1.Clinical Safety Monitoring of 3 035 Cases of Juvenile Feilike Mixture After Marketing in Hospital
Jian ZHU ; Zhong WANG ; Jing LIU ; Jun LIU ; Wei YANG ; Yanan YU ; Hongli WU ; Sha ZHOU ; Zhiyu PAN ; Guang WU ; Mengmeng WU ; Zhiwei JING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):194-200
ObjectiveTo explore the clinical safety of Feilike Mixture (FLK) in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21,2021 and December 25,2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved,which are distributed across 12 provinces,including one traditional Chinese medicine (TCM) hospital and 28 general hospitals. The average age among the juveniles was (4.77±3.56) years old,and the average weight was (21.81±12.97) kg. Among them,119 cases (3.92%) of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles,with 1 656 cases (54.46%). FLK was first used in 2 016 cases (66.43%),and 142 juvenile patients had special dosages,accounting for 4.68%. Among them,92 adverse drug reactions (ADRs) occurred,including 73 cases of gastrointestinal system disorders,10 cases of metabolic and nutritional disorders,eight cases of skin and subcutaneous tissue diseases,two cases of vascular and lymphatic disorders,and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea,stool discoloration,and vomiting,and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages (the use of FLK)[odds ratio (OR) of 2.642, 95% confidence interval (CI) of 1.105-6.323],combined administration: spleen aminopeptide (OR of 4.978, 95%CI of 1.200-20.655),and reason for combined administration: anti-infection (OR of 1.814, 95%CI of 1.071-3.075) were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%,and the severity was mainly mild or moderate. Generally,the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction,suggesting that FLK has good clinical safety.
2.Mechanism of Exogenous Melatonin in Inhibiting Early Bolting in Angelica sinensis
Jiang ZHAO ; Zhanwen TANG ; Tao YANG ; Jie SHA ; Tong PENG ; Weiwen LU ; Yinquan WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):234-240
ObjectiveThis study aims to investigate the effects of different sizes of seedlings and melatonin treatment on physiological and biochemical indicators and bolting-related gene expression in Angelica sinensis, find substances related to early bolting, and elucidate the inhibitory mechanism of melatonin on bolting. MethodsSpectrophotometry was used to detect the related enzyme activities of A. sinensis leaves. The contents of endogenous hormones and polyamines were detected using ultra-high performance liquid chromatography-tandem mass spectrometry. Real-time polymerase chain reaction (Real-time PCR) was used to detect the expression levels of bolting-related genes. Inter-group differential indicator analysis, orthogonal partial least squares discriminant analysis, and principal component analysis were comprehensively applied to identify factors related to early bolting. ResultsEndogenous jasmonic acid and melatonin were identified as the most important factors affecting early bolting. Secondly, the activity of antioxidant enzymes, abscisic acid content, gibberellin content, and the expression levels of CO3, HD3A, and FD genes had important effects on the bolting process. Compared with small seedlings, exogenous melatonin treatment mainly inhibited early bolting by increasing endogenous melatonin content, reducing gibberellin content, and decreasing the expression levels of SOC1 and FD genes. ConclusionExogenous melatonin can inhibit early bolting in A. sinensis by regulating its physiological, biochemical, and gene expression levels.
3.Key Points for Quality Management in Phase Ⅰ Clinical Trials of Anti-Tumor Drugs
Li GONG ; Bin LIAO ; Jie SHEN ; Juan ZHAO ; Yi GONG ; Xiaoxiao LU ; Huiyao YANG ; Sha LI ; Yongsheng LI
Cancer Research on Prevention and Treatment 2025;52(5):347-354
Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.
4.Mechanism of Exogenous Melatonin in Inhibiting Early Bolting in Angelica sinensis
Jiang ZHAO ; Zhanwen TANG ; Tao YANG ; Jie SHA ; Tong PENG ; Weiwen LU ; Yinquan WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):234-240
ObjectiveThis study aims to investigate the effects of different sizes of seedlings and melatonin treatment on physiological and biochemical indicators and bolting-related gene expression in Angelica sinensis, find substances related to early bolting, and elucidate the inhibitory mechanism of melatonin on bolting. MethodsSpectrophotometry was used to detect the related enzyme activities of A. sinensis leaves. The contents of endogenous hormones and polyamines were detected using ultra-high performance liquid chromatography-tandem mass spectrometry. Real-time polymerase chain reaction (Real-time PCR) was used to detect the expression levels of bolting-related genes. Inter-group differential indicator analysis, orthogonal partial least squares discriminant analysis, and principal component analysis were comprehensively applied to identify factors related to early bolting. ResultsEndogenous jasmonic acid and melatonin were identified as the most important factors affecting early bolting. Secondly, the activity of antioxidant enzymes, abscisic acid content, gibberellin content, and the expression levels of CO3, HD3A, and FD genes had important effects on the bolting process. Compared with small seedlings, exogenous melatonin treatment mainly inhibited early bolting by increasing endogenous melatonin content, reducing gibberellin content, and decreasing the expression levels of SOC1 and FD genes. ConclusionExogenous melatonin can inhibit early bolting in A. sinensis by regulating its physiological, biochemical, and gene expression levels.
