1.General considerations for the design of bioequivalence studies of etomidate medium/long-chain fat emulsion injection
Na AN ; Dong LI ; Li-Li LIU ; Fang LI ; Li-Li HA ; Man-Ru REN ; Yu ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(10):1541-1544
Etomidate reversibly blocks 11-β-hydroxylated steroid dehydrogenase inhibits the synthesis of cortisol by adrenal cells.This product is a special injection.When evaluating the quality and efficacy of the generic and the reference preparations,it should be based on pharmaceutical and non-clinical consistency and adopt a step-by-step research strategy,firstly,bioequivalence(BE)was studied.In bioequivalence study,the research type,dosage and method,bioequivalence evaluation,safety monitoring and pharmacodynamics(PD)evaluation should be considered and designed reasonably.Based on the pharmacokinetics(PK)characteristics of etomidate medium-long chain fat emulsion injection and the bioequivalence study of its generic drug before its domestic market,the general design requirements and relevant considerations for the bioequivalence study of this product were systematically discussed.The purpose is to provide useful reference and guidance for domestic research and development of generic drugs.
2.Clinical Characteristics and Use of Traditional Chinese Medicine Therapy in 222 Malignant Tumor Cases with COVID-19: A Retrospective Study
Yingtian WANG ; Hong SUN ; Man LI ; Na SONG ; Jiao GOU ; Wenfang LUO ; Jun LIU ; Rong MA ; Wei WANG ; Zhandong LI ; Bo MENG ; Xiaoyan YAO
Journal of Traditional Chinese Medicine 2024;65(7):716-721
ObjectiveTo analyze the clinical characteristics and the use of traditional Chinese medicine (TCM) therapy in cancer patients with COVID-19, and to provide reference for making TCM prevention and treatment strategies and determining diagnosis and treatment priorities for patients with malignant tumors in the COVID-19 epidemic. MethodsThe medical records of 225 malignant tumor cases with COVID-19 who were admitted to 7 national research centers from January 1st to 20th, 2023 were retrospectively collected, and the main symptoms and duration after infection, nucleic acid negative conversion time, use of TCM therapy, and changes in adverse reactions after resuming anti-tumor treatment were analyzed. ResultsA total of 222 malignant tumor patients with COVID-19 were included in the analysis, involving 205 mild cases and 17 moderate cases. The top four most frequently reported clinical symptoms were fever (165 cases), expectoration or dry cough (99 cases), decreased appetite (95 cases) and fatigue (85 cases), of which 40 expectoration or dry cough cases , 37 fatigue cases and 29 decreased appetite cases lasted for more than 14 days. One hundred and five patients with nucleic acid detection report had a median negative conversion time of 14 days. The nucleic acid negative conversion time was significantly longer in patients with lung cancer compared to those with digestive system malignant tumors, and in those with myelosuppression than those without (P<0.01). During the infection period, 47.30% (105/222) of the patients used Chinese patent medicine, and 21.17% (47/222) were treated with herbal decoctions. The use of TCM in patients during the prevention and rehabilitation period, was 1.80%(4/222) and 7.21%(16/222), respectively. Fifty-five patients resumed anti-tumor treatment after nucleic acid negative conversion, and received TCM simultaneously. Observed adverse reactions, including gastrointestinal reactions, bone marrow suppression, and neurotoxicity, were all grade 1 to 2, and no new adverse events occurred during follow-up. ConclusionCertain malignant tumor patients with COVID-19 had prolonged symptoms and nucleic acid negative conversion time Rational use of TCM can help to promote the rehabilitation of the patients and ensure the smooth process of anti-tumor treatment after infection.
