1.Study on patients’medicine instruction regulatory system in the European Union and the enlightenment
Sihan YUAN ; Rong JIANG ; Yujie ZHENG ; Haiqi LI ; Yixuan CHEN ; Rong SHAO
China Pharmacy 2025;36(3):269-274
OBJECTIVE To provide reference for the establishment and improvement of the regulatory system of patients’ medicine instructions in China. METHODS Through searching the official website of the European Medicines Agency (EMA) and related literature, the definition, basic nature, and content of patients’ medicine instructions in the European Union were introduced, and the characteristics of the management system of patients’ medicine instructions in the European Union were analyzed in terms of the management department, approval and change procedures, readability requirements and information accessibility requirements. At the same time, the pilot situation of patients’ medicine instructions in China, as well as problems in the paths of classification and management, readability of content, and information timeliness were analyzed to put forward suggestions. RESULTS & CONCLUSIONS European Union had a dedicated department for the management of medicine instructions; the approval and change procedures for patients’ medicine instructions were clear, the readability requirements were detailed, the readability verification program with patient participation was established, and multi-channel and timely information disclosure was adopted. It is recommended that China establish a mechanism to categorize and manage professionals’ and patients’ medicine instructions, guide multiple parties to participate in the design of patients’ medicine instructions and refine the readability requirements, and improve the mechanism for disclosure of medicine instructions to enhance the timeliness of medication information.
2.Analysis of xenobiotics in colon and immune tissues of ulcerative colitis mice after administration of Sini San by LC-MS
Yanfang CAO ; Yali WANG ; Anhui WANG ; Yongshun CHEN ; Sihan LI ; Kai FENG ; FENG YANG ; Rui SONG
Journal of China Pharmaceutical University 2025;56(1):73-79
Dysregulation of immune response is currently recognized as one of the important pathological factors in ulcerative colitis (UC). Based on the confirmation that the Sini San (SNS) can significantly improve the colon inflammation induced by dextran sulfate sodium sulfate (DSS) in mice, the present work systematically studied the xenobiotics in the colon and mesenteric lymph nodes, spleen, and thymus of UC mice after administration of SNS by high-performance liquid chromatography-ion trap time-of-flight mass spectrometry (HPLC-IT-TOF-MS). The results showed that, in addition to the colon, some components and their metabolites in SNS could be distributed in immune tissues, and it was found that the quality of relatively low-abundance and weakly responsive components such as saikosaponin a, paeoniflorin, and glycyrrhizic acid had the characteristics of efficient transmission to the colon and lymphoid organs. These components were very likely to be the source of pharmacodynamic substances of SNS. The findings of this study lay a foundation for the study of the efficacy and molecular mechanism of the components against ulcerative colitis, and also provide a scientific basis for the rational clinical application of SNS, which is expected to promote the secondary development of its preparations.
3.International practice and experience insights of electronic drug instructions
Yujie ZHENG ; Rong JIANG ; Yixuan CHEN ; Haiqi LI ; Sihan YUAN ; Rong SHAO
China Pharmacy 2024;35(17):2061-2067
OBJECTIVE To analyze the practices of electronic drug instructions in the European Union (EU), the United States (US) and Japan, so as to provide references for promoting electronic drug instructions under Chinese existing regulatory systems. METHODS By searching the official websites of FDA, European Medicines Agency (EMA) and Pharmaceuticals and Medical Devices Agency (PMDA), as well as relevant literature, the practice and system of electronic drug instructions in different countries/regions were compared and analyzed. The problems of regulatory system, accessibility form and management system of electronic drug instructions in China were analyzed to put forward the suggestions. RESULT && CONCLUSIONS The EU, the US and Japan had established relevant laws for the implementation of electronic drug instructions, issued guidance to specify management requirements and work processes, and set up information platforms to standardize data requirements and enrich search channels. In contrast, the practice of electronic drug instructions in China is still in its infancy, the implementation of electronic drug instructions in China still lacks legislative support, and its accessibility form and future regulatory system need to be further explored. It is suggested to take the opportunity to carry out the pilot reforms of the age-friendly and barrier-free environment for drug instructions in China, improve the regulatory system of electronic drug instructions, promote the readability of drug instructions by exploring the accessibility form of electronic drug instructions in stages, establish and improve the regulatory system of electronic drug instructions, actively build an electronic information platform for it, and promote the development and implementation of electronic drug instructions.
