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.Effect of "Internet plus" exercise prescription intervention on upper limb function and quality of life of breast cancer patients at home after surgery
Yang JIANG ; Weiting ZHAO ; Qing CHU ; Ziyu LU ; Yujie GAO ; Wenxia YAN ; Yaoyao JIANG
Chinese Journal of Practical Nursing 2024;40(11):809-816
Objective:To explore the effect of "Internet plus" exercise prescription intervention on upper limb dysfunction and quality of life of breast cancer patients at home after surgery, so as to provide reference for health management of breast cancer patients after surgery.Methods:Adopting a prospective randomized controlled trial research method. From November 2021 to January 2023, 124 breast cancer patients in the breast and thyroid surgery department of Xiang′an Hospital Affiliated to Xiamen University were selected for the study. According to the random number table method, they were randomly divided into an intervention group (62 cases) and a control group (62 cases). The control group patients were given routine training, and the intervention group patients received routine training in the first four weeks after operation, and "Internet plus" exercise prescription intervention in the fifth week after operation. The upper limb dysfunction, quality of life before and after the intervention and motor compliance after the intervention between the two groups were compared.Results:A total of 117 patients were ultimately included, and they were all female, with 58 patients in the intervention group aged (51.01 ± 9.77) years old and 59 patients in the control group aged (51.47 ± 9.85) years old. There was no statistically significant difference in upper limb dysfunction and quality of life between the two groups of patients before intervention ( P>0.05). After the intervention, the degree of upper limb dysfunction in the intervention group was (63.55 ± 7.02) points, which were lower than that in the control group (67.13 ± 7.25) points, and the difference was statistically significant ( t = 2.71, P<0.01). After the intervention, the total score of quality of life and the scores of physiological status, social/family status, emotional status, functional status and additional attention of breast cancer patients in the intervention group were (115.27 ± 17.35), (22.65 ± 4.53), (22.79 ± 4.36), (20.96 ± 3.95), (19.56 ± 4.22), (29.31 ± 5.24) points, which were higher than those in the control group (104.28 ± 17.04), (20.57 ± 4.48), (20.85 ± 4.23), (18.75 ± 4.04), (17.18 ± 4.06), (26.93 ± 5.21) points, the differences were statistically significant ( t values were 2.44-3.46, all P<0.05). In terms of exercise compliance of breast cancer patients in the intervention group, the aerobic exercise completion rate was 91.38% (53/58), muscle strength training completion rate was 77.59% (45/58), stretching exercise completion rate was 86.21% (50/58), exercise frequency was (3.96 ± 1.13) times/week, exercise duration was (29.51 ± 7.64) min/time, which was superior to 77.97% (46/59), 57.63% (34/59), 69.49% (41/59), (3.38 ± 0.94) times/week, (23.96 ± 7.33) min/time in the control group, the differences were statistically significant ( χ2 = 4.04, 5.31, 4.73, t = 3.02, 4.01, all P<0.05). Conclusions:"Internet plus" exercise prescription intervention has the characteristics of convenience, intuition and strong operability, which is conducive to improving the upper limb dysfunction, quality of life and exercise compliance of breast cancer patients at home after surgery. It is recommended to be popularized and applied clinically.
