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.Process parameter optimization and immunogenicity evaluation of calcium phosphate-coated foot-and-mouth disease virus-like particles.
Lihua REN ; Wei GUO ; Qianqian XIE ; Ruipeng LIU ; Shiqi SUN ; Hu DONG ; Yun ZHANG ; Manyuan BAI ; Huichen GUO ; Zhidong TENG
Chinese Journal of Biotechnology 2025;41(7):2672-2681
Bio-mineralization has emerged as a promising strategy to enhance vaccine immunogenicity. This study optimized the calcium phosphate (CaP) mineralization process of foot-and-mouth disease virus-like particles (FMD VLPs) to achieve high mineralization efficiency and scalability. Key parameters, including concentrations of Ca2+, HPO42-, NaCl, and VLPs, as well as stirring speed, were systematically optimized. Stability of the scaled-up reaction system and immunogenicity of the mineralized vaccine were evaluated. Optimal conditions [25.50 mmol/L Ca(NO3)2, 15 mmol/L Na2HPO4, 300 mmol/L NaCl, 0.75 mg/mL VLPs, and 1 500 r/min] yielded CaP-mineralized VLPs (VLPs-CaP) with high mineralization efficiency, uniform morphology, and a favorable particle size. Scaling up the reaction by 25 folds maintained consistent mineralization efficiency and particle characteristics. Immunization in mice demonstrated that VLPs-CaP induced higher titers of specific antibodies and neutralizing antibodies than unmineralized VLPs (P < 0.05). Higher IgG2a/IgG1 ratio and enhanced IFN-γ secretion (P < 0.05) further indicated robust cellular immune responses. We establish a stable and scalable protocol for VLPs-CaP, providing a theoretical and technical foundation for developing high-efficacy VLPs-CaP vaccines.
Vaccines, Virus-Like Particle/immunology*
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Immunogenicity, Vaccine
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Calcium Phosphates/chemistry*
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Foot-and-Mouth Disease Virus
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Biomineralization
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Particle Size
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Animals
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Mice
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Antibodies, Neutralizing/blood*
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Antibodies, Viral/blood*
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Immunity, Cellular
3.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Perimenopausal Syndrome
Shiwan HU ; Haiyan LIANG ; Kun MA ; Xiaona MA ; Zihan FANG ; Wenpei BAI ; Xinmin LIU ; Hongtian LI ; Fengmei LIAN ; Wei ZHANG ; Lihua QIN ; Min SHANG ; Ailuan LAI ; Xiuxiang TENG ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(21):234-242
Perimenopausal syndrome (MPS), a common endocrine system disease, is one of the diseases responding specifically to traditional Chinese medicine (TCM). The China Association of Chinese Medicine organized experts in endocrinology, gynecology, and interdisciplinary fields of both Western and Chinese medicine to discuss the advantages and challenges of diagnosing and treating MPS with Western medicine, TCM, and integrative medicine. Experts at the conference believe that MPS is initiated by estrogen decline and rooted in deficiency, with the pathogenesis being imbalance between Yin and Yang in the kidney. The hormone replacement therapy in Western medicine for menopause can rapidly alleviate related symptoms by quickly restoring the estrogen level and timely detect and delay complications of menopause, whereas such a therapy has certain risks, necessitating close monitoring of adverse reactions. Moreover, the various contraindications and precautions limit the clinical application of the hormone replacement therapy. TCM has advantages in synergistically alleviating symptoms such as hot flashes, sweating, sleep disorders, and emotional abnormalities of MPS without causing obvious adverse reactions. However, its efficacy is slower than the hormone replacement therapy, and the TCM evidence for preventing and treating complications of menopause remains unclear. Three suggestions were proposed for the future development of both Western and TCM for ameliorating MPS. First, an integrated diagnosis and treatment system for MPS with both Western and Chinese medicine should be established. Second, high-quality evidence-based interventions for MPS should be developed with TCM alone or in combination with Western medicine. Third, efforts should be made to promote the new TCM drug development and the interdisciplinary cooperation for treating MPS.
