• 제목/요약/키워드: Clinical safety

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Clinical safety and efficacy of a novel marine source of the long-chain omega-3 fatty acids

  • Park, Joung-Hyun;Musa-Veloso, Kathy;Ji, Ho-Seok
    • 한국해양바이오학회지
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    • 제14권1호
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    • pp.43-50
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    • 2022
  • Squid is a sustainable source of long-chain omega 3 fatty acids. This study aims to assess the safety and triglyceride-lowering efficacy of refined oil derived from the squid(Todarodes pacificus) viscera. Male and female participants with elevated fasting serum lipids (i.e., total cholesterol of ≥5.2 mmol/L or fasting serum triglyceride of ≥1.65 mmol/L) were randomly allocated to the control (n = 52) or squid oil group (n = 52), and participants in the latter group were instructed to consume 3 g of squid oil daily for 60 days. None of the subjects reported adverse events associated with the consumption of squid oil. Baseline clinical chemistry and hematological parameter values and those toward the end of the treatment period were similar, and all values were within the normal range. Fasting cholesterol and triglyceride levels in the control and squid oil groups were similar; however, toward the end of the 60 day study period, these levels significantly reduced in the squid oil group relative to those in the control group (P< 0.01). However, high-density lipoprotein-cholesterol remained unchanged in both groups. Thus, it can be inferred that squid oil is a safe source of long-chain omega-3 fatty acids and has beneficial effects on the blood lipid levels. This is the first clinical study on squid oil usage, and suggests that it could be a sustainable source of omega 3 fatty acids.

소아 야뇨증의 매선치료에 대한 문헌 고찰 - 중의학 논문을 중심으로 - (Review of Clinical Researches of Thread-Embedding Therapy for Pediatric Enuresis)

  • 김연정;장규태;이선행
    • 대한한방소아과학회지
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    • 제38권3호
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    • pp.1-12
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    • 2024
  • Objectives This study aimed to evaluate the efficacy and usefulness of thread-embedding therapy for pediatric enuresis by analyzing clinical evidence. Methods Six clinical studies on thread-embedding therapy for pediatric enuresis were selected from the China National Knowledge Infrastructure (CNKI) database, with a focus on traditional Chinese medicine. The study designs, patient characteristics, treatment methods, and safety assessments were analyzed. Results Among the six studies, four were case reports and two were randomized controlled trials. Thread-embedding therapy was performed two to four times, with intervals ranging from one week to one month. CV3 (中極), SP6 (三陰交), ST36 (足三里) were used frequently, and the total effective rate for thread-embedding therapy ranged from 88.89% to 100%. Conclusions Thread-embedding therapy is effective for pediatric enuresis; however, more research is needed to evaluate its safety.

봉독의 피부자극시험 및 안점막자극시험 (Dermal and Ocular Irritation Studies of Honeybee (Apis mellifera L.) venom)

  • 한상미;이광길;여주홍
    • 생약학회지
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    • 제42권1호
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    • pp.76-81
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    • 2011
  • The study of irritation and toxicity of honeybee(Apis mellifera. L) venom collected by a bee venom collector applied topically to the skin and mucous membrane were carried out to prove the safety of honeybee venom in clinical use. Animal for the research was the rabbit and the solution for the test was made from honeybee venom. Six animals were used for the skin test and nine animals were used for the eye mucous membrane test. In results, both tests proved that honeybee venom makes no irritable reaction on skin and eye mucous membrane of rabbit. We consider that this result is helpful for saying about the safety of honeybee venom in clinical use.

침도 침술시 부작용과 예방법에 관한 연구 (Clinical Characteristics of Poor Responders to Acupotomy and Safety Pretreatment Management)

  • 김성철
    • Journal of Acupuncture Research
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    • 제25권4호
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    • pp.117-125
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    • 2008
  • Objectives : Analyze according to types of event causing the adverse outcome due to acupotomy, and discuss problems and safety reqirements to using this therapy in Korea. Methods : Based upon the indication, contraindication, treatment procedures, clinical obsevations, acupotomy-related adverse outcome case reports, the factors of damaging event were classified. Results : The main factors of adverse outcome by acupotomy were anatomical ignorance, contamination of device or hospital staff, failure to notice preexisting disease(cardiovascular disease, hypertension, renal failure, hemophilia, chronic Liver Disease, etc.), unskilled treatment procedures(massive bleeding) and techniques(nerve injury, hepatic and splenic injury, Pneumothorax). Conclusions : It is mandatory to prepare adequate sterilie aseptic technique. The clinician should ensure understand genernal health state of patient and anatomical direction.

