• 대한의료기공학회지
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• 제13권1호
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• pp.77-104
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• 2013

In this study we examined the concerned literature for clinical use of Balsaminaceae plants focusing on the latest literature "zhong hua ben cao"(chinese materia medica, 1998). The findings were summarized as follows: 1. As an original plant, 27 species have been reviewed. 2. As a result of investigating oriental drug names by medicinal using part, a survey reported that the total of 22 species of oriental drug names, including 14 species of herba, 3 species of flos, 4 species of radix and rhizoma, and 1 species of semen, are being used for clinical use. 3. When we examined oriental drugs with five flavors by calculating and arranging their nature, effect, toxicity with points for conveniences sake, pungent and bitte showed 13 points, respectively, as main flavors. In drug nature, warm property of drug indicated 10 points and cold property of drug obtained 6 points. But as for other oriental drug, it is thought that we can recognize their significance. 4. With respect to efficacy, activating blood drug reached 10 kinds and wind- damp-dispelling 7 kinds, according to the examination. 5. In the examination on components and medicinal action, we examined that components are recorded in only impatiens balsamina's whole grass, flowers, root, root stems, and seeds, and Impatiens noli-tangere's whole grass. In medical action, we found out that the components are recorded in impatiens balsamina' flowers and seeds; impatiens noli-tangere's whole grass and flowers; and Impatiens textori' whole grass. 6. As a result of examining clinical prescription, the total of 84 kinds of clinical prescriptions by disease nature were examined, of which the prescription of Impatiens balsamina showed 19 cases in total, which was remarkable.

• 대한한의학방제학회지
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• 제17권2호
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• pp.111-121
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• 2009

Objectives : This study was performed to evaluate the efficacy of ampule containing herbal extract(Ulmus davidiana, Ginkgo biloba, Perilla ocymoides, Morus alba, Glycyrrhiza uralensis (licorice), and Angelica gigas) on skin wrinkles in adult women with facial wrinkles. Methods : A total of 12 women, 30 to 46 years of age, with wrinkles in the corner of eyes, applied ampule containing herbal extract twice daily for up to 12 weeks. Silicon replicas of right crow's feet area and antecubital fossa were taken before use of test product and at 4, 8 and 12 weeks. The replicas were analyzed by optical profilometry with Skin Visiometer SV600. The wrinkle and roughness parameters, R1, R2, R3, R4 and R5 were calculated and statistically analyzed. In addition, a subjective evaluation of product efficacy was conducted by patient's assessment. Results : The mean values of all the skin roughness parameters were decreased at 4-week, and decreased significantly at 8 and 12-week except R4 at 12-week after test product use. The subjective evaluation of wrinkle by patient's assessment was also improved. However, one patient noted stiffness of face after use of test product. Conclusions : These study suggested that the application of ampule containing herbal extract twice daily for 12 weeks may effectively improve the facial wrinkles without severe side effect.

• Communications for Statistical Applications and Methods
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• 제25권4호
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• pp.341-354
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• 2018

The one of the principles described in ICH E9 is that only results obtained from pre-specified statistical methods in a protocol are regarded as confirmatory evidence. However, in multi-regional clinical trials, even when results obtained from pre-specified statistical methods in protocol are significant, it does not guarantee that the test treatment is approved by regional regulatory agencies. In other words, there is no so-called global approval, and each regional regulatory agency makes its own decision in the face of the same set of data from a multi-regional clinical trial. Under this situation, there are two natural methods a regional regulatory agency can use to estimate the treatment effect in a particular region. The first method is to use the overall treatment estimate, which is to extrapolate the overall result to the region of interest. The second method is to use regional treatment estimate. If the treatment effect is completely identical across all regions, it is obvious that the overall treatment estimator is more efficient than the regional treatment estimator. However, it is not possible to confirm statistically that the treatment effect is completely identical in all regions. Furthermore, some magnitude of regional differences within the range of clinical relevance may naturally exist for various reasons due to, for instance, intrinsic and extrinsic factors. Nevertheless, if the magnitude of regional differences is relatively small, a conventional method to estimate the treatment effect in the region of interest is to extrapolate the overall result to that region. The purpose of this paper is to investigate the effects produced by this type of extrapolation via estimations, followed by hypothesis testing of the treatment effect in the region of interest. This paper is written from the viewpoint of regional regulatory agencies.

