1.Bioequivalence study of pyrazinamide tablets in Chinese healthy subjects
Li-Bing YE ; Chong YAO ; Ying-Rong CHEN ; Lu-Yuan TONG ; Tao YANG ; Xiao LU ; Min XU ; Qiu-Yue JIN ; Shui-Xin YANG
The Chinese Journal of Clinical Pharmacology 2024;40(15):2236-2240
Objective To evaluate the bioequivalence and safety of two pyrazinamide tablets in healthy Chinese subjects.Methods An open,randomized,single-dose,two-sequence,two-cycle,double-cross trial design was used.All 48 healthy subjects(24 in fasting and 24 in fed trial)were randomized to receive a single oral dose of a 0.5 g pyrazinamide tablet(test or reference)per cycle.The plasma concentration of the drug was determined by liquid chromatography coupled to tandem mass spectrometry method.The pharmacokinetic parameters were calculated by WinNonlin v8.2,and the bioequivalence was evaluated by SAS 9.4.Results In the fasting group,the Cmax of the test and reference preparation of pyrazinamide tablets were(13.28±2.82)and(12.88±4.49)μg·mL-1,the AUC0-t were(139.17±26.58)and(138.63±28.92)h·μg·mL-1,the AUC0-∞ were(148.96±33.65)and(148.71±36.97)h·μg·mL-1 respectively.In the fed group,the Cmax of the test and reference preparation of pyrazinamide tablets were(11.89±1.96)and(11.99±1.92)μg·mL-1,the AUC0-t were(138.22±37.21)and(141.68±25.80)h·μg·mL-1,the AUC0-∞ were(152.20±32.41)and(151.04±28.05)h·μg·mL-,respectively.The 90%confidence intervals of Cmax,AUC0-t and AUC0-∞ geometric mean ratios of the test and reference preparation were all within 80.00%to 125.00%.The incidence of adverse events was 16.70%for both the test and reference preparation in the fasting group and 8.30%for both the test and reference preparation in the fed group,all of which were mild in severity.Conclusion The test and reference preparation of pyrazinamide tablets were bioequivalent,safe and well tolerated in healthy Chinese subjects under fasting and fed conditions.
2.A multicenter study assessing the efficacy of various preoperative/pre-transfusion screening methods for blood transmitted disease
Junhua HU ; Li QIN ; Juan LIU ; Xinghuan MA ; Qin MENG ; Peng WANG ; Jiangcun YANG ; Rong GUI ; Chunhong DU ; Xiying LI ; Xianping LYU ; Rong XIA ; Fenghua LIU ; Shu SU ; Jinqi MA ; Yuan ZHANG ; Juan CAI ; Huifang JIN ; Qi ZHANG ; Jun ZHANG ; Rongyi CAO ; Bing HAN ; Jiwu GONG ; Jun ZHOU
Chinese Journal of Laboratory Medicine 2023;46(1):32-37
Objective:This multi-centre study was conducted to assess the efficacy of various preoperative/pre-transfusion screening methods for blood transmitted disease.Methods:From July 2021 to December 2021, plasma samples of patients admitted to 10 hospitals were collected for screening preoperative/pre-transfusion blood transmitted disease. Nucleic acid detection technology was used to detect hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus (HIV)(1+2) RNA, and the results were compared with the immuno-serological methods. χ 2 test and Kappa test were used to analyze the efficacy of these two methods. Results:A total of 8 655 valid specimens were collected from 10 hospitals. There was a statistically significant difference in the positive detection rate of HCV between the two methods ( P<0.001). There was no significant difference in the positive detection rate of HBV and HIV assessed by the two methods ( P>0.05), but the number of positive cases detected by HBV DNA and HIV RNA (218 and 4 cases) was significantly higher than the corresponding serological results (216 and 2 cases). At the same time, there were HBV, HCV and HIV immuno-serological omissions by the immuno-serological methods, among which 28 cases were HBsAg negative and HBV DNA positive, 2 cases were HCV antibody negative and HCV RNA positive, and 2 cases were HIV antigen/antibody negative and HIV RNA positive. In addition, in the 66 samples with inconsistent results from the two detection methods, 83.3% (55/66), 68.2% (45/66), 63.6% (42/66) and 62.1% (41/66) of patients aged was>45 years, tumor, surgery and male, respectively. Conclusions:Compared with immuno-serological tests, nucleic acid tests have the advantage in terms of sensitivity on detecting HBV, HCV and HIV infection and could reduce missed detection. The risk of transmission can be reduced by adding HBV, HCV, and HIV nucleic acid tests to preoperative/pre-transfusion immuno-serological tests screening for patients over 45 years of age and tumor patients.
