1.Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products
Mengxia ZHAO ; Lina SUN ; Dan XU ; Wen CHAI ; Xuekong JIANG ; Zhihai MAO ; Shengliang HE
China Pharmacy 2024;35(7):783-786
In July 2023, the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products (hereinafter referred to as the Measures). This article interprets the main content of the Measures, and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter, and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time, and build a national drug standard data-sharing platform based on the basic framework of user interface layer, computing processing layer, and data storage layer. Digital drug standards will be free, and access and download services for the public will be provided.
2.Construction of Knowledge Graph Based on Literature Data by Taking Treatment of Diabetic Peripheral Neuropathy with Traditional Chinese Medicine as An Example
Jiaqi CHAI ; Yumeng TAN ; Xinghua XIANG ; Miaomiao LI ; Tiancai WEN ; Hui ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):144-150
ObjectiveTo systematically sort out the knowledge framework and conceptual logic relationship of "disease-syndrome-treatment-prescription-medicine" in the existing literature on traditional Chinese medicine(TCM) treatment of diabetic peripheral neuropathy(DPN), to construct of the knowledge map of TCM treatment of DPN, and to promote the explicitation of the implicit knowledge in the literature on the treatment of DPN with TCM. MethodTaking the literature of China National Knowledge Infrastructure about TCM treatment of DPN as the main data source, TCM-related concepts and entities were constructed by manual citation, and the corresponding relationships between the entities were established. Structured data were formed by processing with Python 3.7, and the knowledge graph was constructed based on Neo4j 3.5.34 graph database. ResultThe resulting knowledge graph with TCM diagnosis and treatment logic, defined 12 node labels such as prescriptions, Chinese medicines and syndrome types at the schema layer, as well as 4 types of relationships, such as inclusion, correspondence, selection and composition. It could support the query and discovery of nodes(syndrome elements, syndrome types and treatment methods), as well as the relationship between each node. ConclusionBased on the literature data, this study constructed a knowledge map for TCM treatment of DPN, which brought together various methods of TCM treatment of DPN, including internal and external treatment. The whole chain knowledge structure of syndrome differentiation and classification for DPN treatment is formed from syndrome element analysis, syndrome type composition to treatment method selection, which can provide new ideas and methods for literature data to serve clinical and scientific research work, as well as reference for visualization of TCM literature knowledge, intellectualization of TCM knowledge services and the standardization of TCM diagnosis and treatment.
3.Mechanism of Traditional Chinese Medicine Intervening in Pyroptosis to Prevent and Treat Bone and Joint Related Diseases: A Review
Jutang CHAI ; Hongxia NING ; Yongzhang LI ; Xiaoyu LIU ; Xiaotao WEI ; Tao LIU ; Zhigang WEN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):289-298
Osteoarthritis (OA), rheumatoid arthritis (RA), gouty arthritis (GA), and intervertebral disc degeneration (IVDD) are the most common bone and joint-related diseases in clinical practice. They can all affect related joints, leading to joint pain, swelling, dysfunction, and other symptoms. The difference is that OA is mainly caused by joint wear and age-related degradation and is manifested as joint pain, stiffness, and limited movement. RA is an autoimmune disease, manifested as joint pain, swelling, morning stiffness, and systemic symptoms. GA is caused by abnormal uric acid metabolism, manifested as acute arthritis, and IVDD is caused by intervertebral disc degeneration. Studies have shown that the mechanism of the occurrence and development of these bone and joint diseases is extremely complex. Pyroptosis is closely related to these bone and joint-related diseases by participating in bone and joint inflammation, cartilage metabolism imbalance, extracellular matrix degradation, and pathological damage of bone and joint. Inhibition of bone and joint-related pyroptosis will effectively prevent and treat bone and joint-related diseases. At the same time, many studies have confirmed that traditional Chinese medicine (TCM) has a prominent curative effect and obvious advantages in the prevention and treatment of bone and joint-related diseases. TCM can reduce the inflammatory reaction of bone and joints, improve the pathological damage of bone and joint diseases, and relieve bone and joint pain by inhibiting pyroptosis. Therefore, this article aims to briefly explain the relationship between pyroptosis and the occurrence and development of bone and joint-related diseases and summarize the latest research reports on the intervention of pyroptosis in the treatment of bone and joint-related diseases by TCM monomers, TCM extracts, and TCM compounds. It offers new ideas for the in-depth study of the pathogenesis and drug treatment of bone and joint diseases and provides a basis for the clinical use of TCM to prevent and treat bone and joint diseases.