• 대한임상독성학회지
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• 제13권1호
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• pp.1-10
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• 2015

Purpose: The purpose of this study was to evaluate the usefulness of intravenous lipid emulsion as well as adverse events in acute poisoning patients. Methods: Literature was accessed through PubMed, EMBASE, Cochrane library, Web of science, and KoreaMed. All forms of literatures relevant to human use of intravenous lipid emulsion for acute poisoning were included. Cases reports or letters without description of clinical outcomes for each case were excluded. The literature search was conducted by two investigators in March, 2015, with publication language restricted to English and Korean. The effect, onset time, and adverse event of lipid emulsion and final outcome of each case were analyzed. Results: Eighty-one published articles were included, excluding articles whose title and abstract were not relevant to this study. No articles were classified as high level of evidence. Sixty-eight case reports were identified, consisting of 25 local anesthetics and 43 other drugs, such as tricyclic antidepressants and calcium channel blockers. Although most cases described significant clinical improvements, some of them showed no beneficial effect or worsening of clinical course. Several adverse events including hyperamylasemia and laboratory interference were reported. Conclusion: Although there were many case reports illustrating successful use of lipid for various drug poisonings, the effect cannot be estimated due to significant possibility of publication bias. Therefore, lipids might be considered in severe hemodynamic instability resulting from lipophilic drug poisoning, however further studies should follow to establish the use of lipid as the standard of care.

• Journal of Yeungnam Medical Science
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• 제2권1호
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• pp.183-190
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• 1985

본 시안(MCRCODE-N)은 말 그대로 시안인 바 많은 수정과 첨가가 필요할 것이라고 생각되나 국내 실정에 맞는 검사법이라고 생각된다. 본 시안을 이용하여 결정을 보완하는 일이 시급한 바 동학 선후배의 지도 편달을 바라는 바 이다.

• 한국임상약학회지
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• 제20권1호
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• pp.78-84
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• 2010

Background: Clostridium difficile is the primary reason of the nosocomial diarrhea. The antimicrobial therapy plays a central role in the pathogenesis of Clostridium difficile associated diarrhea (CDAD). Although nearly all classes of antimicrobial agents have been associated with CDAD, clindamycin and the third-generation cephalosporins have traditionally been considered to the greatest risk factor. Recent studies have also implicated fluoroquinolones as high-risk agents due to increasing use of the agents. This study was to determine the incidence and the risk factors of CDAD related to the administered antibiotics and to assess the therapeutic regimen of metronidazole or vancomycin based on the C. difficile toxin assay Methods: A retrospective study was performed in patients with Clostridium difficile toxin assay at I Hospital (Incheon, South Korea) during the period from January 2007 through December 2007. Administrative, laboratory, and pharmacy data were collected from Electronic Medical Databases. Results: The analysis included 129 reported C.difficile toxin assay results, with 42 positive cases and 87 negative cases. Significant antibiotic risk factors for CDAD included the use of the fourth-generation cephalosporinse (OR=5.97, 95% CI 1.37-25.98, P=0.017). Administration of metronidazole was protective against CDAD (OR=0.30, 95% CI 0.12-0.74, P=0.009). Prolonged antimicrobial therapy has been associated with an increased risk of CDAD. The third-generation cephalosporins (OR=3.81, 95% CI 1.08-13.41, P=0.037) and aminoglycoside (OR=5.50, 95% CI 1.43-21.10, P=0.013) demonstrated greater risk for CDAD over 15 days than 8days or less days of treatment duration. Conclusions: The fourth and third generation cephalosporin, aminglycoside were the significant risk factors compared with other antibiotics, whereas metronidazole appears to be protective. The longer duration of antiobiotic use increased CDAD.

• Journal of Genetic Medicine
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• 제8권1호
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• pp.28-34
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• 2011

대부분의 의사들은 임상시험을 치료약제개발 후 의료현장에서 사용하기 위해 진행되는 과정으로 생각할 것이다. 실험실에서 개발된 기술이 진단검사로써 도입되기 위해서는 치료약제의 경우와 유사한 임상시험 과정을 거쳐 그 안정성과 유효성에 대한 검증을 필요로 한다. 치료약제의 효과검증에서 가장 우수한 근거를 얻을 수 있는 연구방법은 무작위대조연구 방법이지만, 이를 검체진단검사에 그대로 적용하기는 어렵다. 검체진단검사의 경우 비교연구가 진단정확도의 검증을 위해 현실적으로 사용할 수 있는 연구방법이지만 대상군의 모집 방법과 구분 방법, 질환대상자의 질환 심각도, 참고표준의 선택과 적용, 눈가림 여부 등 여러 요인들이 진단정확도 지표에 직접적인 영향을 주기 때문에, 좋은 근거수준의 연구결과를 얻기 위해서는 이러한 요소들을 고려한 잘 고안된 연구디자인이 중요하다. 또한 검체진단검사는 치료약제의 경우와 달리 결과를 얻기 위한 검사과정이 사용자인 일선 검사실에 의해 계속 생산되어야 하고, 검사의 개발과 발전의 속도가 빠르며, 일선검사실이 최종사용자이자 개발자인 경우가 흔하다는 특성이 있다. 저자들은 이러한 검사의 특성을 고려하여 검사법 자체의 수행능력에 대한 검증으로부터 검사법 성능평가를 위한 질환확진군과 정상군에 대한 비교연구, 일련의 질환의심자 대상의 진단정확도 평가와 임상 효과성 평가, 도입 후 일상감시로 이어지는 임상시험의 진행단계를 제안하고자 한다.

