1.Safety evaluation of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma
Hao ZHONG ; Hang LIN ; Yaxin LU ; Haiyan MAI
China Pharmacy 2025;36(4):482-485
OBJECTIVE To assess the safety profile of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma. METHODS The data of patients with cholangiocarcinoma from January 1st, 2021 to December 31st, 2022 were collected and divided into control group (29 cases) and observation group (18 cases) based on different medication regimens. Patients in the control group were treated with Gemcitabine hydrochloride for injection+Cisplatin for injection or Oxaliplatin for injection, the observation group was treated with Sintilimab injection based on the control group. Patients in each group underwent blood routine, liver and kidney function, biochemical and other examinations before and after each treatment cycle to observe the occurrence of adverse drug reactions. The correlation of adverse drug reactions with drugs was evaluated with Naranjo’s scale. RESULTS The correlation between blood toxicity and drug use was deemed “probable” in both groups; however, the observation group exhibited a significantly higher score, indicating a stronger correlation. In the control group, hepatotoxic reactions were classified as “suspicious” whereas in the observation group, they were categorized as “probable”. The correlation of gastrointestinal symptoms between the two groups was considered “possible”. Systemic symptoms, skin toxicity, musculoskeletal toxicity, endocrine toxicity and renal toxicity were all classified as having a “suspicious” correlation with drug use. The total incidence of blood toxicity in the observation group was significantly higher than control group (P=0.014). There was no statistically significant difference in the total incidences of hepatotoxic, gastrointestinal symptoms, systemic symptoms, skin toxicity, musculoskeletal toxicity, endocrine toxicity, renal toxicity, or the incidence of grade 3 or higher blood toxicity, hepatotoxic between the two groups (P>0.05). For the patients experiencing adverse drug reactions, the symptoms were alleviated following drug discontinuation or symptomatic supportive treatment. No fatalities occurred during the treatment period. CONCLUSIONS Sintilimab combined with chemotherapy may significantly increase the risk of blood toxicity in patients with cholangiocarcinoma, especially thrombocytopenia, but the adverse reactions are within a controllable range, and the overall safety is good.
2.Retrospective analysis of adverse events associated with traditional Chinese medicine formula granules and decoction pieces in hospitalized patients using the global trigger tool
Yaxiong LI ; Fusang WANG ; Mei ZHANG ; Jiawei LIN ; Wenge CHEN ; Min HUANG ; Junyan WU
China Pharmacy 2025;36(5):606-611
OBJECTIVE To provide technical support for improving recognition rate of adverse drug events (ADEs) related to traditional Chinese medicine (TCM) formula granules and decoction pieces among inpatient patients. METHODS By referencing the global trigger tool (GTT) whitepaper, literature on adverse reactions to TCM, and expert review opinions, ADE trigger items for TCM formula granules and decoction pieces used in the inpatients were established. GTT was applied to analyze ADEs in inpatients who had used TCM formula granules and decoction pieces in our hospital from August 2013 to August 2023, utilizing the Chinese Hospital Pharmacovigilance System. The effectiveness of GTT and the characteristics of these ADEs were analyzed. RESULTS A total of forty-eight triggers were established, including thirty-two laboratory test indexes, thirteen clinical symptoms, and three antidotes. Among the 1 682 patients included, GTT identified 652 potential ADEs, 284 true positive ADEs,with a trigger rate of 38.76% and a positive predictive value of 43.56%. After review by the auditor, 278 cases of ADEs were finally confirmed, with an incidence rate of 16.53%, significantly higher than the number of spontaneously reported ADEs during the same period (0). The 278 cases of ADEs were mostly grade 1 (223 cases), mainly involving hepatobiliary system, gastrointestinal system, blood- lymphatic system, etc;a total of 219 types of TCMs are involved,and the top five suspected TCMs used at a frequency higher than 1% were Poria cocos, Codonopsis pilosula, Atractylodes macrocephala, fried Glycyrrhiza uralensis, and Scutellaria baicalensis. CONCLUSIONS The established GTT can improve the recognition rate of ADEs for hospitalized patients using traditional Chinese medicine formula granules and decoction pieces.
