1.Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial
Se Hyun KIM ; Do-Un JUNG ; Do Hoon KIM ; Jung Sik LEE ; Kyoung-Uk LEE ; Seunghee WON ; Bong Ju LEE ; Sung-Gon KIM ; Sungwon ROH ; Jong-Ik PARK ; Minah KIM ; Sung Won JUNG ; Hong Seok OH ; Han-yong JUNG ; Sang Hoon KIM ; Hyun Seung CHEE ; Jong-Woo PAIK ; Kyu Young LEE ; Soo In KIM ; Seung-Hwan LEE ; Eun-Jin CHEON ; Hye-Geum KIM ; Heon-Jeong LEE ; In Won CHUNG ; Joonho CHOI ; Min-Hyuk KIM ; Seong-Jin CHO ; HyunChul YOUN ; Jhin-Goo CHANG ; Hoo Rim SONG ; Euitae KIM ; Won-Hyoung KIM ; Chul Eung KIM ; Doo-Heum PARK ; Byung-Ook LEE ; Jungsun LEE ; Seung-Yup LEE ; Nuree KANG ; Hee Yeon JUNG
Psychiatry Investigation 2024;21(7):762-771
Objective:
This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia.
Methods:
Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed.
Results:
Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea.
Conclusion
Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.
2.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
3.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
4.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
5.Monitoring Radiation Doses during Diagnostic and Therapeutic Neurointerventional Procedures: Multicenter Study for Establishment of Reference Levels
Yon-Kwon IHN ; Bum-soo KIM ; Hae Woong JEONG ; Sang Hyun SUH ; Yoo Dong WON ; Young-Jun LEE ; Dong Joon KIM ; Pyong JEON ; Chang-Woo RYU ; Sang-il SUH ; Dae Seob CHOI ; See Sung CHOI ; Sang Heum KIM ; Jun Soo BYUN ; Jieun RHO ; Yunsun SONG ; Woo Sang JEONG ; Noah HONG ; Sung Hyun BAIK ; Jeong Jin PARK ; Soo Mee LIM ; Jung-Jae KIM ; Woong YOON
Neurointervention 2021;16(3):240-251
Purpose:
To assess patient radiation doses during diagnostic and therapeutic neurointerventional procedures from multiple centers and propose dose reference level (RL).
Materials and Methods:
Consecutive neurointerventional procedures, performed in 22 hospitals from December 2020 to June 2021, were retrospectively studied. We collected data from a sample of 429 diagnostic and 731 therapeutic procedures. Parameters including dose-area product (DAP), cumulative air kerma (CAK), fluoroscopic time (FT), and total number of image frames (NI) were obtained. RL were calculated as the 3rd quartiles of the distribution.
Results:
Analysis of 1160 procedures from 22 hospitals confirmed the large variability in patient dose for similar procedures. RLs in terms of DAP, CAK, FT, and NI were 101.6 Gy·cm2, 711.3 mGy, 13.3 minutes, and 637 frames for cerebral angiography, 199.9 Gy·cm2, 3,458.7 mGy, 57.3 minutes, and 1,000 frames for aneurysm coiling, 225.1 Gy·cm2, 1,590 mGy, 44.7 minutes, and 800 frames for stroke thrombolysis, 412.3 Gy·cm2, 4,447.8 mGy, 99.3 minutes, and 1,621.3 frames for arteriovenous malformation (AVM) embolization, respectively. For all procedures, the results were comparable to most of those already published. Statistical analysis showed male and presence of procedural complications were significant factors in aneurysmal coiling. Male, number of passages, and procedural combined technique were significant factors in stroke thrombolysis. In AVM embolization, a significantly higher radiation dose was found in the definitive endovascular cure group.
Conclusion
Various RLs introduced in this study promote the optimization of patient doses in diagnostic and therapeutic interventional neuroradiology procedures. Proposed 3rd quartile DAP (Gy·cm2) values were 101.6 for diagnostic cerebral angiography, 199.9 for aneurysm coiling, 225.1 for stroke thrombolysis, and 412.3 for AVM embolization. Continual evolution of practices and technologies requires regular updates of RLs.
