Objective To explore the adverse drug event(ADE)signals of anifrolumab,and to provide references for clinical safe medication.Methods The ADE reports related to anifrolumab from the third quarter of 2021 to the third quarter of 2024 in the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)were collected.The report odds ratio(ROR)method,the comprehensive standard method of the U.K.Medicines and Healthcare Products Regulatory Agency(MHRA),and the Bayesian Confidence Interval Progressive Neural Network(BCPNN)method were employed to identify ADE signals related to anifrolumab.System-organ class(SOC)and preferred term in the Medical Dictionary for Regulatory Activities were used for data classification and statistics.Results A total of 1,186 ADE reports with anifrolumab as the primary suspected drug were collected,and 49 signals were identified,involving 14 SOCs.The top 3 SOCs in terms of report frequency ranking were general disorders and administration site reactions,infections and infestations,and nervous system disorders.The top 3 ADEs in terms of report frequency ranking were headache,joint pain,and herpes zoster.Vasculitis,pericarditis,proteinuria,and blood pressure abnormalities were suspected ADEs not documented in the specification and were also ADE signals with a high signal strength ranking.Conclusion The common ADE signals of anifrolumab are consistent with its drug instructions.However,when using anifrolumab in clinical practice,it is also necessary to be vigilant against the increase of various infectious diseases such as herpes zoster and new ADEs not included in the instructions such as pericarditis,to ensure the safety of patients'medication.

Objective To explore the adverse drug event(ADE)signals of anifrolumab,and to provide references for clinical safe medication.Methods The ADE reports related to anifrolumab from the third quarter of 2021 to the third quarter of 2024 in the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)were collected.The report odds ratio(ROR)method,the comprehensive standard method of the U.K.Medicines and Healthcare Products Regulatory Agency(MHRA),and the Bayesian Confidence Interval Progressive Neural Network(BCPNN)method were employed to identify ADE signals related to anifrolumab.System-organ class(SOC)and preferred term in the Medical Dictionary for Regulatory Activities were used for data classification and statistics.Results A total of 1,186 ADE reports with anifrolumab as the primary suspected drug were collected,and 49 signals were identified,involving 14 SOCs.The top 3 SOCs in terms of report frequency ranking were general disorders and administration site reactions,infections and infestations,and nervous system disorders.The top 3 ADEs in terms of report frequency ranking were headache,joint pain,and herpes zoster.Vasculitis,pericarditis,proteinuria,and blood pressure abnormalities were suspected ADEs not documented in the specification and were also ADE signals with a high signal strength ranking.Conclusion The common ADE signals of anifrolumab are consistent with its drug instructions.However,when using anifrolumab in clinical practice,it is also necessary to be vigilant against the increase of various infectious diseases such as herpes zoster and new ADEs not included in the instructions such as pericarditis,to ensure the safety of patients'medication.

Purpose Polypoid endometriosis is an uncommon and distinctive variant of endometriosis, and its detailed histopathological features have been investigated and analysed. Methods A retrospective analysis was performed in 10 cases with polypoid endometrio-sis by comparing clinical data, histopathologic and immunohistochemical changes. Results The patients were 27 to 54 years ( mean 39. 4 years) of age. The most common clinical presentations were a pelvic mass. The intraoperative findings suggested a neoplasm. Sites of involvement in order of frequency included ovary, uterine serosa and cervix. Polypoid, pink, gray or tan masses ranged up to 9 cm in maximal dimension. On microscopic examination, the polypoid masses were composed of an admixture of endometriotic glands and stroma. Most commonly glandular architectural patterns were simple hyperplasia. Tubal epithelial metaplasia was common. The stroma was fibrous, resembling to some extent the stroma of the endometrial polyp and atypical stromal cells can be seen. Nine cases were associated with usual endometriosis. Follow-up data in nine patients indicated that all of patients were alive without evidence of re-sidual disease. The main lesion in the differential diagnosis is a mullerian adenosarcoma. Conclusion Polypoid endometriosis is a rare manifestation of endometriosis, and probably is overgrowth of local ectopic endometrium based on endometriosis. Understanding of such lesions is avoided misdiagnosing for other benign or malignant tumors on clincal, intraoperative or pathologic assesment, and influ-ences the clinical treatment.

