1.Bioequivalence study of ezetimibe tablets in Chinese healthy subjects
Pei-Yue ZHAO ; Tian-Cai ZHANG ; Yu-Ning ZHANG ; Ya-Fei LI ; Shou-Ren ZHAO ; Jian-Chang HE ; Li-Chun DONG ; Min SUN ; Yan-Jun HU ; Jing LAN ; Wen-Zhong LIANG
The Chinese Journal of Clinical Pharmacology 2024;40(16):2378-2382
Objective To evaluate the bioequivalence and safety of ezetimibe tablets in healthy Chinese subjects.Methods The study was designed as a single-center,randomized,open-label,two-period,two-way crossover,single-dose trail.Subjects who met the enrollment criteria were randomized into fasting administration group and postprandial administration group and received a single oral dose of 10 mg of the subject presparation of ezetimibe tablets or the reference presparation per cycle.The blood concentrations of ezetimibe and ezetimibe-glucuronide conjugate were measured by high-performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS),and the bioequivalence of the 2 preparations was evaluated using the WinNonlin 7.0 software.Pharmacokinetic parameters were calculated to evaluate the bioequivalence of the 2 preparations.The occurrence of all adverse events was also recorded to evaluate the safety.Results The main pharmacokinetic parameters of total ezetimibe in the plasma of the test and the reference after a single fasted administration:Cmax were(118.79±35.30)and(180.79±51.78)nmol·mL-1;tmax were 1.40 and 1.04 h;t1/2 were(15.33±5.57)and(17.38±7.24)h;AUC0-t were(1 523.90±371.21)and(1 690.99±553.40)nmol·mL-1·h;AUC0-∞ were(1 608.70±441.28),(1 807.15±630.00)nmol·mL-1·h.The main pharmacokinetic parameters of total ezetimibe in plasma of test and reference after a single meal:Cmax were(269.18±82.94)and(273.93±87.78)nmol·mL-1;Tmax were 1.15 and 1.08 h;t1/2 were(22.53±16.33)and(16.02±5.84)h;AUC0_twere(1 463.37±366.03),(1 263.96±271.01)nmol·mL-1·h;AUC0-∞ were(1 639.01±466.53),(1 349.97±281.39)nmol·mL-1·h.The main pharmacokinetic parameters Cmax,AUC0-tand AUC0-∞ of the two preparations were analyzed by variance analysis after logarithmic transformation.In the fasting administration group,the 90%CI of the log-transformed geometric mean ratios were within the bioequivalent range for the remaining parameters in the fasting dosing group,except for the Cmax of ezetimibe and total ezetimibe,which were below the lower bioequivalent range.The Cmax of ezetimibe,ezetimibe-glucuronide,and total ezetimibe in the postprandial dosing group was within the equivalence range,and the 90%CI of the remaining parameters were not within the equivalence range for bioequivalence.Conclusion This test can not determine whether the test preparation and the reference preparation of ezetimibe tablets have bioequivalence,and further clinical trials are needed to verify it.
2.A Campylobacteriosis Outbreak Caused by One Asymptomatic Food Handler Carrier.
Ai Xia YAN ; Gui Lan ZHOU ; Peng GAO ; Ying KANG ; Shou Fei LI ; Yuan Yuan WANG ; Feng Shuang WANG ; Hai Rui WANG ; Ying LI ; Mao Jun ZHANG
Biomedical and Environmental Sciences 2023;36(8):779-782
In August 2021, three students with diarrhea from the same school visited a local hospital in the S district of Beijing. An epidemic investigation showed that there were more students with diarrhea in the same school and they had one meal together. Campylobacter jejuni was isolated from both patients with diarrhea and asymptomatic food handlers; however, the latter also carried Campylobacter coli. Phylogenomic analysis showed that there was a campylobacteriosis outbreak among the students, and the asymptomatic food handler may have been the source of the infection. Routine inspection and surveillance for Campylobacter is needed for the food producing staff, particularly those cooking in the cafeteria in schools or other public food services.
