1.Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study
Jin Hwa PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung-Gyu CHOI ; Hyunsoo CHUNG ; Suck-Chei CHOI ; Nayoung KIM ; Hyojin PARK ; In-Kyung SUNG ; Chong Il SOHN ; Sam Ryong JEE ; Jae Young JANG ; Poong-Lyul RHEE ; Moo In PARK ; Joong Goo KWON ; Kyung Sik PARK ; Kwang Jae LEE ; Joon Seong LEE
Journal of Neurogastroenterology and Motility 2021;27(1):87-96
Background/Aims:
Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD.
Methods:
In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed.
Results:
The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: − 10.04 ± 4.45 and − 10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, − 1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion
In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.
2.Diagnosis and Treatment of Growth Hormone Deficiency: A Position Statement from Korean Endocrine Society and Korean Society of Pediatric Endocrinology
Jung Hee KIM ; Hyun Wook CHAE ; Sang Ouk CHIN ; Cheol Ryong KU ; Kyeong Hye PARK ; Dong Jun LIM ; Kwang Joon KIM ; Jung Soo LIM ; Gyuri KIM ; Yun Mi CHOI ; Seong Hee AHN ; Min Ji JEON ; Yul HWANGBO ; Ju Hee LEE ; Bu Kyung KIM ; Yong Jun CHOI ; Kyung Ae LEE ; Seong-Su MOON ; Hwa Young AHN ; Hoon Sung CHOI ; Sang Mo HONG ; Dong Yeob SHIN ; Ji A SEO ; Se Hwa KIM ; Seungjoon OH ; Sung Hoon YU ; Byung Joon KIM ; Choong Ho SHIN ; Sung-Woon KIM ; Chong Hwa KIM ; Eun Jig LEE
Endocrinology and Metabolism 2020;35(2):272-287
Growth hormone (GH) deficiency is caused by congenital or acquired causes and occurs in childhood or adulthood. GH replacement therapy brings benefits to body composition, exercise capacity, skeletal health, cardiovascular outcomes, and quality of life. Before initiating GH replacement, GH deficiency should be confirmed through proper stimulation tests, and in cases with proven genetic causes or structural lesions, repeated GH stimulation testing is not necessary. The dosing regimen of GH replacement therapy should be individualized, with the goal of minimizing side effects and maximizing clinical improvements. The Korean Endocrine Society and the Korean Society of Pediatric Endocrinology have developed a position statement on the diagnosis and treatment of GH deficiency. This position statement is based on a systematic review of evidence and expert opinions.
3.Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement
Sang Ouk CHIN ; Cheol Ryong KU ; Byung Joon KIM ; Sung Woon KIM ; Kyeong Hye PARK ; Kee Ho SONG ; Seungjoon OH ; Hyun Koo YOON ; Eun Jig LEE ; Jung Min LEE ; Jung Soo LIM ; Jung Hee KIM ; Kwang Joon KIM ; Heung Yong JIN ; Dae Jung KIM ; Kyung Ae LEE ; Seong Su MOON ; Dong Jun LIM ; Dong Yeob SHIN ; Se Hwa KIM ; Min Jeong KWON ; Ha Young KIM ; Jin Hwa KIM ; Dong Sun KIM ; Chong Hwa KIM
Endocrinology and Metabolism 2019;34(1):53-62
The Korean Endocrine Society (KES) published clinical practice guidelines for the treatment of acromegaly in 2011. Since then, the number of acromegaly cases, publications on studies addressing medical treatment of acromegaly, and demands for improvements in insurance coverage have been dramatically increasing. In 2017, the KES Committee of Health Insurance decided to publish a position statement regarding the use of somatostatin analogues in acromegaly. Accordingly, consensus opinions for the position statement were collected after intensive review of the relevant literature and discussions among experts affiliated with the KES, and the Korean Neuroendocrine Study Group. This position statement includes the characteristics, indications, dose, interval (including extended dose interval in case of lanreotide autogel), switching and preoperative use of somatostatin analogues in medical treatment of acromegaly. The recommended approach is based on the expert opinions in case of insufficient clinical evidence, and where discrepancies among the expert opinions were found, the experts voted to determine the recommended approach.
