1.Pharmacokinetics and Bioequivalence Study of Zidovudine and Lamivudine Tablets in Chinese Healthy Subjects
Haiyun ZHOU ; Yuming XIA ; Chenlin SHEN ; Lin CAI ; Jiatao LIU
Herald of Medicine 2025;44(4):516-522
Objective To study the pharmacokinetic profile of zidovudine and lamivudine tablets(ZL)in Chinese healthy subjects and to evaluate its bioequivalence and safety.Methods A randomized,open,single-dose,two-sequence,four-cycle and fully replicated crossover bioequivalence trial was conducted in 32 healthy subjects both fasting and postprandial,and two preparations of ZL tablets were administered orally in each cycle,with a washout period of 5 days.The concentrations of zidovudine and lamivudine in plasma were determined using high performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic evaluation index parameters were statistically analyzed using Phoenix WinNonlin version 8.1 data statistical software to evaluate bioequivalence.Results The Cmax of zidovudine under fasting and postprandial conditions between ZL and the reference drugs after a single dose were(3 782.499±1 921.649)vs.(3 543.164±1 946.076)ng·mL-1 and(1 585.827±914.246)vs.(1 667.595±862.945)ng·mL-1,respectively.And the AUC0-t for fasting and postprandial conditions of zidovudine was(3 177.091±819.538)vs.(3 071.375±972.145)h·ng·mL-1 and(2 437.999±478.147)vs.(2 402.725±477.792)h·ng·mL-1,respectively;while the AUC0-∞ were(3 225.674±825.131)vs.(3 093.448±972.340)h·ng·mL-1and(2 464.310±480.790)vs.(2 427.693±477.933)h·ng·mL-1,respectively.The Cmax of a single dose of lamivudine under fasting and postprandial conditions between ZL and the reference drugs were(1 923.329±490.572)vs.(1 830.570±476.947)ng·mL-1 and(1 922.711±589.130)vs.(1 881.857±527.577)ng·mL-1,respectively.The AUC0-t for preprandial and postprandial lamivudine was(7 598.265±1 376.774)vs.(7 283.422±1 356.146)h·ng·mL-1 and(7 554.169±958.379)vs.(7 329.376±924.075)h·ng·mL-1,respectively,whereas the AUC0-∞ were(7 734.038±1 326.907)vs.(7 405.088±1 340.036)h·ng·mL-1 and(7 660.916±958.694)vs.(7 435.102±930.448)h·ng·mL-1,in fasting and fed tests,the 90%confidence intervals(CI)of the geometric mean ratios of the main pharmacokinetic parameters between test and reference preparations were all within the range of 80%-125%,respectively.A total of 37 adverse events occurred during the trial period,including 21 in the fasting group and 16 in the postprandial group,and no serious adverse events occurred.Conclusion The test formulations of zidovudine and lamivudine tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions compared to the reference tablets.
2.Pharmacokinetics and Bioequivalence Study of Zidovudine and Lamivudine Tablets in Chinese Healthy Subjects
Haiyun ZHOU ; Yuming XIA ; Chenlin SHEN ; Lin CAI ; Jiatao LIU
Herald of Medicine 2025;44(4):516-522
Objective To study the pharmacokinetic profile of zidovudine and lamivudine tablets(ZL)in Chinese healthy subjects and to evaluate its bioequivalence and safety.Methods A randomized,open,single-dose,two-sequence,four-cycle and fully replicated crossover bioequivalence trial was conducted in 32 healthy subjects both fasting and postprandial,and two preparations of ZL tablets were administered orally in each cycle,with a washout period of 5 days.The concentrations of zidovudine and lamivudine in plasma were determined using high performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic evaluation index parameters were statistically analyzed using Phoenix WinNonlin version 8.1 data statistical software to evaluate bioequivalence.Results The Cmax of zidovudine under fasting and postprandial conditions between ZL and the reference drugs after a single dose were(3 782.499±1 921.649)vs.(3 543.164±1 946.076)ng·mL-1 and(1 585.827±914.246)vs.(1 667.595±862.945)ng·mL-1,respectively.And the AUC0-t for fasting and postprandial conditions of zidovudine was(3 177.091±819.538)vs.(3 071.375±972.145)h·ng·mL-1 and(2 437.999±478.147)vs.(2 402.725±477.792)h·ng·mL-1,respectively;while the AUC0-∞ were(3 225.674±825.131)vs.(3 093.448±972.340)h·ng·mL-1and(2 464.310±480.790)vs.(2 427.693±477.933)h·ng·mL-1,respectively.The Cmax of a single dose of lamivudine under fasting and postprandial conditions between ZL and the reference drugs were(1 923.329±490.572)vs.(1 830.570±476.947)ng·mL-1 and(1 922.711±589.130)vs.(1 881.857±527.577)ng·mL-1,respectively.The AUC0-t for preprandial and postprandial lamivudine was(7 598.265±1 376.774)vs.(7 283.422±1 356.146)h·ng·mL-1 and(7 554.169±958.379)vs.(7 329.376±924.075)h·ng·mL-1,respectively,whereas the AUC0-∞ were(7 734.038±1 326.907)vs.(7 405.088±1 340.036)h·ng·mL-1 and(7 660.916±958.694)vs.(7 435.102±930.448)h·ng·mL-1,in fasting and fed tests,the 90%confidence intervals(CI)of the geometric mean ratios of the main pharmacokinetic parameters between test and reference preparations were all within the range of 80%-125%,respectively.A total of 37 adverse events occurred during the trial period,including 21 in the fasting group and 16 in the postprandial group,and no serious adverse events occurred.Conclusion The test formulations of zidovudine and lamivudine tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions compared to the reference tablets.
