1.Improvement of China's legal system for public health emergency management from the perspective of lifecycle management.
Kai Yuan CHEN ; Chen Guang WANG ; Yi ZHANG ; Rong Xin HE ; Jin Yu HE ; Ji Ming ZHU ; Wan Nian LIANG
Chinese Journal of Epidemiology 2023;44(5):689-693
A crucial lesson gained through the pandemic preparedness and response to COVID-19 is that all measures for epidemic control must be law-based. The legal system is related not only to public health emergency management per se but also to all aspects of the institutional supporting system throughout the lifecycle. Based on the lifecycle emergency management model, this article analyses the problems of the current legal system and the potential solutions. It is suggested that the lifecycle emergency management model shall be followed to establish a more comprehensive public health legal system and to gather the intelligence and consensus of experts with different expertise, including epidemiologists, sociologists, economists, jurist and others, which will collaboratively promote the science-based legislation in the field of epidemic preparedness and response for the establishment of a comprehensive legal system for public health emergency management and with Chinese characteristics.
Humans
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China
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Pandemics/prevention & control*
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Public Health
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Emergencies
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Disaster Planning
2.Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies.
Jun LIU ; Nian WANG ; Hai-Xia DANG ; Bing-Wei CHEN ; Li ZHANG ; Chong ZOU ; Cheng-Liang ZHONG ; Ju-Kai HUANG ; Qiong LIU ; Ya-Nan YU ; Meng JIANG ; Wei-Xiong LIANG ; Qi-Guang CHEN ; Yong-Yan WANG ; Chun-Ti SHEN ; Zhong WANG
Chinese journal of integrative medicine 2021;27(7):483-489
Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.
3.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
BACKGROUND:
Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE:
This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
MAIN OUTCOME MEASURES:
The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS:
A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION:
SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER
NCT02063100 on ClinicalTrials.gov.
4.Bufotenine and its derivatives: synthesis, analgesic effects identification and computational target prediction.
Chao ZHAO ; Min CHEN ; Shan-Liang SUN ; Jiao-Jiao WANG ; Yue ZHONG ; Huan-Huan CHEN ; He-Min LI ; Han XU ; Nian-Guang LI ; Hong-Yue MA ; Xiao-Long WANG
Chinese Journal of Natural Medicines (English Ed.) 2021;19(6):454-463
Natural product bufotenine (5) which could be isolated from Venenum Bufonis, has been widely used as a tool in central nervous system (CNS) studies. We present here its quaternary ammonium salt (6) which was synthesized with high yields using 5-benzyloxyindole as raw materials, and we firstly discover its analgesic effects in vivo. The analgesic evaluation showed that compounds 5 and 6 had stronger effects on the behavior of formalin induced pain in mice. Moreover, the combination of compound 6 and morphine has a synergistic effect. We intended to explain the molecular mechanism of this effect. Therefore, 36 analgesic-related targets (including 15 G protein-coupled receptors, 6 enzymes, 13 ion channels, and 2 others) were systemically evaluated using reverse docking. The results indicate that bufotenine and its derivatives are closely related to acetyl cholinesterase (AChE) or α
5.Sex-specific and Dose-response Relationship between the Incidence of Gallstones and Components of the Metabolic Syndrome in Jinchang Cohort: A Prospective Study.
Jing Li YANG ; Jun Jun HUANG ; Ning CHENG ; De Sheng ZHANG ; Si Min LIU ; Wen Ya HUANG ; Na LI ; Pei Yao HUANG ; Jiao DING ; Nian LIU ; Kai Fang BAO ; Jie DING ; Xiao Liang CHEN ; Tong Zhang ZHENG ; Ya Na BAI
Biomedical and Environmental Sciences 2020;33(8):633-638
6.Typical case analysis of COVID-19 cluster epidemic in Shaanxi, 2020
Sa CHEN ; Yi ZHANG ; Chao LI ; Shaoqi NING ; Xinxin LI ; Ni ZHU ; Yunpeng NIAN ; Lei CAO ; Guojing YANG ; Weihua WANG ; Yezhou LIU ; Liang WANG ; Fangliang LEI ; Feng LIU ; Mingwang SHEN
Chinese Journal of Epidemiology 2020;41(8):1204-1209
Objective:By analyzed the transmission patterns of 4 out of the 51 COVID-19 cluster cases in Shaanxi province to provide evidences for the COVID-19 control and prevention.Methods:The epidemiological data of RT-PCR test-confirmed COVID-19 cases were collected. Transmission chain was drawn and the transmission process was analyzed.Results:Cluster case 1 contained 13 cases and was caused by a family of 5 who traveled by car to Wuhan and returned to Shaanxi. Cluster case 2 had 5cases and caused by initial patient who participated family get-together right after back from Wuhan while under incubation period. Cluster case 3 contained 10 cases and could be defined as nosocomial infection. Cluster case 4 contained 4 cases and occurred in work place.Conclusion:Higher contact frequency and smaller places were more likely to cause a small-scale COVID-19 cluster outbreak, with potential longer incubation period. COVID-19 control strategies should turn the attention to infection prevention and control in crowded places, management of enterprise resumption and prevention of nosocomial infection.