4.Factors influencing patient involvement in decision-making for initial administration of insulin in patients with Type II diabetes:a Meta integration of qualitative study
Jingyuan ZHANG ; Dan YANG ; Yiyi YIN ; Meiqi MENG ; Sihan CHEN ; Yufang HAO
Modern Clinical Nursing 2024;23(8):71-80
Objective To summarise and analyse the qualitative studies on the factors that influence patient involvement in decision-making for the initial administration of insulin for the patients with Type II diabetes,from the perspectives of patients and healthcare staff in order to provide a reference to promote patient involvement in decision-making.Methods Systematic searches were conducted across databases,such as CINAHL,Cochrane Library,EMBASE,PubMed,Web of Science,PsycINFO,China National Knowledge Infrastructure(CNKI),Wanfang Data,VIP,and SinoMed,for qualitative studies on the factors that affect patient involvement in initial insulin decision-making for the patients with Type II diabetes.The search was limited to articles from the inception of the databases to 30th September,2023.Quality of the included studies was assessed using the Joanna Briggs Institute(JBI)evidence-based healthcare centre for qualitative research quality assessment tool.The results were integrated using a synthesising integration method.Results A total of 19 articles were included,yielding 20 study results,which were categorised into 7 themes of patient decision-making related values,patient role preferences in decision-making,condition of patient,the role of healthcare staff in patient participation in decision-making,professional quality of healthcare staff,relationship between patient and healthcare staff,and the support from a medical institution.The data were ultimately integrated into 4 overarching themes of patient personal factors,healthcare staff factors,patient-staff interaction factors and medical institution factors.Conclusion The involvement of the patients with Type II diabetes in the decision-making for the initial administration of insulin is influenced by patients themselves,healthcare staff and medical institutions.It requires efforts of multiple parties:not only with the patients actively participate in decision-making,but also with the healthcare staff and institutions who provide effective decision supports.
5.Different regulatory effects of S100A8/A9 expressed by keratinocytes in three common inflammatory skin injury modes
Mengyao HU ; Min LI ; Sihan CHEN ; Xuecui WEI ; Yujie CHEN ; Song XU ; Xu CHEN
Chinese Journal of Dermatology 2024;57(5):435-444
Objective:To investigate different regulatory effects of S100A8/A9 expressed by keratinocytes in 3 common inflammatory skin injury modes: UVB-induced skin injury, allergic contact dermatitis, and psoriasis.Methods:Wild-type C57BL/6JGpt mice aged 6 to 8 weeks were selected for the following experiments: (1) mouse models of UVB-induced skin injury were established by single exposure to ultraviolet B (UVB) radiation on the shaved dorsal skin of mice (UVB group, n = 4), with the mice receiving no UVB radiation serving as a control group ( n = 4) ; (2) mouse models of allergic contact dermatitis were established by application of 2,4-dinitrochlorobenzene (DNCB) to the right ears of mice (DNCB group, n = 4), with the left ears of mice treated with a vehicle control serving as a control group ( n = 4) ; (3) mouse models of psoriasis-like skin inflammation were established by topical application of imiquimod cream to the depilated dorsal skin of mice (imiquimod group, n = 4), with the mice treated with vaseline serving as a control group ( n = 4). Hematoxylin-eosin (HE) staining was performed to assess histopathological changes in mouse skin tissues obtained from each group, and immunohistochemical study and Western blot analysis were performed to determine the expression of S100A8 and S100A9 in the mouse dorsal epidermis or ear skin lesions. In vitro cultured HaCaT cells were subjected to the following experiments: (1) cells in the UVB group were treated with a single UVB irradiation at a dose of 50 mJ/cm 2, and cells in the control group received no irradiation; (2) some cells were treated with tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) (collectively