1.Palpitations, Shortness of Breath, Weakness in Limbs, Edema, and Dyspnea: A Rare Inflammatory Myopathy with Positive Aniti-mitochondrial Antibodies and Cardiac Involvement
Chunsu LIANG ; Xuchang ZHANG ; Ning ZHANG ; Lin KANG ; Xiaohong LIU ; Jiaqi YU ; Yingxian LIU ; Lin QIAO ; Yanli YANG ; Xiaoyi ZHAO ; Ruijie ZHAO ; Na NIU ; Xuelian YAN
Medical Journal of Peking Union Medical College Hospital 2025;16(1):248-255
This article presents a case study of a patient who visited the Geriatric Department of Peking Union Medical College Hospital due to "palpitations, shortness of breath for more than 2 years, limb weakness for 6 months, edema, and nocturnal dyspnea for 2 months". The patient exhibited decreased muscle strength in the limbs and involvement of swallowing and respiratory muscles, alongside complications of heart failure and various arrhythmias which were predominantly atrial. Laboratory tests revealed the presence of multiple autoantibodies and notably anti-mitochondrial antibodies. Following a comprehensive multidisciplinary evaluation, the patient was diagnosed with anti-mitochondrial antibody-associated inflammatory myopathy. Treatment involved a combination of glucocorticoids and immunosuppressants, along with resistance exercises for muscle strength and rehabilitation training for lung function, resulting in significant improvement of clinical symptoms. The case underscores the importance of collaborative multidisciplinary approaches in diagnosing and treating rare diseases in elderly patients, where careful consideration of clinical manifestations and subtle abnormal clinical data can lead to effective interventions.
2.Evaluation of the performance of the artificial intelligence - enabled snail identification system for recognition of Oncomelania hupensis robertsoni and Tricula
Jihua ZHOU ; Shaowen BAI ; Liang SHI ; Jianfeng ZHANG ; Chunhong DU ; Jing SONG ; Zongya ZHANG ; Jiaqi YAN ; Andong WU ; Yi DONG ; Kun YANG
Chinese Journal of Schistosomiasis Control 2025;37(1):55-60
Objective To evaluate the performance of the artificial intelligence (AI)-enabled snail identification system for recognition of Oncomelania hupensis robertsoni and Tricula in schistosomiasis-endemic areas of Yunnan Province. Methods Fifty O. hupensis robertsoni and 50 Tricula samples were collected from Yongbei Township, Yongsheng County, Lijiang City, a schistosomiasis-endemic area in Yunnan Province in May 2024. A total of 100 snail sample images were captured with smartphones, including front-view images of 25 O. hupensis robertsoni and 25 Tricula samples (upward shell opening) and back-view images of 25 O. hupensis robertsoni and 25 Tricula samples (downward shell opening). Snail samples were identified as O. hupensis robertsoni or Tricula by schistosomiasis control experts with a deputy senior professional title and above according to image quality and morphological characteristics. A standard dataset for snail image classification was created, and served as a gold standard for recognition of snail samples. A total of 100 snail sample images were recognized with the AI-enabled intelligent snail identification system based on a WeChat mini program in smartphones. Schistosomiasis control professionals were randomly sampled from stations of schistosomisis prevention and control and centers for disease control and prevention in 18 schistosomiasis-endemic counties (districts, cities) of Yunnan Province, for artificial identification of 100 snail sample images. All professionals are assigned to two groups according the median years of snail survey experiences, and the effect of years of snail survey experiences on O. hupensis robertsoni sample image recognition was evaluated. A receiver operating characteristic (ROC) curve was plotted, and the sensitivity, specificity, accuracy, Youden’s index and the area under the curve (AUC) of the AI-enabled intelligent snail identification system and artificial identification were calculated for recognition of snail sample images. The snail sample image recognition results of AI-enabled intelligent snail identification system and artificial identification were compared with the gold standard, and the internal consistency of artificial identification results was evaluated with the Cronbach’s coefficient alpha. Results A total of 54 schistosomiasis control professionals were sampled for artificial identification of snail sample image recognition, with a response rate of 100% (54/54), and the accuracy, sensitivity, specificity, Youden’s index, and AUC of artificial identification were 90%, 86%, 94%, 0.80 and 0.90 for recognition of snail sample