3.Oral anti-coagulants use in Chinese hospitalized patients with atrial fibrillation
Jing LIN ; Deyong LONG ; Chenxi JIANG ; Caihua SANG ; Ribo TANG ; Songnan LI ; Wei WANG ; Xueyuan GUO ; Man NING ; Zhaoqing SUN ; Na YANG ; Yongchen HAO ; Jun LIU ; Jing LIU ; Xin DU ; Louise MORGAN ; C. Gregg FONAROW ; C. Sidney SMITH ; Y.H. Gregory LIP ; Dong ZHAO ; Jianzeng DONG ; Changsheng MA
Chinese Medical Journal 2024;137(2):172-180
Background::Oral anti-coagulants (OAC) are the intervention for the prevention of stroke, which consistently improve clinical outcomes and survival among patients with atrial fibrillation (AF). The main purpose of this study is to identify problems in OAC utilization among hospitalized patients with AF in China.Methods::Using data from the Improving Care for Cardiovascular Disease in China-Atrial Fibrillation (CCC-AF) registry, guideline-recommended OAC use in eligible patients was assessed.Results::A total of 52,530 patients with non-valvular AF were enrolled from February 2015 to December 2019, of whom 38,203 were at a high risk of stroke, 9717 were at a moderate risk, and 4610 were at a low risk. On admission, only 20.0% (6075/30,420) of patients with a diagnosed AF and a high risk of stroke were taking OAC. The use of pre-hospital OAC on admission was associated with a lower risk of new-onset ischemic stroke/transient ischemic attack among the diagnosed AF population (adjusted odds ratio: 0.54, 95% confidence interval: 0.43–0.68; P <0.001). At discharge, the prescription rate of OAC was 45.2% (16,757/37,087) in eligible patients with high stroke risk and 60.7% (2778/4578) in eligible patients with low stroke risk. OAC utilization in patients with high stroke risk on admission or at discharge both increased largely over time (all P <0.001). Multivariate analysis showed that OAC utilization at discharge was positively associated with in-hospital rhythm control strategies, including catheter ablation (adjusted odds ratio [OR] 11.63, 95% confidence interval [CI] 10.04–13.47; P <0.001), electronic cardioversion (adjusted OR 2.41, 95% CI 1.65–3.51; P <0.001), and anti-arrhythmic drug use (adjusted OR 1.45, 95% CI 1.38–1.53; P <0.001). Conclusions::In hospitals participated in the CCC-AF project, >70% of AF patients were at a high risk of stroke. Although poor performance on guideline-recommended OAC use was found in this study, over time the CCC-AF project has made progress in stroke prevention in the Chinese AF population.Registration::ClinicalTrials.gov, NCT02309398.
4.Design of portable collection device for exhaled breath condensate
An XIANG ; Lei ZHOU ; Qi-Feng JI ; Yuan-Zhe LI ; Qin WANG ; Shi-Man ZHU ; Jie PENG ; Xiao-Ying LEI ; Wei-Na LI ; Li WANG ; Yan-Hai GUO ; Zi-Fan LU
Chinese Medical Equipment Journal 2024;45(8):32-37
Objective To develop a portable collection device of human exhaled breath condensate(EBC)based on natural breathing to meet the needs for rapid screening of human respiratory tract(especially lower respiratory tract)infections.Methods The device consisted of a refrigeration unit,a heat dissipation unit and a condensation unit.The refrigeration unit adopted a TES1-7102 thermoelectric Peltier cooler semiconductor as the refrigeration element;the heat dissipation unit was composed of a high thermal conductivity aluminum heat sink and a high-speed brushless cooling fan;the condensation unit was made up of a cold guide plate and a condenser,in which the cold guide plate was made of thin sheet of aluminum alloy,and the condenser was prepared by 3D printing technology and made of hydrophobic polylactic acid,with primary and secondary 2-stage guide grooves and an ultra-thin condensing surface.The performance of the device was verified in terms of cooling,thermal conductivity,condensation and human EBC collection and content analysis.Results Performance analysis showed that after refrigeration began the temperature difference between the condenser surface and the exhaled gas met the requirements of the condenser,and no obvious thermal resistance was found on the condensing surface so that large droplets could be formed rapidly and then be collected after the gas-liquid phase change of the exhaled gas on the condensing surface.Human EBC collection and content analysis indicated the device realized home self-collection of EBCs from people of all ages,and the concentrations of interleukins,C-reactive protein and other inflammation-related indexes and the pH value of the collected EBC samples were all correlated with respiratory infections in the subjects.Conclusion The device developed with easy operation avoids the discomfort of blowing collection and the risk of saliva contamination,and is worthy promoting for rapid diagnosis and dynamic monitoring of respiratory tract infection and other related diseases.[Chinese Medical Equipment Journal,2024,45(8):32-37]
5.Effects of a multiple heat-preservation approach on core body temperature during perioperative period of hip arthroscopy
Di ZHANG ; Tong ZHENG ; Man LI ; Na LI ; Rui XIAO
Chinese Journal of Sports Medicine 2024;43(8):613-618
Objective To explore the effect of a multiple heat-preservation approach during the peri-operative period of hip arthroscopy on core body temperature,anesthesia recovery time and postopera-tive shivering.Methods Eighty patients who underwent arthroscopic acetabular labral repair between Jan-uary 2020 and June 2021 were selected and randomly divided into a control group and an observation group,each of 40.During the perioperative period,both groups received routine nursing,while the ob-servation group was additionally provided with a series of heat-preservation measures including raising the room temperature,liquid heating and warm blanket insulation.The core body temperature was mon-itored by an axillary probe.Moreover,the perioperative core body temperature,anesthesia recovery time,and incidence of postoperative shivering were compared between the two groups.Results There was no significant differences were found between the two groups in the preoperative core body temper-ature(P>0.05).However,the core body temperature of the observation group was significantly higher than the control group intraoperatively(36.2℃±0.2℃vs 35.9℃±0.2℃,P<0.001)and postoperatively(36.6℃±0.2℃vs 36.4℃±0.2℃,P<0.001),while the incidence of intraoperative hypothermia(<36.0℃)of the observation group was significantly lower than the latter(7.5%vs 70.0%,P<0.001).Meanwhile,the anesthesia recovery time[27.0(24.0,30.0)min vs 30.0(28.0,33.0)min,M(P25,P75),P<0.001]and incidence of postoperative shivering(7.5%vs 25.0%,P=0.034)in the observation group were significantly lower than the control group.Conclusion Adopting a multiple heat-preservation approach during the perioperative period of hip arthroscopy can help maintain the core body tempera-ture,shorten the anesthesia recovery time,and reduce the incidence of postoperative shivering.
