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.Diagnostic Criteria of Spleen and Kidney Deficiency Syndrome in Ischemic Stroke Patients
Wenyue DONG ; Xiangzhe LIU ; Xinzhi WANG ; Yongkun LU ; Haiyan YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):134-141
ObjectiveTo establish preliminary diagnostic criteria for spleen and kidney deficiency syndrome in ischemic stroke patients and provide a basis for standardized diagnosis and treatment of ischemic stroke. MethodsRelevant literature on the diagnostic criteria for spleen and kidney deficiency syndrome in ischemic stroke patients was retrieved, and data were mined and extracted to form an item pool. Based on the formation of the item pool, this study used the Delphi method to initiate two rounds of questionnaire surveys with selected experts to complete the initial screening of items and the discrimination of symptom importance. A prospective clinical investigation method was adopted to collect clinical information from patients, and statistical analysis methods and data mining techniques were comprehensively used to determine their primary and secondary symptoms. Based on the clear main and secondary symptoms identified, combined with expert group discussions, the study established preliminary diagnostic criteria for spleen and kidney deficiency syndrome in ischemic stroke patients. ResultsA total of 25 relevant syndrome differentiation standards were included. After splitting, standardizing, and screening the items, the study established a pool of 48 items. The first round of questionnaire survey consulted 30 experts, with both the positive coefficient of experts and the effectiveness rate of the questionnaire reaching 100%. The Kendall's coefficient of concordance was 0.359. According to the item screening criteria, 26 items were retained in this round of questionnaire survey. A total of 176 cases were collected through clinical information investigation, including 94 cases with spleen and kidney deficiency syndrome and 82 cases without spleen and kidney deficiency syndrome. The statistical results were as follows: ① Descriptive statistics: The main symptoms with a frequency of ≥ 30% included mental fatigue and lack of strength, weakness of the lower back and knees, etc. The secondary symptoms with a frequency of ≥ 10% and ≤ 30% were lassitude and disinclination to talk, shortness of breath, etc. ② Binary logistic regression analysis: The main symptoms with an odds ratio (OR) value of ≥ 3 were mental fatigue and lack of strength, weakness of the lower back and knees, etc. The secondary symptoms with an OR value of ≥ 1 and ≤ 3 were lassitude and disinclination to talk, shortness of breath, etc. Artificial neural network: The main symptoms with a weight value(Wij)of ≥ 0.5 and < 1 were mental fatigue and lack of strength, lassitude and disinclination to talk, etc. The secondary symptoms with Wij of ≥ 0.3 and < 0.5 were shortness of breath, flaccid limbs, etc. In the second round of questionnaire survey, a total of 37 experts were consulted, with both the positive coefficient of experts and the effectiveness rate of the questionnaire reaching 100%. The Kendall's coefficient of concordance was 0.237. According to the criteria to determine primary and secondary symptoms based on the Delphi method, the main symptoms included in this round of the questionnaire were mental fatigue and lack of strength, lassitude and disinclination to talk, etc., and the secondary symptoms were shortness of breath, dizziness, etc. ConclusionThe main symptoms of spleen and kidney deficiency syndrome in ischemic stroke patients are mental fatigue and lack of strength, weakness of the lower back and knees, loose stool, pale and edematous tongue texture possibly with tooth marks, and deep and thready pulse or weak pulse. The secondary symptoms include shortness of breath, dizziness, tinnitus and deafness, decreased appetite or postprandial abdominal distension, pale complexion, frequent micturition at night, dull tongue texture, and white and slippery tongue coating. The preliminarily established diagnostic criteria for spleen and kidney deficiency syndrome in ischemic stroke patients can provide a standardized and objective basis, thereby better guiding clinical diagnosis and treatment of ischemic stroke.