Humans
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Campylobacter Infections/epidemiology*
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Gastroenteritis
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Diarrhea
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Campylobacter
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Disease Outbreaks
3.A Novel Diagnostic and Therapeutic Strategy for Cancer Patients by Integrating Chinese Medicine Syndrome Differentiation and Precision Medicine.
Shu-Xian YU ; Zi-Mao LIANG ; Qi-Biao WU ; Lan SHOU ; Xing-Xing HUANG ; Qian-Ru ZHU ; Han XIE ; Ru-Yi MEI ; Ruo-Nan ZHANG ; Xiang-Yang ZHAI ; Tian XIE ; Xin-Bing SUI
Chinese journal of integrative medicine 2022;28(10):867-871
Applying Chinese medicine (CM) is an important strategy for malignant tumor treatment in China. One of the significant characteristics of CM is to treat diseases based on syndrome differentiation. For Western medicine, it is of important clinical significance to formulate guidelines for the diagnosis and treatment of cancer patients based on the characteristics of disease differentiation. In Chinese clinical practice, the combination of disease differentiation and syndrome differentiation is an important feature for cancer treatment in the past. Currently, molecular profiling and genomic analysis-based precision medicine optimizes the anticancer drug design and holds the greatest success in treating cancer patients. Therefore, we want to know which populations of cancer patients can benefit more from CM treatment if the theory of precision medicine is applied to CM clinical practice. So, we developed a novel diagnostic and therapeutic strategy "disease-syndrome differentiation-genomic profiling-prescriptions" for cancer patients by CM syndrome differentiation and precision medicine. As a result, this strategy has greatly enhanced the anti-tumor efficacy of CM and improved clinical outcomes for cancer patients with some gene mutations. Our idea will hopefully establish a novel approach for the inheritance and innovation of CM.
Antineoplastic Agents
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Drugs, Chinese Herbal/therapeutic use*
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Humans
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Medicine, Chinese Traditional
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Neoplasms/therapy*
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Precision Medicine
;
Syndrome
4.Prevalence and influencing factors of Enterobius vermicularis infections among children in Fanxian County of Henan Province in 2019
Chuan-Qing SONG ; Xue-Cheng JIAO ; Tian-Tian JIANG ; Gui-Hua LIANG ; Lan-Zhen WANG ; Yin-Huai XU ; Shou-Hai HUANG ; Wei-Qi CHEN ; Yan DENG ; Ya-Lan ZHANG
Chinese Journal of Schistosomiasis Control 2021;33(4):406-410
Objective To investigate the prevalence and influencing factors of Enterobius vermicularis infections among children in Fanxian County, Henan Province in 2019, so as to provide insights into the management of enterobiasis. Methods Five kindergartens were selected in urban and rural areas of Fanxian County, Henan Province using the stratified sampling method in 2019, and a census of E. vermicularis infections was performed among all children in the kindergartens. E. vermicularis eggs were detected using adhesive and scotch cellophane-tape anal swab methods, and the basic characteristics of children and their families, health habits and the kindergartens’ information were investigated with questionnaires. Logistic regression analysis was used to investigate the risk factors and protective factors of pinworm infection in children. Results A total of 671 children were tested, and the mean prevalence of E. vermicularis infections was 15.50% (104/671). The prevalence of E. vermicularis infections was higher among children in rural kindergartens (28.13%, 72/256) than in urban kindergartens (7.71%, 32/415) (χ2 = 50.380, P < 0.01), and greater in private kindergartens (32.26%, 60/186) than in public kindergartens (9.07%, 44/485) (χ2 = 55.183, P < 0.01). There was no gender-specific prevalence of E. vermicularis infections among children (χ2 = 1.442, P > 0.05), and the prevalence of E. vermicularis infections presented a tendency towards a rise with age (χ2trend = 8.373, P < 0.05) and school grade (χ2trend = 30.274, P < 0.05). Logistic regression analysis identified rural kindergartens and high grades as risk factors, and separate washing of children’s and adults’ cloths, frequent bathing and frequent dinnerware disinfection in kindergartens as protective factors for E. vermicularis infections among children. In addition, there was no significant difference in the detection of E. vermicularis infections among children by using adhesive (73.08%, 76/104) and scotch cellophane-tape anal swab methods (56.73%, 59/104) (χ2 = 3.959, P > 0.05). Conclusions The prevalence of E. vermicularis infection is high among children in Fanxian Country, Henan Province. Health education and surveillance of enterobiasis are required to be intensified among children in rural kindergartens and senior grades and their parents and teachers.