3.Effect of dementia on postoperative complications in older patients with hip fractures
Yu JIANG ; Yan LUO ; Xisheng LIN ; Yilin WANG ; Zefu GAO ; Houchen LYU ; Licheng ZHANG ; Peifu TANG ; Yujie LIU
Chinese Journal of Tissue Engineering Research 2024;28(18):2895-2900
BACKGROUND:The number of hip fracture patients with dementia is increasing with an aging population,posing challenges for surgical treatment. OBJECTIVE:To determine the effect of dementia on postoperative complications in older patients with hip fractures. METHODS:Patients aged over 60 years old with hip fractures from 2000 to 2019 at Chinese PLA General Hospital were included.Dementia patients with a preexisting diagnosis of dementia at admission were identified.Each dementia patient was matched,for age±5 years,gender,and fracture type with 10 non-dementia patients.The differences in postoperative complications were compared between the two groups,including pneumonia,respiratory failure,gastrointestinal bleeding,urinary tract infection,surgical site infection,deep venous thrombosis,pulmonary embolism,angina pectoris,arrhythmia,heart failure,myocardial infarction,stroke,and death.The impact of dementia on major complications was evaluated using multivariate conditional logistic regression. RESULTS AND CONCLUSION:A total of 2 887 patients were included,of whom 125(4.3%)were dementia patients and matched with 1 243 non-dementia patients.The average age of dementia patients was(80.6±7.4)years;64.8%were female;53.6%were intertrochanteric fractures,and 46.4%were femoral neck fractures.Major complications occurred in 25(20.0%)patients with dementia and 123(9.9%)patients without dementia(P<0.01).The risk of major complications was 200.0 per 1 000 persons(95%CI,139.3-278.6)in dementia patients and 99.0 per 1 000 persons(95%CI,83.6-116.9)in non-dementia patients.Multivariate conditional logistic regression showed that a 2-fold risk of major postoperative complications after hip fracture surgery was found in dementia patients than in those without dementia(adjusted OR,2.11;95%CI,1.08-4.10).The results show that dementia is an independent risk factor for postoperative complications in elderly patients with hip fractures.Appropriate preoperative risk assessment and corresponding preventive and therapeutic measures should be given to this vulnerable population to mitigate postoperative complications.
4.Analysis of iodine nutritional status of children aged 8-10 years in Zhejiang Province from 2016 to 2021
Guangming MAO ; Zhe MO ; Simeng GU ; Yuanyang WANG ; Yujie JIANG ; Yahui LI ; Xueqing LI ; Zhijian CHEN ; Xiaofeng WANG ; Xiaoming LOU ; Chenyang LIU
Chinese Journal of Preventive Medicine 2024;58(1):11-17
Objective:To analyze the iodine nutrition status of children aged 8 to 10 years in Zhejiang Province from 2016 to 2021.Methods:A multi-stage stratified sampling method was used to select non-residential children aged 8 to 10 years from 90 counties in Zhejiang Province. A total of 114 103 children were included in the study from 2016 to 2021. Direct titration method and arsenic-cerium catalytic spectrophotometry were used to detect salt iodine content and urinary iodine level, respectively, to evaluate the iodine nutritional status of children. Ultrasound was used to detect thyroid volume and analyze the current prevalence of goiter in school-age children.Results:The age of 114 103 children was (9.04 ± 0.81) years old, with 50.0% of (57 083) boys. The median of iodine content M ( Q1, Q3) in children's household salt was 23.00 (19.80, 25.20) mg/kg, including 17 242 non-iodized salt, 6 173 unqualified iodized salt, and 90 688 qualified iodized salt. The coverage rate of iodized salt was 84.89%, and the coverage rate of qualified iodized salt was 79.48%. The proportion of non-iodized salt increased from 11.85% in 2016 to 16.04% in 2021 ( χ 2trend=111.427, P<0.001). The median of urinary iodine concentration M ( Q1, Q3) in children was 182.50 (121.00, 261.00) μg/L, among which the proportions of iodine deficiency, iodine suitability, iodine over suitability, and iodine excess were 17.25% (19 686 cases), 39.21% (44 745 cases), 26.85% (30 638 cases), and 16.68% (19 034 cases), respectively. The median of urinary iodine concentration in children in inland areas [ M ( Q1, Q3): 190.90 (128.80, 269.00) μg/L] was significantly higher than that in children in coastal areas [ M ( Q1, Q3): 173.00 (113.00, 250.30) μg/L] ( P<0.001). From 2016 to 2021, a total of 39 134 ultrasound examinations were conducted, and 1 229 cases of thyroid enlargement were detected. The goiter rate was 3.14% (95% CI: 2.97%-3.32%). The incidence of goiter in children in coastal areas [3.45% (95% CI: 3.19%-3.72%), 641/18 604] was higher than that in children in inland areas [2.86% (95% CI: 2.64%-3.10%), 588/20 530] ( P=0.001). Conclusion:From 2016 to 2021, the iodine nutrition level of children aged 8-10 years in Zhejiang Province is generally suitable, and the rate of goiter in children meets the limit of iodine deficiency disease elimination standards.