3.Application study on the prevention and treatment of spleen aminopeptide oral solution on seasonal allergic rhinitis
Haiyun SHI ; Kaili ZHENG ; Change FAN ; Huijiao CAI ; Tingting MA ; Huiyu NING ; Hongtian WANG ; Junjing ZHANG ; Xueyan WANG
Chinese Journal of Preventive Medicine 2024;58(8):1219-1229
Methods:A total of 392 patients with seasonal allergic rhinitis were selected from the population of the epidemiological investigation project of allergic diseases in Hohhot, Inner Mongolia. The project was led by Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, and assisted by Hohhot First Hospital from April to May 2023. The patients were randomly divided into a spleen aminopeptide group (296 cases) and control group (96 cases) at a ratio of 3∶1, and the enrollment period was from June 1 to 14, 2023. The treatment group was treated with spleen aminopeptide oral solution for 12 weeks starting from 4-6 weeks (±7 days) before the pollen dispersal period, while the control group was treated with a simulated agent of spleen aminopeptide oral solution. Both the treatment group and the control group were treated with oral antihistamines and/or nasal glucocorticoids as needed during the pollen dispersal period. Evaluate the therapeutic effect by comparing the symptom scores, drug scores and quality of life scores of the two groups, and detect the expression levels of cytokines in serum. Symptom scores, quality of life scores, drug scores and laboratory results were compared by independent sample t test/Kruskal-Wallis test and χ2 test/Fisher′s exact test. Results:Compared with the control group, spleen aminopeptide treatment for 12 weeks significantly improved symptoms of nasal congestion [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=6.308, P<0.05], nasal itching [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=4.966, P<0.05], sneezing [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.245, P<0.05], runny nose [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.41, P<0.05] and tearing [ M( Q1, Q3):1(0, 2) vs. 1(0, 3), H=4.664, P<0.05]. At 12 weeks of treatment, the scores of nasal symptoms and ocular symptoms in control group and experimental group were significantly increased compared with baseline ( P<0.05). In experimental group, nasal congestion [ M( Q1, Q3):1(0, 1) vs. 1(0, 2), H=4.042, P<0.05], eye itching/foreign body sensation/redness symptom scores [ M( Q1, Q3):1(0, 2) vs. 1(0, 2), H=5.302, P<0.05] and total scores [ M( Q1, Q3):4(-1, 9) vs. 5(0, 12.5), H=3.958, P<0.05] were significantly increased. The antihistamine drug score of the splenic peptide treatment group at 6 weeks were lower than that of the control group ( H=4.232, P<0.05). After 12 weeks of treatment, the antihistamine drug score [ M( Q1, Q3):10(0, 24) vs. 19(2, 36.5), H=6.67, P<0.05] and the total drug score [ M( Q1, Q3):28.5(5, 77.5) vs. 46(6, 155.5), H=3.995, P<0.05] were significantly lower than those of the control group. The serum IL-17A levels of the treatment group were significantly lower than those of the control group after 6 weeks (0.7±1.77 vs. 0.85±1.67 ,H=10.08, P<0.05) and 12 weeks (0.81±1.63 vs. 0.94±1.73, H=5.196, P<0.05) of splenic aminopeptide treatment. Conclusions:Early treatment with spleen aminopeptide oral solution can significantly improve nasal and ocular symptoms of patients with seasonal allergic rhinitis, reduce the use of drugs during the onset period, and improve the quality of life. It may exert an immunomodulatory effect by reducing the expression level of IL-17A in the serum of patients.Objects:To conduct a study on the prevention and treatment of seasonal allergic rhinitis in Hohhot, Inner Mongolia, evaluate the preventive and therapeutic effects of spleen aminopeptide oral solution on seasonal allergic rhinitis, and explore its related mechanisms.