3.Clinical characteristics analysis of 263 deceased organ donors
Benhua JIANG ; Ying LIN ; Leibo XU ; Juejing LI ; Xiaohong QIU
Organ Transplantation 2025;16(2):288-294
Objective To explore the clinical characteristics of organ donors in the intensive care unit (ICU), analyze the impact of comprehensive ICU treatment on organ function maintenance and donation efficiency, and provide data support for optimizing organ donation management strategies. Methods A retrospective analysis was conducted on the data of 263 donors who underwent organ donation after ineffective active treatment in the ICU of Sun Yat-sen Memorial Hospital of Sun Yat-sen University from January 2020 to January 2024. The clinical characteristics, main therapeutic measures in the ICU, and organ donation situations were analyzed. Results The 263 organ donors had an out-of-hospital hospitalization duration of 2 (1, 5) days and an in-hospital hospitalization duration of 4 (3, 6) d. The acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score at admission was (21±5). Among them, 16.7% had a history of cardiopulmonary resuscitation, 30.4% had a history of hypertension, and 48.7% had a history of cranial surgery. The duration of enteral nutrition provided in the ICU was 18 (8, 32) h, with daily energy provision of 160 (0, 320) kcal, parenteral nutrition provided non-protein energy of 877 (710, 1 058) kcal daily. Fiberoptic bronchoscopy was performed 0.25 (0, 0.50) times a day. Continuous renal replacement therapy (CRRT) was performed in 90.1% of the cases, with an average daily duration of 10 (6, 16) h. The daily dosage of human albumin was 40 (30, 50) g, and the daily dosage of methylprednisolone was 120 (80, 160) mg. The most commonly used empirical anti-infection regimens included cefoperazone-sulbactam in 59 cases (22.4%), meropenem combined with vancomycin in 31 cases (11.8%), and piperacillin-tazobactam in 29 cases (11.0%). The most commonly used goal-directed anti-infection adjustment regimen was meropenem combined with vancomycin in 21 cases (8.0%). After comprehensive treatment in the ICU, cardiac function, some liver functions, some coagulation functions, renal function, electrolytes, and infection indicators improved. A total of 981 organs were donated by the 263 organ donors, with 23 organs discarded. The average organ yield rate was 3.64, and the organ utilization rate was 97.7%. Conclusions Comprehensive ICU treatment may significantly improve the cardiac function, some liver functions, coagulation functions, and infection indicators of organ donors, enhance the effect of organ function maintenance, and provide an effective guarantee for optimizing organ donation management in the ICU and improving organ utilization rates.
4.Association between ambient ozone exposure during pregnancy and risk of preterm birth in Guangdong Province
Peng HU ; Shanshan RAN ; Qingmei LIN ; Yin YANG ; Zilong ZHANG ; Xiaoling GUO ; Yonggui GAO ; Jinde ZHAO ; Hualiang LIN
Journal of Environmental and Occupational Medicine 2025;42(4):379-384
Background Air pollution exposure has a significant impact on maternal and child health. However, the research on the association between ambient ozone (O3) exposure during pregnancy and the risk of premature birth in newborns is limited, and the conclusions are inconsistent. Objective To investigate the association of ambient O3 exposure during pregnancy with the risk of preterm birth in Guangdong Province. Methods Data of pregnant women in Guangzhou from 2013 to 2019 and Foshan from 2018 to 2023 were collected, and O3 concentrations during different trimesters were assessed according to maternal residential addresses. Bilinear interpolation was used to evaluate the concentrations of air pollution. A cohort study design was adopted in our study. Restricted cubic spline curves were used to evaluate the exposure-response relationship between O3 exposure and preterm birth risk and explore potential exposure threshold of O3. Logistic regression models were used to evaluate the association of O3 exposure with preterm birth. Results A total of 702 924 pregnant women were included in this study, of whom 43 051 (6.12%) were preterm. The average O3 exposure concentrations of pregnant women during the first, second, third, and whole trimesters were 95.51, 97.51, 100.60, and 97.87 μg·m−3, respectively. We observed J-shaped associations between O3 exposure and preterm birth risk during the second, third, and whole trimesters of pregnancy using restricted cubic spline curves. This study found that there were threshold concentrations between O3 exposure and preterm birth risk during different gestational periods, and the threshold concentrations in the first, second, third, and whole trimesters were 112.32, 99.83, 111.74, and 112.46 μg·m−3, respectively. During the