• Journal of Korean Neurosurgical Society
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• 제59권4호
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• pp.352-356
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• 2016

Objective : The efficacy and safety of manual aspiration thrombectomy using Penumbra in an acute occlusion of large intracranial arteries has been proven in many previous studies. Our study aimed to retrospectively assess the efficacy and safety of manual aspiration thrombectomy using Penumbra in patients with small vessel occlusions (M2 segment of the MCA). Methods : We conducted a retrospective review of 32 patients who underwent manual aspiration thrombectomy using the Penumbra 4 MAX Reperfusion Catheter for treatment of an M2 occlusion between January 2013 and November 2014. We evaluated immediate angiographic results and clinical outcomes through review of patient electronic medical records. Results : There were slightly more men in this study (M : F=18 : 14) and the median age was 72.5 (age range : 41-90). The rate of successful recanalization (TICI grade ${\geq}2b$) was 84% (27/32). NIHSS at discharge and favorable clinical outcomes at 3 months were significantly improved than baseline. Median initial NIHSS score was 10 (range : 4-25) and was 4 (range : 0-14) at discharge. Favorable clinical outcomes (mRS score ${\leq}2$ at 3 months) were seen in 25 out of 32 patients (78%). There were no procedure-related symptomatic intracerebral hemorrhages. One patient expired after discharge due to a cardiac problem. Conclusion : Manual aspiration thrombectomy might be safe and is capable of achieving a high rate of successful recanalization and favorable clinical outcomes in patients with distal cerebral vessel occlusion (M2).

• 한국의료질향상학회지
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• 제28권1호
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• pp.45-54
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• 2022

Purpose: The study aims to identify the theme list and priority criteria of patient safety theme reports in South Korea. Methods: The survey was conducted twice, and the importance of each criterion and theme was measured on a nine-point scale using the Delphi technique by a panel of 19 patient safety experts. The criteria included severity, universality, preventability, and organizational-social impact. Descriptive statistics such as frequency, percentage, mean, standard deviation, median, and interval quartile range were used to analyze the data. Results: The parameters were assigned a weighted average of 35% for severity, 20% for universality, 30% for preventability, and 15% for organizational-social impact, respectively. The final top three rankings were surgery safety, blood transfusion safety, and medication safety. In addition to expert opinion, for the theme that is selected based on the priority ranking, one to five sub-topics can be derived from the theme based on the priority ranking, societal demands, or the yearly priority list of patient safety incidents. Conclusion: It is recommended that the official patient safety center distribute the report in the form of a summary that can be utilized nationwide at medical institutions, government institutions, and other places. Updates, as well as accumulated theme reports, will serve as the baseline data for the proposal of the system and for the policy designed to implement and improve institutions' safety practices as a standard of domestic patient safety practice guidelines.

• Journal of Acupuncture Research
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• 제21권1호
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• pp.136-148
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• 2004

Objective: Recently scolopendrid aquacupuncture has been a good effect on pain control but it has not been known about clinical safety. So, In order to prove the clinical safety of scolopendrid aquacupuncture, We have observed the physical reac-tion and clinical pathology test after scolopendrid aquacupuncture treatment. Methods: We analyzed physical reaction and clinical pathology test before and after Scolopendrid aquacupuncture treatment of 30 patients suffering from pain, who admitted department of Acupunture and Moxibustion, College of Oriental Medicine, Won-Kwang University Kwangju hospital. Results & Conclusions: The results were summarized as follows. 1) The distribution of sex was 14 males and 16 females, and the average of patients age was 46.2 years. 2) The distribution of symptom was lumbago, lumbago with radiating pain, nuchal pain and knee joint pain. 3) In the 30 patients treated with Scolopendrid aquacupuncture, hematologic test did not show remarkable change. 4) In the 30 patients treated with Scolopendrid aquacupuncture, Liver function test(AST, ALT, ALP) showed a slight decrease on the contrary, and abnormal rate showed a decrease of 1.0%(from 3.3% to 2.3%) compared with previous study. 5) In the 30 patients treated with Scolopendrid aquacupuncture, Renal function test(BUN, Cr) and abnormal rate(from 2.5% to 2.0%) showed a slight decrease on the contrary. 6) In the 30 patients treated with Scolopendrid aquacupuncture. Electrolyte were normal range before & after treatment. 7) In the results of the Urine analysis of 30 patients, Leukocyte, Protein. Glucose, Keton, Bilirubin, U-bilinogen were not detected before and after Scolopendrid aquacupuncture treatment, and the rest almost made no difference. 8) In the Physical reactions, all of the patients complained of pain of body partially, only one patient showed reddish and itch, but symptoms like those were entirely disappeared within 24 hours and whole body pain, swelling, headache, dizziness, fatigue and nausea was not observed.

• 생명과학회지
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• 제22권12호
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• pp.1729-1739
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• 2012

발효 한약의 안전성과 유효성을 평가하기 위하여 CNKI, PubMed, 국내 한의학 저널에서 2000년부터 2011년까지 이루어진 관련 연구를 검색하였다. 발효 한약에 대한 유효성을 검증하기 위한 11개의 무작위 대조군 임상 연구로 국내에서는 면역 기능과 심혈관 기능에 대한 연구가 있었고, 중국에서는 만성 천표성 위염을 비롯한 각종 질환에 대한 임상 연구가 이루어졌다. 그 외의 국가에서는 식도암이나 국소 면역 반응에 대하여 검증하였다. 결과, 발효 한약은 특정 질환에 있어 명백한 효과를 보이고 있으며 부작용 또한 발견되지 않았다. 따라서 발효 한약에 대한 지속적인 관심과 연구가 필요할 것으로 사료된다.