images, respectively. The overall Cronbach’s coefficient alpha of artificial identification was 0.768 for recognition of snail sample images, and the Cronbach’s coefficient alpha was 0.916 for recognition of O. hupensis robertsoni snail sample images and 0.925 for recognition of Tricula snail sample images. The overall accuracy of artificial identification was 90% for recognition of snail sample images, and there was no significant difference in the accuracy of artificial identification for recognition of O. hupensis robertsoni (86%) and Tricula snail sample images (94%) (χ2 = 1.778, P > 0.05). There was no significant difference in the accuracy of artificial identification for recognition of snail sample images with upward (88%) and downward shell openings (92%) (χ2 = 0.444, P > 0.05), and there was a significant difference in the accuracy of artificial identification for recognition of snail sample images between schistosomiasis control professionals with snail survey experiences of 6 years and less (75%) and more than 6 years (90%) (χ2 = 7.792, P < 0.05). The accuracy, sensitivity, specificity and AUC of the AI-enabled intelligent snail identification system were 88%, 100%, 76% and 0.88 for recognition of O. hupensis robertsoni snail sample images, and there was no significant difference in the accuracy of recognition of O. hupensis robertsoni snail sample images between the AI-enabled intelligent snail identification system and artificial identification (χ2 = 0.204, P > 0.05). In addition, there was no significant difference in the accuracy of artificial identification for recognition of snail sample images with upward (90%) and downward shell openings (86%) (χ2 = 0.379, P > 0.05), and there was a significant difference in the accuracy of artificial identification for recognition of snail sample images between schistosomiasis control professionals with snail survey experiences of 6 years and less and more than 6 years (χ2 = 5.604, Padjusted < 0.025). Conclusions The accuracy of recognition of snail sample images is comparable between the AI-enabled intelligent snail identification system and artificial identification by schistosomiasis control professionals, and the AI-enabled intelligent snail identification system is feasible for recognition of O. hupensis robertsoni and Tricula in Yunnan Province.
3.Mechanism of Huangqi Chifengtang in Treating Atherosclerosis Based on 16S rRNA Sequencing and Metabolomics
Yuqin LIANG ; Jiaqi FU ; Yunhe SHI ; Fang LU ; Donghua YU ; Shumin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):94-103
ObjectiveTo investigate the mechanism of action of Huangqi Chifengtang (HQCFT) on rats with atherosclerosis (AS) by regulating the gut microbiota and their metabolites. MethodsA rat model of AS was induced through high-fat diet feeding and vitamin D3 injection, and the modeling lasted for 12 weeks. Fifty eight-week-old male SD rats were randomly divided into five groups: A blank group, a model group, a group receiving a low dose of HQCFT at 1.53 g·kg-1 (HQCFT-L group), a group receiving a high dose of HQCFT at 3.06 g·kg-1 (HQCFT-H group), and a group receiving atorvastatin calcium tablets at 1.8 mg·kg-1 (Ato group), with 10 rats in each group. Oral gavage administration started on the day after model establishment, once daily for four weeks. The efficacy of HQCFT was verified using aortic hematoxylin-eosin (HE) staining and determination of lipid levels and hemorrheology. The real-time polymerase chain reaction (Real-time PCR) was used for detecting inflammatory factor levels in the aorta, high-throughput sequencing for analyzing the gut microbiota composition in intestinal contents, targeted metabolomics for detecting short-chain fatty acid (SCFA) levels, and non-targeted metabolomics for identifying metabolomic profiles of intestinal contents. ResultsCompared with that in the blank group, the aortic tissue of rats in the model group showed significant AS lesions, including endothelial damage, inflammatory infiltration, and formation of fibrous plaques and calcified foci. Moreover, serum triacylglycerol (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) levels were significantly elevated (P<0.05), while high-density lipoprotein cholesterol (HDL-C) levels were significantly reduced (P<0.05). Significant increases were observed in whole blood viscosity, plasma viscosity, and the mRNA expression levels of NOD-like receptor pyrin domain containing 3 (NLRP3), Caspase-1, interleukin (IL)-β, IL-6, and tumor necrosis factor-α (TNF-α) in aortic tissue (P<0.05). Additionally, gut microbiota composition, SCFA levels, and metabolomic