referred to as TI), and named as the TI group, which simulated the inflammatory environment in allergic contact dermatitis, while cells treated with corresponding solvents served as the control group; (3) cells were treated with 5 cytokines (interleukin 17A [IL-17A], IL-22, IL-1α, oncostatin M, and TNF-α, collectively referred to as M5), and named as the M5 group, which simulated the inflammatory environment in psoriasis, while cells treated with corresponding solvents served as the control group. Real-time fluorescence-based quantitative PCR, Western blot analysis, and enzyme-linked immunosorbent assay were performed to determine the mRNA and protein expression of S100A8 and S100A9, and to detect the extracellular secretion level of S100A8/A9, respectively. Results:Immunohistochemical study and Western blot analysis revealed that S100A8 and S100A9 expression levels were significantly higher in the skin lesions of mouse models of UVB-induced skin injury, allergic contact dermatitis, and psoriasis-like skin inflammation than in their corresponding control groups; immunohistochemical study further demonstrated that the increase in the expression of the two proteins was more pronounced in the mouse models of psoriasis-like skin inflammation. In the in vitro cell experiments, the mRNA expression of S100A8 and S100A9 in HaCaT cells at 12 and 24 hours were markedly higher in the UVB group (e.g., at 24 hours, 6.14 ± 0.60 vs. 1.00 ± 0.08, 2.58 ± 0.06 vs. 1.02 ± 0.22, respectively, both P < 0.01), TI group (e.g., at 24 hours, 3.90 ± 0.75 vs. 1.00 ± 0.02, 2.42 ± 0.30 vs. 1.01 ± 0.13, respectively, both P < 0.05), and M5 group (e.g., at 24 hours, 157.59 ± 9.30 vs. 1.00 ± 0.11, 251.37 ± 6.63 vs. 1.00 ± 0.03, both P < 0.001) than in the corresponding control groups, so were the extracellular secretion levels of S100A8/A9 at 24 and 48 hours (all P < 0.001), with some differences observed in their response patterns; notably, the response was more pronounced in the mouse model of psoriasis-like skin inflammation. Additionally, the protein expression levels of S100A8 and S100A9 in HaCaT cells were significantly higher in the M5 group than in the control group ( t = 4.66, 4.63, respectively, both P < 0.01), but were significantly lower in the UVB group ( t = -3.75, -3.34, P = 0.020, 0.029, respectively) and TI group ( t = -3.30, -4.50, P = 0.030, 0.011, respectively) than in the control groups. Conclusion:Keratinocytes exhibited active responses following 3 common inflammatory skin injuries, with their effector molecules S100A8 and S100A9, as damage-associated molecular patterns, playing crucial roles in UVB-induced skin injury, allergic contact dermatitis, and psoriasis, and the response seemed to be more pronounced in psoriasis-like dermatitis.
6.Construction of triple prerehabilitation protocol for patients undergoing pancreaticoduodenectomy
Sihan WANG ; Jin XIA ; Xiaomei WANG ; Yanfei WU ; Mei WANG ; Yaling WANG ; Xiaoxue CHEN ; Huixia LIU
Chongqing Medicine 2024;53(15):2339-2342,2348
Objective To construct the triple pre-rehabilitation program for the patients undergoing pancreaticoduodenectomy to provide a theoretical basis for the preoperative management of this operation mode.Methods The raft plan was formed by the literature research and group discussion,then the experts were invited to conduct the two rounds of expert consultation,and the final draft of the plan was finally formed.Results The draft plan included the 3 first-level items,9 second-level items and 28 third-level items.The questionnaire recovery rate of the two rounds of expert correspondence was 100%,and the authority coef-ficients were 0.88 and 0.93,respectively.The mean importance and feasibility scores of each item in the two rounds of expert consultation were ≥3.5,and the coefficient of variation was<0.25.The first draft of the final formation plan included the 3 first-level items,9 second-level items and 31 third-level items.Conclusion This program has ne-cessity,scientificity and feasibility.Clarifying the specific contents and scope of preoperative management of this operation mode could provide a theoretical basis for medical staff to carry out pre-rehabilitation.
