1.Comparative analysis on elderly-friendly management of drug instructions in China,the United States and Japan
Siyi WANG ; Xiaoyong YU ; Jiayuan JIANG ; Kan TIAN
China Pharmacy 2025;36(9):1030-1034
OBJECTIVE To compare the measures taken by China, the U.S. and Japan to adapt drug instructions to aging, and provide reference for the reform of elderly-friendly drug instructions in China. METHODS The relevant documents published by the official websites of National Medical Products Administration of China, the U.S. FDA, and Pharmaceuticals and Medical Devices Agency of Japan, were consulted. Additionally, relevant literature from comprehensive databases such as CNKI, Wanfang data, and Web of Science, as well as search engines, was reviewed to understand the measures taken by the above countries in elderly-friendly management process of drug instructions. The comparative analysis was conducted for elderly-friendly adaptations of drug instructions in China, the U.S. and Japan, and the suggestions were put forward for the reform of elderly-friendly drug instructions in China. RESULTS & CONCLUSIONS The measures taken by China, the U. S., and Japan in the process of elderly- friendly management of drug labels had different emphases: China adopted large fonts and simplified drug instructions to alleviate the problem of the elderly being unable to read and understand drug instructions; the U.S. had set up a special section for the elderly in the drug instructions for special populations and issued the principles for writing information on medications for the elderly. The U. S. and Japan had established a classification management system for patient instructions and professional instructions, promoted structured electronic instructions, and built a unified electronic instructions platform. It is recommended that China incorporate elderly-specific medication information into the writing requirements of drug instructions, improve specific measures to encourage the reform of drug instructions suitable for the elderly, improve the accessibility and readability of electronic drug instructions, and build a drug instruction information disclosure platform to better ensure the safety of medication for the elderly.
2.Guidelines on the Technical Plan for Emergency Health Response to Acute Gelsemium Poisoning
Jiaxin JIANG ; Ruibo MENG ; Zhongxiang GAO ; Rongzong LI ; Weifeng RONG ; Weihui LIANG ; Shibiao SU ; Jian HUANG ; Cheng JIN ; LlU XIAOYONG
China Occupational Medicine 2025;52(2):203-206
Acute Gelsemium poisoning is a systemic disease primarily affecting the central nervous system and respiratory symptoms caused by the ingestion of a substantial amount of Gelsemium within a short period. It manifests as sudden onset and rapid progression, primarily caused by accidental ingestion due to misidentification, and posing significant health risks. The compilation of the Technical Plan for Emergency Health Response to Acute Gelsemium Poisoning describes in detail the specialized practice and technical requirements in the process of handling acute Gelsemium poisoning, including accident investigation and management, laboratory testing and identification, in-hospital treatment, and health monitoring. The guidelines clarify key procedures and requirements such as personal protection, investigation elements, etiology determination, medical rescue, and health education. The key to acute Gelsemium poisoning investigation lies in promptly identifying the toxin through exposure history, clinical manifestations, and sample testing. Because there is no specific antidote for Gelsemium poisoning, immediate removal from exposure, rapid elimination of the toxin, and respiratory monitoring are critical on-site rescue measures. Visual identification of food or herbal materials, followed by laboratory testing to determine Gelsemium alkaloids in samples is a rapid effective screening method. These guidelines offer a scientific, objective, and practical framework to support effective emergency responses to acute Gelsemium poisoning incidences.
3.Self monitoring of blood glucose combined with digital diabetes management to improve clinical relevant indicators in type 2 diabetes
Jun YANG ; Qiuwen ZHU ; Ling WANG ; Yanni WU ; Xia QI ; Mengfei JIANG ; Xiaoyong YAN ; Hongyun MIAO
Chongqing Medicine 2024;53(1):79-83,88
Objective To compare the influence between self-monitoring of blood gluocose(SMBG)combined with digital diabetes management and traditional management mode on the related clinical indexes in the patients with type 2 diabetes mellitus(T2DM).Methods A total of 100 patients with T2DM treated in the endocrinology and metabolism outpatient department of this hospital from January 2022 to June 2022 and meeting the inclusion criteria of this study were successively included.They were divided into the experimental group and control group.The experimental group was managed by SMBG combined with digital diabetes man-agement mode,while the control group adopted the traditional management mode,the outpatient clinic follow up once a month.After 6 months of follow-up,fasting blood glucose,glycosylated hemoglobin(HbA1c),low density lipoprotein cholesterol(LDL-C)and urinary microalbumin/creatinine ratio(UACR)were compared between the two groups.Results The FBG,HbA1c,LDL-C,and UACR of the experimental group decreased after intervention when compared with baseline.Compared with the control group,the FBG[8.7(7.7,9.2)mmol/L vs.10.8(8.8,12.7)mmol/L,Z=-4.660,P<0.001],HbA1c[6.3%(5.3,7.8)%vs.8.5%(7.2,10.0)%,Z=-5.130,P<0.001],LDL-C[2.6(1.8,3.1)mmol/L vs.3.3(2.6,4.0)mmol/L,Z=-4.112,P<0.001],UACR[16.1(3.5,46.5)mg/g vs.58.4(11.9,108.0)mg/g,Z=-2.220,P=0.026]for patients in the expriemental group after intervention were significantly decreased.Conclusion SMBG combined with digital diabetes management model can significantly improve the clinical indicators of patients.