• 한국임상약학회지
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• 제30권1호
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• pp.11-18
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• 2020

Background: Nivolumab and pembrolizumab are antagonists of the programmed death-ligand 1 (PD-L1) receptor that function as immuno-oncological agents. This study aimed to evaluate the safety and efficacy of nivolumab and pembrolizumab in elderly patients in outpatient settings. Methods: The safety and efficacy of nivolumab and pembrolizumab were compared retrospectively among patients at the Veterans Health Service (VHS) Medical Center in Seoul, South Korea, from September 1, 2017 to August 25, 2018. Results: Eighty-seven patients were selected for the study. The median progression-free survival was 63 days for nivolumab (95% confidence interval (CI), [14 to 282]) vs. 243 days for pembrolizumab (95% CI, [22 to 348]) (p =0.04). The objective response rate (ORR) was 0% in the nivolumab group vs 5.6% in the pembrolizumab group (p =0.310). All the patients exhibited treatment-related adverse effects. More than 89% of the patients exhibited diseases of the gastrointestinal (GI) tract. Pneumonia, of grades three or higher, was the most common adverse effect, followed by weakness and anorexia. Conclusions: There was no statistically significant difference between the nivolumab group and the pembrolizumab group with respect to the ORR. The incidence and severity of the adverse effects in this study were higher than those of previous studies; however, these adverse effects are generally manageable in a real-world clinical setting. Further randomized controlled studies will be necessary to confirm these results in elderly patients.

• Korean Journal of Acupuncture
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• 제30권1호
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• pp.21-26
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• 2013

Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.

• 대한한의학방제학회지
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• 제27권3호
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• pp.213-221
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• 2019

Objectives : The purpose of this study is to confirm the efficacy and safety of the treatment of gastritis with 'Hwangryunhaedok-tang'. Methods : Total 20 people, between 19 and 65 years old, will be recruited to participate in a comparative clinical trial. All subjects will take 2 capsules of Hwangryunhaedok-tang (Redoxin Cap.), 3 times a day, 30 minutes after meals, for 8 weeks. Outcomes will be measured at the baseline, 4th week, and 8th week. Primary outcomes is the improvement rates of gastritis symptoms, such as heartburn, nausea/vomiting, abdominal bloating, anorexia, heartburn, and trim. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2018011), and registered in Clinical Research information Service, one of WHO. Recruitment opened in April 2019 and is supposed to be completed by December 2019. Conclusions : This trial will provide clinical information to determine the efficacy and safety of treatment of gastritis with 'Hwangryunhaedok-tang'.

• 동의신경정신과학회지
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• 제33권4호
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• pp.389-400
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• 2022

Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

• 한국임상약학회지
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• 제33권4호
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• pp.290-304
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• 2023

Background: Innovative Alzheimer's disease drugs received approval in the United States in 2021 and 2023. This study aims to assess the safety and efficacy of these novel treatments, elucidate their mechanisms of action, and compare their impact on cognitive function improvement with approved drugs. Methods: We conducted a comprehensive search of pivotal clinical studies related to Alzheimer's disease treatments in PubMed/Medline, Embase, and the Cochrane Library databases from January 1st, 2020 to December 31st, 2022. Meta-analysis was performed using RevMan 5.4 software. Results: A total of 14 studies were included in this systematic review. When compared to the placebo, the new drugs did not exhibit a statistically significant effect on MMSE (Mini-Mental State Examination) (mean difference= -0.04, 95% confidence intervals [CIs]: -0.31, 0.23, N=3662, I²=0%). However, they demonstrated a significant impact on ADAS-cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale) (standardized mean difference= -0.15, 95% CIs: -0.2, -0.1, N=6710, I²=17%). When compared to the approved drugs, the new drugs showed a statistically significantly lower effect on MMSE (test for subgroup difference Chi²=23.13, N = 5870, p<0.00001) but showed only a trend of decreased efficacy on ADAS-cog (Chi²=1.16, N = 8670, p=0.28). Conclusion: New drugs yielded diverse clinical endpoint results compared to the placebo, and in comparison to existing approved drugs, they exhibited lower efficacy in improving cognitive function. The safety profile of these new drugs, as reported in clinical trials, was generally well-tolerated.

• Toxicological Research
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• 제34권1호
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• pp.49-53
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• 2018

Cyclohexanone ($C_6H_{10}O$, CAS No. 108-94-1) is a colorless oily liquid obtained through the oxidation of cyclohexane or dehydrogenation of phenol. It is used in the manufacture of adhesives, sealant chemicals, agricultural chemicals, paint and coating additives, solvent, electrical and electronic products, paints and coatings, photographic supplies, film, photochemicals, and as an intermediate in nylon production. Owing to the lack of information on repeated inhalation toxicity of cyclohexaone, in this study, we aimed to characterize the subacute inhalation toxicity. B6C3F1 mice were exposed to 0, 50, 150, and 250 ppm of cyclohexanone for 6 hr/day, 5 days/week for 4 weeks via whole-body inhalation in accordance with the OECD Test Guideline 412 (subacute inhalation toxicity: 28-day study). Mortality, clinical signs, body weights, food consumption, hematology, serum biochemistry, organ weights, as well as gross and histopathological findings were evaluated between the control and exposure groups. No mortality or remarkable clinical signs were observed during the study. No adverse effects on body weight, food consumption, hematology, serum biochemistry, and organ weights, gross or histopathological lesions were observed in any male or female mice in any of the exposure groups, although some statistically significant changes were observed in organ weights. We concluded that no observable adverse effect level (NOAEL) is above 250 ppm in mice exposed to cyclohexanone for 6 hr/day for 5 days/week.