second, third, and whole trimesters of pregnancy, after adjusting for maternal age, baby sex, pre-pregnancy body mass index, mode of delivery, baby birth weight, gestational diabetes, and gestational hypertension, the odds ratios (OR) of preterm birth were 1.02 (95%CI: 1.01, 1.04), 1.02 (95%CI: 1.00, 1.03), and 1.17 (95%CI: 1.13, 1.21) for each 10 μg·m−3 increase in O3 concentration above the O3 threshold. No significant association was found between O3 exposure and the risk of preterm birth during the first trimester. Conclusion There is a nonlinear association between the risk of preterm birth and O3 exposure during pregnancy, and higher concentrations of O3 exposure during pregnancy are associated with the risk of preterm birth. Above the O3 threshold concentration during pregnancy, especially during the second, third, and whole trimesters, the risk of preterm birth elevates with the increase of O3 exposure concentrations.
5.Introduction and enlightenment of the Recommendations and Expert Consensus for Plasm a and Platelet Transfusion Practice in Critically ill Children: from the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB)
Lu LU ; Jiaohui ZENG ; Hao TANG ; Lan GU ; Junhua ZHANG ; Zhi LIN ; Dan WANG ; Mingyi ZHAO ; Minghua YANG ; Rong HUANG ; Rong GUI
Chinese Journal of Blood Transfusion 2025;38(4):585-594
To guide transfusion practice in critically ill children who often need plasma and platelet transfusions, the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB) developed Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children. This guideline addresses 53 recommendations related to plasma and platelet transfusion in critically ill children with 8 kinds of diseases, laboratory testing, selection/treatment of plasma and platelet components, and research priorities. This paper introduces the specific methods and results of the recommendation formation of the guideline.
6.Single-center experience in the diagnosis and treatment of gastrointestinal bleeding after renal transplantation
Organ Transplantation 2025;16(3):467-473
Objective To analyze the clinical characteristics of patients with gastrointestinal bleeding after renal transplantation and summarize the diagnostic and therapeutic experience. Methods Clinical data of 16 patients with gastrointestinal bleeding after renal transplantation admitted to the Third Affiliated Hospital of Sun Yat-sen University from January 2015 to January 2025 were collected, including clinical manifestations, laboratory tests and auxiliary examination results such as gastroscopy and colonoscopy. The bleeding sites, causes, treatment plans and outcomes of the patients were analyzed, and relevant literature was reviewed. Results Among the 16 patients with gastrointestinal bleeding, 12 had upper gastrointestinal bleeding (3 with esophageal bleeding, 7 with gastric bleeding and 2 with duodenal bleeding) and 4 had lower gastrointestinal bleeding (2 with ileal bleeding and 2 with anal bleeding). Among the 16 patients, the 4 with lower gastrointestinal bleeding all presented with hematochezia. Of the 12 with upper gastrointestinal bleeding, 2 patients only had positive fecal occult blood and decreased hemoglobin levels without hematemesis or melena, 9 patients had melena and 1 patient had hematemesis. The hemoglobin levels of the 16 patients were (71±18) g/L. One patient had symptoms of shock, 9 had symptoms of anemia such as dizziness, fatigue and chest tightness, and 6 had good general conditions. Among the 16 patients, 10 had mild gastrointestinal bleeding and stable general conditions, which were curable by drugs. Two patients with peptic ulcers and exposed vessels on gastroscopy were treated with hemostasis by titanium clips. One patient with gastroesophageal tear was treated with hemostasis by titanium clips. One patient with esophageal variceal rupture bleeding was treated with endoscopic variceal ligation. One patient with hemorrhoidal bleeding underwent selective annual resection of the superior hemorrhoidal mucosa with stapled hemorrhoidopexy. One patient with active ileal bleeding on emergency enhanced abdominal CT was treated with endovascular embolization of the mesenteric artery. One patient was discharged automatically due to coma caused by extensive cerebral infarction, and the remaining patients were all cured and discharged with good prognosis. Conclusions Gastrointestinal bleeding after renal transplantation has diverse clinical manifestations, varying severity and many causes. Early diagnosis and treatment should be actively carried out. In addition to drug therapy, endoscopic, interventional or surgical treatment may be used when necessary to improve the diagnostic and therapeutic effects and minimize the functional damage of gastrointestinal bleeding to the transplant kidney.
