Purpose: We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. Materials and Methods: Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations. Results: Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. Conclusion This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

Background: This study aimed to investigate the recent prevalence, management, and comorbidities of diabetes among Korean adults aged ≥30 years by analyzing nationally representative data. Methods: This study used data from the Korea National Health and Nutrition Examination Survey from 2016 to 2018, and the percentage and total number of people ≥30 years of age with diabetes and impaired fasting glucose (IFG) were estimated. Results: In 2018, 13.8% of Korean adults aged ≥30 years had diabetes, and adults aged ≥65 years showed a prevalence rate of 28%. The prevalence of IFG was 26.9% in adults aged ≥30 years. From 2016 to 2018, 35% of the subjects with diabetes were not aware of their condition. Regarding comorbidities, 53.2% and 61.3% were obese and hypertensive, respectively, and 72% had hypercholesterolemia as defined by low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL in people with diabetes. Of the subjects with diabetes, 43.7% had both hypertension and hypercholesterolemia. With regard to glycemic control, only 28.3% reached the target level of <6.5%. Moreover, only 11.5% of subjects with diabetes met all three targets of glycosylated hemoglobin, blood pressure, and LDL-C. The percentage of energy intake from carbohydrates was higher in diabetes patients than in those without diabetes, while that from protein and fat was lower in subjects with diabetes. Conclusion The high prevalence and low control rate of diabetes and its comorbidities in Korean adults were confirmed. More stringent efforts are needed to improve the comprehensive management of diabetes to reduce diabetes-related morbidity and mortality.

BACKGROUND: This study was undertaken to compare the outcome of supervised and home exercises with respect to range of motion (ROM), pain, and Single Assessment Numeric Evaluation (SANE). We further correlated the ROM recovery and pain reduction as well. METHODS: The study included 49 patients who underwent arthroscopic rotator cuff repair. Rehabilitation was initiated after 4 weeks of immobilization. A total of 29 patients performed supervised exercise 3 times a week. Standardized education and brochures for review were provided to the remaining 20 patients who insisted on home rehabilitation. Statistical analysis was performed for comparing pain Numerical Rating Scale (NRS), SANE, and ROM. In addition, we also evaluated the correlation between pain and ROM. RESULTS: Comparison of the two groups revealed no significant differences in forward flexion, internal rotation, abduction, and pain NRS. However, SANE at the 9th week (63.8 vs. 55.0, p=0.038) and improvement of external rotation from the 5th to the 9th week (17.6 vs. 9.3, p=0.018) were significantly higher in the supervised exercise group as compared to the home exercise group. Correlation of pain NRS with forward flexion, external rotation, internal rotation and abduction were statistically not significant (correlation coefficient=0.032 [p=0.828], −0.255 [p=0.077], 0.068 [p=0.642], and −0.188 [p=0.196], respectively). CONCLUSIONS: The supervised rehabilitation after arthroscopic rotator cuff repair showed better improvement in external rotation and higher SANE score after 4 weeks of rehabilitation exercise. However, no statistically significant correlation was observed between the recovery of ROM and short-term pain relief.
Education ; Exercise ; Humans ; Immobilization ; Pamphlets ; Range of Motion, Articular ; Rehabilitation ; Rotator Cuff ; Shoulder

Lindera obtusiloba has been used in traditional herbal medicine for the treatment of blood stasis and inflammation. The leaves of Lindera obtusiloba have been reported to exhibit various physiological activities. However, there is little information available on their antiplatelet and antithrombotic activities. Thus, the present study aimed to evaluate the effect of Lindera obtusiloba leaf extract (LLE) on platelet activities, coagulation and thromboembolism. In a platelet aggregation study, LLE significantly inhibited various agonist-induced platelet aggregations in vitro and ex vivo. Furthermore, LLE significantly inhibited collagen-induced thromboxane A2 (TXA2) production in rat platelets. In addition, oral administration of LLE was protective in a mouse model of pulmonary thromboembolism induced by intravenous injection of a mixture of collagen and epinephrine. Interestingly, LLE did not significantly alter prothrombin time (PT) and activated partial thromboplastin time (aPTT). This study indicates that the antithrombotic effects of LLE might be due to its antiplatelet activities rather than anticoagulation. Taken together, these results suggest that LLE may be a candidate preventive and therapeutic agent in cardiovascular diseases associated with platelet hyperactivity.
Administration, Oral ; Animals ; Blood Platelets ; Cardiovascular Diseases ; Collagen ; Epinephrine ; Herbal Medicine ; In Vitro Techniques ; Inflammation ; Injections, Intravenous ; Lindera* ; Mice ; Partial Thromboplastin Time ; Platelet Aggregation ; Prothrombin Time ; Pulmonary Embolism ; Rats ; Thromboembolism ; Thrombosis ; Thromboxane A2