5.Bacterial Diversity in Phyllosphere and Rhizosphere Soil of Angelica sinensis in Continuous Cropping and Effects of Different Disease Control Measures
Zhanwen TANG ; Tao YANG ; Tong PENG ; Yinquan WANG ; Jiang ZHAO ; Jie SHA ; Zhiye WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):199-207
ObjectiveTo investigate the bacterial diversity in the rhizosphere soil and phyllosphere of Angelica sinensis and examine the effects of foliar applications of a composite bacterial agent,salicylic acid,and coronatine on the bacterial diversity,disease incidence,and plant yield,thus providing a theoretical basis and guidance for the artificial construction of functional minimal communities and the regulation of rhizosphere through foliar treatments. MethodsUnder continuous cropping conditions in the field,foliar applications of a composite bacterial agent,salicylic acid,coronatine,and sterile water were conducted. The 100-plant weight was measured via the conventional method,and the incidence of diseases was recorded. The microbial community composition,diversity,and inter-group differences in the phyllosphere and rhizosphere soil of A. sinensis were analyzed by 16S high-throughput sequencing,and the potential microbial functions were predicted. ResultsCompared with the blank control,foliar applications of salicylic acid and coronatine both significantly reduced the yield and root rot incidence of A. sinensis. The foliar application of salicylic acid decreased the content of ferulic acid and increased that of ligustilide. The foliar application of coronatine increased the content of both ferulic acid and ligustilide. The microbial communities and functions in the phyllosphere and rhizosphere soil were significantly different. The phyllosphere had lower microbial diversity,with all bacteria being Gram-negative,mainly Cyanobacteria and Proteobacteria with limited functions. The rhizosphere soil had higher microbial diversity,harboring dominant phyla including Proteobacteria,Actinobacteria,Acidobacteria,and Bacteroidetes with rich functions. All foliar treatments regulated the microbial community in the rhizosphere soil,with a more significant effect on the microbial community in the rhizosphere soil than that in the phyllosphere. The coronatine treatment significantly reduced the abundance of Proteobacteria and nitrate-reducing and aromatic compound-degrading microorganisms in the rhizosphere soil,thus affecting nutrient cycling and autotoxic substance degradation and leading to a yield reduction. Compared with the salicylic acid treatment,the coronatine treatment significantly increased the abundance of Bacillus and Streptomyces in the rhizosphere soil,demonstrating enhanced disease control efficacy. ConclusionFoliar application of coronatine and salicylic acid can significantly regulate the composition and function of bacterial communities in the rhizosphere soil,thereby reducing the disease incidence and the plant yield.
6.Serological and molecular biological analysis of a rare Dc- variant individual
Xue TIAN ; Hua XU ; Sha YANG ; Suili LUO ; Qinqin ZUO ; Liangzi ZHANG ; Xiaoyue CHU ; Jin WANG ; Dazhou WU ; Na FENG
Chinese Journal of Blood Transfusion 2025;38(8):1101-1106
Objective: To reveal the molecular biological mechanism of a rare Dc-variant individual using PacBio third-generation sequencing technology. Methods: ABO and Rh blood type identification, DAT, unexpected antibody screening and D antigen enhancement test were conducted by serological testing. The absorption-elution test was used to detect the e antigen. RHCE gene typing was performed by PCR-SSP, and the 1-10 exons of RHCE were sequenced by Sanger sequencing. The full-length sequences of RHCE, RHD and RHAG were detected by PacBio third-generation sequencing technology. Results: Serological findings: Blood type O, Dc-phenotype, DAT negative, unexpected antibody screening negative; enhanced D antigen expression; no detection of e antigen in the absorption-elution test. PCR-SSP genotyping indicated the presence of only the RHCE
c allele. Sanger sequencing results: Exons 5-9 of RHCE were deleted, exon 1 had a heterozygous mutation at c. 48G/C, and exon 2 had five heterozygous mutations at c. 150C/T, c. 178C/A, c. 201A/G, c. 203A/G and c. 307C/T. Third-generation sequencing results: RHCE genotype was RHCE
02N. 08/RHCE-D(5-9)-CE; RHD genotype was RHD
01/RHD
01; RHAG genotype was RHAG
01/RHAG
01 (c. 808G>A and c. 861G>A). Conclusion: This Dc-individual carries the allele RHCE
02N. 08 and the novel allele RHCE-D(5-9)-CE. The findings of this study provide data support and a theoretical basis for elucidating the molecular mechanisms underlying RhCE deficiency phenotypes.
