1.Scientific and Ethical Analysis of 840 Registered COVID-19 Clinical Studies
Donghai ZHANG ; Xiuhua MA ; Lili MA
Chinese Medical Ethics 2024;35(4):427-432
From January 23, 2020 to May 29, 2021, there were 17,550 clinical research registrations on the China Clinical Trial Registry Platform. The index of clinical research on COVID-19 showed 840 registrations, accounting for 4.79% (840/17 550) of the total registrations. According to the trend chart of epidemic development, 487 clinical research projects of COVID-19 registered from January 23, 2020 to March 18, 2020 were set as the early stage of epidemic discovery in the region, the following 15 months were divided into stable initial stage, stable later stage and the later stage of the first wave of domestic epidemic every five months. The proportion of COVID-19 research projects registered in each stage was 29.80%, 5.87%, 0.76% and 1.15% of all registered projects respectively. The registration ratios of COVID-19 in each clinical stage was 57.98%, 28.81%, 5.95% and 7.26% respectively. Intervention studies were 61.60% (300/487) in the early stage of the epidemic, and most of them were in biological agent and drug therapy, which were 40.49%, 50.00% and 73.77% respectively in the later stages. Stable initial stage biological agent projects decreased. Then the vaccine research program became a focused research program. Among the 58 registration projects involving vaccines, 25 were clinical trials of vaccines in different stages, with the major research units being biopharmaceutical companies. Of the 487 clinical studies registered in the early stage, 10.23%(50/487) were withdrawn, of which 38 were intervention treatment studies, most notably drug studies (17) and blood biological products (16), but they were still registered in the stable initial stage. It is necessary to reflect on the scientific and ethical nature of early COVID-19 clinical trials or research, including whether the three core values of equal respect, help to alleviate pain and fairness can be achieved. Whether the "ethics review meeting should pay special attention to the scientificity, safety, fairness, subject protection, informed consent documents and informed consent process, avoidance of conflicts of interest, etc. of clinical trials or research" has been implemented. Competent government departments at all levels and all clinical medical research institutions should organize evaluation, and then establish an effective evaluation mechanism when new clinical trials or research projects are registered in the future.
2.Explorations of Clinical Teaching and Training Model for Refresher Anesthesiologists
Manjiao MA ; Lulu MA ; Ruiying WANG ; Xiuhua ZHANG
Medical Journal of Peking Union Medical College Hospital 2024;15(2):462-465
3.Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
Huiqiang HUANG ; Zhiming LI ; Lihong LIU ; Liang HUANG ; Jie JIN ; Hongyan TONG ; Hui ZHOU ; Zengjun LI ; Zhenqian HUANG ; Wenbin QIAN ; Kaiyang DING ; Quande LIN ; Ming HOU ; Yunhong HUANG ; Jingbo WANG ; Pengcheng HE ; Xiuhua SUN ; Xiaobo WANG ; Zunmin ZHU ; Yao LIU ; Jinhai REN ; Huijing WU ; Liling ZHANG ; Hao ZHANG ; Liangquan GENG ; Jian GE ; Ou BAI ; Liping SU ; Guangxun GAO ; Xin LI ; Yanli YANG ; Yijian CHEN ; Aichun LIU ; Xin WANG ; Yi WANG ; Liqun ZOU ; Xiaobing HUANG ; Dongping HUANG ; Shujuan WEN ; Donglu ZHAO ; Jun MA
Journal of Leukemia & Lymphoma 2023;32(8):457-464
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
4.Prognosis of the glucose metabolism and its impacting factors at 6-12 weeks postpartum in women with abnormal blood glucose during pregnancy
Mingyi LIU ; Xinhui YANG ; Xiaoxiao PENG ; Qi ZHANG ; Lili MA ; Yi CHEN ; Fengli SONG ; Xiuhua MA
Chinese Journal of Health Management 2023;17(6):424-428
