• Title/Summary/Keyword: Efficacy and safety assessment

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A prospective study to assess the efficacy and safety of oral propranolol as first-line treatment for infantile superficial hemangioma

  • Yun, Yeong Ju;Gyon, Yun Hee;Yang, Sohyoung;Lee, Youn Kyung;Park, Joohyun;Park, Meerim
    • Clinical and Experimental Pediatrics
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    • v.58 no.12
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    • pp.484-490
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    • 2015
  • Purpose: To determine the efficacy and safety of oral propranolol as a first-line treatment for superficially located infantile hemangioma (IH) and propose an assessment tool to measure treatment response. Methods: Patients with superficial IH under 1 year of age were prospectively recruited between May 2012 and December 2013 at the Department of Pediatrics of Chungbuk National University Hospital. Propranolol was administered to 12 infants (median age, 3.8 months) while monitoring cardiovascular and adverse metabolic effects. If a patient showed no adverse events, the dosage was gradually increased up to 3 mg/kg/day and maintained for 1 year. We used our own scoring system to assess treatment response using parameters like change in color, and longest diameter, and thickness of the IH. Results: Eleven out of 12 patients completed the protocol with consistent improvement of hemangiomas during therapy. Patients on propranolol showed a more than 50% involution in the first 3 months, with additional steady involution until 1 year. Patients with the highest scores at 1 month maintained their score and showed better responses until treatment termination. The patient with the lowest score at 1 month did not show any further regression and stopped propranolol treatment 4 months after initiation. In two children with recurrences after successful therapeutic regression, propranolol was effective after being reintroduced. Propranolol treatment was not interrupted in any patient due to adverse events. Conclusion: Oral propranolol at 3 mg/kg/day showed a consistent, rapid, and therapeutic effect on superficial IHs without significant adverse events.

A Comparative Clinical Study on an Electronic Moxibustion with Acupuncture for Dry Eye Syndrome (건성안 증후군에 대한 전자뜸과 침의 효과 비교 임상연구)

  • Ji-Shik Park;Ji-Hoon Song;Min-Yeong Jung;Jung-Hwa Choi;Soo-Yeon Park
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.1
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    • pp.64-77
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    • 2023
  • Objectives : Recently, the number of patients with dry eye syndrome has been steadily increasing. However, established treatment for it does not yet exist. This study compared electronic moxibustion with acupuncture for patients with dry eye in terms of efficacy and safety. Methods : This trial was designed as an investigator-initiated, single-blinded, comparative, randomized controlled trial. Thirty patients with dry eye were randomized to the electronic moxibustion treatment group(EMG) or the acupuncture treatment group(AG) in equal proportion. The participants who assigned to the EMG were treated with electronic moxibustion to ten acupoints including both sides of BL2, GB14, TE23, and LI4 for 12 minutes. The participants who were assigned to the AG were treated with acupuncture to the same acupoints for 15 minutes. Over 4 weeks, each intervention was carried out twelve times in total. The primary outcome was the ocular surface disease index(OSDI). The secondary outcomes were the subjective symptoms visual analog scale(VAS), quality of life(QoL), Schirmer I test(SIT), and general assessment. Adverse events and vital signs were also investigated for safety assessment. Results : In intragroup comparisons, both the EMG and the AG significantly improved the OSDI scores, the subjective symptoms VAS scores, the QoL scores, and the SIT results after 4 weeks of the trial. However, there were no statistical differences in intergroup comparisons between the two groups after 4 weeks. The safety of electronic moxibustion and acupuncture was confirmed by no occurrence of serious adverse events. Conclusions : Both electronic moxibustion and acupuncture were effective for dry eye syndrome, and they were safe. Electronic moxibustion and acupuncture can be used for dry eye syndrome as equivalent treatments.

