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OBJECTIVES@#There is a high coagulation state in pregnant women, which is prone to coagulation and fibrinolysis system dysfunction. This study aims to explore the latest coagulation markers-thrombomodulin (TM), thrombin-antithrombin complex (TAT), plasmin-α2 plasmin inhibitor complex (PIC), and tissue plasminogen activator/plasminogen activator inhibitor compound (tPAI-C) in different stages of pregnancy, establish reference intervals (RIs) for healthy pregnant women of Chinese population, and to provide an effective and reliable reference for clinicians.@*METHODS@#A total of 492 healthy pregnant women, who underwent pregnancy examination and delivery in the Department of Obstetrics, Second Xiangya Hospital of Central South University from October 2019 to October 2020, were enrolled for this study. They were assigned into the first trimester group, the second trimester group, the third trimester group, and the puerperium group according to the pregnancy period, and 123 healthy non-pregnant women were selected as the controls. Plasma levels of TM, TAT, PIC and tPAI-C were analyzed by automatic chemiluminescence immunoassay analyzer. The RIs for TM, TAT, PIC, and tPAI-C were defined using non-parametric 95% intervals, determined following Clinical and Laboratory Standards Institute Document C28-A3c (CLSI C28-A3c), and Formulation of Reference Intervals for the Clinical Laboratory Test Items (WS/T402-2012).@*RESULTS@#TM and TAT levels increased gradually in the first, second, and third trimester women and decreased in the puerperium women (P<0.05 or P<0.01). PIC level of healthy non-pregnant women was lower than that of pregnant women (P<0.05 or P<0.01), but PIC level of pregnant and puerperium women did not differ significantly (P>0.05). tPAI-C level in healthy non-pregnant women was lower than that of pregnant women (P<0.05 or P<0.01), and tPAI-C level was significantly decreases in the puerperium women (P<0.01). The RIs for TM were as follows: Healthy non-pregnant women at 3.20-4.60 TU/mL, the first and second trimester at 3.12-7.90 TU/mL, the third trimester at 3.42-8.29 TU/mL, puerperium at 2.70-6.40 TU/mL. The RIs for TAT were as follows: Healthy non-pregnant women at 0.50-1.64 ng/mL, the first and second trimester at 0.52-6.91 ng/mL, the third trimester at 0.96-12.92 ng/mL, puerperium at 0.82-3.75 ng/mL. The RIs for PIC were as follows: Healthy non-pregnant women at 0.160-0.519 ng/mL, pregnant women at 0.162-0.770 μg/mL. The RIs for tPAI-C were as follows: Healthy non-pregnant women at 1.90-4.80 ng/mL, the first and second trimester at 2.03-9.33 ng/mL, the third trimester at 2.80-14.20 ng/mL, puerperium at 1.10-8.40 ng/mL.@*CONCLUSIONS@#The levels of 4 new coagulation markers TM, TAT, PIC, and tPAI-C in pregnant women are increased significantly during pregnancy and gradually return to normal after delivery. The RIs for TM, TAT, PIC, and tPAI-C in pregnant women by trimester are established according to CLSI C28-A3c, thus providing a clinical reference for clinician in judgement of thrombotic risk.
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Feminino , Humanos , Gravidez , Biomarcadores/sangue , Coagulação Sanguínea , Período Pós-Parto , Valores de ReferênciaRESUMO
OBJECTIVE To provide reference for developing pharmacovigilance and constructing an active surveillance system with extensive participation of pharmaceutical enterprises in China. METHODS Retrieving the literature and data from databases such as CNKI ，PubMed，and the official website of observational medical outcomes partnership （OMOP），the mechanism of pharmaceutical enterprises ’participation and its operation mode were investigated ，while specific path and code of conduct for pharmaceutical enterprises to participate in active surveillance system were analyzed. Finally ，the corresponding suggestions were put forward according to the actual situation of China. RESULTS & CONCLUSIONS Pharmaceutical enterprises in OMOP participated in project construction and operation through public private partnership （PPP）mechanism，and played the role of project funding ，project governance and project research. Pharmaceutical enterprises participating in OMOP need to carry out activities in accordance with the code of conduct of extensive cooperation ，transparency and openness and the protection of patient privacy. In the future practice of active surveillance system in China ，it is necessary to promote the relevant legislation of active monitoring system ，emphasize the responsibility of active surveillance of pharmaceutical enterprises ，establish a PPP mechanism of industry-university-research integration ，form a good governance ecology and strengthen the protection of patients ’privacy.
