1.In vitro Dissolution and Virtual Bioequivalence of Domestic Nifedipine Sustained Release Tablets
Xiaodi SUN ; Wei ZHANG ; Shuang HU ; Jianfang LIU
China Pharmacist 2017;20(5):791-794
Objective: To evaluate the quality consistency of four domestic nifedipine sustained release tablets by dissolution test and virtual bioequivalence study by GastroPlus software.Methods: The dissolution curves of the four preparations were determined with the methods described in Japanese orange book and Chinese Pharmacopeia.The f2 factor of dissolution curves was calculated to compare the similarity.The in vitro dissolution data of the original preparation were combined with GastroPlus software to obtain the simulated in vivo absorption curves which were correlated with the actual concentration-time curves.The suitable dissolution medium was selected to evaluate the quality of domestic nifedipine sustained release tablets according to the better in vivo-in vitro correlation (IVIVC).The simulated in vivo absorption parameters obtained from the dissolution data combined with GastroPlus software were used to conduct the virtual bioequivalence study of domestic nifedipine sustained release tablets compared with the original products.Results: The f2 similar factors of the four domestic nifedipine sustained release tablets compared with the original preparation were all less than 50.Compared with that from the method in Japanese orange book, the correlation between the dissolution profiles in vitro and in vivo of original nifedipine sustained release tablets obtained from the method in Chinese Pharmacopoeia was better.The deviation between the simulated Cmax and AUC0-∞ values of the four test tablets and the measured values of the original preparation was within the range of ±20%.Conclusion: The dissolution curves of the four domestic nifedipine sustained release tablets are not similar to that of the original preparation, however, the four preparations are all bioequivalent to the original preparation according to the simulated absorption parameters based on the dissolution method in Chinese Pharmacopeia and GastroPlus software.
2.Changes of serum interleukin-6 and biochemical markers of bone metabolism in the occurrence and development of osteoporosis
Wensona MA ; Zhuowa SU ; Lei LIU ; Yihui DU ; Xiaodi ZHU ; Guangxun HU
Chinese Journal of Tissue Engineering Research 2005;9(7):222-223
BACKGROUND: In post-menopausal women, the reduction of estrogen level is followed by gradual increase of bone absorption, accompanied by increased cytokine synthesis and bone metabolism disorder. Observation of serum interleukin-6(IL-6), osteocalcin(OC), estradiol(E2)and urinary pyridinoline (PYD) in women with osteoporosis may help understand role of these factors in the onset and development of osteoporosis.OBJECTIVE: To investigate the relationship of serum IL-6, OC, E2, and urinary PYD levels with bone metabolism in women with osteoporosis, so as to identify the factors responsible for the occurrence and development of osteoporosis.DESIGN: A case-controlled clinical observation.SETTING: Central Laboratory of Orthopedics, Nanshan People's Hospital of Shenzhen City.PARTICIPANTS: Between January 1999 and December 2001, 25 post-menopausal women with osteoporosis aged 42 -69 years were selected from the Department of Orthopedics, Nanshan People' s Hospital of Shenzhen to constitute the experimental group, with 10 healthy women from the same hospital serving as control group.METHODS: Two milliliters of fasting venous blood and 2 mL urine samples were collected from women in both groups in the morning to determine the contents of IL-6, OC, PYD and E2, respectively.MAIN OUTCOME MEASURES: Serum IL-6, OC, E2 and urinary PYD levels in the subjects.RESULTS: In the experimental group, the IL-6 level was(201.0±79. 9) ng/L, OC(25.5 ± 16.2) μg/L, and PYD(41.3 ±9.7) nmol/mmol (creatinine), all significantly higher than those in control group( t = 2. 159 -2. 953, P < 0.05-0.01) . Serum E2 level in the experimental group (79. 8 ± 73.2) ng/L, however, was significantly lower than that in control group ( t = 2.071, P < 0.05).CONCLUSION: IL-6, OC, PYD and E2 may play important roles in the occurrence and development of osteoporosis, and adjustment of the levels of these factors can be necessary in the treatment of women with osteoporosis.