4.Efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia: a prospective, randomized, double-blinded, multicenter, positive-controlled clinical trial
Gong CHEN ; Wen OUYANG ; Ruping DAI ; Xiaoling HU ; Huajing GUO ; Haitao JIANG ; Zhi-Ping WANG ; Xiaoqing CHAI ; Chunhui WANG ; Zhongyuan XIA ; Ailin LUO ; Qiang WANG ; Ruifeng ZENG ; Yanjuan HUANG ; Zhibin ZHAO ; Saiying WANG
Chinese Journal of Anesthesiology 2024;44(2):135-139
Objective:To evaluate the efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia in patients.Methods:The patients with moderate to severe pain (numeric pain rating scale ≥4) after abdominal surgery with general anesthesia from 14 hospitals between July 6, 2021 and November 9, 2021 were included in this study. The patients were assigned to either experiment group or control group using a random number table method. Experiment group received oliceridine, while control group received morphine, and both groups were treated with a loading dose plus patient-controlled analgesia and supplemental doses for 24 h. The primary efficacy endpoint was the drug response rate within 24 h after giving the loading dose. Secondary efficacy endpoints included early (within 1 h after giving the loading dose) drug response rates and use of rescue medication. Safety endpoints encompassed the development of respiratory depression and other adverse reactions during treatment.Results:After randomization, both the full analysis set and safety analysis set comprised 180 cases, with 92 in experiment group and 88 in control group. The per-protocol set included 170 cases, with 86 in experiment group and 84 in control group. There were no statistically significant differences between the two groups in 24-h drug response rates, rescue analgesia rates, respiratory depression, and incidence of other adverse reactions ( P>0.05). The analysis of full analysis set showed that the experiment group had a higher drug response rate at 5-30 min after giving the loading dose compared to control group ( P<0.05). The per-protocol set analysis indicated that experiment group had a higher drug response rate at 5-15 min after giving the loading dose than control group ( P<0.05). Conclusions:When used for treatment of moderate to severe pain after surgery with general anesthesia in patients, oliceridine provides comparable analgesic efficacy to morphine, with a faster onset.
5."Impending illness" Concept Research and Modern Interpretation
Wen TANG ; Ruiting CHAI ; Hui CHEN ; Zhibin WANG ; Yang WANG
Journal of Traditional Chinese Medicine 2024;65(9):877-881
This paper elucidates the connotation and extension of the concept of "impending illness" from the perspective of logic. The connotation of impending illness refers to the intermediate state between health (not yet sick) and disease (already sick), characterized by the initial instability of yin and yang or a low-level balance of yin and yang as its internal mechanism, and mild dysfunctions in physiological, psychological, and social functions as its manifestations. The extension of impending illness includes latent disease status and pre-disease status. By adopting a creative hermeneutic approach to explore the deep-seated connotations of impending illness, this paper systematically analyzes the concept of impending illness from five levels: the existential level, the intentional level, the implicational level, the situational level, and the necessitational level, arguing that impending illness represents the unity of ambiguity and precision, the deviation of the human body system from homeostasis within a certain range, and an important component of the improvement of the traditional Chinese medicine health management system. Thoroughly explicating and clarifying the concept of "impending illness" can provide theoretical references for the study of transitional states between health and disease and the improvement of the traditional Chinese medicine health management system.