3.Efficacy comparison of foldable capsular body with scleral buckling in treating experimental retinal detachment
Yifan DONG ; Baike ZHANG ; Yong JIA ; Fan YANG ; Lisha GUO ; Xiangyang ZHANG ; Cong LU ; Zhonghao ZHANG ; Haiyan WU ; Xuemin TIAN
International Eye Science 2025;25(10):1566-1573
AIM: To compare the effectiveness of foldable capsular body(FCB)with traditional scleral buckling(SB)in the treatment of experimental retinal detachment animal models.METHODS: After successfully establishing rhegmatogenous retinal detachment(RRD)animal models, 24 New Zealand white rabbits were randomly divided into three groups(RRD models group, SB group, and FCB group), with 8 rabbits in each group. The FCB and SB groups underwent SB and FCB surgeries for the RRD animal models, while the RRD models group only consists of RRD models without any surgical intervention during the follow-up period. The follow-up duration was 3 mo. Wide-field neonatal fundus imaging system and ophthalmic B-ultrasound were used to assess the fundus conditions before and after surgery. The Icare® TONOVET Plus tonometer was utilized to evaluate intraocular pressure changes before and after surgery. The Eaton and Draize scoring systems were selected to monitor postoperative inflammatory reactions.RESULTS: The retinal reattachment rates in the FCB and SB groups were 87.5% and 75.0%, respectively, with no statistically significant difference between the groups(P>0.05). The intraocular pressure in both the FCB and SB groups increased postoperatively compared to preoperative levels(P<0.01), and there were no significant differences in intraocular pressure at any time points during the follow-up period between the groups(P>0.05). The intraocular pressure in the RRD models group remained at a low level throughout the follow-up period. The average surgical time for the FCB group was 16.87±2.29 min, which was shorter than 46.25±4.74 min in the SB group(t=-15.166, P<0.001). According to the Eaton and Draize scoring systems, the FCB group had lower grades of conjunctival hyperemia and edema in the early postoperative period compared to the SB group, indicating milder inflammatory reactions(P<0.05).CONCLUSION: Both FCB and SB are effective in treating experimental RRD. Compared to SB, FCB is simpler to operate, and also has a shorter surgical time and milder postoperative inflammatory reactions.
5.Probability of premature death from 4 major chronic diseases among the registered residents in Xuhui District, Shanghai from 2007 to 2021
Jingshu XU ; Deng NIU ; Haiyan GU ; Xiaolin QIAN ; Lu LU ; Jianhua SHI
Shanghai Journal of Preventive Medicine 2024;36(8):802-806
ObjectiveTo understand the death status of major chronic diseases among the registered residents in Xuhui District, Shanghai from 2007 to 2021, and to analyze the probability and trend of premature death, so as to provide an evidence for the policy-making of disease control and prevention. MethodsBased on the data from the death registration system of the registered residents in Xuhui District, Shanghai from 2007 to 2021, the mortality rate of major chronic diseases, life expectancy without cause of death, potential years of life lost (PYLL), average years of life lost (AYLL), and premature death rate were calculated. Joinpoint 4.8 software was used to calculate the annual percentage change (APC) of premature death rate and its trend. ResultsIn 2021, the mortality rate and standardized mortality rate of four major chronic diseases, namely cardiovascular and cerebrovascular diseases, malignant tumors, diabetes mellitus and chronic lower respiratory diseases among the registered residents in Xuhui District, Shanghai was 767.75/100 000 and 234.69/100 000, respectively, accounting for 85.63% of the total causes of death among the residents in Xuhui District, Shanghai. The PYLL, AYLL and PYLL rate were 10 710.00 person-years, 1.49 years per person, and 11.43‰, respectively. Life expectancy increased by 14.91 years after removing the four major chronic diseases. From 2007 to 2021, the premature death rate of chronic diseases among the registered residents in Xuhui District decreased from 9.38% to 7.91% (APC=-1.09%,P<0.05). Malignant tumors had the highest rate in premature death, and the premature death rate was higher in males than that in females, with a slower rate of decline than in females. Cardiovascular and cerebrovascular diseases, malignant tumors and chronic lower respiratory diseases showed a significant decreasing trend in premature death rate (APC=-1.30%, -1.20%, -5.42%, P<0.05), while diabetes mellitus showed a significant increasing trend in premature death rate (APC=3.20%, P<0.05). There was a significant increasing trend in the rate of premature death from diabetes mellitus in males (APC=5.15%, P<0.05) and a decreasing trend in the rate of premature death from diabetes mellitus in females (APC=-0.76%, P<0.05). ConclusionCardiovascular and cerebrovascular diseases, malignant tumors, diabetes mellitus and chronic lower respiratory diseases are the main causes of death among the registered residents in Xuhui District. The probability of premature death of the residents in Xuhui District from major chronic diseases is at a low level, indicating that the prevention and control of chronic diseases in Xuhui District has achieved some success, but it is still difficult to realize the goals of the Outline of the "Healthy China 2030" Plan. Therefore, it is necessary to comprehensively carry out the control of risk factors such as tobacco use, harmful alcohol consumption, salt intake, hypertension, hyperglycemia and obesity, especially to strengthen the control of risk factors for male residents, as well as early diagnosis and treatment of malignant tumors, cardiovascular and cerebral vascular diseases and diabetes mellitus, and to implement the disease management mechanism to reduce premature death.
