1.A Korean Post-Marketing Surveillance Study of Dolutegravir Single-Agent Tablets in Patients with HIV-1
Sungshin KWON ; Jung-Eun CHO ; Eun-Bin LEE ; Yeon-Sook KIM ; Jang-Wook SOHN
Infection and Chemotherapy 2022;54(4):711-721
Background:
The integrase strand transfer inhibitor dolutegravir has been indicated in Korea since 2014 for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with other antiretroviral agents. This regulatory post-marketing surveillance (PMS) study evaluated the real-life safety and effectiveness of dolutegravir in patients with HIV-1 in clinical practice in Korea.
Materials and Methods:
This open-label PMS study examined data from consecutive patients (aged ≥12 years) with HIV-1 infection receiving dolutegravir according to locally approved prescribing information; treatment-naïve and treatment-experienced patients were permitted. Data regarding patient demographics, medical history, clinical characteristics, medications (HIV-related and concomitant), and comorbidities were extracted from patient records over a 1-year treatment period. Outcomes included the safety of dolutegravir (primary endpoint) and real-life effectiveness according to the Physician Global Assessment (PGA) and the proportion of patients with plasma HIV-1 RNA count <50 copies/mL at 48 weeks.
Results:
Of 147 patients treated with dolutegravir at 18 centers in Korea (August 2014 – August 2020), 139 were eligible for the safety analyses and 75 for effectiveness analyses.Patients (mean age 47 years) were mostly male (92.8%) and received dolutegravir in combination with nucleoside reverse transcriptase inhibitor (70.5%) or protease inhibitors (21.6%). Adverse events (AEs) (n = 179 in total) were mostly mild in severity, with the most common being nasopharyngitis (5.0%), dyspepsia (5.0%), pruritus (4.3%), and rash (4.3%).Of 16 adverse drug reactions (ADRs), the most frequent were rash, diarrhea, headache, insomnia, and somnolence (1.4% each). Of 2 serious ADRs, only 1 (gastroenteritis) was unexpected, and both resolved. The risk of experiencing an AE while receiving dolutegravir appeared to be especially increased in patients receiving concomitant medications for other conditions. Dolutegravir effectively suppressed HIV-1 (93.3% of patients had plasma HIV-1 RNA <50 copies/mL), and 100% of patients showed symptom improvement based on physician global assessment.
Conclusion
Results of this PMS study showed that dolutegravir administered as highly active antiretroviral therapy was well tolerated and effective in patients with HIV-1 infection.
2.Two Cases of Sebaceous Carcinoma on Scalp.
Sang Hoon ROH ; Hyung Bin SOHN ; Young Jin JUNG ; In Pyo HONG
Journal of the Korean Society of Plastic and Reconstructive Surgeons 2009;36(3):361-364
PURPOSE: Sebaceous carcinoma is a rare malignant tumor derived from the adnexal epithelium of sebaceous glands. This tumor usually occurs on the eyelids, but uncommonly it may occur on the extraocular sites. It is characterized by a tendency of local recurrence and occasional metastasis. Surgical excision is appropriate treatment for patients with sebaceous carcinoma. While this kind of case is rare, we report two cases of sebaceous carcinoma developed on scalp. METHODS: Case 1 was a 69-year-old woman. She visited the hospital with a 1.5 x 2.5 cm sized reddish yellow-colored, slowly growing mass on the left parietal scalp. The mass began at birth and started growing 5 years ago. Case 2 was a 67-year-old woman. She had 2.5 x 3.0 cm sized yellow-colored mass on the right parietal scalp. It occurred at birth and started growing 3 years ago. And the masses had erythematous ulcer with sanguineous discharge. In the beginning, the masses were miliary nodule. RESULTS: CT scan and fine needle biopsy were done. Case 1 and 2 were diagnosed as sebaceous carcinoma. Wide excision with safety margin of 10 mm and split thickness skin graft was done. Histological examination revealed well demarcated, irregular, variable sized tumor lobules. Each lobule was composed of sebaceous and undifferentiated cells. Postoperatively, the patients did well and the lesion did not recur. CONCLUSION: Sebaceous carcinoma is an aggressive malignant tumor. It is often confused with other skin tumors. Authors experienced two rare cases of sebaceous carcinoma developed on scalp. We recommend early wide excision with enough safety margin as treatment of sebaceous carcinoma.