7.Epidemiological characteristics of mumps in Guangxi in 2012-2024
Jiagui CHEN ; Qiuyun DENG ; Rencong YANG ; Jing LIU ; Sha LI ; Ying HUANG ; Jianan WEI ; Jinfa DU
Journal of Public Health and Preventive Medicine 2025;36(6):21-24
Objective To analyze the epidemiological characteristics of mumps in Guangxi from 2012 to 2024, and to provide a scientific basis for formulating prevention and control strategies. Methods Descriptive epidemiological methods were used to analyze the incidence data of mumps in Guangxi from 2012 to 2024. Results A total of 159 873 mumps cases were reported from 2012 to 2024 in Guangxi, with an average annual reported incidence of 25.41/100 000, and no death. Mumps occurred every month, with the peak incidence mainly concentrated in April to July and October to January of the next year. There were 96,118 male cases (29.43 /100 000), and 63 755 female cases (21.07 /100 000). The male to female ratio was 1.40:1, and the difference between male and female was significant (χ2=4 321.276,P<0.05). The annual incidence of mumps showed a certain periodic change, with the incidence peak and trough alternating every 4 - 5 years. The majority of patients were under 15 years old, accounting for 85.32% of the total number of cases. The patients mainly included students, preschool children and scattered children. The highest average incidence was in Nanning City with 40 231 cases (42.08/100 000), and the lowest was in Qinzhou City with 3 466 cases (8.16/100 000). From 2012 to 2024, a total of 210 mumps outbreaks with 4 483 cases were reported in Guangxi. Conclusion The incidence of mumps in Guangxi from 2012 to 2024 shows a periodic change and obvious seasonality. People under 15 years old are the key group at risk of mumps. The prevention and control of the epidemic of mumps in schools and kindergartens should be strengthened. It is suggested to carry out long-term monitoring of mumps as well as immune effect research, and continue to maintain a high vaccination rate of 2 doses of mumps-containing vaccines.
8.Textual research on the evolution of the meridian-zangfu related theory in the Warring States, Qin and Han dynasties.
Xiaohong CHEN ; Dekun LIU ; Ruibin ZHANG ; Yahan ZENG ; Sha YANG ; Shuguang YU
Chinese Acupuncture & Moxibustion 2025;45(3):280-287
The paper reviews the evolution of the theory related to meridians and zangfu organs during the Warring States, Qin and Han dynasties, so as to reveal the rules and value of its development. By analyzing historical documents, especially Zubi Shiyimai Jiujing (Moxibustion Classics of Eleven Meridians of Legs and Arms), Yinyang Shiyimai Jiujing (Moxibustion Classic on Eleven Yin and Yang Meridians), Laoguanshan bamboo medical slips of Han Dynasty and lacquer figure of meridian points, the evolutionary stages, i.e. the germination, development, and maturity of meridian-zangfu theory, are explored. In the time of the Warring States, Qin and Han dynasties, the meridian-zangfu related theory was developed from the germination to the maturity. In the classics of the early time, Zubi Shiyimai Jiujing and Yinyang Shiyimai Jiujing demonstrated the preliminary relationship between meridians and zangfu organs, focusing on the physiological connection and pathogenesis of three yin meridians of foot and zangfu organs. In the literature of Laoguanshan bamboo medical slips of Han Dynasty and lacquer figure of meridian points, the physiological connection between the yin meridians of hand and foot, and five zang organs, as well as the related diseases were further clarified; additionally, the meridian-zangfu theory had been developed in the field of diagnosis and treatment. In the era of Chapter of Meridians in Lingshu (Miraculous Pivot), there were up to 31 descriptions relevant with the connection of meridian distribution and zangfu physiological functions. It marks the construction of the "circular" flow of meridians and the interior-exterior communication of zang and fu organs; and enriches the knowledge in diseases, diagnosis and treatment with meridians and zangfu organs involved. The review on the evolution of the meridian-zangfu theory is conductive to supplementing and improving the development history of this theory of early time, and further recognizing its development rules and value. The maturity of this theoretical system not only links the meridians with the five zang and six fu organs, but also provides an important theoretical basis for the diagnosis and treatment of traditional Chinese medicine.
