize healing micro-environment by removing necrotic tissue and foreign matter, reducing microbial load, breaking bacterial biofilm formation and so on. Many randomized controlled trials and meta-analysis abroad have concluded that there is no significant difference in the incidence of wound infection and healing rate between the wounds irrigated with tap water and with sterile normal saline for skin wound cleansing. Considering the current requirements of medical fee policies in China, we recommend the use of tap water instead of saline or other wound cleansing solutions for cleansing skin wounds.
4.Diagnosis and radiation dosimetry of 64Cu-PSMA-Q PET/CT imaging in patients with advanced prostate cancer
Fei CHEN ; Hao ZHANG ; Tielong TANG ; Yousheng ZHAN ; Fei LUO ; Fanhui YANG ; Xiaohong HUANG ; Zongxi HE ; Huajian GU ; Suping LI
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(11):641-647
Objective:To evaluate the diagnostic performance of 64Cu-prostate specific membrane antigen (PSMA)-Q compared with 18F-FDG in patients with advanced prostate cancer and to analyze the radiation dosimetry of 64Cu-PSMA-Q. Methods:This study was an open-label, single-arm, self-controlled diagnostic evaluation trial. A total of 29 patients (age 58-87 years) with pathologically confirmed advanced prostate cancer in the Affiliated Hospital of North Sichuan Medical College from September 2023 to December 2023 were included. All patients underwent both 64Cu-PSMA-Q PET/CT and 18F-FDG PET/CT examinations. McNemar test was used to compare the detection rates of 64Cu-PSMA-Q PET/CT and 18F-FDG PET/CT for primary lesions, lymph node metastases, and bone metastases. Mann-Whitney U test was applied to compare differences in SUV max and tumor-to-background ratio (TBR) between 64Cu-PSMA-Q PET/CT and 18F-FDG PET/CT. Radiation dosimetry of 64Cu-PSMA-Q PET/CT imaging was performed using OLINDA/EXM 2.1 (adult male model) in 9 patients. Results:Primary lesions were detected in 21 patients. 64Cu-PSMA-Q PET/CT demonstrated a detection rate of 95.2%(20/21) for primary lesions, which was significantly higher than that of 18F-FDG PET/CT (66.7%(14/21); χ2=6.00, P=0.031). Detection rates of lymph node metastases were 65.5%(19/29) for 64Cu-PSMA-Q and 55.2%(16/29) for 18F-FDG, with no significant difference ( χ2=3.00, P=0.250). Similarly, detection rates of bone metastases were 72.4%(21/29) for 64Cu-PSMA-Q and 65.5%(19/29) for 18F-FDG respectively ( χ2=2.00, P=0.500). TBRs on 64Cu-PSMA-Q PET/CT were significantly higher than those on 18F-FDG PET/CT across primary lesions (8.3(2.2, 13.3) vs 2.3(1.0, 5.5); Z=7.16, P=0.002), regional lymph node metastases (4.9(1.4, 8.3) vs 1.7(0.9, 4.0), Z=189.34, P=0.001), and bone metastases (18.7(4.5, 26.9) vs 5.1(2.1, 9.7); Z=24.83, P=0.003). No significant difference in TBR was observed for distant lymph node metastases ( Z=1.49, P=0.135) or benign lesions ( Z=0.91, P=0.558). The whole-body effective dose of 64Cu-PSMA-Q was (28.200±1.590)μSv/MBq among the 9 patients analyzed, with no adverse events related to the tracer observed. Conclusion:64Cu-PSMA-Q is a promising novel PET imaging agent with potential clinical utility for diagnosing prostate cancer and supporting clinical decision-making.