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복강내침술과 관련 혈위의 자침 깊이에 대한 고찰 (Review on Intraperitoneal Acupuncture and Needling Depth)

  • 김소연
    • Korean Journal of Acupuncture
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    • 제40권3호
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    • pp.55-61
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    • 2023
  • Objectives : To review the needling depth, therapeutic and adverse effects of intraperitoneal acupuncture and related acupoints. Methods : Studies and reports from the literature, Korean medical health insurance data and databases were searched and selected. Results : The depth of needle insertion for acupoints related to intraperitoneal acupuncture has been documented to range from 0.9 to 10.5 cm depending on the acupoints and literature. In studies of safe needling depth, the justice of safe needling depth varied from study to study, but was generally based on the peritoneum, and the depth varies by patient age, sex, body type, and weight. Clinical studies in China have shown good efficacy and no side effects of abdominal long needle acupuncture, but there have been case reports of adverse events following abdominal acupuncture. Conclusions : To ensure both therapeutic effectiveness and safety of intraperitoneal acupuncture, It is necessary to utilize the ultrasound in clinical practice and conduct related research.

그레이브스병 환자에 대한 안전백호탕의 임상적 유효성 안전성 연구 (The Clinical Study of Ahnjeonbaekho-tang on Patients with Graves' Disease)

  • 이병철;한양희;신선미;안세영;조충식
    • 대한한방내과학회지
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    • 제39권1호
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    • pp.9-21
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    • 2018
  • Objective: Graves' disease, the most common cause of primary hyperthyroidism, is a thyroid specific autoimmune disorder. When resistance to medication is shown in spite of long term therapy with anti-thyroid drugs, radioactive iodine therapy would be chosen in Western medicine. However, this therapy has often been reported to cause patients have hypothyroidism, thus requiring them to take levothyroxine for the rest of their lives. In this study, we evaluate the clinical efficacy and safety of Ahnjeonbaekho-tang (AJBHT) on patients with Graves' disease. Methods: We prescribed AJBHT for 3 months to two groups: patients who had been taking antithyroid drugs were administered AJBHT after discontinuing the antithyroid drugs ($Com-Tx{\rightarrow}Single-Tx$), and patients who had not been taking antithyroid drugs were started with AJBHT (Single-Tx) immediately. We evaluated the thyroidal function test (TFT) and visual analogue scale (VAS) for clinical symptoms for 3 months. Results: Serum T3 and fT4 were significantly decreased in both groups and remission rate of thyroidal hormones were significantly improved in the Single-Tx group. The clinical symptoms of palpitation, fatigue, and heat intolerance were significantly improved in both groups. In the safety analysis, all patients were in normal range of liver, renal function blood test and common blood count. Conclusion: From these results, we suggested that AJBHT was effective on TFT and clinical symptoms of Graves' disease. The study supports that AJBHT may be a useful agent for patients with Graves' disease who are resistant to antithyroid medication or radioactive iodine therapy, and for patients at first diagnosis.

기계환기관련 폐렴치료 시 Aerosolized Colistin의 효과 및 안전성에 대한 체계적 문헌 고찰 및 메타분석 (Efficacy and Safety of Aerosolized Colistin in the Treatment of Ventilator-Associated Pneumonia: A Systematic Review and Meta-analysis)

  • 백민우;정경혜;김은영
    • 한국임상약학회지
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    • 제27권4호
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    • pp.207-213
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    • 2017
  • Background: It is recommended to use aerosolized (AS) colistin in patients undergoing mechanical ventilation therapy as an adjunctive in the latest guidelines, in spite of high nephrotoxicity and limited studies. In this study, systematic reviews and meta-analyzes were conducted to evaluate the safety and efficacy of AS colistin in patients with ventilator-associated pneumonia Methods: Two authors independently searched related literature published from Pubmed and EMBASE until July 2016 and included a study comparing adjunctive AS colistin with intravenous (IV) colistin monotherapy. The primary outcome was the clinical response rate, the secondary outcome was the overall mortality, and nephrotoxicity. The publication bias was evaluated using the Egger's test. Results: Of the total 279 articles, nine were finally included in the final analysis. There was a significant difference between the adjunctive AS colistin group and the IV colistin monotherapy group for the treatment-response rate (odds ratio (OR), 1.56; 95% CI, 1.14-2.14; p = 0.005; $I^2=36%$), although there was no significant difference in overall mortality (OR, 0.77; 95% CI, 0.57-1.04; p = 0.09; $I^2=20%$). However, there was no significant difference between the two groups in nephrotoxicity (OR, 1.13; 95% CI, 0.74-1.74; p = 0.57; $I^2=4%$). Conclusion: The addition of aerosolized colistin to IV colistin monotherapy showed better results in terms of efficacy than IV colistin monotherapy and did not show any significant difference in terms of total mortality and nephrotoxicity. Additional large-scale studies of this need to be verified.