3.Evaluation of metoprolol standard dosing pathway in Chinese patients with acute coronary syndrome: a prospective multicenter single-arm interventional study.
Xiao-Yun YIN ; Yun-Mei ZHANG ; Ai-Dong SHEN ; Jing-Ping WANG ; Zhe-Xun LIAN ; Yi-Bing SHAO ; Wen-Qi ZHANG ; Shu-Ying ZHANG ; Yang ZHENG ; Kang CHENG ; Biao XU ; Cheng-Xing SHEN ; Rong-Chong HUANG ; Jin-Cheng GUO ; Guo-Sheng FU ; Dong-Kai SHAN ; Dan-Dan LI ; Yun-Dai CHEN
Journal of Geriatric Cardiology 2023;20(4):256-267
OBJECTIVE:
To evaluate the feasibility and tolerability of metoprolol standard dosing pathway (MSDP) in Chinese patients with acute coronary syndrome (ACS).
METHODS:
In this multicenter, prospective, open label, single-arm and interventional study that was conducted from February 2018 to April 2019 in fifteen Chinese hospitals. A total of 998 hospitalized patients aged ≥ 18 years and diagnosed with ACS were included. The MSDP was applied to all eligible ACS patients based on the standard treatment recommended by international guidelines. The primary endpoint was the percentage of patients achieving the target dose at discharge (V2). The secondary endpoints included the heart rate and blood pressure at V2 and four weeks after discharge (V4), and percentage of patients experiencing bradycardia (heart rate < 50 beats/min), hypotension (blood pressure < 90/60 mmHg) and transient cardiac dysfunction at V2 and V4.
RESULTS:
Of the 998 patients, 29.46% of patients achieved the target dose (≥ 95 mg/d) at V2. The total population was divided into two groups: target group (patients achieving the target dose at V2) and non-target group (patients not achieving the target dose at V2). There was significant difference in the reduction of heart rate from baseline to discharge in the two groups (-4.97 ± 11.90 beats/min vs. -2.70 ± 9.47 beats/min, P = 0.034). There was no significant difference in the proportion of bradycardia that occurred in the two groups at V2 (0 vs. 0, P = 1.000) and V4 (0.81% vs. 0.33%, P = 0.715). There was no significant difference in the proportion of hypotension between the two groups at V2 (0.004% vs. 0.004%, P = 1.000) and V4 (0 vs. 0.005%, P = 0.560). No transient cardiac dysfunction occurred in two groups during the study. A total of five adverse events (1.70%) and one serious adverse event (0.34%) were related to the pathway in target group.
CONCLUSIONS
In Chinese ACS patients, the feasibility and tolerability of the MSDP have been proved to be acceptable.
4.Effects of chloropicrin fumigation on soil and growth and development of Panax notoginseng.