4.Diagnostic value of ultrasonography in Poland′s syndrome
Liyuan CUI ; Lishan ZHANG ; Hengtao QI ; Tiezheng WANG ; Lihua LIU ; Shougang BAO ; Xiaofei MU ; Jianbo TENG
Chinese Journal of Ultrasonography 2022;31(2):157-160
Objective:To investigate the diagnostic value of ultrasonography in Poland′s syndrome.Methods:From February 2016 to December 2020, the ultrasonographic images of 15 patients with Poland′s syndrome diagnosed by Provincial Hospital Affiliated to Shandong First Medical University were retrospectively analyzed, and the ultrasonographic features were summarized.Results:High-frequency ultrasound could clearly show the anatomical structures of each layer of the chest wall of the patients with Poland′s syndrome. The sonogram of Poland′s syndrome mainly showed the absence of all or part of the pectoralis major on the affected side, some of which were combined with the absence of pectoralis minor. The difference between the thickness of the affected chest wall and the healthy side was statistically significant ( P<0.01). Among the 15 cases of Poland′s syndrome, 11 cases had brachydactyly or syndactyly. Ultrasound showed that the bifurcation position of the common palmar digital artery of the middle finger was lower than that of the healthy side. Conclusions:The ultrasonography is an effective imaging method for diagnosis of Poland′s syndrome.
5.Influencing factors of adult thyroid volume in Lanzhou City
Huixin TAO ; Songbo FU ; Xulei TANG ; Jingfang LIU ; Chengxu MA ; Gaojing JING ; Nan ZHAO ; Lihua MA ; Weiming SUN ; Ying NIU ; Qianglong NIU ; Juntao RAN ; Weiping TENG ; Zhongyan SHAN
Chinese Journal of Endemiology 2022;41(1):39-43
Objective:To investigate the thyroid volume of adults in Lanzhou City, and analyze its influencing factors.Methods:In June 2016, according to the principle of multi-stage stratified cluster sampling, Han residents aged 18 and above in Chengguan, Xigu and Qilihe districts of Lanzhou City who had lived there for more than 5 years were selected as research subjects, and a portable B-ultrasound machine was used for thyroid examination. Morning urine samples of the subjects were collected to test urinary iodine; fasting venous blood samples of the subjects were collected to test serum thyroid stimulating hormone (TSH), thyroid peroxidase antibody (TPOAb), anti-thyroglobulin antibody (TgAb), blood lipids [triglycerides (TG), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL)] and blood uric acid (Ua) levels. At the same time, body indexes systolic blood pressure (SP), diastolic blood pressure (DP), waist circumference, height and weight were measured, and the body mass index (BMI) was calculated. Multiple linear regression was used to analyze the influencing factors of thyroid volume.Results:A total of 1 009 subjects were included, aged (43.50 ± 15.16) years, and the thyroid volume was (8.74 ± 3.39) ml. Among them, 534 males had a thyroid volume of (9.46 ± 3.43) ml; 475 females had a thyroid volume of (7.93 ± 3.15) ml, the thyroid volume of males was larger than that of females ( t = 7.36, P < 0.01). Thyroid volume was positively correlated with age, height, weight, BMI, SP, waist circumference, LDL, Ua and TgAb ( r = 0.07, 0.23, 0.33, 0.27, 0.10, 0.27, 0.10, 0.08, 0.07, P < 0.05), and it was negatively correlated with thyroid nodules, TPOAb, TSH and urinary iodine ( r = - 0.16, - 0.07, - 0.10, - 0.08, P < 0.05). After multiple linear regression analysis, TSH, TPOAb, TgAb and thyroid nodules were included in the regression equation, and the standardized B values were - 0.135, - 0.065, 0.123 and - 0.197, respectively. Conclusions:The thyroid volume of males is larger than that of females in Lanzhou City. TSH, TPOAb, TgAb and thyroid nodules are influencing factors of thyroid volume.
