1.Evidence-based guideline for the management of clinical application of biosimilars in China (2024 edition)
Zaiwei SONG ; Yang HU ; Lingling YU ; Jun ZHU ; Lingli ZHANG ; Yu ZHANG ; Liyan MIAO ; Suodi ZHAI ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1933-1945
OBJECTIVE To provide standardized guidance for the clinical application and management of biosimilars, and promote their widespread and rational use in clinical treatment. METHODS The design, planning, and drafting process as well as the full report of Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China (2024 Edition) followed the WHO Handbook for Guideline Development (2nd edition), which fully considered the best current evidence from evidence-based medicine, multidisciplinary expert experience, and patient preferences and values. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was adopted to evaluate the quality of evidence and determine the strength of recommendations. RESULTS & CONCLUSIONS Evidence-based Guideline for the Management of Clinical Application of Biosimilars in China (2024 Edition) presented 10 recommendations including 7 strong recommendations and 3 weak recommendations. The recommendations covered the entire process of clinical application and management of biosimilars. Medical institutions and relevant health regulatory departments can refer to this guideline for the scientific management of the extrapolation of unapproved indications of biosimilars. Healthcare providers can refer to this guideline for pre-treatment assessments, patient education, pre-treatment regimen before administration, and dosage regimen adjustments. Multidisciplinary medical teams can refer to this guideline to provide pharmacovigilance and patient management throughout the treatment process.
2.Updated Interpretation of the NCCN Clinical Practice Guidelines (Version 3. 2023) for Non-small Cell Lung Cancer.
Lingling ZHU ; Ting WANG ; Juan WU ; Xiaoqian ZHAI ; Qiang WU ; Hanyu DENG ; Changlong QIN ; Long TIAN ; Qinghua ZHOU
Chinese Journal of Lung Cancer 2023;26(6):407-415
Lung cancer is the malignant tumor with the highest morbidity and mortality in China. Non-small cell lung cancer (NSCLC) is the main pathological subtype of lung cancer. On April 13, 2023, the National Comprehensive Cancer Network (NCCN) released the third edition of the 2023 NCCN Oncology Clinical Practice Guidelines: Non-small Cell Lung Cancer, which reflects the latest advances in international lung cancer research. This article will interpret the main updated contents of the new edition of the guidelines, and compare it with the third edition of the NCCN guidelines in 2022, so as to provide references about the diagnosis and treatment of NSCLC for clinical medical personnel in China.
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Humans
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Carcinoma, Non-Small-Cell Lung
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China
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Lung Neoplasms
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Thorax
3.Case-control study of early liferelated risk factors associated with type 1 diabetes mellitus in children
LIU Hezuo, SUN Qi, WEI Wei, ZHAI Lingling, BAI Yinglong, JIA Lihong
Chinese Journal of School Health 2021;42(1):128-131
Objective:
To investigate the affecting factors of type 1 diabetes mellitus(T1DM) in children, and to provide reference for the prevention and treatment measures in the future.
Methods:
A case-control study was carried out among 106 children diagnosed with T1DM in a hospital in Shenyang. At the same time, 106 healthy children were selected as the control group by 1∶1 matching of age, gender and living area. The early life-related factors that may affect the development of T1DM in two groups were investigated by questionnaire.
Results:
The average age of diagnosis in 106 cases with T1DM was(8.02±3.49) years, girls accounted for 60.4% and boys 39.6%. Multi-factor Logistic regression analysis showed that high family socioeconomic status and higher education of fathers were associated with lower odds of development of T1DM. Family member smoking(OR=2.51, 95%CI=1.19-5.29), family history of diabetes(OR=2.56, 95%CI=1.18-5.55), maternal obesity(OR=5.42, 95%CI=2.49-11.83) and infection during pregnancy(OR=3.45, 95%CI=1.04-11.46) were associated with higher risk of T1DM(P<0.05).
Conclusion
The occurrence of T1DM in children is affected by many factors including heredity, maternal health during pregnancy and family economy,highlighting the importance of early life prevention of T1DM.
