1.Clinical analysis of 15 cases of severe Mycoplasma pneumoniae pneumonia complicated by cardiac thrombosis in children
Juan YANG ; Fengqin LIU ; Xing CHEN ; Chunyan GUO ; Yan LIANG ; Fangfang DAI ; Ning DING ; Ke WANG ; Jing ZHANG
Chinese Journal of Pediatrics 2025;63(5):535-540
Objective:To investigate the clinical manifestations, therapeutic strategies and prognostic outcomes in pediatric patients with severe Mycoplasma pneumoniae pneumonia (SMPP) complicated by cardiac thrombosis. Methods:This case series study retrospectively analyzed 15 pediatric patients with SMPP complicated by cardiac thrombosis. The patients was recruited from the Department of Pediatric Respiratory Medicine at Shandong Provincial Hospital Affiliated to Shandong First Medical University between July 2018 and January 2025. Comprehensive clinical data and follow-up information were collected.Results:Among the 15 children, 10 were male and 5 were female, and the age of onset was 8.0 (6.3, 10.0) years. All 15 children presented with fever and cough, while additional symptoms included dyspnea in 7 cases, chest pain in 6 cases, hemoptysis in 3 cases, and chest tightness in 1 case. The white blood cell count was 11.7 (9.5, 15.9)×10 9/L, C-reactive protein was 31.6 (17.5, 64.8) mg/L and lactate dehydrogenase was 548.2 (410.4, 768.3) U/L. A total of 14 children underwent testing for the Mycoplasma pneumoniae drug resistance genes 2063A>G and 2064A>G, of which 13 tested positive. The plasma D-dimer levels of 15 children were 8.77 (7.23, 12.50) mg/L, all of which were higher than normal. Among the 15 children, 5 had decreased activity of anticoagulant proteins (protein C, protein S, antithrombin Ⅲ), and 8 tested positive for antiphospholipid antibodies. Chest CT scans of all 15 children showed pulmonary consolidation and (or) atelectasis, with pleural effusion present in 12 cases. In the 15 children, thrombosis was detected at 14.0 (11.0, 18.0) days after the onset of illness. The locations of cardiac thrombosis included the right ventricle in 9 cases, the right atrium in 5 cases, and the left atrium in 1 case. Additionally, 10 cases had pulmonary vascular embolism, comprising 9 cases of pulmonary artery thrombosis and 1 case of pulmonary vein thrombosis. After anticoagulant treatment, cardiac thrombi disappeared in 10 children. Five children who did not show improvement with anticoagulation underwent surgical thrombectomy. In the follow-up of 15 children, lung imaging basically returned to normal, with no major hemorrhagic events or other adverse events. Conclusions:In children with Mycoplasma pneumoniae pneumonia, the presence of clinical symptoms such as shortness of breath, chest pain and hemoptysis, along with elevated plasma D-dimer levels, should raise suspicion for the possibility of cardiac thrombosis. SMPP complicated by cardiac thrombosis, prognosis is good following anticoagulation or surgical treatment.
2.Quality Control and Application Analysis of Metallic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Hao DING ; Fangfang ZHANG ; Lei CHEN
Herald of Medicine 2025;44(11):1757-1762
To promote the understanding of the requirements for metal materials and containers used for drug packaging in the 2025 edition of the Pharmacopoeia of the People's Republic of China for related enterprises.Based on this edition of the Chinese Pharmacopoeia,national standards for drug packaging materials,and relevant international standards such as the United States Pharmacopoeia(USP).The raw material selection,production process,and quality control indicators of metal pharmaceutical packaging materials were systematically sorted out.It was necessary to clarify that for the metal material itself,the base material and coating type should be selected based on the characteristics of the medicine.In terms of the production process,attention should be paid to the impact of the forming process on the material performance.In terms of quality control,it is necessary to combine the material characteristics and the drug requirements,and ensure its protection,safety,and functionality through standardized testing methods.By strengthening the quality control of metal pharmaceutical packaging materials,product quality can be ensured,and the innovative development of the industry can be promoted.
3.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
4.Quality Control and Application Analysis of Metallic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Hao DING ; Fangfang ZHANG ; Lei CHEN
Herald of Medicine 2025;44(11):1757-1762
To promote the understanding of the requirements for metal materials and containers used for drug packaging in the 2025 edition of the Pharmacopoeia of the People's Republic of China for related enterprises.Based on this edition of the Chinese Pharmacopoeia,national standards for drug packaging materials,and relevant international standards such as the United States Pharmacopoeia(USP).The raw material selection,production process,and quality control indicators of metal pharmaceutical packaging materials were systematically sorted out.It was necessary to clarify that for the metal material itself,the base material and coating type should be selected based on the characteristics of the medicine.In terms of the production process,attention should be paid to the impact of the forming process on the material performance.In terms of quality control,it is necessary to combine the material characteristics and the drug requirements,and ensure its protection,safety,and functionality through standardized testing methods.By strengthening the quality control of metal pharmaceutical packaging materials,product quality can be ensured,and the innovative development of the industry can be promoted.