6.Detection of thyroid nodules in people with abnormal lipid metabolism and related factors
Xingyu CHANG ; Songbo FU ; Xulei TANG ; Jingfang LIU ; Nan ZHAO ; Gaojing JING ; Qianglong NIU ; Lihua MA ; Yinlong CHANG ; Junqin MOU ; Weiping TENG ; Zhongyan SHAN
Chinese Journal of Endemiology 2021;40(9):718-723
Objective:To investigate the detection rate and related factors of thyroid nodules in people with abnormal lipid metabolism.Methods:From September 4, 2016 to February 1, 2017, community residents living in Lanzhou City, Longnan City, Dingxi City and Linxia City of Gansu Province for more than 5 years were selected as the respondents. General data were recorded, venous blood was collected, blood lipid related biochemical indexes were detected, and thyroid ultrasound was performed. By comparing the general data and biochemical indexes, the detection of abnormal lipid metabolism and thyroid nodules were analyzed, and the risk factors of thyroid nodules in people with abnormal lipid metabolism were analyzed by logistic regression.Results:Two thousand and fifty-nine residents were included in this study (1 049 males and 1 010 females). The total detection rate of thyroid nodules was 23.17% (477/2 059). The detection rate of thyroid nodules in people with abnormal lipid metabolism [34.16%(151/442)] was significantly higher than that in people with normal lipid metabolism [20.16% (326/1 617) , P < 0.01], and the detection rate of thyroid nodules of women [43.37% (85/196) ] was higher than that of men [26.83% (66/246) , P < 0.01]. Among the people with abnormal lipid metabolism, the highest detection rate of thyroid nodules was in mixed hyperlipidemia [57.14% (16/28)], followed by hypertriglyceridemia [34.59% (92/266)]. The detection rates of thyroid nodules in the groups with elevated total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C) levels [35.16% (32/91), 34.85% (23/66)] were higher than those in the marginal elevated group [27.04%(86/318), 30.42% (73/240)] and the normal groups [21.76% (359/1 650), 21.73% (381/1 753), P < 0.05]. The results of logistic regression analysis showed that the risk factors of thyroid nodules in people with abnormal lipid metabolism were increased age, elevated fasting blood glucose (FPG), elevated blood glucose 2 hours (2 h PG) after oral glucose tolerance test (OGTT) load and elevated glycosylated hemoglobin [HbA1c, odds ratio ( OR)=1.065, 1.387, 1.866, 1.384, P < 0.05]. Conclusions:The prevalence of TN is higher in populations with abnormal lipid metabolism. The control of blood sugar and blood lipid levels may play a role in the prevention of thyroid nodules.
7.Value of ultrasonography in diagnosis of closed volar plate injury of proximal interphalangeal joint
Fei GUO ; Tiezheng WANG ; Liyuan CUI ; Lihua LIU ; Shougang BAO ; Xiaofei MU ; Jianbo TENG ; Hengtao QI
Chinese Journal of Ultrasonography 2021;30(12):1077-1080
Objective:To evaluate the role of high frequency ultrasonography in diagnosis of closed volar plate injury of proximal interphalangeal joint.Methods:From May 2015 to may 2021, 41 patients with acute closed volar plate injury confirmed by Department of Hand and Foot Surgery of the Provincial Hospital Affiliated to Shandong First Medical University were examined by high frequency ultrasonography. The sonographic features were analyzed and classified.Results:High frequency ultrasonography could not only clearly show the thickness, shape and echo of volar plate, but also the degree of injury and avulsion fracture of volar plate, according to which the closed volar plate injury could be divided into three types: A, B and C. Type A(13 cases): Avulsion fracture of the middle phalangeal base was found with volar plate rupture, the sonogram showed that the continuity of the volar plate attachment of the middle phalangeal base was interrupted, and avulsion fracture was found at the distal end of the volar plate. Type B(11 cases): Complete rupture of the volar plate attachment of the middle phalangeal base was found without avulsion fracture, the sonogram showed that the continuity of the volar plate attachment of the middle phalangeal base was interrupted, and the end of the volar plate contracted and thickened. Type C(17 cases): Tear of the volar plate was found, the sonogram showed enlarging volar plates, heterogeneous internal echo, and liquid dark area was visible in some cases. The average thickness of the three types of closed volar plate injury of the proximal interphalangeal joint measured by ultrasound was (0.33±0.05)cm, and the average thickness of the volar plate at the same position of the corresponding finger on the opposite side was (0.22±0.03)cm. There was significant difference between the two groups ( t=7.864, P=0.006). Conclusions:High frequency ultrasonography is the preferred imaging examination method for the diagnosis of closed volar plate injury in proximal interphalangeal joint, which has an important guiding significance for the selection of clinical treatment.