4.Research progress of the role of microRNAs in puberty initiation
SHI Mengmeng, LIU Li, LI Xuesi, ZHAI Lingling
Chinese Journal of School Health 2021;42(5):788-791
Abstract
MiRNAs are a type of single-stranded, endogenous, non-coding small RNAs, which can regulate the post-transcriptional expression of genes and a variety of biological functions. Puberty development involves a complex regulatory network, among which the the hypothalamic-pituitary-gonad axis may play the key role. Studies have found that there was a relationship between the miRNAs and puberty development. The absence and abnormal expression of miRNAs can affect the initiation of puberty. But the mechanism is not clear. It may be related to the secretion of GnRH in the hypothalamus. This article mainly introduced several miRNAs which were currently closely related to the initiation of puberty, and reviewed their role and possible mechanisms in the initiation of puberty.
5.Dietary factors associated with overweight and obesity in primary school students in Shenyang
LI Chenyang, XIAO Zhe, SUN Qi, LIU Yang, WEI Wei, ZHAI Lingling, BAI Yinglong, JIA Lihong
Chinese Journal of School Health 2021;42(6):906-909
Objective:
To understand the prevalence of overweight and obesity, dietary habits and main food intake frequency among primary school students in Shenyang, so as to provide a reference for exploring the effect of diet related factors on the development of overweight and obesity in children.
Methods:
A total of 2 041 students from two primary schools in a certain district of Shenyang were selected by convenience sampling in May 2017, with height and weight measured, meanwhile the questionnaire survey regarding dietary habits and the frequency of main food intake were administered.
Results:
The rates of overweight and obesity were 18.4% and 22.1% respectively, and the rate of overweight and obesity in boys (21.0%,27.8%) were significantly higher than that in girls (15.8%,16.2%)(χ 2=22.45,53.40,P<0.01). The results of univariate analysis showed that frequency of eating breakfast, eating speed, appetite, picky eaters or not, and the frequency of fruit, seafood and canned food intake were associated with overweight and obesity in primary school students (χ 2=7.67,97.92,229.70,95.88,6.40,6.58,7.96,P<0.05). Multivariate Logistic regression analysis showed that slow eating speed (OR=0.46, 95%CI=0.29-0.69) and normal eating speed (OR=0.47, 95%CI=0.32-0.69) were associated with lower rates of overweight and obesity; good appetite (OR=43.73, 95%CI=5.88-325.36) was associated with higher rates of overweight and obesity in primary school students (P<0.01).
Conclusion
The detection rate of overweight and obesity is relatively high among primary school students in Shenyang, and the rate of obesity is already higher than that of overweight; The frequency of common food intake has little impact on the development of overweight and obesity in primary school students, but fast eating speed and good appetite are the risks of overweight and obesity among them.
