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Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Subject(s)
Pregnancy , Child , Humans , Female , Glycated Hemoglobin , Cohort Studies , Diabetes Mellitus/diagnosis , Sensitivity and Specificity , ROC CurveABSTRACT
BACKGROUND@#Gestational diabetes mellitus (GDM) is usually diagnosed between 24th and 28th gestational week using the 75-g oral glucose tolerance test (OGTT). It is difficult to predict GDM before 24th gestational week because fast plasma glucose (FPG) decreases as the gestational age increases. It is controversial that if FPG ≥5.1 mmol/L before 24th gestational week should be intervened or not. The aim of this study was to evaluate the value of FPG to screen GDM before 24th gestational week in women with different pre-pregnancy body mass index (BMI).@*METHODS@#This was a multi-region retrospective cohort study in China. Women who had a singleton live birth between June 20, 2013 and November 30, 2014, resided in Beijing, Guangzhou and Chengdu, and received prenatal care in 21 selected hospitals, were included in this study. Pre-pregnancy BMI, FPG before the 24th gestational week, and one-step GDM screening with 75 g-OGTT at the 24th to 28th gestational weeks were extracted from medical charts and analyzed. The pregnant women were classified into four groups based on pre-pregnancy BMI: Group A (underweight, BMI < 18.5 kg/m), Group B (normal, BMI 18.5-23.9 kg/m), Group C (overweight, BMI 24.0-27.9 kg/m) and Group D (obesity, BMI ≥28.0 kg/m). The trend of FPG before 24th week of gestation was described, and the sensitivity and specificity of using FPG before the 24th gestational week to diagnose GDM among different pre-pregnancy BMI groups were reported. Differences in the means between groups were evaluated using independent sample t-test and analysis of variance. Pearson Chi-square test was used for categorical variables.@*RESULTS@#The prevalence of GDM was 20.0% (6806/34,087) in the study population. FPG decreased gradually as the gestational age increased in all pre-pregnancy BMI groups until the 19th gestational week. FPG was higher in women with higher pre-pregnancy BMI. FPG before the 24th gestational week and pre-pregnancy BMI could be used to predict GDM. The incidence of GDM in women with FPG ≥5.10 mmol/L in the 19th to 24th gestational weeks and pre-pregnancy overweight or obesity was significantly higher than that in women with FPG ≥5.10 mmol/L and pre-pregnancy BMI <24.0 kg/m (78.5% [62/79] vs. 52.9% [64/121], χ = 13.425, P < 0.001).@*CONCLUSIONS@#FPG decreased gradually as the gestational age increased in all pre-pregnancy BMI groups until the 19th gestational week. Pre-pregnancy overweight or obesity was associated with an increased FPG value before the 24th gestational week. FPG ≥5.10 mmol/L between 19 and 24 gestational weeks should be treated as GDM in women with pre-pregnancy overweight and obesity.
Subject(s)
Adult , Female , Humans , Pregnancy , Blood Glucose , Body Mass Index , Diabetes, Gestational , Blood , Diagnosis , Epidemiology , Fasting , Blood , Gestational Age , Glucose Tolerance Test , Incidence , Prevalence , ROC Curve , Retrospective StudiesABSTRACT
As the rate of cesarean section increases,the incidence of pernicious placenta previa increases,and risk of complications also increases.At present,interventional therapy in obstetrics,especially postpartum hemorrhage,has a wide range of application,which may lead to corresponding complications such as puncture site damage,vascular injury,thrombosis,etc.This article focuses on the complications of prophylactic balloon occlusions.