Aged
;
Biopsy, Fine-Needle
;
Epithelium
;
Eyelids
;
Female
;
Humans
;
Neoplasm Metastasis
;
Parturition
;
Recurrence
;
Scalp
;
Sebaceous Glands
;
Skin
;
Transplants
;
Ulcer
3.Delta Neutrophil Index as a Prognostic Marker in the Pediatric Intensive Care Unit.
In Suk SOL ; Hyun Bin PARK ; Min Jung KIM ; Seo Hee YOON ; Yoon Hee KIM ; Kyung Won KIM ; Myung Hyun SOHN ; Kyu Earn KIM
Korean Journal of Critical Care Medicine 2016;31(4):351-358
BACKGROUND: The delta neutrophil index (DNI) is a useful marker for diagnosing and predicting the prognosis of sepsis. The purpose of this study was to investigate the usefulness of DNI as a prognostic marker in patients within the pediatric intensive care unit (PICU), as well as its association with other prognostic factors. METHODS: A total of 516 children admitted to Severance Children's Hospital PICU from December 2009 to February 2015 were analyzed. DNI was measured on the day of PICU admission. Mortality was defined as death within 28 days following PICU admission. RESULTS: The median value of DNI was 1.2% (interquartile range [IQR] 0-4.3%) in the survivor group and 9.5% (IQR 2.3-20.8%) in the non-survivor group, and the difference was statistically significant (p < 0.001). DNI was significantly positively correlated with ICU scores such as Pediatric Index of Mortality 3 and Pediatric Risk of Mortality III, as well as with C-reactive protein and lactate levels. The area under the receiver operating characteristic curve of DNI for mortality was 0.748 (95% CI: 0.687-0.808) and the cut-off value was 4.95%. CONCLUSIONS: The initial DNI level can be considered a useful indicator for predicting prognosis in PICU patients.
C-Reactive Protein
;
Child
;
Critical Care*
;
Humans
;
Intensive Care Units*
;
Lactic Acid
;
Mortality
;
Neutrophils*
;
Prognosis
;
ROC Curve
;
Sepsis
;
Survivors
4.A Case of Bilateral Warthin's Tumor.
Sang Hoon ROH ; Hyung Bin SOHN ; Young Jin JUNG ; In Pyo HONG
Journal of the Korean Cleft Palate-Craniofacial Association 2008;9(2):97-100
Warthin's tumor is a benign neoplasm that most frequently occurs in the parotid gland. Warthin's tumor shows a tendency of bilateral occurrence, but most of bilateral tumors occur at different time. It usually affects older man and grows slowly. Surgical excision is appropriate treatment for patients with Warthin's tumor and rarely recurs after removal. We report a rare case of bilateral Warthin's tumor which detected at the same time. A 54-year-old man had painless, slowly growing masses on the both mandibular angles. The masses were detected ten years ago. CT scan, ultrasonographic evaluation and fine needle biopsy was performed for preoperative diagnostic study. Superficial parotidectomy was done one after the other at ten-day intervals. After excision, histological examination revealed a mixture of ductal epithelium and a lymphoid stroma. The overlying surface of lymphoid tissue was covered with epithelial cells that was abundant of eosinophilic cytoplasm. Both masses were diagnosed as Warthin's tumor. Postoperatively, the patient did well and had no evidence of recurrence of tumor for 2 years follow-up period. Authors experienced a rare case of bilateral Warthin's tumor which detected at the same time. We recommend stepwise superficial parotidectomy at one or two-week intervals as treatment of bilateral Warthin's tumor.
Biopsy, Fine-Needle
;
Cytoplasm
;
Eosinophils
;
Epithelial Cells
;
Epithelium
;
Follow-Up Studies
;
Humans
;
Lymphoid Tissue
;
Middle Aged
;
Parotid Gland
;
Recurrence
5.Venous Varix of the Digit: Two Cases Report.