5.Development, reliability, and validity of a treatment-related quality of life scale for Chinese patients with multiple myeloma
Chunyan SUN ; Zhen CAI ; Bing CHEN ; Lijuan CHEN ; Wenming CHEN ; Kaiyang DING ; Juan DU ; Rong FU ; Chengcheng FU ; Da GAO ; Guangxun GAO ; Yanjuan HE ; Jian HOU ; Ming JIANG ; Fei LI ; Jian LI ; Juan LI ; Zhenyu LI ; Aijun LIAO ; Jing LIU ; Jun LUO ; Jianmin LUO ; Yanping MA ; Jianqing MI ; Ting NIU ; Hongling PENG ; Yongping SONG ; Luqun WANG ; Rong ZHAN ; Xi ZHANG ; Yu HU
Chinese Journal of Hematology 2025;46(8):713-721
Objective:To develop a treatment-related quality of life scale for Chinese patients with multiple myeloma (MM) and to test its reliability and validity.Methods:The initial scale was constructed through a literature search, Delphi expert correspondence, and cognitive testing. This study conducted a preliminary survey of 379 patients with MM and a formal survey of 865 patients from the hematology departments of 155 hospitals nationwide from February 2024 to March 2024. The final scale was obtained after conducting item analysis and reliability and validity tests on the initial scale.Results:The constructed scale contains 36 items covering six domains: physiological, psychological, social, treatment side effects, general health, and others. In the preliminary survey, the Cronbach’s alpha coefficient of each item ranged from 0.597 to 0.939, and the test-retest reliability was 0.747 ( P<0.001). Exploratory factor analysis extracted eight common factors with a cumulative variance contribution of 60.058%. In the formal survey, the Cronbach’s alpha coefficient of each item ranged from 0.484 to 0.930, and the test-retest reliability was 0.835 ( P<0.001). Confirmatory factor analysis revealed a comparative fit index of 0.750, a root-mean-square error of approximation of 0.090, and a root-mean-square residual of 0.067. Conclusion:The treatment-related quality of life scale for Chinese patients with MM designed in this study exhibited good reliability and validity, reflecting the impact of treatment on the quality of life of patients. This scale can provide a reference to clinicians for assessing the disease status of patients.
6.Research progress on variety breeding of root- and rhizome-derived traditional Chinese medicine.
Yan CHEN ; Miao-Yin DONG ; Zhan-Feng CAO ; Xue-Zhou LIU ; Meng-Fei LI ; Jian-He WEI
China Journal of Chinese Materia Medica 2025;50(2):363-383
Germplasm degeneration occurs during the long-term cultivation of root-and rhizome-derived traditional Chinese medicine(RR-TCM), which seriously restricts the high-quality development of their industry. Therefore, it is urgent to solve the problem of germplasm degeneration through variety breeding. In this paper, based on previously published research articles, monographs, and news reports, the research progresses on the number and origins, breeding methods, and selection of new varieties of RR-TCM listed in the Chinese Pharmacopoeia(Edition 2020) were summarized and analyzed. The results show that there are 169 kinds of RR-TCM listed in the Chinese Pharmacopoeia(Edition 2020), originated from 223 origins with three breeding methods(i.e., seed propagation, vegetative reproduction, and tissue culture), and there are 215 species derived from seed propagation, 177 species derived from vegetative reproduction, and 164 species derived from tissue culture. To date, there are 62 origins breeding new varieties through conventional breeding, cross breeding, mutation breeding, ploidy breeding, or modern biotechnology breeding methods, including 57 origins breeding 145 new varieties through conventional breeding, 10 origins breeding 43 new varieties through mutation breeding, and seven origins breeding 12 new varieties through cross breeding method. They are used mainly to improve yield, disease resistance, and active ingredient content, but only a few new varieties have been widely used. This review will provide useful references in variety breeding, quality breeding, and standardized planting of RR-TCM.
Plant Breeding/methods*
;
Plant Roots/growth & development*
;
Rhizome/growth & development*
;
Drugs, Chinese Herbal
;
Plants, Medicinal/classification*
;
Medicine, Chinese Traditional
7.Clinical Applications of Circulating Tumor DNA in Response Evaluation and Relapse Monitoring of Primary Mediastinal Large B-Cell Lymphoma.
Lu PAN ; Xin-Miao JIANG ; Yan TENG ; Ning WANG ; Ling HUANG ; Han-Guo GUO ; Si-Chu LIU ; Xiao-Juan WEI ; Fei-Li CHEN ; Zhan-Li LIANG ; Wen-Yu LI
Journal of Experimental Hematology 2025;33(2):407-415
OBJECTIVE:
To explore the clinical significance of circulating tumor DNA (ctDNA) in response evaluation and relapse monitoring for patients with primary mediastinal large B-cell lymphoma (PMBCL).