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OBJECTIVE: To evaluate the efficacy and safety of motherwort(herba leonuri)injection in the treatment of fetal membrane retention after vaginal delivery.METHODS: The prospective study was designed as a multicenter,open,randomized,controlled research from December 2017 to October 2018.A total of 244 women who achieved fullterm vaginal delivery were enrolled from 7 tertiary hospitals in China.Sixteen people were lost to follow-up(7 in the experimental group and 9 in the control group).All cases were randomly divided into group of motherwort(experimental group)and group of basic treatment(control group).Full Analysis Set(FAS)and Per ProtocolSet(PPS)were used for statistical analysis.The results of main validity indicators were the same.Therefore,only the results of PPS set analysis were reported in detail.PPS set included 109 cases in control group and 114 cases in experimental group.Control group were administered by oxytocin 20 U and cephalosporinⅡintravenous injection daily for3 days after birth;experimental group were administered by motherwort 20 mg intramuscular injection per 12 hours for 5 consecutive days on the basis of basic treatment.Both groups of patients were given oral herb medicine Chan-fu-kang or Chan-fu-an Granules after discharge for 7 consecutive days.The following clinical parameters were collected and analyzed for evaluation of the efficacy and safety of motherwort injection in the treatment of retained fetal membrane after vaginal delivery.The main effectiveness indicators were maternal lochia,uterine volume change,and discharge of retained fetal membrane;the secondary effectiveness indicators were the maternal infection-related factors and infections,the incidence of secondary postpartum hemorrhage,postpartum body temperature changes,and the use of other hemostatic drugs.Safety indicators were laboratory tests(blood routine,electrocardiogram),adverse reactions/events,which were used to evaluate the safety and efficacy of motherwort injection in the treatment of retained fetal membrane after vaginal delivery.RESULTS:(1)Lochia:the duration of bloody lochia was significantly shorter in the experiment group than in the control group([(5.12±1.83)d]vs.(6.27±2.07)d,P=0.000);rate of termination of bloody lochia within 5 days was significantly higher in the experiment group than in the control group(64.91% vs. 35.78%,P=0.000).(2)Comparison of uterine volume:the reduction of uterus volume in the experiment group was significantly greater than that in the control group(Z=-2.27,P8.0 mg/L or PCT>0.5 ng/L was defined as infection,the infection rate of the experiment group after 5 days of treatment was significantly lower than that of the control group(P0.05).No other hemostatic drugs were used in the two groups,and no secondary postpartum hemorrhage occurred.(6)There were no adverse reactions reported in both groups,and no abnormal blood routine indicators or electrocardiogram appeared.CONCLUSION: The application of motherwort injection combined with the basic treatment after the vaginal delivery can significantly shorten the duration of bloody lochia,promote uterine involution,increase the discharge rate of retained fetal membrane,and reduce the rate of uterine curettage.
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<p><b>Background</b>The effect of maternal weights on the risk of iron deficiency anemia (IDA) during pregnancy remains unclear. The study aimed to investigate the association between maternal weight indicators and IDA during pregnancy.</p><p><b>Methods</b>We conducted a cohort study to examine the association between maternal weight indicators, including prepregnancy body mass index and the rate of gestational weight gain (GWG), and the risk of IDA among Chinese pregnant women. Data about new-onset IDA at different trimesters from a national cross-sectional survey were collected; information regarding baseline variables and rate of GWG from women participating in the survey were retrospectively collected. Tested IDA and reported IDA were documented. Multilevel logistic regression to examine the association between maternal weight indicators and the risk of IDA after adjusting for potential confounders was conducted.</p><p><b>Results</b>This study enrolled 11,782 pregnant women from 24 hospitals from September 19, 2016, to November 20, 2016. Among those, 1515 (12.9%) IDA events were diagnosed through test (test IDA); 3915 (33.3%) were identified through test and patient reporting (composite IDA). After adjusting for confounders and cluster effect of hospitals, underweight pregnant women, compared with normal women, were associated with higher risk of test IDA (adjusted odds ratio [aOR]: 1.35, 95% confidence interval [CI]: 1.17-1.57 and composite IDA (aOR: 1.35, 95% CI: 1.21-1.51); on the contrary, overweight and obese women had lower risk of test IDA (aOR: 0.68, 95% CI: 0.54-0.86 overweight; aOR: 0.30, 95% CI: 0.13-0.69 obese) and composite IDA (aOR: 0.77, 95% CI: 0.67-0.90 overweight; aOR: 0.34, 95% CI: 0.21-0.55 obese). The higher rate of GWG was associated with higher risk of IDA (test aOR: 1.86 95% CI: 1.26-2.76; composite aOR: 1.54, 95% CI: 1.16-2.03).</p><p><b>Conclusions</b>Pregnant women who are underweight before pregnancy and who have faster GWG are more likely to develop IDA. Enforced weight control during pregnancy and use of iron supplements, particularly among underweight women, may be warranted.</p>
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Objective To analysis of consistency of results in evaluating urine dry chemical method and nephelometry in the detection of urine albumin(UAlb) and urine dry chemical method and enzymatic method in the detection of urinary creatinine (Cr) and albumin-to-creatinine ratio(ACR).Methods In 157 urine samples collected firstly in the morning,urine microalbumin was determined by the urine dry chemistry method and nephelometry,and urine creatinine was determined by the urine dry chemistry method and the enzyme method respectively.The kappa was applied to evaluating the consistency.Results The results of UAlb showed that the kappa was 0.837 9 (95%CI:0.718 1~0.957 7),the results of urine creatinine showed that the kappa was 0.769 7 (95%CI:0.665 2~0.874 2),and the results of albumin-to creatinine ratio showed that the kappa was 0.756 6 (95%CI:0.628 6~0.884 6).Conclusion The results of urine Alb,urinary creatininc and ACR by urine dry chemistry method and urine albumin by nephelometry,and urine Cr by enzymatic method and ACR had high consistency.Urine dry chemical method can be used for screening of early renal disease and for screening in CKD grading,screening for early screening or for long-term maintenance.
