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.Analysis of IL-2R β gene promoter region polymorphism in Han males from a high radiation background area in Yangjiang City
Ying TANG ; Jing WANG ; Liting YAN ; Wenting ZHONG ; Cuiju WEN ; Shibiao SU
China Occupational Medicine 2025;52(1):45-49
Objective To analyze the distribution characteristics of the single nucleotide polymorphism (SNP) site rs76206423 in the promoter region of the interleukin-2 receptor (IL-2R) β gene among Han males in a high radiation background area (HBRA) in Yangjiang City. Methods A total of 48 male participants from Tangkou Town, Yangxi County, Yangjiang City (HBRA group), and 51 male participants from Hengpo Town, Enping City (control group) were selected as the research subjects using the random number table method. Peripheral venous blood samples of participants from both groups were collected, and genomic DNA was extracted. The genotyping and allele frequency distribution of the rs76206423 (A/G) site in the IL-2R β promoter region was detected among the participants in both groups using the SNP detection method. The difference of allele frequencies between population in HBRA group and five area of East Asia, South Asia, Africa, Europe, and the Americas published in the Human Genome Project database from National Center for Biotechnology Information were analyzed. Results The allele frequencies of rs76206423 of population in both groups conformed to Hardy-Weinberg equilibrium (P>0.05). In the HBRA group, the AA genotype was predominant (64.6%), while the AG genotype was the most common in the control group (51.0%), with a significant difference (P<0.05). Population in both groups showed a predominance of the variant allele A (78.1% and 72.5%, respectively), with no significant difference (P>0.05). The frequency of the G allele of rs76206423 in the population in HBRA group was higher than those in South Asian, African, European, and American populations (all P<0.01), but showed no significant difference compared with East Asian populations (P>0.05). Conclusion In the Han male population from the HBRA in Yangjiang City, the rs76206423 site in the IL-2R β gene promoter region is predominantly composed of the wild-type A allele and AA genotype, indicating genetic stability and a relatively high degree of variation at this locus.
3.Expert consensus on the deployment of DeepSeek in medical institutions
Yanlin CAO ; Jing WANG ; Yuxi LI ; Yi ZHANG ; Guangzhen ZHONG ; Ping SONG
Chinese Medical Ethics 2025;38(5):674-678
The Expert Consensus on the Deployment of DeepSeek in Medical Institutions serves as a detailed guideline for the deployment of DeepSeek in medical institutions. It was developed by experts in the fields of healthcare, hospital management, medical information, health policy, law, and medical ethics from nearly 30 leading domestic medical and academic research institutions, based on relevant domestic and international laws and regulations as well as the practices of medical institutions. It aims to provide medical institutions with a scientific, standardized, and secure deployment guideline to ensure that the application of artificial intelligence (AI) technologies in healthcare, including but not limited to DeepSeek, conforms to the unique characteristics of the healthcare industry and effectively promotes the improvement of medical service levels. From the three aspects of pre-deployment evaluation, deployment implementation, and post-deployment management and monitoring, the key factors that medical institutions should consider when introducing DeepSeek were elaborated in detail, including medical demand compatibility, technical capabilities and infrastructure, legal and ethical risks, data preparation and management, model selection and optimization, system integration and training, performance monitoring and continuous optimization, risk management and emergency response, as well as compliance review and evaluation. This provides a comprehensive deployment framework for medical institutions to ensure the safety and effectiveness of technology applications.
