Purpose: This study aimed to compare the short-term outcomes and safety profiles of androgen-deprivation therapy (ADT)+abiraterone/prednisone with those of ADT+docetaxel in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC). Materials and Methods: A web-based database system was established to collect prospective cohort data for patients with mHSPC in Korea. From May 2019 to November 2022, 928 patients with mHSPC from 15 institutions were enrolled. Among these patients, data from 122 patients who received ADT+abiraterone/prednisone or ADT+docetaxel as the primary systemic treatment for mHSPC were collected. The patients were divided into two groups: ADT+abiraterone/prednisone group (n=102) and ADT+docetaxel group (n=20). We compared the demographic characteristics, medical histories, baseline cancer status, initial laboratory tests, metastatic burden, oncological outcomes for mHSPC, progression after mHSPC treatment, adverse effects, follow-up, and survival data between the two groups. Results: No significant differences in the demographic characteristics, medical histories, metastatic burden, and baseline cancer status were observed between the two groups. The ADT+abiraterone/prednisone group had a lower prostate-specific antigen (PSA) progression rate (7.8% vs. 30.0%; p=0.011) and lower systemic treatment discontinuation rate (22.5% vs. 45.0%; p=0.037). No significant differences in adverse effects, oncological outcomes, and total follow-up period were observed between the two groups. Conclusions ADT+abiraterone/prednisone had lower PSA progression and systemic treatment discontinuation rates than ADT+docetaxel. In conclusion, further studies involving larger, double-blinded randomized trials with extended follow-up periods are necessary.

Background: and Purpose: Blood pressure (BP) control is strongly recommended, but BP control rate has not been well studied in patients with stroke. We evaluated the BP control rate with fimasartan-based antihypertensive therapy initiated in patients with recent cerebral ischemia. Methods: This multicenter, prospective, single-arm trial involved 27 centers in South Korea. Key inclusion criteria were recent cerebral ischemia within 90 days and high BP [systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg]. BP lowering was initiated with fimasartan. BP management during the follow-up was at the discretion of the responsible investigators. The primary endpoint was the target BP goal achievement rate (<140/90 mm Hg) at 24 weeks. Key secondary endpoints included achieved BP and BP changes at each visit, and clinical events (ClinicalTrials.gov Identifier: NCT03231293). Results: Of 1,035 patients enrolled, 1,026 were included in the safety analysis, and 951 in the efficacy analysis. Their mean age was 64.1 years, 33% were female, the median time interval from onset to enrollment was 10 days, and the baseline SBP and DBP were 162.3±16.0 and 92.2±12.4 mm Hg (mean±SD). During the study period, 55.5% of patients were maintained on fimasartan monotherapy, and 44.5% received antihypertensive therapies other than fimasartan monotherapy at at least one visit. The target BP goal achievement rate at 24-week was 67.3% (48.6% at 4-week and 61.4% at 12-week). The mean BP was 139.0/81.8±18.3/11.7, 133.8/79.2±16.4/11.0, and 132.8/78.5±15.6/10.9 mm Hg at 4-, 12-, and 24-week. The treatment-emergent adverse event rate was 5.4%, including one serious adverse event. Conclusions Fimasartan-based BP lowering achieved the target BP in two-thirds of patients at 24 weeks, and was generally well tolerated.

Background: and Purpose: Blood pressure (BP) control is strongly recommended, but BP control rate has not been well studied in patients with stroke. We evaluated the BP control rate with fimasartan-based antihypertensive therapy initiated in patients with recent cerebral ischemia. Methods: This multicenter, prospective, single-arm trial involved 27 centers in South Korea. Key inclusion criteria were recent cerebral ischemia within 90 days and high BP [systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg]. BP lowering was initiated with fimasartan. BP management during the follow-up was at the discretion of the responsible investigators. The primary endpoint was the target BP goal achievement rate (<140/90 mm Hg) at 24 weeks. Key secondary endpoints included achieved BP and BP changes at each visit, and clinical events (ClinicalTrials.gov Identifier: NCT03231293). Results: Of 1,035 patients enrolled, 1,026 were included in the safety analysis, and 951 in the efficacy analysis. Their mean age was 64.1 years, 33% were female, the median time interval from onset to enrollment was 10 days, and the baseline SBP and DBP were 162.3±16.0 and 92.2±12.4 mm Hg (mean±SD). During the study period, 55.5% of patients were maintained on fimasartan monotherapy, and 44.5% received antihypertensive therapies other than fimasartan monotherapy at at least one visit. The target BP goal achievement rate at 24-week was 67.3% (48.6% at 4-week and 61.4% at 12-week). The mean BP was 139.0/81.8±18.3/11.7, 133.8/79.2±16.4/11.0, and 132.8/78.5±15.6/10.9 mm Hg at 4-, 12-, and 24-week. The treatment-emergent adverse event rate was 5.4%, including one serious adverse event. Conclusions Fimasartan-based BP lowering achieved the target BP in two-thirds of patients at 24 weeks, and was generally well tolerated.