6.Characteristics of respiratory syncytial virus infection among hospitalized children in Ningbo City
MAO Bibo ; LU Wenbo ; CHEN Changshui ; QIU Haiyan ; LIU Wenyuan
Journal of Preventive Medicine 2024;36(12):1097-1100
Objective:
To investigate the epidemiological characteristics of respiratory syncytial virus (RSV) in hospitalized children in Ningbo City, so as to provide insights into developing prevention and control strategies for RSV.
Methods:
Basic information, clinical data and throat swab samples were collected from hospitalized children with respiratory infection in Ningbo University Affiliated Women and Children's Hospital from July 2019 to December 2023. Multiple fluorescence PCR-capillary electrophoresis was employed to detect nucleic acids of 11 non-bacterial respiratory pathogens. RSV detection in hospitalized children by time, gender and age was descriptively analyzed.
Results:
A total of 49 449 throat swab samples of hospitalized children with respiratory infections were detected. There were 4 310 samples positive for RSV, with a detection rate of 8.72%. The detection of positive specimens peaked from November to February in 2019 and 2020, from August to October in 2021, and from May to September in 2023. The RSV detection rate in boys was higher than that in girls (9.25% vs. 8.04%, P<0.05). The detection rate of RSV was highest in the children under 1 year of age (16.37%). The RSV detection rate tended to decrease with age (P<0.05). Among the specimens with positive RSV detection, 3 407 were positive for RSV alone (79.05%), while 903 were detected as mixed infections (20.95%). The non-bacterial pathogens with higher percentages of mixed detection were human rhinovirus, Mycoplasma pneumoniae and human parainfluenza virus.
Conclusion
Atypical seasonal epidemic of RSV infections appeared in 2021 and 2023 among hospitalized children in Ningbo City, with high detection rates in boys and children under 1 year of age, and a certain percentage of mixed infections.
7.Determination of three forms of mercury in human hair by high performance liquid chromatography-atomic fluorescence spectrometry
Haiyan YI ; Yunfeng NIE ; Qiang XI ; Lu YANG
China Occupational Medicine 2024;51(4):434-438
Objective To establish a method for the determination of mercury, methylmercury (MeHg) and ethylmercury (EtHg) in the hair of mercury-exposed individuals using high performance liquid chromatography-atomic fluorescence spectrometry. Methods About 0.20 g of hair was mixed with 5.0 mL of hydrochloric acid to a concentration of 5.00 mol/L. After standing for 12 hours, ultrasonic extraction was carried out for 30 minutes at room temperature. Ammonia solution was added dropwise into 2.0 mL supernatant after centrifuge to adjust the pH to 4-5. The solution was diluted to 10.0 mL with pure water after mixed with 0.2 mL of L-cysteine with a mass concentration of 10.0 g/L. The mobile phase consisted of 5.0% methanol + a mass concentration of 0.06 mol/L ammonium acetate + a 0.1% L-cysteine, and was used for separation by a C18 liquid chromatography column, followed by detection using atomic fluorescence spectrometry after UV digestion. Results The linear relationship of mercury, MeHg and EtHg in human hair was good at mass concentrations of 0.0-10.0 μg/L, with all correlation coefficients >0.999 0. The detection limit of mercury, MeHg and EtHg was 0.008, 0.008, and 0.010 μg/g, respectively. The within- and between- run relative standard deviations of the three forms of mercury were 1.6%-4.3% and 2.0%-5.6%, respectively, and the recovery rates were 94.0%-101.2%. Conclusion This method is simple, with low detection limit, high sensitivity, and good accuracy, and is suitable for the simultaneous determination of mercury, MeHg and EtHg in the hair of mercury-exposed individuals.
8.Application of OSCE-guided Scenario-based Practical Teaching Model in Clinical Pharmacist Training
Tiantian TANG ; Yiwen XIAO ; Haiyan YUAN ; Qiong LU ; Ying WANG ; Wenhui LIU ; Shenglan TAN ; Bikui ZHANG ; Daxiong XIANG ; Yan CHENG ; Yangang ZHOU ; Ping XU
Chinese Journal of Modern Applied Pharmacy 2024;41(10):1409-1414
OBJECTIVE
To explore the specific application and evaluation effect of objective structured clinical examination(OSCE)-guided scenario-based practical teaching mode in training clinical pharmacists.
METHODS
Fifty-six trainees who participated in the clinical pharmacist training program in the Second Xiangya Hospital of Central South University from October 2020 to September 2022 were selected as the research objects. OSCE-guided teaching was conducted, and the application effect of OSCE-guided teaching mode in clinical pharmacist training was explored and analyzed by using theoretical examination results and OSCE assessment results as evaluation indicators.
