ABSTRACT
A randomized, open, fasting, single dose, two sequence, two cycle and double cross administration trial design was adopted. Took the test or reference efavirenz tablets of 200 mg orally in a single time. The plasma concentration of efavirenz in healthy subjects was determined by LC-MS/MS. WinNonLin8.1 software was used to calculate the main pharmacokinetic parameters of efavirenz and to evaluate the bioequivalence. The main pharmacokinetic parameters within 72 h: tmax were 2.574 ± 0.871 and 2.808 ± 0.912 h; Cmax were 1 586.732 ± 424.538 and 1 549.518 ± 366.086 ng·mL-1; AUC0-72 h were 28 464.672 ± 5 682.518 and 27 828.826 ± 5 082.487 h·ng·mL-1; t1/2 were 63.524 ± 26.037 and 58.748 ± 20.950 h; λz were 0.013 ± 0.006 and 0.013 ± 0.005 h-1. The main bioequivalence indicators were as follows: The 90% confidence interval of Cmax was 95.62%-107.15%, and the geometric mean ratio was 101.22%; The 90% confidence interval of AUC0-72 h was 100.43%-104.38%, and the geometric mean ratio was 102.38%. The results showed that the main pharmacokinetic parameters of the test drug and the reference drug were similar, and the two preparations had bioequivalence. This human bioequivalence clinical study was approved by the drug clinical trials ethics committee of the Second Hospital of Anhui Medical University (ethics approval No.: YW2021-110).
ABSTRACT
The present study aimed to examine the value of ultrasonic soft markers in prenatal screening by analyzing the clinical outcome of fetuses with ultrasonic soft markers during the second trimester of pregnancy.A retrospective analysis was performed to evaluate the outcome of 591 fetuses with ultrasonic soft markers from January 2015 to August 2016 in Zhongnan Hospital of Wuhan University,China.It was found that 591 fetuses showed ultrasonic soft markers in 4927 cases with the occurrence rate being 12.0％.Among them,564 fetuses (95.4％) were delivered and the remaining 27 cases (4.6％) were aborted.Five hundred and sixty-seven cases had single ultrasonic soft marker,including echogenic intracardiac focus (n=343),mild renal pelvis dilatation (n=116),short long bones (n=72),single umbilical artery (n=31),mild lateral ventriculomegaly (n=21),choroid plexus cysts (n=19),and echogenic bowel (n=13),with the disappearing rates in pregnancy being 97.1％ (333/343),77.6％ (90/116),0％ (0/72),0％ (0/31),57.1％ (12/21),89.5％ (17/19) and 61.5％ (8/13) respectively.The rate of pregnancy termination due to single ultrasonic soft marker was 3.4％ (19/567),and that was 33.3％ (8/24) due to two ultrasonic soft markers with the difference being statistically significant (P＜0.05).The reasons of pregnancy termination included malformations (polycystic kidney,cleft lip and palate,congenital heart diseases,pcromphalus,hypospadias,hydrocephalus),chromosome abnormality,and stillbirth.It was concluded that single ultrasonic soft marker is usually transient manifestation in pregnancy.Without the other structural defects,single ultrasonic soft marker usually disappears spontaneously with favorable prognosis in a low-risk population.It is suggested that ultrasonic soft markers should be appropriately interpreted to avoid unnecessary invasive examination.