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.Quality Control of Salvianolic Acids Reference Extract
Yao-lei LI ; Li-na LIU ; Ying WANG ; Hong-yu JIN ; Hong-shui YUE ; Shuang-cheng MA
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(10):136-140
Objective::To establish the quality control method for multi-index content determination and fingerprint of salvianolic acids. Method::Agilent ZORBAX SB-C18 (4.6 mm×250 mm, 5μm) column was adopted, with 0.1%formic acid-water as mobile phase A and 0.1%formic acid-acetonitrile as mobile phase B for gradient elution (0-30 min, 20%-21.5%B; 30-35 min, 21.5%-25%B; 35-45 min, 25%-40%B; 45-50 min, 40%-95%B). The column temperature was set at 30 ℃, the flow rate was set at 1 mL·min-1, and the detection wavelength was set at 288 nm. Relative correction factors of caffeic acid, salvianolic acid E, rosmarinic acid, lithosperic acid, salvianolic acid B and salvianolic acid Y were determined by the concentration method. The content of each indicator component of the reference extract of salvianolic acid polyphenolic acid was determined and compared with the results of the monomer reference substance by the external standard method. At the same time, the fingerprint method was established. and the similarity evaluation was carried out on 10 batches of extracts. Result::Caffeic acid, salvianolic acid E, rosmarinic acid, lithospermic acid, salvianolic acid B, and salvianolic acid Y had a good linear relationship within the respective detection mass concentration ranges (
3.Guiding value of ambulatory blood pressure monitoring index in clinical prevention and treatment of elderly hypertensive population
Yong-jun ZHANG ; Shang-yin XU ; Zhu-xia WU ; Zi-qing FAN ; Wen-jiao ZHOU ; Ying-shui YAO
Chinese Journal of Disease Control & Prevention 2019;23(7):785-789
Objective To study the application value of dynamic monitoring of blood pressure in the prevention and treatment of elderly hypertension. Methods 519 hypertensive patients from December 2017 to December 2018 were monitored with ambulatory blood pressure monitoring, and were divided into the elderly group (≥60 years old, 264 cases) and the control group (<60 years old, 255 cases). The results of ambulatory blood pressure monitoring in two groups were analyzed, which inclued the circadian rhythm of blood pressure, blood pressure, pulse pressure, coefficient of variation of blood pressure, blood pressure load value, average heart rate and morning blood pressure surge. Results The incidence of abnormal circadian rhythm of ambulatory blood pressure in the elderly group was 76.5%. Compared with the control group, there were differences in the indexes of diastolic blood pressure (DBP), diastolic blood pressure load value (DBPLV), pulse pressure (PP), 24 h average heart rate (24 hAHR), systolic blood pressure coefficient of variation (SBPCV), 24 h diastolic blood pressure coefficient of variation (24 h DBPCV) and morning diastolic blood pressure surge (MDBPS) between the two groups(all P<0.05). There were differences in 24 h systolic blood pressure (24hSBP), night systolic blood pressure (nSBP), night diastolic blood pressure (nDBP), night pulse pressure (nPP), day systolic blood pressure load value (dSBPLV), ninght systolic blood pressure load value (nSBPLV), 24 h SBPCV, 24 h dDBPCV and other indicators among different blood pressure types in the elderly group (all P<0.05). Conclusion Ambulatory blood pressure monitoring indicators have important guiding value for the prevention and treatment of elderly hypertension.
4.Evaluating inferior vena cava wall invasion in renal cell carcinoma tumor thrombus with MRI.
Jing Yun WU ; Yue MI ; Shui LIU ; Lin YAO ; Qi TANG ; Zhi Song HE ; Xiao Ying WANG
Journal of Peking University(Health Sciences) 2019;51(4):673-677
OBJECTIVE:
To evaluate the diagnostic performance of MRI for the assessment of inferior vena cava (IVC) wall invasion by IVC thrombus in patients with renal cell carcinoma (RCC).
METHODS:
We retrospectively collected patients who underwent radical nephrectomy and thrombectomy for RCC between 2010 and 2018 at Peking University First Hospital. All the patients underwent imaging on a 1.5 Tesla or 3.0 Tesla MRI scanner. Fifty-six patients met the inclusion criteria. Preoperative imaging was reviewed by two radiologists blinded to details of the patient's surgical procedure and histopathology. Two radiologists measured the maximum anterior-posterior diameter and coronal diameters of the IVC and renal vein, and the craniocaudal extent of tumor thrombus, and evaluated the MRI features of IVC thrombus, including occlusion of the IVC lumen, the margin of the tumor thrombus (smooth vs. irregular), contact of the IVC thrombus and IVC wall, and altered signal of the IVC wall. Univariable and multivariable associations of clinical and radiographic features with IVC wall invasion were evaluated by Logistic regression.
