1.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
2.Blades and barriers: Oral vaccines for conquering cancers and warding off infectious diseases.
Kun YANG ; Jinhua LIU ; Yi ZHAO ; Haiting XU ; Menghang ZU ; Baoyi LI ; Xiaoxiao SHI ; Rui L REIS ; Subhas C KUNDU ; Bo XIAO
Acta Pharmaceutica Sinica B 2025;15(8):3925-3950
Global public health faces substantial challenges from malignant tumors and infectious diseases. Vaccination provides an approach for treating and preventing these diseases. Oral vaccinations are particularly advantageous in disease treatment and prevention due to their non-invasive nature, high patient compliance, convenience, cost-effectiveness, and capacity to stimulate comprehensive and adaptive immune responses. However, the overwhelming majority of oral vaccines remain in experimental development, struggling with clinical and commercial translation due to their suboptimal efficacy. Thus, enhancing scientists' understanding of the interaction between vaccines and gastrointestinal immune system, creating antigen delivery systems suitable for the gut mucosal environment, developing more potent antigenic epitopes, and using personalized combination therapies are critical for advancing the next generation of oral vaccines. This article explores the fundamental principles and applications of current oral anti-tumor and anti-infective vaccines and discusses considerations necessary for designing future oral vaccines.
3.Structure-based development of potent and selective type-II kinase inhibitors of RIPK1.
Ying QIN ; Dekang LI ; Chunting QI ; Huaijiang XIANG ; Huyan MENG ; Jingli LIU ; Shaoqing ZHOU ; Xinyu GONG ; Ying LI ; Guifang XU ; Rui ZU ; Hang XIE ; Yechun XU ; Gang XU ; Zheng ZHANG ; Shi CHEN ; Lifeng PAN ; Ying LI ; Li TAN
Acta Pharmaceutica Sinica B 2024;14(1):319-334
Receptor-interacting serine/threonine-protein kinase 1 (RIPK1) functions as a key regulator in inflammation and cell death and is involved in mediating a variety of inflammatory or degenerative diseases. A number of allosteric RIPK1 inhibitors (RIPK1i) have been developed, and some of them have already advanced into clinical evaluation. Recently, selective RIPK1i that interact with both the allosteric pocket and the ATP-binding site of RIPK1 have started to emerge. Here, we report the rational development of a new series of type-II RIPK1i based on the rediscovery of a reported but mechanistically atypical RIPK3i. We also describe the structure-guided lead optimization of a potent, selective, and orally bioavailable RIPK1i, 62, which exhibits extraordinary efficacies in mouse models of acute or chronic inflammatory diseases. Collectively, 62 provides a useful tool for evaluating RIPK1 in animal disease models and a promising lead for further drug development.
4.Causal relationship between relative abundance of gut microbiota and teratozoospermia:A two-sample Mendelian randomization analysis
Xiao-Hui HAO ; Rui-Min MA ; Si-Cheng MA ; Wen-Bang LIU ; Chen-Ming ZHANG ; Wen-Lin YU ; Jing HU ; Zu-Long WANG
National Journal of Andrology 2024;30(5):387-396
Objective:To explore the potential causal relationship between gut microbiota and teratozoospermia.Methods:We searched the database of Genome-Wide Association Study(GWAS)for gut microbiota-and teratozoospermia-related data.We used gut microbiota as an exposure factor,determined the instrumental variables according to the GWAS data on 18 340 participants released by the MiBioGen Alliance,and derived the outcome variables from the European data on teratozoospermia,with a sample size of 85 716,including 915 cases and 209 006 controls.Using inverse-variance weighting(IVW),MR-Egger regression and the weighted median estimator(WME),we performed two-sample Mendelian randomization(MR)analysis on the retrieved data,and estimated the causal relationship between gut microbiota and teratozoospermia based on the β value.Results:Two-sample MR analysis indicated that the class Erysipelotrichia,family Erysipelotrichaceae,family Streptococcaceae,genus Coprococcusl,genus Ruminococcaceae UCG009,genus Streptococcus,order Clostridialesm and order Erysipelotrichales were causally related with the increased risk,while the family Porphyromonadaceae with the decreased risk of teratozoospermia.Conclusion:The class Erysipelotrichia,family Erysipe-lotrichaceae,family Streptococcaceae,genus Coprococcusl,genus Ruminococcaceae UCG009,genus Streptococcus,order Clostridia-lesm and order Erysipelotrichales are one of the causes of teratozoospermia,related to the increased risk of the condition,while the family Porphyromonadaceae has a protective effect on sperm morphology,reducing the risk of teratozoospermia.
