1.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
2.A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol
Eun Kyung LEE ; Yea Eun KANG ; Young Joo PARK ; Bon Seok KOO ; Ki-Wook CHUNG ; Eu Jeong KU ; Ho-Ryun WON ; Won Sang YOO ; Eonju JEON ; Se Hyun PAEK ; Yong Sang LEE ; Dong Mee LIM ; Yong Joon SUH ; Ha Kyoung PARK ; Hyo-Jeong KIM ; Bo Hyun KIM ; Mijin KIM ; Sun Wook KIM ; Ka Hee YI ; Sue K. PARK ; Eun-Jae JUNG ; June Young CHOI ; Ja Seong BAE ; Joon Hwa HONG ; Kee-Hyun NAM ; Young Ki LEE ; Hyeong Won YU ; Sujeong GO ; Young Mi KANG ;
Endocrinology and Metabolism 2021;36(3):574-581
Background:
Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.
Methods:
This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.
Conclusion
The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
3.Effectiveness and Safety of Adding Basal Insulin Glargine in Patients with Type 2 Diabetes Mellitus Exhibiting Inadequate Response to Metformin and DPP-4 Inhibitors with or without Sulfonylurea
Yu Mi KANG ; Chang Hee JUNG ; Seung Hwan LEE ; Sang Wook KIM ; Kee Ho SONG ; Sin Gon KIM ; Jae Hyeon KIM ; Young Min CHO ; Tae Sun PARK ; Bon Jeong KU ; Gwanpyo KOH ; Dol Mi KIM ; Byung Wan LEE ; Joong Yeol PARK
Diabetes & Metabolism Journal 2019;43(4):432-446
BACKGROUND: We aimed to investigate the effectiveness and safety of adding basal insulin to initiating dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin and/or sulfonylurea (SU) in achieving the target glycosylated hemoglobin (HbA1c) in patients with type 2 diabetes mellitus (T2DM). METHODS: This was a single-arm, multicenter, 24-week, open-label, phase 4 study in patients with inadequately controlled (HbA1c ≥7.5%) T2DM despite the use of DPP-4 inhibitor and metformin. A total of 108 patients received insulin glargine while continuing oral antidiabetic drugs (OADs). The primary efficacy endpoint was the percentage of subjects achieving HbA1c ≤7.0%. Other glycemic profiles were also evaluated, and the safety endpoints were adverse events (AEs) and hypoglycemia. RESULTS: The median HbA1c at baseline (8.9%; range, 7.5% to 11.1%) decreased to 7.6% (5.5% to 11.7%) at 24 weeks. Overall, 31.7% subjects (n=33) achieved the target HbA1c level of ≤7.0%. The mean differences in body weight and fasting plasma glucose were 1.2±3.4 kg and 56.0±49.8 mg/dL, respectively. Hypoglycemia was reported in 36 subjects (33.3%, 112 episodes), all of which were fully recovered. There was no serious AE attributed to insulin glargine. Body weight change was significantly different between SU users and nonusers (1.5±2.5 kg vs. −0.9±6.0 kg, P=0.011). CONCLUSION: The combination add-on therapy of insulin glargine, on metformin and DPP-4 inhibitors with or without SU was safe and efficient in reducing HbA1c levels and thus, is a preferable option in managing T2DM patients exhibiting dysglycemia despite the use of OADs.
Blood Glucose
;
Body Weight
;
Body Weight Changes
;
Diabetes Mellitus, Type 2
;
Fasting
;
Hemoglobin A, Glycosylated
;
Humans
;
Hypoglycemia
;
Hypoglycemic Agents
;
Insulin Glargine
;
Insulin
;
Metformin
;
Morinda
4.The Efficacy of Fentanyl Transdermal Patch as the First-Line Medicine for the Conservative Treatment of Osteoporotic Compression Fracture.
June Ho CHOI ; Hui Dong KANG ; Jin Hoon PARK ; Bon Sub GU ; Sang Ku JUNG ; Se Hyun OH
Korean Journal of Neurotrauma 2017;13(2):130-136
OBJECTIVE: There are no strong guidelines on how long or how we should undertake conservative treatment during the acute period of an osteoporotic vertebral compression fracture (VCF). METHODS: We treated 202 patients with conservative treatment on VCF from March 2012 to August 2015. On inclusion criteria, 75 patients (22 males and 53 females) were included in the final analysis. After admission, a transdermal fentanyl patch with low dose (12.5 µg) application was attempted in all patients. In an unresponsive patient, the fentanyl patch was increased by 25 µg. After identifying the tolerable toilet ambulation of the patient without any assistance, hospital discharge was recommended. We classified two patient groups into one favorable group and one unfavorable group and compared several clinical and radiological factors. RESULTS: Among 75 patients, the clinical outcome of 57 patients (76%) was favorable, but that of 18 patients (24%) was unfavorable. In clinical outcomes, the numeric rating scale at 6 and 12 months and Odom's criteria at 12 months was significantly different between the favorable and the unfavorable groups. The dose of the patches used showed statistically significant differences between the two groups (p=0.001). CONCLUSION: The only statistically significant affecting factor for an unfavorable outcome was the use of a higher dose fentanyl patch. Our data inferred that the unresponsiveness to a low-dose fentanyl patch could be helpful to select patients necessary for percutaneous vertebroplasty or kyphoplasty.