4.Application study on the prevention and treatment of spleen aminopeptide oral solution on seasonal allergic rhinitis
Haiyun SHI ; Kaili ZHENG ; Change FAN ; Huijiao CAI ; Tingting MA ; Huiyu NING ; Hongtian WANG ; Junjing ZHANG ; Xueyan WANG
Chinese Journal of Preventive Medicine 2024;58(8):1219-1229
Methods:A total of 392 patients with seasonal allergic rhinitis were selected from the population of the epidemiological investigation project of allergic diseases in Hohhot, Inner Mongolia. The project was led by Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, and assisted by Hohhot First Hospital from April to May 2023. The patients were randomly divided into a spleen aminopeptide group (296 cases) and control group (96 cases) at a ratio of 3∶1, and the enrollment period was from June 1 to 14, 2023. The treatment group was treated with spleen aminopeptide oral solution for 12 weeks starting from 4-6 weeks (±7 days) before the pollen dispersal period, while the control group was treated with a simulated agent of spleen aminopeptide oral solution. Both the treatment group and the control group were treated with oral antihistamines and/or nasal glucocorticoids as needed during the pollen dispersal period. Evaluate the therapeutic effect by comparing the symptom scores, drug scores and quality of life scores of the two groups, and detect the expression levels of cytokines in serum. Symptom scores, quality of life scores, drug scores and laboratory results were compared by independent sample t test/Kruskal-Wallis test and χ2 test/Fisher′s exact test. Results:Compared with the control group, spleen aminopeptide treatment for 12 weeks significantly improved symptoms of nasal congestion [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=6.308, P<0.05], nasal itching [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=4.966, P<0.05], sneezing [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.245, P<0.05], runny nose [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.41, P<0.05] and tearing [ M( Q1, Q3):1(0, 2) vs. 1(0, 3), H=4.664, P<0.05]. At 12 weeks of treatment, the scores of nasal symptoms and ocular symptoms in control group and experimental group were significantly increased compared with baseline ( P<0.05). In experimental group, nasal congestion [ M( Q1, Q3):1(0, 1) vs. 1(0, 2), H=4.042, P<0.05], eye itching/foreign body sensation/redness symptom scores [ M( Q1, Q3):1(0, 2) vs. 1(0, 2), H=5.302, P<0.05] and total scores [ M( Q1, Q3):4(-1, 9) vs. 5(0, 12.5), H=3.958, P<0.05] were significantly increased. The antihistamine drug score of the splenic peptide treatment group at 6 weeks were lower than that of the control group ( H=4.232, P<0.05). After 12 weeks of treatment, the antihistamine drug score [ M( Q1, Q3):10(0, 24) vs. 19(2, 36.5), H=6.67, P<0.05] and the total drug score [ M( Q1, Q3):28.5(5, 77.5) vs. 46(6, 155.5), H=3.995, P<0.05] were significantly lower than those of the control group. The serum IL-17A levels of the treatment group were significantly lower than those of the control group after 6 weeks (0.7±1.77 vs. 0.85±1.67 ,H=10.08, P<0.05) and 12 weeks (0.81±1.63 vs. 0.94±1.73, H=5.196, P<0.05) of splenic aminopeptide treatment. Conclusions:Early treatment with spleen aminopeptide oral solution can significantly improve nasal and ocular symptoms of patients with seasonal allergic rhinitis, reduce the use of drugs during the onset period, and improve the quality of life. It may exert an immunomodulatory effect by reducing the expression level of IL-17A in the serum of patients.Objects:To conduct a study on the prevention and treatment of seasonal allergic rhinitis in Hohhot, Inner Mongolia, evaluate the preventive and therapeutic effects of spleen aminopeptide oral solution on seasonal allergic rhinitis, and explore its related mechanisms.