5.Association of Overlapped and Un-overlapped Comorbidities with COVID-19 Severity and Treatment Outcomes: A Retrospective Cohort Study from Nine Provinces in China.
Yan MA ; Dong Shan ZHU ; Ren Bo CHEN ; Nan Nan SHI ; Si Hong LIU ; Yi Pin FAN ; Gui Hui WU ; Pu Ye YANG ; Jiang Feng BAI ; Hong CHEN ; Li Ying CHEN ; Qiao FENG ; Tuan Mao GUO ; Yong HOU ; Gui Fen HU ; Xiao Mei HU ; Yun Hong HU ; Jin HUANG ; Qiu Hua HUANG ; Shao Zhen HUANG ; Liang JI ; Hai Hao JIN ; Xiao LEI ; Chun Yan LI ; Min Qing LI ; Qun Tang LI ; Xian Yong LI ; Hong De LIU ; Jin Ping LIU ; Zhang LIU ; Yu Ting MA ; Ya MAO ; Liu Fen MO ; Hui NA ; Jing Wei WANG ; Fang Li SONG ; Sheng SUN ; Dong Ting WANG ; Ming Xuan WANG ; Xiao Yan WANG ; Yin Zhen WANG ; Yu Dong WANG ; Wei WU ; Lan Ping WU ; Yan Hua XIAO ; Hai Jun XIE ; Hong Ming XU ; Shou Fang XU ; Rui Xia XUE ; Chun YANG ; Kai Jun YANG ; Sheng Li YUAN ; Gong Qi ZHANG ; Jin Bo ZHANG ; Lin Song ZHANG ; Shu Sen ZHAO ; Wan Ying ZHAO ; Kai ZHENG ; Ying Chun ZHOU ; Jun Teng ZHU ; Tian Qing ZHU ; Hua Min ZHANG ; Yan Ping WANG ; Yong Yan WANG
Biomedical and Environmental Sciences 2020;33(12):893-905
Objective:
Several COVID-19 patients have overlapping comorbidities. The independent role of each component contributing to the risk of COVID-19 is unknown, and how some non-cardiometabolic comorbidities affect the risk of COVID-19 remains unclear.
Methods:
A retrospective follow-up design was adopted. A total of 1,160 laboratory-confirmed patients were enrolled from nine provinces in China. Data on comorbidities were obtained from the patients' medical records. Multivariable logistic regression models were used to estimate the odds ratio (
Results:
Overall, 158 (13.6%) patients were diagnosed with severe illness and 32 (2.7%) had unfavorable outcomes. Hypertension (2.87, 1.30-6.32), type 2 diabetes (T2DM) (3.57, 2.32-5.49), cardiovascular disease (CVD) (3.78, 1.81-7.89), fatty liver disease (7.53, 1.96-28.96), hyperlipidemia (2.15, 1.26-3.67), other lung diseases (6.00, 3.01-11.96), and electrolyte imbalance (10.40, 3.00-26.10) were independently linked to increased odds of being severely ill. T2DM (6.07, 2.89-12.75), CVD (8.47, 6.03-11.89), and electrolyte imbalance (19.44, 11.47-32.96) were also strong predictors of unfavorable outcomes. Women with comorbidities were more likely to have severe disease on admission (5.46, 3.25-9.19), while men with comorbidities were more likely to have unfavorable treatment outcomes (6.58, 1.46-29.64) within two weeks.