7.Epidemiological characteristics of COVID-19 in Shaanxi province
Ni ZHU ; Chao LI ; Shaoqi NING ; Sa CHEN ; Lei CAO ; Guojing YANG ; Xinxin LI ; Yunpeng NIAN ; Weihua WANG ; Yezhou LIU ; Liang WANG ; Fangliang LEI ; Yi ZHANG ; Guihua ZHUANG
Chinese Journal of Epidemiology 2020;41(9):1411-1414
Objective:To understand the incidence trend and epidemiological characteristics of COVID-19 in Shaanxi province.Methods:The incidence data of COVID-19 reported in Shaanxi as of 22 February, 2020 were collected for an epidemiological descriptive analysis.Results:A total of 245 confirmed cases of COVID-19 were reported in Shaanxi. Most cases were mild (87.76%). As time passed, the areas where confirmed cases were reported continued to increase. The case number in Xi’an was highest, accounting for nearly half of the total reported cases in the province. The epidemic pattern in Shaanxi had gradually shifted from imported case pattern to local case pattern, and the transmission of local cases was mainly based on family cluster transmission. The confirmed cases from different sources had caused the secondary transmission in Shaanxi. After February 7, the number of reported cases began to fluctuate and decrease stably, indicating a decrease-to-zero period.Conclusions:At present, the overall epidemic of COVID-19 in Shaanxi has gradually been mitigated. However, considering the approaching of return to work and study and the increasing of imported cases from other countries, the prevention and control of COVIS-19 in Shaanxi will face new challenges.
8.Effect of autonomous motivation on the severity and short-term clinical effcacy of depression
Nian LI ; Kezhi LIU ; Wei LEI ; Jing CHEN ; Bo XIANG ; Xuemei LIANG
Chinese Journal of Behavioral Medicine and Brain Science 2018;27(1):47-51
Objective To investigate the traits of autonomous motivation and its effect on the de-pression severity and short-term clinic outcome. Methods Behavioral Approach System and Behavioral In-hibition System Scale(BAS / BIS),Motivational Traits Questionnaire Short Form(MTQ),the Hamilton De-pression Scale(HAMD-17)and the Hamilton Anxiety Scale(HAMA)were applied to 82 depression patients (case group)at baseline and after 2 weeks of treatment and 82 gender-matched healthy controls(control group). The reduction rate of HAMD total scores before and after treatment was used as the main efficacy in-dicator.Results The scores of MTQ-desire to learn((30.37 ± 6.78)vs(33.72 ± 4.34))and MTQ-mastery ((28.68±6.24)vs(32.29±4.74)),BAS-drive scores((9.90±2.76)vs(11.18±2.13))were significantly lower in the case group than those in the control group,and the difference was statistically significant(all P<0.001),While the scores of MTQ-emotionality((36.26± 7.14)vs(27.29± 5.73)),MTQ-worry((40.87± 7.56)vs(33.69±6.38)),BIS scores((22.68±2.61)vs(15.51±3.62))were significantly higher than those in the control group,the difference was statistically significant(all P<0.01).Correlation analysis found that baseline HAMD-17total scores were significantly positively correlated with baseline HAMA total scores(r=0.666,P<0.05),BIS(r=0.278,P<0.05),MTQ-worry(r=0.264,P<0.05)and MTQ- emotionality(r=0.371, P<0.05). Baseline HAMA total scores were significantly positively correlated with baseline HAMD-17 total scores(r=0.666,P<0.05),MTQ-worry(r=0.228,P<0.05)and MTQ-emotionality(r=0.282,P<0.05). The reduction rate of HAMD-17 and HAMA in patients with 2 weeks of treatment was respectively used with step-wise regression analysis,which showed that the significant contribution of MTQ-mastery and BAS-drive,and explained the reduction rate variables 19%(R2=0.19)of HAMD. BAS-drive contributed significantly,and explained the reduction rate variables 16.9%(R2=0.169)of HAMA. Conclusion Autonomous motivation levels of depression patients are significantly lower than that of healthy controls,while higher levels of autono-mous motivation(BAS-drive)may be associated with better short-term clinic outcome.
9.Analysis of In-hospital Neonatal Death in the Tertiary Neonatal Intensive Care Unit in China: A Multicenter Retrospective Study.