Meridians
;
Humans
;
History, Ancient
;
China
;
History, Medieval
;
History, 19th Century
;
History, 20th Century
;
History, 18th Century
;
History, 17th Century
;
History, 16th Century
;
Medicine, Chinese Traditional/history*
9.Research and prospect of integrated traditional Chinese and western medicine in treatment of bronchiectasis.
Qing MIAO ; Zi YANG ; Bo XU ; Sha-Sha YUAN ; Yu-Chen WEI ; Jin-Zhi ZHANG ; Rui LI ; Chang-Zheng FAN
China Journal of Chinese Materia Medica 2025;50(13):3692-3698
Bronchiectasis(BE) is the third major chronic airway disease, and its incidence rate shows a continuously increasing trend. Bronchiectasis is a highly heterogeneous chronic airway disease. Due to structural alterations, airflow limitation, and mucus hypersecretion, clinical treatment faces many challenges. Particularly, problems including Pseudomonas aeruginosa-dominant drug-resistant bacterial colonization, recurrent infections, airway mucus hypersecretion, and impaired lung function are the most urgent, requiring long-term and personalized treatment and management integrating traditional Chinese and western medicine to prevent the recurrence and continuous progression of the disease. In recent years, both traditional Chinese medicine and western medicine have made certain progress in pathogenesis theories, clinical studies, and basic research regarding the therapeutic challenges of bronchiectasis. Therefore, this paper summarized relevant research from the past 10 years and explored future directions and potential advantages of integrated traditional Chinese and western medicine treatment, providing references for optimizing the clinical management strategies for bronchiectasis.
Bronchiectasis/drug therapy*
;
Humans
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Drugs, Chinese Herbal/therapeutic use*
;
Medicine, Chinese Traditional/methods*
;
Animals
10.A new cephalotaxine-type alkaloid dimer from Cephalotaxus lanceolata.
Jia-Yang MA ; Jing WANG ; Sha CHEN ; Chun-Lei YUAN ; Jin-Yuan YANG ; Da-Hong LI ; Hui-Ming HUA
China Journal of Chinese Materia Medica 2025;50(13):3729-3741
The chemical constituents from Cephalotaxus lanceolata were isolated and purified by using multiple chromatographic techniques, including octadecylsilane(ODS), silica gel, Sephadex LH-20 column chromatography, and semi-preparative high-performance liquid chromatography(HPLC). A total of 17 compounds obtained were identified by using spectroscopic methods such as nuclear magnetic resonance(NMR), mass spectrometry(MS), and ultraviolet(UV) combined with literature data. Compound 1 was a new alkaloid dimer, named cephalancetine E. The known compounds were determined as cephalancetine A(2), 11-hydroxycephalotaxine(3), 4-hydroxycephalotaxine(4), cephalotaxine(5), epicephalotaxine(6), cephalotaxine β-N-oxide(7), acetylcephalotaxine(8), cephalotine A(9), cephalotine B(10), 11-hydroxycephalotaxine hemiketal(11), 3-deoxy-3,11-epoxy-cephalotaxine(12), cephalotaxinone(13), isocephalotaxinone(14), 2,11-epoxy-1,2-dihydro-8-oxo-cephalotaxine(15), cephalotaxamide(16), and drupacine(17), respectively. Compounds 11, 12, and 15 were isolated from the Cephalotaxus genus for the first time. The biological activity was tested for compounds 1-17. The results reveal that compound 17 displays potent inhibitory activities against three human cancer cell lines(HepG-2, MCF-7, and SH-SY5Y).
Cephalotaxus/chemistry*
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Humans
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Cell Line, Tumor
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Drugs, Chinese Herbal/pharmacology*
;
Harringtonines/pharmacology*
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Molecular Structure
;
Dimerization
;
Alkaloids/isolation & purification*
;
Magnetic Resonance Spectroscopy


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