profiles were significantly altered. Compared with those in the model group, serum TC, TG, and LDL-C levels, as well as the whole blood viscosity and plasma viscosity, were significantly reduced in all groups treated with HQCFT (P<0.05). Significant decreases were observed in NLRP3 mRNA expression levels in all groups treated with HQCFT, Caspase-1, IL-β, and IL-6 mRNA expression levels in the HQCFT-H group, and TNF-α mRNA expression levels in the HQCFT-L group (P<0.05). HQCFT reversed the increase in the F/B ratio and dialled back the decrease in the relative abundance of Blautia and the increase in that of Desulfovibrio. HQCFT promoted the production of acetic acid, valeric acid, and propionic acid. Non-targeted metabolomics identified 39 differential metabolites, which were mainly enriched in metabolic pathways such as arachidonic acid metabolism and primary bile acid biosynthesis. ConclusionThe mechanism by which HQCFT ameliorates AS injury may be related to the improvement of dyslipidemia and body inflammatory responses by altering gut microbiota composition, promoting SCFA production, and regulating the levels of metabolites in intestinal contents.
4.Mechanism of Huangqi Chifengtang in Treating Atherosclerosis Based on 16S rRNA Sequencing and Metabolomics
Yuqin LIANG ; Jiaqi FU ; Yunhe SHI ; Fang LU ; Donghua YU ; Shumin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):94-103
ObjectiveTo investigate the mechanism of action of Huangqi Chifengtang (HQCFT) on rats with atherosclerosis (AS) by regulating the gut microbiota and their metabolites. MethodsA rat model of AS was induced through high-fat diet feeding and vitamin D3 injection, and the modeling lasted for 12 weeks. Fifty eight-week-old male SD rats were randomly divided into five groups: A blank group, a model group, a group receiving a low dose of HQCFT at 1.53 g·kg-1 (HQCFT-L group), a group receiving a high dose of HQCFT at 3.06 g·kg-1 (HQCFT-H group), and a group receiving atorvastatin calcium tablets at 1.8 mg·kg-1 (Ato group), with 10 rats in each group. Oral gavage administration started on the day after model establishment, once daily for four weeks. The efficacy of HQCFT was verified using aortic hematoxylin-eosin (HE) staining and determination of lipid levels and hemorrheology. The real-time polymerase chain reaction (Real-time PCR) was used for detecting inflammatory factor levels in the aorta, high-throughput sequencing for analyzing the gut microbiota composition in intestinal contents, targeted metabolomics for detecting short-chain fatty acid (SCFA) levels, and non-targeted metabolomics for identifying metabolomic profiles of intestinal contents. ResultsCompared with that in the blank group, the aortic tissue of rats in the model group showed significant AS lesions, including endothelial damage, inflammatory infiltration, and formation of fibrous plaques and calcified foci. Moreover, serum triacylglycerol (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) levels were significantly elevated (P<0.05), while high-density lipoprotein cholesterol (HDL-C) levels were significantly reduced (P<0.05). Significant increases were observed in whole blood viscosity, plasma viscosity, and the mRNA expression levels of NOD-like receptor pyrin domain containing 3 (NLRP3), Caspase-1, interleukin (IL)-β, IL-6, and tumor necrosis factor-α (TNF-α) in aortic tissue (P<0.05). Additionally, gut microbiota composition, SCFA levels, and metabolomic profiles were significantly altered. Compared with those in the model group, serum TC, TG, and LDL-C levels, as well as the whole blood viscosity and plasma viscosity, were significantly reduced in all groups treated with HQCFT (P<0.05). Significant decreases were observed in NLRP3 mRNA expression levels in all groups treated with HQCFT, Caspase-1, IL-β, and IL-6 mRNA expression levels in the HQCFT-H group, and TNF-α mRNA expression levels in the HQCFT-L group (P<0.05). HQCFT reversed the increase in the F/B ratio and dialled back the decrease in the relative abundance of Blautia and the increase in that of Desulfovibrio. HQCFT promoted the production of acetic acid, valeric acid, and propionic acid. Non-targeted metabolomics identified 39 differential metabolites, which were mainly enriched in metabolic pathways such as arachidonic acid metabolism and primary bile acid biosynthesis. ConclusionThe mechanism by which HQCFT ameliorates AS injury may be related to the improvement of dyslipidemia and body inflammatory responses by altering gut microbiota composition, promoting SCFA production, and regulating the levels of metabolites in intestinal contents.