BACKGROUND AND PURPOSE: Intracranial atherosclerotic stenosis (ICAS) is considered as a major cause of stroke. The carotid intima-media thickness (CIMT), which accurately reflects the burden of generalized atherosclerosis, is also associated with stroke. The aim of this study was to determine the association between the CIMT and ICAS responses to medical treatment. METHODS: This study constituted part of the "Trial of cilostazol in symptomatic intracranial arterial stenosis"-2 that evaluated the ICAS response after randomized antiplatelet treatment. Magnetic resonance angiography and CIMT measurement were performed at baseline and after 7 months of treatment. CIMT was measured using semiautomated software, and was presented as maximum (CIMT-max) and average (CIMT-ave) values. The change in CIMT was compared relative to the ICAS response (i.e., progression, no-change, and regression). Ordinal logistic regression and analysis of covariance (ANCOVA) were used to analyze the association between the responses. RESULTS: Among the 101 enrolled patients, 85 underwent follow-up CIMT measurement. CIMT increased most in the ICAS progression group (CIMT-max: 0.09+/-0.23, CIMT-ave: 0.04+/-0.12), and to a lesser degree in the no-change group (CIMT-max: 0.02+/-0.16, CIMT-ave: 0.02+/-0.11), but decreased in patients with ICAS regression (CIMT-max: -0.04+/-0.11, CIMT-ave: -0.03+/-0.07; CIMT-max: p=0.010, CIMT-ave: p=0.015). Ordinal logistic regression analysis demonstrated that the change in CIMT-max was independently associated with the ICAS response (p=0.032). However, the ANCOVA revealed that the reverse was not true, in that the ICAS response was not independently associated with the change in CIMT after adjusting for confounding factors. CONCLUSIONS: The ICAS response may be associated with the CIMT response to medical treatment.
Atherosclerosis ; Carotid Intima-Media Thickness* ; Constriction, Pathologic ; Follow-Up Studies ; Humans ; Intracranial Arteriosclerosis* ; Logistic Models ; Magnetic Resonance Angiography ; Stroke ; Tetrazoles

BACKGROUND AND PURPOSE: Stroke requires consistent care, but there is concern over the "weekend effect", whereby a weekend admission results in a poor outcome. Our aim was to determine the impact of weekend admission on clinical outcomes in patients with acute ischemic stroke in Korea. METHODS: The outcomes of patients admitted on weekdays and weekends were compared by analyzing data from a prospective outcome registry enrolling 1247 consecutive patients with acute ischemic stroke admitted to four neurology training hospitals in South Korea between September 2004 and August 2005. The primary outcome was a poor functional outcome at 3 months, defined as modified Rankin Scale (mRS) of 3-6. Secondary outcomes were 3-month mortality, use of thrombolysis, complication rate, and length of hospitalization. Shift analysis was also performed to compare overall mRS distributions. RESULTS: On weekends, 334 (26.8%) patients were admitted. Baseline characteristics were comparable between the weekday and weekend groups except for more history of heart disease and shorter admission time in weekend group. Univariate analysis revealed poor functional outcome at 3 months, 3-month mortality, complication rate, and length of hospitalization did not differ between the two groups. In addition, overall mRS distributions were comparable (p=0.865). After adjusting for baseline factors and stroke severity, weekend admission was not associated with poor functional outcome at 3 months (adjusted odds ratio, 1.05; 95% CI, 0.74-1.50). Furthermore, none of secondary endpoints differed between the two groups in multivariate analysis. CONCLUSIONS: Weekend admission was not associated with poor functional outcome than weekday admission in patients with acute ischemic stroke in this study. The putative weekend effect should be explored further by considering a wider range of hospital settings and hemorrhagic stroke.
Heart Diseases ; Hospitalization ; Humans ; Neurology ; Odds Ratio ; Prospective Studies ; Republic of Korea ; Stroke