Conclusion
Besides hypertension, diabetes, and CVD, fatty liver disease, hyperlipidemia, other lung diseases, and electrolyte imbalance were independent risk factors for COVID-19 severity and poor treatment outcome. Women with comorbidities were more likely to have severe disease, while men with comorbidities were more likely to have unfavorable treatment outcomes.
Adult
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Aged
;
COVID-19/virology*
;
China/epidemiology*
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Comorbidity
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Female
;
Humans
;
Male
;
Middle Aged
;
Retrospective Studies
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Severity of Illness Index
;
Treatment Outcome
6.Fermentation of cellulase with multiple types of Salvia miltiorrhiza residues and other solid wastes from Chinese materia medica industrialization.
Shou-Zhe QIU ; Fei ZENG ; Sen ZHANG ; Shu-Lan SU ; Sheng GUO ; Da-Wei QIAN ; Ming-Zhe ZHAO ; Jin-Ao DUAN
China Journal of Chinese Materia Medica 2020;45(4):890-895
The solid wastes of Chinese materia dedica industrialization represented by Salvia miltiorrhiza residues have a strong small-molecule bio-recalcitrance in the process of high-value utilization of biotransformation. Highly tolerant strains were bred to break bio-recalcitrance of Salvia miltiorrhiza residues and produce high-value added cellulose, which has a significant significance for recycling and industrial utilization of solid waste. In this study, a strain of fungus, Penicillium expansum SZ13, was found with small-molecule antibacterial substance tanshinone contained in Salvia miltiorrhiza residues by a biological method. The optimal enzyme production process and peak period of SZ13 were determined. It was found that SZ13 could maintain peak enzyme production for 5 days by degrading residues under the conditions of temperature 35 ℃, rotation speed 180 r·min~(-1), 5% of residues addition, and 5% seed solution addition. Meanwhile, the ability of SZ13 to degrade the enzyme production of multiple types of residues was explored. The results showed a high enzyme activity and stable enzyme production of SZ13 in the process of degrading residues. SZ13 could efficiently utilize various types of Chinese medicine residues, such as Salvia miltiorrhiza residues, to realize the high-value utilization of cellulose in multiple types of residues.
Cellulase/biosynthesis*
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China
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Drug Industry
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Drugs, Chinese Herbal
;
Fermentation
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Materia Medica
;
Penicillium/metabolism*
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Salvia miltiorrhiza
;
Solid Waste
7.The relationship between inflammatory factors and the risk of breast cancer in Kailuan cohort
Gang WANG ; Ni LI ; Xiao-shuang FENG ; Zhang-yan LV ; Luo-pei WEI ; Xin LI ; Yu-heng CHEN ; Lan-wei GUO ; Hong-da CHEN ; Jian YIN ; Hong CUI ; Jian-song REN ; Shou-ling WU ; Ju-fang SHI ; Min DAI ; Jie HE
Chinese Journal of Disease Control & Prevention 2019;23(5):517-521
Objective To investigate whether elevated baseline levels of high sensitivity C-Reactive Protein (hsCRP) and neutrophil (NE) are associated with an increased risk of breast cancer in Kailuan female cohort. Methods Females from Kailuan cohort (2006-2007) were included in this study. Information on check-up, hsCRP and NE were collected at baseline for all subjects. Multivariable Cox proportional hazards regression models were used to calculate hazard ratios (HR) and 95% confidence intervals (95%CI) of association between baseline hsCRP and NE values and breast cancer risk. Results By December 31, 2015, a total of 18 866 participants were enrolled in this study. During the follow-up, 183 new cases of breast cancer were observed. All participants were divided into three groups according to the level of hsCRP (<1 mg/L, 1-3 mg/L and >3 mg/L). The cumulative incidence of breast cancer were 829/105, 1 211/105 and 1 495/105 in these 3 groups, respectively ( 2=12.08, P=0.002). Compared with participants with lower hsCRP levels (<1 mg/L), individuals with the highest hsCRP (>3 mg/L) levels had significantly increased risk of breast cancer (HR=1.71,95%CI: 1.18-2.47, P=0.005), howerver, we didn’t find the statistically significant association between NE level (<3.70×109/Lvs. ≥3.70×109/L) and the risk of brease cancer (P>0.05). Conclusions Elevated levels of hsCRP at baseline might increase the risk of breast cancer in females.