3.Role of A2B adenosine receptor in 6% HES 130/0.4-induced reduction of pulmonary capillary permeability in a rat model of sepsis
Tingting HU ; Xiaodi SUN ; Shanshan TAN ; Xiaolei MIAO ; Manlin DUAN ; Jianguo XU
Chinese Journal of Anesthesiology 2010;30(12):1475-1478
Objective To investigate the role of A2B adenosine receptor(A2BAR)in 6% HES 130/0.4-induced reduction of pulmonary capillary permeability in a rat model of sepsis.Methods Fifty male SD rats weighing 250-300 g were randomly divided into 5 groups(n = 10 each): group Ⅰ sham operation(group S);group Ⅱ sepsis(group CLP);group Ⅲ ,Ⅳ,Ⅴ low,medium,high dose HES(group H1,2,3).The animals were anesthetized with intraperitoneal pentobarbital sodium 50 mg/kg.Left carotid artery and left femoral vein were cannulated for MAP and HR monitoring and fluid and drug administration.Sepsis was induced by cecal ligation and puncture (CLP).6% HES 130/0.4 7.5,15.0 and 30.0 ml/kg were infused iv over 2 h in group H1,2,3 respectively at 4 h after CLP.The animals were sacrificed at 6 h after CLP.The lungs were isolated for determination of pulmonary capillary permeability(by iv Evans blue injection),the expression of A2BAR and the contents of cAMP,protein kinase A(PKA),TNF-α,IL-6 and IL-10 in the lung tissue.Results CLP significantly increased pulmonary capillary permeability,A2BAR expression and cAMP,IL-6 and TNF-α contents in the lung tissue in group Ⅱ as compared with group S.0.6% HES 130/0.4 significantly reduced pulmonary capillary permeability,increased A2BAR expression,cAMP,PKA and IL-10 and decreased IL-6 and TNF-αcontents in the lung tissue in group H1,2,3 as compared with group CLP.6% HES 130/0.4 decreased pulmonary capillary permeability and up-regulated A2BAR expression in a dose-dependent manner.6% HES 130/0.4 15.0 ml/kg was most effective in increasing cAMP and PKA contents in the lung and depressing inflammatory response.Conclusion 6% HES 130/0.4 decreases pulmonary capillary permeability in a rat model of sepsis by up-regulating A2BAR expression in lung tissue.
4.Reform of public hospitals in Zhejiang province:practice and policy options
Xiaodi WANG ; Qing GUO ; Weihang MA ; Hua YANG ; Xiaqiu WU ; Jianping REN ; Xiaopu HU ; Fanli MENG
Chinese Journal of Hospital Administration 2017;33(2):92-95
Described in the paper is the reform made at public hospitals in Zhejiang province,with analysis of its problems and causes. Based on such,the authors proposed the following actions:to accelerate the reform of public hospitals centering on health promotion, and encourage such hospitals to shoulder the health care responsibility on behalf of the government; to proceed with hierarchical medical system and contract-based service focusing on capacity building of general practitioners; to attract private capital into building the healthcare system; and to motivate non-governmental organizations to cater to diversified healthcare needs of the people.
5.Relationship between thyroid hormone levels during pregnancy and neonatal thyroid function
Huihui HU ; Xiaodi WANG ; Rumin WANG ; Xiaohong HU
Chinese Journal of Primary Medicine and Pharmacy 2021;28(8):1172-1175
Objective:To investigate the relationship between thyroid hormone levels during pregnancy and neonatal thyroid function.Methods:Forty pregnant women with abnormal thyroid stimulating hormone (TSH) level during pregnancy and their newborns who received treatment in Yongkang First People's Hospital, China between July 2019 and August 2020 were included in the observation group. An additional 38 healthy pregnant women and their newborns who concurrently received health examination were included in the control group. The clinical data in the two groups were retrospectively analyzed. The levels of thyroid hormones [(triiodothyronine (T 3), tetraiodothyronine (T 4), TSH, free T 3 (FT 3), free T 4 (FT 4)] in pregnant women were compared between the two groups. TSH level in newborns was compared between the two groups. Thyroid dysfunction in newborns was assessed in each group. The correlation between thyroid hormone levels during pregnancy and neonatal thyroid function was analyzed. Results:TSH level during pregnancy in the observation group was significantly higher than that in the control group [(2.89 ± 0.44) mU/L vs. (2.13 ± 0.22) mU/L, t = 9.570, P < 0.001]. T 3, T 4, FT 3 and FT 4 in the observation group were (0.45 ± 0.07) μg/L, (90.87 ± 8.93) μg/L, (1.08 ± 0.19) ng/L and (10.45 ± 1.73) ng/L, respectively, which were significantly lower than those in the control group [(2.13 ± 0.22) μg/L, (1.31 ± 0.21) μg/L, (2.16 ± 0.34) ng/L, (15.31 ± 21) ng/L, t = 24.514, 9.254, 17.432, 10.845, all P < 0.001]. TSH level in newborns in the observation group was significantly higher than that in the control group ( t = 37.041, P < 0.05). The incidence of thyroid dysfunction in the observation group was significantly higher than that in the control group ( χ2 = 4.780, P < 0.05). TSH level in pregnant women was positively correlated with that in newborns ( r = 0.819, P < 0.05). T 3, T 4, FT 3 and FT 4 levels in pregnant women were negatively correlated with TSH level in newborns ( r = -0.773, -0.802, -0.794, -0.824, all P < 0.05). Conclusion:Compared with healthy pregnant women, pregnant women with abnormal thyroid hormone levels have higher TSH levels and lower T 3, T 4, FT 3 and FT 4 levels. The newborns of pregnant women with abnormal thyroid hormone levels have higher TSH levels and a greater risk of thyroid dysfunction than the newborns of healthy pregnant women. The level of thyroid hormone during pregnancy is related to the thyroid function of newborns. This study is scientific and innovative.