Acromegaly
;
Consensus
;
Expert Testimony
;
Insurance Coverage
;
Insurance, Health
;
Octreotide
;
Somatostatin
4.Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement
Sang Ouk CHIN ; Cheol Ryong KU ; Byung Joon KIM ; Sung Woon KIM ; Kyeong Hye PARK ; Kee Ho SONG ; Seungjoon OH ; Hyun Koo YOON ; Eun Jig LEE ; Jung Min LEE ; Jung Soo LIM ; Jung Hee KIM ; Kwang Joon KIM ; Heung Yong JIN ; Dae Jung KIM ; Kyung Ae LEE ; Seong Su MOON ; Dong Jun LIM ; Dong Yeob SHIN ; Se Hwa KIM ; Min Jeong KWON ; Ha Young KIM ; Jin Hwa KIM ; Dong Sun KIM ; Chong Hwa KIM
Korean Journal of Medicine 2019;94(6):485-494
Acromegaly is a chronic disorder caused by excessive growth hormone (GH) secretion. In most cases, the excess GH originates from GH-producing pituitary adenomas. Surgery is the preferred first-line treatment for patients with acromegaly, but medical management is considered when the disease persists after surgery or in cases where patients refuse surgery or are poor candidates for surgery. Somatostatin analogues are commonly used to treat acromegaly. The Korean Endocrine Society and the Korean Neuroendocrine Study Group have developed a position statement for the use of somatostatin analogues in the medical treatment of acromegaly. This position statement is based on evidence from the current literature and expert opinions. In the case of discrepancies among expert opinions, the experts voted to determine the recommended approach.
Acromegaly
;
Expert Testimony
;
Growth Hormone
;
Humans
;
Octreotide
;
Pituitary Neoplasms
;
Somatostatin
5.Medical Treatment with Somatostatin Analogues in Acromegaly: Position Statement
Sang Ouk CHIN ; Cheol Ryong KU ; Byung Joon KIM ; Sung Woon KIM ; Kyeong Hye PARK ; Kee Ho SONG ; Seungjoon OH ; Hyun Koo YOON ; Eun Jig LEE ; Jung Min LEE ; Jung Soo LIM ; Jung Hee KIM ; Kwang Joon KIM ; Heung Yong JIN ; Dae Jung KIM ; Kyung Ae LEE ; Seong Su MOON ; Dong Jun LIM ; Dong Yeob SHIN ; Se Hwa KIM ; Min Jeong KWON ; Ha Young KIM ; Jin Hwa KIM ; Dong Sun KIM ; Chong Hwa KIM
Korean Journal of Medicine 2019;94(6):485-494
Acromegaly is a chronic disorder caused by excessive growth hormone (GH) secretion. In most cases, the excess GH originates from GH-producing pituitary adenomas. Surgery is the preferred first-line treatment for patients with acromegaly, but medical management is considered when the disease persists after surgery or in cases where patients refuse surgery or are poor candidates for surgery. Somatostatin analogues are commonly used to treat acromegaly. The Korean Endocrine Society and the Korean Neuroendocrine Study Group have developed a position statement for the use of somatostatin analogues in the medical treatment of acromegaly. This position statement is based on evidence from the current literature and expert opinions. In the case of discrepancies among expert opinions, the experts voted to determine the recommended approach.
6.Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.
Hye Kyung JUNG ; Kwang Jae LEE ; Myung Gyu CHOI ; Hyojin PARK ; Joon Seong LEE ; Poong Lyul RHEE ; Nayoung KIM ; Kyung Sik PARK ; Suck Chei CHOI ; Oh Young LEE ; Kyu Chan HUH ; Geun Am SONG ; Su Jin HONG ; Chong Il SOHN ; Hwoon Yong JUNG ; Yong Chan LEE ; Jong Sun REW ; Sam Ryong JEE ; Joong Goo KWON
Journal of Neurogastroenterology and Motility 2016;22(2):254-263
BACKGROUND/AIMS: The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. METHODS: In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. RESULTS: The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups. CONCLUSIONS: DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacy of DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 and pantoprazole in patients with FD.
Asian Continental Ancestry Group
;
Dyspepsia*
;
Gastric Emptying
;
Humans
;
Hypersensitivity
;
Proton Pump Inhibitors
;
Quality of Life
7.Efficacy and Safety of Tiropramide in the Treatment of Patients With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-blind, Non-inferiority Trial, Compared With Octylonium.
Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Chong Il SOHN ; Kyu Chan HUH ; Kyung Sik PARK ; Joong Goo KWON ; Nayoung KIM ; Poong Lyul RHEE ; Seung Jae MYUNG ; Joon Seong LEE ; Kwang Jae LEE ; Hyojin PARK ; Yong Chan LEE ; Suck Chei CHOI ; Hye Kyung JUNG ; Sam Ryong JEE ; Chang Hwan CHOI ; Gwang Ha KIM ; Moo In PARK ; In Kyung SUNG
Journal of Neurogastroenterology and Motility 2014;20(1):113-121
BACKGROUND/AIMS: Antispasmodics such as octylonium are widely used to manage irritable bowel syndrome (IBS) symptoms. However, the efficacy and safety of another antispasmodic, tiropramide, remain uncertain. We aimed to evaluate the efficacy and safety of tiropramide compared with octylonium in patients with IBS. METHODS: In this multicenter, randomized, non-inferiority trial, 287 patients with IBS (143 receiving tiropramide and 144 octylonium) were randomly allocated to either tiropramide 100 mg or octylonium 20 mg t.i.d (means 3 times a day) for 4 weeks. Primary endpoint was the mean change of abdominal pain from baseline assessed by visual analogue scales (VAS) score after 4 weeks of treatment. Secondary endpoints were the changes in abdominal pain from baseline at week 2 and in abdominal discomfort at weeks 2 and 4, using VAS scores, patient-reported symptom improvement including stool frequency and consistency, using symptom diaries, IBS-quality of life (IBS-QoL), and depression and anxiety, at week 4. RESULTS: The VAS scores of abdominal pain at week 4, were significantly decreased in both tiropramide and octylonium groups, but the change from baseline did not differ between the 2 groups (difference,-0.26 mm; 95% CI,-4.33-3.82; P = 0.901). Abdominal pain and discomfort assessed using VAS scores, diaries, and IBS-QoL were also improved by both treatments, and the changes from baseline did not differ. The incidence of adverse events was similar in the 2 groups, and no severe adverse events involving either drug were observed. CONCLUSIONS: Tiropramide is as effective as octylonium in managing abdominal pain in IBS, with a similar safety profile.
Abdominal Pain
;
Anxiety
;
Depression
;
Humans
;
Incidence
;
Irritable Bowel Syndrome*
;
Parasympatholytics
;
Weights and Measures
8.Comparison between Emergency Patient Poisoning Cases and the Tox-Info System Database.
Hyun Jong KIM ; Yang Weon KIM ; Hyun KIM ; Chang Bae PARK ; Byung Hak SO ; Kyeong Ryong LEE ; Kyung Woo LEE ; Kyung Won LEE ; Sung Woo LEE ; Jang Young LEE ; Gyu Chong CHO ; Junho CHO ; Sung Phil CHUNG
Journal of The Korean Society of Clinical Toxicology 2012;10(1):8-14
PURPOSE: The Tox-Info system is a poisonous substance information database developed by the Korean National Institute of Food and Drug Safety Evaluation. The aim of this study was to estimate the coverage effectiveness of the Tox-Info system by comparing the toxic substances included in the database with the distribution of the toxic substances implicated in the cases of intoxicated patients presenting to emergency departments. The secondary aim of the study was to propose any additional substances that should be added to the database. METHODS: We retrospectively reviewed the medical records of patients suffering with toxic exposure who had visited any of 12 selected emergency departments in Korea from January 2010 to December 2011. The identified toxic substances were classified into groups including prescription drugs, agricultural chemicals, household products, animals or plants, herbal drugs, and others. We calculated the coverage rate of the Tox-Info database relative to the number of intoxication cases and the type of toxic substances involved. RESULTS: A total of 5,840 intoxicated patient records were collected. Their mean age was 46.6+/-20.5 years and 56.2% were female. Of the total intoxication cases, 87.8% of the identified toxic substances were included in the Tox-Info database, while only 41.6% of all of the types of identified toxic substances were included. Broken down by category, 122 prescription drugs, 15 agricultural chemicals, 12 household products, 14 animals or plants and 2 herbal drugs involved in poisoning cases were not included in the Tox-info database. CONCLUSION: This study demonstrated the clinical usefulness of the Tox-Info system. While 87.8% of the substances involved in the cases were included in the Tox-Info database, the database should be continuously updated in order to include even the most uncommon toxic substances.
Agrochemicals
;
Animals
;
Emergencies
;
Female
;
Household Products
;
Humans
;
Korea
;
Medical Records
;
Prescription Drugs
;
Retrospective Studies
;
Stress, Psychological
9.Clinical Characteristics of Intentional Carbon Monoxide Poisoning.