7.Investigation on the Current Situation and Influencing Factors of Attitudes and Training Needs of Hospice Care among Nursing Staff in Hainan Province
Dandan XU ; Shuang YE ; Sihan CHEN ; Guo’an WANG ; Jiaxiao CHEN ; Xing GAO
Chinese Medical Ethics 2023;36(1):57-63
【Objective:】 To investigate the current situation of attitudes and training needs of hospice care among nursing staff in Hainan Province, and analyze the influencing factors, so as to provide basis for formulating scientific and standardized hospice care training programs for nursing staff. 【Methods:】 From October to December in 2021, a total of 1 819 nursing staff from 45 general hospitals, specialized hospitals and nursing homes in 14 cities and counties of Hainan province were selected by convenience sampling method to conduct the questionnaire on hospice care attitude and training needs. 【Results:】 1 789 valid questionnaires were collected with effective recovery of 98.35%. Nursing staff hospice care attitude score was (88.13±12.10) points, the standard score was 70.4 points, hospice care attitude was at medium level. Nursing staff training needs score was (26.96±5.16) points, the standard score was 89.87, the needs of each dimension and item were higher than 75.1%, the training needs were at high level. Professional title, currently engaged in hospice care services, and willingness to engage in hospice care services were the influencing factors of hospice care training needs (P<0.05), and the hospital, have witnessed the death of dying patients or relatives, willingness to engage in hospice care services were the main influencing factors of nurses’ attitude toward hospice care (P<0.05). 【Conclusion:】 At present, nursing staff in Hainan Province held a moderate attitude towards hospice care, and had a high demand for training. The major obstacles for nursing staff to engage in hospice care at present were high stress in the face of dying patients and symptom management. Nursing managers should combine the current situation, pay attention to stimulate nurses’ intrinsic motivation, strengthen the training of nursing staff’s concept of hospice nursing, construct a diversified training system, and carry out specialized and modular skill practice and theoretical training to improve nursing staff’s hospice care ability.
8.Etiology and risk factors of gastric cancer after Helicobacter pylori eradication in Fuzhou area
Aijin CHEN ; Xiaoxiong GUO ; Sihan ZHANG
Journal of Public Health and Preventive Medicine 2023;34(5):99-102
Objective To analyze the epidemiological characteristics and risk factors of gastric cancer after eradication of ( Helicobacter pylori , Hp) in Fuzhou area, to provide a theoretical basis for reducing the incidence and mortality of gastric cancer after eradication of Hp, and to provide effective suggestions for the prevention of gastric cancer in residents in Fuzhou. Methods A total of 699 patients with Hp eradication admitted to our hospital from January 2020 to December 2020 were selected. According to whether the patients had gastric cancer after eradication, they were divided into control group (no gastric cancer) and observation group (gastric cancer). The serum levels of tumor markers including CEA, CA125 and CA199 were detected and compared between the two groups. Clinical data of the two groups, including age, sex, family history of gastric cancer, course of Hp infection, open atrophy, severe atrophy of gastric mucosa, presence of intestinal metaplasia (IM) of gastric mucosa, xanxoma of gastric mucosa, and long-term use of proton pump inhibitors (PPIs), were analyzed using the self-made survey scale in our hospital. Univariate analysis and logistic regression were used to analyze the risk factors for gastric cancer after Hp eradication. Results Among of 699 patients with Hp eradication, 48 cases (6.96%) developed gastric cancer, including 29 male cases and 19 female cases. The incidence rate of males was significantly higher than that of females (P<0.05). The incidence rate of elderly patients was significantly higher than that of non-elderly patients (P<0.05). Serum CEA, CA125 and CA199 levels in the observation group were significantly higher than those in the control group (P<0.05). There were statistically significant differences in open atrophy, severe atrophy of gastric mucosa, presence of IM, xanxoma of stomach and PPIs use time >3 years between the two groups (P<0.05). The presence of IM (OR=4.874), severe atrophy of gastric mucosa (OR=4.412) and the time using PPIs >3 years (OR=3.631) were independent risk factors for gastric cancer after Hp eradication (P<0.05). Conclusion There is a high risk of gastric cancer after HP eradication in Fuzhou, mainly in elderly male patients, especially in patients with IM, severe atrophy of gastric mucosa and long-term use of PPIs, often accompanied by elevated levels of tumor markers. Close gastroscopy follow-up examination must be conducted within 4 to 5 years after Hp eradication, which is helpful for screening high-risk groups of gastric cancer, preventing gastric cancer and treating gastric cancer as early as possible after Hp eradication.