Fentanyl*
;
Fractures, Compression*
;
Humans
;
Kyphoplasty
;
Male
;
Transdermal Patch*
;
Vertebroplasty
;
Walking
5.Factors Influencing Skin Tolerability to the Rivastigmine Patch in Patients with Alzheimer's Disease.
Hae Ri NA ; Moon Ho PARK ; Sangyun KIM ; Dong Won YANG ; Seong Hye CHOI ; Hyun Duk YANG ; Youngsoon YANG ; Hyun Jeong HAN ; Jung Seok LEE ; Young Chul YOON ; Seong Ho KOH ; Jung Eun KIM ; Bon D KU ; Hee Jin KIM ; Kyung Won PARK ; Eun Joo KIM ; Bora YOON ; Key Jung PARK
Dementia and Neurocognitive Disorders 2015;14(1):31-38
BACKGROUND AND PURPOSE: The one-day rivastigmine patch is reportedly well tolerated and has minimal side effects. However, Asian patients show more side effects than those in Western countries. We evaluated tolerability of the rivastigmine patch in South Korean patients with Alzheimer's disease (AD) and the specific factors affecting adverse events of the skin. METHODS: A 6-month, open labeled, multi-centered, observational study was carried out in 440 patients with probable AD from July 2009 to September 2010 (NCT01312363). RESULTS: A total of 25.9% of the patients experienced adverse skin events at the rivastigmine patch application site and 17.0% discontinued treatment due to adverse events at the skin application site. The most common adverse events were itching and erythema. Patients with an allergic history and users of electric heating appliances reported skin discomfort. Older age was associated with discontinuing treatment. CONCLUSION: These results suggest that the rivastigmine patch induced some adverse skin events and may contribute to understanding and improving skin tolerability to the rivastigmine patch.
Alzheimer Disease*
;
Asian Continental Ancestry Group
;
Erythema
;
Heating
;
Hot Temperature
;
Humans
;
Observational Study
;
Pruritus
;
Skin*
;
Rivastigmine
6.Tophaceous Gout Misidentified as Inflammatory Polyp in External Auditory Canal.
Myeong Jae YOON ; Hye Jin OH ; Bon Seung KU ; Yeong Wook SONG ; Jun Ho LEE ; Eun Bong LEE
Journal of Rheumatic Diseases 2015;22(1):25-28
Gout is an inflammatory disorder in which urate crystals are deposited in the joints or soft tissues causing severe inflammation and pain. Urate crystals usually deposit in the joints, and sometimes in the extra-articular sites. A 67-year-old woman visited the otolaryngology clinic due to otalgia and discharge from the ear. She had experienced recurrent arthritis in the left second metatarsophalangeal joint from five years ago. She visited the otolaryngology clinic of our university hospital due to persistent inflammation in the ear canal despite treatment with antibiotics. An otoscopic examination showed a polyp-like mass near the eardrum. Computed tomography scan of temporal bone showed thickening of the eardrum and increased soft tissue density in the external ear canal. On histologic examination the polyp was finally found to be a urate crystal mass. She is now in a good state with urate lowering therapy. We report on a Korean case of tophaceous gout in the external ear canal that was misidentified as an inflammatory polyp.
Aged
;
Anti-Bacterial Agents
;
Arthritis
;
Ear
;
Ear Canal*
;
Earache
;
Female
;
Gout*
;
Humans
;
Inflammation
;
Joints
;
Metatarsophalangeal Joint
;
Otolaryngology
;
Polyps*
;
Temporal Bone
;
Tympanic Membrane
;
Uric Acid
7.Tazarotene-Induced Gene 3 May Affect Inflammatory Angiogenesis in Psoriasis by Downregulating Placental Growth Factor Expression.
Su Young JEON ; Seung Min HA ; Dong Yeob KO ; Bon Seok KU ; Chae Young LEE ; Ki Hoon SONG ; Ki Ho KIM
Annals of Dermatology 2014;26(4):517-520
No abstract available.
Psoriasis*
8.A Case of Endometriosis with Chylous Ascites.
Yoon Jung LEE ; Young Cheol JO ; Tae Hoon JANG ; Bon Ho KU ; Chi Hoon KIM ; Hye Yon PARK ; Kwang Hyuk LEE ; Jeong Won LEE
Korean Journal of Gastrointestinal Endoscopy 2010;41(6):368-372
Chylous ascites is the extravasation into the peritoneal cavity of milky chyle that is rich in triglycerides. Sixty to seventy percent of chylous ascites cases are caused by cirrhotic liver disease, congestive heart failure, or malignancy. The most common malignancy associated with chylous ascites is lymphoma. Rarely, tuberculosis has been reported as a cause of chylous ascites. Appropriately, lymphoma, ovarian cancer or tuberculosis is considered first in the differential diagnosis when a young woman of reproductive age presents with chylous ascites. Recently, we examined a 26-year-old woman who visited our hospital because of abdominal distension. Ascites tapping, esophagogastroduodenoscopy, colonoscopy and diagnostic laparoscopic biopsy led to a diagnosis of intraperitoneal endometriosis with chylous ascites. To date, some cases of endometriosis complicated by massive ascites have been reported. However, endometriosis complicated by chylous ascites has not been previously reported. The case was successfully treated using a gonadotropin-releasing hormone agonist and diuretics.