Status of Application and Analysis of Results of New Health Technology Assessment - Strategies for Development of New Health Technology in Korean Medicine (신의료기술 신청 현황과 평가 결과 분석을 통한 한의 신의료기술 개발 방안)

  • Choi, Young-eun;Kim, Dongsu;Lee, Jun-Hwan
    • Journal of Society of Preventive Korean Medicine
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    • v.21 no.3
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    • pp.75-85
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    • 2017
  • Objectives : The new health technology assessment (nHTA) involves evaluating the safety and efficacy of the new health technology under the Medical Services Act by the New Health Technology Assessment Project Division from 2007. The purpose of this study is to understand the status of applications and recent trends of the results, and suggest strategies for the development of new health technologies in Korean Medicine. Methods : We investigated and analyzed the results of evaluation of new health technology of whole conventional medical and the list of new health technologies in Korean Medicine provided by the New Health Technology Assessment Project Division from 2007 to 2016. Results : The number of applications for new health technology of Korean medicine was low as 41 items in the whole number of 2,013 items. The evaluation method of new health technologies in both, the whole medical and Korean medicine fields was the same, but the tendency in results was very different. Most of the new health technology items in Korean medicine were classified as existing technology (20 items), early stage technology (7 items), and Only 2 items were evaluated as research stage technology. Conclusions : In order to develop new health technology in the Korean medical field, we have made suggestions about the health technology assessment systems, R&D infrastructures, and corporation with conventional medicines.

ASSESSMENT OF A NEW DESIGN FOR A REACTOR CAVITY COOLING SYSTEM IN A VERY HIGH TEMPERATURE GAS-COOLED REACTOR

  • PARK GOON-CHERL;CHO YUN-JE;CHO HYOUNGKYU
    • Nuclear Engineering and Technology
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    • v.38 no.1
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    • pp.45-60
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    • 2006
  • Presently, the VHTGR (Very High Temperature Gas-cooled Reactor) is considered the most attractive candidate for a GEN-IV reactor to produce hydrogen, which will be a key resource for future energy production. A new concept for a reactor cavity cooling system (RCCS), a critical safety feature in the VHTGR, is proposed in the present study. The proposed RCCS consists of passive water pool and active air cooling systems. These are employed to overcome the poor cooling capability of the air-cooled RCCS and the complex cavity structures of the water-cooled RCCS. In order to estimate the licensibility of the proposed design, its performance and integrity were tested experimentally with a reduced-scale mock-up facility, as well as with a separate-effect test facility (SET) for the 1/4 water pool of the RCCS-SNU to examine the heat transfer and pressure drop and code capability. This paper presents the test results for SET and validation of MARS-GCR, a system code for the safety analysis of a HTGR. In addition, CFX5.7, a computational fluid dynamics code, was also used for the code-to-code benchmark of MARS-GCR. From the present experimental and numerical studies, the efficacy of MARS-GCR in application to determining the optimal design of complicated systems such as a RCCS and evaluation of their feasibility has been validated.

Antimicrobial photodynamic therapy as an adjunct to nonsurgical periodontal treatment - Systematic review and Meta-analysis (광역학요법을 이용한 치주염치료 - 체계적 문헌고찰 및 메타분석)

  • Mo, Jin-A
    • The Journal of the Korean dental association
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    • v.54 no.6
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    • pp.429-437
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    • 2016
  • Objectives: Photodynamic therapy has been proven to promote additional clinical and microbiological benefits in the treatment of chronic periodontitis and aggressive periodontitis. The purpose of this study is to assess the effectiveness of the photodynamic therapy for patient with periodontitis. Methods: We searched the eight Korean databases and Ovid-MEDLINE, Ovid-EMBASE, Cochrane Library. Total 300 studies were searched and 13 studies were included in the final assessment. Each of the stages from literature search and extraction of data were carried out independently by 2 researchers. We used tools of Scottish Intercollegiate Guidelines Networks for assessment of the quality of studies. Results: The safety of the photodynamic therapy was assessed by bleeding. The effectiveness of the photodynamic therapy was assessed by the reduction of Probing pocket depth (PPD) and the gain of Clinical attachment level (CAL). The mean difference of PPD was 0.46(95% CI 0.09~0.82), (p=.01).). The mean difference of CAL was ?0.49(95% CI ?1.12~0.14), (p=.13). Conclusion: The additional use of $^{\circ}{\infty}$Antimicrobial Photodynamic Therapy for Periodontitis$^{\circ}{\pm}$ caused hemorrhage to similar extents to conventional treatment modalities, where scaling and root planing are solely performed, in patients with periodontitis who are expected to have a lower degree of treatment response to non-surgical or surgical periodontal therapies (implant or refractory periodontitis) and those where there is a concern for the possible occurrence of antimicrobial side effects or resistance. This indicates that there are no problems with its safety. But there were no consistent reports about the effects of the additional use of photodynamic therapy. This led to a decision that the safety and efficacy of the current technology deserve further studies (Recommendation rating of A, Classification of technology II-a).