PURPOSE: As a result of various independently proposed nomenclatures and classifications, there is confusion in the diagnosis and prediction of biological behavior of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). A comprehensive nationwide study is needed in order to understand the biological characteristics of GEP-NETs in Korea. MATERIALS AND METHODS: We collected 4,951 pathology reports from 29 hospitals in Korea between 2000 and 2009. Kaplan-Meier survival analysis was used to determine the prognostic significance of clinicopathological parameters. RESULTS: Although the GEP-NET is a relatively rare tumor in Korea, its incidence has increased during the last decade, with the most significant increase found in the rectum. The 10-year survival rate for well-differentiated endocrine tumor was 92.89%, in contrast to 85.74% in well differentiated neuroendocrine carcinoma and 34.59% in poorly differentiated neuroendocrine carcinoma. Disease related death was most common in the biliary tract (62.2%) and very rare in the rectum (5.2%). In Kaplan-Meier survival analysis, tumor location, histological classification, extent, size, mitosis, Ki-67 labeling index, synaptophysin expression, lymphovascular invasion, perineural invasion, and lymph node metastasis showed prognostic significance (p<0.05), however, chromogranin expression did not (p=0.148). The 2000 and 2010 World Health Organization (WHO) classification proposals were useful for prediction of the prognosis of GEP-NET. CONCLUSION: The incidence of GEP-NET in Korea has shown a remarkable increase during the last decade, however, the distribution of tumors in the digestive system differs from that of western reports. Assessment of pathological parameters, including immunostaining, is crucial in understanding biological behavior of the tumor as well as predicting prognosis of patients with GEP-NET.
Biliary Tract ; Carcinoma, Neuroendocrine ; Digestive System ; Humans ; Incidence ; Intestinal Neoplasms ; Korea ; Lymph Nodes ; Mitosis ; Neoplasm Metastasis ; Neuroendocrine Tumors ; Pancreatic Neoplasms ; Population Characteristics ; Prognosis ; Rectum ; Stomach Neoplasms ; Survival Rate ; Synaptophysin ; World Health Organization

OBJECTIVE: To investigate adverse pregnancy outcomes in non-obese women with polycystic ovary syndrome (PCOS) compared with obese-PCOS and control groups. METHODS: Women with PCOS who underwent assisted reproductive technology (ART) from August, 2003 to December, 2007, were considered. A total of 336 women with PCOS were included in the study group and 1,003 infertile women who had tubal factor as an indication for ART were collected as controls. They were divided into four groups: a non-obese PCOS group, obese-PCOS group, non-obese tubal factor group, and obese tubal factor group, with obesity defined by a body mass index over 25 kg/m2, and reviewed focusing on the basal characteristics, ART outcomes, and adverse pregnancy outcomes. RESULTS: There was no difference among the groups' the clinical pregnancy rate or live birth rate. Regarding adverse pregnancy outcomes, the miscarriage rate, multiple pregnancy rate, and prevalence of preterm delivery and pregnancy induced hypertension were not different among the four groups. The incidence of small for gestational age infant was higher in the PCOS groups than the tubal factor groups (p<0.02). On the other hand, the morbidity of gestational diabetes mellitus (GDM) was not high in the non-obese PCOS group but was in the obese groups. And in the obese PCOS group, the newborns were heavier than in the other groups (p<0.02). CONCLUSION: Non-obese PCOS presents many differences compared with obese PCOS, not only in the IVF-parameters but also in the morbidity of adverse pregnancy outcomes, especially in GDM and fetal macrosomia.
Abortion, Spontaneous ; Body Mass Index ; Case-Control Studies ; Diabetes, Gestational ; Female ; Fetal Macrosomia ; Gestational Age ; Hand ; Humans ; Hypertension, Pregnancy-Induced ; Incidence ; Infant ; Infant, Newborn ; Live Birth ; Obesity ; Ovary ; Polycystic Ovary Syndrome ; Pregnancy ; Pregnancy Outcome ; Pregnancy Rate ; Pregnancy, Multiple ; Prevalence ; Reproductive Techniques, Assisted