4.Preparation and in vitro evaluation of platelet membrane biomimetic liposomes loaded with vincristine sulfate
Jing XIAO ; Xunyi YOU ; Along ZHANG ; Rui ZHONG ; Jiaxin LIU ; Ye CAO ; Hong WANG
Chinese Journal of Blood Transfusion 2025;38(5):652-659
Objective: To prepare platelet membrane biomimetic liposomes loaded with vincristine sulfate (VCR) for targeted delivery to tumor. Methods: Vincristine sulfate liposomes (LIPO) were prepared using the pH-gradient method, followed by the fusion of platelet membranes and subsequent drug loading to obtain platelet membrane biomimetic liposomes (PLM-LIPO). The particle size, polydispersity index (PDI), Zeta potential, and drug encapsulation efficiency (EE%) of both liposomes were characterized. The tumor-targeting capability was evaluated through in vitro cellular experiments and in vivo biodistribution studies. Results: The optimal preparation conditions for LIPO were determined as follows: DPPC-to-cholesterol molar ratio of 1∶1, internal aqueous phase of 0.3 M pH 4.0 citrate buffer, external aqueous phase of 1 M Na
HPO
solution, drug-to-lipid ratio of 1∶10, drug loading temperature of 60℃, and loading time of 10 minutes. The LIPO exhibited a mean particle size of (147.3±2.24) nm, PDI of 0.078±0.014, Zeta potential of (-3.54±0.75) mV, and EE% of 91.37±0.47. For PLM-LIPO, prepared via membrane fusion followed by drug loading, the mean particle size was (185.3±3.61) nm, PDI was 0.075±0.022, Zeta potential was (-18.91±1.54) mV, and EE% was 63.36±2.45. In the CD62P validation experiment, the fluorescence intensity of PLM-LIPO was five times higher than that of LIPO. In vitro cellular uptake experiments revealed that PLM-LIPO showed 1.3-fold and 1.2-fold higher uptake rates compared to LIPO at 6 h and 12 h, respectively. In vivo experiments demonstrated that 1h after administration, the accumulation of PLM-LIPO at tumor sites was 4-fold higher than that of LIPO and 6-7 times higher than that in healthy mice. Conclusion: The platelet membrane biomimetic liposomes loaded with vincristine sulfate were successfully developed. Both cellular uptake and tissue distribution studies confirmed the PLM-LIPO enhanced tumor-targeting capability.
5.Two new glycosides from the Citri Sarcodactylis Fructus
Jing-jing MIAO ; Ge-ge XIA ; Ge-ge ZHAO ; Yu-zhong ZHENG ; Yan-zhi WANG
Acta Pharmaceutica Sinica 2025;60(1):196-200
Six compounds were isolated from the ethyl acetate fraction of
6.Analysis of the current status and countermeasures of safety content control of traditional Chinese medicine based on the revision announcement of the instruction and the national adverse drug reaction monitoring report
Jian ZHU ; Zhong WANG ; Hongli WU ; Zhiwei JING
China Pharmacy 2025;36(17):2092-2096
OBJECTIVE To provide a reference for revising the safety content of traditional Chinese medicine(TCM) instructions. METHODS A systematic analysis was conducted on the relevant announcements on the revision of TCM instruction from 2013 to 2024, including the year of publication, drug name, drug formulation, announcement release time, and the average number of revisions made to three safety contents (contraindication, adverse drug reaction, and precaution). According to the report data of national adverse drug reaction monitoring from 2013 to 2024, analyze the proportion of TCM in all adverse drug reactions, the composition ratio of adverse drug reaction of different dosage forms of drugs [TCM injection, oral TCM, other (topical) TCM]. RESULTS From 2013 to 2024, the National Medical Products Administration issued a total of 101 notices on the revision of TCM instruction, involving 241 types of TCM. Among them, there were 163 types of oral TCM, 25 types of TCM injection, and 53 types of other (topical) TCM. There were 3, 10 and 0 types of TCM injection, oral TCM, and other (topical) TCM with missing safety content, respectively. The main source of adverse drug reaction data for TCM injections was post- marketing monitoring data (accounting for 48.00%); the main source of adverse drug reaction data for oral TCM was monitoring data (accounting for 71.17%); 73.58% of other (topical) TCM did not mention the source of adverse drug reaction data. The report on national adverse drug reaction monitoring showed that the proportion of all adverse drug reactions of TCM had decreased from 17.3% in 2013 to 12.1% in 2024. Among them, the proportion of adverse drug reaction of TCM injection in the three dosage forms of TCM had decreased from 61.3% in 2015 to 24.6% in 2024, while the proportion of adverse drug reaction of oral TCM in the three dosage forms of TCM had increased from 34.7% in 2015 to 64.0% in 2024. CONCLUSIONS The risk management of TCM safety content has achieved results in China, but still faces three major challenges: strongdependence on passive monitoring, insufficient data traceability, and missing key content. It is urgent to improve safety content by dosage form, optimize data sources, and fully utilize real-world evidence to supplement safety content.