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Clinical Evaluation of Granules Containing Antacids, Digestive Eneymes and Herb Drugs in Patients with Various Symptoms of Upper Gastrointestinal Disorders (상부 소화관 질환증상에 대한 제산, 소화효소 및 생약 세립의 유용성)

  • 구자영;박능화;최종수;안수열
    • YAKHAK HOEJI
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    • v.37 no.5
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    • pp.520-526
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    • 1993
  • The purpose of this study is to assess the clinical efficacy and safety of NRM granules which were newly developed as a combination product containing antacids, digestive enzymes and herb drugs for the treatmet of various symptoms of upper gastrointestinal disorders taking SGN granules of similiar but different composition as a control. One hundred and twenty one patients were randomly allocated to receive one pack of either NRM granule(80 cases) or SGN granules(41 cases) three times a day after meal and undergone symptomatic, endoscopic and clinical laboratory assessment before and after two weeks of treatment. The results were as follows; 1. All symptoms except anorexia showed improvements in more than 90% of total cases with each symptom in the NRM group. 2. The general improvement rate was 97.5% in NRM group, and was superior to the(92.5%) of SGN group. 3. Two cases of NRM group and one case of SGN group developed mild nausea, and onecase of SGN group developed mild epigastric soreness. No cases of the two groups developed laboratory(blood, biochemical, urine) abnormalities. 4. The overall clinical efficacy rate was 95.0% in NRM group, 87.8% in SGN group. kccording to the result of this trial, it was concluded that NRM granule was an effective and safe drug and(but not statistically significant) was slightly more efficient than SGN for treatment of various symptoms in upper gastrointestinal disorders.

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Trends in Domestic and International Clinical Research on Korean Medicine Treatments for Triangular Fibrocartilage Complex Injury (삼각섬유연골 복합체 손상의 한의학 치료에 대한 국내외 임상 연구 동향)

  • Sang-Min Park;Tae-Gyeong Kwon;Jee-Hoon Baek;Min-Joo Lee;Sae-Rom Choi;Jee-Yeun Choi
    • Journal of Korean Medicine Rehabilitation
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    • v.34 no.2
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    • pp.71-83
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    • 2024
  • Objectives The purpose of this study is to analyze the trends in domestic and international clinical research on the Korean medicine for triangular fibrocartilage complex (TFCC) injuries and to contribute to future domestic research. Methods In this study, clinical studies on TFCC injuries treated with Korean medicine were searched through databases such as Research Information Sharing Service, ScienceON, DBpia, China National Knowledge Infrastructure, PubMed, Medline, and Embase. Fifteen clinical studies were selected, of which publication years, intervention methods, assessment tools, and various other factors were analyzed, including potential side effects. Results Among the selected 15 studies, total of 13 intervention methods were used. Electroacupuncture was the most frequently used method (40%), followed by herbal medicine (33%), acupuncture (26.7%), chuna manual therapy (26.7%), pharmacopuncture (20%), acupotomy (13%), herbal ointment (13%), hot medicinal compress therapy (13%) and etc. Most studies showed that Korean medicine treatments effectively alleviated TFCC injuries, with visual analogue scale being the most commonly used assessment tool. Conclusions Korean medicine treatments for TFCC injuries appears to be effective; however, further research is needed to enhance understanding. Large-scale clinical trials comparing the efficacy of Korean medicine treatments, along with investigations into side effects and recurrence rates are necessary. By doing so, the safety and efficacy of Korean medicine treatments for TFCC injuries can be further established.

A Clinical Study for the Efficacy and Safety of Functional Cosmetics Containing Humulus japonicus Extract in Patients with Dry Skin due to Mild Atopic Dermatitis (아토피성 피부로 건조함을 가진 대상자에 대한 환삼덩굴추출물 함유 기능성 화장품의 유효성 및 안전성을 평가하기 위한 임상적 연구)