4.Assessment of health emergency drill capacity for poisoning incidents at the municipal level in Guangdong Province
Jiaxin JIANG ; Shanyu ZHOU ; Xinyu LIU ; Xiaoyong LIU ; Jian HUANG ; Ming LIU ; Yongshun HUANG ; Xudong LI
China Occupational Medicine 2024;51(1):94-98
ObjectiveTo assess the capacity of health emergency drills for poisoning emergencies at the municipal level in Guangdong Province. Methods A total of 21 municipal teams from cities in Guangdong Province participated in the health emergency drill competition, which included comprehensive tests and practical assessments. Results The pass rate for the total score, comprehensive tests, practical assessments of 21 municipal teams was 66.7%, 33.3%, 66.7%, respectively. The pass rate of the comprehensive tests was lower than that of practical assessments (P<0.01). The pass rate for the total score, comprehensive tests, and practical assessments of team from the Pearl River Delta region was higher than those in non-Pearl River Delta regions (88.9% vs 50.0%, 55.5% vs 16.7%, 88.9% vs 50.0%). For the four comprehensive test items, the highest pass rate was for personal protective principles against chemical poisoning (57.1%). For the five practical assessment items, the highest pass rate was for the selection and matching of personal protective equipment and practice of poisoning detection (both 71.4%). Conclusion It is urgent to improve the capacity of health emergency drills at the municipal level in Guangdong Province. Emphasis should be placed on strengthening capacity building in teams from non-Pearl River Delta regions.
5.Near-infrared Spectroscopic Quality Control on Coating Process of Vitamin C Yinqiao Tablets
Qing TAO ; Li JIANG ; Youbing ZHONG ; Zhengji JIN ; Xiaoyong RAO ; Wei LIU ; Yan HE ; Yongkun GUO ; Xiaojian LUO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):184-190
ObjectiveTo construct a quantitative prediction model of three indicators(moisture absorption rate, film thickness and coating weight gain) during the coating process of Vitamin C Yinqiao tablets(VCYT) by near-infrared spectroscopy(NIRS), and to realize the endpoint judgment. MethodReal-time NIRS data of 4 batches of VCYT during the coating process were collected by diffuse reflection method. The coating method employed was the rolling coating method, and the samples were obtained at the spray stage from the coater's sampling port every 10 minutes, and 57 batches of samples(about 1 800 tablets) were collected at various coating times, the tablets were embedded in molten paraffin, cut longitudinally, and observed by stereomicroscope. The film thickness, with a target value of 38 μm, was then measured using Motic Images Advanced 3.2 software. Furthermore, the mositure absorption rate of samples, aiming for a target value of 3%, was determined in accordance with guiding principles for drug hygroscopicity testing in the 2020 edition of Chinese Pharmacopoeia, and 3 samples were randomly selected from each batch(10 tablets per batch), and the coating weight gain was calculated(target value of 4%). Partial least squares regression(PLSR) was used to construct a quantitative model of the 3 coating indicators, and the predicted values of the coating indicators were smoothed using the moving average method and used to determine the coating endpoints. ResultThe prediction determination coefficients(Rp2) for moisture absorption rate, film thickness and coating weight gain were 0.933 4, 0.932 6 and 0.965 9, the root mean square errors of prediction(RMSEP) were 0.163 5%, 1.870 9 μm and 0.240 3%, the relative percent deviations(RPD) were 3.711 0, 2.760 7 and 5.415 8, respectively. The results of the external validation set demonstrated that the real-time predicted values obtained by the models exhibited the same trend as the measured values, and the coating endpoint could be accurately predicted(with a prediction error of less than 7.32 min and a relative error of less than 5.63%). ConclusionThe established NIRS model exhibits excellent predictive performance and can be used for quality control of VCYT during the coating process.
