Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

Bariatric surgery is the best known procedure for treating severe obesity and the majority of patients who received surgical weight loss procedure were at childbearing age. Female patients who successfully lost weight following bariatric procedure, become pregnant and those are need to be evaluated carefully due to various operative procedures and to ensure intake of quality nutrition. A 35-year-old female, gravida 4, para 2, treated for morbid obesity with vertical sleeve gastrectomy performed 14 months earlier, presented 7 weeks of gestation. Before surgery, she had weighed 92.4 kg (body mass index (BMI); 32.9 kg/m(2)); she had gradually reduced her weight to 65.5 kg (BMI; 23.5 kg/m(2)) postoperatively at 14 months. For the first trimester of pregnancy, her average intake was 698.6 kcal/day from food, and 840~1352.8 kcal/day in second and third trimester. During pregnancy, significant iron, cobalamin and vitamin B12 deficiencies were not founded. She has gained a total of 8 kg. She delivered a healthy female infant at full term. Nutritional supplementation following bariatric surgery and close supervision during pregnancy can prevent nutrition-related complications and improve maternal and fetal health.
Adult ; Bariatric Surgery ; Female ; Gastrectomy* ; Humans ; Infant ; Iron ; Obesity, Morbid ; Organization and Administration ; Pregnancy Trimester, First ; Pregnancy Trimester, Third ; Pregnancy* ; Surgical Procedures, Operative ; Vitamin B 12 ; Vitamin B 12 Deficiency ; Weight Loss

Purpose: This study aims to design that using formative assessment as an instructional strategy in real-time online classes, and to explore the application of Bloom’s taxonomy in the development of formative assessment items. Methods: We designed the instruction using formative assessment in real-time online classes, developed the items of formative assessment, analyzed the items statistically, and investigated students' perceptions of formative assessment through a survey. Results: It is designed to consist of 2–3 learning outcomes per hour of class and to conduct the formative assessment with 1–2 items after the lecture for each learning outcome. Formative assessment was 31 times in the physiology classes (total 48 hours) of three basic medicine integrated. There were nine “knowledge” items, 40 “comprehension” items, and 55 “application” items. There were 33 items (31.7%) with a correct rate of 80% or higher, which the instructor thought was appropriate. As a result of the survey on students’ perceptions of formative assessment, they answered that it was able to concentrate on the class and that it was helpful in achieving learning outcomes. Conclusion The students focused during class because they had to take formative assessment immediately after the learning outcome lecture. “Integration of lesson and assessments” was maximized by solving the assessment items as well as through the instructor’s immediate explanation of answers. Through formative assessment, the students were able to utilize metacognition by learning what content they understood or did not understand. Items that consider Bloom’s taxonomy allow students to remember, understand, and apply to clinical contexts.

Purpose: This study aims to design that using formative assessment as an instructional strategy in real-time online classes, and to explore the application of Bloom’s taxonomy in the development of formative assessment items. Methods: We designed the instruction using formative assessment in real-time online classes, developed the items of formative assessment, analyzed the items statistically, and investigated students' perceptions of formative assessment through a survey. Results: It is designed to consist of 2–3 learning outcomes per hour of class and to conduct the formative assessment with 1–2 items after the lecture for each learning outcome. Formative assessment was 31 times in the physiology classes (total 48 hours) of three basic medicine integrated. There were nine “knowledge” items, 40 “comprehension” items, and 55 “application” items. There were 33 items (31.7%) with a correct rate of 80% or higher, which the instructor thought was appropriate. As a result of the survey on students’ perceptions of formative assessment, they answered that it was able to concentrate on the class and that it was helpful in achieving learning outcomes. Conclusion The students focused during class because they had to take formative assessment immediately after the learning outcome lecture. “Integration of lesson and assessments” was maximized by solving the assessment items as well as through the instructor’s immediate explanation of answers. Through formative assessment, the students were able to utilize metacognition by learning what content they understood or did not understand. Items that consider Bloom’s taxonomy allow students to remember, understand, and apply to clinical contexts.

OBJECTIVE: The purpose of this study was to evaluate the impact of pelvic organ prolapse (POP) repair on overactive bladder (OAB) symptoms in women with POP and the effect of baseline POP severity on improvement in OAB after surgical repair of POP. And we also tried to identify any preoperative factors for persistent postoperative OAB symptoms. METHODS: A total of 87 patients with coexisting POP and OAB who underwent surgical correction of POP were included and retrospectively analyzed and postoperative data was obtained by telephone interview. OAB was defined as an affirmative response to item no. 15 (urinary frequency) and item no. 16 (urge incontinence) of the Pelvic Floor Distress Inventory. POP severity was dichotomized by Pelvic Organ Prolapse Quantification stage 1 to 2 (n=22) versus stage 3 to 4 (n=65). RESULTS: OAB symptoms were significantly improved after surgical treatment (P<0.001). But there was no significant differences in postoperative improvement of frequency and urge incontinence between stage 1 to 2 group versus stage 3 to 4 group. Preoperative demographic factors (age, parity, and POP stage) were not significantly related to persistent postoperative OAB symptoms. CONCLUSION: Women with coexisting POP and OAB who undergo surgical repair experience significant improvement in OAB symptoms after surgery, but severity of POP had no significant difference in improvement of OAB symptoms. Postoperative persistent OAB symptoms were not related to age, parity, body mass index, and POP stage.
Body Mass Index ; Demography ; Female ; Humans ; Interviews as Topic ; Parity ; Pelvic Floor ; Pelvic Organ Prolapse* ; Retrospective Studies ; Urinary Bladder, Overactive* ; Urinary Incontinence, Urge