• Child Health Nursing Research
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• 제8권3호
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• pp.344-356
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• 2002

This study was conducted to analyse the current clinical education of pediatric nursing in baccalaurate nursing program, then to give basic data for enhancing the quality of future clinical education of pediatric nursing. Data were collected through self-reported questionnaire by mail from December 2001 to February 2002. The subjects were 29 schools of 50 baccalaurate nursing education programs. The data were analysed by double raters, researcher and assistant researcher. The results were summarized as follows: 1. Twenty-eight schools had the objectives of the clinical education of pediatric nursing, and 28 schools in pediatric ward, 23 schools in nursery, 22 schools in neonatal intensive care unit(NICU), 15 schools in objectives related to profession by clinical site. 2. Credits on clinical education of pediatric nursing were most 15 schools of 3 credits. 3. The clinical sites were mainly the hospital that sick children were admitted in. 4. The clinical teacher were 9 types including pediatric professor and field nurse. 5. On teacher's role, the professor instructed the case study and conference, and field nurse instructed the patient assignment and nursing procedures. 6. All of schools used explanation and conference as a method of clinical education, 1 or 2 schools used PBL or role play or field study. 7. On clinical education content, most of school included Apgar scoring system, physical examination in newborn assessment, respira- tion maintenance, temperature maintenance, infection prevention, nutrition, and bath in newborn care. 8. On clinical education content, most of school included care of incubator, phototheraty, infusion, gavage feeding and how to use the instruments in NICU. Eighteen schools included attachment promotion, and 20 schools case study. 9. On clinical education content, most of school included a checklist of nursing procedures, case study, assessment of growth and development in pediatric ward and other sites. 10.There were various evaluation types in scores, measuring items. In conclusion, the results of this study revealed that there were some discrepancy in the objectives and contents, clinical sites on hospital focused, teacher's role, and diversity of measurement items and ratings in clinical education of pediatric nursing. There is a need for a standardization of content, clinical site, and evaluation tool to improve a quality of clinical education of pediatric nursing based on this study.

• 한국임상약학회지
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• 제25권4호
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• pp.254-263
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• 2015

Objectives: The present study assessed the prevalence of the potentially inappropriate medication (PIM) use in Korean elderly patients with Parkinson's disease. In addition, this study examined risk factors that affect PIM use. Method: A retrospective, observational study was conducted using Korean National Health Insurance claims database of 2009. PIM use in Parkinson's disease patients aged 65 years or older was examined based on 2012 Beers Criteria. Multivariable logistic regression was conducted to identify risk factors for PIM use. Results: Among 5,277 elderly patients with Parkinson's disease, 88.9% of patients used PIM(s) at least once. The average number of PIM items used per patient was 4.2. PIM use ratio, the proportion of total amount of PIMs to all medications per patient, was 12.6%. Frequently used PIM therapeutic classes were benzodiazepines (32.7%), first-generation antihistamines (19.2%), and prokinetics (17.5%). Individual PIMs most commonly used included chlorpheniramine (11.4%), levosulpiride (10.9%), diazepam (9.0%), and alprazolam (7.6%). Women (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.11-1.16), medical aid (OR 1.18, 95% CI 1.15-1.21), and long-term facilities (OR 2.43, 95% CI 2.22-2.65) were shown to be risk factors associated with PIM use. Of particular, wide variation in PIM use was associated with the types of healthcare facility. Conclusion: The PIM prevalence was very high in elderly Parkinson's disease patients. Nationally effective and systematic efforts to identify and prevent PIM use should be made to ensure patient safety and to improve quality of care in the elderly.

• 약학회지
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• 제58권2호
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• pp.112-124
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• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.