5.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
6.Clinical analysis of 15 cases of severe Mycoplasma pneumoniae pneumonia complicated by cardiac thrombosis in children
Juan YANG ; Fengqin LIU ; Xing CHEN ; Chunyan GUO ; Yan LIANG ; Fangfang DAI ; Ning DING ; Ke WANG ; Jing ZHANG
Chinese Journal of Pediatrics 2025;63(5):535-540
Objective:To investigate the clinical manifestations, therapeutic strategies and prognostic outcomes in pediatric patients with severe Mycoplasma pneumoniae pneumonia (SMPP) complicated by cardiac thrombosis. Methods:This case series study retrospectively analyzed 15 pediatric patients with SMPP complicated by cardiac thrombosis. The patients was recruited from the Department of Pediatric Respiratory Medicine at Shandong Provincial Hospital Affiliated to Shandong First Medical University between July 2018 and January 2025. Comprehensive clinical data and follow-up information were collected.Results:Among the 15 children, 10 were male and 5 were female, and the age of onset was 8.0 (6.3, 10.0) years. All 15 children presented with fever and cough, while additional symptoms included dyspnea in 7 cases, chest pain in 6 cases, hemoptysis in 3 cases, and chest tightness in 1 case. The white blood cell count was 11.7 (9.5, 15.9)×10 9/L, C-reactive protein was 31.6 (17.5, 64.8) mg/L and lactate dehydrogenase was 548.2 (410.4, 768.3) U/L. A total of 14 children underwent testing for the Mycoplasma pneumoniae drug resistance genes 2063A>G and 2064A>G, of which 13 tested positive. The plasma D-dimer levels of 15 children were 8.77 (7.23, 12.50) mg/L, all of which were higher than normal. Among the 15 children, 5 had decreased activity of anticoagulant proteins (protein C, protein S, antithrombin Ⅲ), and 8 tested positive for antiphospholipid antibodies. Chest CT scans of all 15 children showed pulmonary consolidation and (or) atelectasis, with pleural effusion present in 12 cases. In the 15 children, thrombosis was detected at 14.0 (11.0, 18.0) days after the onset of illness. The locations of cardiac thrombosis included the right ventricle in 9 cases, the right atrium in 5 cases, and the left atrium in 1 case. Additionally, 10 cases had pulmonary vascular embolism, comprising 9 cases of pulmonary artery thrombosis and 1 case of pulmonary vein thrombosis. After anticoagulant treatment, cardiac thrombi disappeared in 10 children. Five children who did not show improvement with anticoagulation underwent surgical thrombectomy. In the follow-up of 15 children, lung imaging basically returned to normal, with no major hemorrhagic events or other adverse events. Conclusions:In children with Mycoplasma pneumoniae pneumonia, the presence of clinical symptoms such as shortness of breath, chest pain and hemoptysis, along with elevated plasma D-dimer levels, should raise suspicion for the possibility of cardiac thrombosis. SMPP complicated by cardiac thrombosis, prognosis is good following anticoagulation or surgical treatment.
7.Determination of surface wettability of metallic coatings
Weiming GU ; Hao DING ; Fangfang ZHANG
Drug Standards of China 2024;25(6):567-570
Objective:Establish a method for measuring the surface wettability of metal material coatings.Methods:The wettability of the inner surface of metal can coating was measured by standard static contact angle goniometer and Dyne pen.Results:Dyne pen analysis method is simple and effective,and can know the result quickly.The contact angle goniometer has higher measurement accuracy,and can more accurately obtain the wetta-bility of metal material coating surface.Conclusion:Standard static contact angle goniometer and Dyne pen can be used to determine the wettability of metal coating surface,and improve the reference for the determination of the wettability of metal coating surface.