RESULTS:
Of the 56 patients [male: 43, female: 13, mean age: (55.64±0.43) years], 17 (30.36%) were detected with IVC wall invasion, and most were clear cell carcinoma. Tumor thrombus with IVC wall invasion showed an increase in length of IVC thrombus [(7.91±3.59) cm vs. (5.94±3.57) cm, P=0.049], and more features of complete occlusion of the IVC lumen (P=0.002), irregular margin of the IVC thrombs (P=0.005), contact of the IVC thrombus and IVC wall (P=0.001), and altered signal of the low-intensity vessel wall (P<0.001), with a sensitivity of 94.12% and a specificity of 79.49%.
CONCLUSION
The present study indicates that MRI could be a means of evaluating RCC with IVC wall invasion, and the combination of tumor thrombus length and subjective impression of IVC wall invasion achieved a high sensitivity and specificity for diagnosis.
Carcinoma, Renal Cell
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Female
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Humans
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Kidney Neoplasms
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Magnetic Resonance Imaging
;
Male
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Middle Aged
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Nephrectomy
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Retrospective Studies
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Thrombectomy
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Thrombosis
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Vena Cava, Inferior
5.Study on application of salvianolic acids reference extract in quality control of Salvia miltiorrhiza and salvianolic acids for injection.
Yao-Lei LI ; Li-Na LIU ; Ying WANG ; Hong-Yu JIN ; Hong-Shui YUE ; Shuang-Cheng MA
China Journal of Chinese Materia Medica 2019;44(24):5446-5450
The purpose of this study was to investigate the feasibility of the salvianolic acids reference extract for quality control for Salvia miltiorrhiza and salvianolic acids for injection. An Agilent ZORBAX SB-C18( 4. 6 mm×250 mm,5 μm) column was used with mobile phase consisting of 0. 1% formic acid-water and 0. 1% formic acid-acetonitrile in gradient elution procedure. The column temperature was 30 ℃; the flow rate was 1 m L·min-1; and the detection wavelength was 288 nm. The content of rosmarinic acid,lithospermic acid and salvianolic acid B in S. miltiorrhiza was determined by using the salvianolic acids reference extract as control substance. The content of caffeic acid,salvianolic acid E,rosmarinic acid,lithospermic acid,salvianolic acid B,and salvianolic acid Y in the salvianolic acids for injection was also determined. The linear relationship between chemicals was good( r>0. 998 9),and the injection precision RSD was 0. 30%-0. 90%. The sexual RSD is between 1. 4% and 3. 0%,and the RSD of the reproducibility of the extract is between 2. 1% and 5. 2%. The recovery rate of the three components in S. miltiorrhiza was 96. 80%-99. 20%,and the recovery rate of the six components in salvianolic acids for injection was 88. 90%-107. 5%. The solution of S. miltiorrhiza and salvianolic acids for injection were stable within 48 h. A total of 8 batches of S. miltiorrhiza and injection were determined by the reference extract,and the difference was smaller than that measured by the monomer control. This study preliminarily verified that the salvianolic acids reference extract can be used as a substitute for the monomer control for the quality control of S. miltiorrhiza and salvianolic acids for injection.
Alkenes/analysis*
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Chromatography, High Pressure Liquid
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Drugs, Chinese Herbal/standards*
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Polyphenols/analysis*
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Quality Control
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Reproducibility of Results
;
Salvia miltiorrhiza/chemistry*
6.Association between transforming growth factor -β1 gene T869C polymorphism and essential hypertension:A Meta-analysis
Jie-Gen YU ; Rong LI ; Wei-Wei CHANG ; Meng-Sha TANG ; Yue-Long JIN ; Ying-Shui YAO
The Chinese Journal of Clinical Pharmacology 2016;32(13):1231-1233
Objective To evaluate the relationship between transforming growth factor-β1(TGF-β1) T869C polymorphism and essential hyper-tension (EH) using Meta-analysis, and to provide a basis for evidence-based medicine of the genetic background of EH .Methods Eligible articles published before October 2015 were collected the Chinese and foreign databases.Results A total of 7 studies(2822 cases) were avai-lable in this analysis , including 1560 cases in treatment group and 1322 cases in control group .The Meta -analysis results of T869 C genotype and the allele results showed significant difference ( P<0.01 ) .Conclu-sion TGF-β1 T869 C polymorphism might be associated with EH.
7.Progress in search for relationship between Toll like receptor 4 with the pathogenesis of diabetic nephropathy
Wei-Wei CHANG ; Lian-Ping HE ; Ying-Shui YAO
The Chinese Journal of Clinical Pharmacology 2015;(11):1066-1068
So far, the etiology and pathogenesis of diabetic nephropathy have not been clear.Recent studies indicated that inflammatory factors play important roles in the pathogenesis and development of diabetic nephropathy.While Toll like receptor 4 can activate the downstream sig-nal molecules through the myeloid differentiation factor 88 ( MyD88 ) depen-dent and the MyD88 independent pathway, so as to induce immune responses.This article makes a new survey on the pathogene-sis of diabetic nephropathy inflammation and its relationship with Toll like receptor 4.
8.Research progress of Ypsilandra thibetica, a medicinal plant of Liliaceae.