Jin Seok LEE ; Young Jin JUNG ; Hyung Bin SOHN ; In Pyo HONG
Journal of the Korean Microsurgical Society 2008;17(1):55-59
Varix of the digit is generally defined as an enlarged, tortuous palmar digital vein with or without thrombus within it. It usually presents as a firm, blue mass on the volar aspect of the finger. Mechanical compression or chronic trauma to veins on the volar surface of a digit appears central to the pathogenesis of this lesion. Aging phlebectasia has also been considered as a cause of this lesion in the elderly. A tourniquet test may be useful in demonstrating the presence of a digital varix, but it is confirmed by postoperative microscopic examination. Excision of a symptomatic lesion has proven to be curative. We report two cases of symptomatic digital varix which developed in the fourth finger with a review of literatures.
Aged
;
Aging
;
Fingers
;
Humans
;
Thrombosis
;
Tourniquets
;
Varicose Veins
;
Veins
6.Concentric and Eccentric Isokinetic Trunk Muscle Evaluation in Chronic Low Back Pain.
Jung Bin SHIN ; Sung Woo KIM ; Sung YOU ; Hong Seok SOHN ; Yoon Soo CHO
Journal of the Korean Academy of Rehabilitation Medicine 2001;25(6):1016-1022
OBJECTIVE: The purpose of this study is to evaluate concentric and eccentric trunk muscle strength in patients with chronic low back pain and compare it with healthy controls to determine the role of trunk muscle in chronic low back pain METHOD: Subjects were 20 chronic low back pain patients with the duration at least 6 months and 20 normal adults. Concentric and eccentric isokinetic trunk muscle test was performed at specific speeds (30degrees, 60degrees, 120degrees/sec) with Cybex 770 machine in back pain patients and healthy control. RESULTS: The strength of trunk flexor and extensor muscles of chronic low back pain patients was significantly weaker than that of normal controls. Eccentric peak torque was significantly higher than concentric peak torque in both patients and healthy control. A concentric and eccentric ratio of patients was lower than that of normal controls. The correlation between concentric and eccentric variables was high. Our results show that concentric peak torque has the highest correlation with eccentric peak torque. CONCLUSION: Isokinetic evaluations of the trunk muscle offer objective and quantitative data of patients with chronic low back pain and will be clinically useful in muscle power measurement of lumbar muscles.
Adult
;
Back Pain
;
Humans
;
Low Back Pain*
;
Muscle Strength
;
Muscles
;
Torque
7.Neoadjuvant chemotherapy in patients with advanced epithelial ovarian cancer.
Jung Bin SOHN ; Duck Yeong RO ; Yong Wook KIM ; Tae Eung KIM ; Jae Keun JUNG ; Chi Wha HAN ; Ye Hoon CHOI
Korean Journal of Obstetrics and Gynecology 2007;50(10):1371-1377
OBJECTIVE: This study was aimed at comparison of women with advanced ovarian cancer treated with neoadjuvant chemotherapy (NAC) followed by surgery with those treated conventionally with primary debulking surgery followed by cytotoxic chemotherapy (conventional group). METHODS: Between January 1998 and December 2005, 11 patients with advanced epithelial ovarian cancer were treated by NAC followed by debulking surgery and 20 patients were treated by primary cytoreductive surgery followed by cytotoxic chemotherapy conventionally. The files were reviewed retrospectively. RESULTS: The mean age was 54.8+/-11.6 in NAC and 53.0+/-11.9 years in conventional group. 10 cases were serous adenocarcinoma in NAC group and 16 cases were serous, 1 was mucinous and 2 cases were endometrioid type in conventional group (Table 1). Mean courses of NAC were 3 cycles (range 1-4) and carboplatin and paclitaxel regimen was most common (Table 2). After NAC, 2 complete responses (18.2%) were achieved, 4 patients (36.4%) achieved a partial response, and 5 (45.5%) had no response or progressive disease. At debulking surgery, no pathological complete response was noted, and residual ovarian cancer was present in all cases. The optimal surgery (residual tumor <2 cm) was obtained in 9 cases (81.8%) of NAC and 5 cases (25.0%) of conventional group (Table 3). The mean estimated blood loss was 604.54+/-178 ml (range 400-1,000 ml) in NAC group and 752.5+/-335 ml (range 400-2,000 ml) in conventional group , blood transfusion 2.2 pints (range 0-5 pints) in NAC and 4.6 pints (range 1-19 pints) in conventional group, the mean operative time was 244.54+/-108 minutes in NAC group and 251.5+/-94.5 minutes in conventional group, mean intensive care unit stay was 1.6 days (range 0-3 days) in NAC and 2.5 days (range 0-13 days) in conventional group, and mean hospital stay was 17.36+/-8.97 days (range 7-42 days) in NAC and 24.45+/-11.7 days (range 10-48 days) in conventional group respectively (Table 4). There were no significant statistical differences in two groups except hospital stay (p=0.04). There were no significant statistical differences of disease-free and overall survival in two groups (Fig 1&2). CONCLUSION: The rate of optimal debulking surgery, blood loss, operative time, disease-free and overall survival, excluding the length of hospital stay, showed no significant statistical differences in both groups. Even though we might have statistical shortage because we were able to get only limited cases to show meaningful results, there is enough validity of conducting prospective clinical research using NAC since the overall survival rate in both groups showed no significant difference.