7.Research hotspots in nutrition for patients with head and neck cancer from 2014 to 2024
WANG Shuai ; LIU Manfeng ; AN Na ; WANG Dikan ; HUANG Qiuyu ; LIN Zhumei
Journal of Prevention and Treatment for Stomatological Diseases 2025;33(6):509-518
Objective:
To understand the current status, international cooperation, research hotspots, and development trends of nutritional studies on patients with head and neck cancer from 2014 to 2024, and to predict future research trends.
Methods:
The Web of Science Core Collection database was searched to retrieve nutritional studies on patients with head and neck cancer from January 2014 to March 2024. The type of studies were “articles,” the language was English, CiteSpace 6.1 R6 software was used to conduct the bibliometric analysis, and the results were visualized to form a scientific knowledge map.
Results:
A total of 1 528 documents were retrieved, with a linear increase in the number of annual publications. The country with the highest number of publications was the United States, and the institution with the highest number of publications was the University of Queensland, with closer collaboration between authors and institutions. The most frequently cited publication was a set of nutrition guidelines, and the highest-impact articles were mainly concerned with performing percutaneous endoscopic gastrostomy. Keyword analysis showed that quality of life, radiotherapy, and weight loss were the keywords of highest interest. The keyword cluster analysis resulted in 17 clusters, which were divided into five main categories: head and neck cancer, treatment, outcome results, intervention modalities, and rehabilitation. Body composition, enteral nutrition, and accelerated postoperative rehabilitation were persistent research hotspots. Keyword highlighting revealed that “enhanced recovery after surgery” has been the focus of research in the last two years, with “index” and “model” emerging as theme words.
Conclusion
The number of publications in the literature related to nutrition for patients with head and neck cancer has increased annually over the past 10 years. The research hotspots mainly focus on the quality of life and weight loss during radiotherapy, the content and application prospect of body composition assessment, different modes of nutritional support interventions and enteral nutritional tube feeding routes, and perioperative nutritional management in enhanced recovery after surgery. The potential clinical value of preoperative nutritional intervention under the concept of enhanced recovery and the construction of new types of nutritional index are the trends of future research.
8.Analysis of the comparison results of dental CBCT phantoms in radiological health technical service institutions in Guangdong Province, China
Xuan LONG ; Hongwei YU ; Zhan TAN ; Lei CAO ; Weixu HUANG ; Huifeng CHEN ; Aihua LIN
Chinese Journal of Radiological Health 2025;34(2):219-224
Objective To understand the situation of dental cone beam computed tomography (CBCT) quality control testing phantoms in radiation health technical service institutions in Guangdong province, analyze the differences among different phantoms, and provide a reference for dental CBCT quality control testing. Methods The testing phantoms of 49 radiation health technical service institutions were used as the research objects. The designated CBCT equipment was used for scanning and imaging. The Z-score method was used to evaluate the high-contrast resolution, low-contrast resolution, and distance measurement deviation of each phantom. Results The satisfaction rates of various items for the phantoms in 49 institutions ranged from 85.7% to 100%. The distance measurement deviations of four institutions were “suspicious”, and the high-contrast resolution of four institutions and the distance measurement deviation of one institution were “unsatisfactory”. Conclusion The overall performance of dental CBCT quality control testing phantoms in radiological health technical service institutions in Guangdong province is satisfactory. However, there are still some phantoms with poor results in items such as distance measurement deviation and high-contrast resolution. The structural design, material selection, and manufacturing process of the phantom may all affect the results of quality control testing. Therefore, appropriate phantoms, optimized exposure conditions, and suitable reconstruction algorithms should be used in CBCT quality control testing to ensure accurate and reliable measurements.