6.Effects of tirofiban application time on middle-term clinical prognesis in patients with acute ST segment elevation myocardial infarction treated by primary percutaneous coronary intervention
Jun GU ; Wei HU ; Hongbing XIAO ; Xiaodi FENG ; Xian JIN ; Qiang YU ; Guizhi YIN ; Ping GUAN ; Chengjun CHEN ; Yueguang CHEN ; Dadong ZHANG
Chinese Journal of Postgraduates of Medicine 2008;31(25):20-22
Objective To investigate the effects of tirofiban application time on middle-term clinical prognosis in patients with acute ST segment elevation myocardial infarction (STEMI)treated by primary percutsneous coronary intervention (PCI). Methods The study of tirofiban was carried out in 50 patients with STEM[in cardiology department from January to December 2006. Twenty-nine patients were randomized to receive tirofiban after PCI for 24 - 36 hours(short time group, STG) and 21 patients for 48 - 72 hours (long time group,LTG). Clinical characteristics, angiography data, main adverse cardiovascular events (MACE) and coronary restenosis rate in 6-month follow-up of the two groups were. compared. Results Follow-up data showed that there was less intractable angina pectoris (14.3% vs 24.1%, P< 0.05) in LTG. But there was no significant difference in coronary restenosis rate between two groups. Conclusion Long time application of tirofiban following PCI in patients with STEMI could improve middle-term clinical prognosis by alleviating the incidence of intractable angina pectoris.
7.Infection status of HIV and its influence factors among men who have sex with men in Sichuan province.
Li LIANG ; Jingyu ZHANG ; Li LIU ; Yingjuan LUO ; Xiaodi PEI ; Ying HU
Chinese Journal of Preventive Medicine 2014;48(11):980-984
OBJECTIVETo investigate HIV infection status and its influence factors in men who have sex with men (MSM) in Sichuan province.
METHODSA face to face investigation and Syphilis and HIV serological detection were conducted among 2 783 MSM who have the insertion of oral or anal sex with men over the past year recruited by snowball sampling and respondent driven sampling methods in nine cities' Gay venues of Sichuan province. χ(2) test and logistic regression analysis were used for statistical analysis.
