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.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.A prediction model for high-risk cardiovascular disease among residents aged 35 to 75 years
ZHOU Guoying ; XING Lili ; SU Ying ; LIU Hongjie ; LIU He ; WANG Di ; XUE Jinfeng ; DAI Wei ; WANG Jing ; YANG Xinghua
Journal of Preventive Medicine 2025;37(1):12-16
Objective:
To establish a prediction model for high-risk cardiovascular disease (CVD) among residents aged 35 to 75 years, so as to provide the basis for improving CVD prevention and control measures.
Methods:
Permanent residents aged 35 to 75 years were selected from Dongcheng District, Beijing Municipality using the stratified random sampling method from 2018 to 2023. Demographic information, lifestyle, waist circumference and blood biochemical indicators were collected through questionnaire surveys, physical examinations and laboratory tests. Influencing factors for high-risk CVD among residents aged 35 to 75 years were identified using a multivariable logistic regression model, and a prediction model for high-risk CVD was established. The predictive effect was evaluated using the receiver operating characteristic (ROC) curve.
Results:
A total of 6 968 individuals were surveyed, including 2 821 males (40.49%) and 4 147 females (59.51%), and had a mean age of (59.92±9.33) years. There were 1 155 high-risk CVD population, with a detection rate of 16.58%. Multivariable logistic regression analysis showed that gender, age, smoking, central obesity, systolic blood pressure, fasting blood glucose, triglyceride and low-density lipoprotein cholesterol were influencing factors for high-risk CVD among residents aged 35 to 75 years (all P<0.05). The area under the ROC curve of the established prediction model was 0.849 (95%CI: 0.834-0.863), with a sensitivity of 0.693 and a specificity of 0.863, indicating good discrimination.
Conclusion
The model constructed by eight factors including demographic characteristics, lifestyle and blood biochemical indicators has good predictive value for high-risk CVD among residents aged 35 to 75 years.
4.Study on the influential factors of blood concentration for duloxetine based on therapeutic drug monitoring
Yang LUN ; Liguang DUAN ; Feiyue AN ; Ran FU ; Jing YU ; Chaoli CHEN ; Mengqiang ZHAO ; Shi SU ; Yang SONG ; Jiaqi WANG ; Yuhang YAN ; Chunhua ZHOU
China Pharmacy 2025;36(6):727-731
OBJECTIVE To explore the main factors influencing the blood concentration of duloxetine, and provide a scientific basis for the individualized use of duloxetine. METHODS Retrospective analysis was conducted on 434 inpatients with depressive disorders at the First Hospital of Hebei Medical University, who were treated with duloxetine and underwent blood concentration monitoring between January 2022 and April 2024. The study examined the impact of various factors, including gender, age, body mass index (BMI), gene phenotypes, combined medication, drug type (original/generic), and genotyping results of gene single nucleotide polymorphism loci, on blood concentration and the concentration-to-dose (C/D) after dose adjustment. RESULTS The blood concentration of duloxetine was 76.65 (45.57, 130.31) ng/mL, and C/D was 0.96 (0.63, 1.60) ng·d/(mL·mg). The blood concentration of duloxetine was positively correlated with the daily dose of administration (R2=0.253 7, P<0.001). Blood concentration of duloxetine in 38.94% of patients exceeded the recommended range specified in the guidelines. Gender, age, BMI, combined use of CYP2D6 enzyme inhibitors, and CYP2D6 and CYP1A2 phenotypes had significant effects on C/D of duloxetine (P<0.05). CONCLUSIONS The patient’s age, gender, BMI, combined medication, and genetic phenotypes are closely related to the blood concentration of duloxetine.
