1.Overview of China′s pediatric drug situation and regulatory policy
Hongjie XIAO ; Mengdie ZHOU ; Yang SUN ; Wu ZHONG
Journal of International Pharmaceutical Research 2016;43(4):579-584
Pediatric drug accessibility has become a global problem,pediatric drug shortages and off-label uses are very seri?ous. In China,lack of suitable varieties,appropriate dosage forms and specifications,weak foundations on clinical trials,irregular prescribing behavior and irrational drug use and other issues on pediatric drugs are still outstanding. To improve pediatric drug accessi?bility,it may need all aspects work together,that is,cooperation of the national macro-policy support,participation of enterprises and medical institutions,to establish realistic goals and programs to address pediatric drug problem. This paper studies the foreign pediat?ric regulation measures and policies and by comparing foreign policies to China′s current situation,we can find out the problems and defects,give appropriate advice,in order to provide advice and reference to promote the development of pediatric drug.
2.Clinical efficacy of moxibustion for ulcerative colitis and its influence on vitamin D receptor
Hyoyoung IM ; Wenjia WANG ; Qin QI ; Qi LI ; Mengdie WU ; Huangan WU ; Yanan LIU ; Yan HUANG ; Yi ZHU ; Handan ZHENG ; Luyi WU
Journal of Acupuncture and Tuina Science 2023;21(1):40-50
Objective: To observe the clinical efficacy of herbal cake-partitioned moxibustion for ulcerative colitis (UC) and elucidate its mechanism by targeting the vitamin D receptor (VDR) signaling pathway. Methods: A total of 63 patients with UC were randomly divided into an observation group (30 cases, treated with herbal cake-partitioned moxibustion) and a control group (33 cases, treated with sham herbal cake-partitioned moxibustion). Moxibustion treatment was performed at Qihai (CV6) and bilateral Tianshu (ST25) and Shangjuxu (ST37), 3 times per week for 12 weeks. The total effective rate, visual analog scale (VAS) score for abdominal bloating and pain, and hospital anxiety and depression scale (HADS) score were compared between the two groups. Enzyme-linked immunosorbent assay was used to detect the concentrations of serum C-reactive protein (CRP), 25-hydroxyvitamin D [25(OH)D], and interleukin-12 (IL-12)/interleukin-23 (IL-23) p40. Immunohistochemistry was used to observe the expression levels of VDR and regenerating gene Ⅳ (Reg Ⅳ) proteins in colonic mucosa. The expression levels of VDR, cytochrome p45027B1 (CYP27B1), and Reg Ⅳ mRNAs were detected by real-time fluorescence quantitive polymerase chain reaction. Results: After treatment, the total effective rate in the observation group was 86.7%, which was significantly higher than 51.5% in the control group (P<0.05). After treatment, the VAS scores for abdominal bloating and pain in the observation group were significantly decreased (P<0.01), as well as the HADS-depression subscale (HADS-D) and HADS-anxiety subscale (HADS) scores (P<0.05), while only the VAS score for abdominal pain in the control group was reduced (P<0.05), and the improvements of the scores in the observation group were more significant than those in the control group (P<0.05). After treatment, the serum CRP concentrations in both groups and the IL-12/IL-23 p40 concentration in the observation group were significantly decreased (P<0.05), and the concentrations in the observation group were lower than those in the control group (P<0.05). The expression levels of VDR protein and mRNA in the colon in both groups were all increased (P<0.01), and the expression levels of Reg Ⅳ protein and mRNA and CYP27B1 mRNA were all decreased in the two groups (P<0.05 or P<0.01); the improvements in the observation group were more notable than those in the control group (P<0.05 or P<0.01). Conclusion: Herbal cake-partitioned moxibustion can effectively alleviate abdominal pain and diarrhea in patients with UC, improve depression and anxiety disorders, and regulate the expression of related proteins in the VDR signaling pathway. The mechanism may be related to inhibiting intestinal inflammation by reducing the release of the proinflammatory cytokine IL-12/IL-23 p40.
3.Body weight change and metabolic index control in patients with type 2 diabetes mellitus under standardized metabolic disease management model
Zhixiao XU ; Ying WU ; Dandan HU ; Mengdie CAO ; Lei CHEN
Chinese Journal of Endocrinology and Metabolism 2023;39(4):327-335
Objective:To explore the relationship between weight change and metabolic control of type 2 diabetic patients after 1 year treatment under the standardized metabolic disease management model.Methods:From November 2017 to November 2021, 950 patients with T2DM in the Standardized Metabolic Management Center of Suzhou Municipal Hospital were recruited in this research, who were divided into normal(BMI 18.5-23.9 kg/m 2), overweight(BMI 24.0-27.9 kg/m 2), and obese(BMI≥28 kg/m 2)groups according to baseline BMI. The metabolic indicators and control rates were compared. The overweight and obese 599 patients were divided into weight reduction(<-3 kg), maintenance(-3-1 kg) and gain(>1 kg)groups according to weight changes by one year, and metabolic indicators and control rates were compared to analyze the influence of weight change on metabolic control of overweight and obese patients. Results:(1) The overweight and obese groups had worse metabolic control at baseline and the obese group was younger. After 1 year, the metabolic indicators of three groups were significantly improved. (2) After 1 year, the metabolic control was better in weight reduction group and worse in weight gain group. The control rates were increased in weight reduction and maintenance groups. (3) For every 1 kg reduction in body weight of overweight and obese patients, blood glucose, blood lipids, blood pressure and comprehensive control rate increased by 1.206, 1.046, 1.069 and 1.107 times, respectively. There was a positive linear relationship between weight reduction and metabolic improvement.Conclusion:Standardized metabolic disease management model promotes metabolic control in type 2 diabetic patients, especially in overweight and obese patients who actively lose weight. In the future we should strengthen the management of overweight and obese patients, enhance self-management ability, and manage body weight scientifically and effectively.