8.Correlation between nutritional status and toxicity of concurrent chemoradiotherapy in patients with rectal cancer
Xiaowei FU ; Lihua TENG ; Jinwen SHEN ; Qi PENG ; Na ZHANG ; Yuan ZHU ; Shuping XIE
Chinese Journal of Radiation Oncology 2020;29(9):757-761
Objective:To analyze the correlation between nutritional status and acute toxicity induced by concurrent chemoradiotherapy in patients with rectal cancer.Methods:A total of 115 patients with rectal cancer who underwent concurrent chemoradiotherapy in Zhejiang Cancer Hospital from March 2018 to August 2019 were prospectively selected. Nutritional risk was assessed by NRS 2002 and PG-SGA nutritional screening tools before, during and after radiotherapy. The acute toxicity was assessed by RTOG and CTCAE 3.0 scoring criteria. The correlation between nutritional status and the acute toxicity of chemoradiotherapy was analyzed by Spearman′ s correlation analysis. Results:The nutritional risk of the cohort was gradually increased from the beginning of chemoradiotherapy to the fourth week of chemoradiotherapy, and then decreased gradually. Spearman′ s correlation analysis showed that NRS 2002 and PG-SGA scores were positively correlated with acute hematological toxicity ( r=0.26, P<0.05; r=0.31, P<0.01), upper gastrointestinal toxicity ( r=0.51, P<0.01; r=0.63, P<0.01), proctitis ( r=0.23, P<0.05; r=0.45, P<0.01) and fatigue ( r=0.47, P<0.01; r=0.64, P<0.01) in patients with rectal cancer undergoing chemoradiotherapy. The correlation coefficients between PG-SGA and various toxicities were higher than those of NRS 2002. Stratified analysis showed that patients with stage Ⅱ-Ⅲ B, age<65 years and postoperative adjuvant chemoradiotherapy, nutritional status was significantly associated with the severity of toxicity (all P<0.05). Conclusions:Patients with rectal cancer has a high risk of malnutrition during concurrent chemoradiotherapy. The higher the risk of malnutrition, the greater the acute toxicity of chemoradiotherapy. Therefore, dynamic nutrition assessment and nutritional support should be strengthened for rectal cancer patients during chemoradiotherapy.
9. A study on urinary iodine levels and influencing factors of urban and rural residents in some areas of Gansu Province
Jie GAO ; Jingfang LIU ; Xulei TANG ; Songbo FU ; Lihua MA ; Caihong JIAO ; Weiming SUN ; Ying NIU ; Gaojing JING ; Qianglong NIU ; Nan ZHAO ; Yujuan LI ; Dan WU ; Pei SONG ; Huiping GUO ; Fang YANG ; Weiping TENG ; Zhongyan SHAN
Chinese Journal of Endemiology 2019;38(11):898-902
Objective:
To analyze the urinary iodine status of urban and rural residents in some areas of Gansu Province and its related influencing factors, and to provide certain references for scientific iodine intake of urban and rural residents in Gansu Province.
Methods:
Subjects in Gansu Province with normal thyroid function were recruited in the investigation of thyroid diseases and iodine nutritional status, conducted a questionnaire survey and measured height, weight, waist circumference, collected 1 urine sample, and tested their urinary iodine levels. The urinary iodine levels of different groups were compared based on different gender, region, age, body weight, the waist, and salt intaking. The affecting factors of urinary iodine levels were analyzed by multiple linear regression models.
Results:
Totally 1 964 subjects were recruited, including 1 099 males, and 865 females. The age was (41.23 ± 14.75) years old. The median urinary iodine of the selected group was 225.60 (158.80, 311.58) μg/L. The urinary iodine level of rural residents was significantly higher than that of urban residents [μg/L: 249.80 (180.58, 336.88)
10.Establishment of a novel TB-ARMS qPCR method for kras mutation detection.
Lihua YU ; Fei TENG ; Ming JIANG ; Jia GUO
Chinese Journal of Biotechnology 2019;35(5):880-891
A simple, robust and highly sensitive TB-ARMS method based on qPCR technique was developed to detect kras mutations. The technique was evaluated, and its clinical application was investigated. Mutation specific primers for eight common kras mutations and wild type gene targeted blockers were designed and optimized. Moreover, a mutant-enriched condition was used in to improve the sensitivity and specificity of mutation detection. Constructed plasmids carrying mutant kras genes, as well as confirmed wild type genomic DNA, were used as standard samples for evaluation of the methodology. The performance of our new method was validated by comparing the results of our method with that of a commercial kras kit in testing 40 clinical samples. Preoperative plasma samples, as well as paired tissue samples, were tested in parallel for evaluation of its clinical application. We have developed a new TB-ARMS method for kras mutation detection that can detect minor mutant alleles with a frequency as low as 0.01% in a heterogeneous sample. We have successfully demonstrated its 0.01% detection sensitivity with highly specific mutant amplification in conjunction with selective wild type suppression by blocker under a mutant-enriched reaction condition. We also showed that our TB-ARMS method was more accurate than the commercial kras kit, which is widely used presently. Furthermore, we have validated our method as an efficient liquid biopsy method, and the results of the plasma DNA detection with our TB-ARMS method were in consistent with the sequencing results of paired tissue samples. In conclusion, our TB-ARMS qPCR method could be effectively applied in kras mutation test for clinical tissue samples, as well as for liquid biopsy samples such as plasma.
DNA Primers
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Diagnostic Techniques and Procedures
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Humans
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Mutation
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Neoplasms
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diagnosis
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genetics
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Proto-Oncogene Proteins p21(ras)
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genetics
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Real-Time Polymerase Chain Reaction

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