5.Preparation Methods and Evaluation Criteria Analysis of Animal Models for Perimenopausal Syndrome
Tianwei LIANG ; Yasheng DENG ; Hui HUANG ; Na RONG ; Xin LIU ; Yujie WANG ; Jiang LIN
Laboratory Animal and Comparative Medicine 2024;44(1):74-84
Objective To comprehensively analyze the reported preparation methods for animal models of perimenopausal syndrome (PS), to compare the advantages and disadvantages of various preparation elements and detection indexes, so as to provide useful references for the optimization of the relevant animal models as well as the standardization of their application in the efficacy evaluation of new drugs.MethodsIn this paper, literature research methods were applied using "perimenopausal syndrome" as the subject term. The publication period of the literature was limited to January 2016 to February 2023. Relevant literature on the preparation of PS animal models was retrieved from databases such as China National Knowledge Infrastructure, Wanfang database, and PubMed. After screening the experimental literature that met the inclusion and exclusion criteria, detailed information on experimental animal strains, modeling methods, duration of drug administration, positive drugs, detection indexes and other relevant information were collected. After the above information was standardized, the PS animal model database was established using Excel 2010 software. The model preparation elements and evaluation indexes were summarized systematically, and the statistical results were processed and analyzed using Excel 2010 software.Results A total of 247 articles were screened. SD rats (164 times, 65.86%) and Wistar rats (35 times, 14.06%) were often used to prepare PS animal models. Bilateral ovariectomy (139 times, 53.87%) and natural aging (43 times, 16.80%) were chosen as modeling methods. The ages of rats used for modeling ranged from 7 weeks to 18 months, with 3-month-old rats (22 times, 21.78%) being the most common. The detection indexes were comprehensively evaluated from multiple perspectives, including serum biochemistry, vaginal exfoliated cell smear, histomorphology, general observation, behavioral observation, and organ tissue protein immunoblotting. Western medical evaluation indexes were commonly used to test the successful preparation of models, with vaginal exfoliated cell smears being the most frequently used method (125 times, 85.04%). A model was considered successfully prepared when estrous cycle disorder or irregularity was observed. Some literature also determined modeling success by detecting a significant decrease in serum estradiol levels (5 times, 3.04%). Traditional Chinese medicine (TCM) syndrome evaluation often used a combination of Chinese and Western medical evaluation indexes for comprehensive evaluation, with researchers determining the TCM syndrome through vaginal exfoliated cell smears supplemented by general observation (3 times, 2.04%).Conclusion There are many methods for preparing PS animal models, but there are still significant differences in the selection of animal species, age, criteria for successful modeling, and TCM syndrome evaluation in the related literature.