5.Factors for low libido in male patients with sexual dysfunction
Qiu-Chen LÜ ; Rui WANG ; Zu-Long WANG ; Tian-Ji ZHANG ; Tao ZHENG ; Kun-Long LÜ ; Yong-Hao NAN
National Journal of Andrology 2024;30(8):734-737
Objective:To analyze the factors for low libido in male patients with sexual dysfunction and provide some evidence for the clinical diagnosis and treatment of the condition.Methods:We retrospectively analyzed the clinical data on 111 cases of sex-ual dysfunction(including disorders in erection,ejaculation or libido)treated in the Zhengzhou University First Hospital from June to September 2023.According to the patients'complaints of low libido or accompanied symptoms,we divided them into a normal libido group(n=68)and a low libido(n=43),obtained their scores on IIEF-5,Premature Ejaculation Diagnostic Tool(PEDT),13-1-tem Self-Rating Libido Scale for Males(SRLS-M),Patients'Health Questionnaire-9(PHQ-9)and General Anxiety Disorder-7(GAD-7),examined the levels of the sexual hormones FSH,LH,PRL,T,free testosterone(fT),E2,?insulin-like growth factor 1(IGF-1)and growth hormone(GH),compared the basic parameters between the two groups,and analyzed their correlation with the libido values.Results:The IIEF-5,PEDT and libido scores and IGF-1 level were significantly higher and the GAD-7 score remark-ably lower in the normal than in the low libido group(P<0.05),but no statistically significant differences were observed between the two groups in the PHQ-9 score and the levels FSH,LH,PRL,T,fT,E2,T/E2 and GH(P>0.05).The libido value was correla-ted positively with the I1EF-5(r=0.28,P<0.01)and PEDT scores(r=0.29,P<0.01)and IGF-1 level(r=0.23,P<0.05),but negatively with the GAD-7 score(r=-0.21,P<0.05).Conclusion:Low libido results from multiple factors,which cannot be fully explained by sexual hormone levels but is closely related to the decreased level of IGF-1 and severity of ED and anxiety.
6.Differential Analysis of Gut Flora in Patients with Osteoporosis of Different Traditional Chinese Medicine Syndrome Types
Zhi-Cheng ZHOU ; Han TIAN ; Xu-Rui ZHUANG ; Zu-Jian LIANG
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(9):2289-2295
Objective To analyze the characteristics and differences of gut flora in patients with osteoporosis of different traditional Chinese medicine(TCM)syndrome types,thus to find out new therapeutic targets for the treatment of osteoporosis.Methods The clinical data and fecal samples of 57 patients with osteoporosis recruited in the Department of Osteoporosis,the Third Affiliated Hospital of Guangzhou University of Chinese Medicine from February 2023 to November 2023 were collected.The patients were differentiated as the TCM syndrome types of spleen and kidney yang deficiency group(22 cases),liver and kidney yin deficiency group(18 cases)and kidney deficiency and blood stasis group(7 cases).The differences in the structure and abundance of gut flora in patients with the above three TCM syndrome types were analyzed by16S rDNA sequencing technique.Results The results of Alpha(α)diversity showed that there were no significant differences in species richness,evenness and diversity of gut flora among the three groups(P>0.05).Beta(β)diversity analysis showed that there were significant differences in gut flora among the three groups(P=0.011).At the phylum level,Bacteroidota,Firmicutes and Proteobacteria were the top three kinds of gut flora with the highest proportion in the three groups.At the genus level,the relative abundance of Bacteroides,Escherichia-Shigella,and Faecalibacterium was higher in the group of liver and kidney yin deficiency and in the group of kidney deficiency and blood stasis,while the group of spleen and kidney yang deficiency has a large proportion of other bacteria.Conclusion There exist differences in the composition of gut flora among patients with different TCM syndrome types,and the differences are shown at the level of phylum and genus.The results indicate that gut flora may be the targets in the TCM prevention and treatment of osteoporosis.
7.Total flavonoids of Dracocephalum moldavica L. inhibit oxidative stress against H9c2 cell ischemia-reperfusion injury via VEGF-B/AMPK pathway
Kaderyea KADER ; Jian-guo XING ; Di-wei LIU ; Rui-fang ZHENG ; Zu-wen MA
Acta Pharmaceutica Sinica 2023;58(9):2685-2693
Total flavonoids of
8.Status of fungal sepsis among preterm infants in 25 neonatal intensive care units of tertiary hospitals in China.