6.Investigation of a group occupational acute dimethylacetamide poisoning incident
Jian HUANG ; Xiaoyong LIU ; Jintong HE ; Jiaheng HE ; Qifeng WU ; Jiaxin JIANG
China Occupational Medicine 2024;51(4):476-480
Objective To investigate and analyze a group occupational acute dimethylacetamide (DMA) poisoning incident occurred during the post-fire cleaning operation in a spandex manufacturing enterprise. Methods This study focused on the involved enterprise, employing units, poisoning patients, and workers with similar occupational exposure history from a group occupational acute chemical poisoning incident in Guangdong Province in 2023. Occupational health on-site investigation data, clinical records of poisoned patients, and occupational disease diagnostic data were collected to determine the cause of the poisoning. Results The incident occurred at a spandex manufacturing enterprise during the cleaning of polymerization reaction vessels after a fire, resulting in poisoning of six cleaning workers. The clinical symptoms of patients included varying degrees of liver function abnormalities and skin damage. All six patients wore long-tube air-supplied full-face masks during work. The patients were in a confined work space with poor ventilation, and worked more than 8 hours per day. Patients felt unwell after 5-13 days of work. Post-incident investigation revealed that the DMA exposure concentration of short term near the reaction vessels was 36.06 mg/m³. DMA accounted 13.74% to 30.09% of the volatile organic compounds in the raw and auxiliary materials and waste in the vessel. N-methylacetamide was detected in the urine of these six patients, with levels up to 1 639.78 mg/g creatinine, exceeding the occupational exposure limit (20.00 mg/g creatinine). All six patients were diagnosed as occupational acute DMA poisoning. Conclusion Occupational acute DMA poisoning mainly causes liver damage, has a latent onset, and poses a risk of group occurrence. The main causes of group poisoning are confined work space, inadequate management, insufficient protective measures, and excessive working hours.
7.Efficacy of different treatment duration of vonoprazan combined with low-dose amoxicillin in Helicobacter pylori eradication
Yizhou JIANG ; Kai MA ; Cheng CUI ; Xin CAO ; Xiaoyong WANG
Chinese Journal of Digestion 2024;44(6):361-367
Objective:To investigate the efficacy and safety of different treatment duration of dual therapy including vonoprazan and low-dose amoxicillin in Helicobacter pylori ( H. pylori) eradication. Methods:From December 1, 2022 to November 30, 2023, a total of 150 H. pylori-infected patients who underwent primary treatment in the Affiliated Changzhou No.2 People′s Hospital of Nanjing Medical University were recruited. The patients were divided into 10-day treatment group and 14-day treatment group with 75 patients in each group by random number table method. Patients of both groups were treated with vonoprazan (20 mg each time, twice per day) combined with amoxicillin (0.75 g each time, 3 times per day), and the treatment duration was 10 and 14 days, respectively. Intention-to-treat (ITT) and per-protocol (PP) analyses were used to evaluate the eradication efficacy of H. pylori of the 10-day treatment group and 14-day treatment group. PP analysis was used to compare the incidence of adverse events between the 2 groups. Cost-effectiveness analysis was performed to evaluate the economic efficiency of the 2 treatment regimens. Identified factors affecting the eradication rate in the 10-day treatment group based on the PP. Independent sample t-test and chi-square test were used for statistical analysis. Results:In ITT and PP analysis, a total of 75, 75 patients and 70, 72 patients were included in the 10-day treatment group and 14-day treatment group, respectively. The results of ITT analysis showed that the eradication rates of 10-day treatment group and 14-day treatment group were 86.7% (65/75) and 90.7% (68/75), respectively. The results of PP analysis showed that the eradication rates of the 2 groups were 92.9% (65/70) and 94.4% (68/72), respectively, and the differences were not statistically significant (both P>0.05). The results of PP analysis showed that the incidences of adverse events of the 10-day treatment group and 14-day treatment group were 12.9% (9/70) and 9.7% (7/72), respectively, and the difference was not statistically significant( P>0.05). The cost-effectiveness ratios of the 10-day treatment group and 14-day treatment group were 3.29 and 4.19 yuan/%, respectively. The optimal cut-off values were 63.5 kg for body weight and 1.73 m 2 for body surface area to affect the H. pylori eradication rate. The H. pylori eradication rate of patients with body weight ≤ 63.5 kg was higher than that of patients with body weight >63.5 kg (100.0%, 42/42 vs. 82.1%, 23/28), and the H. pylori eradication rate of the patients with body surface area≤1.73 m 2 was higher than that of patients with body surface area>1.73 m 2 (100.0%, 45/45 vs. 80.3%, 20/25), and the differences were statistically significant ( χ2=5.61 and 6.91, P=0.018 and 0.009). Conclusions:The 10-day combination therapy of vonoprazan and low-dose amoxicillin is a safe and effective primary treatment regimen for H. pylori eradication. Body weight and body surface area are influencing factors of the eradication rate.