5.Treatment of pathological myopic foveoschisis by pars plana vitrectomy with fovea-sparing internal limiting membrane peeling and silicone oil tamponade
Jun ZHOU ; Yingqi LI ; Jing XU ; Zhumin YANG ; Xing HUANG ; Xian WANG
International Eye Science 2025;25(8):1358-1362
AIM: To investigate the clinical efficacy of pars plana vitrectomy(PPV)combined with fovea-sparing internal limiting membrane(ILM)peeling and silicone oil(SO)tamponade for treating pathological myopic foveoschisis(PMF).METHODS:This study is a retrospective observational analysis of 10 cases(10 eyes)diagnosed with PMF that underwent PPV with fovea-sparing ILM peeling and SO tamponade between January 2023 and November 2024. The best-corrected visual acuity(BCVA), central foveal thickness(CFT), foveoschisis(FS), and the detachment and reattachment of FS and macular fovea were assessed preoperatively and at 1 wk, 1 and 3 mo postoperatively.RESULTS:Among the 10 cases of PMF patients(10 eyes), the complete reattachment rate was 30%(3 eyes), while partial reattachment was observed in 70%(7 eyes). At 3 mo postoperatively, BCVA(LogMAR)was significantly improved to 0.957±0.393 compared with 1.432±0.509 before surgery(P<0.05), and both CFT(437.9±180.4 vs. 207.5±76.1 μm)and FS(686.5±172.2 vs. 290.7±86.6 μm)showed significant decreases(P<0.05). No complications such as macular hole, retinal detachment, silicone oil emulsification, or endophthalmitis were observed during the surgery or throughout the follow-up period.CONCLUSION:PPV with SO tamponade and fovea-sparing ILM peeling has been demonstrated to facilitate both visual acuity improvement and anatomical reattachment in cases of PMF.
6.Research progress on polysaccharides in the cell wall of Mycobacterium tuberculosis
Ming CAI ; Jing ZHOU ; Sijie YANG ; Shidong ZHAO ; Yan YIN ; Fan CHEN
Journal of Public Health and Preventive Medicine 2025;36(5):134-139
Tuberculosis (TB) is a chronic infectious disease caused by Mycobacterium tuberculosis, which is primarily transmitted through the respiratory tract, and remains one of the diseases with the highest mortality rate of single-pathogen infections globally. The cell wall polysaccharides of M. tuberculosis are critical for maintaining bacterial structure, mediating pathogenesis, and enabling immune evasion. Lipoarabinomannan (LAM), a key polysaccharide component, has revolutionized non-invasive diagnostic technologies as a TB biomarker, while polysaccharide-based vaccines have emerged as innovative strategies for TB prevention. This review systematically examines the composition, subcellular distribution, and functional roles of M. tuberculosis cell wall polysaccharides in bacterial metabolism, drug resistance, and immune regulation. A particular emphasis is placed on recent advancements in LAM-based diagnostics and vaccine development. Future studies should utilize advanced technologies to precisely characterize the structural features of TB polysaccharides and explore their biological functions, providing a foundation for targeted diagnostic and therapeutic innovations. This article aims to provide reference for advancing both basic research and clinical applications related to M. tuberculosis.
7.Herbal Textual Research on Tribuli Fructus and Astragali Complanati Semen in Famous Classical Formulas
Jiaqin MOU ; Wenjing LI ; Yanzhu MA ; Yue ZHOU ; Wenfeng YAN ; Shijun YANG ; Ling JIN ; Jing SHAO ; Zhijia CUI ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(22):241-251
By systematically combing ancient and modern literature, this paper examined Tribuli Fructus and Astragali Complanati Semen(ACS) used in the famous classical formulas from the aspects of name, origin, production area, harvesting and processing, clinical efficacy, so as to provide a basis for the development of famous classical formulas containing such medicinal materials. The results showed that the names of Tribuli Fructus in the past dynasties were mostly derived from its morphology, and there were nicknames such as Baijili, Cijili and Dujili. The name of ACS in the past dynasties were mostly originated from its production areas, and there were nicknames such as Baijili, Shayuan Jili and Tongjili. Because both of them had the name of Baijili, confusion began to appear in the Song dynasty. In ancient and modern times, the main origin of Tribuli Fructus were Tribulus terrestris, and ancient literature recorded the genuine producing areas of Tribuli Fructus was Dali in Shaanxi and Tianshui in Gansu, but today it is mainly cultivated in Anhui and Shandong. The fruit is the medicinal part, harvested in autumn throughout history. There is no description of the quality of Tribuli Fructus in ancient times, and the plump, firm texture, grayish-white color is the best in modern times. Traditional processing