Adult
;
Ascites
;
Biopsy
;
Chyle
;
Chylous Ascites
;
Colonoscopy
;
Diagnosis, Differential
;
Diuretics
;
Endometriosis
;
Endoscopy, Digestive System
;
Female
;
Gonadotropin-Releasing Hormone
;
Heart Failure
;
Humans
;
Liver Diseases
;
Lymphoma
;
Ovarian Neoplasms
;
Peritoneal Cavity
;
Triglycerides
;
Tuberculosis
9.A Case of Degos' Disease Presenting with Abdominal Angina and Widespread Skin Lesions.
Bon Ho KU ; Yeun Jung LIM ; Hyo Kyung CHOI ; Young Ho KIM ; Jongwook PARK ; Chi Hoon KIM ; Tae Hoon JANG ; Yong Woo SEO ; Young Cheol JO ; Kee Taek JANG ; Chang Ohk SUNG ; Dong Kyung CHANG
Intestinal Research 2010;8(1):70-74
Malignant atrophic papulosis (MAP), also known as Degos' disease, is a rare and often fatal occlusive thrombotic vasculopathy, with fewer than seven cases reported in Korea. MAP is characterized by porcelain-white, atrophic, papular skin lesions and multi-organ system involvement, especially the gastrointestinal (GI) tract and nervous system. Involvement of the GI tract is usually associated with a poor prognosis. To date, no treatment has been shown to be effective in the treatment of MAP. We describe a 52-year-old man who presented with a 5-month history of abdominal angina and a 2-year history of multiple skin lesions on the trunk and extremities. The skin lesions were papules, 4-6 mm in diameter, with a porcelain-white center and a slightly raised erythematous telangiectatic rim. A biopsy of a skin lesion showed a wedge-shaped degeneration of collagen in the dermis and atrophic epidermis. An explorative laparoscopy revealed multiple, yellow-white plaques scattered throughout the small bowel. A biopsy of the small bowel showed sclerotic vascular alterations containing intravascular fibrin thrombi. He was started on aspirin (100 mg daily) and has survived for 24 months since the onset of gastrointestinal symptoms.
Aspirin
;
Biopsy
;
Collagen
;
Dermis
;
Epidermis
;
Extremities
;
Fibrin
;
Gastrointestinal Tract
;
Humans
;
Korea
;
Laparoscopy
;
Malignant Atrophic Papulosis
;
Middle Aged
;
Nervous System
;
Prognosis
;
Skin
10.A Case of Degos' Disease Presenting with Abdominal Angina and Widespread Skin Lesions.
Bon Ho KU ; Yeun Jung LIM ; Hyo Kyung CHOI ; Young Ho KIM ; Jongwook PARK ; Chi Hoon KIM ; Tae Hoon JANG ; Yong Woo SEO ; Young Cheol JO ; Kee Taek JANG ; Chang Ohk SUNG ; Dong Kyung CHANG
Intestinal Research 2010;8(1):70-74
Malignant atrophic papulosis (MAP), also known as Degos' disease, is a rare and often fatal occlusive thrombotic vasculopathy, with fewer than seven cases reported in Korea. MAP is characterized by porcelain-white, atrophic, papular skin lesions and multi-organ system involvement, especially the gastrointestinal (GI) tract and nervous system. Involvement of the GI tract is usually associated with a poor prognosis. To date, no treatment has been shown to be effective in the treatment of MAP. We describe a 52-year-old man who presented with a 5-month history of abdominal angina and a 2-year history of multiple skin lesions on the trunk and extremities. The skin lesions were papules, 4-6 mm in diameter, with a porcelain-white center and a slightly raised erythematous telangiectatic rim. A biopsy of a skin lesion showed a wedge-shaped degeneration of collagen in the dermis and atrophic epidermis. An explorative laparoscopy revealed multiple, yellow-white plaques scattered throughout the small bowel. A biopsy of the small bowel showed sclerotic vascular alterations containing intravascular fibrin thrombi. He was started on aspirin (100 mg daily) and has survived for 24 months since the onset of gastrointestinal symptoms.
Aspirin
;
Biopsy
;
Collagen
;
Dermis
;
Epidermis
;
Extremities
;
Fibrin
;
Gastrointestinal Tract
;
Humans
;
Korea
;
Laparoscopy
;
Malignant Atrophic Papulosis
;
Middle Aged
;
Nervous System
;
Prognosis
;
Skin

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