METHODS:
The clinical characteristics, efficacy and survival of 38 PMBCL patients in our hospital from January 2010 to April 2020 were retrospectively analyzed. The ctDNA monitoring was conducted by targeted next-generation sequencing (NGS).
RESULTS:
Among the 38 patients, 26 cases were female, and 32 cases were diagnosed with Ann Arbor stage I-II. The 5-year overall survival (OS) rate and progression-free survival (PFS) rate were 74.7% and 61.7%, respectively. Males and those with high aaIPI scores (3 points) had a relatively poor prognosis. The NGS results of 23 patients showed that STAT6 (65.2%), SOCS1 (56.5%), and TNFAIP3 (56.5%) were the most common mutated genes. Patients with stable disease (SD)/progressive disease (PD) exhibited enrichment in cell cycle, FoxO, and TNF signaling pathways. A total of 29 patients underwent end-of-treatment PET/CT (EOT PET/CT), and 16 of them received ctDNA monitoring with 12 negative. Among 6 patients with EOT PET/CT positive (Deauville 4), 4 underwent ctDNA monitoring, and 3 of them were negative, being still in continuous remission without any subsequent anti-tumor therapy.
CONCLUSION
CtDNA may be combined with PET/CT to assess efficacy, monitor relapse, and guide treatment of PMBCL.
Humans
;
Circulating Tumor DNA/blood*
;
Female
;
Mediastinal Neoplasms
;
Male
;
Retrospective Studies
;
High-Throughput Nucleotide Sequencing
;
Prognosis
;
Lymphoma, Large B-Cell, Diffuse/genetics*
;
Middle Aged
;
Adult
;
Aged
;
Neoplasm Recurrence, Local
;
Mutation
8.Novel Structural Features of Isoflavone Synthase from Medicago truncatula Shed Light on Its Unique Enzymatic Mechanism
Chao SHI ; Zhao-Yang YE ; Fei XU ; Xiang-Ning DU ; Zhang-Xin CHEN ; Ming-Yue GU ; Jie DENG ; Wei WANG ; Liang-Yu LIU ; Mei-Ying WANG ; Xiao-Dong SU ; He-Li LIU ; Ming-Ying SHANG ; Li-Xin HUANG ; Zhen-Zhan CHANG
Chinese Journal of Biochemistry and Molecular Biology 2025;41(8):1204-1213,中插1-中插6
Isoflavones which mainly distributed in leguminous plants have plenty of health benefits.Isoflavone synthase(IFS)is a membrane-associated cytochrome P450 enzyme(CYP450)which carries out the unique aryl-ring migration and hydroxylation.So far,few crystal structures of plant P450s have been obtained.We determined the crystal structure of IFS from Medicago truncatula at 1.9 ? by MAD method using a selenomethionine substituted crystal and conducted molecular docking and mutagenesis study.The structure of IFS complexed with imidazole exhibits the helix Ⅰa-loop-helix Ⅰβ motif which cor-responds to helix Ⅰ of other P450s.Compared with structures of common P450s,IFS/imidazole structure contains an extra domain,i.e.,the γ-domain.The structure reveals a homodimer in which the γ-domain of one molecule interacts with the β-domain of another.The plane of heme group makes an angle of ap-proximately 40° with the helix Ⅰa-loop-helix Ⅰβ motif.Molecular docking combined with mutagenesis study suggested that Trp-128 and Asp-300 might play important roles in substrate binding and recogni-tion.Phe-301,Ser-303 and Gly-305 from the helix Ⅰa-loop-helix Ⅰβ motif may play important roles in the aryl-ring migration.These novel structural features reveal insights into the unique reaction mechanism of IFS and provide a basis for engineering IFS in leguminous crops for health purpose.