Xin Cheng CAO ; Si Yuan JIANG ; Shu Juan LI ; Jun Yan HAN ; Qi ZHOU ; Meng Meng LI ; Rui Miao BAI ; Shi Wen XIA ; Zu Ming YANG ; Jian Fang GE ; Bao Quan ZHANG ; Chuan Zhong YANG ; Jing YUAN ; Dan Dan PAN ; Jing Yun SHI ; Xue Feng HU ; Zhen Lang LIN ; Yang WANG ; Li Chun ZENG ; Yan Ping ZHU ; Qiu Fang WEI ; Yan GUO ; Ling CHEN ; Cui Qing LIU ; Shan Yu JIANG ; Xiao Ying LI ; Hui Qing SUN ; Yu Jie QI ; Ming Yan HEI ; Yun CAO
Chinese Journal of Pediatrics 2023;61(1):29-35
Objective: To analyze the prevalence and the risk factors of fungal sepsis in 25 neonatal intensive care units (NICU) among preterm infants in China, and to provide a basis for preventive strategies of fungal sepsis. Methods: This was a second-analysis of the data from the "reduction of infection in neonatal intensive care units using the evidence-based practice for improving quality" study. The current status of fungal sepsis of the 24 731 preterm infants with the gestational age of <34+0 weeks, who were admitted to 25 participating NICU within 7 days of birth between May 2015 and April 2018 were retrospectively analyzed. These preterm infants were divided into the fungal sepsis group and the without fungal sepsis group according to whether they developed fungal sepsis to analyze the incidences and the microbiology of fungal sepsis. Chi-square test was used to compare the incidences of fungal sepsis in preterm infants with different gestational ages and birth weights and in different NICU. Multivariate Logistic regression analysis was used to study the outcomes of preterm infants with fungal sepsis, which were further compared with those of preterm infants without fungal sepsis. The 144 preterm infants in the fungal sepsis group were matched with 288 preterm infants in the non-fungal sepsis group by propensity score-matched method. Univariate and multivariate Logistic regression analysis were used to analyze the risk factors of fungal sepsis. Results: In all, 166 (0.7%) of the 24 731 preterm infants developed fungal sepsis, with the gestational age of (29.7±2.0) weeks and the birth weight of (1 300±293) g. The incidence of fungal sepsis increased with decreasing gestational age and birth weight (both P<0.001). The preterm infants with gestational age of <32 weeks accounted for 87.3% (145/166). The incidence of fungal sepsis was 1.0% (117/11 438) in very preterm infants and 2.0% (28/1 401) in extremely preterm infants, and was 1.3% (103/8 060) in very low birth weight infants and 1.7% (21/1 211) in extremely low birth weight infants, respectively. There was no fungal sepsis in 3 NICU, and the incidences in the other 22 NICU ranged from 0.7% (10/1 397) to 2.9% (21/724), with significant statistical difference (P<0.001). The pathogens were mainly Candida (150/166, 90.4%), including 59 cases of Candida albicans and 91 cases of non-Candida albicans, of which Candida parapsilosis was the most common (41 cases). Fungal sepsis was independently associated with increased risk of moderate to severe bronchopulmonary dysplasia (BPD) (adjusted OR 1.52, 95%CI 1.04-2.22, P=0.030) and severe retinopathy of prematurity (ROP) (adjusted OR 2.55, 95%CI 1.12-5.80, P=0.025). Previous broad spectrum antibiotics exposure (adjusted OR=2.50, 95%CI 1.50-4.17, P<0.001), prolonged use of central line (adjusted OR=1.05, 95%CI 1.03-1.08, P<0.001) and previous total parenteral nutrition (TPN) duration (adjusted OR=1.04, 95%CI 1.02-1.06, P<0.001) were all independently associated with increasing risk of fungal sepsis. Conclusions: Candida albicans and Candida parapsilosis are the main pathogens of fungal sepsis among preterm infants in Chinese NICU. Preterm infants with fungal sepsis are at increased risk of moderate to severe BPD and severe ROP. Previous broad spectrum antibiotics exposure, prolonged use of central line and prolonged duration of TPN will increase the risk of fungal sepsis. Ongoing initiatives are needed to reduce fungal sepsis based on these risk factors.
Infant
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Infant, Newborn
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Humans
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Birth Weight
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Intensive Care Units, Neonatal
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Retrospective Studies
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Tertiary Care Centers
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Infant, Extremely Low Birth Weight
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Gestational Age
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Infant, Extremely Premature
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Sepsis/epidemiology*
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Retinopathy of Prematurity/epidemiology*
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Bronchopulmonary Dysplasia/epidemiology*
9.Incidence of extrauterine growth retardation and its risk factors in very preterm infants during hospitalization: a multicenter prospective study.
