PURPOSE: To evaluate the efficacy and safety of BOTULAX® in subjects with essential blepharospasm.METHODS: In this study, a total of 250 subjects with essential blepharospasm were enrolled at 15 investigational sites and a total of 220 subjects completed the study. The efficacy and safety were evaluated at weeks 4 and 16 after treatment compared with baseline. In total, 240 subjects were enrolled, treated with the investigational product, and evaluable for the primary efficacy assessment at week 4 after treatment; these subjects were included in the intention-to-treat (ITT) population. With the ITT set as the main efficacy set, efficacy assessment included Jankovic rating scale (JRS), functional disability score, investigator evaluation of global response and quality of life. Safety assessment including the incidence of adverse events was also performed.RESULTS: In terms of the primary efficacy endpoint (i.e., change in JRS total score at week 4 after treatment from baseline [ITT set]), mean change indicated a statistically significant reduction (p < 0.0001) and demonstrated the non-inferiority of the test drug to similar drugs. In terms of the secondary efficacy endpoints, mean change in JRS total score at week 16 after treatment and mean change in functional disability score at weeks 4 and 16 after treatment both exhibited a statistically significant reduction compared with baseline (p < 0.0001 for all). Among the 249 subjects treated with the investigational product in this study, 44 (17.67%) experienced 76 treatment emergent adverse events but no serious adverse events were observed.CONCLUSIONS: Based on the study results, BOTULAX® is considered to be an effective and safe treatment for essential blepharospasm.

Transient receptor potential vanilloid subtype 1 (TRPV1) on astrocytes prevents ongoing degeneration of nigrostriatal dopamine (DA) neurons in MPP⁺-lesioned rats via ciliary neurotrophic factor (CNTF). The present study determined whether such a beneficial effect of astrocytic TRPV1 could be achieved after completion of injury of DA neurons, rather than ongoing injury, which seems more relevant to therapeutics. To test this, the MPP⁺-lesioned rat model utilized here exhibited approximately 70~80% degeneration of nigrostriatal DA neurons that was completed at 2 weeks post medial forebrain bundle injection of MPP⁺. TRPV1 agonist, capsaicin (CAP), was intraperitoneally administered. CNTF receptor alpha neutralizing antibody (CNTFRαNAb) was nigral injected to evaluate the role of CNTF endogenously produced by astrocyte through TRPV1 activation on DA neurons. Delayed treatment of CAP produced a significant reduction in amphetamine-induced rotational asymmetry. Accompanying this behavioral recovery, CAP treatment increased CNTF levels and tyrosine hydroxylase (TH) activity in the substantia nigra pars compacta (SNpc), and levels of DA and its metabolites in the striatum compared to controls. Interestingly, behavioral recovery and increases in biochemical indices were not reflected in trophic changes of the DA system. Instead, behavioral recovery was temporal and dependent on the continuous presence of CAP treatment. The results suggest that delayed treatment of CAP increases nigral TH enzyme activity and striatal levels of DA and its metabolites by CNTF endogenously derived from CAP-activated astrocytes through TRPV1, leading to functional recovery. Consequently, these findings may be useful in the treatment of DA imbalances associated with Parkinson's disease.
Animals ; Antibodies, Neutralizing ; Astrocytes ; Capsaicin ; Ciliary Neurotrophic Factor ; Dopamine ; Dopaminergic Neurons ; Medial Forebrain Bundle ; Models, Animal ; Neurons ; Parkinson Disease ; Pars Compacta ; Rats ; Receptor, Ciliary Neurotrophic Factor ; Tyrosine 3-Monooxygenase