4.Evaluation of Moxibustion with Monkshood Cake for Functional Dyspepsia on the Acupoints along Related Meridian: a Randomized and Controlled Clinical Trial
Mengdie WU ; Xinyun HUANG ; Shuang ZHAO ; Xue ZHENG ; Menglu QIN ; Huangan WU ; Jing LI
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(9):1585-1589
Objective: To evaluate the clinical efficacy of moxibustion with monkshood cake on the acupoints along related meridian for functional dyspepsia (FD) patients. Methods: Sixty patients suffering from functional dyspepsia who met with the inclusion criteria were enrolled in our randomized and controlled trial and randomly divided into two different groups, 30 and 28 patients have finished the treatment respectively. Patients of each group were given with moxibustion with monkshood cake on different acupoints, Group A chose acupoints along related meridian (ST 34, ST 36, ST 40 and ST42), while Group B chose acupoints along non-related meridian (GB 34, GB 36, GB 37 and GB 40) . Patients of each group received moxibustion treatment on alternate days, 3 times a week for a total of 12 times. The efficacy was evaluated using the Nepean Dyspepsia Index (NDI) and the Somatic Self-rating Scale (SSS) before, 2 weeks after and 4 weeks after the treatment, respectively. Results: Considering the NDI scale, the result showed that improvement scores of Group A were higher than that of Group B with statistical significance (P < 0.01) . Both groups had improved patients' quality of life after the treatment (P < 0.05), but the improvements in Group A were significantly better than those in Group B (P < 0.01) . Conclusion: The clinical efficacy of moxibusion with monkshood cake on the acupoints along related meridian was better than that of the non-related meridian.
5.Progresses in Objective Assessment Tools to Assess the Subjects' Function and Spasticity of Upper Extremity after Stroke
Xinyun HUANG ; Mengdie WU ; Yan YU ; Yanli ZHOU ; Shuyun JIANG ; Jing LI
World Science and Technology-Modernization of Traditional Chinese Medicine 2017;19(10):1758-1763
Spastic-paralysis impacts the function of upper extremity in most apoplexy patients.Assessing spasticity condition precisely,timely and effectively plays an important role in guiding rehabilitation treatment,therapeutic evaluation and prognosis of functional outcome.Owing to the limitations of subjective scales,the issue of quantifing the spasticity objectively has become a new research direction in recent years.By reviewing the literatures,we summed up the application of objective assessment tools,which were based on rehabilitation engineering,electrophysiology or biomechanics,in assessing the function of upper extremity with spastic paralysis,as well as put forward the research directions of prospects,in order to give a reference to the systematic integration of assessment tools in the near future.
6.Network Pharmacological Analysis of Yi-Guan Decoction on "Different Diseases with Same Treatment"
Mengdie YANG ; Feifei CAI ; Rong WU ; Xiaole CHEN ; Qiusha PAN ; Yuanjia HU ; Shibing SU
World Science and Technology-Modernization of Traditional Chinese Medicine 2017;19(12):1912-1919
This study was aimed to predict active compounds,drug targets and potential diseases of Yi-Guan decoction (YGD) by network pharmacological technology,and to clarify molecular mechanisms of YGD efficiency on different diseases with liver and kidney yin deficiency syndrome (LKYDS).Chemistry compounds,targets and related diseases from YGD were collected from TCMSP,TCM Database@Taiwan,TCMID,HIT,Drugbank,PubChem and TTD databases.The YGD compounds-targets-diseases network was constructed.The network topology was analyzed by Cytoscape software.The analysis of GO biological processes and KEGG pathways enrichment were performed by DAVID website.The results showed that 849 chemical compounds were identified from Beishashen,Maidong,Danggui,Shengdihuang,Chuanlianzi and Gouqizi.There were 49 active CHM compounds that were both oral bioavailability (OB) ≥ 30% and drug-likeness (DL) ≥ 0.18,corresponding to 200 target proteins and 264 diseases.The top three GO biological processes were response to organic substance,regulation of cell proliferation,and response to endogenous stimulus,respectively.The top three KEGG pathways were pathways in cancer,hepatitis B,and prostate cancer,respectively.It was concluded that the analysis on YGD was conducted based on network pharmacology,and the compound-target-disease network was built,which may help to clarify the mechanisms of YGD efficiency on different diseases with LKYDS.It can provide clues to find new potential clinical adaptation of disease and new drugs.