8.Research on the intelligent management system for equipment and supplies of provincial medical rescue teams for nuclear and radiation accidents
Meixia WANG ; Weixu HUANG ; Xiaoyong LIU ; Jiaxin JIANG ; Diexian ZHONG ; Xu LIANG ; Haijuan XU ; Min LIU
China Occupational Medicine 2023;50(5):591-595
{L-End}Objective To establish the construction of intelligent management system for equipment and supplies of medical rescue teams for provincial nuclear and radiation accidents, based on modern Internet+ Internet of Things. {L-End}Methods The current status and requirements of emergency equipment and supplies allocation and management of medical emergency teams for provincial nuclear and radiation accidents were analyzed. Utilizing technologies such as Internet of Things, low-power Bluetooth, and radio frequency identification, an intelligent management system for medical rescue teams, its equipment and supplies for provincial nuclear and radiation accidents was designed. {L-End}Results The intelligent management system for medical rescue teams, its equipment and supplies for nuclear and radiation accidents was able to perform the inventory warning, expiration date warning, maintenance alert, and warning for emergency personnel health status, based on dynamic management of rescue personnel, equipment and supplies. It provided an effective support for on-site commanders in making emergency decisions. {L-End}Conclusion The use of Internet+Internet of Things technology can achieve intelligent management for medical rescue teams and its equipment and supplies can effectively improve the level of personnel and equipment support for the rescue of nuclear and radiation accidents at the provincial level.
9.Current status and future prospects for the use of tertiary lymphatic structures in the diagnosis and treatment of lung cancer
Shuai JIANG ; Fuzhi YANG ; Xiaoyong SHEN
Chinese Journal of Thoracic and Cardiovascular Surgery 2023;39(11):685-691
Lung cancer is one of the malignant tumors with the highest incidence and mortality rate worldwide and has a poor prognosis. With the popularization of thin layer CT, more and more early lung cancers are being detected. In recent years, thoracoscopic technology and robotic surgery technology have been innovated, and multiple adjuvant therapies such as chemotherapy, targeted therapy and immunotherapy have progressed rapidly, providing lung cancer patients with multiple treatment options. However, the prognosis of lung cancer patients has not been significantly improved, which is related to the overall poor prognosis of lung cancer patients on the one hand, and the urgent need to find effective predictive markers for patients' prognosis, to accurately screen patients, and to carry out targeted treatment in order to improve patients' prognosis on the other hand. In this paper, we review the progress of tertiary lymphoid structures (TLSs) in lung cancer and discuss the prognostic predictive value of TLSs in lung cancer and their feasibility as biomarkers for adjuvant therapy.
10.Enlightenment of Japan expanded access clinical trial system to China’s compassionate drug use system
Qian WANG ; Yu YIN ; Feng JIANG ; Kan TIAN ; Xiaoyong YU ; Haoyu YANG
China Pharmacy 2023;34(9):1038-1041
The system of compassionate drug use in China is in the preliminary exploration stage, and the formal management methods and specific implementation rules have not been promulgated, which needs to be further optimized and perfected. Japan realizes the advanced use of unapproved drugs by expanded access clinical trial system, and makes clear provisions on information acquisition, target patient, informed consent, subject of application, implementation plan, handling of refusal to administer medication, drug expenses, implementation deadline, compensation for accidental damages, post-approval data review after expanded access clinical trials. When the enterprise refuses to give drugs because of the “legitimacy reasons of the system”, the attending physician can also apply to the Ministry of Health, Labor and Welfare, and the Ministry of Health, Labor and Welfare will conduct the licensing evaluation to maximize the drug for patients. This “refusal to administer” reprocessing is a unique regulation in Japan, which ensures the accessibility of drugs to the greatest extent possible. Based on the analysis of the expanded access clinical trial system in Japan, it is found that our country could further build the information platform for compassionate drug use, play the leading role of physicians, protect the interests of enterprises, pay attention to the ethical review, and make drug cost payment problems further clear in order to improve and optimize the system of compassionate drug use.

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