PURPOSE: We conducted a randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S-1 plus cisplatin (SP) as adjuvant chemotherapy for stage III gastric cancer patients. MATERIALS AND METHODS: Stage III gastric cancer patients who had received curative gastrectomy with D2 lymphadenectomy were randomized into equal groups to receive adjuvant chemotherapy of eight cycles of DS (S-1 70 mg/m2/day on days 1-14 plus docetaxel 35 mg/m2on days 1 and 8) every 3 weeks or SP (S-1 70 mg/m2/day on days 1-14 plus cisplatin 60 mg/m2on day 1) every 3 weeks. The primary endpoint was 3-year disease-free survival (DFS) rate. RESULTS: Between November 2010 and July 2013, 153 patients (75 patients to DS and 78 patients to SP) were enrolled from 8 institutions in Korea. After the capecitabine plus oxaliplatin was approved based on the CLASSIC study, itwas decided to close the study early. With a median follow-up duration of 56.9 months, the 3-year DFS rate between two groups was not significantly different (49.14% in DS group vs. 52.5% in SP group). The most common grade 3-4 adverse event was neutropenia (42.7% in DS and 38.5% in SP, p=0.351). SP group had more grade 3-4 anemia (1.3% vs. 11.5%, p=0.037), whereas grade 3-4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common in DS group. Fifty-one patients (68%) in DS group and 52 (66.7%) in SP group finished planned treatment. CONCLUSION: Our findings suggest that SP or DS is an effective and tolerable option for patients with curatively resected stage III gastric cancer.
Anemia ; Capecitabine ; Chemotherapy, Adjuvant* ; Cisplatin ; Disease-Free Survival ; Follow-Up Studies ; Gastrectomy ; Hand-Foot Syndrome ; Humans ; Korea ; Lymph Node Excision ; Mucositis ; Neutropenia ; Stomach Neoplasms*

BACKGROUND: Pathologic diagnosis of central nervous system (CNS) neoplasms is made by comparing light microscopic, immunohistochemical, and molecular cytogenetic findings with clinicoradiologic observations. Intraoperative frozen cytology smears can improve the diagnostic accuracy for CNS neoplasms. Here, we evaluate the diagnostic value of cytology in frozen diagnoses of CNS neoplasms. METHODS: Cases were selected from patients undergoing both frozen cytology and frozen sections. Diagnostic accuracy was evaluated. RESULTS: Four hundred and fifty-four cases were included in this retrospective single-center review study covering a span of 10 years. Five discrepant cases (1.1%) were found after excluding 53 deferred cases (31 cases of tentative diagnosis, 22 cases of inadequate frozen sampling). A total of 346 cases of complete concordance and 50 cases of partial concordance were classified as not discordant cases in the present study. Diagnostic accuracy of intraoperative frozen diagnosis was 87.2%, and the accuracy was 98.8% after excluding deferred cases. Discrepancies between frozen and permanent diagnoses (n = 5, 1.1%) were found in cases of nonrepresentative sampling (n = 2) and misinterpretation (n = 3). High concordance was observed more frequently in meningeal tumors (97/98, 99%), metastatic brain tumors (51/52, 98.1%), pituitary adenomas (86/89, 96.6%), schwannomas (45/47, 95.8%), high-grade astrocytic tumors (47/58, 81%), low grade astrocytic tumors (10/13, 76.9%), non-neoplastic lesions (23/36, 63.9%), in decreasing frequency. CONCLUSIONS: Using intraoperative cytology and frozen sections of CNS tumors is a highly accurate diagnostic ancillary method, providing subtyping of CNS neoplasms, especially in frequently encountered entities.
Brain Neoplasms ; Central Nervous System Neoplasms ; Central Nervous System ; Cytogenetics ; Diagnosis ; Frozen Sections ; Humans ; Meningeal Neoplasms ; Methods ; Neurilemmoma ; Pituitary Neoplasms ; Retrospective Studies