6.Establishment of prediction model for symptomatic radiation pneumonitis: based on a longitudinal cohort
Li WANG ; Han BAI ; Fei LU ; Yaoxiong XIA ; Man LI ; Na PENG ; Zhe ZHANG ; Simeng TAN ; Bo LI ; Chengshu GONG ; Jingyan GAO ; Qian AN ; Lan LI ; Wenhui LI
Chinese Journal of Radiation Oncology 2024;33(10):915-921
Objective:To establish a prediction model for symptomatic radiation pneumonitis (SRP) after radiotherapy for thoracic cancer based on a longitudinal cohort and dose interval variations.Methods:Clinical data of 587 patients who received thoracic radiotherapy in Department of Radiotherapy of Yunnan Cancer Hospital from July 2022 to June 2023 were retrospectively analyzed. The National Cancer Institute common terminology criteria for adverse events (CTCAE) version 5.0 was used to grade radiation pneumonitis, and clinical factors, traditional independent dosimetric characteristics and dose interval variation characteristics were collected. Features used to predict the occurrence of SRP were screened using genetic algorithms and analyzed the correlation between the selected features and SRP occurrence. Predictive models for SRP occurrence were established using the selected features and evaluated, and the optimal predictive model was visualized using a column chart.Results:The incidence of SRP was 35.94%. Five clinical factors, seven independent dosimetric features and six dose interval variation features were screened out by genetic algorithms to effectively predict the occurrence of SRP. The area under ROC curve (AUC) of clinical factors combined with traditional independent dosimetric factors and dose interval variation factors was 76%. The AUC of clinical factors combined with traditional independent dosimetric factors and that of clinical factors combined with dose interval variation factors was 69% and 67%, respectively. The addition of the characteristics of dose interval variation factors significantly improved the effectiveness of the prediction model.Conclusions:The supplement of the characteristics of dose interval variation factors can significantly improve the performance of the SRP prediction model for thoracic tumors after radiotherapy. The SRP prediction model based on dose interval variations can effectively predict the occurrence of SRP.
7.Preventive effect of early comfort using analgesia, minimal sedatives and maximal humane care concept on delirium in patients in coronary care unit
Na LIU ; Zexia HE ; Man LIU ; Tingting LI ; Shasha YANG ; Ying XU
Journal of Clinical Medicine in Practice 2024;28(2):101-104
Objective To observe the preventive effect of early comfort using analgesia, minimal sedatives and maximal humane care (eCASH)concept on delirium in patients in coronary care unit(CCU). Methods The clinical data of 136 CCU patients admitted from June 2021 to January 2023 were retrospectively analyzed. Patients received routine delirium prevention care from June 2021 to March 2022 were included in control group (
8.Fast food consumption behaviors among senior primary school students in agricultural and pastoral areas of Qinghai Province
Chinese Journal of School Health 2023;44(6):809-813
Objective:
To investigate fast food consumption behaviors among 4th and 5th grade primary school students in agricultural and pastoral areas in Qinghai Province, and to provide scientific basis for nutrition education and intervention measures for school age children in agricultural and pastoral areas.
Methods:
Using multi stage stratified cluster random sampling method, a total of 969 fourth and fifth grade students were selected from 10 primary schools in 4 counties and districts in 3 cities of Haidong City, Hainan Prefecture and Haixi Prefecture from Qinghai Province. Self administered questionnaires were used to investigate the fast food consumption behaviors of participants.
