• Title/Summary/Keyword: Adverse event

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A Case Series of Polycystic Ovary Syndrome with Improved Hyperandrogenism Treated with Korean Medicine (한방 치료로 고안드로겐혈증을 개선한 다낭성 난소 증후군 연속증례연구)

  • Shin, Haegue;Bae, Ji-Yong;Ji, Young-Geun;Ahn, Hae In;Yoon, Youngheum;Kim, Namkwen
    • The Journal of Korean Obstetrics and Gynecology
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    • v.34 no.3
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    • pp.175-191
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    • 2021
  • Objectives: This study aims to analyze the medical record of eight cases of polycystic ovary syndrome (PCOS) in a local Korean medicine clinic, in order to provide evidence on Korean medicine treatment of PCOS and to suggest the direction of future studies. Methods: The medical records of eight cases diagnosed with PCOS based on 2003 Rotterdam Criteria and whose total testosterone level was 0.53 ng/ml and over were retrospectively analyzed. The primary outcome was total testosterone level, and the secondary outcomes included luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels, LH/FSH ratio, weight, last mentrual period (LMP), numerical rating scale (NRS) score of dysmenorrhea, and other associated symptoms pre- and post-treatment. Korean medicine treatment consists of the complex herbal prescription consisting of Yukmijihwang-tang, Baekho-tang, Daesiho-tang, and Gyejibokryeong-hwan, modified according to symptoms; acupuncture and electroacupuncture on 中脘 (CV12), 下脘 (CV10), 關元 (CV4), 石門 (CV5), 合谷 (LI4), 太衝 (LR3), 三陰交 (SP6), and 懸鍾 (GB39); and indirect moxibustion on 神闕 (CV8). Results: The average total testosterone level lowered statistically significantly after the treatment. The average FSH and LH levels lowered with insignificance, while the average LH/FSH ratio and weight lowered statistically significantly. During the treatment period of three to six months, every patient had the menstrual cycle shortened except for one case; and two cases with infertility problem succeeded in being pregnant. There was no adverse event. Conclusions: The Korean medicine treatment was found effective in treating PCOS, especially regarding hyperandrogenism, amenorrhea or oligomenorrhea, and infertility.

Cost Avoidance and Clinical Pharmacist Interventions on Hospitalized Patients in Hematologic malignancies (혈액종양 입원 환자 대상 임상약사의 처방중재활동 및 회피비용 분석)

  • Kim, Ye Seul;Hong, So Yeon;Kim, Yoon Hee;Choi, Kyung Suk;Lee, Jeong Hwa;Lee, Ju-Yeun;Lee, Euni
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.3
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    • pp.215-225
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    • 2022
  • Background: Patients with hematologic cancers have a risk of drug-related problems (DRPs) from medications associated with chemotherapy and supportive care. Although the role of oncology pharmacists has been widely documented in the literature, few studies have reported its impact on cost reduction. This study aimed to describe the activities of oncology pharmacists with respect to hematologic diseases and evaluate the associated cost avoidance. Methods: From January to July 2021, patients admitted to the department of hemato-oncology at Seoul National University, Bundang Hospital were studied. The activities of oncology pharmacists were reported by DRP type following the Pharmaceutical Care Network version 9.1 guidelines, and the acceptance rate was calculated. The avoided cost was estimated based on the cost of the pharmacy intervention, pharmacist manpower, and prescriptions associated with the intervention. Results: Pharmacists intervened in 584 prescriptions from 208 patients during the study period. The most prevalent DRP was "adverse drug event (possibly) occurring" (32.4%), followed by "effect of drug treatment not optimal" (28.6%). "Drug selection" (42.5%) and "dose selection" (30.3%) were the most common causes of DRPs. The acceptance rate of the interventions was 97.1%. The total avoidance cost was KRW 149,468,321; the net profit of the avoidance cost, excluding labor costs, was KRW 121,051,690; and the estimated cost saving was KRW 37,223,748. Conclusion: Oncology pharmacists identified and resolved various types of DRPs from prescriptions for patients with hematologic disease, by reviewing the prescriptions. Their clinical service contributed to enhanced patient safety and the avoidance of associated costs.

