• Title/Summary/Keyword: Clinical safety

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The analysis of present condition and the method of medical treatment studies on Scolopendrid Herbal Acupuncture (오공약침(蜈蚣藥鍼)에 대한 연구현황분석(硏究現況分析)과 치료법(治療法)에 관한 연구(硏究))

  • Kim, Sung-Chul
    • Journal of Pharmacopuncture
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    • v.9 no.2
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    • pp.113-127
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    • 2006
  • Objectives : We review a result of studies until the present and suggest the method of medical treatment for the clinical treatment of Scolopendrid Herbalacupuncture. Methods : We analysis the paper of the bibliographic studies, the experiment studies and the clinical studies from 2001 developed Scolopendrid Herbalacupuncture and grope for the course of studies. Results : 1. Scolopendrid Herbalacupuncture is proved the clinical safety by the aninmal and human tests. 2. The pharmacological action of Scolopendra subspinipes mutilans L. Koch is anti-convulsive action, analgesic action, lowering blood pressure, anti-inflammatory action, anti-tumor action and microbe inhibition 3. Scolopendrid Herbalacupuncture has been a fine effect to the entrapment neuropathy and inflammatory. 4. Scolopendrid Herbalacupuncture was thought effective on a acute phase and to the excessive symptoms. The Sub-chronic toxicity experiment observing the response after hypodermic medication over 90 days, The Genetic-mutagenic toxity experiment and the clinical effect studies are necessary.

Phase IV Clinical Trial, the Evaluation of Efficacy and Safety of Deoxyribonuclease-Bromelain Tablet in Patients with Traumatic Edema (외상성 부종에 대한 데옥시리보뉴클레아제-브로멜라인정의 유효성 및 안전성 평가를 위한 제IV상 임상시험)

  • Choi, Hyung-Suk
    • Korean Journal of Clinical Pharmacy
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    • v.14 no.1
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    • pp.24-31
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    • 2004
  • There was clinical study to support the efficacy that the anti-inflammatory and analgesic properties of deoxyribonuclease, bromelain helped to reduce symptoms of inflammation. The current study investigated the effects of deoxyribonuclease, bromelain on local traumatic edema. The author used a drug containing proteolytic and mucolytic enzymes, deoxyribonuclease and bromelain, into 61 patients from 16 to 89 years old. The therapeutic response and tolerance had been excellent, which was permitted to a swift resolution on local traumatic edema and a prompt functional reestablishment. These results demonstrated that the drug was effective in local edema symptoms, pains and improving general condition suffering from trauma. Consequently, the use of the proteolytic and mucolytic enzyme$(Deanase^{(R)})$ require improvement in the rehabilitation of the injured.

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Current Development Status of Cytokines for Cancer Immunotherapy

  • Kyoung Song
    • Biomolecules & Therapeutics
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    • v.32 no.1
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    • pp.13-24
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    • 2024
  • Cytokines influence the overall cancer immune cycle by triggering tumor antigen expression, antigen presenting, immune cell priming and activation, effector immune cell recruitment and infiltration to cancer, and cancer killing in the tumor microenvironment (TME). Therefore, cytokines have been considered potential anti-cancer immunotherapy, and cytokine-based anti-cancer therapies continue to be an active area of research and development in the field of cancer immunotherapy, with ongoing clinical trials exploring new strategies to improve efficacy and safety. In this review, we examine past and present clinical developments for major anticancer cytokines, including interleukins (IL-2, IL-15, IL-12, IL-21), interferons, TGF-beta, and GM-CSF. We identify the current status and changes in the technology platform being applied to cytokine-based immune anti-cancer therapeutics. Through this, we discuss the opportunities and challenges of cytokine-based immune anti-cancer treatments in the current immunotherapy market and suggest development directions to enhance the clinical use of cytokines as immuno-anticancer drugs in the future.

The Influences of the Awareness of Patient Safety Culture on Safety Care Activities among Operating Room Nurses (수술실 간호사의 환자안전문화에 대한 인식이 안전간호활동에 미치는 영향)

  • Lee, Kyung Hee;Lee, Young Shin;Park, Hae Kyung;Rhu, Jung Ok;Byun, In Seung
    • Journal of Korean Clinical Nursing Research
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    • v.17 no.2
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    • pp.204-214
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    • 2011
  • Purpose: This study was aimed to provide information on the awareness of patient safety culture and safety care activities among operating room (OR) nurses and to analyze the factors influencing the safety care activities. Methods: For this descriptive research, self-reported questionnaires were administered to 168 OR nurses who were working at the university-affiliated and general hospitals. The collected data were analyzed using descriptive statistics, t-test, ANOVA, $Scheff{\grave{e}}$ test, Pearson's correlation coefficient and Stepwise multiple regression with SPSS/WIN 17.0. Results: The mean score of the awareness on patient safety culture was 3.27 out of 5 points and that of safety care activity was 4.31 out of 5. The statistically significant difference was found between experience of safety education and the awareness on patient safety culture. Also, the scores of safety care activities were significantly different according to OR nurses' position, education levels, and experience of safety education. There was a positive correlation between the awareness of patient safety culture and safety care activity. Their explanatory power on safety care activity was 8.8%, which includes working environment in operating room 3.3% and nursing position 5.5%. Conclusion: Compared to the level of patient safety activities, the OR nurses' awareness on patient safety culture was low. Given the specific characteristics and conditions in each hospital, it needs to increase the OR nurses' awareness on patient safety culture and activities related to patient safety.