7.Syndrome Differentiation and Treatment of Polycystic Ovary Syndrome with Classical Formula: A Review
Kening GUO ; Zihan ZHU ; Zhenliang WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):231-240
Polycystic ovarian syndrome (PCOS) is a common endocrine and metabolic disease mainly occurring among women of childbearing age. Its main symptoms include menstrual disorders, acne, hirsutism, infertility, oily skin, acanthosis nigricans, and obesity. Currently, the etiology and pathogenesis of PCOS remain unclear. Classical formulas, which have rigorous compatibility, concise composition, precise alignment with syndromes, and definitive therapeutic effects, demonstrate unique practical and scientific value in the treatment of PCOS. These formulas exhibit significant clinical efficacy, mild adverse effects, and sustained therapeutic outcomes. To explore the current status and mechanisms of classical formulas in treating PCOS, on the basis of Zhang Zhongjing's academic thoughts on gynecological diseases, this paper reviewed the relevant literature on the treatment of PCOS with classical formulas in recent years. The findings reveal that the pathogenesis of PCOS predominantly involves a combination of internal deficiency and superficial excess, closely related to dysfunction of the liver, spleen, and kidney. The root cause lies in deficiency, and on this basis, there are also symptoms of qi stagnation, blood stasis, phlegm obstruction, and dampness encumbrance. Commonly used classical formulas for treating this disease include Guizhi Fuling pills, Danggui Shaoyao powder, Wenjing decoction, and Jingui Shenqi pills. These classical formulas have good clinical efficacy in treating PCOS. Their mechanisms of action may be related to improving serum levels of sex hormones, increasing the dominant follicle diameter and endometrial thickness, alleviating insulin resistance, lowering glucose and lipid metabolism, inhibiting oxidative and inflammatory reactions in the ovarian tissue, regulating the intestinal flora, correcting the flora disorder, protecting the intestinal barrier function, and regulating the phosphatidylinositol 3-kinase/protein kinase B signaling pathway. The above research results can help doctors use classical formulas flexibly, broaden diagnostic and therapeutic approaches for PCOS and provide ideas for improving the traditional Chinese medicine diagnosis and treatment plan for PCOS.
8.Syndrome Differentiation and Treatment of Polycystic Ovary Syndrome with Classical Formula: A Review
Kening GUO ; Zihan ZHU ; Zhenliang WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):231-240
Polycystic ovarian syndrome (PCOS) is a common endocrine and metabolic disease mainly occurring among women of childbearing age. Its main symptoms include menstrual disorders, acne, hirsutism, infertility, oily skin, acanthosis nigricans, and obesity. Currently, the etiology and pathogenesis of PCOS remain unclear. Classical formulas, which have rigorous compatibility, concise composition, precise alignment with syndromes, and definitive therapeutic effects, demonstrate unique practical and scientific value in the treatment of PCOS. These formulas exhibit significant clinical efficacy, mild adverse effects, and sustained therapeutic outcomes. To explore the current status and mechanisms of classical formulas in treating PCOS, on the basis of Zhang Zhongjing's academic thoughts on gynecological diseases, this paper reviewed the relevant literature on the treatment of PCOS with classical formulas in recent years. The findings reveal that the pathogenesis of PCOS predominantly involves a combination of internal deficiency and superficial excess, closely related to dysfunction of the liver, spleen, and kidney. The root cause lies in deficiency, and on this basis, there are also symptoms of qi stagnation, blood stasis, phlegm obstruction, and dampness encumbrance. Commonly used classical formulas for treating this disease include Guizhi Fuling pills, Danggui Shaoyao powder, Wenjing decoction, and Jingui Shenqi pills. These classical formulas have good clinical efficacy in treating PCOS. Their mechanisms of action may be related to improving serum levels of sex hormones, increasing the dominant follicle diameter and endometrial thickness, alleviating insulin resistance, lowering glucose and lipid metabolism, inhibiting oxidative and inflammatory reactions in the ovarian tissue, regulating the intestinal flora, correcting the flora disorder, protecting the intestinal barrier function, and regulating the phosphatidylinositol 3-kinase/protein kinase B signaling pathway. The above research results can help doctors use classical formulas flexibly, broaden diagnostic and therapeutic approaches for PCOS and provide ideas for improving the traditional Chinese medicine diagnosis and treatment plan for PCOS.