8.Applicability of three surveillance methods for Aedes albopictus in dengue risk indication
Yan-xia CHEN ; Xi-ru ZHANG ; Shuang-lan YE ; Ming-ji PENG ; Yan-qing ZENG ; Xiao-ting CHEN ; Yong-zhi LI ; Qing CHEN ; Shou-yi YU
Chinese Journal of Disease Control & Prevention 2019;23(6):723-727
Objective To disscus the applicability of three surveillance methods for Aedes albopictus in dengue risk indication. Methods Larval and adult mosquito surveillance were conducted in two villages of Guangzhou by using three vector monitoring methods. Meteorological data and dengue cases were obtained in the same period. Results The population dynamics of larvae and adult mosquitoes were affected by temperature and their overall trend was consistent, but there were differences between the abundance of larvae and adult mosquitoes. From December to February the next year, Breteau index(BI) ranged from 5.66 to 24.53 with a risk of level 1 to 3 for dengue fever, while the mosquito and oviposition positive index(MOI) and adult-mosquito density index(ADI) were 0 to 4.00 and 0 to 1 per man-hour, respectively, indicating no risk for dengue fever. In March, compared with BI which indicated a risk of level 3, MOI were 2.13 and 3.77, respectively, representing for no risk. ADI were 4 to 6 per man-hour, indicating a risk of level 1 and level 2, respectively. After April, the dengue risk level reflected by each indicator became to be consistent. Conclusions The risk of dengue fever indicated by BI is always higher than or equal to the risk indicated by the other two. Compared with BI, MOI and ADI are more sensitively in reflecting the activity of Ae. albopictus.
10.Artificial Cycle with or without a Depot Gonadotropin-releasing Hormone Agonist for Frozen-thawed Embryo Transfer: An Assessment of Infertility Type that Is Most Suitable
Di XIE ; Fan CHEN ; Shou-Zhen XIE ; Zhi-Lan CHEN ; Ping TUO ; Rong ZHOU ; Juan ZHANG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2018;38(4):626-631
The clinical outcomes of five groups of infertility patients receiving frozenthawed,cleavage-stage embryo transfers with exogenous hormone protocols with or without a depot gonadotropin-releasing hormone (GnRH) agonist were assessed.A retrospective cohort analysis was performed on 1003 cycles undergoing frozen-thawed,cleavage-stage embryo transfers from January 1,2012 to June 31,2015 in the Reproductive Medicine Center of Wuhan General Hospital of Guangzhou Military Region.Based on the infertility etiologies of the patients,the 1003 cycles were divided into five groups:tubal infertility,polycystic ovary syndrome (PCOS),endometriosis,male infertility,and unexplained infertility.The main outcome was the live birth rate.Two groups were set up based on the intervention:group A was given a GnRH agonist with exogenous estrogen and progesterone,and group B (control group) was given exogenous estrogen and progesterone only.The results showed that the baseline serum hormone levels and basic characteristics of the patients were not significantly different between groups A and B.The live birth rates in groups A and B were 41.67% and 29.29%,respectively (P<0.05).The live birth rates in patients with PCOS in groups A and B were 56.25% and 30.61%,respectively (P<0.05).The clinical pregnancy,implantation and on-going pregnancy rates showed the same trends as the live birth rates between groups A and B.The ectopic pregnancy rate was significantly lower in group A than in group B.We concluded that the live birth rate was higher and other clinical outcomes were more satisfactory with GnRH agonist cotreatment than without GnRH agonist co-treatment for frozen-thawed embryo transfer.The GnRH agonist combined with exogenous estrogen and progesterone worked for all types of infertility tested,especially for women with PCOS.

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