Despite the great socioeconomic burden of stroke, there have been few reports of stroke statistics in Korea. In this scenario, the Epidemiologic Research Council of the Korean Stroke Society launched the “Stroke Statistics in Korea” project, aimed at writing a contemporary, comprehensive, and representative report on stroke epidemiology in Korea. This report contains general statistics of stroke, prevalence of behavioral and vascular risk factors, stroke characteristics, pre-hospital system of care, hospital management, quality of stroke care, and outcomes. In this report, we analyzed the most up-to-date and nationally representative databases, rather than performing a systematic review of existing evidence. In summary, one in 40 adults are patients with stroke and 232 subjects per 100,000 experience a stroke event every year. Among the 100 patients with stroke in 2014, 76 had ischemic stroke, 15 had intracerebral hemorrhage, and nine had subarachnoid hemorrhage. Stroke mortality is gradually declining, but it remains as high as 30 deaths per 100,000 individuals, with regional disparities. As for stroke risk factors, the prevalence of smoking is decreasing in men but not in women, and the prevalence of alcohol drinking is increasing in women but not in men. Population-attributable risk factors vary with age. Smoking plays a role in young-aged individuals, hypertension and diabetes in middle-aged individuals, and atrial fibrillation in the elderly. About four out of 10 hospitalized patients with stroke are visiting an emergency room within 3 hours of symptom onset, and only half use an ambulance. Regarding acute management, the proportion of patients with ischemic stroke receiving intravenous thrombolysis and endovascular treatment was 10.7% and 3.6%, respectively. Decompressive surgery was performed in 1.4% of patients with ischemic stroke and in 28.1% of those with intracerebral hemorrhage. The cumulative incidence of bleeding and fracture at 1 year after stroke was 8.9% and 4.7%, respectively. The direct costs of stroke were about ₩1.68 trillion (KRW), of which ₩1.11 trillion were for ischemic stroke and ₩540 billion for hemorrhagic stroke. The great burden of stroke in Korea can be reduced through more concentrated efforts to control major attributable risk factors for age and sex, reorganize emergency medical service systems to give patients with stroke more opportunities for reperfusion therapy, disseminate stroke unit care, and reduce regional disparities. We hope that this report can contribute to achieving these tasks.
Adult ; Aged ; Alcohol Drinking ; Ambulances ; Atrial Fibrillation ; Cerebral Hemorrhage ; Emergency Medical Services ; Emergency Service, Hospital ; Epidemiology ; Female ; Hemorrhage ; Hope ; Humans ; Hypertension ; Incidence ; Korea ; Male ; Mortality ; Prevalence ; Reperfusion ; Risk Factors ; Smoke ; Smoking ; Stroke ; Subarachnoid Hemorrhage ; Writing

BACKGROUND: Hepatitis B virus (HBV) infection leads to hepatic and extrahepatic manifestations including chronic kidney disease (CKD). However, the association between HBV and CKD is not clear. This study investigated the association between chronic HBV infection and CKD in a nationwide multicenter study. METHODS: A total of 265,086 subjects who underwent health-check examinations in 33 hospitals from January 2015 to December 2015 were enrolled. HBV surface antigen (HBsAg) positive cases (n = 10,048), and age- and gender-matched HBsAg negative controls (n = 40,192) were identified. CKD was defined as a glomerular filtration rate (GFR) < 60 mL/min/1.73 m² or proteinuria as at least grade 2+ of urine protein. RESULTS: HBsAg positive cases showed a significantly higher prevalence of GFR < 60 mL/min/1.73 m² (3.3%), and proteinuria (18.9%) than that of the controls (2.6%, P < 0.001, and 14.1%, P < 0.001, respectively). In the multivariate analysis, HBsAg positivity was an independent factor associated with GFR < 60 mL/min/1.73 m² along with age, blood levels of albumin, bilirubin, anemia, and hemoglobin A1c (HbA1c). Likewise, HBsAg positivity was an independent factor for proteinuria along with age, male, blood levels of bilirubin, protein, albumin, and HbA1c. A subgroup analysis showed that HBsAg positive men but not women had a significantly increased risk for GFR < 60 mL/min/1.73 m². CONCLUSION: Chronic HBV infection was significantly associated with a GFR < 60 mL/min/1.73 m² and proteinuria (≥ 2+). Therefore, clinical concern about CKD in chronic HBV infected patients, especially in male, is warranted.
Anemia ; Antigens, Surface ; Bilirubin ; Case-Control Studies* ; Female ; Glomerular Filtration Rate ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Male ; Multivariate Analysis ; Prevalence ; Proteinuria ; Renal Insufficiency, Chronic*