6.Development and validation of a prognostic nomogram for locally advanced renal cell carcinoma patients after surgery
Fei LI ; Xiaodong WEN ; Hongqiang CHAI ; Ming WU ; Lei PANG
Journal of Modern Urology 2024;29(4):334-341
【Objective】 To construct a nomogram survival prediction model for patients with locally advanced renal cell carcinoma based on SEER database (n=7893), so as to provide reference for future prognosis study. 【Methods】 Case data were downloaded from the SEER database, and divided into the experimental group and validation group with a ratio of 7∶3 by simple randomization.The clinical information was analyzed, independent risk factors influencing prognosis were screened, and the overall survival (OS) and tumor-specific survival (CSS) were mapped.Model performance was evaluated using consistency index, area under the receiver operating characteristic curve (AUC), internal and external validation, and calibration curves. 【Results】 Patients’ age, tumor size, disease progression tpye, TNM stage, number of positive lymph nodes, marital status and pathological type were significantly correlated with OS and CSS (P<0.01).Based on the above predictors, the internal verification AUC of the 1-, 3- and 5- year OS nomogram model was 0.809, 0.721 and 0.715, respectively.The internal validation AUC of the nomogram model for 1-, 3- and 5- year CSS was 0.802, 0.745 and 0.735, respectively.The external validation AUC of the OS nomogram model was 0.792, 0.628 and 0.620 at 1, 3 and 5 years, respectively, and the external validation AUC of CSS was 0.943, 0.803 and 0.737 at 1.3 and 5 years, respectively, showing good model differentiation and accuracy. 【Conclusion】 The prediction performance of the nomogram model is good, and it can provide reference for individualized treatment.
7.Clinical Observation on the Shugan Tiaoshen Acupuncture in the Treatment of Mild-to-Moderate Perimenopausal Depressive Disorder
Zi-Qing LIANG ; Cheng-Cheng CHAI ; Wen-Bin FU ; Ding LUO
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(5):1226-1232
Objective To observe the clinical efficacy of Shugan Tiaoshen Acupuncture in the treatment of mild-to-moderate perimenopausal depressive disorder(PDD).Methods A total of 66 patients with mild-to-moderate PDD were randomly divided into the observation group and the control group,with 33 cases in each group.The observation group was treated with Shugan Tiaoshen Acupuncture,and the control group was treated with conventional western medicine for 8 weeks.After 2 months of treatment,the clinical efficacy of the two groups was evaluated,and the changes in Hamilton Depression Scale(HAMD-17)scores before and after treatment,as well as the scores of Menopausal Quality of Life Scale(MENQOL)were observed in the two groups.The changes in serum luteinising hormone(LH),follicle-stimulating hormone(FSH)and oestradiol(E2)levels were compared before and after treatment between the two groups,and the safety and the occurrence of adverse reactions in the two groups were evaluated.Results(1)During the study,3 cases in the observation group and 2 cases in the control group were lost to followup.Finally,30 cases in the observation group and 31 cases in the control group were included in the efficacy statistics.(2)After treatment,the total score of HAMD-17 and the scores of each factor in the two groups were significantly improved(P<0.05),and the total score of HAMD-17 and the scores of anxiety/somatization factor and sleep factor in the observation group were significantly superior to those in the control group,the differences were statistically significant(P<0.05).(3)After treatment,the total score of MENQOL and the scores of vascular dimension,physiological dimension and sexual life dimension in the two groups were significantly improved(P<0.05),and the total score of HAMD-17 and the scores of vascular dimension and physiological dimension in the observation group were significantly superior to those in the control group,the differences were statistically significant(P<0.05).(4)After treatment,the levels of LH,FSH and E2 in the two groups were significantly improved(P<0.05),and the improvement of LH,FSH and E2 levels in the observation group was significantly superior to that in the control group(P<0.05).(5)The total effective rate was 93.33%(28/30)in the observation group and 74.19%(23/31)in the control group.The curative effect of the observation group was superior to that of the control group,and the difference was statistically significant(P>0.05).Conclusion Shugan Tiaoshen Acupuncture in the treatment of mild-to-moderate PDD can significantly improve the clinical symptoms of patients,improve the quality of life of patients,regulate the level of sex hormones,and have a significant effect.
