Gyu Yeon Choi

Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients

Abstract Objective Severe iron deficiency resulting in anemia is a common problem during pregnancy and in menstruating women. Several choices for IV iron replacement therapies exist and increased pressures on budgets may require cheaper ‘iron sucrose similar’ (ISS) to be used. In our practice, an iron sucrose similar (Ferex; ISSFRX) was introduced to reduce costs in the treatment of pregnant women or those planned for surgery. Post several months of use we observed increased rates of adverse events from patients and hence performed this analysis to confirm these findings. Methods Data on adverse events was retrospectively collected from 658 patients treated between September 2004 and December 2011. Patients were analyzed in three cohorts, iron sucrose originator (ISORIG), ISSFRX diluted in 100 mL saline and ISSFRX diluted in 200 mL saline. Results The mean age was 38.5 years and included patients having normal delivery, Cesarean section, myomectomy, hysterectomy, cystectomy and adnexectomy. There were 169 patients in the ISORG group and 210 and 279 in the ISSFRX-100 and ISSFRX-200 groups respectively. Adverse drug reactions were more frequent in the ISSFRX groups vs. ISORIG (11.0 vs. 14.3 vs. 1.8%; p < 0.02). Events were mild-to-moderate in nature and were predominately injection site reactions and phlebitis. Results may be impacted by imbalance in baseline characteristics and cumulative iron dose received, however events were mostly acute and all patients received 200 mg iron as single administration. Conclusion This is the first large analysis suggesting increased adverse events due to an ISS. For our practice, the use of ISSFRX was discontinued owing to safety concerns outweighing the theoretical cost benefit. This study raises the question on the appropriate approval process for complex drugs and if these can be substituted without appropriate clinical testing, both for efficacy and most importantly safety, in routine clinical practice.

A new compound heterozygous mutation in the CYP17A1 gene in a female with 17α-hydroxylase/17,20-lyase deficiency.

Abstract Background: Congenital adrenal hyperplasia due to 17α-hydroxylase/17,20-lyase deficiency (OMIM #202110) is a rare autosomal recessive disorder, which is caused by mutations of the CYP17A1 gene located on chromosome 10q24.3. It has been reported that the type of mutation of the CYP17A1 gene was associated with the extent of 17α-hydroxylase/17,20-lyase deficiency, and the prevalence of common mutation was different among ethnic groups. Case: A 21-year-old Korean female presented with primary amenorrhea and sexual infantilism, and intermittent hypokalemic episodes. Laboratory test was consistent with hypergonadotropic hypogonadism. The karyotype was 46,XX[20]. Genomic DNA was extracted from peripheral blood leukocytes. All the eight exons of the CYP17A1 gene including flanking regions of introns were amplified by PCR. The mutations of the CYP17A1 gene were detected by direct sequencing. A compound heterozygous mutation was identified; one allele had a missense mutation of c.1118A>T (p.His373Leu), which was reported previously and induced the complete loss of both 17α-hydroxylase/17,20-lyase activity. This mutation has been known to be one of the common mutation types in East Asia. The other allele had a novel 1-bp deletion c.1148delA causing frameshift, premature termination codon (p.Glu383fs) and induced truncated enzymes. Conclusion: Our experience for stepwise clinical, laboratory and molecular approach would be helpful to diagnose these patients accurately and understand the genetic events in 17α-hydroxylase/17,20-lyase deficiency patients.

Practice patterns in the management of threatened preterm labor in Korea: A multicenter retrospective study

Objective This study aimed to examine clinical practice patterns in the management of pregnant women admitted with threatened preterm labor (TPL) in Korea. Methods Data from women admitted with a diagnosis of TPL were collected from 22 hospitals. TPL was defined as regular uterine contractions with or without other symptoms such as pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show and cervical changes. Data on general patient information, clinical characteristics at admission, use of tocolytics, antibiotics, and corticosteroids, and pregnancy outcomes were collected using an online data collections system. Results A total of 947 women with TPL were enrolled. First-line tocolysis was administered to 822 (86.8%) patients. As a first-line tocolysis, beta-agonists were used most frequently (510/822, 62.0%), followed by magnesium sulfate (183/822, 22.3%), calcium channel blockers (91/822, 11.1%), and atosiban (38/822, 4.6%). Of the 822 women with first-line tocolysis, second-line tocolysis were required in 364 (44.3%). Of 364 with second-line, 199 had third-line tocolysis (37.4%). Antibiotics were administered to 29.9% of patients (284/947) with single (215, 22.7%), dual (26, 2.7%), and triple combinations (43, 4.5%). Corticosteroids were administered to 420 (44.4%) patients. Betamethasone was administered to 298 patients (71.0%), and dexamethasone was administered to 122 patients (29.0%). Conclusion Practice patterns in the management of TPL in Korea were quite various. It is needed to develop standardized practice guidelines for TPL management.

Avoiding unnecessary blood transfusions in women with profound anaemia

Blood transfusions may be associated with risks and the risk: benefit ratio is not always clear, even in the setting of haemorrhage.