methods for Tribuli Fructus included stir-frying and wine processing, while modern commonly used is purified, fried and salt-processed. The ancient records of Tribuli Fructus were spicy, bitter, and warm in nature, with modern research adding that it is slightly toxic. The main effects of ancient and modern times include treating wind disorders, improving vision, promoting muscle growth, and treating vitiligo. The mainstream base of ACS used throughout history is Astragalus complanatus. Ancient texts indicated ACS primarily originated from Shaanxi province. Today, the finest varieties come from Tongguan and Dali in Shaanxi. The medicinal part is the seed, traditionally harvested in autumn. Modern harvesting occurs in late autumn or early winter, followed by sun-drying. Ancient texts valued seeds with a fragrant aroma as superior, while modern standards prioritize plump, uniform and free of impurities. Traditional processing methods for ACS included frying until blackened and wine-frying, while modern practice commonly employs purification methods. In terms of medicinal properties, the ancient and modern records are sweet and warm in nature. Due to originally classified under Tribuli Fructus, its effects were thus regarded as equivalent to those of Tribuli Fructus, serving as the medicine for treating wind disorders, additional functions included tonifying the kidneys and treating vitiligo. The present record of its efficacy is to tonify the kidney and promote Yang, solidify sperm and reduce urine, nourish the liver and brighten the eye, etc. Based on the textual research results, it is suggested that when developing the famous classical formulas of Tribuli Fructus medicinal materials, we should pay attention to the specific reference object of Baijili, T. terrestris and A. complanatus should be identified and selected, and the processing method should be in accordance with the requirements of the formulas.
8.Study on bioequivalence evaluation of Pemirolast potassium tablets in Chinese healthy volunteers on an empty stomach/after meals
Yi-Ming MA ; Wang HU ; Feng ZHANG ; Wen ZHANG ; Sheng-Long ZHAO ; Yang CAO ; Jing XIE ; Huan ZHOU ; Shun-Wang HUANG
Chinese Pharmacological Bulletin 2024;40(6):1075-1081
Aim To compare the pharmacokinetics of pemirolast potassium tablets in healthy subjects in Chi-na under single fasting and postprandial conditions,and to evaluate the bioequivalence of the test prepara-tion(T)and the reference preparation(R).Methods A randomized,open-ended,single-dose,two-cycle,double-cross bioequivalence trial design was adopted,and 26 and 30 subjects were enrolled in the fasting group and the postprandial group,respectively,and 10 mg of the test preparation and the reference preparation were taken in the fasting or postprandial state each cy-cle,and venous blood was collected at the designed time points before and after the administration cycle.The concentration of pemirolast potassium in plasma was determined by LC-MS/MS method,and the phar-macokinetic parameters were calculated with PhoenixTM WinNonlin ?(8.3)software,and the bioequivalence analysis of the two preparations was performed.Re-sults The t1/2 of the test preparation and the reference preparation was(4.44±0.91)h and(4.49±0.93)h,respectively;the median tmax was(1.96±1.29)h and(2.18±1.25)h,respectively;the Cmax was(867.12±205.56)μg·L-1 and(863.35±172.03)μg·L-1,respectively;the AUC0-t was(5 513.23±1463.67)h·μg·L-1 and(5 661.32±1 628.65)h·μg·L-1,respectively;AUC0_∞ was(5 699.81±1477.68)h·μg·L-1 and(5 849.44±1 644.75)h·μg·L-1,respectively.The statistical results of the 90%confidence intervals of the main pharmacokinetic parameters Cmax,AUC0-t,and AUC0-∞ was 92.49%~107.53%,94.71%~100.67%and 95.28%~100.27%,respectively,all of which were within the range of 80.00%~125.00%,and the safety of the tested preparation and the reference preparation was good when taken orally on an empty stomach.The t1/2 of single oral administration after prandial administra-tion of the tested preparation and the reference prepara-tion was(4.46±0.78)and(4.51±0.84)h,respec-tively;the median tmax was(3.08±1.36)h and(3.28±1.28)h,respectively;the Cmax was(683.83±111.87)μg·L-1 and(689.77±110.24)μg·L-1,respectively;the AUC0-t was(5 695.99±1566.05)h·μg·L-1 and(5 773.60±1 551.04)h·μg·L-1,respectively;the AUC0-∞ was(5 914.06±1 551.86)h·μg·L-1 and(5 967.30±1552.89)h·μg·L-1,respectively.The 90%confi-dence interval of Cmax,AUC0-t,and AUC0-∞ was 93.56%~104.69%,96.43%~100.83%,and 97.29%~101.14%,respectively,which was in the range of 80.00%~125.00%,and the safety of the tested preparation and the reference preparation was good after meals.Conclusion In the state of fasting and postprandial single oral administration,the two kinds of pemirolast potassium tablets have good bio-equivalence.