5.The Effect of Smoking on the Semen Quality in Male Infertile
Yingjie YAO ; Jinfeng CAI ; Jianghou HOU ; Yunyan CHEN ; Ming XIA ; Haiyun YANG ; Pengying XIAO ; Lijun WANG
Journal of Kunming Medical University 2024;45(1):163-167
Objective To investigate the effect of smoking on the semen quality in infertile men.Methods A total of 360 male infertility patients were enrolled and divided into the smoking group(n=190)and non-smoking group(n=170)based on whether they smoked or not.Furthermore,the smoking group was subdivided into group A(≤10 sticks/d,n=63),group B(11~20 sticks/d,n=80),and group C(>20 sticks/d group,n=47)according to the amount of smoking.Semen volume,liquefaction time,sperm concentration,motility,DNA fragmentation rate and normal morphological rate were observed and compared between and within the groups.Results There were significant differences in semen volume,liquefaction time,sperm motility,normal morphological rate and DNA fragmentation rate between the smoking group and the non-smoking group(P<0.05).The semen volume,sperm motility and normal morphological rate of the smoking group were lower than those in the non-smoking group,and the DNA fragmentation rate and semen liquefaction time were higher than those in the non-smoking group.And with the increase of smoking volume,sperm motility and normal morphological rate decreased,semen liquefaction time and DNA fragmentation rate increased,and there was no significant difference in the sperm concentration between the smoking group and non-smoking group(P>0.05).There was no significant difference in the semen volume between the three groups with different smoking amounts(P>0.05).Conclusion Smoking has a negative impact on the sperm quality parameters such as semen volume,sperm motility,normal morphological rate,sperm motility,liquefaction time and DNA fragmentation,and the effect of heavy smoking is particularly obvious.We should strengthen the comprehensive health education,promote the healthy lifestyles and reduce smoking.
6.Application effect of immersive experiential teaching strategies in the teaching of clinical anesthesiology for undergraduates
Guangchao ZHAO ; Min CAI ; Haiyun GUO ; Yonghui WANG ; Hailong DONG
Chinese Journal of Medical Education Research 2023;22(7):1026-1029
Objective:To explore the application effect of immersive experiential teaching strategies in the teaching of clinical anesthesiology for undergraduates.Methods:Undergraduates majoring in 5-year clinical medicine in Air Force Medical University from January 2022 to May 2022 were enrolled as the research objects. Students were randomly divided into the immersive teaching group and the traditional teaching group, with 35 students in each. Students in the immersive teaching group underwent immersive experiential teaching strategies and the traditional teaching group received lecture-based teaching strategies. After classes, all students in these two groups took the same theoretical and operational examination, and conducted a teaching satisfaction survey and a comprehensive ability evaluation. The results were analyzed by t-test and Chi-square test using SPSS 22.0 software. Results:Students in the immersive teaching group were more satisfied with teaching (88.32±7.28 vs.70.15±7.11) ( P=0.001), and had higher scores of theorical examination (86.34±7.42 vs. 77.31±5.32) ( P=0.020) and operational examination (92.23±5.33 vs. 81.21±4.98) ( P=0.022) than those in the traditional teaching group. In addition, the scores of communication ability ( P=0.026), response ability ( P<0.001) adaptability ( P=0.007), and critical thinking ( P<0.001) in the immersive teaching group were higher than those in the traditional teaching group. Conclusion:The immersive experiential teaching strategies can effectively improve the theoretical and practical operational ability of undergraduates after completing courses of clinical anesthesiology, and can effectively stimulate the enthusiasm of students. It is worthy to be popularized in subsequent teaching abilities.