9.Value of CT perfusion imaging combined with serum EPA/AA in predicting hemorrhage transformation and short-term prognosis after thrombolysis in acute ischemic stroke with leukoaraiosis
Jian XIONG ; Zhan-li QU ; Yu REN ; Jun-ming YIN ; Yi-fei JI
Journal of Regional Anatomy and Operative Surgery 2025;34(1):32-37
Objective To investigate the value of CT perfusion imaging (CTP) combined with serum eicosapentaenoic acid (EPA)/arachidonic acid (AA) in predicting hemorrhage transformation and short-term prognosis after thrombolysis in acute ischemic stroke (AIS) patients with leukoaraiosis. Methods Ninety-eight AIS patients with leukoaraiosis admitted to the department of neurology of our hospital from January 2021 to December 2022 were selected and divided into the hemorrhage transformation group and non-hemorrhage transformation group according to whether hemorrhage transformation occurred after thrombolysis. The Fazekas scale was used to evaluate the leukoaraiosis of the patients. CTP parameters and EPA/AA were compared between patients in the two groups and patients with different degrees of leukoaraiosis in the hemorrhage transformation group. The predictive value of CTP parameters and EPA/AA on the occurrence of hemorrhage transformation was evaluated by receiver operating characteristic (ROC) curve. The prognosis was assessed according to the modified Rankin scale (mRS) score 1 month after thrombolysis;the linear and linear combinations are used to evaluate the linear relationship between variables;the ROC curve was used to evaluate the predictive value of CTP parameters and EPA/AA in the short-term prognosis of patients. Results The reactive cerebral blood flow (rCBF),reactive cerebral blood volume (rCBV),CTP integration index and EPA/AA in the hemorrhage transformation group were significantly lower than those in the non-hemorrhage transformation group (P<0.05),while the relative time to peak (rTTP) was significantly longer than that in the non-hemorrhage transformation group (P<0.05). The incidence of hemorrhage transformation increased with the increase of leukoaraiosis degree (P<0.05). In the hemorrhage transformation group,rCBF,rCBV,CTP integration index and EPA/AA of patients with mild leukoaraiosis were higher than those of patients with moderate-severe leukoaraiosis (P<0.05). In patients with mild leukoaraiosis,the area under the curve (AUC) of rCBF and EPA/AA in predicting hemorrhage transforma-tion were 0.712 and 0.720,respectively (P<0.05);in patients with moderate-severe leukoaraiosis,the AUC of rCBF,rCBV,rTTP,CTP integration index and EPA/AA in predicting hemorrhage transformation were 0.738,0.714,0.717,0.739 and 0.742,respectively (P<0.05). Among the 98 patients received thrombolysis,35 patients had a poor prognosis. The AUC of rCBF,rCBV,CTP integration index and EPA/AA in predicting short-term prognosis were 0.742,0.732,0.704 and 0.738,respectively,and the AUC of the four combined prediction was 0.968. Conclusion CTP parameters and EPA/AA have a certain predictive value for the occurrence of hemorrhage transformation after thrombolysis in AIS patients with leukoaraiosis,and rCBV,rCBF,CTP integration index and EPA/AA are important influencing factors of the short-term prognosis for these patients.
10.Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, doubleblind, non-inferiority phase Ⅲ trial
Huiyun ZHU ; Qian XUE ; Yingxiao SONG ; Zhenyu ZHANG ; Xing LI ; Shengxiang LYU ; Qiang ZHAN ; Fei LIU ; Lungen LU ; Liang ZHONG ; Weixing CHEN ; Dong SHAO ; Yanbing DING ; Deliang LIU ; Xiaozhong YANG ; Zhiming HUANG ; Zhaoshen LI ; Yiqi DU
Chinese Medical Journal 2025;138(19):2464-2471
Background::An evidence gap still exists regarding the efficacy and safety of tegoprazan in patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China. Methods::This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50 mg/day vs. esomeprazole 40 mg/day. This study was conducted in 32 sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. Results::A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8 weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: -1.7%, 95% confidence interval [CI]: -8.5%, 5.0%, P = 0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P >0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups (all P >0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively. Conclusion::Tegoprazan 50 mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40 mg/day.

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