Li XIA ; Qiang GUO ; Shui-Ying ZHANG ; Yong-Shu LIANG ; Wan-Long YAO ; Xian-Tao ZHANG
China Journal of Chinese Materia Medica 2013;38(20):3413-3418
Ypsilandra thibetica belongs to the family Liliaceae. Its whole plant has the medicinal functions of heat-clearing and detoxifying, relieving congestion and other effects, and is used as the folk medicine to cure scrofula, dysuria embolism and other symptoms. Previous chemical studies revealed that its major and active ingredient is steroidal saponin. Up to now, more than fifty steroidal saponins, mainly composed of spirostan and furostanol types, have been described. Pharmacological and clinical studies have demonstrated that Y. thibetica has anti-tumor, uterine contractions, hemostatic and antibacterial activities, in particular for the treatment of a variety of gynecological hemorrhagic diseases. In an effort to provide references for the advanced research and development of this species, this paper summarized the research progress on its pharmacognosy, including botany and authentication, its isolated secondary metabolites, biological activities and pharmacological applications. In addition, some advantages of this species which could be potentially used as a substitute for Paridis Rhizoma, one of ingredients of the well-known drug "Yunnan Baiyao", together with the future prospect are also briefly included.
Animals
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Drugs, Chinese Herbal
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chemistry
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pharmacology
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Humans
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Liliaceae
;
chemistry
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Molecular Structure
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Plants, Medicinal
;
chemistry
9.A systematic evaluation on the quality of Meta-analysis in articles published in the Chinese Journal of Epidemiology
Jie LI ; Ying-Shui YAO ; Yue-Long JIN ; Yan CHEN ; Yu ZHU ; Lian-Ping HE
Chinese Journal of Epidemiology 2013;34(8):819-825
Objective To assess the methodology and quality on Meta-analysis used in papers being published in the Chinese Journal of Epidemiology.Methods Computerized literature searching was carried out in Wanfang Medical Online to collect articles that Meta-analysis was used in the Chinese Journal of Epidemiology since it was founded till December,2012.Manual retrieval was also conducted.Two researchers independently screened for literature and extracted data.Disagreements were resolved through discussion or by resort to a third reviewer if consensus was not reached.Qualities on methodologies or on the processes of reporting and reviewing,were evaluated by both AMSTAR and PRISMA scales.Statistical calculations and analyses were performed using SPSS 13.0.Results Fifty-five papers on meta-analyses were included in this study.Results on the qualities of methodology or evaluation showed that only 2 articles (3.6%) were rated as high,35 articles (63.7%) as moderate and 18 (32.7%) as low.The quality on methodology being used in literature had improved since 2008.However,there were still some problems seen in the following areas as the list of studies (included and excluded),comprehensive search on literature,quality of the included studies having been assessed and documented,etc.Results on evaluation of quality showed that the included reviews had high quality on the titles of the report,sources of information,summary measures and synthesis of results.However,areas as:structured summary,methods on searching,data collection,risk of bias in individual studies,summary of evidence,limitations,funding etc.,were still lack of comprehensive reports.Conclusion Articles on Meta-analysis published in the Chinese Journal of Epidemiology provided substantial evidence for more reliable information on the etiology and risk factors of the studies.However,both of the qualities on methodology and reports in the included literature presented problems at different levels that called for careful improvement.
10.Analysis on physical and mental health and related influential factors among those ‘left behind ’ adolescents in Anhui province
Ying-Shui YAO ; Yao-Wen KANG ; Yue-Long JIN ; Yan CHEN ; Wei-Zhi GONG ; Li ZHENG ; Zhou AN ; Fang-Biao TAO ; Jia-Hu HAO
Chinese Journal of Epidemiology 2012;33(7):681-684
Objective To explore the physical and mental health status on the ‘left behind ’ students in Anhui province and the related influential factors.Methods Stratified cluster sampling method was used to investigate the 682 out of 3421 students from 7 middle schools in both south and north Anhui province,using multidimensional sub-health questionnaire of adolescents (MSQA) and mental health test (MHT),for assessment of the general condition,physical and mental health status.Results 14.22% of the ‘left behind’ students were in sub-health condition compared to 11.28% among the normal students,and the mental sub-health status represented 13.64% for the former and 10.84% for the latter.In addition,the ‘left behind’ students appeared less content with their life than those of staying with their parents (P<0.05).MHT scores in the subjects were positively correlated with the scores on MSQA and showed significant difference (P<0.01).Results from the multiple linear regression analysis showed that the mental health condition among the left behind students was in linear regression relationship with the decreased physical activity (β =1.456,P=0.001 ),emotional problems (β =1.096,P=0.000 ) and problems of social adaptation (β=1.011,P=0.006).The status of physical sub-health in the Anhui province showed that there was no significant difference in each of the study group (P>0.05).Conclusion Decreased physical activity and emotion aporia as well as difficult social adaptation were major factors leading to degenerated mental health levels in the‘left-behind’ adolescents.The findings suggested that the mental health status could be improved inthis population through better management on their body-health condition.

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