Objective:To analyze the prognosis of glucose metabolism and its impacting factors at 6-12 weeks postpartum in patients with abnormal blood glucose during pregnancy.Methods:In this cross-sectional study, a total of 192 patients with abnormal blood glucose during pregnancy enrolled and delivered in the maternity clinic of Daxing Teaching Hospital of Capital Medical University from December 1, 2019 to December 31, 2020 were collected. The 75 g oral glucose tolerance test (OGTT) was applied for diabetes screening at 6-12 weeks after delivery. According to the results of postpartum blood glucose, the patients were divided into two groups: postpartum normal blood glucose group (148 cases) and abnormal blood glucose group (44 cases). Hypothesis testing was used to compare the clinical data before, during and after the pregnancy between the two groups. Multi-factor logistic regression was performed to analyze the influencing factors of postpartum abnormal blood glucose in patients with abnormal blood glucose during pregnancy.Results:Among the 192 patients with abnormal blood glucose during pregnancy, the incidence of postpartum abnormal blood glucose was 22.92% (44/192), including 6 cases of diabetes mellitus (DM) (13.64%), 38 cases of impaired glucose tolerance (IGT) (86.36%). Neck circumference, waist circumference, multiparous women and insulin use during pregnancy in postpartum abnormal blood glucose group were all significantly higher than those in postpartum normal blood glucose group [34.25(33.00, 36.00) vs 33.55 (32.00, 35.00) cm, 87.00 (82.00, 93.00) vs 84.00 (78.00, 90.00) cm, 54.55% vs 37.16%, 18.18% vs 6.76%] (all P<0.05). Neck circumference ( OR=1.315, 95% CI: 1.026-1.685), multiparous women ( OR=2.261, 95% CI: 1.057-4.836), insulin use during pregnancy ( OR=3.767, 95% CI: 1.236-11.478) were positively correlated with the occurrence of postpartum abnormal blood glucose (all P<0.05). Conclusions:The incidence of postpartum abnormal blood glucose is high at 6-12 weeks postpartum in patients with abnormal blood glucose during pregnancy. Neck circumference, waist circumference, parity and insulin use during pregnancy are important impacting factors of postpartum abnormal blood glucose.
5.Modification effect of overweight and obesity on the association between short term PM 2.5 exposure and high blood pressure in adolescents
Chinese Journal of School Health 2022;43(2):296-299
Objective:
To analyze the association between short term PM 2.5 exposure and high blood pressure in adolescents and its modification effect of overweight and obesity, and to provide a reference for the refined management of students physical health and the scientific prevention and controlling of air pollution.
Methods:
A total of 148 956 junior high school students and senior high school students who passed the annual physical examination data of middle school students in Beijing from 2017 to 2018 were selected; The inverse distance weighted interpolation method was used to get the meteorological elements and air quality of the research area; Linear mixed effect model was used to estimate the cumulative lag effect of short term PM 2.5 exposure on systolic and diastolic blood pressure within 7 days, and analyze the modification effect of overweight and obesity on the association between short term PM 2.5 exposure and high blood pressure in adolescents.
Results:
From September 1, 2017 to June 30, 2018, the average concentration of PM 2.5 was (56.53±45.85)μg/m 3; The detection rate of overweight and obesity was 34.22%, and the detection rate of high blood pressure was 8.03%. The cumulative lag effect of PM 2.5 on systolic blood pressure in overweight and obesity group was the largest at lag07, that is, the daily average concentration of PM 2.5 increased by 10 μg/m 3 was significantly correlated with higher systolic blood pressure ( OR =1.05,95% CI =1.03-1.07); the cumulative lag effect of PM 2.5 on systolic blood pressure in non overweight and obese group was the largest at lag05, that is, the daily average concentration of PM 2.5 increased by 10 μg/m 3 was significantly correlated with higher systolic blood pressure ( OR =1.04,95% CI =1.02-1.06). Short term exposure to PM 2.5 did not affect the high diastolic blood pressure in adolescents. Overweight and obese adolescents were more susceptible to high blood pressure caused by short term PM 2.5 exposure within 3 days of cumulative lag (lag01-lag03).
Conclusion
The short term exposure of PM 2.5 has a significant positive correlation with adolescent blood pressure, and shows a lag effect. Overweight and obese adolescents have higher blood pressure after PM 2.5 short term exposure.