6.The Two Cases of Multifocal Fixed Drug Eruption Caused by Diclofenac
Ho Jung LEE ; Jeong Yeon HONG ; Tae Heum PARK ; Sung Yul LEE ; Jong Suk LEE ; Euy Hyun CHUNG ; Sang Hoon LEE ; Jung Eun KIM
Korean Journal of Dermatology 2020;58(6):411-415
Fixed drug eruption (FDE) is a drug-induced disorder that may appear as patches or bullae. It recurs at the same sites as those involved in exposure to the same drug (causative drug). We encountered two cases of generalized FDE, and both patients had a history of diclofenac exposure before the onset of skin lesions. In the first case, an 82-year-old female patient presented with multiple erythematous patches on the trunk and lower extremities. In the second case, a 71-year-old male patient developed multiple bullae on violaceous patches on the trunk and extremities. The findings of histopathologic examinations were indicative of the diagnosis of FDEs. Although diclofenac is commonly used as a non-steroidal inflammatory drug, diclofenac-induced generalized FDE occurs rarely and has not been reported in Korea. With reuse of causative drugs, the size and number of lesions tend to increase. Therefore, early diagnosis of FDE is important, and avoidance of repeated exposure to drugs should be educated.
7.High incidence of subsequent re-operation following treatments for medial meniscus tears combined with anterior cruciate ligament reconstruction: second-look arthroscopic study
Sang Gyun KIM ; Soo Hyun KIM ; Jung Heum BAEK ; Jae Gyoon KIM ; Ki Mo JANG ; Hong Chul LIM ; Ji Hoon BAE
The Journal of Korean Knee Society 2019;31(4):e11-
BACKGROUND:
The Multicenter Orthopaedic Outcomes Network (MOON) group recently reported that medial meniscus (MM) repairs are associated with more frequent re-operations when compared to lateral meniscus (LM) repairs. The purpose of this study was to compare the meniscal healing and the incidence of subsequent re-operation of medial and lateral meniscal tears that occurred concurrently with anterior cruciate ligament (ACL) injuries.
METHODS:
We retrospectively reviewed patients who underwent second-look arthroscopy after primary ACL reconstruction (ACLR) between June 2005 to December 2016. The healing of meniscal tears following repair or left in situ, and re-tear following partial meniscectomy, were evaluated via second-look arthroscopy and compared between medial and lateral meniscus. Moreover, the incidence of subsequent meniscal re-operation after the index ACLR were investigated and compared between medial and lateral meniscus. Subsequent meniscal re-operation was performed in cases of the following three symptomatic meniscus tears: re-tears at the meniscectomy site; new tears; and failed healing of repaired or left in situ meniscus.
RESULTS:
There were 148 meniscal tears in 121 patients at index ACLR. There were 62 MM tears, 38 LM tears, and 24 bilateral meniscus tears. At second-look arthroscopy, the “successful healing†rate for tears following repair was higher in LM tears (91.2%) compared to MM tears (80.0%), although it was not statistically significant (p > 0.05). No significant differences were observed in the healing of left in situ tears or re-tear of meniscectomy site between medial and lateral meniscus. Patients with MM tears combined with ACL injuries had a higher incidence of subsequent meniscal re-operation compared to patients with LM tears (25.6% vs 16.1%, p = 0.025).
CONCLUSIONS
There was a trend for the successful healing rate to be higher in LM repairs than MM repairs. Subsequent meniscal re-operations after ACLR were more frequent in patients with medial meniscal tears concurrently with ACL injuries in comparison to patients with lateral meniscal tears.LEVEL OF STUDY: Level IV, retrospective case series.
8.Gender Differences in Somatic Symptoms and Current Suicidal Risk in Outpatients with Major Depressive Disorder.
Hong Jin JEON ; Jong Min WOO ; Hyo Jin KIM ; Maurizio FAVA ; David MISCHOULON ; Seong Jin CHO ; Sung Man CHANG ; Doo Heum PARK ; Jong Woo KIM ; Ikki YOO ; Jung Yoon HEO ; Jin Pyo HONG
Psychiatry Investigation 2016;13(6):609-615
OBJECTIVE: Although somatic symptoms are common complaints of patients with major depressive disorder (MDD), their associations with suicide are still unclear. METHODS: A total of 811 MDD outpatients of aged between 18 to 64 years were enrolled nationwide in Korea with the suicidality module of the Mini-International Neuropsychiatric Interview (MINI) and the Depression and Somatic Symptom Scale (DSSS). RESULTS: On stepwise regression analysis, current suicidality scores were most strongly associated with chest pain in men, and neck or shoulder pain in women. Severe chest pain was associated with higher current suicidality scores in men than in women, whereas severe neck or shoulder pain showed no significant differences between the genders. In conclusion, MDD patients of both sexes with suicidal ideation showed significantly more frequent and severe somatic symptoms than those without. Current suicidal risk was associated with chest pain in men, and neck or shoulder pain in women. CONCLUSION: We suggest that clinicians pay attention to patients' somatic symptoms in real world practice.
