• 한국임상약학회지
• /
• 제25권2호
• /
• pp.80-93
• /
• 2015

Objective: Pegfilgrastim is recently introduced that is long acting G-CSF for prophylaxis of febrile neutropenia. Treatment of non-Hodgikin's lymphoma (NHL) with R-CHOP is classified with relative high risk of febrile neutropenia. The study evaluated the prophylactic effect of pegfilgrastim to reduce the incidence of febrile neutropenia associated with R-CHOP of patient in NHL. And the risk factors associated with the incidence of FN and related events were evaluated. Methods: This retrospective study reviews the Electronic Medical Record of 68 NHL patients who received R-CHOP chemotherapy in single center between September 2013 and August 2014. These patients were classified who receive prophylaxis pegfilgrastim or no prophylaxis. Results: Sixty eight patients received R-CHOP with NHL. In 144 cycles of patients receiving pegfilgrastim, compared with no prophylaxis 178 cycles, had a lower incidence of febrile neutropenia (5.5% vs. 23.6%, p = 0.001), grade 3 or grade 4 neutropenia (14.4% vs. 89.8%, p < 0.001) and neutropenia related events (p < 0.05). The risk of febrile neutropenia after prophylaxis was significantly associated with age ${\geq}65$ (OR: 5.87, 95% CI 1.07-32.27, p = 0.042), $IPI{\geq}3$ (OR: 7.2, 95% CI 1.31-39.6, p = 0.023), S.alb < 3.5 g/dL (OR: 31.01, 95% CI 6.32-152.17, p < 0.0001). In multiple logistic regression analysis, lower baseline serum albumin (OR: 21.1, 95% CI 3.8-116.98, p = 0.001) was significantly associated with occurrence of febrile neutropenia. Conclusion: The study recommends prophylactic pegfilgrastim through risk assessment of febrile neutropenia in patients with non-Hodgikin's lymphoma receiving R-CHOP.

• Journal of Korean Neurosurgical Society
• /
• 제57권2호
• /
• pp.108-113
• /
• 2015

Objective : Although the L5-S1 has distinct structural features in comparison with other lumbar spine segments, not much is known about adjacent segment degeneration (ASD) at the L5-S1 segment. The aim of study was to compare the incidence and character of ASD of the cephalad and L5-S1 segments after L5 floating lumbar fusion. Methods : From 2005 to 2010, 115 patients who underwent L5 floating lumber fusion were investigated. The mean follow-up period was 46.1 months. The incidence of radiological and clinical ASD of the cephalad and the L5-S1 segments was compared using survival analysis. Risk factors affecting ASD were analyzed using a log rank test and the Cox proportional hazard model. Results : Radiological ASD of the L5-S1 segment had a statistically significant higher survival rate than that of the cephalad segment (p=0.001). However, clinical ASD of the L5-S1 segment was significantly lower survival rates than that of the cephalad segment (p=0.038). Risk factor analysis showed that disc degeneration of the cephalad segment and preoperative spinal stenosis of the L5-S1 segment were risk factors. Conclusion : In L5 floating fusion, radiological ASD was more common in the cephalad segment and clinical ASD was more common in the L5-S1 segment. At the L5-S1 segment, the degree of spinal stenosis appears to be the most influential risk factor in ASD incidences, unlike the cephalad segment.

• Journal of Korean Neurosurgical Society
• /
• 제52권4호
• /
• pp.372-376
• /
• 2012

Objective : The purpose of this large prospective study is to assess the association between the disappearance of the lateral spread response (LSR) before and after microvascular decompression (MVD) and clinical long term results over two years following hemifacial spasm (HFS) treatment. Methods : Continuous intra-operative monitoring during MVD was performed in 244 consecutive patients with HFS. Patients with persistent LSR after decompression (n=22, 9.0%), without LSR from the start of the surgery (n=4, 1.7%), and with re-operation (n=15, 6.1%) and follow-up loss (n=4, 1.7%) were excluded. For the statistical analysis, patients were categorized into two groups according to the disappearance of their LSR before or after MVD. Results : Intra-operatively, the LSR was checked during facial electromyogram monitoring in 199 (81.5%) of the 244 patients. The mean follow-up duration was $40.9{\pm}6.9$ months (range 25-51 months) in all the patients. Among them, the LSR disappeared after the decompression (Group A) in 128 (64.3%) patients; but in the remaining 71 (35.6%) patients, the LSR disappeared before the decompression (Group B). In the post-operative follow-up visits over more than one year, there were significant differences between the clinical outcomes of the two groups (p<0.05). Conclusion : It was observed that the long-term clinical outcomes of the intra-operative LSR disappearance before and after MVD were correlated. Thus, this factor may be considered a prognostic factor of HFS after MVD.