6.The effects of competency-based diversified training on the comprehensive ability and transition shock of newly recruited nurses
Hui JIANG ; Qinghua ZHAI ; Dandan WANG ; Lingling BIAN ; Peipei KONG ; Lina WANG ; Liyan DENG ; Wenling HUANG ; Yan WANG
Chinese Journal of Practical Nursing 2021;37(21):1653-1659
Objective:To explore the effects of competency-based diversified training on the bedside nursing comprehensive ability aand transition shock of newly recruited nurses.Methods:A total of 62 newly recruited nurses from the Second Affiliated Hospital of Zhengzhou University in June 2018 were selected as the control group, and 70 newly recruited nurses from June 2019 were selected as the experimental group by cluster sampling. The control group received routine pre-job training, and the experimental group received diversified training based on the control group. After one year of training, the differences in the scores of bedside nursing comprehensive ability, post competency and transition shock between the two groups of nurses were analyzed.Results:After 1 year of training, the total scores and the scores of nursing problems, nursing evaluation, nursing plan, nursing theory, nursing operation and bedside nursing comprehensive ability in the experimental group were 12.20±1.76, 24.29±2.38, 13.54±1.88, 9.77±1.35, 15.14±2.30 and 79.24±6.59, which were all higher than those of the control group (10.26±1.55,22.31±1.84,10.45±1.58, 8.56±1.80, 13.27±2.38 and 69.82±4.09), the differences were statistically significant ( t value was 4.582-13.679, P<0.05). The total scores and the scores of each dimension of the Post-competency the experimental group were 31.46 ±4.32, 51.03± 4.64, 20.27± 3.78, 17.86±3.99, 58.43± 4.44, 179.37±9.97, which were all higher than those of the control group 24.76±4.12, 40.56±5.55, 16.61±2.88, 15.15± 2.96, 49.74±3.07, 146.66±17.98, the differences were statistically significant ( t value was 4.466-13.197, P<0.05). The scores of psychological knowledge, skills, social culture and development and the total scores of Transition shock in the experimental group were 30.90±3.15, 19.69±2.74, 32.17±3.06, 103.81±12.24, which were all higher than those in the control group (25.69±2.76, 15.92±3.24, 27.50±4.15, 88.32±11.54), the differences were statistically significant ( t value was 7.237-10.040, P<0.05). Conclusions:competency-based diversified training can effectively improve the bedside nursing comprehensive ability and post competency, reduce their transition shock, and has strong clinical reference significance.
7.An analysis of the status quo of ground-level ozone pollution research
Xin'ai LIU ; Lingling FU ; Yifan ZHAI ; Zhiping WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(2):123-129
Objective:To analyze the research status of ground-level ozone pollution, explore research trends and hot spots, and provide references for future research on air pollution.Methods:Papers on ground-level ozone pollution research published before December 31, 2019 had been retrieved in SCI-E database of the "Web of Science Core Collection" in January 2020. The retrieval strategies were set as follows: TS= ( ("Tropospheric Ozone" OR "Low Level Ozone" OR "Ground Level Ozone") AND ("Air pollution*" OR "Air quality") ) . The survey included 2084 articles. By using bibliometric research and visual analysis tools, the research status of global ground-level ozone pollution was revealed from the aspects of time, discipline, journal, financing, institution, country and key words.Results:Cumulative publications increased in a cubic function of y=0.05 x3+0.80 x2+0.74 x+4.55 ( R2=0.999, P<0.01) . The most studied subject was Environmental sciences ecology (1401 articles, 67.23%) . Atmospheric Environment was the journal with the most articles (332 articles, 15.93%) . The United States was the country with the most publications (44.67%, 931/2084) , while China ranked second (17.13%, 357/2084) . 80.39% (287/357) of Chinese papers had funding information. Among the top 10 research institutions, 7 and 2 were affiliated to the United States and China respectively. Source apportionment and human health were high frequency keywords that had appeared in the last 5 years. Conclusion:The research on ground-level ozone pollution is in a good period of development. The United States has a leading position in this area, and China has a good prospect in this field. Pollution source apportionment and human health effects are new research directions.
8.An analysis of the status quo of ground-level ozone pollution research
Xin'ai LIU ; Lingling FU ; Yifan ZHAI ; Zhiping WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(2):123-129
Objective:To analyze the research status of ground-level ozone pollution, explore research trends and hot spots, and provide references for future research on air pollution.Methods:Papers on ground-level ozone pollution research published before December 31, 2019 had been retrieved in SCI-E database of the "Web of Science Core Collection" in January 2020. The retrieval strategies were set as follows: TS= ( ("Tropospheric Ozone" OR "Low Level Ozone" OR "Ground Level Ozone") AND ("Air pollution*" OR "Air quality") ) . The survey included 2084 articles. By using bibliometric research and visual analysis tools, the research status of global ground-level ozone pollution was revealed from the aspects of time, discipline, journal, financing, institution, country and key words.Results:Cumulative publications increased in a cubic function of y=0.05 x3+0.80 x2+0.74 x+4.55 ( R2=0.999, P<0.01) . The most studied subject was Environmental sciences ecology (1401 articles, 67.23%) . Atmospheric Environment was the journal with the most articles (332 articles, 15.93%) . The United States was the country with the most publications (44.67%, 931/2084) , while China ranked second (17.13%, 357/2084) . 80.39% (287/357) of Chinese papers had funding information. Among the top 10 research institutions, 7 and 2 were affiliated to the United States and China respectively. Source apportionment and human health were high frequency keywords that had appeared in the last 5 years. Conclusion:The research on ground-level ozone pollution is in a good period of development. The United States has a leading position in this area, and China has a good prospect in this field. Pollution source apportionment and human health effects are new research directions.