5.Quality Evaluation of Zhuye Shigao Granules and Its Therapeutic Effect on Mice with Cold-dampness Pestilence Attacking Lung Syndrome
Haihong LI ; Jiaqi SHEN ; Liwen LIANG ; Ziqi YANG ; Yuting YANG ; Shuyun LIANG ; Zhiliang SUN ; Jiannan LI ; Guangzhi CAI ; Jiyu GONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):182-190
ObjectiveTo establish a quality evaluation method for Zhuye Shigao granules(Zhuye Shigaotang) based on fingerprint and determination of index components, and to investigate the therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome. MethodsThe fingerprint of Zhuye Shigao granules was established by high performance liquid chromatography(HPLC), and the methods for determination of total calcium, orientin, isoorientin, ginsenosides Rg1, Re and Rb1 and other 2 index components were established. Fifty ICR mice were randomly divided into the blank group, model group, Zhuye Shigao granules low, medium and high dose groups(9.3, 18.6, 37.2 g·kg-1·d-1), with 10 mice in each group. In addition to the blank group, the model mice with cold-dampness pestilence attacking lung syndrome was prepared by nasal drip of lipopolysaccharide combined with cold-dampness environment. Each administration group was given the corresponding liquid by gavage according to the dose, while the blank group and model group were given the same volume of normal saline by gavage. Then, the body temperature and organ index of mice in each group were measured, hematoxylin-eosin(HE) staining was used to investigate the lung tissue injury of mice in each group, and enzyme-linked immunosorbent assay(ELISA) was used to detect the changes of tumor necrosis factor-α(TNF-α), interleukin(IL)-lβ, IL-6, IL-10 levels in serum and lung tissue, as well as immunoglobulin(Ig)A and IgM levels in serum. ResultsThe fingerprint similarity of 10 batches of Zhuye Shigao granules was>0.950, and 20 common peaks were calibrated. Seven of them were identified, including peak 11(isoorientin), peak 12(orientin), peak 14(apioside liquiritin), peak 15(liquiritin), peak 17(apioside isoliquiritin), peak 19(isoliquiritin) and peak 20(liquiritigenin). The results of quantitative analysis showed that the content range of each index component in 10 batches of Zhuye Shigao granules was as follows:Total calcium of 9.978-11.294 mg·g-1, isoorientin of 0.033-0.041 mg·g-1, orientin of 0.046-0.055 mg·g-1, ginsenoside Rg1+ginsenoside Re of 0.748-0.762 mg·g-1, ginsenoside Rb1 of 0.151-0.197 mg·g-1, liquiritin of 1.106-1.366 mg·g-1, glycyrrhizic acid of 0.904-1.182 mg·g-1. Compared with the blank group, the body temperature of mice in the model group was significantly increased, the organ indexes of liver, lung and spleen were significantly decreased, the organ index of thymus was significantly increased, HE staining of lung tissue showed infiltration of inflammatory cells, a small amount of serous exudation was observed in the alveoli, and lung tissue was damaged. After the intervention of Zhuye Shigao granules, the pathological changes were improved compared with the model group. The expression levels of IL-1β, IL-6 and TNF-α were significantly increased, the expression level of IL-10 was significantly decreased in serum and lung tissue. The levels of IgA and IgM in serum were significantly decreased(P<0.01). Compared with the model group, the body temperature, the organ indexes and immune factor levels in serum and lung tissue of mice in the Zhuye Shigao granules medium and high dose groups were significantly reduced(P<0.05, P<0.01). ConclusionIn this study, the quality evaluation of Zhuye Shigao granules was carried out based on fingerprint combined with determination of index components, and the fingerprint of four herbs(Lophatheri Herba, Ophiopogonis Radix, Pinelliae Rhizoma and Glycyrrhizae Radix et Rhizoma) in this formula and the determination of 8 index components were established. The therapeutic effect of Zhuye Shigao granules on mice with cold-dampness pestilence attacking lung syndrome may be related to inhibiting inflammatory response and mediating immune regulation.