Extracranial carotid stenosis is a well-established, modifiable risk factor for stroke. Asymptomatic extracranial carotid stenosis is increasingly being detected due to the introduction of less-invasive and more-sensitive advanced diagnostic technologies. For severe asymptomatic stenosis, earlier pivotal clinical trials demonstrated the benefit of carotid endarterectomy over the best medical therapy. Since then, great advances have been made in interventional and medical therapies as well as surgical techniques. The first edition of the Korean Stroke Clinical Practice Guidelines for primary stroke prevention for the management of asymptomatic carotid stenosis reflected evidences published before June 2007. After the publication of the first edition, several major clinical trials and observational studies have been published, and major guidelines updated their recommendation. Accordingly, the writing group of Korean Stroke Clinical Practice Guidelines (CPG) decided to provide timely updated evidence-based recommendations. The Korean Stroke CPG writing committee has searched and reviewed literatures related to the management of asymptomatic carotid stenosis including published guidelines, meta-analyses, randomized clinical trials, and nonrandomized studies published between June 2007 and Feb 2011. We summarized the new evidences and revised our recommendations. Key changes in the updated guidelines are the benefit of intensive medical therapy and further evidence of carotid artery stenting as an alternative to carotid endarterectomy. The current updated guidelines underwent extensive peer review by experts from the Korean Stroke Society, Korean Society of Intravascular Neurosurgery, Korean Society of Interventional Neuroradiology, Korean Society of Cerebrovascular Surgery, and Korean Neurological Association. New evidences will be continuously reflected in future updated guidelines.
Carotid Arteries ; Carotid Stenosis ; Constriction, Pathologic ; Endarterectomy, Carotid ; Neurosurgery ; Peer Review ; Primary Prevention ; Publications ; Risk Factors ; Stents ; Stroke ; Writing

BACKGROUND: This scientific statement is intended to provide a systematic review of new evidences in dyslipidemia and inflammation for primary stroke prevention. METHODS: Using a structured literature search, we identified major observational studies, clinical trials, meta-analyses, and updated major guidelines published between July 2007 and November 2010. In addition to the brief summary of earlier evidences employed in the first edition of Korean clinical practice guideline for primary prevention of stroke, we summarized the newly identified evidences. RESULTS: For dyslipidemia, observational studies further support a strong association between ischemic stroke and high total and low-density lipoprotein cholesterol and low high-density lipoprotein cholesterol. Two clinical trials and 6 meta-analyses confirm statin efficacy for primary prevention of stroke in high risk patients. Efficacy of other lipid-lowering agents is not established. For inflammation, inflammatory markers might help to identify patients having high risk for stroke or cardiovascular event and to decide whether statin therapy is indicated, but its usefulness for broad population needs to be confirmed. CONCLUSIONS: Writing committee will continue to keep an eye on upcoming evidences to timely update the guideline for primary stroke prevention in dyslipidemia and inflammation.
Cholesterol ; Dyslipidemias ; Eye ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Inflammation ; Lipoproteins ; Meta-Analysis as Topic ; Practice Guidelines as Topic ; Primary Prevention ; Stroke ; Writing

Pivotal clinical trials testing the efficacy of new antithrombotics for the prevention of stroke and systemic embolism in patients with atrial fibrillation have been published since the release of the first edition of Korean clinical practice guidelines for primary stroke prevention. From July 2007 to August 2012, 5 clinical studies and update of guidelines in Europe and North America were identified through systematic search. In patients with atrial fibrillation who were unsuitable for warfarin, the combination of clopidogrel and aspirin reduced the risk of stroke at the cost of increased major bleedings as compared to aspirin. In patients with nonvalvular atrial fibrillation and risk factors for stroke, new oral anticoagulants, dabigatran, rivaroxaban and apixaban, were as effective as or more effective than warfarin in preventing stroke or systemic embolism. The risks of major bleeding with novel anticoagulants were similar to or lower than that of warfarin. Particularly, the risk of intracranial bleeding was significantly lower with novel anticoagulants than with warfarin. In this report, we summarized the new evidences and updated our recommendations for primary stroke prevention in patients with atrial fibrillation.
Anticoagulants ; Aspirin ; Atrial Fibrillation ; Benzimidazoles ; beta-Alanine ; Embolism ; Europe ; Hemorrhage ; Humans ; Morpholines ; North America ; Primary Prevention ; Pyrazoles ; Pyridones ; Risk Factors ; Stroke ; Thiophenes ; Ticlopidine ; Warfarin ; Dabigatran ; Rivaroxaban