RESULTSA total of 2 783 MSM were surveyed, of which HIV and Syphilis infection rates were 11.1% (147/2 783) , 5.3% (310/2 783) , respectively. The HIV infection rates of <20 year-old age group, 20-29 year-old age group, 30-39 year-old age group, 40-49 year-old age group, ≥ 50 year-old age group were 6.6% (15/227), 9.7% (143/1 471), 11.8% (80/679), 18.0% (53/294), 17.0% (19/112) (χ(2) = 25.91, P < 0.05). The risk of HIV infection in 30-39 year-old age group, 40-50 year-old age group,> 50 years age group were 2.05 (1.14-3.69) times, 3.24 (1.75-6.01) times, 2.60 (1.22-5.52) times respectively of the <20 years age group. The risk of HIV infection in middle school and below one was 16.5% (73/443) , higher than the high school/college education MSM (11.1% (99/891) ) and the college and higher education MSM (9.5% (138/1 446)) (χ(2) = 16.46, P < 0.05). The risk of HIV infection in High school/college education MSM were 0.64 (0.45-0.90) times of the middle school and below. The HIV infection rates of MSM who accepted a HIV test and knew the result within the last year was 8.2% (119/1 446) , lower than the group who did not accepted any HIV test (14.3% (191/1 336) ) (χ(2) = 25.81, P < 0.05). The HIV infection rates of MSM who received intervention services was 10.1% (256/2 539), lower than the group who did not receive any intervention services (22.1% (54/244) ) (χ(2) = 32.65, P < 0.05) . The HIV infection rates of Syphilis-positive MSM was 32.0% (47/147) , higher than the Syphilis-negative one (10.0% (263/2 636) ) (χ(2) = 68.06, P < 0.05). Received intervention services (OR (95%CI) was 0.52 (0.40-0.68) ) and accepted a HIV test and knew the result within the last year (OR (95%CI) was 0.52 (0.36-0.74) ) were the protective factors of HIV infection. At the same time, the syphilis infection (OR (95%CI) was 4.01 (2.73-5.88) ) were risk factors for HIV infection.
CONCLUSIONThe prevalence rates of HIV infections were considered to be high among MSM in Sichuan province. The MSM of low-literacy, 30 years or older, not received any intervention services, not received any intervention services.Syphilis-positive have a greater risk of HIV infection.
Adolescent ; Adult ; China ; Data Collection ; Demography ; HIV Infections ; HIV Seropositivity ; Homosexuality, Male ; Humans ; Male ; Middle Aged ; Prevalence ; Risk Factors ; Sexual Behavior ; Surveys and Questionnaires ; Syphilis
8.Nursing of radiofrequency ablation for adrenocortical adenoma with Cushing's syndrome combined steroid-induced diabetes mellitus: one case report
Xiaodi GUO ; Yanhua ZHU ; Xiling HU
Chinese Journal of Practical Nursing 2021;37(35):2769-2773
Objective:To summarize experience of nursing in radiofrequency ablation (RFA) for adrenocortical adenoma with Cushing′s syndrome combined steroid-induced diabetes mellitus.Methods:The key of preoperative nursing was precise glucose control by using insulin pump. Focus on patients psychological intervention. It was important for closely monitor the change of blood pressure, cortisol levels and biochemical index to prevent acute complications such as adrenal crisis during RFA. Pay attention to postoperative nutrition management for reduce blood glucose fluctuation and adverse reactions of hydrocortisone at postoperative.Results:No severe complications occurred during this procedure. After twenty-day nursing and treatment, the patient′s blood glucose control was stable, and the symptoms related to Cushing′s syndrome gradually disappeared.Conclusion:The ultrasound guided radiofrequency ablation in adrenocortical adenoma with Cushing′s syndrome combined with steroid-induced diabetes mellitus was a feasible, safe, and minimally invasive treatment. The key to effectively reduce postoperative complications and ensure the success of the operation. Are adequate preoperative preparation and strict monitor.
9.The relationship between elevated antiphospholipid antibodies and thrombosis in hospitalized patients
Xiaomin SHI ; Yan GONG ; Xiaodi HU ; Le ZHAI
Chinese Journal of Preventive Medicine 2021;55(9):1100-1104
Objective:Assess the relationship between elevated antiphospholipid antibodies and thrombosis in hospitalized patients.Methods:Case control study. A total of 385 patients (149 males and 236 females, aged from 1 to 105 years, with a median age of 37 years) who were hospitalized in Peking University First Hospital from January 2015 to December 2019 and tested positive for any one of the anti-phospholipid antibodies were included in the study. All subjects were divided into thrombotic group and non-thrombotic group according to whether thrombus was detected by imaging examination during hospitalization. In thrombosis group, there were 66 males and 36 females, aged from 3 to 105 years, with a median age of 58 years. In non-thrombosis