금사, 금침, 금주를 중심으로 한 금(金)의 인체 내 매장요법에 대한 연구동향 고찰연구 (A Review of Research Trends in Gold Implantation Therapy Focused on Gold Thread, Gold Needle and Gold Bead)

  • 조대현;아리온치멕;조예은;이상훈;이재동
    • Journal of Acupuncture Research
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    • 제33권1호
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    • pp.79-93
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    • 2016
  • Objectives : The purpose of this study is to explore research trends in gold implantation therapy performed on the animal and human body, through a review of clinical studies focused on gold thread, gold needle and gold bead. Methods : Medical databases, including Pubmed, CENTRAL, MEDLINE, EMBASE, RISS4u, KISTI, OASIS and KTKP, were searched for relevant articles published from their launch to December 31, 2015 using the key word 'gold' with '$thread^*$', '$needle^*$', '$acupuncture^*$', '$wire^*$', '$bead^*$', '$embed^*$', '$implant^*$', or '$insert^*$'. The results were classified into in vivo studies, clinical trials and clinical reports. Analysis of the results was conducted in several research areas, from the identity of studies such as nationality and published year, to the gold preparations-features and implanted locations and to the outcomes that reflect the clinically favorable or adverse effect of gold implantation therapy. Results : A total of 30 studies including 11 in vivo studies, 4 clinical trials and 15 case reports, were found in the search. We observed certain research trends according to the research time, nationality and target indication of the studies. The studies primarily revealed a chronic local inflammatory response which could be a useful mechanism for pain-relief in musculoskeletal diseases and facial rejuvenation. Researches concerning long-term reactions or adverse effects were rare. Conclusion : The results show that the efforts to discover the level of clinical efficacy of gold implantation therapy were steady and worldwide. However, further researches on the longterm effect, and more importantly, the safety of gold implantation therapy are required.

고관절치환술 후의 Rivaroxaban의 국내임상적용 (Rivaroxaban in Patients Undergoing Hip Arthroplasty in Korean Patients: Implications in Clinical Practice)

  • 유옥리;나현오;이정연
    • 한국임상약학회지
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    • 제24권1호
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    • pp.1-8
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    • 2014
  • Objective: Currently, rivaroxaban is widely used clinically for thromboprophylaxis after surgery. However, there are concerns on effectiveness and safety of rivaroxaban for its proper use. We aimed to evaluate the effectiveness and safety of rivaroxaban in orthopaedic patients after total hip replacement surgery in a large medical centre after the preferred formulary was switched from enoxaparin to rivaroxaban. Methods: The study was conducted on the patients who underwent hip arthroplasty surgery at the department of Orthopaedic Surgery at Seoul St. Mary's Hospital, South Korea. Electronic medical records were retrospectively reviewed to identify patients treated with rivaroxaban following total hip replacement between February 2011 and March 2012. Evaluation criteria included indications for use, dose, initiation and duration of therapy, drug interactions, adverse reactions, and status of health care reimbursement. The patients who were on enoxaparin were also reviewed as a reference. Results: We identified 57 patients who received rivaroxaban and 50 who received enoxaparin. All patients were prescribed the drugs for Korean Food and Drug Administration-approved indications. No thromboembolic or bleeding events were observed in either group. However, only 5.3% of rivaroxaban- treated patients had an appropriate length of prophylaxis and only 3.5% began rivaroxaban treatment at the recommended time. Surprisingly, 47.4% of rivaroxaban-treated patients received rivaroxaban despite being ineligible for reimbursement benefits. Conclusion: Rivaroxaban was generally well tolerated clinically. However, the duration of treatment, the time of initiation and patient eligibility for reimbursement require improvements, emphasising the need for education which indicates the area of pharmacists' involvement.

병원 진단검사의학부의 공간구조와 설비기준에 대한 조사 - 미국, 영국, 독일을 중심으로 - (A Study on the Space Organization and Facility Equipment of Medical Laboratory - focusing on the USA, UK and Germany -)

  • 김영애
    • 의료ㆍ복지 건축 : 한국의료복지건축학회 논문집
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    • 제22권3호
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    • pp.7-15
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    • 2016
  • Purpose: As medicare services have gotten spreaded, clinical laboratory has been dominant position. So, it has been acted for quality control and clinical pathology accreditation. But there has been quite deficient information to evaluate working space and technical standards of medical laboratory for accreditation. This study goals to figure out accreditation standard and design guideline for clinical laboratory, and to give safe and efficient design information. Methods: This study has been searched by literature for accreditation standards and design guidelines of clinical pathology in USA, UK, and Germany. Results: Three countries have accredited based on working lab space, staff space, storage space, patient space and health and safety equipment. Design guidelines of three countries commonly have focused on worktable layout, worktable distance and module, and specific laboratory biosafety level. And USA guidelines stress on the architectural design such as design process and passage distance for escape, UK stress on the efficiency as functional work flow and construction cost, lastly Germany design guidelines stress on the operator's safety distance and workstation. Three countries have not only accreditation standards but also design guidelines for more specific quality management, separating from accrediting institute. Implications: In korea, it has been needed to make clinical laboratory design guideline for the safe and efficient environment and reliable and competitive medical service.