OBJECTIVE: The aim of our study is to reveal the correlation between the posterior vaginal wall and apex in pelvic organ prolapse. METHODS: We retrospectively reviewed the records of all new patient visits to a urogynecology clinic between January 2013 and December 2015. RESULTS: Four hundred five cases were enrolled in our study. When all POP stages were included, the Bp (pelvic organ prolapse quantification point) had a moderate correlation with the C (Pearson's r=0.419; P < 0.001). Cases where Bp was stage 3 and above presented strong positive correlations with C (Spearman's ρ=0.783; P < 0.001). Cases where C was stage 3 and above presented also strong positive correlations with Bp (Spearman's ρ=0.718; P < 0.001). CONCLUSION: Posterior vaginal wall prolapse and apical prolapse were correlated with each other, and this correlation was more prominent as stage increased. Therefore, when admitting a patient suspected of posterior vaginal wall prolapse or apical prolapse, it is necessary to evaluate both conditions. Especially in cases more severe or equal to stage 3, it is a must to suspect both conditions as the 2 are strongly correlated.
Cystocele ; Humans ; Pelvic Organ Prolapse* ; Prolapse ; Rectocele ; Retrospective Studies ; Uterine Prolapse ; Vagina

D-penicillamine, a chelating agent of copper, is the drug of choice for the treatment of Wilson's disease. Breast enlargement is a rare complication arising from its use, and we report a case of breast gigantism which developed after it had been used for ten months to treat this condition. Mammography demonstrated bilaterally enlarged dense breasts; ultrasonography, similarly, demonstrated enlargement, revealing the presence of a mass, shown at biopsy to be benign, in the left one.
Biopsy ; Breast* ; Copper ; Gigantism* ; Hepatolenticular Degeneration ; Mammography ; Penicillamine* ; Ultrasonography

There are no reports regarding pneumomediastinum caused by thoracic epidural block complications. We believe that it is possible to experience an occurrence of pneumomediastinum caused by air in the epidural space after performing a thoracic epidural block using the loss of resistance (LOR) technique with air. We report a witnessed case where pneumomediastinum appeared after a thoracic epidural block. Pneumorrrhachis, paravertebral muscle emphysema, and pneumomediastinum were diagnosed by Positron Emission Tomography-Computed Tomography. Although extremely rare, pneumomediastinum can be caused by an epidural block using LOR technique with air. In order to avoid the above danger, the use of saline or very minimal amount of air is required during a careful LOR technique.
Electrons ; Emphysema ; Epidural Space ; Injections, Epidural ; Mediastinal Emphysema ; Muscles ; Wit and Humor as Topic

PURPOSE: Rapid multidisciplinary trauma care by trauma team is essential for severely injured patients. Different protocols for trauma team activation are used in each hospital. Correct trauma triage is needed to ensure appropriate use of medical resources. The aim of this study was to evaluate the performance of our modified protocol for trauma team activation. METHODS: This is an observational, retrospective cohort study. Injured patients with trauma team activation (TTA) or who had been admitted to a surgical intensive care unit were investigated from 1st March 2010 to 31st May 2012. The TTA protocol was analyzed with respect to sensitivity, positive predictive value (PPV), and overtriage (1-PPV). Undertriage (1-sensitivity) was defined as no TTA despite severe injury (Injury Severity Score (ISS) >15). RESULTS: A total of 229 patients were included. There were 201 patients with TTA and 28 patients without TTA. Of the 201 patients with TTA, 104 were identified as severely injured (ISS>15), yielding sensitivity of 79%, PPV of 51%, and overtriage of 49%. Undertriage was 21% (n=28) when considering all severely injured patients (n=132). Among 12 criteria of our TTA protocol, 'injury in two or more body regions' accounted for 85.6% of the overtriage. Of the patients with undertriage, 75% represented isolated head injury and 28.5% from interhospital transfer. CONCLUSION: The rate of overtriage of TTA protocol in our hospital is appropriate, but the rate of undertriage is relatively high. We believe, to decrease the overtriage of all and undertriage in patients with injury in an isolated specific body region, more research for evaluation of effects of protocol excluding the criteria of 'injury in two or more body regions' is needed.
Body Regions ; Cohort Studies ; Craniocerebral Trauma ; Emergency Service, Hospital* ; Humans ; Critical Care ; Retrospective Studies ; Triage

BACKGROUND: Aspirin resistance (AR) in platelet function assays showed substantial variation depending on the methods used to evaluate it. METHODS: In this study, we prospectively compared the results of Multiplate impedance platelet aggregometry (IPA) with those of light transmission aggregometry (LTA) and VerifyNow(R) system in determination of the prevalence of aspirin resistance (AR) and investigated the correlation between its presence and poor outcome (modified Rankin scale >2) in 105 patients with aspirin after acute ischemic stroke (AIS). RESULTS: After 5 days of using aspirin, 15 patients (14.3%) were classified as aspirin-resistance with the use of IPA, 24 patients (22.9%) by the LTA, and 14 patients (13.3%) by VerifyNow. Good agreement between the results of IPA and VerifyNow, was found (R=0.674, P<0.01). The concordance rate of AR detection was high between VerifyNow and IPA (k=0.72, P<0.01), albeit quite low between LTA and IPA. Regarding on its influence on clinical outcome after AIS, there wasn't any significant relationship between occurrence of poor outcome and the presence of AR in three platelet function assays. CONCLUSION: This study reveals that the incidence of AR in AIS might be highly test-specific. IPA seems to be similar to VerifyNow as a platelet function test.
Aspirin ; Blood Platelets ; Electric Impedance ; Humans ; Incidence ; Light ; Platelet Function Tests ; Prevalence ; Prospective Studies ; Stroke