Adenocarcinoma
;
Blood Transfusion
;
Carboplatin
;
Drug Therapy*
;
Female
;
Humans
;
Intensive Care Units
;
Length of Stay
;
Mucins
;
Operative Time
;
Ovarian Neoplasms*
;
Paclitaxel
;
Retrospective Studies
;
Survival Rate
8.Multicenter Surgical Site Infection Surveillance Study about Prosthetic Joint Replacement Surgery in 2006.
Hee Jung CHOI ; Ji Young PARK ; Sun Young JUNG ; Yoon Soo PARK ; Yong Kyun CHO ; Shin Young PARK ; Ji Hea KANG ; Jang Wook SOHN ; Sung Eun LEE ; Hong Bin KIM ; Ja Hyun KANG ; Tae Yeal CHOI
Korean Journal of Nosocomial Infection Control 2008;13(1):42-50
BACKGROUND: Surgical site infection (SSI) is generally considered second or third most important infection type in nosocomial infections. However, there are only a few national surveillances about surgical site infection and prophylactic antibiotics use. We performed the surveillance of surgical site infections and antibiotic use in joint replacement operation, which is difficult and costly to treat. METHODS: The surveillance study of the hip joint (HRA) and knee joint replacement surgery (KRA) was performed in four university hospitals from July 2006 to December 2006. The Clinical variables, operative risk factors for SSI, and information of prophylactic antibiotics uses were evaluated. SSI surveillance was done in 2 weeks, 1 month, 3 month, 6 month, and 1 year after surgery. RESULTS: A total of 436 cases (HRA, 227; KRA, 209) were enrolled for SSI surveillance. The SSI rates of HRA and KRA were 1.32 (3/227), and 1.44 (3/209) per 100 operations, respectively. The most of operation site was clean wound (97.9%). Staphylococcus aureus was observed in 19.8% before operation and among S. aureus infections about 20% was methicillin-resistant strain. The 1st generation cephalosporins were most frequently used for prophyaxis occupying 65.1%. The median duration of antibiotic use was 12 days (1-79 days). Any other specific risk factors were not correlated with SSI development. CONCLUSION: The multicenter surveillance study of SSI was first performed in Korea. The SSI rate was comparable with SSI reported in other country. We need to analyze the risk factors of SSI after collecting the data through further studies.
Anti-Bacterial Agents
;
Cephalosporins
;
Cross Infection
;
Hip Joint
;
Hospitals, University
;
Joints
;
Knee Joint
;
Korea
;
Methicillin Resistance
;
Risk Factors
;
Sprains and Strains
;
Staphylococcus aureus
9.Adult Immunization Schedule Recommended by the Korean Society of Infectious Diseases, 2007.