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ObjectiveTo observe the clinical effect of governor meridian moxibustion combined with modified Youguiwan in treating erectile dysfunction of kidney Yang deficiency type and its influence on the level of sex hormones and penile hemodynamics. MethodA total of 120 patients were randomized into the control group （60 cases in total， 3 dropouts/lost to follow-ups， 57 finally included） and treatment group （60 cases in total， 2 dropouts/lost to follow-ups， 58 finally included） with the random number table method. Both groups received governor meridian moxibustion （1 time/w， a total of 4 times）. In addition， the control group took oral compound Xuanju capsule （3 capsules/time， 3 times/d）， and the treatment group was given Jiawei Youguiwan （Chinese medicine decoction， 1 dose/d）. The administration lasted 4 weeks for both groups. The scores of 5th edition international index of erectile function （IIEF-5）， erection quality scale （EQS）， and erectile hardness score （EHS）， traditional Chinese medicine （TCM） syndrome score， levels of sex hormones ［testosterone （T）， follicle-stimulating hormone （FSH）， luteinizing hormone （LH）， prolactin （PRL）］， and parameters of penile hemodynamics ［peak systolic velocity （PSV）， end-diastolic volume （EDV）， and resistance index （RI）］ were recorded. ResultAfter treatment， the total effective rate was 87.93% （51/58） in the treatment group， higher than the 71.93% （41/57） in the control group （χ2=4.600 3， P<0.05）. After treatment， compared with before treatment，the treatment group registered increase in the scores of IIEF-5， EQS， and EHS （P<0.01）， decrease in TCM syndrome score （P<0.01）， rise of serum T level （P<0.05）， reduction in the levels of FSH， LH， and PRL （P<0.05）， increase in the levels of PSV and RI （P<0.05）， and down-regulation of EDV level （P<0.05）. ConclusionGovernor meridian moxibustion combined with modified Youguiwan can effectively improve the penile erectile function， erectile hardness， and erection quality， and relieve the clinical symptoms of erectile dysfunction patients of kidney Yang deficiency type.
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Objective@#To explore the relationship between weight change and the changes in blood pressure, blood glucose and blood lipid profiles in middle-aged and elderly Chinese people.@*Methods@#All participants were from the Dongfeng-Tongji cohort study. The study included 16 606 middle-aged and elderly Chinese people with complete information in the baseline survey in 2008 and the first follow-up survey in 2013. We collected the data on demographic characteristics, lifestyle, history of diseases and medication, and the results of medical health examinations, including height, weight, blood pressure, fasting blood glucose and lipid profiles. We divided the weight change into five groups, moderate or above weight loss (<-8.0%), slight weight loss (-8.0%, -3.1%), weight maintenance (-3.0%, 3.0%), slight weight increased (3.1%, 8.0%), and moderate or above weight increased (>8.0%). Generalized linear regression model was used to analyze the relationship between weight change and the changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting blood glucose (FBG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride (TG). Subgroup analyses were used to explore the influences of gender, age and baseline BMI level on the relationship between weight change and the above-mentioned metabolic indicators.