A Narrative Review of the Korean Medicine Treatments for Achilles Tendinopathy (아킬레스 건병증의 한의학적 치료에 대한 국내외 연구 동향 분석)

  • Yoon, Kyung-Young;Hwang, Dong-Wook;Bae, In-Su;Youn, Jun-Heum;Lee, Yu-Jin;Jang, Won-Suk;Yoo, Sang-Joon;Lee, Do-Hoon;Kang, Dong-Hyeob;Son, Ja-Yean;Yang, Seok-Gyu;Cho, Hyun-Woo
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.4
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    • pp.33-45
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    • 2022
  • Objectives The purpose of this review was to investigate clinical treatment trends of Achilles tendinopathy. Methods Clinical studies about Korean medicine treatments on Achilles tendinopathy were searched in 5 databases. The included studies were classified according to the authors, published years, study designs, purposes of study, methods, interventions outcome measures and adverse event. Results In 23 studies, total number of patients were 1,135. The included studies consist of 14 randomized controlled trials (RCT), 5 non-RCT, 2 retrospective study and 2 case reports. Patients were conducted with 9 kinds of treatment, which is acupuncture, electro-acupuncture, pharmacopuncture, acupotomy, moxibustion, cupping, Chuna, herbal medicine, physiotherapy. Most studies used visual analogue scale as primary outcome. Conclusions Based on the results of the collected studies, the use of Korean medicine treatment on Achilles tendinopathy seem to be effective. Despite the large number of RCTs, the level of research cannot be guaranteed, so it is considered that more rigorous researches are needed in future studies.

Role of Adjunctive Tranexamic Acid in Facilitating Resolution of Chronic Subdural Hematoma after Surgery

  • Kiyoon Yang;Kyung Hwan Kim;Han-Joo Lee;Eun-Oh Jeong;Hyon-Jo Kwon;Seon-Hwan Kim
    • Journal of Korean Neurosurgical Society
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    • v.66 no.4
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    • pp.446-455
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    • 2023
  • Objective : Chronic subdural hematoma (CSDH) is a common neurosurgical disease and generally treated with burr-hole surgery alone. Tranexamic acid (TXA) is an antifibrinolytic agent that potentially reduces recurrence rates and the residual hematoma volume. However, the role of postoperative TXA medication remains unclear to date. This study aimed to verify the effectiveness of adjunctive TXA in the view of early hematoma resolution. Methods : Between January 2018 and September 2021, patients with CSDH who underwent burr-hole trephination in a single tertiary institute were reviewed. The study population was divided into three groups, TXA, non-TXA, and antithrombotics (AT) groups, according to the medical history of cardio-cerebrovascular disease and TXA administration. The primary endpoint was CSDH recurrence, defined as re-appearance or re-accumulation of CSDH requiring neurosurgical interventions. The secondary outcome was CSDH resolution, defined as complete or near-complete resorption of the CSDH. The CSDH resolution time and serial changes of hematoma thickness were also investigated. Results : A total of 240 patients was included in the analysis consisting of 185 male and 55 female, with a median age of 74 years. During the median imaging follow-up period of 75 days, 222 patients were reached to the primary or secondary endpoint. TXA was administered as an adjunctive therapy in 41 patients (TXA group, 16.9%) while 114 patients were included in the non-TXA group (47.9%) and 85 were in the AT group. The recurrence rate was the lowest in the TXA group (2.4%), followed by non-TXA (7.0%) and AT (8.2%) groups. However, there was no statistical significance due to the small number of patients with recurrence. CSDH resolution was achieved in 206 patients, and the median estimated time to resolution was significantly faster in the TXA group (p<0.001). Adjunctive TXA administration was a significant positive factor for achieving CSDH resolution (p<0.001). The hematoma thickness was comparable among the three groups at the initial time and after surgery. However, CSDH thickness in the TXA group decreased abruptly in a month and showed a significant difference from that in the other groups (p<0.001). There was no TXA-related adverse event. Conclusion : The adjunctive use of TXA after CSDH surgery significantly facilitated the resorption of residual CSDH and resulted in the early CSDH resolution. Adjunctive TXA may be an effective treatment option to reduce recurrence by enhancing CSDH resolution in the selective patients.