6.Prospective association study of sleep status and risk of coronary heart disease in adults in Suzhou
Jiang HUA ; Xikang FAN ; Jian SU ; Lulu CHEN ; Yan LU ; Yujie HUA ; Hongfu REN ; Pei PEI ; Dianjianyi SUN ; Canqing YU ; Jun LYU ; Jinyi ZHOU ; Ran TAO
Chinese Journal of Epidemiology 2024;45(7):914-922
Objective:To investigate the association between sleep status and the risk for coronary heart disease in adults in Suzhou.Methods:Using the baseline and follow up information of 53 269 local residents aged 30-79 years in China Kadoorie Biobank conducted in Wuzhong District, Suzhou, 51 929 subjects were included in this study after excluding those reporting coronary heart disease, stroke and cancer at the baseline survey. A Cox proportional hazards regression model was used to analyze the association of healthy sleep score (0-3 points) and sleep factors (snoring, insomnia, long sleep duration and nap) with the risk for coronary heart disease.Results:The median follow-up time was 11.12 years, and 1 304 individuals were diagnosed with coronary heart disease during the follow-up. After adjusting for potential confounders, occasional snoring ( HR=1.20, 95% CI: 1.04-1.38), usual snoring ( HR=1.17, 95% CI: 1.02-1.33), insomnia disorder ( HR=1.41, 95% CI: 1.12-1.78), daytime dysfunction ( HR=1.56, 95% CI: 1.20-2.03) and perennial nap ( HR=1.37, 95% CI: 1.19-1.59) were associated with increased risk of coronary heart disease. Compared with those with sleep score of 0 - 1 (low sleep quality), the people with sleep score of 3 had reduced risk of coronary heart disease by 26% ( HR=0.74, 95% CI: 0.63-0.87). Stratified analysis showed that the association of healthy sleep score 3 with risk of coronary heart disease was stronger in low physically active individuals (interaction P<0.05). Conclusions:Snoring, insomnia disorders, daytime dysfunction, and perennial napping were all associated with increased risk for coronary heart disease, and keep healthy sleep mode might reduce the risk for coronary heart disease in adults.
7.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.
8.Research progress in application of sleep scale in the assessment and diagnosis of sleep disorders
Yujie XIANG ; Beier JIANG ; Ruoxi WANG ; Chunli BAN ; Ying HE
Military Medical Sciences 2024;48(9):695-700
Sleep disorders are characterized by difficulty falling asleep or maintaining sleep,excessive sleepiness,abnormalities of respiration during sleep,disturbances of the sleep-wake cycle and abnormal movements that disturb sleep.The incidence is increasing year by year,which causes a wide range of mental diseases and metabolic disorders,and impacts the health of soldiers.Sleep scales,regarded as one of the main methods for screening and diagnosing sleep disorders,are currently in the spotlight.This review describes the characteristics of different sleep scales in the hopes of providing data for proper selection of sleep scales in the assessments and diagnosis of different sleep disorders,and improving the sleep quality of soldiers.
9.A pilot study on clinical application of three-dimensional morphological completion of lesioned mandibles assisted by generative adversarial networks
Ye LIANG ; Qian WANG ; Yiyi ZHANG ; Jingjing HUAN ; Jie CHEN ; Huixin WANG ; Zhuo QIU ; Peixuan LIU ; Wenjie REN ; Yujie MA ; Canhua JIANG ; Jiada LI
Chinese Journal of Stomatology 2024;59(12):1213-1220
Objective:To explore the clinical application pathway of the CT generative adversarial networks (CTGANs) algorithm in mandibular reconstruction surgery, aiming to provide a valuable reference for this procedure.Methods:A clinical exploratory study was conducted, 27 patients who visited the Department of Oral and Maxillofacial Surgery, Xiangya Hospital of Central South University between January 2022 and January 2024 and required mandibular reconstruction were selected. The cohort included 16 males and 11 females, with the age of (46.6±11.5) years; among them, 7 cases involved mandibular defects crossing the midline. The CTGANs generator produced 100 images, and the mean squared error (MSE) was calculated for differences between any two generated images. Preoperative cone-beam CT data from 5 patients were used to construct a labeled test database, divided into groups: normal maxilla, normal mandible, diseased mandible, and noise (each group containing 70 cross-sectional images). The CTGANs discriminator was used to evaluate the loss values for each group, and one-way ANOVA and intergroup comparisons were performed. Using the self-developed KuYe multioutcome-option-network generation system (KMG) software, the three-dimensional (3D) completion area of the mandible under cone-beam CT was defined for the 27 patients. The CTGANs algorithm was applied to obtain a reference model for the mandible. Virtual surgery was then performed, utilizing the fibular segment to reconstruct the mandible and design the surgical expectation model. The second-generation combined bone-cutting and prebent reconstruction plate positioning method was used to design and 3D print surgical guides, which were subsequently applied in mandibular reconstruction surgery for the 27 patients. Postoperative cone-beam CT was used to compare the morphology of the reconstructed mandible with the surgical expectation model and the mandibular reference model to assess the three-dimensional deviation.Results:The MSE for the CTGANs generator was 2 411.9±833.6 (95% CI: 2 388.7-2 435.1). No significant difference in loss values was found between the normal mandible and diseased mandible groups ( P>0.05), while both groups demonstrated significantly lower loss values than the maxilla and noise groups ( P<0.001). All 27 patients successfully obtained mandibular reference models and surgical expectation models. In total, 14 162 negative deviation points and 15 346 positive deviation points were observed when comparing the reconstructed mandible morphology with the surgical expectation model, with mean deviations of -1.32 mm (95% CI:-1.33- -1.31 mm) and 1.90 mm (95% CI: 1.04-1.06 mm), respectively. Conclusions:The CTGANs algorithm is capable of generating diverse mandibular reference models that reflect the natural anatomical characteristics of the mandible and closely match individual patient morphology, thereby facilitating the design of surgical expectation models. This method shows promise for application in patients with mandibular defects crossing the midline.