8.The role of BDNF polymorphism in the association between fluoride exposure and ACTH/CORT in children
Na LI ; Zichen FENG ; Guoyu ZHOU ; Anqi WANG ; Limin DING ; Fangfang YU ; Yue BA
Chinese Journal of Endemiology 2024;43(9):689-697
Objective:To study the relationship between fluoride exposure and adrenocorticotropic hormone (ACTH)/cortisol (CORT) in rural children in eastern Henan, and to reveal the modifying effect of brain-derived neurotrophic factor (BDNF) gene polymorphism.Methods:A total of 463 children aged 7 - 12 (245 boys and 218 girls) from 4 primary schools in Tongxu County, Henan Province were recruited by a cluster sampling method for questionnaire survey, physical examination, and collection of morning urine and fasting venous blood. The concentrations of urinary fluoride and creatinine were determined by a fluoride ion selective electrode method and picric acid method, respectively. Serum ACTH and CORT levels were determined with a fully automated biochemical analyzer, and the genotyping of BDNF gene loci of single nucleotide polymorphism was conducted by a customized 48-Plex SNPscan TM reagent kit. Besides, the relationships between urinary fluoride concentrations and serum ACTH/CORT levels in children were analyzed by multiple linear regression models. The interaction term between urinary fluoride concentration and BDNF gene polymorphism was established, and the interaction between unit point gene polymorphism and environment on serum ACTH or CORT levels of children was analyzed by multiple linear regression. Results:For every 1 mg/L increase in urinary fluoride concentration, serum ACTH level in girls increased by 1.98 pg/ml [95% confidence interval ( CI): 0.71, 3.24; P = 0.002], while serum CORT level in boys decreased by 37.48 ng/ml (95% CI: - 63.99, - 10.97; P = 0.006). Regardless of stratified analysis, the urinary fluoride concentration of individuals carrying the TA genotype at the rs6484320 locus was positively correlated with serum ACTH level (β > 0, P < 0.05); in addition, there was a positive correlation between urinary fluoride concentration and serum ACTH level in the total population and boys carrying the CC genotype of rs7103873 locus (β > 0, P < 0.05); and the serum ACTH and CORT levels in girls carrying the AA genotype of rs12291186 locus were positively correlated with urinary fluoride concentration (β > 0, P < 0.05). The interaction analysis showed that there was an interaction between urinary fluoride concentrations and rs6484320/rs7103873 loci polymorphisms on serum ACTH level in the total population and boys ( Pinteraction < 0.1), as well as urinary fluoride concentrations and rs12291186 locus polymorphism on serum CORT level in girls ( Pinteraction = 0.035). Conclusions:Urinary fluoride concentration is associated with increased serum ACTH level in girls and decreased serum CORT level in boys. BDNF gene polymorphism can modify the association between fluoride exposure and serum ACTH or CORT levels in children, and the modification effect varies by gender.
9.Determination and Risk Assessment of 33 Prohibit Pesticides Residues in Ginkgo Biloba Leaves and the Extracts
Dandan LIU ; Xiaohong YIN ; Ting HUANG ; Nan DING ; Yutian WANG ; Fangfang WANG ; Ping WU ; Jianbiao YAO
Chinese Journal of Modern Applied Pharmacy 2024;41(4):476-488
OBJECTIVE
To establish the analysis methods of 33 banned pesticides in Ginkgo Biloba leaves and the extracts, and conduct the risk assessment study.
METHODS
One hundred and thirty-six batches of Ginkgo Biloba leaves and 58 batches of Ginkgo Biloba leaves extract were detected by UPLC-MS and GC-MS. The acute and chronic intake risk of pesticide residues in samples were calculated by point assessment method, and the risk scores of the pesticides were calculated by the Britain veterinary residues matrix ranking.
RESULTS
Six kinds of banned pesticides were detected in 136 batches of Ginkgo Biloba leaves, the total detection rate was 35.29%, and the detection amount was 0.002−0.210 mg·kg−1. The chronic dietary intake risk was 0.018%−0.620%, and the acute dietary intake risk was 0.000 1%−0.014 0%, indicated that the dietary exposure risk of pesticides in Ginkgo biloba leaves was at a low level. Two kinds of banned pesticides were detected in 58 batches of Ginkgo Biloba leaves extract, the detection rate was 55.17%, and the detection amount was 0.002−1.788 mg·kg−1. The percentage of acceptable daily intake was 0.003%−0.143%, and the percentage of acute reference dose was 0.002 4%, which was also at a low level. Risk ranking results indicated that the risk of phorate was the highest and should be focused on the production and safety supervision.
CONCLUSION
The method has good stability, high precision and promising repeatability, which can be used for the detection of 33 prohibited pesticides in Ginkgo biloba leaves and their extracts. The results show that the residual amounts of 33 banned pesticides in Ginkgo Biloba leaves and its extracts were extremely low, and there is no significant health risks.
10.Determination of surface wettability of metallic coatings
Weiming GU ; Hao DING ; Fangfang ZHANG
Drug Standards of China 2024;25(6):567-570
Objective:Establish a method for measuring the surface wettability of metal material coatings.Methods:The wettability of the inner surface of metal can coating was measured by standard static contact angle goniometer and Dyne pen.Results:Dyne pen analysis method is simple and effective,and can know the result quickly.The contact angle goniometer has higher measurement accuracy,and can more accurately obtain the wetta-bility of metal material coating surface.Conclusion:Standard static contact angle goniometer and Dyne pen can be used to determine the wettability of metal coating surface,and improve the reference for the determination of the wettability of metal coating surface.


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