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<p><b>OBJECTIVE</b>To investigate the effect of core protein of hepatitis C virus (HCV) on the expression of hypoxia-inducible factor-1alpha (HIF-1alpha) and vascular endothelial growth factor (VEGF).</p><p><b>METHODS</b>Huh7.5.1 cells were transfected with plasmid flag2B-core carrying HCV core gene, expression of HIF-1alpha and VEGF were measured by reverse transcription-polymorphism chain reaction (RT-PCR) and western blot. Enzyme link immunoabsorbent assay (ELISA) were used to detect the level of VEGF in the supernatants.</p><p><b>RESULTS</b>The expression of HIF-1alpha and VEGF mRNA and protein were upregulated after flag2B-core was transfected into Huh7.5.1 cells, and VEGF level in the supernatant was significant elevated as compared to controls [(654.5+/-43.7) pg/ml vs (365.9+/-26.8) pg/ml, t = 653.1%, P less than 0.01]. The expression of HIF-1alpha and VEGF mRNA and protein were downregulated after flag2B-core and HIF-1alpha siRNA were co-transfected into Huh7.5.1 cells, and VEGF level in the supernatant was significantly reduced as compared to controls [(389.2+/-29.6) pg/ml vs (768.8+/-47.3)pg/ml, t = 1330.22, P less than 0.01].</p><p><b>CONCLUSIONS</b>HCV core protein enhances the expression of HIF-1alpha and VEGF. HCV may regulate the expression of HIF-1alpha and VEGF via the core protein.</p>
Subject(s)
Humans , Cell Line, Tumor , Hypoxia-Inducible Factor 1, alpha Subunit , Metabolism , RNA, Small Interfering , Transfection , Vascular Endothelial Growth Factor A , Metabolism , Viral Core Proteins , GeneticsABSTRACT
<p><b>OBJECTIVE</b>To assess the allele and genotype frequencies of the estrogen receptor alpha ( ESR alpha) Pvu II and Xba I polymorphisms in patients with severe preeclampsia and compare them with those of normal pregnant women.</p><p><b>METHODS</b>Blood samples from 131 patients with severe preeclampsia and 223 normal pregnant women from Chinese Han in Chengdu area were analyzed, using PCR-RFLP method. Pregnant patients with blood pressure exceeding 140/90 mmHg (or 18.7/12 kPa) were recruited with a strict definition of preeclampsia. Genotyping was performed using PCR-RFLP for Pvu II and Xba I polymorphisms in the ESR alpha gene.</p><p><b>RESULTS</b>The T and C allele frequencies for Pvu II site were 0.580 and 0.420 in the patient group, and 0.576 and 0.424 in the controls, respectively. The A and G allele frequencies for Xba I site were 0.763 and 0.237 in the patient group, and 0.807 and 0.193 in control group, respectively. No significant difference in the allele frequencies of either site was observed between the two groups. However, the CC homozygotes or CT heterozygotes in the control pregnant women had higher systolic blood pressure levels than TT homozygotes for Pvu II site after the data was adjusted for age and BMI (114.00+/-21.44 mmHg or 114.33+/-1.21 mmHg vs. 108.62+/-1.91 mmHg, P<0.05). No genotype effect on the blood pressures was found for Pvu II site in the case group, nor for Xba I site in either group.</p><p><b>CONCLUSION</b>Our work has excluded the association of the ESRalpha Pvu II and Xb I polymorphism with severe preeclampsia in a Southwest Chinese population, although this polymorphism may be associated with the systolic blood pressure level in the normal pregnant women.</p>
Subject(s)
Adult , Female , Humans , Pregnancy , Asian People , Genetics , Case-Control Studies , China , Deoxyribonucleases, Type II Site-Specific , Metabolism , Estrogen Receptor alpha , Genetics , Gene Frequency , Genotype , Polymorphism, Genetic , Pre-Eclampsia , Genetics , PathologyABSTRACT
<p><b>OBJECTIVE</b>This study investigated the life style and health status of preterm and term infants' mothers in order to explore the risk factors for preterm delivery.</p><p><b>METHODS</b>A total of 600 matched cases, including 120 pairs of preterm infants and their mothers and 180 pairs of term infants and their mothers were recruited. All of the mothers participated in a questionnaire survey on life style and health status during or before pregnancy. General data of the infants were also collected. Logistics regression analysis was used for evaluating the risk factors for preterm delivery.