RESULTS
Through comparative analysis, it was found that the OSCE-guided teaching mode not only enabled students to better grasp the theoretical knowledge points required by the training outline, but also improved their clinical thinking ability, problem-solving ability, and communication and coordination skills to varying degrees.
CONCLUSION
For clinical pharmacist trainees, the OSCE teaching mode is conducive to the comprehensive improvement of clinical pharmacist skills and is suitable for cultivating clinical pharmacists who are capable of independently carrying out clinical pharmacy services in the new situation.
9.Comprehensive evaluation of research outputs from the Capital′s Funds for Health Improvement and Research
Enci XUE ; Xinyi LU ; Xueying WANG ; Lin ZENG ; Bishan ZHANG ; Haiyan LI
Chinese Journal of Medical Science Research Management 2024;37(1):39-44
Objective:The Capital′s Funds for Health Improvement and Research (referred to as ″CFH″), established to address clinical medical issues, have been operating for over a decade. This study aims to comprehensively evaluate the achievements of this fund and provide empirical support and recommendations for optimizing the operational model of the clinical research fund.Methods:An online questionnaire was used to investigate the following aspects of CFH: subject area, the person in charge, derived projects, theses, patents, transformation of results, and popularization and promotion.Results:A total of 745 projects were collected through the online survey, and after rechecking for outliers, 720 completed projects were ultimately included. The top three disciplinary domains, in terms of the number of completed projects, were oncology, cardiovascular diseases, and neurological disorders. The age distribution of project leaders exhibited a left-skewed pattern, with a median age of 45 years. 319 (44%) received support from other related projects subsequently. 95% of the projects resulted in paper publication. 211 (29%) projects applied for patents and copyrights, with 141 projects being granted patent authorization. 78 (11%) projects successfully achieved technology transfer, with transfer and licensing being the most common modes. 156 (22%) projects disseminated their outputs, often targeting secondary hospitals and community health institutions.Conclusions:CFH aligns with local needs, and the outputs are substantial. In the future, consideration can be given to establishing an evaluation mechanism, increasing efforts to promote high-quality outputs, strengthening the organizational model set by the project guidelines, and further improving the rolling support mechanism.
10.Physical and neuropsychological development of the offspring born to mother with gestational diabetes mellitus at 2 years old
Anfeng LU ; Peilu HUANG ; Lei BI ; Guosheng HUANG ; Haiyan HUANG
Chinese Journal of Child Health Care 2024;32(2):208-211
【Objective】 To investigate the physical and neuropsychological development of the offspring born to mothers with gestational diabetes mellitus (GDM) at 2 years of age, and to provide evidence to enhance the physical and neuropsychological development of GDM offspring. 【Methods】 A retrospective analysis was conducted on neonates born in the Department of Obstetrics at Qinzhou Maternal and Child Health Hospital from January 2018 to December 2018 and regularly followed at the outpatient service. The neonates were categorized into two groups based on whether their mothers were diagnosed with GDM during pregnancy: the GDM group (n=243) and the control group (n=362). The general clinical data, follow-up information on physical development and neuropsychological development at 1 year and 2 years of age for all children were collected. Their height, head circumference, body weight, BMI, and Gesell developmental quotients (DQs) at 1 year and 2 years of age for both groups were analyzed. 【Results】 1) There were no significant differences in height, head circumference, body weight, and body mass index (BMI) between the two groups at 1 year and 2 years of age during the follow-up period (P>0.05). 2) At 1 year of age, the GDM group exhibited higher rates of abnormal language development (8.6% vs. 3.3%, χ2=7.854), adaptive behavior(11.4% vs. 5.0%,χ2=8.605), and personal social behavior(8.2% vs. 3.0%, χ2=8.062) compared to the control group (P<0.05), and lower DQs for these Gesell subscales (language development 87.6±7.7 vs. 89.4±9.2, t=2.591; adaptive behavior: 88.4±7.8 vs. 90.5±8.9, t=2.957; personal social behavior: 89.1±7.0 vs. 91.2±7.5, t=3.495, P<0.05). 3) At 2 year of age, the GDM group also showed higher rates of adaptive behavior (8.2% vs. 4.1%, χ2=3.927) and personal social behavior (7.3% vs. 3.0%, χ2=4.093) compared to the control group (P<0.05), and lower DQs for these Gesell subscales (adaptive behavior: 89.5±6.5 vs. 91.9±6.9, t=3.878; personal social behavior: 89.9±7.1 vs. 92.1±6.9, t=3.311, P<0.05). 【Conclusions】 The development of adaptive behavior and personal social behavior in offspring born to mothers with GDM remains delayed. Follow-up for GDM offspring should prioritize achieving a balanced development of adaptive behavior and personal social behavior.


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