9.Study on mechanism of Tibetan medicine Rhodiola crenulata in treatment of cerebral microcirculatory disorders based on network pharmacology and experimental validation in rats
Si-Qing MA ; Yu-Jing SHI ; Yuan-Bai LI ; Yang YANG ; Meng LI ; Yu DU ; Yi-Hao LI ; Fang-Zhou LIU
Chinese Pharmacological Bulletin 2024;40(9):1781-1791
Aim To explore the core target,key com-ponents and mechanism of Tibetan medicine Rhodiola crenulata in improving cerebral microcirculation based on literature research,network pharmacology,molecu-lar docking and experimental verification.Methods The chemical components of Rhodiola were collected through literature and database,and the potential tar-gets of Rhodiola crenulata were predicted by reverse pharmacophore matching.The related targets of cere-bral microcirculation disorder were obtained and targets were mapping with Rhodiola crenulata.PPI network was constructed and the core targets were screened.The regulatory network of"herb-component-target-dis-ease"was constructed and key components were screened.GO and KEGG enrichment analysis were conducted,and a"Core target-Pathway-Biological Process"network was constructed.Finally,molecular docking validation was carried out,and RT-qPCR and Western blot were used for animal experiments to fur-ther confirm the results of network pharmacology analy-sis.Results A total of 76 active components of Rhodiola crenulata were obtained and corresponding to 285 targets.Altogether 1074 related targets related to cerebral microcirculation disorder were obtained.A-mong them,there were 97 common targets and the main core targets were 6.The key components were 6.The results of molecular docking showed that the bind-ing activity of three key components to the core target was greater than that of the core target protein and its original ligand.The result of RT-qPCR and Western blot demonstrated that Tibetan medicine Rhodiola cre-nulata could significantly reduce the expression of core target CASP3 and AKT1(P<0.01).Conclusions Tibetan medicine Rhodiola crenulata can improve the cerebral microcirculation disorder through multi compo-nents,multi targets and multi pathways.This study provides an experimental basis for clinical application of Tibetan medicine Rhodiola crenulata to treat cerebral microcirculation disorder.
10.Research progress on mechanism of interaction between traditional Chinese medicine and intestinal flora
Jing WU ; Wei-Yi TIAN ; Kun CAI ; Su-Fang ZHOU ; Yao-Feng LI ; Xiang-Yun CHEN ; Hai-Bing QIAN ; Sha-Sha YANG
Chinese Pharmacological Bulletin 2024;40(10):1823-1829
Modern Chinese medicine studies have confirmed that the interaction between traditional Chinese medicine(TCM)and intestinal flora is the key to the treatment of diseases with tradi-tional Chinese medicine.This interplay includes such activities as:traditional Chinese medicine can be metabolized by intestinal flora into effective components with different biological activities from its precursors;TCM chemicals improve the composition of gut microbiota,consequently ameliorating its dysfunction as well as associated pathological conditions;and gut microbiota mediate the interactions between the multiple chemicals in TCM.There-fore,it becomes an important way to understand the modern sci-entific connotation of traditional Chinese medicine theory to study the pharmacological mechanism of the efficacy of traditional Chi-nese medicine by targeting Gut microbiota.


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