ABSTRACT
【Objective】 To investigate the activity level of coagulation factor Ⅺ(FⅪ) in IVIG products, which would provide support for improving the safety and quality control of IVIG products in China. 【Methods】 A total of 71 batches of IVIG products(half of which were closed to expiry date) from 23 domestic manufacturers (brands) were submitted for inspection and assayed for procoagulant activity including FⅪa, FⅪ and NAPTT activity with a chromogenic assay, coagulation proenzymes levels using one stage clotting assays and non-activated partial thromboplastin time (NAPTT). 【Results】 FⅪa(mIU/mL): 32 lots of IVIGs from 15 manufacturers(brands) possessed activities below 0.1 or the detection limit of the assays, 24 IVIG lots from 12 manufacturers were between 0.1~1(0.39±0.20), the remaining 15 IVIG lots from 6 manufacturers had FⅪa activity greater than 1 up to 47(13.27±15.61). FⅪ(mIU/mL): there were no detectable activities of FⅪ in 58 lots from 21 manufacturers, the other 13 lots from 6 manufacturers had IVIGs between 13~309(69.0±98.1), which included in 15 lots of IVIG whose FⅪa activity were greater than 1mIU/mL. NAPTT(s): The coagulation times for aforementioned 15 IVIG lots were all above 150s in the NAPTT test. The NAPTT ratios varied between 0.67 and 0.94(0.83±0.07), and 7 of 15 IVIGs had NAPTT ratios below or equal to 0.8. 【Conclusion】 There are substantial differences in the FⅪ and FⅪa activities in the IVIG preparations from 23 different manufacturers. Most of them had a lower activities; certain lots from specific manufacturers had relatively higher FⅪa activities. Manufactures should evaluate the manufacturing processes and monitor IVIG preparations for the presence of factor Ⅺ-like activity in case of thrombotic risks.
ABSTRACT
Objective To observe the features of fetus unilateral pulmonary agenesis in antenatal ultrasonography and analyse the causes of misdiagnosed,so that fetus unilateral pulmonary agenesis can be known more deeply.Methods From January 2012 to October 2017,8 fetuses underwent prenatal ultrasound examination of fetal system in Guangdong Maternal and Child Health Hospital.The prenatal ultrasound data and postnatal clinical data were retrospectively analyzed.Results Among 8 cases of unilateral pulmonary agenesis,there were 4 males and 4 females,5 cases involving right lung,3 cases involving left lung,3 cases of single lung absence,and 5 cases combined with other deformities.There were 4 cases of induced labor,and 4 cases of surviving children were confirmed unilateral pulmonary agenesis by chest computed tomography (CT) examination.2 cases of missed prenatal diagnosis were left pulmonary agenesis,including 1 case only found left pulmonary artery absence and 1 case only found left axis deviation and cardiac enlargement before delivery.Conclusions Cardiac displacement and absence of left or right pulmonary artery are important clues for prenatal ultrasound diagnosis of fetal unilateral pulmonary absence.Prenatal ultrasound is the preferred method to detect and diagnose fetal unilateral pulmonary absence.
ABSTRACT
Objective To investigate the value of prenatal ultrasound in prognosis assessment of congenital diaphragmatic hernia.Methods The ultrasonographic features of 65 fetuses with congenital diaphragmatic hernia were analyzed,which were confirmed by after birth surgery or examination.The lung-to-head ratio (LHR) of unaffected side and O/E LHR (LHR compared to normal fetuses on same gestational weeks) were obtained,and then the relationship with the prognosis of neonates were analyzed.Results In 65 cases,45 fetuses survived and 8 fetuses died after surgery,while 12 cases did not undergo surgery and death promptly.Overall mortality was 30.77％ (20/65).In 12 hepatic intrathoracic type of diaphragmatic hernia cases,the mortality rate was 66.67 ％ (8/12).In 53 hepatic intra-abdominal type of diaphragmatic hernia cases,the mortality rate was 22.64 ％ (12/53).In 9 cases combined with other structural abnormalities,there were 8 cases were dead and 6 cases (6/8) with abnormal chest structure.LHR values were from 0.40 to 2.72,the average value was 1.59±0.69.It showed statistical difference on the mortality rate in fetus of congenital diaphragmatic hernia with different LHR (x2 =19.360,P＜0.001),The mortality rate in fetal of congenital diaphragmatic hernia with LHR 1.0 or less was higher than that with LHR ＞1.0.O/E LHR measurement values were from 23％ to 90％ and the average value was (58.25±17.61) ％.It showed statistical difference on the mortality rate in fetus of congenital diaphragmatic hernia with different O/E LHR (x2 15.261,P=0.002).The mortality rate in fetal of congenital diaphragmatic hernia with O/E LHR ≤45 ％ was higher than that with O/E LHR＞45 ％.Conclusion The prenatal ultrasound can be used to diagnose congenital diaphragmatic hernia,and to assess the development of unaffected lung and prognosis.