Long LI ; Rong-Feng PU ; Ming-Hua LI ; Chun-Yan DAI ; Kai ZHENG ; Zheng-Qiang JIN ; Chen-Bing MO ; Xiu-Ming CUI ; Ye YANG
China Journal of Chinese Materia Medica 2022;47(3):635-642
The continuous cropping obstacle of Panax notoginseng is serious, and effective control measures are lacking. Soil disinfection with chloropicrin(CP) has been proven to be effective in reducing the obstacles to continuous cropping of other crops. In order to ascertain the effect of CP in the continuous cropping of P. notoginseng, this paper explored the influences of CP at different treatment concentrations(0,30,40,50 kg/Mu, 1 Mu≈667 m~2) on soil macro-element nutrients, soil enzyme activity, growth and development of P. notoginseng, and the accumulation of medicinal components. The results showed that CP fumigation significantly increased the content of total nitrogen, alkali-hydrolyzable nitrogen, ammonium nitrogen, nitrate nitrogen, and available phosphorus in the soil, but it had no significant effect on potassium content. The soil protease activity showed a trend of first increasing and then decreasing with the prolonging of the treatment time. Both the soil urease and acid phosphatase activities showed a trend of first decreasing and then increasing with the prolonging of the treatment time. The higher the CP treatment concentration was, the lower the urease and acid phosphatase activities would be in the soil. The protease activity was relatively high after CP40 treatment, which was better than CP30 and CP50 treatments in promoting the nitrogen-phosphorus-potassium accumulation in P. notoginseng. The seedling survival rates after CP0, CP30, CP40, and CP50 tratments in October were 0, 65.56%, 89.44%, and 83.33%, respectively. Compared with the CP30 and CP50 treatments, CP40 treatment significantly facilitated the growth and development of P. notoginseng, the increase in fresh and dry weights, and the accumulation of root saponins. In summary, CP40 treatment accelerates the increase in soil nitrogen and phosphorus nutrients and their accumulation in P. notoginseng, elevates the seedling survival rate of P. notoginseng, enhances the growth and development of P. notoginseng, and promotes the accumulation of medicinal components. CP40 treatment is therefore recommended in production.
Fumigation
;
Growth and Development
;
Hydrocarbons, Chlorinated
;
Panax notoginseng
;
Soil
5.Clinical treatment outcomes and their changes in extremely preterm twins: a multicenter retrospective study in Guangdong Province, China.
Bi-Jun SHI ; Ying LI ; Fan WU ; Zhou-Shan FENG ; Qi-Liang CUI ; Chuan-Zhong YANG ; Xiao-Tong YE ; Yi-Heng DAI ; Wei-Yi LIANG ; Xiu-Zhen YE ; Jing MO ; Lu DING ; Ben-Qing WU ; Hong-Xiang CHEN ; Chi-Wang LI ; Zhe ZHANG ; Xiao RONG ; Wei SHEN ; Wei-Min HUANG ; Bing-Yan YANG ; Jun-Feng LYU ; Hui-Wen HUANG ; Le-Ying HUO ; Hong-Ping RAO ; Wen-Kang YAN ; Xue-Jun REN ; Yong YANG ; Fang-Fang WANG ; Dong LIU ; Shi-Guang DIAO ; Xiao-Yan LIU ; Qiong MENG ; Yu WANG ; Bin WANG ; Li-Juan ZHANG ; Yu-Ge HUANG ; Dang AO ; Wei-Zhong LI ; Jie-Ling CHEN ; Yan-Ling CHEN ; Wei LI ; Zhi-Feng CHEN ; Yue-Qin DING ; Xiao-Yu LI ; Yue-Fang HUANG ; Ni-Yang LIN ; Yang-Fan CAI ; Sha-Sha HAN ; Ya JIN ; Guo-Sheng LIU ; Zhong-He WAN ; Yi BAN ; Bo BAI ; Guang-Hong LI ; Yue-Xiu YAN
Chinese Journal of Contemporary Pediatrics 2022;24(1):33-40
OBJECTIVES:
To investigate the clinical treatment outcomes and the changes of the outcomes over time in extremely preterm twins in Guangdong Province, China.
METHODS:
A retrospective analysis was performed for 269 pairs of extremely preterm twins with a gestational age of <28 weeks who were admitted to the department of neonatology in 26 grade A tertiary hospitals in Guangdong Province from January 2008 to December 2017. According to the admission time, they were divided into two groups: 2008-2012 and 2013-2017. Besides, each pair of twins was divided into the heavier infant and the lighter infant subgroups according to birth weight. The perinatal data of mothers and hospitalization data of neonates were collected. The survival rate of twins and the incidence rate of complications were compared between the 2008-2012 and 2013-2017 groups.
RESULTS:
Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of severe asphyxia and smaller head circumference at birth (P<0.05). The mortality rates of both of the twins, the heavier infant of the twins, and the lighter infant of the twins were lower in the 2013-2017 group compared with the 2008-2012 group (P<0.05). Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of pulmonary hemorrhage, patent ductus arteriosus (PDA), periventricular-intraventricular hemorrhage (P-IVH), and neonatal respiratory distress syndrome (NRDS) and a higher incidence rate of bronchopulmonary dysplasia (P<0.05).