Min Ki CHO ; Yang Weon KIM ; Kyeong Ryong LEE ; Kyung Woo LEE ; Jang Young LEE ; Gyu Chong CHO ; Junho CHO ; Hyun Jong KIM ; Seong Hwan KIM ; Sung Phil CHUNG ; Hahn Shick LEE
Journal of The Korean Society of Clinical Toxicology 2012;10(2):73-79
PURPOSE: The purpose of this study was to identify the changes in the characteristics of patients with carbon monoxide (CO) poisoning, as well as the distinctive differences in intentionally exposed patients. METHODS: The medical records of CO poisoning patients, who visited nine emergency departments between January 2010 and December 2011, were reviewed retrospectively. The clinical information including age, gender, hospitalization, type of discharge, cause and location of exposure, site of onset, concentration of initial blood carboxyhemoglobin (COHb), methods of treatment and presence of neurological complications was examined. The subjects were divided into an intentional and non-intentional group and the differences between them was compared. RESULTS: A total 209 subjects were recruited. The median age was 38 years (29~49.5 years). They frequently complained of nausea and vomiting, and the most common exposures occurred in winter, normally in the home. The cause of exposure was usually fire, followed by incomplete combustion of fuels. The median initial blood COHb was 13.15%. The proportion of intentionally exposed patients was 21%. They were significantly younger, more frequently discharged against medical advice, and showed a higher initial blood COHb level (22.85%) than the non-intentional group. CONCLUSION: This study suggests that those with intentional CO poisoning are normally discharged against medical advice even when they have a higher initial COHb level. An adequate explanation of the delayed neurologic sequelae and short term follow-up observation is recommended for those patients with intentional exposure.
Carbon
;
Carbon Monoxide
;
Carbon Monoxide Poisoning
;
Carboxyhemoglobin
;
Emergencies
;
Fires
;
Follow-Up Studies
;
Hospitalization
;
Humans
;
Intention
;
Medical Records
;
Nausea
;
Retrospective Studies
;
Suicide
;
Vomiting
10.A Case of IgA Nephropathy with Systemic Lupus Nephritis.
Kweon Woo HAN ; Young Ki LEE ; Hae Ri LEE ; Sang Ik HWANG ; Seong Gyun KIM ; Ji Eun OH ; Jang Won SEO ; Ja Ryong KOO ; Hyung Jik KIM ; Jung Woo NOH ; Chong Woo YOO ; Eun Sook NAM
Korean Journal of Nephrology 2005;24(2):326-331
Renal involvement is common in systemic lupus erythematosus (SLE). The typical lupus nephropathy demonstrates polyclonal immunoglobulin immune deposits with predominance of IgG, usually heavy polytypic complement factors C1q, C3 and C4. In SLE patients, the superimposition and occurrence of non- lupus nephropathy have rarely been reported. We describe a 28-year-old, 15 weeks pregnant women affected by SLE and IgA nephropathy. She was admitted to our hospital due to generalized edema and arthralgia. The ANA titer was 1: 640, anti-ds DNA levels were 354.2 U/mL and other blood tests included thrombocytopenia and hypoclomplementemia. These clinical and laboratory data allowed the diagnosis of SLE. Renal biopsy showed modest segmental mesangial hypercellularity. Immunofluorescence microscopy revealed distinct mesangial IgA and C3 with absence of IgG, IgM, C1q, and C4. Electron microscopy confirmed the presence of electron-dense deposits throughout the mesangium. These features were consistent with the coexistence of IgA nephropathy. A course of prednisolone (50 mg/day) was given for six months and she responded well with resolution of proteinuria. At the present follow- up time point (48 months), she continues to be treated with prednisolone (5 mg/day); proteinuria and ANA are undetectable.
Adult
;
Arthralgia
;
Biopsy
;
Complement System Proteins
;
Diagnosis
;
DNA
;
Edema
;
Female
;
Glomerulonephritis, IGA*
;
Hematologic Tests
;
Humans
;
Immunoglobulin A*
;
Immunoglobulin G
;
Immunoglobulin M
;
Immunoglobulins
;
Lupus Erythematosus, Systemic
;
Lupus Nephritis*
;
Microscopy, Electron
;
Microscopy, Fluorescence
;
Nephrotic Syndrome
;
Prednisolone
;
Pregnant Women
;
Proteinuria
;
Thrombocytopenia

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