9.Prevalence and influencing factors of eczema among children in a district of Shenyang
ZHANG Jinheng, TANG Hua, SUN Qi, WEI Wei, ZHAI Lingling, BAI Yinglong, JIA Lihong
Chinese Journal of School Health 2020;41(3):416-419
Objective:
To investigate the prevalence and associated factors of eczema in children in order provide reference for the prevention and treatment of eczema.
Methods:
Two primary schools in a district of Shenyang were randomly selected to conduct a questionnaire survey on 2 240 students in May 2017. Children with eczema need to be diagnosed by a doctor.
Results:
There were 838 cases of eczema with a reported rate of 37.4%, 38.7% in boys and 36.1% in girls. The age of 6 to 12 months was the peak period of first eczema in children, and the proportion of eczema within 1 year was up to about 70%. Children who have had eczema in the past were now more likely to catch a cold, and the reported rates of allergic rhinitis, asthma and food allergies were also significantly higher. The Logistic regression analysis showed that the mother was unhappy during pregnancy(OR=1.32,95%CI=1.03-1.69), the parents were more educated (OR=1.60, 95%CI=1.19-2.16), and the parents were allergic (OR=1.58,95%CI=1.07-2.33;OR=1.41, 95%CI=1.02-1.94), family history of diabetes(OR=1.95, 95%CI=1.41-2.68), and cesarean(OR=1.33, 95%CI=1.07-1.65) were risk factors of eczema in children.
Conclusion
The incidence of children eczema is affected by maternal mood during pregnancy, family factors and delivery mode. It is of practical significance to prevent children eczema in early development for reducing the incidence of other allergic diseases in the future.
10.Study progress of adipose tissue endopIasmic reticuIum stress and chiIdhood obesity-reIated type 2 diabetes
Mingxia WANG ; Lihong JIA ; Lingling ZHAI ; Wei WEI ; Qi SUN ; Yinglong BAI
Chinese Journal of Applied Clinical Pediatrics 2019;34(3):231-233
In rkcknt ekars,thk incidknck of childhood obksite has also incrkaskd ekar be ekar as pkoplk's living standards ckkp improving. Ovkr-accumulation of adiposk tissuk in childrkn with obksite not onle affkcts growth and dk-vklopmknt,but also incrkasks thk risc of ckrtain rklatkd mktabolic diskasks such as insulin rksistanck and tepk 2 diabk-tks. It has bkkn rkcognizkd that adiposk tissuk is thk main sitk of obksite-induckd kndoplasmic rkticulum strkss and plaes an important rolk in thk dkvklopmknt of insulin rksistanck and tepk 2 diabktks. Ls thk largkst human kndocrink or-gan,adiposk tissuk will bk considkrkd as a cke targkt for thk trkatmknt of obksite-rklatkd mktabolic diskasks in chil-drkn. Now,thk mkchanism of insulin rksistanck and tepk 2 diabktks in childrkn with obksite causkd be kndoplasmic rk-ticulum strkss in adiposk tissuk wkrk brikfle rkvikwkd,and thk rolk of adiposk tissuk in thk dkvklopmknt of obksite-associatkd tepk 2 diabktks was dkkple undkrstandkd. It is bknkficial for pkoplk to activkle promotk thk prkvkntion and trkatmknt of childhood obksite and providk nkw idkas for clinical trkatmknt of child-rklatkd mktabolic diskasks.


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