10.In vitro experimental study on relationship between bone texture parameters in sheep lumbar CT and osteoporosis
Yujie GAO ; Wei ZHANG ; Xiaotong JIANG ; Xu SI ; Yuqi LI
Chongqing Medicine 2024;53(14):2085-2091
Objective To establish the sheep model of lumbar spine osteoporosis in vitro,and to search the texture parameters with identification significance and establish its regression formula relation with DXA measured bone mineral density,bone ash density and bone ash degree.Methods The L1-L3 trigeminy verte-bral body in 120 sheep conducted the immersion and decalcification by EDTA-Na2 solution (0.4916 mmol/L) immersion method,the muscles and attachment bone were removed.Then they were randomly divided into 4 groups (group A,B,C and D),30 cases in each group.They were immersed in 10% formaldehyde solution for anticorrosion.The group A,B,C and D were immersed in the prepared EDTA-Na2 solution for decalcification 0,4,9,15 d to prepare the in vitro osteoporosis models.Thin-slice CT scan and DXA bone density measure-ment on the above-mentioned lumbar vertebrae were performed,and the volume and dry weight of each verte-bral body were measured,and then calcined at a constant temperature of 1100 ℃ in a muffle furnace for 6 h to measure the weight of ashes.The bone ash weight,bone ash density and bone ash degree were measured.The MaZda texture analysis software was used to conduct the texture analysis on the cancellous substance of the vertebral body in the above CT images,and the texture features were screened by the Fisher coefficient,classi-fication error probability combined with average correlation coefficient,interactive information and the three combined method.The 4 groups of bone mineral density conducted the classification analysis by the original data analysis (ODA),principal component analysis (PCA),linear discriminant analysis (LDA) and nonlinear discriminant analysis (NDA).The correlation analysis between the texture parameters screened by the above method with the bone density,bone grey degree and bone ash density for searching the texture parameters with strongest correlation.The texture parameters with strongest correlation served as the independent varia-bles,the bone density,bone grey degree and bone ash density as the dependent variables,and the unitary and binary linear regression analyses were performed for obtaining the regression equation.Results With the pro-longation of decalcification time,the CT images showed that the bone cortex gradually thinned,the cancellous bone density was decreased,and the trabecular bone became sparse.The identification ability of FPM com-bined with NDA was strongest,and the false judgment rate was only 2.5%.Among them,the contrast in the gray symbiosis matrix had strongly negative correlation with the bone gray degree (r=-0.938).The entropy in the gray co-occurrence matrix had strongly negative correlation with the bone ash density and bone mineral density (r=-0.927,-0.896).The unitary linear regression equation was expressed as bone grey degree=0.692-0.002×Contrast,bone ash density=0.802-0.121×Entropy,bone density=1.301-0.200×Entro-py.Conclusion The significant correlation exists between some texture parameters and bone mineral density related parameters in thin slice CT images of sheep lumbar spine,which could establish a regression formula relationship.

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