6.Effects of Netupitant and palonosetron hydrochloride capsules on the pharmacokinetics of albumin-bound paclitaxel in rats under different intestinal microenvironments
Yuanman QIN ; Wenhao CHU ; Jiaqi XU ; Yutong LI ; Bo LIANG ; Xueliang ZHANG ; Jian LIU
China Pharmacy 2025;36(16):1993-1999
OBJECTIVE To investigate the impact of Netupitant and palonosetron hydrochloride capsules (NEPA) on the pharmacokinetics of Paclitaxel for injection (albumin bound) (i. e. albumin-bound paclitaxel) under different intestinal microenvironment conditions. METHODS Male SD rats were divided into a normal group and a model group (n=16). Rats in the model group were intragastrically administered vancomycin solution to establish an intestinal disorder model. The next day after modeling, intestinal microbiota diversity was analyzed, and the mRNA expressions of cytochrome P450 3A1 (CYP3A1) and CYP2C11 in small intestine and liver tissues as well as those protein expressions in liver tissue were measured. Male SD rats were grouped as described above (n=16). The normal group was subdivided into the TP chemotherapy group (TP-1 group) and the TP chemotherapy+NEPA group (TP+NEPA-1 group); the model group was subdivided into the TP chemotherapy group (TP-2 group) and the TP chemotherapy+NEPA group (TP+NEPA-2 group) (n=8). Rats in the TP+NEPA-1 and TP+NEPA-2 groups received a single intragastric dose of NEPA suspension (25.8 mg/kg, calculated by netupitant). One hour later, all four groups received a single tail vein injection of albumin-bound paclitaxel and cisplatin. Blood samples were collected at different time points after the last administration. Using azithromycin as the internal standard, plasma paclitaxel concentrations were determined by liquid chromatography-tandem mass spectrometry. The main pharmacokinetic parameters were calculated using DAS 2.0 software and compared between groups. RESULTS Compared with the normal group, the model group showed significantly decreased Chao1 and Shannon indexes (P<0.05), significant alterations in microbiota composition and relative abundance, and significantly downregulated expressions of CYP3A1 mRNA in liver tissue and CYP2C11 mRNA in both small intestine and liver tissues (P<0.05). Compared with the TP-1 group, the AUC0-t, AUC0-∞, MRT0-t of paclitaxel in the TP-2 group, the cmax, AUC0-t, AUC0-∞ of paclitaxel in the TP+NEPA-1 group and TP+NEPA-2 group were significantly increased or prolonged; CL of paclitaxel in the TP-2 group, Vd and CL of paclitaxel in the TP+NEPA-1 group and the TP+NEPA-2 group were significantly decreased or shortened (P<0.05). Compared with the TP-2 group, cmax of paclitaxel in the TP+NEPA-2 group was significantly increased, and Vd and MRT0-t were significantly decreased or shortened (P<0.05). CONCLUSIONS Intestinal microbiota disorder affects the mRNA expressions of CYP3A1 and CYP2C11, leading to decreased clearance and increased systemic exposure of paclitaxel. Concomitant administration of NEPA under normal intestinal microbiota condition increases paclitaxel exposure. However, under conditions of intestinal microbiota disorder, concomitant administration of NEPA has a limited impact on paclitaxel systemic exposure.