• Clinical and Experimental Reproductive Medicine
• /
• 제24권1호
• /
• pp.143-151
• /
• 1997

The present study was designed to investigate if antithyroid antibodies (ATA) could affect the pregnancy outcome in euthyroid women undergoing in vitro fertilization and embryo transfer (IVF-ET). From October 1995 to September 1996, 28 euthyroid women with ATA who underwent IVF-ET were studied. Fifty-one euthyroid women without ATA who underwent IVF-ET served as control. Thyroid peroxidase antibody (TPOA) and thyroglobulin antibody (TGA) were assayed using radio ligand assay kits as ATA. All patients included in study and control groups had only tubal factor in infertility. Long protocol of gonadotropin-releasing hormone agonist (GnRH-a) was used for controlled ovarian hyperstimulation (COH) in all patients. There were no significant differences between study and control groups in patient characteristics such as age, infertility duration and hormonal profile. There were also no significant differences between two groups with respect to the clinical response to COH and IVF results such as number of retrieved oocytes, fertilization rate, number of embryos frozen and number of embryos transfered. There were no correlations between ATA (TPOA and TGA) titers and fertilization rate. The clinical pregnancy rate per cycle seemed to be lower in the study group than in the control group (26.3% vs 39.3%), but the difference was not statistically significant. The biochemical pregnancy rate per cycle and miscarriage rate were significantly higher in the study group at 18.4% (7/38) and 40.0% (4/10) compared with 5.6% (5/89) and 11.4% (4/35) in the control group. In the study group, both TPOA and TGA titers were significantly higher in the biochemical pregnancy group than in the clinical pregnancy group or non-pregnancy group. In 10 women with ATA who achieved pregnancy following IVF-ET, both TPOA and TGA titers were significantly higher in the miscarriage group than in the ongoing or delivery group. In conclusion, euthyroid women with ATA appear to represent a less favorable subset within other tubal factor patients when treated with IVF-ET.

• 대한의생명과학회지
• /
• 제18권4호
• /
• pp.362-368
• /
• 2012

Enterotoxigenic Bacteroides fragilis (ETBF) is an intestinal commensal bacterium implicated as a risk factor for colon cancer. The key virulence factor is a secreted toxin called B. fragilis toxin (BFT). In this study we used an in vitro bioassay to examine the prevalence of ETBF in colonic washings from patients with colorectal polyps and normal control patients. We found that 9.3% of polyp patients and 10.9% of non-polyp patients harbored ETBF, respectively. A total of nine ETBF clinical isolates were isolated and confirmed to be positive for the BFT gene by PCR analysis and the ability to induce IL-8 secretion in the colonic epithelial cell line HT29/c1. Two of the ETBF clinical strains were characterized further in vitro and in vivo. We found that the two ETBF clinical isolates induced E-cadherin cleavage in HT29/c1 cells and promoted colonic inflammation in C57BL/6 mice. Our results indicate that the prevalence of ETBF in polyp patients were similar in non-polyp patients suggesting that ETBF carriage does not positively correlate to polyp incidence.

• Communications for Statistical Applications and Methods
• /
• 제25권4호
• /
• pp.341-354
• /
• 2018

The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.

• 대한임상검사과학회지
• /
• 제38권1호
• /
• pp.72-81
• /
• 2006

Wee1 is a kinase regulator of the M-phase promoting factor (MPF; a complex of cdc2 and cyclin B1). The present study was undertaken to determine the role(s) of wee1 in the early stages of mouse ovarian follicles. The expression of wee1 and the correlated cell-cycle components, namely cdc2, cyclin B1, and cdc25C, were evaluated by immunohistochemistry. In addition, the expression of Tyr15-phosphorylated cdc2 (cdc2-p) was also examined to determine whether wee1 kinase phosphorylates cdc2 existed. Each component except cdc25C was found cytoplasmic in the oocytes at all stages of follicles, while cdc25C was not detected in primordial follicles. It was found primarily in ovarian somatic cells and to a small extent in granulosa cells of the growing follicles. To further confirm the expression of cell-cycle components in the primordial follicular oocytes, day1 ovaries were enzymatically and mechanically dissociated, then oocytes were isolated from somatic including pre-granulosa cells, and we confirmed that cdc2-p was expressed in oocytes of primordial follicles. From the results of the present study, we concluded wee1, without the counteracting cdc25C, would cause meiotic arrest of oocytes by the inhibitory phosphorylation of cdc2. The expression of all these proteins in the granulosa cells of growing follicles may regulate their mitosis concurrently with the growth of oocytes and follicles.