</p><p><b>RESULTS</b>The height, body weights and body mass index before pregnancy in preterm infants' mothers were significantly lower than those in term infants' mothers (p<0.05). The birth height and weights and Apgar scores in preterm infants were significantly lower than those in term infants (p<0.05). The whole nutritional Knowledge-Attitude-Practice (KAP) scores in preterm infants' mothers were significantly lower than those in term infants' mothers (P<0.05). Multiple factor regression analysis showed that recurrent abortions before gestation (OR=2.332, P<0.05) and premature rupture of membrane before delivery (OR=7.979, P<0.01) were risk factors for preterm delivery, while maternal nutritional KAP scores (OR=0.949, P<0.01) and body weights before pregnancy (OR=0.954, P<0.05) were protective factors.</p><p><b>CONCLUSIONS</b>The women with low body weight, low nutritional KAP scores or recurrent abortions history before pregnancy or presenting premature rupture of membrane before delivery are at high risk for preterm delivery.</p>
Subject(s)
Female , Humans , Infant, Newborn , Pregnancy , Case-Control Studies , Fetal Membranes, Premature Rupture , Health Knowledge, Attitudes, Practice , Health Status , Infant, Premature , Life Style , Logistic Models , Premature BirthABSTRACT
<p><b>OBJECTIVE</b>To investigate calcium, iron and magnesium intakes of preterm infants' mothers before and during pregnancy and calcium, iron and magnesium levels of preterm infants and their mothers in order to provide basis for studying the effect of nutritional factors on the occurrence of prematurity.</p><p><b>METHODS</b>Two hundred and forty matched cases (preterm infants and their mothers) and controls (term infants and their mothers) were recruited. A nutritional survey of calcium, iron and magnesium intakes was performed in the mothers before and during pregnancy. Calcium, iron and magnesium levels in maternal plasma and in cord blood, placenta, breast milk, meconium, and amniotic fluid were measured with axial view inductively coupled plasma optical emission spectrometry (ICP-OES).</p><p><b>RESULTS</b>Iron and magnesium intakes in preterm infants' mothers were significantly less than those in term infants' mothers before pregnancy (P<0.05). Iron and calcium intakes in preterm infants' mothers were also significantly less than those in term infants' mothers during pregnancy (P<0.05). Multivariate analysis of variance showed that iron and calcium levels of preterm infants' mothers were significantly lower than those of term infants' mothers (P<0.05). The preterm infants showed significantly lower iron and magnesium levels than term infants (P<0.05). Plasma levels of calcium, iron and magnesium in infants were positively correlated to maternal plasma levels of calcium, iron and magnesium (r=0.517, 0.622, 0.518, respectively; P<0.05).</p><p><b>CONCLUSIONS</b>The iron and calcium levels of preterm infants' mothers were lower than those of term infants' mothers, and the iron and magnesium levels of preterm infants were lower than those of term infants. The exact relationship between calcium, iron and magnesium levels and intakes before and during pregnancy needs to be explored further.</p>
Subject(s)
Female , Humans , Infant, Newborn , Pregnancy , Calcium , Blood , Calcium, Dietary , Gestational Age , Infant, Premature , Blood , Iron , Blood , Iron, Dietary , Magnesium , Blood , BloodABSTRACT
<p><b>OBJECTIVE</b>To study the clinical features and diagnosis of intrahepatic cholestasis of pregnancy (ICP).</p><p><b>METHODS</b>During the last 10 years 1241 cases of ICP stayed in our hospital. Their clinical data were retrospectively reviewed.</p><p><b>RESULTS</b>5.2% of all the maternity patients had ICP. It occurred more in winter and 3.5% of ICP occurred in multiple pregnancies. The recurrence rate of ICP was 30.2%. On the average, it occurred at gestational week 32.6. Skin pruritus was the characteristic manifestation and the presenting symptom in 1201 patients (96.8%). The other presenting features included elevated serum ALT and AST (2.3%), jaundice (8 patients), diarrhea (3 patients), deep yellow urine (2 patients) and right upper abdominal pain (1 patient). The serum transaminases levels were elevated, of which 60% were between 50-200 IU/L. Serum total bile acid (TBA) levels were elevated in 82.4% of the patients and bilirubin levels in 33.4%. The elevated bilirubin levels were 30 to 90 micromol/L in 85% of those patients with this condition, and it was never higher than 170 micromol/L.</p><p><b>CONCLUSION</b>The basic diagnostic points of ICP are pruritus and abnormal liver function characterized by increased transaminases and TBA. Therefore paying attention to typical pruritus and other atypical features such as elevated serum transaminases, jaundice, diarrhea, deep yellow urine and right upper abdominal pain during antenatal care is important for an early diagnosis of ICP.</p>