FOLFIRI Regimen as a Second-line Chemotherapy after Failure of First-line Chemotherapy in Advanced Gastric Cancer (진행성 위암에서 1차 항암화학요법에 실패한 환자에서 2차 항암화학요법으로 FOLFIRI요법의 효용성에 대한 연구)

  • Yong Kang Lee;Jae Hyun Kim;Jun Chul Park;Hee Seok Moon;Sung Eun Kim;Jin Seok Jang;Joo Young Cho;Eun Sun Kim;Si Hyung Lee;Sang Kil Lee
    • Journal of Digestive Cancer Research
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    • v.5 no.2
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    • pp.113-119
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    • 2017
  • Background: Second line chemotherapy is often considered in advanced gastric cancers. We assessed irinotecan in combination with fluorouracil in patients experienced diseases progression after first line chemotherapy. Methods: Prospective trial was done at 7 centers in republic of Korea. Patients aged 18 years or older with advanced gastric adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy were assigned to receive irinotecan 180 mg/m2 and 5-fluorouraicl 400 mg/m2 intravenously bolus injection on days 1 and leucovorin 200 mg/m2 for 2 hours and 5-fluorouracil 600 mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle (FOLFIRI group). The primary endpoint was objective tumor response (OR). Efficacy analysis was by per-protocol, and safety analysis included all patients who received at least one treatment with study drug. Results: Between January 1, 2014 and December 31, 2016, 28 patients were assigned to FOLFIRI treatment. Of those 20 patients were completed the study protocol. Per-protocol analysis, two patients among 20 subjects (10.0%) showed partial response. Overall survivals of FOLFIRI group; median 10.1 months [95% CI 4.9-15.3] Grade 3 and higher adverse event that occurred about 5%, but grade 3 or higher febrile neutropenia or life threatening complication was not reported. Conclusion: Combination chemotherapy with irinotecan, 5-FU, and LV is feasible in gastric cancer patients previously treated with platinum-based chemotherapy

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Efficacy and Safety of Trastuzumab Deruxtecan and Nivolumab as Third- or Later-Line Treatment for HER2-Positive Advanced Gastric Cancer: A Single-Institution Retrospective Study

  • Keitaro Shimozaki;Izuma Nakayama ;Daisuke Takahari;Kengo Nagashima;Koichiro Yoshino ;Koshiro Fukuda;Shota Fukuoka ;Hiroki Osumi ;Mariko Ogura ;Takeru Wakatsuki;Akira Ooki ;Eiji Shinozaki;Keisho Chin ;Kensei Yamaguchi
    • Journal of Gastric Cancer
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    • v.23 no.4
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    • pp.609-621
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    • 2023
  • Purpose: Determination of optimal treatment strategies for HER2-positive advanced gastric cancer (AGC) in randomized trials is necessary despite difficulties in direct comparison between trastuzumab deruxtecan (T-DXd) and nivolumab as third or later-line treatments. Materials and Methods: This single-institution, retrospective study aimed to describe the real-world efficacy and safety of T-DXd and nivolumab as ≥ third line treatments for HER2-positive AGC between March 2016 and May 2022. Overall, 58 patients (median age, 64 years; 69% male) were eligible for the study (T-DXd group, n=20; nivolumab group, n=38). Results: Most patients exhibited a HER2 3+ status (72%) and presented metastatic disease at diagnosis (66%). The response rates of 41 patients with measurable lesions in the T-DXd and nivolumab groups were 50% and 15%, respectively. The T-DXd and nivolumab groups had a median progression-free survival of 4.8 months (95% confidence interval [CI], 3.3, 7.0) and 2.3 months (95% CI, 1.5, 3.5), median overall survival (OS) of 10.8 months (95% CI, 6.9, 23.8) and 11.7 months (95% CI, 7.6, 17.1), and grade 3 or greater adverse event rates of 50% and 2%, respectively. Overall, 64% patients received subsequent treatment. Among 23 patients who received both regimens, the T-DXd-nivolumab and nivolumab-T-DXd groups had a median OS of 14.0 months (95% CI, 5.0, not reached) and 19.3 months (95% CI, 9.5, 25.1), respectively. Conclusions: T-DXd and nivolumab showed distinct efficacy and toxicity profiles as ≥ third line treatments for HER2-positive AGC. Considering the distinct features of each regimen, they may help clinicians personalize optimal treatment approaches for these patients.