7.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT
Fuqiang ZHANG ; Ziteng HU ; Yujing ZHANG ; Lijiao YAN ; Juyi WANG ; Cehan ZHANG ; Jiaqi CHEN ; Mengyi WANG ; Shuoming LIU ; Xinyi XIE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):185-191
ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine (CPM) with internationally recognized tools the appraisal of guidelines for research and evaluation (AGEREE) Ⅱ and reporting items for practice guidelines in healthcare (RIGHT), thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI, VIP, Wanfang and Sinomed were searched for CPM guidelines, as well as medlive.cn, websites of China Association of Chinese Medicine and Chinese Medical Association, and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools, and consistency tests were performed using Interclass Correlation Coefficient, and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally, 140 CPM guidelines were included, of which 51 were disease-oriented and 89 were drug-oriented, all of which were issued by China. For 51 disease-oriented CPM guidelines, the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity, and the lowest was 26.80% for application; for 89 drug-oriented CPM guidelines, the highest average score was 55.62% for scope and purpose, and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist, the highest reporting rate was 68.26% for background, and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines; the highest reporting rate was 61.31% for background, and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ (rigour of development, clarity of presentation, editorial independence), as well as four domains of RIGHT checklist (basic information, evidence, funding and declaration and management of interests, and other areas). ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist, and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines, thereby guiding the clinical use of CPM in a better way.
8.Analysis of nutritional status and related factors of school aged children with cerebral palsy in a welfare institution of Guangzhou
CHEN Jingyi, XIAO Jiaqi, GUO Feng, LIANG Quanquan, YANG Jiewen
Chinese Journal of School Health 2024;45(9):1238-1241
Objective:
To under the prevalence of malnutrition and its associated factors in school aged children with cerebral palsy, so as to provide a basis for relevant departments to formulate targeted policies.
Methods:
From July to August 2023, the researchers selected 333 children with cerebral palsy and 960 children with other diseases aged 6-18 years who were residents of a social welfare institution in Guangzhou, China. Their height and weight were measured and a nutritional status analysis was carried out using a cluster sampling method. Multivariate Logistic analysis was performed to analyze the relative factors and malnutrition status of school aged children with cerebral palsy.
Results:
The prevalence of growth retardation among school aged children with cerebral palsy was 74.5%, with rates of stunting, normal nutrition status, and overweight/obesity being 17.7%, 7.2%, and 0.6%, respectively. The results of the univariate analysis revealed statistically significant differences in the detection rate of malnutrition among school aged children with cerebral palsy based on gender, gross motor function classification system (GMFCS) grading, and the presence of swallowing disorders ( χ 2=6.02, 15.23, 32.16, P <0.05). The results of the multivariate Logistic regression analysis showed that gender ( OR=0.37, 95%CI =0.15-0.91), dysphagia (OR=4.10, 95%CI =1.39-12.12), and GMFCS classification ( OR=1.45, 95%CI =1.04-3.01) were influencing factors of malnutrition ( P <0.05).
Conclusions
The detection rate of malnutrition among children and adolescents with cerebral palsy in welfare institutions was found to be relatively high, and influenced by various factors. Corresponding nutritional interventions should be developed and implemented based on the risk factors of malnutrition in school aged children with cerebral palsy to improve their nutritional status.