Chest Pain
;
Depression
;
Depressive Disorder, Major*
;
Female
;
Humans
;
Korea
;
Male
;
Neck
;
Outpatients*
;
Shoulder Pain
;
Suicidal Ideation
;
Suicide
9.The Impact of High-Risk HPV Genotypes Other Than HPV 16/18 on the Natural Course of Abnormal Cervical Cytology: A Korean HPV Cohort Study.
Kyeong A SO ; Mi Jung KIM ; Ki Heon LEE ; In Ho LEE ; Mi Kyung KIM ; Yoo Kyung LEE ; Chang Sun HWANG ; Mi Seon JEONG ; Mee Kyung KEE ; Chun KANG ; Chi Heum CHO ; Seok Mo KIM ; Sung Ran HONG ; Ki Tae KIM ; Won Chul LEE ; Jong Sup PARK ; Tae Jin KIM
Cancer Research and Treatment 2016;48(4):1313-1320
PURPOSE: The purpose of this study is to evaluate the impact of high-risk human papillomaviruses (HPVs) other than HPV 16/18 on the natural course of atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL). MATERIALS AND METHODS: The study population was derived from the Korean HPV cohort (2010-2014). Women aged 20 to 60 who satisfied the criteria of having both HPV infection and abnormal cervical cytology of either ASC-US or LSIL were recruited from five institutions nationwide. Enrolled patients underwent cervical cytology and HPV DNA testing every 6 months. RESULTS: A total of 1,158 patients were enrolled. The 10 most common HPV types were HPV 16 (12.3%), 58 (10.0%), 56 (8.8%), 53 (8.4%), 52 (7.7%), 39 (6.2%), 18 (6.0%), 51 (5.7%), 68 (5.1%), and 66 (4.6%). Among these patients, 636 women were positive for high-risk HPVs other than HPV 16 or 18, and 429 women were followed for more than 6 months. Cytology evaluations showed progression in 15.3% of women, no change in 22.6%, and regression in 62.1% of women at 12 months. In cases of HPV 58 single infection, a more highly significant progression rate, compared to other high-risk types, was observed at 6 months (relative risk [RR], 3.3; 95% confidence interval [CI], 2.04 to 5.30; p < 0.001) and 12 months (RR, 5.03; 95% CI, 2.56 to 9.91; p < 0.001). CONCLUSION: HPV genotypes numbered in the 50s were frequent in Korean women with ASC-US and LSIL. HPV 58 was the second most common type, with a high progression rate of cervical cytology.
Atypical Squamous Cells of the Cervix
;
Cohort Studies*
;
Female
;
Genotype*
;
Human papillomavirus 16
;
Human Papillomavirus DNA Tests
;
Humans
;
Squamous Intraepithelial Lesions of the Cervix
10.Generalized Joint Laxity is Associated with Primary Occurrence and Treatment Outcome of Lumbar Disc Herniation.
Woo Jin HAN ; Hong Bae KIM ; Gun Woo LEE ; Jung Heum CHOI ; Won Jin JO ; Sun Mi LEE
Korean Journal of Family Medicine 2015;36(3):141-145
BACKGROUND: We investigated relationships between generalized joint laxity and primary lumbar disc herniation occurrence and compared clinical outcomes after conservative treatment in lumbar disc herniation patients with and without generalized joint laxity. METHODS: The study group included 128 men, and the control group included 276 men matched for age and body mass index with the study group. The primary outcome measure was the presence or absence of generalized joint laxity using the Beighton scale. Clinical outcomes measured by the visual analog scale and the Oswestry disability index 2 years after conservative treatment were the secondary outcome measure. RESULTS: Generalized joint laxity prevalence was 13.2% in the study group and 5.1% in the control group, a significant difference (P=0.01). Spearman correlation analysis revealed that weight (r=0.162, P=0.03), body mass index (r=0.131, P=0.03), and generalized joint laxity (r=0.372, P<0.01) significantly correlated with lumbar disc herniation occurrence. In multivariate regression analysis, generalized joint laxity was the only significant lumbar disc herniation predictor (P=0.002; 95% confidence interval, 1.08 to 5.26). Generalized joint laxity in lumbar disc herniation patients was associated with worse clinical outcomes after conservative treatment measured by visual analog scale scores for lower extremity pain (P=0.02), lower back pain (P=0.03), and Oswestry disability index scores (P=0.03). CONCLUSION: Generalized joint laxity might be associated with lumbar disc herniation occurrence and might also be a negative predictor of worse clinical outcomes after conservative treatment.
Body Mass Index
;
Humans
;
Intervertebral Disc Displacement
;
Joint Instability*
;
Low Back Pain
;
Lower Extremity
;
Lumbar Vertebrae
;
Male
;
Outcome Assessment (Health Care)
;
Prevalence
;
Treatment Outcome*
;
Visual Analog Scale

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