  • Park, Hye-Su;Kim, Yong-Min;Kim, Hee-Tack
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.2
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    • pp.24-58
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    • 2019
  • Objectives : The purpose of this study is to confirm the Efficacy and Safety of "Functional cosmetics containing Humulus japonicus Extract" on dry skin due to mild atopic dermatitis. Methods : A total of 48 patients who visited Semyung Oriental Medical Center from March 20th, 2018 to July 5th, 2018 were included in the study. In this study, the patients were treated with Functional cosmetics containing Humulus japonicus Extract and positive control group. For 6 weeks of gross examination, instrumental assessment were made before and after the study to evaluate how well the products for treatment group with positive control products for control group in recovering the dry skin barriers by mild atopic dermatitis. Results : 1. In the primary endpoint, Skin Hydration showed a statistically significant increase and Transepidermal Water Loss(TEWL) showed a statistically significant decrease in treatment group between Baseline and 6 weeks. 2. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between Baseline and 3 weeks, but TEWL showed no statistical significance. 3. In the secondary endpoint, Skin Hydration showed a statistically significant increase in treatment group between 3 weeks and 6 weeks, but TEWL showed no statistical significance. 4. In the secondary endpoint, Change of Skin Hydration and TEWL between treatment and control group showed a statistical significance in 6 weeks. 5. In the secondary endpoint, Change of Skin Hydration of 1cm below the medial aspect of the elbow between treatment and control group showed a statistical significance in 3 weeks. 6. In the secondary endpoint, Change of Skin Hydration between treatment and control group showed a statistical significance in 3 weeks and 6 weeks except Center between the medial aspect of the elbow and the wrist in 3 weeks, and Change of TEWL between treatment and control group showed a statistical significance in 6 weeks. 7. To evaluate the safety of the products for the human body, Adverse events, EASI Score, Itching Symptoms Assessment, vital sign check were conducted; There were no severe adverse events during this study. And both experimental group and control group showed no abnormal level. Therefore, it is suggested that products, if used for certain period, should be safe for the human body. Conclusions : According to the above experiments, it is suggested that "Functional cosmetics containing Humulus japonicus Extract" should be effective for dry skin due to mild atopic dermatitis.

Study on Improving Maritime English Proficiency Through the Use of a Maritime English Platform (해사영어 플랫폼을 활용한 표준해사영어 실력 향상에 관한 연구)

  • Jin Ki Seor;Young-soo Park;Dongsu Shin;Dae Won Kim
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.29 no.7
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    • pp.930-938
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    • 2023
  • Maritime English is a specialized language system designed for ship operations, maritime safety, and external and internal communication onboard. According to the International Maritime Organization's (IMO) International Convention on Standards of Training, Certification and Watchkeeping for Seafarers (STCW), it is imperative that navigational officers engaged in international voyages have a thorough understanding of Maritime English including the use of Standard Marine Communication Phrases (SMCP). This study measured students' proficiency in Maritime English using a learning and testing platform that includes voice recognition, translation, and word entry tasks to evaluate the resulting improvement in Maritime English exam scores. Furthermore, the study aimed to investigate the level of platform use needed for cadets to qualify as junior navigators. The experiment began by examining the correlation between students' overall English skills and their proficiency in SMCP through an initial test, followed by the evaluation of improvements in their scores and changes in exam duration during the mid-term and final exams. The initial test revealed a significant dif erence in Maritime English test scores among groups based on individual factors, such as TOEIC scores and self-assessment of English ability, and both the mid-term and final tests confirmed substantial score improvements for the group using the platform. This study confirmed the efficacy of a learning platform that could be extensively applied in maritime education and potentially expanded beyond the scope of Maritime English education in the future.

Comparison of Clinical Development and Evaluation of Triple Antihypertensive Therapy in Advanced Foreign Countries (항고혈압 약물 3종 복합제에 대한 선진 외국의 임상자료 심사사례 비교)

  • Wang, So Young;Shon, Soo Jung;Um, Jung Yoon;Lim, Hwa Kyung;Lim, Sook;Kang, Seung Ho;Lee, Sun Hee
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.3
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    • pp.239-247
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    • 2013
  • Background: Fixed drug combinations are formulations containing two or more active ingredients in a single dosage form. Such combination therapies are commonly applied to improve efficacy, reduce adverse events and replace co-administration, etc. National and international guidelines for hypertension treatment recommend addition of other classes of antihypertensive drugs rather than incremental dose of mono-therapy, when blood pressure is not adequately controlled. Thus, many dual combinations of antihypertensive drugs have been approved and pharmaceutical companies are recently interested in developing antihypertensive triple combinations. Clinical trial designs for the fixed combinations are various depending on the target patients, dosage and clinical endpoints. Thereby, further discussions for the clinical trials of antihypertensive triple therapies are required regarding the indication claimed. Conclusion: This article provides a review for the assessment of the label and medical reports of the clinical trials on antihypertensive triple therapies in advanced foreign countries.