9.Morphological changes of liver in patients with postoperative intestinal adhesion under artificial pneumoperitoneum CT
Muqing LIU ; Xiaoxia CHEN ; Rongrong HUA ; Sihan DU ; Xucheng HE ; Guisheng WANG
Journal of Practical Radiology 2023;39(12):1967-1970,1979
Objective To investigate the characteristics of liver deformation and changes in abdominal vascular diameter under artificial pneumoperitoneum based on CT images,and also to reveal the impact of intestinal adhesion on these characteristics.Methods A retrospective study was conducted on 61 patients who underwent abdominal CT scan and artificial pneumoperitoneum CT.Eight cases did not meet the inclusion criteria.The sample included 41 patients with postoperative intestinal adhesion(POIA)and 12 patients without POIA.A three-dimensional post-processing software was used to quantify the gas volume,liver volume,liver surface area,and lumen of the abdominal aorta,inferior vena cava,and portal vein on CT images of patients who underwent abdominal CT scan and artificial pneumoperitoneum CT.The measured indices were compared before and after artificial pneumoperitoneum in all patients,and the impact of intestinal adhesion on the aforementioned indices was evaluated.Results At equivalent levels of pneumoperitoneum pressure,no statistically significant difference was observed in the quantity of gas in the abdominal cavity between patients with and without POIA(P=0.753).In the absence of pneumoperitoneum,POIA patients exhibited a significantly higher liver volume than non-adhesion patients(P<0.01).Following the application of artificial pneumoperitoneum pressure,both liver volume and liver surface area were reduced in all patients,with a more pronounced decrease in POIA group(P=0.003,P=0.002).In addition,the reductions in the internal diameters of the inferior vena cava at three locations and the portal vein position 1 were also observed in all patients(P<0.05).Notably,the POIA group exhibited more significant decrease in the internal diameters of inferior vena cava position 1 and the portal vein position 1(P=0.022,P=0.038).No significant differences were observed in the changes of internal diameter of other blood vessels or in the intergroup comparison.Conclusion Artificial pneumoperitoneum can reduce the volum,the surface area of liver,and the inner diameter of some abdominal vessels,which provides a scientific basis for navigation and real-time correction in laparoscopic abdominal surgery for patients,especially for patients with POIA.
10.Effect of graded motor imagery combined with repetitive transcranial magnetic stimulation on upper limb function of stroke patients
Fan JIA ; Ying ZHAO ; Zhao WANG ; Jie CHEN ; Sihan LU ; Ming ZHANG
Chinese Journal of Rehabilitation Theory and Practice 2023;29(5):516-520
ObjectiveTo explore the effects of graded motor imagery (GMI) combined with repetitive transcranial magnetic stimulation (rTMS) on upper limb function and activities of daily living of stroke patients. MethodsFrom June, 2022 to February, 2023, 45 stroke patients from Xuzhou Rehabilitation Hospital and Xuzhou Central Hospital were recruited and divided into control group (n = 15), GMI group (n = 15) and combined group (n = 15) randomly. All the groups received conventional rehabilitation, in addition, GMI group received GMI and the combined group received GMI and rTMS, for four weeks. They were assessed with Fugl-Meyer Assessment-Upper Extremities (FMA-UE), Action Research Arm Test (ARAT), modified Barthel Index (MBI) and Hong Kong version of Functional Test for the Hemiplegic Upper Extremity (FTHUE-HK) before and after treatment. ResultsThe scores of FMA-UE, ARAT and MBI, and grades of FTHUE-HK improved in all the groups after treatment (|t| > 9.681, P < 0.001), and all these indexes were the best in the combined group (F > 13.241, P < 0.001). ConclusionGMI combined with rTMS can further improve the motor function of upper limbs and activities of daily living of stroke patients.


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