• Journal of Periodontal and Implant Science
• /
• 제38권sup2호
• /
• pp.299-308
• /
• 2008

Purpose: The aim of this study was to evaluate adhesion and gene expression of the MC3T3-E1 cells cultured on machined titanium surface (MS) and anodized titanium surface (AS) using MTT test, Scanning electron micrograph and cDNA microarray. Materials and Methods: The MTT test assay was used for examining the proliferation of MC3T3-E1 cells, osteoblast like cells from Rat calvaria, on MS and AS for 24 hours and 48 hours. Cell cultures were incubated for 24 hours to evaluate the influence of the substrate geometry on both surfaces using a Scanning Electron Micrograph (SEM). The cDNA microarray Agilent Rat 22K chip was used to monitor expressions of genes. Results: After 24 hours of adhesion, the cell density on AS was higher than MS (p < 0.05). After 48 hours the cell density on both titanium surfaces were similar (p > 0.05). AS had the irregular, rough and porous surface texture. After 48 hours incubation of the MC3T3-E1 cells, connective tissue growth factor (CTGF) was up-regulated on AS than MS (more than 2 fold) and the insulin-like growth factor 1 receptor was down-regulated (more than 2 fold) on AS than MS. Conclusion: Microarray assay at 48 hours after culturing the cells on both surfaces revealed that osteoinductive molecules appeared more prominent on AS, whereas the adhesion molecules on the biomaterial were higher on MS than AS, which will affect the phenotype of the plated cells depending on the surface morphology.

• 사상체질의학회지
• /
• 제20권1호
• /
• pp.67-88
• /
• 2008

1. Objectives The aim of this study was to find out clinical characteristics of atopic dermatitis according to Sasang Constitutions and to help on Sasang Constitutional management and treatment of atopic dermatitis 2. Methods 108patients with atopic dermatitis were involved in the study. The patients had visited C Oriental Clinic from January 2007 to September 2007 and had taken oriental herbal medicine for over one month. They were divided into four groups by Sasang Constitutions and were evaluated the clinical features of atopic dermatitis according to Sasang Constitutions. 3. Results and Conclusions The clinical characteristics for 108 patients with atopic dermatitis was surveyed 1. Soyangin with atopic dermatitis had significantly more Allergic conjunctivitis than other Constitutions, and Taeumin with atopic dermatitis had significantly less Allergic conjunctivitis than other Constitutions. 2. Soyangin with atopic dermatitis had significantly more 'Sleep loss' than other Constitutions. 3. Emotion was significantly more aggravating factor of atopic dermatitis in Soyangin than in other Constitutions. 4. Soeumin with atopic dermatitis had significantly more 'Orbital darkening' than other Constitution. 5. 'Tuna' was significantly more aggravating factor of atopic dermatitis in Soeumin than in other Constitution. The treatment progress for 57 patients with atopic dermatitis was surveyed 6. Soyangin with atopic dermatitis had significantly more improvement than other Constitution and Soeumin with atopic dermatitis had significantly less improvement than other Constitution in Sasang Constitutional Medicine treatment.

• 대한정형도수물리치료학회지
• /
• 제16권1호
• /
• pp.1-8
• /
• 2010

Purpose : This study aimed to examine the relationships among five clinical measures for functional alignment of the lower extremity. Methods : Thirty healthy subjects (15 males and 15 females) were recruited for the study. The five clinical measures of functional alignment of the lower extremity included navicular drop, quadriceps angle, internal rotation of hip, and anterior and lateral pelvic tilt angles. The level of navicular drop was calculated by the difference between the height of the navicular bone in the sitting (non-weight bearing) and standing (weight bearing) positions. The quadriceps angle and internal rotation of hip were measured using a standard goniometer with photographic markers while the subjects were lying in a prone position on a table with their knee at $90^{\circ}$ flexion. Anterior and lateral pelvic tilt angles were determined using a inclinometer. Results : Correlation and a simple linear regression analysis were used to assess relationships between the clinical measures. There were significant correlations between navicular drop and quadriceps angle (p<.05), between navicular drop and internal rotation of hip (p<.05), and between quadriceps angle and internal rotation of hip (p<.01). In simple linear regression analysis, the navicular drop appeared to be a factor affecting the quadriceps angle and internal rotation of hip (p<.05). The findings suggest that navicular drop has a great impact on lower extremity alignment. Conclusion : This study might help us to examine lower extremity function and clarify its role as a potential injury risk factor.