PURPOSE: This is the methodological study to develop the cognitive function scale for breast cancer patients. METHODS: Study was consisted with 1st and 2nd items developing and testify for reliability and validity of them. 94 breast cancer patients in 2 university hospitals and 1 general hospitals responded to a questionnaire that assessed cognitive function scale. Collected data were analysed using the program SPSS/PC Win 21.0. Structural validity was determined factor analysis and convergent validity. This method yielded Cronbach's α value as an internal consistency for the reliability. RESULTS: Factor analysis resulted in six factors and 24 items accounted for 76.31% of the variance. Cronbach's α of scale developed was high as a .95. CONCLUSION: The developed cognitive function scale in breast cancer patients scale has reliability and validity as linear analogue scale witch quantitatively measure the subjectivity. Over these results, providing the way on an assessment in cognitive function in effect for breast cancer patients, it is supposed to contribute the development of nursing knowledge about the cognitive function in breast cancer patients.
Breast Neoplasms* ; Breast* ; Cognition* ; Hospitals, General ; Hospitals, University ; Humans ; Methods ; Nursing ; Reproducibility of Results

PURPOSE: The purpose of this study was to evaluate the effect of diet intervention in breast cancer patients through meta-analysis. METHODS: For the study purpose, 18 studies were selected using PubMed, ScienceDirect, ProQuest and CINAHL. Meta-analysis was performed using a random effects model, and the effect size on outcome variables in breast cancer were calculated. RESULTS: The effect size for body mass index, body weight, energy intake from fat (%), and energy intake of diet intervention was −0.75 (95% CI:−1.22~−0.27), −0.93 (95% CI:−1.58~−0.28), −0.82 (95% CI:−1.11~−0.52), and −1.10 (95% CI:−1.85~−0.34). For heterogeneity, moderator analysis was performed using intervention type and intervention duration. As a result of the moderator analysis, BMI, body weight, energy intake from fat (%), and energy intake were not statistically significant on intervention type and intervention duration. But, only BMI had a significant difference on intervention duration (p=.013). CONCLUSION: Further research is needed to determine whether exercise intervention will be included in nutritional intervention for breast cancer patients. Also, even if the duration of the intervention is less than six months, a strategy for sustaining long-term intervention effects will be needed.
Body Mass Index ; Body Weight ; Breast Neoplasms* ; Breast* ; Diet* ; Energy Intake ; Humans ; Population Characteristics

PURPOSE: The purpose of this study was to evaluate the effect of smart health care service in the breast cancer patients through a systematic review. METHODS: For the study, 10 studies were selected by using PubMed, ScienceDirect, ProQuest, CINAHL, RISS4U, KISS, DBpia and the National Assembly Library. The Risk of Bias Assessment Tool was used by two reviewers to evaluate independently the quality of the selected articles. RESULTS: 10 studies for the analysis of the effect of smart health care service using mobile applications on breast cancer patients since 2000 were found. The purpose of mobile based intervention was to check whether post-operative outpatient follow up could be substituted with mobile apps to measure and monitor weight loss or weight management, sleep, mood, depression and mental state, exercise, uncertainty management and feedback. CONCLUSION: Although mobile research is still limited, it may be sufficient to monitor the symptoms of breast cancer patients and to provide dietary and exercise interventions. This study suggests that various mobile apps can be used for breast cancer patients in various situations. Future study is recommended for repeated intervention studies on the effect of apps.
Bias (Epidemiology) ; Breast Neoplasms* ; Breast* ; Delivery of Health Care ; Depression ; Follow-Up Studies ; Humans ; Mobile Applications ; Outpatients ; Telemedicine* ; Uncertainty ; Weight Loss

No abstract available.
Stroke*