Results:
The proportions of senior primary school students in agricultural and pastoral areas of Qinghai Province who had consumed western fast food and traditioal fast food in the past week were 45.8% and 75.6%, respectively, with statistically significant differences ( χ 2=290.24, P <0.05). The times of traditional fast food consumption in the past week among boarding students were higher than that of non boarding students( Z =6.44,5.84, P <0.05). The main reasons for senior primary school students in agricultural and pastoral areas of Qinghai Province to choose to consume western fast food were that it was delicious (84.7%), nutritious (62.6%), clean and hygienic (57.4%), and a better environment (57.0%). The top 4 reasons for chousing Chinese fast food were yummy(83.8%),nutritious(82.8%),clean and healthy(67.4%),and good environment(53.5%). Among the surveyed primary school students, 64.7% believed that diet structure of Chinese fast food was reasonable, 43.0% believed that the nutritional value of Chinese fast food was high, and 39.4% believed that the energy content of western fast food was high.
Conclusion
Fast food consumption is a common dietary behavior of senior primary school students in agricultural and pastoral areas of Qinghai Province. Relevant departments should strengthen the nutrition education related to fast food, promote the dissemination of health knowledge, enable students to develop a good lifestyle and reduce fast food consumption.
9.Beverage behaviors of senior primary school students in agricultrual and pastoral areas of Qinghai Province
Chinese Journal of School Health 2023;44(6):814-818
Objective:
To study the consumption of beverages among senior primary school students in rural and pastoral areas of Qinghai Province, China, in order to provide evidence for the development of nutrition and intervention strategies.
Methods:
A multi stage stratified cluster random sampling method was employed to select 969 primary school students in grades 4 and 5 from 10 schools in Hainan Autonomous Prefecture, Haixi Autonomous Prefecture and Haidong City. All participants completed a questionnaire survey on daily beverage consumption. The Chi square test was performed to compare differences in reported rates of beverage consumption among students in different groups.
Results:
The proportion of students who consumed beverages at home, school and elsewhere were 96.9%, 64.5% and 84.9%, respectively. The most popular beverages consumed at home were milk and yogurt ( 63.1 %), tea water (53.0%), and tea drinks (52.4%). The most popular beverages consumed at school were tea(29.8%), milk and yogurt (27.8%) and tea drinks (18.4%), while the most popular beverages consumed in other places were tea drinks ( 42.0 %), carbonated drinks (38.1%) and milk and yogurt (35.0%). The top five reasons for choosing a given beverage were taste delicious (81.2%), nutritious (57.6%),healthy and clean(52.6%),many students like to drink(39.6%),family members often drink(37.7%).
Conclusion
The consumption of beverages was popular among students, and sugared beverages represented a large proportion of the beverages consumed. Therefore, there is an urgent need to improve the food environment and provide effective nutrition education for students, so as to encourage the consumption of healthy beverages and cultivate healthy eating behaviors.
10.Status of snack behavior of senior primary school students in agricultural and pastoral areas of Qinghai Province
Chinese Journal of School Health 2023;44(6):819-823
Objective:
To understand the current situation regarding snack food consumption among grade 4 and grade 5 primary school students in agricultural and pastoral areas of Qinghai Province, China, and to provide a scientific basis for nutrition education and intervention strategies.
Methods:
Multistage stratified cluster random sampling was employed. The research included 969 fourth and fifth grade students were selected from 10 primary schools in four counties and districts of three cities in Haidong City, Hainan Prefecture and Haixi Prefecture in Qinghai Province. The self report questionnaire method was used to investigate the current status regarding snack food consumption in this population.
Results:
The proportion of students who consumed snack food at home, school and elsewhere were 98.2%, 88.5% and 75.4%, respectively. Male students reported a lower rate of snack consumption at school than female students ( χ 2=9.66). The fifth grade students reported a higher rate of snack consumption at home and other places than the fourth grade students ( χ 2=10.31, 6.77). The reported rate of snack consumption of students in the rural was higher than that in the county( χ 2=6.03,100.53, 24.77). The reported rate of snack consumption of boarding students at home was lower than that of non-boarding students ( χ 2=7.22), while the reported rate of snack consumption at school was higher than that of non-boarding students ( χ 2=9.04)( P <0.01). The most popular snacks consumed at home included fruits and vegetables, cereals and nuts (76.9%, 67.2%, 63.7%), while the most popular snacks consumed at school were fruits and vegetables, cereals and candies (45.1%, 36.9%, 24.4%). The most popular snacks consumed in other settings included ice cream, candies and beverages(54.7%, 51.6%, 42.9%). The top three reasons for snacking were that snacks were regarded as delicious, healthy/nutritious and clean (76.9%, 65.5% and 59.0%, respectively).
Conclusion
Snacking is popular among students, although many snacks are unhealthy. Therefore, there is a need to improve food environments and nutrition education, so as to help students to choose healthy beverages and adopt healthy eating behaviors.


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