6.Analysis of the registered dietitian competence assessment examination during 2017-2021 in China
Xiaoli WANG ; Yajie ZHANG ; Jing LIAO ; Aiguo MA ; Wei CAI ; Junsheng GUO ; Ya LIU ; Xiuhua SHEN ; Yuexin YANG
Chinese Journal of Clinical Nutrition 2022;30(5):300-305
Objective:To analyze the competence assessment examinations of registered dietitians in China during 2017-2021 to inform the training of dietetic professionals.Methods:A systematic review was conducted about the composition and changing trends of examination participants during 2017-2021. Participants were divided into subgroups based on gender, age, education, professional background and affiliations and the qualification rate was compared across different subgroups.Results:The number of examination participants showed an increasing trend overall, with the majority being females and aged 26-35 years. The ratio of participants with bachelor's: master's: doctor's degree was about 15: 9: 1. The proportion of participants majoring in nutrition science decreased from 32.1% to 20.3%, while that of participants majoring in other medical and food sciences increased. Among participants from healthcare institutions, a decreasing proportion of participants were with a major in nutrition science, while this proportion among participants from companies were stable at 38.8% to 50.2%. The average qualification rate was 35.7%, showing no significant differences among different gender and age groups. But the qualification rate varied significantly across subgroups with different education level, professional background, and affiliations ( P < 0.05). Subgroups with more advanced degrees showed higher qualification rate and the best rate was observed in the subgroups with professional background in nutrition science and from nutrition-related institutions. Conclusion:The training of dietetic professionals in China should be improved, lifelong learning should be promoted in nutrition practitioners, and the sustainable development of dietitians should be impelled.
7.Scientific and Ethical Analysis of 840 Registered COVID-19 Clinical Studies
Donghai ZHANG ; Xiuhua MA ; Lili MA
Chinese Medical Ethics 2022;35(4):427-432
From January 23, 2020 to May 29, 2021, there were 17,550 clinical research registrations on the China Clinical Trial Registry Platform. The index of clinical research on COVID-19 showed 840 registrations, accounting for 4.79% (840/17 550) of the total registrations. According to the trend chart of epidemic development, 487 clinical research projects of COVID-19 registered from January 23, 2020 to March 18, 2020 were set as the early stage of epidemic discovery in the region, the following 15 months were divided into stable initial stage, stable later stage and the later stage of the first wave of domestic epidemic every five months. The proportion of COVID-19 research projects registered in each stage was 29.80%, 5.87%, 0.76% and 1.15% of all registered projects respectively. The registration ratios of COVID-19 in each clinical stage was 57.98%, 28.81%, 5.95% and 7.26% respectively. Intervention studies were 61.60% (300/487) in the early stage of the epidemic, and most of them were in biological agent and drug therapy, which were 40.49%, 50.00% and 73.77% respectively in the later stages. Stable initial stage biological agent projects decreased. Then the vaccine research program became a focused research program. Among the 58 registration projects involving vaccines, 25 were clinical trials of vaccines in different stages, with the major research units being biopharmaceutical companies. Of the 487 clinical studies registered in the early stage, 10.23%(50/487) were withdrawn, of which 38 were intervention treatment studies, most notably drug studies (17) and blood biological products (16), but they were still registered in the stable initial stage. It is necessary to reflect on the scientific and ethical nature of early COVID-19 clinical trials or research, including whether the three core values of equal respect, help to alleviate pain and fairness can be achieved. Whether the "ethics review meeting should pay special attention to the scientificity, safety, fairness, subject protection, informed consent documents and informed consent process, avoidance of conflicts of interest, etc. of clinical trials or research" has been implemented. Competent government departments at all levels and all clinical medical research institutions should organize evaluation, and then establish an effective evaluation mechanism when new clinical trials or research projects are registered in the future.
8.Association between short-term exposure of fine particulate matters and blood pressure in children and adolescents
HUO Jiakang, DONG Yanhui, LI Weiming, WU Lijuan, CHEN Li, CHEN Manman, MA Ying, GUO Xiuhua, MA Jun
Chinese Journal of School Health 2021;42(5):723-727
Objective:
To evaluate the association of short-term fine particulate matters (PM2.5) exposure and blood pressure in children and adolescents.