Jin Han KANG ; Hong Bin KIM ; Jang Wook SOHN ; Sang Oh LEE ; Moon Hyun CHUNG ; Hee Jin CHEONG ; Young Hwa CHOI ; Jung Hyun CHOI ; Jun Yong CHOI ; Hee Jung CHOE
Infection and Chemotherapy 2008;40(1):1-13
In 2007, the Korean Society of Infectious Diseases recommended an immunization schedule for adults residing in Korea. This recommendation includes four categories: standard immunization for healthy persons, supplementary immunization for persons with underlying illnesses, recommendations for health-care personnel and for international travelers. The Standard Immunization Schedule consists of universal vaccination (tetanus-diphtheria/tetanus-diphtheria-pertussis (Td/Tdap); hepatitis A vaccine for persons aged 20s; human papilloma virus vaccine for women under 26 years old; meningococcal vaccine for military recruits and college students in dormitories; influenza vaccination for persons aged 50 years or more and pregnant women; and pneumococcal vaccination for persons aged 65 years or more) and catch-up vaccination (hepatitis A vaccine for persons aged 30s; hepatitis B vaccine, varicella and MMR vaccines for persons who have uncertain specific immunities). The Supplementary Immunization Schedule recommends 4 vaccines, i.e., pneumococcal, influenza, meningococcal, and Haemophilus influenzae type b, appropriate to the underlying illnesses, and confirmation of the presence of antibodies to hepatitis A and hepatitis B. The Recommendation for Health-Care Personnel includes universal vaccination (influenza and pertussis) and catch-up vaccination (hepatitis B, measles-mumps-rubella and varicella for seronegative health-care personnel). The Recommended Immunization for International Travelers focuses reinforcement of vaccinations for healthy persons and includes certain immunizations necessary for international travel (yellow fever, meningococcal, plaque, tick-borne encephalitis, and cholera). These guidelines can be seen at www.ksid.or.kr.
Adult
;
Aged
;
Antibodies
;
Chickenpox
;
Collodion
;
Communicable Diseases
;
Encephalitis, Tick-Borne
;
Female
;
Fever
;
Haemophilus influenzae type b
;
Hepatitis A
;
Hepatitis A Vaccines
;
Hepatitis B
;
Hepatitis B Vaccines
;
Humans
;
Immunization
;
Immunization Schedule
;
Influenza, Human
;
Korea
;
Meningococcal Vaccines
;
Military Personnel
;
Papilloma
;
Reinforcement (Psychology)
;
Vaccination
;
Vaccines
;
Viruses
10.Adult Immunization Schedule Recommended by the Korean Society of Infectious Diseases, 2007.
Jin Han KANG ; Hong Bin KIM ; Jang Wook SOHN ; Sang Oh LEE ; Moon Hyun CHUNG ; Hee Jin CHEONG ; Young Hwa CHOI ; Jung Hyun CHOI ; Jun Yong CHOI ; Hee Jung CHOE
Infection and Chemotherapy 2008;40(1):1-13
In 2007, the Korean Society of Infectious Diseases recommended an immunization schedule for adults residing in Korea. This recommendation includes four categories: standard immunization for healthy persons, supplementary immunization for persons with underlying illnesses, recommendations for health-care personnel and for international travelers. The Standard Immunization Schedule consists of universal vaccination (tetanus-diphtheria/tetanus-diphtheria-pertussis (Td/Tdap); hepatitis A vaccine for persons aged 20s; human papilloma virus vaccine for women under 26 years old; meningococcal vaccine for military recruits and college students in dormitories; influenza vaccination for persons aged 50 years or more and pregnant women; and pneumococcal vaccination for persons aged 65 years or more) and catch-up vaccination (hepatitis A vaccine for persons aged 30s; hepatitis B vaccine, varicella and MMR vaccines for persons who have uncertain specific immunities). The Supplementary Immunization Schedule recommends 4 vaccines, i.e., pneumococcal, influenza, meningococcal, and Haemophilus influenzae type b, appropriate to the underlying illnesses, and confirmation of the presence of antibodies to hepatitis A and hepatitis B. The Recommendation for Health-Care Personnel includes universal vaccination (influenza and pertussis) and catch-up vaccination (hepatitis B, measles-mumps-rubella and varicella for seronegative health-care personnel). The Recommended Immunization for International Travelers focuses reinforcement of vaccinations for healthy persons and includes certain immunizations necessary for international travel (yellow fever, meningococcal, plaque, tick-borne encephalitis, and cholera). These guidelines can be seen at www.ksid.or.kr.
Adult
;
Aged
;
Antibodies
;
Chickenpox
;
Collodion
;
Communicable Diseases
;
Encephalitis, Tick-Borne
;
Female
;
Fever
;
Haemophilus influenzae type b
;
Hepatitis A
;
Hepatitis A Vaccines
;
Hepatitis B
;
Hepatitis B Vaccines
;
Humans
;
Immunization
;
Immunization Schedule
;
Influenza, Human
;
Korea
;
Meningococcal Vaccines
;
Military Personnel
;
Papilloma
;
Reinforcement (Psychology)
;
Vaccination
;
Vaccines
;
Viruses