Chen-Hong WANG ; Li-Zhong DU ; Xiao-Lu MA ; Li-Ping SHI ; Xiao-Mei TONG ; Hong LIU ; Guo-Fang DING ; Bin YI ; Xin-Nian PAN ; Dan-Ni ZHONG ; Ling LIU ; Mei LI ; Cui-Qing LIU ; Shi-Wen XIA ; Hong-Yun WANG ; Ling HE ; Kun LIANG ; Xiao-Yu ZHOU ; Shu-Ping HAN ; Qin LYU ; Yin-Ping QIU ; Ruo-Bing SHAN ; De-Zhi MU ; Xiao-Hong LIU ; Si-Qi ZHUANG ; Jing GUO ; Li LIU ; Jia-Jun ZHU ; Hong XIONG
Chinese Medical Journal 2016;129(22):2652-2658
BACKGROUNDGlobally, the proportion of child deaths that occur in the neonatal period remains a high level of 37-41%. Differences of cause in neonate death exist in different regions as well as in different economic development countries. The specific aim of this study was to investigate the causes, characteristics, and differences of death in neonates during hospitalization in the tertiary Neonatal Intensive Care Unit (NICU) of China.
METHODSAll the dead neonates admitted to 26 NICUs were included between January l, 2011, and December 31, 2011. All the data were collected retrospectively from clinical records by a designed questionnaire. Data collected from each NICU were delivered to the leading institution where the results were analyzed.
RESULTSA total of 744 newborns died during the 1-year survey, accounting for 1.2% of all the neonates admitted to 26 NICUs and 37.6% of all the deaths in children under 5 years of age in these hospitals. Preterm neonate death accounted for 59.3% of all the death. The leading causes of death in preterm and term infants were pulmonary disease and infection, respectively. In early neonate period, pulmonary diseases (56.5%) occupied the largest proportion of preterm deaths while infection (27%) and neurologic diseases (22%) were the two main causes of term deaths. In late neonate period, infection was the leading cause of both preterm and term neonate deaths. About two-thirds of neonate death occurred after medical care withdrawal. Of the cases who might survive if receiving continuing treatment, parents' concern about the long-term outcomes was the main reason of medical care withdrawal.
CONCLUSIONSNeonate death still accounts for a high proportion of all the deaths in children under 5 years of age. Our study showed the majority of neonate death occurred in preterm infants. Cause of death varied with the age of death and gestational age. Accurate and prompt evaluation of the long-term outcomes should be carried out to guide the critical decision.
Cause of Death ; China ; Female ; Hospital Mortality ; Humans ; Infant ; Infant Mortality ; Infant, Newborn ; Infant, Newborn, Diseases ; mortality ; Intensive Care Units, Neonatal ; statistics & numerical data ; Male ; Perinatal Death ; Retrospective Studies
10.Nerve growth factor potentiates bone morphogenetic protein-9-induced osteogenic differentiation in mouse embryonic fibroblasts
Changjun PI ; Xiang ZOU ; Ranxi ZHANG ; Nian WU ; Baicheng HE ; Zhongliang DENG ; Liang CHEN
Chinese Journal of Trauma 2016;32(2):171-175
Objective To investigate the effect of nerve growth factor (NGF) on osteogenesis induced by bone morphogenetic protein-9 (BMP-9) in mouse embryonic fibroblasts (MEFs).Methods MEFs were respectively transfected with adenovirus-mediated NGF (NGF group), BMP-9 (BMP-9 group) and NGF + BMP-9 (combined group) and green fluorescence protein (GFP) (control group).Cytochemical staining was used to test the activity of alkaline phosphatase (ALP) 3 d and 5 d after treatment.Level of osteopontin (OPN) mRNA was detected by RT-PCR 9 d after treatment.Level of OPN protein was assayed by Western blot and immunocytochemistry 9 d after treatment.Mineralization was detected by Alizarin red staining 14 d after treatment.Results ALP activity in MEFs was elevated in BMP-9 group rather than in NGF group, but a significant increase in ALP activity was noted in combined group.In control group, BMP-9 group, NGF group and combined group, level of OPN mRNA was 0.92 ± 0.03, 1.28 ± 0.04, 0.94 ± 0.03 and 1.62 ± 0.04 respectively (F =214.60, P < 0.01);level of OPN protein was 0.60 ± 0.05, 0.84 ± 0.03, 0.53 ± 0.05 and 1.27 ± 0.05 respectively (F =162.5, P < 0.01).In comparison, OPN mRNA and protein were significantly up-regulated in combined group than in BMP-9 group (t =10.569 and 11.778,P < 0.05).In control group, BMP-9 group, NGF group and combined group, relative density of OPN protein was 3.63 ±0.17, 6.27 ±0.30, 3.86 ±0.18 and 10.16 ±0.18respectively (F =602.6, P < 0.01), with a significant higher level in combined group than in BMP-9 group (t =22.280, P < 0.05).Level of mineralization was significantly higher in combined group than in BMP-9 or NGF group.Conclusion NGF can potentiate the osteogenesis induced by BMP-9 in MEFs.

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