9.Association between negative life events and smartphone addiction among middle school students
Chinese Journal of School Health 2025;46(5):619-623
Objective:
To explore the association between negative life events and smartphone addiction among middle school students, so as to provide theoretical support and practical guidance for prevention and intervention of smartphone addiction among middle school students.
Methods:
Using cluster sampling, 8 890 students were selected to survey from 27 junior high schools and 3 senior high schools in a district of Shenzhen in 2022 (baseline) and 2023 (followup). Data were collected through selfresigned questionnaires on basic information, the Smartphone Addiction Scale-Short Version, and the Adolescent Selfrating Life Events Checklist. Mixedeffects models were employed to analyze the association.
Results:
Compared to 2022, the punishment scores of middle school students in 2023 [1.00 (0.00, 6.00) and 1.00 (0.00, 6.00)] decreased (Z=4.27), while the scores of interpersonal stress, learning stress and adaptation [4.00(0.00, 8.00), 4.00(0.00, 8.00); 4.00(1.00, 8.00), 5.00(2.00, 9.00); 2.00 (0.00, 6.00), 3.00 (0.00, 7.00)] increased (Z=-3.04, -8.36, -6.80) (P<0.01). Mixedeffects models revealed a positive doseresponse relationship between negative life events and smartphone addiction (OR=1.08-1.17, P<0.01). Stepwise regression showed independent positive effects of interpersonal stress (OR=1.05), academic stress (OR=1.03), and adaptation stress (OR=1.11) on smartphone addiction (P<0.01). Subgroup analysis of nonaddicted students in 2022 confirmed persistent associations for academic stress (OR=1.03) and adaptation (OR=1.07) (P<0.01).
Conclusion
Negative life events exhibit a positive doseresponse relationship with smartphone addiction, particularly interpersonal stress, academic stress, and adaptationrelated events.
10.Longitudinal association between only-child status and smartphone addiction in middle school students
Chinese Journal of School Health 2025;46(5):630-633
Objective:
To explore the longitudinal association between only-child status and smartphone addiction among middle school students, so as to provide a basis for establishing family intervention measures for smartphone addiction in middle school students.
Methods:
In October 2022 and October 2023, a preliminary survey and follow-up were conducted among 8 759 middle and high school students from 30 schools in a district of Shenzhen. A self-designed questionnaire was used to determine whether the students were the only-child, and the Chinese Version of the Smartphone Addiction Scale-Short Version (C-SAS-SV) was utilized to assess the students smartphone addiction status. A multilevel mixed-effects model and subgroup analysis were applied to examine the association between only-child status and smartphone addiction among middle school students.
Results:
During 2022 to 2023, the prevalence of smartphone addiction in the cohort of middle school students increased from 24.1% to 25.2%. Compared with only-child, non-only child were more likely to be addicted to smartphones (adjusted model: OR =1.2, 95% CI =1.1-1.4) and also scored higher on smartphone addiction (adjusted model: β =0.9, 95% CI =0.2-1.5)( P <0.05). Subgroup analysis further revealed that compared to baseline, non-only child demonstrated an increased prevalence of smartphone addiction (adjusted model: OR = 1.2 , 95% CI =1.0-1.5) and higher addiction scores (adjusted model: β =0.8, 95% CI =0.2-1.5) after one year( P <0.05).
Conclusions
Non-only child face higher risk of smartphone addiction. Under the current population policy, it is crucial to address smartphone addiction among middle school students who is not only child.


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