Self-expandable metallic stent-induced esophagorespiratory fistulas in patients with advanced esophageal cancer

  • Iatagan R. Josino;Bruno C. Martins;Andressa A. Machado;Gustavo R. de A. Lima;Martin A. C. Cordero;Amanda A. M. Pombo;Rubens A. A. Sallum;Ulysses Ribeiro Jr;Todd H. Baron;Fauze Maluf-Filho
    • Clinical Endoscopy
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    • v.56 no.6
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    • pp.761-768
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    • 2023
  • Background/Aims: Self-expandable metallic stents (SEMSs) are widely adopted for the palliation of dysphagia in patients with malignant esophageal strictures. An important adverse event is the development of SEMS-induced esophagorespiratory fistulas (SEMS-ERFs). This study aimed to assess the risk factors related to the development of SEMS-ERF after SEMS placement in patients with esophageal cancer. Methods: This retrospective study was performed at the Instituto do Cancer do Estado de São Paulo. All patients with malignant esophageal strictures who underwent esophageal SEMS placement between 2009 and 2019 were included in the study. Results: Of the 335 patients, 37 (11.0%) developed SEMS-ERF, with a median time of 129 days after SEMS placement. Stent flare of 28 mm (hazard ratio [HR], 2.05; 95% confidence interval [CI], 1.15-5.51; p=0.02) and post-stent chemotherapy (HR, 2.0; 95% CI, 1.01-4.00; p=0.05) were associated with an increased risk of developing SEMS-ERF, while lower-third tumors were a protective factor (HR, 0.5; 95% CI, 0.26-0.85; p=0.01). No difference was observed in overall survival. Conclusions: The incidence of SEMS-ERFs was 11%, with a median time of 129 days after SEMS placement. Post-stent chemotherapy and a 28 mm stent flare were associated with a higher risk of SEMS-ERF.

A STUDY ON THE EFFECTS OF SEDATION AND RELATED VARIABLES FOR PEDIATRIC DENTAL PATIENTS (소아환자의 진정요법 효과와 그와 연관된 변수에 대한 연구)

  • Kim, Kyoung-Hee;Kim, Seung-Oh;Kim, Jong-Soo
    • Journal of the korean academy of Pediatric Dentistry
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    • v.34 no.2
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    • pp.234-246
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    • 2007
  • The combination of chloral hydrate and hydroxyzine is one of the safest and most commonly used drug regimens for sedating young, uncooperative pediatric dental patients. Midazolam IM or IN and $N_2O/O_2$ inhalation is sometimes administered with chloral hydrate and hydroxyzinecombination when deeper and longer sedation is needed. The purpose of this study was to assess the outcome and safety of chloral hydrate, hydroxyzine and $N_2O/O_2$ in the sedation of a large number of uncooperative pediatric dental patients and to identify variables associated with their effectiveness. In a nine-month retrospective study, 171 records of sedation performed in 94 healthy children(male 46, female 48) with mean age of $30{\pm}8$ months were reviewed. The authors analyzed several variables such as age, sex, weight, methods of drug delivery, waiting time after drug delivery, treatment rendered, treatment time, adverse events, sedation outcome. Eighty five percent of sedation had success behavioral outcome. Sedation sessions rated success used more $N_2O/O_2$ administration and had longer treatment duration than sedation sessions rated failure. A children patient under 36 months of age had enough sleep by only oral administration and the mean waiting time of this case was significantly shorter than that of a children patient over 36 months of age. There was a clear correlation between age and $N_2O/O_2$ using tine, but no correlation between weight and $N_2O/O_2$ using time. There was no statistically significant difference among variables of treatment duration, $N_2O/O_2$ administration and adverse event.