7.Value of ultrasonic measurement of pubic symphysis distance during labor
Guihua WU ; Dazhong ZOU ; Qing ZHANG ; Haiyun CAI ; Yajun LIU ; Shiyi YANG ; Chengwei WU
Chinese Journal of Ultrasonography 2023;32(7):621-626
Objective:To explore the application value of ultrasonic measurement of the pubic symphysis distance in predicting pubic symphysis diastasis(PSD) during delivery.Methods:A total of 262 pregnant women from June 2021 to July 2022 who delivered at Suzhou Wuzhong People′s Hospital and Jiangyin People′s Hospital were retrospectively analyzed. The patients were divided into PSD group of 26 cases and normal pregnant women group (control group) of 234 cases according to whether or not PSD was confirmed during postpartum follow-up. Relevant data of the two groups were collected, including the biparietal diameter and femoral length of the fetus within 7 days before delivery, the pubic symphysis distance of pregnant women when the cervix was not dilated, pubic symphysis distance when the cervix dilated to 5 cm during the first stage of delivery, and the pubic symphysis distance after delivery, the age of the pregnant woman, the gestational week, the number of pregnancies, and the birth weight of the fetus. The differences of the above relevant data between the two groups were compared.Spearman correlation analysis was used to analyze the correlation between various parameters. The occurrence of postpartum PSD, and Logistic regression was used to analyze the predictive value of various parameters on the occurrence of postpartum PSD. ROC curve was used to analyze the diagnostic efficacy of each parameters to predict PSD.Results:The fetal birth weight, number of pregnancies, pubic symphysis distance in three time points in the PSD group were significantly higher than those in the control group (all P<0.05). The age of the pregnant women was negatively correlated with the occurrence of postpartum PSD ( rs=-0.152, P=0.014). The fetal birth weight, the number of pregnancies, the pubic symphysis distance in the cervix no-dilated and the first stage of labor were positively correlated with the occurrence of postpartum PSD( rs=0.160, 0.166, 0.678, 0.581, all P<0.05). Logistic regression analysis showed that the increase of pubic symphysis distance before labor would increase the risk of postpartum PSD, and the difference was statistically significant ( OR=2 506.028, 95% CI=14.293-439 402.630, P=0.003). The increase of pubic symphysis distance at the first stage of labor increased the risk of postpartum PSD, with a statistically significant difference ( OR=10 704.027, 95% CI=33.830-3 386 803.429, P=0.002). The ROC curve analysis showed that the area under the curve of the pubic symphysis distance in the cervix no-dilated and the first stage of labor for the diagnosis of PSD were 0.896 and 0.917 respectively, the sensitivity were 0.731 and 0.885, the specificity were 0.940 and 0.829, and the corresponding critical values were 0.87 cm and 1.06 cm respectively. The area under the curve of the combination of the two parameters for the diagnosis of PSD was 0.930, the sensitivity was 0.885, and the specificity was 0.876. Conclusions:Ultrasonic measurement of pubic symphysis distance during delivery can predict the occurrence of postpartum PSD in pregnant women and can provide a basis for the occurrence and treatment of postpartum pubic symphysis separation in pregnant women.
8.Brain Glycogen: An Angel or a Devil for Ischemic Stroke?
Haiyun GUO ; Yumeng LI ; Wugang HOU ; Yanhui CAI
Neuroscience Bulletin 2023;39(4):690-694
9.Dialysis and dialysis access issues in hemophilia patients with end-stage renal disease: a report of 6 cases and literature review
Bingyan LIU ; Huacong CAI ; Zijuan ZHOU ; Ying WANG ; Yan HU ; Zhichun CHEN ; Haiyun WANG ; Limeng CHEN
Chinese Journal of Nephrology 2023;39(12):927-931
Renal replacement therapy and perioperative management have difficulties in hemophilia patients with end-stage renal disease. The paper summarized the diagnosis and treatment experience of six hemophilia patients complicated with end-stage renal disease from January 1, 2000 to March 31, 2023 in Peking Union Medical College Hospital. Among 6 patients treated with peritoneal dialysis, 3 were treated with hemodialysis or continuous venous-venous hemodialysis. Altogether 11 dialysis access procedures were conducted successfully, and no serious bleeding or thrombotic events. In further conjunction with literature review, the paper summarized the key points of dialysis access appliance relevant to such patients, to provide reference for renal replacement treatment paths.
10.An electroencephalogram-based study of resting-state spectrogram and attention in tinnitus patients.
Haiyun HUANG ; Yuexin CAI ; Xueji FENG ; Yuanqing LI
Journal of Biomedical Engineering 2021;38(3):492-497
The incidence of tinnitus is very high, which can affect the patient's attention, emotion and sleep, and even cause serious psychological distress and suicidal tendency. Currently, there is no uniform and objective method for tinnitus detection and therapy, and the mechanism of tinnitus is still unclear. In this study, we first collected the resting state electroencephalogram (EEG) data of tinnitus patients and healthy subjects. Then the power spectrum topology diagrams were compared of in the band of δ (0.5-3 Hz), θ (4-7 Hz), α (8-13 Hz), β (14-30 Hz) and γ (31-50 Hz) to explore the central mechanism of tinnitus. A total of 16 tinnitus patients and 16 healthy subjects were recruited to participate in the experiment. The results of resting state EEG experiments found that the spectrum power value of tinnitus patients was higher than that of healthy subjects in all concerned frequency bands. The
Attention
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Brain
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Electroencephalography
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Humans
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Parietal Lobe
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Tinnitus

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