@*Results@#The average age of participants in baseline survey was (62.19±7.28) years with a range of 45 to 89 years. During the five-year period, there were 18.86% (2 633), 28.03% (4 655), 35.87% (5 956), 13.96% (2 319), 6.28% (1 043) people with moderate or above weight loss, slight weight loss, weight maintenance, slight weight increased, and moderate or above weight increased, respectively. Regression analyses showed that body weight change were positively correlated with changes in SBP, DBP, FBG, TC, LDL-C and TG, and negatively correlated with change in HDL-C (all linear trend P values were<0.05); As every 10% of weight changed, the β (95%CI) of changes in SBP (mmHg) (1 mmHg=0.133 kPa), DBP (mmHg), FBG (mmol/L), TC (mmol/L), LDL-C (mmol/L), HDL-C (mmol/L) and TG (mmol/L) were 4.94 (4.32, 5.55), 2.50 (2.11, 2.88), 0.05 (0.02, 0.08), 0.13 (0.11, 0.16), 0.14 (0.12, 0.16), -0.05 (-0.07, -0.04) and 0.16 (0.14, 0.18), respectively. Furthermore, subgroup analyses showed that weight change can lead to greater changes in blood pressure in older and overweight or obesity elderly people (all P for interaction<0.05).@*Conclusion@#Weight loss was beneficial for middle-aged and elderly people to improve the blood pressure, blood glucose and blood lipid profiles, regardless of the weight at the baseline, while weight gain was not.
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Objective To explore the value of endothelial dysfunction assessment in predicating major adverse cardiac and cerebrovascular events (MACCE) in peritoneal dialysis (PD) patients.Methods A prospective cohort study included 136 end stage renal disease (ESRD) patients from Jan 1,2009 to Dec 31,2011 was conducted.Endothelial function was assessed by flowmediated dilation (FMD) of brachial artery.Kaplan-Meier method was used to estimate survival rate.The survival difference between the two groups was compared by the log-rank test.Multivariate Cox proportional hazards regression was used to determine the independent risk factors of MACCE.Results In the follow-up period,18 patients in low FMD (FMD≤2.7％) group occurred MACCE,and 13 patients in high FMD (FMD ＞ 2.7％) group occurred MACCE.Compared with high FMD group,MACCE-free survival rate in the low FMD group had a significantly decreased (x2=4.190,P=0.041).Multivariate Cox proportional hazards regression analysis showed that higher level of total cholesterol,lower FMD,longer PD time and higher levels of hs-CRP were all independent predictors of MACCE.Conclusion Reduced brachial artery FMD is an independent risk factor of MACCE,and the application of FMD contributes to the risk stratification of cardiac and cerebrovascular disease in PD patients.
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Objective To explore the tobacco control project based health education curriculum reform's effect of improving medical students' tobacco control.Method Choosing the students of two classes of students in preventive medicine specialty of Harbin Medical University as the research object, investigating the students respectively with the questionnaire prepared uniformly by 7 schools before and after the course.All data were coded by Epidata 3.0, and SPSS 18.0 was used to carry out the relevant information for the chi square test and t test.Result The sample size of baseline survey was114 and after the intervention was 87.The knowledge pass rate of the girls before and after the intervention were 87.3％ (48/55) and 98.2％ (54/55) respectively (P=0.000).The boys' awareness rate of the secondhand smoke safety level were 13.6％ (8/59) and 21.9％ (7/32) respectively, and the girls were 13.0％ (7/55) and 31.5％ (17/55) (P=0.021).Students interested in tobacco increased from 79.8％ (91/114) before intervention to 90.8％ (79/87) after intervention (P=0.033).Students willing to work in the tobacco related increased from 52.2％(59/114) before intervention to 66.7％ (58/87)after intervention (P=0.044).The girl who replied after intervention I am not smoking now, but won't smoke either when working in the disease control in the future reached as high as 96.4％ (53/55), but the students were lack of confidence to help people to stop smoking.Conclusion The reform of social practice activity curriculum designed for tobacco control project is effective, and it is urgent to strengthen the training of preventive medical students' smoking cessation skills and enhance their confidence.