group, there were 83 males and 200 females, aged from 1 to 94 years, with a median age of 31 years. Clinical data and laboratory data of patients were recorded. ACL-IgM/IgG and anti-β2GPI-IgM/IgG were detected by ELISA and LA was detected by dRVVT and SCT on automatic coagulation analyzer. The rates of age, gender, smoking, obesity, hypertension, hyperlipidemia, diabetes and the median level of antiphospholipid antibodies were compared between two groups. Logistic multivariate regression analysis was used to determine the risk factors for thrombotic events. The mid-to-high titer value of aCL was established by the χ 2-trend test and verified by logistic regression. Results:The median age (58 years) and the rates of male (64.7%), smoking (16.7%), hypertension (63.7%) and diabetes (28.4%) in thrombus group were significantly higher than those in non-thrombus group ( Z=7.685, χ2=38.077, 16.312, 37.769, 24.749 respectively; P<0.01). The positive rate of anti-β2GPI-IgG and dRVVT in thrombosis group (11.8% and 78.4%) was significantly higher than that in non-thrombosis group (5.3% and 60.1%), as well as the median level of dRVVT (1.29 RU/ml vs 1.23 RU/ml) (χ2=3.864 and 10.309, Z=3.539; P<0.05). The median level of aCL-IgM was higher in non-thrombosis group (2.3 MPL vs 2.0 MPL). The positive rate of aCL-IgG was slightly higher in thrombosis group (18.6% vs 10.6%). Logistic regression analysis showed that men, hypertension, diabetes, advanced age, elevated dRVVT, and elevated anti-β2GPI-IgG are risk factors for thrombosis. Taking 36 GPL as the medium-to-high titer value of aCL-IgG, the risk of thrombosis increased by 2.45 times. Conclusions:In the anti-phospholipid antibody profile, LA detected by dRVVT method, anti-β2GPI-IgG and aCL-IgG may be valuable laboratory indicators for inpatient thrombotic events. The mid-to-high titer value of aCL-IgG is set at 36 GPL to distinguish the risk of thrombosis.
10.The relationship between elevated antiphospholipid antibodies and thrombosis in hospitalized patients
Xiaomin SHI ; Yan GONG ; Xiaodi HU ; Le ZHAI
Chinese Journal of Preventive Medicine 2021;55(9):1100-1104
Objective:Assess the relationship between elevated antiphospholipid antibodies and thrombosis in hospitalized patients.Methods:Case control study. A total of 385 patients (149 males and 236 females, aged from 1 to 105 years, with a median age of 37 years) who were hospitalized in Peking University First Hospital from January 2015 to December 2019 and tested positive for any one of the anti-phospholipid antibodies were included in the study. All subjects were divided into thrombotic group and non-thrombotic group according to whether thrombus was detected by imaging examination during hospitalization. In thrombosis group, there were 66 males and 36 females, aged from 3 to 105 years, with a median age of 58 years. In non-thrombosis group, there were 83 males and 200 females, aged from 1 to 94 years, with a median age of 31 years. Clinical data and laboratory data of patients were recorded. ACL-IgM/IgG and anti-β2GPI-IgM/IgG were detected by ELISA and LA was detected by dRVVT and SCT on automatic coagulation analyzer. The rates of age, gender, smoking, obesity, hypertension, hyperlipidemia, diabetes and the median level of antiphospholipid antibodies were compared between two groups. Logistic multivariate regression analysis was used to determine the risk factors for thrombotic events. The mid-to-high titer value of aCL was established by the χ 2-trend test and verified by logistic regression. Results:The median age (58 years) and the rates of male (64.7%), smoking (16.7%), hypertension (63.7%) and diabetes (28.4%) in thrombus group were significantly higher than those in non-thrombus group ( Z=7.685, χ2=38.077, 16.312, 37.769, 24.749 respectively; P<0.01). The positive rate of anti-β2GPI-IgG and dRVVT in thrombosis group (11.8% and 78.4%) was significantly higher than that in non-thrombosis group (5.3% and 60.1%), as well as the median level of dRVVT (1.29 RU/ml vs 1.23 RU/ml) (χ2=3.864 and 10.309, Z=3.539; P<0.05). The median level of aCL-IgM was higher in non-thrombosis group (2.3 MPL vs 2.0 MPL). The positive rate of aCL-IgG was slightly higher in thrombosis group (18.6% vs 10.6%). Logistic regression analysis showed that men, hypertension, diabetes, advanced age, elevated dRVVT, and elevated anti-β2GPI-IgG are risk factors for thrombosis. Taking 36 GPL as the medium-to-high titer value of aCL-IgG, the risk of thrombosis increased by 2.45 times. Conclusions:In the anti-phospholipid antibody profile, LA detected by dRVVT method, anti-β2GPI-IgG and aCL-IgG may be valuable laboratory indicators for inpatient thrombotic events. The mid-to-high titer value of aCL-IgG is set at 36 GPL to distinguish the risk of thrombosis.