7.Psychological experience of patients with primary tumors participating in clinical trials:a qualitative study
Shujun XING ; Jun'e LIU ; Mengdie HU ; Shuhang WANG ; Dawei WU ; Hong FANG ; Yu TANG ; Ning LI
China Modern Doctor 2023;61(35):92-95,98
Objective To deeply understand the psychological experience of patients with primary tumors participating in clinical trials,providing a reference basis for meeting the psychological needs of patients and improving the mental health level of patients with primary tumors.Methods From November 2021 to May 2022,13 patients with primary tumors participating in clinical trials were selected by target sampling method,semi-structured interviews were conducted,with Colaizzi 7-step analysis method was used to analyze the data.Results Four themes were extracted from the psychological experience of patients,namely the perception and attitudinal experience of clinical trials,complex and changeable emotional responses,experimental process adaptation,personal growth and transformation.Conclusion The psychological experience and related psychological problems of primary tumors patients participating in clinical trials cannot be ignored,the research team needs to help them complete role transformation and adaptation,pay attention to the experience of patients,improve mental health education programs according to the needs of this type of patients,and improve the quality of life of patients,then promote the development of cancer diagnosis and treatment in China.
8.Research on the regulation of electronic prescription circulation under the mode of “medical science + pharmacy”
Mengdie LI ; Rongli SHI ; Kai SHEN ; Guiping WU
China Pharmacy 2023;34(14):1665-1670
OBJECTIVE To provide reference for the regulation of electronic prescription circulation under the mode of “medical science + pharmacy”. METHODS Based on evolutionary game theory, a tripartite evolutionary game model was constructed for related parties of electronic prescription circulation (government agencies, internet hospitals and third-party drug platforms) under the mode of “medical science + pharmacy”. The influential factors of the three parties’ strategy selection were analyzed and verified by simulation. RESULTS & CONCLUSIONS The strategic choices of all parties in the game were affected by the other two parties. Reducing the cost of strict supervision or increasing the punishment for the other two parties would increase the probability of strict supervision of government agencies. Enhancing reputation losses, increasing penalties, and reducing the cost difference when choosing different strategies would have regulatory and binding effects on internet hospitals and third-party drug platforms. It is suggested that government agencies can introduce diversified supervision mode and establish an integrated “intelligent supervision + traceability” system; pay attention to the construction of reputation mechanism, and promote the coordinated linkage of all parties; increase the punishment for violations, provide policy support, reduce the cost of compliance behavior to promote the high-quality development of electronic prescription circulation under the mode of “medical science + pharmacy”.
9.Non-canonical STING-PERK pathway dependent epigenetic regulation of vascular endothelial dysfunction via integrating IRF3 and NF-κB in inflammatory response.
Xuesong LI ; Xiang CHEN ; Longbin ZHENG ; Minghong CHEN ; Yunjia ZHANG ; Ruigong ZHU ; Jiajing CHEN ; Jiaming GU ; Quanwen YIN ; Hong JIANG ; Xuan WU ; Xian JI ; Xin TANG ; Mengdie DONG ; Qingguo LI ; Yuanqing GAO ; Hongshan CHEN
Acta Pharmaceutica Sinica B 2023;13(12):4765-4784
Inflammation-driven endothelial dysfunction is the major initiating factor in atherosclerosis, while the underlying mechanism remains elusive. Here, we report that the non-canonical stimulator of interferon genes (STING)-PKR-like ER kinase (PERK) pathway was significantly activated in both human and mice atherosclerotic arteries. Typically, STING activation leads to the activation of interferon regulatory factor 3 (IRF3) and nuclear factor-kappa B (NF-κB)/p65, thereby facilitating IFN signals and inflammation. In contrast, our study reveals the activated non-canonical STING-PERK pathway increases scaffold protein bromodomain protein 4 (BRD4) expression, which encourages the formation of super-enhancers on the proximal promoter regions of the proinflammatory cytokines, thereby enabling the transactivation of these cytokines by integrating activated IRF3 and NF-κB via a condensation process. Endothelium-specific STING and BRD4 deficiency significantly decreased the plaque area and inflammation. Mechanistically, this pathway is triggered by leaked mitochondrial DNA (mtDNA) via mitochondrial permeability transition pore (mPTP), formed by voltage-dependent anion channel 1 (VDAC1) oligomer interaction with oxidized mtDNA upon cholesterol oxidation stimulation. Especially, compared to macrophages, endothelial STING activation plays a more pronounced role in atherosclerosis. We propose a non-canonical STING-PERK pathway-dependent epigenetic paradigm in atherosclerosis that integrates IRF3, NF-κB and BRD4 in inflammatory responses, which provides emerging therapeutic modalities for vascular endothelial dysfunction.