Wei SHEN ; Zhi ZHENG ; Xin-Zhu LIN ; Fan WU ; Qian-Xin TIAN ; Qi-Liang CUI ; Yuan YUAN ; Ling REN ; Jian MAO ; Bi-Zhen SHI ; Yu-Mei WANG ; Ling LIU ; Jing-Hui ZHANG ; Yan-Mei CHANG ; Xiao-Mei TONG ; Yan ZHU ; Rong ZHANG ; Xiu-Zhen YE ; Jing-Jing ZOU ; Huai-Yu LI ; Bao-Yin ZHAO ; Yin-Ping QIU ; Shu-Hua LIU ; Li MA ; Ying XU ; Rui CHENG ; Wen-Li ZHOU ; Hui WU ; Zhi-Yong LIU ; Dong-Mei CHEN ; Jin-Zhi GAO ; Jing LIU ; Ling CHEN ; Cong LI ; Chun-Yan YANG ; Ping XU ; Ya-Yu ZHANG ; Si-Le HU ; Hua MEI ; Zu-Ming YANG ; Zong-Tai FENG ; San-Nan WANG ; Er-Yan MENG ; Li-Hong SHANG ; Fa-Lin XU ; Shao-Ping OU ; Rong JU
Chinese Journal of Contemporary Pediatrics 2022;24(2):132-140
OBJECTIVES:
To investigate the incidence of extrauterine growth retardation (EUGR) and its risk factors in very preterm infants (VPIs) during hospitalization in China.
METHODS:
A prospective multicenter study was performed on the medical data of 2 514 VPIs who were hospitalized in the department of neonatology in 28 hospitals from 7 areas of China between September 2019 and December 2020. According to the presence or absence of EUGR based on the evaluation of body weight at the corrected gestational age of 36 weeks or at discharge, the VPIs were classified to two groups: EUGR group (n=1 189) and non-EUGR (n=1 325). The clinical features were compared between the two groups, and the incidence of EUGR and risk factors for EUGR were examined.
RESULTS:
The incidence of EUGR was 47.30% (1 189/2 514) evaluated by weight. The multivariate logistic regression analysis showed that higher weight growth velocity after regaining birth weight and higher cumulative calorie intake during the first week of hospitalization were protective factors against EUGR (P<0.05), while small-for-gestational-age birth, prolonged time to the initiation of total enteral feeding, prolonged cumulative fasting time, lower breast milk intake before starting human milk fortifiers, prolonged time to the initiation of full fortified feeding, and moderate-to-severe bronchopulmonary dysplasia were risk factors for EUGR (P<0.05).
CONCLUSIONS
It is crucial to reduce the incidence of EUGR by achieving total enteral feeding as early as possible, strengthening breastfeeding, increasing calorie intake in the first week after birth, improving the velocity of weight gain, and preventing moderate-severe bronchopulmonary dysplasia in VPIs.
Female
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Fetal Growth Retardation
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Gestational Age
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Hospitalization
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Humans
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Incidence
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Infant
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Infant, Newborn
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Infant, Premature
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Infant, Very Low Birth Weight
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Prospective Studies
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Risk Factors
10.Design and Verification of Human Metabolic Measurement System Based on STM32.
Rui JIN ; Hai-Hong HUANG ; Yuan WANG ; Yan-Yan CHEN ; Qing-Qing CAO ; Rui-de LIU ; Zi-Jun HE ; Yi-Ning SUN ; Zu-Zhang MA
Chinese Journal of Medical Instrumentation 2022;46(3):273-277
A high-precision human metabolic measurement system is designed. The system uses STM32F103 as the main control chip to acquire oxygen, carbon dioxide and flow signals to calculate four quantitative indicators: oxygen consumption(VO2), carbon dioxide production(VCO2), respiratory entropy(RQ) and resting energy metabolism(REE), and finally uses an upper computer to display the calculation results.In this paper, the signal acquisition circuit design was carried out for the oxygen sensor, carbon dioxide sensor and flow sensor, and the validity of the device was verified with the American machine MGCDiagnositcs using Bland-Altman analysis method, and the results showed that the four parameters of VO2,VCO2, RQ and REE of both devices fell in the agreement interval of more than 95%. The device thus provides accurate metabolic measurements and offers an effective tool for the field of general health and clinical nutrition support in China.
Calorimetry, Indirect
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Carbon Dioxide/metabolism*
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Energy Metabolism
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Humans
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Oxygen
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Oxygen Consumption

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