9.Ancient and Modern Literature Analysis and Key Information Research of Classic Formula Qingfeitang
Lyuyuan LIANG ; Jinyan ZHANG ; Jialei CAO ; Jing TANG ; Mengmeng GENG ; Yiqing ZHAO ; Hejia WAN ; Yiping WANG ; Bingqi WEI ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):179-189
Qingfeitang, specialized in resolving phlegm to stop cough and producing fluid to moisten dryness, is a classic prescription inherited and developed by physicians of successive generations and has been included in the Catalogue of Ancient Classic Prescriptions (First Batch) published by the National Administration of Traditional Chinese Medicine (TCM) in 2018. Relevant ancient books data and modern literature were collected by bibliometrics to analyze the historic origin, formula composition, herb origin, preparation methods, processing methods, clinical effect, and indications of Qingfeitang. The key information of Qingfeitang was summarized to provide reference for the clinical application of the decoction. In this study, a total of 43 pieces of effective data on relevant ancient literature, including 35 ancient TCM books, were collected based on a systematic collation of relevant historic and modern literature. Results showed that "Qingfeitang" was originated from the "Renshen Qingfeitang" recorded in the Taiping Holy Prescriptions for Universal Relief from the Qing dynasty. The name of "Qinfeitang" was first recorded in the Yeshi Luyanfang written by YE Dalian in the Song dynasty. We suggested the modern dosage and usage of Qingfeitang as follows: "Scutellariae Radix of 5.60 g, Platycodon grandiflora, Poria, Tangerine, Fritillaria, and Cortex Mori of 3.73 g respectively, Angelicae Sinensis Radix, Asparagi Radix, Gardeniae Fructus, Armeniacae Semen Amarum, and Ophiopogonis Radix of 2.61 g respectively, Schisandra of 1 g, and Glycyrrhizae Radix et Rhizoma of 1.12 g, and they were taken 3 times daily. The above formula is recommended to be decocted with 400 mL of water, with 3.37 g ginger and 6 g jujubae fructus, to 320 mL, and taken after a meal, three times per day". Qingfeitang has the effect of resolving phlegm to stop cough and producing fluid to moisten dryness, specialized in treating cough, asthma, rash, and other symptoms in ancient times. Modern applications are mainly focused on the respiratory system, used for treating diseases such as bronchopneumonia and cough. The above research results provide a reference basis for the later development and research of Qingfeitang.
10.MRI classification of extraprostatic extension of prostate cancer for predicting positive surgical margin after laparoscopic radical prostatectomy
Chao ZHONG ; Junguang WANG ; Kecheng ZHANG ; Jing WANG ; Xiaohui ZHANG ; Hong ZHANG
Chinese Journal of Interventional Imaging and Therapy 2024;21(10):602-606
Objective To explore the value of MRI classification of extraprostatic extension(EPE)of prostate cancer(PCa)for predicting positive surgical margin after laparoscopic radical prostatectomy(LRP).Methods Prostate MRI data of 114 PCa patients with stage T3a who underwent LRP were retrospectively analyzed.The patients were divided into type Ⅰ(n=14),Ⅱ(n=50)and Ⅲ group(n=50)according to EPE location,also into positive margin group(n=58)and negative margin group(n=56)according to postoperative pathology.Then clinical,imaging,surgical and pathological data were compared among type Ⅰ—Ⅲ groups and between positive and negative margin groups.The indicators being significantly different between positive and negative margin groups were included in multivariate logistic regression analysis to screen the independent impact factors of positive margin of stage T3a PCa after LRP.Results Significant differences of patients'age,prostate-specific antigen(PSA),tumor location and positive surgical margin rate were found among type Ⅰ—Ⅲ groups(all P<0.05).Positive surgical margin rate in type Ⅲ group was 68.00%(34/50),higher than that in type Ⅰ(14.29%[2/14])and Ⅱ group(44.00%[22/50])(both P<0.05).Meanwhile,significant differences of PSA,the proportion of positive puncture needles and EPE MRI classification of PCa were found between positive and negative margin groups(all P<0.05),among which the proportion of positive puncture needles and EPE MRI classification of PCa were both independent impact factors of positive margin of stage T3a PCa after LRP(both P<0.05).Conclusion MRI classification of PCa-EPE could be used to predict positive surgical margin after LRP.Positive surgical margin after LRP tended to occur in PCa with MRI type Ⅲ EPE.

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