Objective To assess the clinical significance of fetal pyelectasis and its changing in utero. Methods One hundred and ninty-seven isolated pyelectasis cases were retrospective reviewed from Jan 2012 to Jul 2014.Isolated pyelectasis was defined as a renal pelvis anteroposterior diameter (RPAPD)of ≥5 mm without other fetal anomaly in second trimester.Persistent or progressive pyelectasis was defined as a RPAPD of ≥10 mm before delivery.They were divided into two groups according to the size of renal pelvis in second trimester:group A (RPAPD 5 - 10 mm)and group B (RPAPD ≥ 10 mm).As the same,there were two groups after 32 weeks of gestation:group C (RPAPD < 10 mm)and group D (RPAPD ≥ 10 mm).Results Totally 1 54 cases were followed up.There were 1 88 cases (95.4%)in group A,with 41 cases lost,141 cases (95.9%)RPAPD <10 mm,6 cases (4.1 %)RPAPD ≥10 mm before delivery.There were 9 cases (4.6%)in group B,with 2 cases lost,remained 7 cases RPAPD ≥ 10 mm before delivery. Conclusions Although most of the fetuses with RPAPD 5 - 10 mm in second trimester will remain the same or resolved before delivery,those with RPAPD ≥ 10 mm may persistent or progress.Prenatal assessment of fetal renal pelvis may provide properly consultation.

Objective To establish the reference ranges for fetal cardiac axis in the mid-second trimester and to evaluate the use of fetal cardiac axis in prenatal diagnosis.Methods 6744 unselected singleton pregnancies were enrolled from September 2008 to October 2010.Routine screening scan of second trimester and fetal echocardiography were performed at 18- 23+6 weeks gestation.Fetal cardiac axis was measured on the four-chamber view of the heart.Results The 6744 fetuses had a mean cardiac axis of (37.03 ± 6.10)°,ranging from 9.80° to 102.41°. Using above or below 95％ range of population (26.63° -49.40°) as a cut-off,there were significant difference of cardiac axis between normal group [(36.96 ± 5.91)°,P ＜0.01] and the group with heart defects [(43.12 ± 15.67)°,P ＜0.01],the group with intrathoricic anomalies or abdominal wall defect [(51.74 ± 15.97)°].ConclusionsThe reference ranges of fetal cardiac axis for local population in mid-second trimester may helpful for detecting congenital defects.Presence of an abnormal cardiac axis in the fetuses is associated with a substantial risk of congenital heart disease and/or other extra cardiac defects.

Objective To assess prenatal heart disease screening program by ultrasound. Methods A total of 11 544 second-trimester screening scans were performed before 24 weeks′ gestation on 11 410 women between February 2004 and May 2007 in Obstetrics and Gynecology Hospital of Fudan University. Fetal heart screening was based on four-chamber and outflow tract views( left ventricular outflow + three vessel view). The sensitivity and specificity of different views were evaluated. Follow-up data of newborns was obstained. Results (1) Among 11 544 cases, 48 cases of congenital heart disease (CHD) were diagnosed in utero. Six cases were false negative, and 2 cases were false positive. The incidence of CHD was 0.47% (54/11 544). (2) Thirty-three CHDs were detected based on the four-chamber view, including 18 ventricular septal defect (9 with conotroncal anomalies),6 anomalous atrioventricle valve, 9 disproportion of left/right ventricle. The sensitivity of the four-chamber view alone was 61.11% (33/54), and the specificity was 99. 98% ( 11 488/11 490). Fifteen CHDs were detected based on the left ventricular outflow and three vessel views, including 1 pulmonary atresia, 3 pulmonary valve stenosis, 2 transposition of the great arteries ( TGA ), 1 pulmonary stanosis with TGA, 6 tetralogy of Fallot, and 2 pulmonary stenosis. The sensitivity of the combination of the four-chamber and outflow tract views was 88. 89% (48/54), and the specificity was 99. 98% (11 488/11 490). (3)Of 48 CHDs,11 cases were eceompanied by other malformations. Eleven cases were performed amniocentesis, amony whom 5 cases were trisemy 21. Conclusion The screening program based on four-chamber and outflow tract views shows good sensitivity and excellent specificity. Our prenatal heart screening program is clinically feasible.