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Detection of Pathogenic Viruses in the Atmosphere during Asian Dust Events in Incheon City (인천지역에서 황사 기간 동안 대기 중의 바이러스 검출에 관한 연구)

  • Park, Jeong Woong;Lim, Young Hee;Kyung, Sun Young;An, Chang Hyeok;Lee, Sang Pyo;Jeong, Seong Hwan
    • Tuberculosis and Respiratory Diseases
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    • v.59 no.3
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    • pp.279-285
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    • 2005
  • Background : Ambient particles during Asian dust events are usually less than $10{\mu}m$ in size, and known to be associated with the adverse effects on the general population. There is little evidence linking Asian dust to adverse effects on the airways. In 2002, the authors found that particulate matter during Asian dust events had an effect on the symptoms and pulmonary function of patients with bronchial asthma. An aggravating factor might be that of a viral infection, but this remains unclear. Conversely, it has been speculated that African dust may carry the virus responsible for foot and mouth disease. Asian dust events are also likely to be responsible for transporting viruses, some of which are pathogenic, and common in many environments. Therefore, in this study, air samples were screened for the presence of viruses. Methods : Air samples were collected 20 times each during Asian dust events and under non-dust conditions, for at least 6 hours per sample, using a high volume air sampler (Sibata Model HV500F), with an airflow rate of 500L/min, between April and August 2003, and between April and August 2004. The samples were then screened for the presence of targeted viruses (Influenza A, B, Hog cholera virus, and Aphthovirus) using a polymerase chain reaction method. Results : One Asian dust event occurred between April and August 2003, and 3 between April and August 2004, with a 24 hour average PM10 level of $148.0{\mu}g/m^3$. The 24 hour average PM10 level was $57{\mu}g/m^3$. There was a significant difference in the PM10 concentration between dusty and clear days. No viruses (Influenza virus, Aphthovirus, and Hog cholera virus) were identified in the air samples obtained during the dusty days. Conclusions : Although no virus was detected in this study, further studies will be needed to identify suspected viruses carried during Asian dust events, employing more appropriate virus detection conditions.

Immunogenicity and Reactogenicity of Inactivated HM175 Strain Hepatitis A Vaccine in Healthy Korean Children (건강한 한국 소아에서 HM175주 A형 간염 불활화 백신의 면역원성 및 이상반응에 관한 연구)

  • Kim, Chang Hwi;Pyun, Bok Yang;Hong, Young Jin;Kang, Jin Han
    • Pediatric Infection and Vaccine
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    • v.7 no.1
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    • pp.120-128
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    • 2000
  • Purpose : Active immunization against hepatitis A with an inactivated vaccine reveals excellent immunogenicity, tolerability and protective efficacy. Inactivated hepatitis A vaccines have been selectively used since 1996 in Korea to prevent hepatitis A. This study was performed to assess the immunogenicity and reactogenicity after two doses of HM175 strain hepatitis A vaccine in healthy Korean children. Methods : 128 healthy children(M/F; 65/63) aged 1 to 15 years, who were seronegative for hepaitatis A, participated in this study. A alum-adsorbed vaccine containing 720 EL.U of antigen form HM175 hepatitis A strain per 0.5 mL dose was injected intramuscularly on the deltoid area. The second dose was given 6 months later, Anti-HAV antibodies were measured by ELISA before and 1 month after each vaccination to assess the immunogenicity. Any local and general adverse events were reported by patients parents with the prepared questionnaire after each vaccination. Results : 120 volunteers(M/F; 60/60) completed the whole series of the study. Seroconversion occurred in all cases after primary and booster vaccination. The mean anti-HAV antibody titer after primary vaccination was 389.2mIU/mL, and 3,609mIU/mL after booster vaccination. And levels of anti-HAV antibodies after booster immunization were significantly higher in female children. The most common local adverse event was soreness on the injection site, but it was mild and resolves within 3 days. Fever was not reported after booster vaccination. Conclusion : Based on these data, we conclude that the inactivated HM175 strain hepatitis A vaccine is highly immunogenic and tolerable in healthy Korean children.

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