9.Establishment of antigen reference material for inactivated tick-borne encephalitis vaccine
Chinese Journal of Biologicals 2024;37(11):1281-1285+1293
目的 建立森林脑炎灭活疫苗抗原参考品,以期准确定量检测疫苗的抗原含量。方法 将森林脑炎灭活疫苗原液与冻干保护剂按1∶1的体积分数混合,经冻干,制备为候选参考品,并检测其装量均匀性及抗原均匀性。经3个实验室协作标定,对抗原定量检测结果进行统计并赋值,验证参考品的稳定性及适用性。结果 24瓶候选参考品装量均值为0.497 g/瓶,分装精度为0.48%;7瓶候选参考品抗原含量均值为50.990 EU/支,CV为7.3%。3个实验室协作标定候选参考品抗原含量均值为52.464 EU/支[95%CI:(52.464±3.807)EU/支],同一实验室CV为7.3%~13.3%,不同实验室之间CV为14.1%。候选参考品赋值为50 EU/支。参考品具有良好的加速稳定性、复溶稳定性及冻融稳定性。以该参考品为标准品,检测森林脑炎灭活疫苗病毒收获液、原液、解析附后疫苗均显示较好的平行性和线性关系(R~2均> 0.99)。结论 建立的森林脑炎灭活疫苗抗原参考品具有良好的稳定性,可用于森林脑炎灭活疫苗的质量控制。
Objective To establish an antigen reference material for the inactivated tick-borne encephalitis vaccine, in order to quantitatively detect the antigen content of vaccines accurately. Methods The inactivated tick-borne encephalitis vaccine stock solution was mixed with lyophilized protective agent in equal volume, and prepared as a candidate reference after lyophilized, which was detected for the loading uniformity and antigen uniformity. After the cooperative calibration of three laboratories, the results of antigen detection were statistically analyzed and assigned, and the stability and applicability of the reference material were verified. Results The average loading capacity of 24 pieces of candidate reference material was0. 497 g/piece, with the sub-packaging accuracy of 0. 48%. The average antigen content of 7 pieces of candidate reference material was 50. 990 EU/piece, with the CV of 7. 3%. The average antigen content calibrated by the three laboratories was52. 464 EU/piece [95% CI:(52. 464 ± 3. 807) EU/piece], the intra-assay CVs were 7. 3%-13. 3%, and the inter-assay CV of different laboratories was 14. 1%. The candidate reference was assigned a value of 50 EU/piece. The reference material had good accelerated stability, resolvation stability and freeze-thaw stability. Using the reference material as the standard, the results showed good parallelism and linear relationship(each R~2> 0. 99) in the virus harvested solution, stock solution and unattached vaccine of inactivated tick-borne encephalitis vaccine. Conclusion The established antigen reference material of inactivated tick-borne encephalitis vaccine has good stability and can be used for the quality control of inactivated tickborne encephalitis vaccine.
10.Investigation of a Mycoplasma pneumoniae outbreak in a welfare institution
Jiaqi XIAO ; Jingyi CHEN ; Liang ZHANG ; Quanquan LIANG ; Jianye HU ; Jiewen YANG
Shanghai Journal of Preventive Medicine 2024;36(6):540-542
ObjectiveTo carry out an epidemiological analysis on an outbreak of Mycoplasma pneumoniae infection at a welfare institution to provide a theoretical basis for the corresponding prevention and control measures. MethodsUsing the method of field epidemiological investigation, special field treatment was carried out in September 2022. Serum samples from cases and close contacts in the same ward area were collected for detection of nine respiratory tract infection pathogens (Mycoplasma pneumoniae, chlamydia, influenza, human metapneumosis, respiratory syncytial, human boca, parainfluenza type 1‒4 virus, and Middle East respiratory syndrome, severe acute respiratory syndrome coronavirus) by immunofluorescence immunoglobulin M (IgM) antibody test. ResultsA total of 14 Mycoplasma pneumoniae cases were identified, all of whom were residents of the welfare institution. The first case occurred on September 4, while the last case was reported on September 13. The incidence rate of the fifth ward area where the first case reported was 12.82% (10/78), and it was 3.57% (3/84) in the third ward area and 1.20% (1/83) in the first ward area. There was a significant difference in incidence rates between ward areas (χ2=8.90, P<0.05), but no significant difference was observed in age distribution and length of hospitalization. Thirty-three samples were collected for detection of nine kinds of IgM antibodies against respiratory pathogens. The results showed that the Mycoplasma pneumoniae IgM antibody was weakly positive in the 14 cases. ConclusionBased on the epidemiological history, clinical symptoms and laboratory tests, it was concluded that it was an outbreak of Mycoplasma pneumoniae infection within the welfare institution. Welfare institutions should continue to control the occurrence and outbreak of infection through effective routine hygiene, ventilation, and disinfection so as to ensure the health and safety of their clients.


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