Methods:
A total of 144 813 junior and senior middle school students who participated in the physical examination in the 2017-2018 academic year in a northern city of China, with complete record of demographic characteristics, blood pressure and no history of heart and other important organ diseases were selected as the study subjects. Data on PM2.5 and other pollutants and meteorological data were obtained from the nearest air quality and meteorological monitoring stations of each schools. A generalized linear mixed effect model was used to analyze the association between short-term exposure of PM2.5 and blood pressure.
Results:
The 6 day average concentration of PM2.5 (lag05) increased by 10 μg/m 3 was associated with an increase of 0.177(95%CI=0.148-0.207)mm Hg (1 mm Hg=0.133 kPa) in systolic blood pressure and 4.4%(OR=1.044, 95%CI=1.030-1.058) increase of the prevalence of high systolic blood pressure. And it was also associated with -0.021(95%CI=-0.040--0.002)mm Hg decrease in diastolic blood pressure, but had no significant correlation with the prevalence of high diastolic blood pressure. In general, a 10 μg/m 3 increase of PM2.5 was associated with 3.3% increase in the prevalence of high blood pressure (OR=1.03, 95%CI=1.02-1.05), and difference of boys and girls were found in different lagged days (P<0.05).
Conclusion
Short-term exposure of PM2.5 is associated with increased systolic blood pressure and prevalence of high blood pressure among children and adolescents. Attention should be paid to the prevention of short-term exposure of PM2.5 to protect the health of children and adolescents.
9.Establishment of a hypobaric hypoxia-induced cell injury model in PC12 cells.
Dongmei ZHANG ; Qilu CAO ; Linlin JING ; Xiuhua ZHAO ; Huiping MA
Journal of Zhejiang University. Medical sciences 2021;50(5):614-620
To construct a hypobaric hypoxia-induced cell injury model. Rat pheochromocytoma PC12 cells were randomly divided into control group, normobaric hypoxia group and hypobaric hypoxia group. The cells in control group were cultured at normal condition, while cells in other two groups were cultured in normobaric hypoxia and hypobaric hypoxia conditions, respectively. CCK-8 method was used to detect cell viability to determine the optimal modeling conditions like the oxygen concentration, atmospheric pressure and low-pressure hypoxia time. The contents of lactate dehydrogenase (LDH), superoxide dismutase (SOD) and malondialdehyde (MDA) were detected by microplate method. The apoptosis ratio and cell cycle were analyzed by flow cytometry. The hypobaric hypoxia-induced cell injury model can be established by culturing for 24 h at 1% oxygen concentration and 41 kPa atmospheric pressure. Compared with the control group and normobaric hypoxia group, the activity of LDH and the content of MDA in hypobaric hypoxia group were significantly increased, the activity of SOD was decreased, the percentage of apoptosis was increased (all <0.05), and the cell cycle was arrested in G0/G1 phase. A stable and reliable cell injury model induced by hypobaric hypoxia has been established with PC12 cells, which provides a suitable cell model for the experimental study on nerve injury induced by hypoxia at high altitude.
Animals
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Cell Hypoxia
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Hypoxia
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Malondialdehyde
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PC12 Cells
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Rats
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Superoxide Dismutase/metabolism*
10.Clinical research progress of PET imaging in tumor hypoxia
Yuan MA ; Xiuhua FU ; Lihong WANG ; Yan GU
Chinese Journal of Nuclear Medicine and Molecular Imaging 2021;41(9):562-565
Hypoxia is a common phenomenon of solid tumor, which is closely related to the malignant proliferation, tumor progression, radiotherapy and chemotherapy resistance, treatment failure, and poor prognosis. At present, many researches focus on the application of medical imaging and nuclear medicine methods in detecting the hypoxic areas of tumors. This article focuses on the detection of hypoxia microenvironment and the application of PET tracers in tumor hypoxia imaging.


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