8.Regulation of autophagy by posttranslational modification of TFEB
Yiming YANG ; Jiayin CHAI ; Wen WANG
Chinese Journal of Arteriosclerosis 2024;32(3):185-193
Transcription factor EB(TFEB)is a member of the microphthalmia associated transcription factor family.It plays an important role in lipid metabolism and other biological processes by regulating the expression of auto-phagy and lysosomal related genes.The activity and cellular localization of TFEB can be regulated by posttranslational modifications of proteins.This paper discusses the mechanism of autophagy regulation by TFEB posttranslational modifica-tion,aiming to help understand the pathogenesis of related diseases caused by abnormal autophagy,and provides new ideas and feasible intervention targets for the prevention and treatment of corresponding diseases.
9.The role of Traditional Chinese Medicine in regulating vitamin D in panvascular dis-eases based on kidney storing essence
Qian LI ; Yihui CHAI ; Wen LI ; Jie GAO ; Zhong QIN ; Huanzhen WANG ; Liancheng GUAN ; Yunzhi CHEN
Chinese Journal of Arteriosclerosis 2024;32(8):728-736
Atherosclerosis(As)is a chronic inflammatory disease caused by lipid deposition.Panvascular disea-ses,which are mainly caused by As,have gradually attracted the attention of many scholars,and their main pathological features are vascular lesions.Vitamin D plays an important role in anti-As in panvascular diseases.It is involved in the regulation of renin-angiotensin system(RAS),endothelial cell injury,immune response,neutrophil extracellular traps(NET)regulation,apoptosis and autophagy,and is a new target in panvascular diseases research.Traditional Chinese Medicine(TCM)has certain advantages in the prevention and treatment of panvascular diseases.Among them,single herbs,active ingredients and compound prescriptions can regulate vitamin D-related metabolism,and have unique scientific value for the prevention and treatment of As.This article mainly discusses the role of vitamin D in multiple pathological links of panvascular diseases and related Chinese medicine interventions,aiming to provide effective ideas for the prevention and treatment of panvascular diseases from the perspective of vitamin D.
10.Cost-effectiveness analysis of different cleaning frequency on reducing pathogens on hospital bed-side curtains
Wen-Juan DUAN ; Su-Qin WEN ; Qiang CHAI
Chinese Journal of Infection Control 2024;23(9):1114-1118
Objective To explore the pathogen contamination and cost-effectiveness of hospital bed-side curtains under different cleaning frequencies.Methods Fourteen departments in a hospital with relatively higher incidence but smaller fluctuation of incidence of infection from January to June 2023 were selected.Nine wards in each depart-ment were selected,and two curtains were selected from each ward.According to the cleaning frequency,wards were divided into low,medium and high frequency groups.The qualified rate of environmental hygienic detection on pathogens on the bed-side curtains and bacterial contamination on the surface of curtains after 6 months were com-parted,cost-effectiveness analysis was conducted.Results The qualified rate of environmental hygienic detection of bed-side curtains was the highest in high frequency group,at 88.10%.Bacterial counts on the upper,middle,and lower segments of the bed-side curtains in the high frequency group were all lowest(P<0.05).Within 6 months,the incidence of healthcare-associated infection(HAI)in patients in the high and the medium frequency groups(0.16%and 0.25%,respectively)were both lower than 0.85%in the low frequency group(x2=5.653,3.915,respectively,both P<0.05).Cost-effectiveness analysis showed that for every additional unit of qualified rate for the high and medium frequency groups,the costs increase by 124.51 and 44.10 Yuan,respectively.Conclusion The increase of cleaning frequency can effectively reduce bacterial contamination of bed-side curtains,decrease the risk of HAI,and improve the qualified rate of environmental hygiene of bed-side curtains in the wards.Cleaning once every 2 months can achieve better cost-effectiveness.

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