CONCLUSIONS
There is a significant increase in the survival rate over time in extremely preterm twins with a gestational age of <28 weeks in the 26 grade A tertiary hospitals in Guangdong Province. The incidences of severe asphyxia, pulmonary hemorrhage, PDA, P-IVH, and NRDS decrease in both the heavier and lighter infants of the twins, but the incidence of bronchopulmonary dysplasia increases. With the improvement of diagnosis and treatment, the multidisciplinary collaboration between different fields of fetal medicine including prenatal diagnosis, obstetrics, and neonatology is needed in the future to jointly develop management strategies for twin pregnancy.
Bronchopulmonary Dysplasia/epidemiology*
;
Female
;
Gestational Age
;
Humans
;
Infant
;
Infant, Extremely Premature
;
Infant, Newborn
;
Pregnancy
;
Respiratory Distress Syndrome, Newborn/epidemiology*
;
Retrospective Studies
;
Treatment Outcome
6.Long-term intermittent fasting induces abnormal lipid accumulation in mouse liver.
Peng-Fei GONG ; Zu-Rong JIANG ; Xin HUANG ; Si-Si WANG ; Han-Bing LI ; Yong-Jia PENG ; Jin ZHANG
Acta Physiologica Sinica 2022;74(6):962-969
Short-term intermittent fasting (IF) is beneficial to weight control in patients with nonalcoholic fatty liver disease, but the impact of long-term IF is not clear. In this study, healthy C57BL/6N mice with 4-month alternate day fasting (ADF) were used to study the effects of long-term IF on systemic and liver lipid metabolism. The results showed that, compared with the Ad Libitum group, the weight and food conversion rate of mice in the ADF group were markedly decreased and increased respectively, and the liver index and the liver content of triglyceride were significantly increased by pathological examination. qRT-PCR analysis revealed that the mRNA expression of the lipogenesis gene Pparγ and lipolysis gene Atgl was up-regulated in the ADF group (P < 0.05). Western blot analysis showed that the ratio of microtubule associated protein LC3-II/LC3-I was increased, while the abundance of autophagy adaptor protein p62 was decreased in the ADF group. In addition, autophagy signal positive regulation key factor AMPK phosphorylation was increased (P < 0.05), and negative regulation factor mTOR phosphorylation was decreased (P < 0.05) in the ADF group, indicating that hepatocyte autophagy activity was elevated. Taken together, ADF for 4 months results in an excessive liver triglyceride accumulation, accompanied by a marked decrease in liver mTOR phosphorylation and a significant increase in hepatic autophagy.
Mice
;
Animals
;
Intermittent Fasting
;
Mice, Inbred C57BL
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Liver/pathology*
;
TOR Serine-Threonine Kinases
;
Lipid Metabolism
;
Autophagy
;
Triglycerides
7.Early warning analysis of plastic bronchitis in children and clinical study of flexible bronchoscopy
Qi WANG ; Rong JIN ; Min CHEN ; Bing HAN ; Rujia XIE ; Yongfeng SUN ; Xing CHENG ; Wei WU ; Qin YANG
Chinese Journal of Applied Clinical Pediatrics 2022;37(23):1786-1792
Objective:To study the clinical characteristics and etiological distribution characteristics of plastic bronchitis in children, analyze its early warning indicators, and evaluate the clinical diagnosis and treatment effect of flexible bronchoscopy.Methods:The clinical data of 232 children with severe pneumonia admitted to Guiyang Maternal and Child Health Hospital from January 2019 to February 2021 were retrospectively analyzed.The children were divided into the plastic bronchitis group and non-plastic bronchitis group according to bronchoscopic results.The gender, age, clinical manifestations, auxiliary examinations, imaging features, bronchoscopy findings and treatment of the children were collected, compared and analyzed, comparison between two groups by t test and χ2 test. Results:A total of 232 children were included in this study, including 98 cases in the plastic bronchitis group and 134 cases in the non-plastic bronchitis group.The main symptoms of both groups were fever, cough and shortness of