Nanotechnology in Cancer Therapy: Overview and Applications

  • Choi, Eun-Joo
    • Journal of Pharmaceutical Investigation
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    • v.41 no.2
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    • pp.59-65
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    • 2011
  • Nanotechnology for cancer therapy is playing a pivotal role in dramatically improving current approaches to cancer detection, diagnosis, and therapy while reducing toxic side effects associated with previous cancer therapy. A widespread understanding of these new technologies will lead to develop the more refined design of optimized nanoparticles with improved selectivity, efficacy and safety in the clinical practice of oncology. This review provides an integrated overview of applications and advances of nanotechnology in cancer therapy, based on molecular diagnostics, treatment, monitoring, target drug delivery, approved nanoparticle-based chemotherapeutic agents, and current clinical trials in the development of nanomedicine and ultimately personalized medicine.

Bone graft material using teeth

  • Kim, Young-Kyun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.38 no.3
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    • pp.134-138
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    • 2012
  • Autogenous tooth bone graft material contains organic and inorganic components for osteoinductive and osteoconductive healing. The clinical availability and safety of this material have been confirmed by various experimental and clinical studies. In the future, allogenic and xenogenic tooth bone graft materials, ideal scaffold using teeth for stem cells and bone growth factors, and endodontic and tooth restorative material will be developed.

Considerations in the Design of the Preclinical Safety Program for PegIntron

  • Davis, Thomas
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2003.10b
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    • pp.87-88
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    • 2003
  • PegIntron is the pegylated form of human recombinant interferon alfa-2b (IFN${\alpha}$2b). IFN ${\alpha}$2b, known as Intron A, has been in approved clinical use since the 1980's for various cancer indications, and for the treatment of Hepatitis C. In the mid 1990's, several clinical investigators reported that combination therapy with ribavirin and Intron A dramatically increased the therapeutic efficacy for treatment of Hepatitis C.(omitted)

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Clinical Application of Gold Nanoparticles for Diagnosis and Treatment

  • Baek, Seung-Kuk
    • Medical Lasers
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    • v.10 no.2
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    • pp.61-67
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    • 2021
  • Advances in nanobiotechnology have presented numerous possibilities of more effective diagnostic and therapeutic options. In particular, gold nanoparticles have demonstrated the potential for application in molecular imaging and treatment of cancers, including drug delivery system of certain target molecules, enhancement of radiation therapy, and photothermal treatment. This review discusses the properties, mechanism of action, and clinical application of gold nanoparticles. Although the safety of nanoparticles is yet to be ascertained, there is no doubt that in the future, nanotechnology will play an important role in the development and enhancement of a wide range of diagnostic and treatment modalities.

A Study of Mammalian Erythrocyte Micronucleus Induction with Aluminum Oxide, Calcium Oxide, Sodium Tetraborate (Aluminum oxide, calcium oxide, sodium tetraborate 처리에 의한 설치류 골수세포의 소핵유발 연구)

  • Rim, Kyung-Taek;Kim, Soo-Jin;Kim, Jong-Kyu;Kang, Min-Gu;Kim, Hyeon-Yeong;Yang, Jeong-Sun
    • Environmental Analysis Health and Toxicology
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    • v.24 no.2
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    • pp.127-136
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    • 2009
  • We have investigated the genotoxicity of 3 chemicals, aluminum oxide, calcium oxide, sodium tetraborate using mammalian erythrocyte with micronucleus induction. It was performed using 9 week male ICR mice. At 24 hours after treatment with 3 chemicals with oral route, mice were sacrificed and bone marrow cells were prepared for smear slides. As a result of counting the micronucleated polychromatic erythrocyte (MNPCE) of 2,000 polychromatic erythrocytes (PCE), all treatment groups did not show statistically significant increase than negative control group. And there was no clinical sign related with injection of the 3 chemicals. It was concluded that the 3 chemicals did not induce micronucleus in the bone marrow cells of ICR mice, and these results indicate that the 3 chemicals have no mutagenic potential under the condition in each studies.

Legal issues of obtaining informed consent in pharmaceutical clinical trial as human material research : Focusing on the use of statutory form (인체유래물연구에 해당되는 의약품임상시험에서 동의 획득 기준의 법적 문제: <인체유래물연구동의서> 법정 서식의 사용을 중심으로)

  • Yoo, Sujung;Kim, Eunae
    • The Journal of KAIRB
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    • v.1 no.2
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    • pp.30-42
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    • 2019
  • In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

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