The first edition of the Korean clinical practice guidelines for primary stroke prevention reflects evidence published before June 2007. Since then, several clinical studies and meta-analyses have been conducted to determine the efficacy of aspirin for the primary prevention of cardiovascular disease including stroke. The aim of this guideline update is to provide timely recommendations taking into consideration the new evidence. Three clinical studies and four meta-analyses performed between July 2007 and November 2010 were identified and included for updating the guidelines. The main finding was a lack of aspirin efficacy for primary stroke prevention in patients with diabetes or peripheral arterial disease. We have summarized the new evidence and revised our recommendations for aspirin for primary stroke prevention. New evidence will need to be reflected continuously in future guideline updates.
Aspirin ; Cardiovascular Diseases ; Humans ; Peripheral Arterial Disease ; Primary Prevention ; Stroke

Immunotherapy with regulatory T lymphocytes is considered to be an attractive new therapeutic modality to prevent allograft rejection. The success of this new therapy is critically dependent on the preparation of highly effective and enough number of regulatory T cells. Here, we tried to establish a proper strategy for the ex vivo expansion of regulatory T cells and evaluated their characteristics. CD4+CD25h+CD62L+ T cells were isolated from the recipient mice and weekly stimulated with various stimuli in the presence of IL-2. The most efficient protocol for the expansion of regulatory T cells maintaining Foxp3 expression and regulatory activity was the three cycles stimulation with donor bone marrow-derived dendritic cells (BM-DCs) which yielded around 400 fold expansion of regulatory T cells. The in vitro-expanded regulatory T cells expressing lymph node homing receptors on their cell surface, were composed of polyclonal population, and did not acquire the ability to produce effector cytokines. Importantly, these expanded regulatory T cells induced a modest prolongation of skin allograft survival when combined with transient T cell depletion in recipient mice. These data indicate that our protocol could be used to obtain an effective population of natural regulatory T cells available for the regulatory T cell therapy to prevent allograft rejection.
Animals ; Cytokines ; Dendritic Cells ; Humans ; Immunotherapy ; Interleukin-2 ; Mice ; Receptors, Lymphocyte Homing ; Rejection (Psychology) ; Skin ; T-Lymphocytes ; T-Lymphocytes, Regulatory ; Tissue Donors ; Tissue Therapy ; Transplantation, Homologous

Practice parameters for non-pharmacological treatment of children and adolescents with pervasive developmental disorders are based on the scientific literature for evidence-based practices. Appropriate educational and behavioral interventions are important in improving the long-term outcome in pervasive developmental disorders. Early and sustained intervention appears to be particularly important. The goal for interventions is to gain pragmatic skills for verbal communication, playing with peers, daily living routines, self-management, and social adaptation. Appropriate involvement and collaboration with parents and family are essential for well-functioning intervention programs. The life-long nature of autism implies that the clinician should maintain an active role in long-term treatment planning and family support. Vocational training and training for more independent living are important for adolescents with autism. Professionals should be knowledgeable about local and national resources and opportunities for family support as well as support of the individual.
Adolescent ; Autistic Disorder ; Child ; Cooperative Behavior ; Humans ; Independent Living ; Parents ; Self Care

The objective of this review is to establish practice parameters for pharmacological treatment of children and adolescents with pervasive developmental disorders. We performed a detailed review of the literature, including a wide range of controlled clinical trials, open trials, case reports, and side-effect profiles of related drugs. Few medications have a treatment indication for pervasive developmental disorders, and few studies with well-controlled methodology are available for evaluating treatment results. Pharmacological treatments focus on associated target symptoms because symptom reduction may improve educational and social ability and enhance quality of life. Well-controlled trials have been conducted for some SSRI(selective serotonin reuptake inhibitor) antidepressants, risperidone, and methylphenidate, and showed reduction of some target symptoms. Since the medications are not specific to autism and do not treat core symptoms of the disorder, their potential side effects should be carefully considered. Family education is necessary to give proper information on target symptoms, limitation of drug treatments, and risks.
Adolescent ; Antidepressive Agents ; Autistic Disorder ; Child ; Education ; Humans ; Methylphenidate ; Quality of Life ; Risperidone ; Serotonin