breath.The age of onset in the plastic bronchitis group was (54.640±37.085) months, and the age of onset in the non-plastic bronchitis group was (14.870±19.813) months.The difference in the age of onset between the two groups was statistically significant ( t=9.656, P<0.001). The average hospitalization days of the plastic and non-plastic bronchitis groups were (16.133±6.227) d and (12.690±4.287) d, respectively.Significant difference was found in the average hospitalization days between the two groups ( t=4.721, P<0.001). The average fever days of the plastic bronchitis group were (10.090±3.473) d, and the average fever days of the non-plastic bronchitis group were (6.030±4.850) d. There was significant difference in the average fever days between the two groups ( t=5.654, P<0.001). The age of onset, hospitalization days, and fever days of the plastic bronchitis group were larger than those of the non-plastic bronchitis group (all P<0.001). The physical examination suggested that 40% (39/98) of patients in the plastic bronchitis group had reduced the breath sounds, and this percentage was significantly higher than that in the non-plastic bronchitis group[6%(8/134)]. The plastic bronchitis group had lower partial pressure of blood oxygen (PO 2) and oxygen saturation (SO 2) levels than the non-plastic bronchitis group (all P<0.01). The plastic bronchitis group had a higher percentage of neutrophils (N), C-reactive protein (CRP) level, procalcitonin (PCT) level, lactate dehydrogenase (LDH) level and D-dimer level than the non-plastic bronchitis group (all P<0.01). According to the imaging results, in the plastic bronchitis group, lung consolidation was found in 72 cases (73%, 72/98), atelectasis in 32 cases (33%, 32/98), and pleural effusion in 33 cases (34%, 33/98). In the non-plastic bronchitis group, 65%(87/134) cases had lung consolidation, 5%(7/134) cases had atelectasis, 3.7% (5/134) cases had pleural effusion.The first pathogen detected in 46.9% of the patients in the plastic bronchitis group was Mycoplasma pneumoniae (MP), and the percentage was significantly higher that in the non-plastic bronchitis group (11.1%). Flexible bronchoscopy was performed on both groups at their admission.The plastic bronchitis group received the flexible bronchoscopy check for (2.960±1.157) times on average, and the non-plastic bronchitis group was tested for (1.140±0.371) times on average.Of 98 children in the plastic bronchitis group, 95 cases were improved and discharged, 2 cases were transferred, and 1 case died.All 134 children in the non-plastic bronchitis group were improved and discharged. Conclusions:Preschool and school-age children, fever ≥10 d, PCT, CRP, LDH, D-dimer levels are early warning signs of plastic bronchitis clinically.MP is still the primary pathogen causing plastic bronchitis.Flexible bronchoscopy technique is a key measure for timely diagnosis and effective treatment of plastic bronchitis.
8.Exploration on the diagnosis and treatment of generalized myasthenia gravis with acupuncture and moxibustion based on the study of ancient medical works.
Zi-Kai JIN ; Bing GAO ; Li-da ZHANG ; Zi-Wei GUO ; Meng SUN ; Rong-Lin CAI ; Shu-Ping NIU ; Ling HU ; Wei TANG
Chinese Acupuncture & Moxibustion 2021;41(7):819-822
Through collecting the relevant provisions and medical cases of
Acupuncture
;
Acupuncture Points
;
Acupuncture Therapy
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Humans
;
Meridians
;
Moxibustion
;
Myasthenia Gravis/therapy*
9.Not Available.
Chuan jin HE ; Rong fang ZHANG ; Lei ZOU ; Bing jie ZHENG ; Dan lu SONG ; Jing feng HUANG ; Jiang wei LAN
Journal of Forensic Medicine 2021;37(5):699-703
10.Simultaneous determination of three antidepressant drugs in feces by HLPC-MS.
Yi-Fan SHAO ; An-Qi ZHANG ; Tian-Jiao CHEN ; Hai-Bei LI ; Zheng-Shan CHEN ; Jing YIN ; Dong YANG ; Dan-Yang SHI ; Yong-Bing LIANG ; Chun-Yan CHENG ; Rong TAN ; Dong-Liang SUN ; Jun-Wen LI ; Min JIN
Chinese Journal of Applied Physiology 2020;36(6):668-672

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