• 대한한방부인과학회지
• /
• 제19권1호
• /
• pp.178-187
• /
• 2006

Purpose : The aim of this study was to investigate objective evaluation of dysmenorrhea. Methods : The study was conducted by 37 articles from year 1979 to 2003 on dysmenorrhea, scale and questionaire. The articles was limited by English, Human, and Clinical trial Results : 1. The 37 articles on dysmenorrhea evaluated by scale or questionaire have been published from 1979. There are 27 articles of randomized controlled trial among them. 2. Scale or question has confidence in the assessment of dysmenorrhea. 3. In the initial stage the article on dysmenorrhea was assessed by only one unidimentional scale. However in recent articles multidimensional scales are applied frequently. Moreover it is the modern trend that point scale such as 100mm VAS and MVRS(multidimensional verbal rating scale) are applied together in one article on dysmenorrhea. Conclusion : It can be suggested that scale or questionaire be the method for objective evaluation of dysmenorrhea.

• Journal of Periodontal and Implant Science
• /
• 제50권4호
• /
• pp.238-250
• /
• 2020

Purpose: This study aimed to evaluate the biocompatibility and the mechanical properties of ultraviolet (UV) cross-linked and biphasic calcium phosphate (BCP)-added collagen membranes and to compare the clinical results of ridge preservation to those obtained using chemically cross-linked collagen membranes. Methods: The study comprised an in vitro test and a clinical trial for membrane evaluation. BCP-added collagen membranes with UV cross-linking were prepared. In the in vitro test, scanning electron microscopy, a collagenase assay, and a tensile strength test were performed. The clinical trial involved 14 patients undergoing a ridge preservation procedure. All participants were randomly divided into the test group, which received UV cross-linked membranes (n=7), and the control group, which received chemically cross-linked membranes (n=7). BCP bone substitutes were used for both the test group and the control group. Cone-beam computed tomography (CBCT) scans were performed and alginate impressions were taken 1 week and 3 months after surgery. The casts were scanned via an optical scanner to measure the volumetric changes. The results were analyzed using the nonparametric Mann-Whitney U test. Results: The fastest degradation rate was found in the collagen membranes without the addition of BCP. The highest enzyme resistance and the highest tensile strength were found when the collagen-to-BCP ratio was 1:1. There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial (P>0.05). Conclusions: The addition of BCP and UV cross-linking improved the biocompatibility and the mechanical strength of the membranes. Within the limits of the clinical trial, the sites grafted using BCP in combination with UV cross-linked and BCP-added collagen membranes (test group) did not show any statistically significant difference in terms of dimensional change compared with the control group.

• 응용통계연구
• /
• 제24권3호
• /
• pp.495-503
• /
• 2011

When a patent of an innovative (brand-name) small-molecule drug expires, generic copies of the innovative drug may be marketed if their therapeutic equivalence to the innovative drug has been shown. The small-molecule drugs are considered therapeutically equivalent and can be used interchangeably if two drugs are shown to be pharmaceutically equivalent with identical active substance and bioequivalent with comparable pharmacokinetics in a crossover clinical trial. However, the therapeutic equivalence paradigm cannot be applied to biosimilars since the active ingredients of biosimilars are huge molecules with complex and heterogeneous structures, and these molecules are difficult to replicate in every detail. The European Medicine Agency(EMEA) has introduced a regulatory biosimilar pathway which mandates clinical trials to show therapeutic equivalence. In this paper, we discuss statistical considerations in the design and analysis of biosimilar cancer clinical trials.

• 대한본초학회지
• /
• 제26권1호
• /
• pp.125-132
• /
• 2011

Objectives : This study was performed to evaluate the efficacy of extract from Citri Pericarpium (CP) on lipid-lowering effect in semi-healthy subjects with increased serum levels of total cholesterol and triglyceride. Methods : A experimental group (n=45) and placebo group (n=46) were randomly established based on the plasma lipid profiles (triglyceride, total cholesterol etc.) in the semi-healthy subjects, then all subjects randomly took experimental or placebo capsules, which contain 1,200 mg of CP or the same dose of soluble starch per day with regular meals for 8 weeks by double-blind method. Results : One-hundred forty (140) subjects were screened, then 91 subjects enrolled in the study. No serious adverse events were reported for trial period. The CP treatment showed statistically significant decrease in serum levels of triglyceride both at 4-weeks (p<0.01) and at 8-weeks (p=0.0001). Futhermore, there was significant difference in the triglyceride levels between CP-treated and placebo group. The CP-treated but not placebo group, experienced decrease in serum levels of total cholesterol at 8-weeks. Then there was no significant difference in the total cholesterol levels between the two groups. In addition, statistically significant difference of AST, ALT, ${\gamma}$-GT serum levels wasn't shown before and after trial in two groups. Conclusion : These results demonstrate that CP can significantly suppress the elevated triglyceride but not total cholesterol level. Therefore, CP may play a role in the improvement of blood lipid levels, as an effective functional food.

• Journal of Periodontal and Implant Science
• /
• 제48권5호
• /
• pp.295-304
• /
• 2018

Purpose: This study was undertaken to evaluate the clinical and microbiological effects of an erythritol powder air-polishing device (EPAP) as a supplement to scaling and root planing (SRP) therapy in patients with moderate chronic periodontitis. Methods: Clinical and microbiological evaluations were performed at 21 sites treated with SRP (control) and 21 sites treated with SRP+EPAP (test). All examinations were performed before treatment, 1 month after treatment, and 3 months after treatment. Results: There were no significant clinical differences between the test group and the control group. Microbiological analysis revealed that the relative expression level of Porphyromonas gingivalis was significantly lower in the test group than in the control group at 1 month after treatment. Clinical and microbiological results showed improvements at 1 month compared to baseline; in contrast, the results at 3 months after treatment were worse than those at 1 month after treatment. Conclusions: In this study, both SRP and SRP+EPAP were clinically and microbiologically effective as non-surgical periodontal treatments. In particular, the SRP+EPAP group showed an antimicrobial effect on P. gingivalis, a keystone bacterium associated with the onset of chronic periodontitis, in a short-term period. Periodic periodontal therapy, at intervals of at least every 3 months, is important for sustaining the microbiological effects of this treatment.

• 대한한방소아과학회지
• /
• 제38권1호
• /
• pp.55-77
• /
• 2024

Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

• 대한암한의학회지
• /
• 제11권1호
• /
• pp.1-21
• /
• 2006

This study was undertaken to evaluate safety and antitumor activity of Nexia, a processed extract of Rhus verniciflua STOKES by heating according to Korean patent 0504160 through toxicology, cancer research and clinical application. Nexia did not exhibit any toxicological symptoms through 13 week continuous treatment, dosage accumulation study and anaphylaxis response. The lifespan of four patients with acute lymphocytic leukemia under complete remission were 110, 83, 97, and 86 months after treatment of Nexia, respectively. These data suggest that Nexia, a processed extract by removing allergen from Rhus verniciflua STOKES, may have safety and antitumor activity and also still need continuous study on its mechanism and clinical trial.

• Journal of Korean Biological Nursing Science
• /
• 제12권1호
• /
• pp.63-72
• /
• 2010

Purpose: The purpose of this study is to assess the effects of raloxifene in prevention of cardiovascular disease in postmenopausal women. Methods: A systematic literature review was conducted. Data sources: The existing literature from 1986 to 2009 was searched electronically using the data base of Medline with the key words of hypertension, obesity, diabetes, cholesterol, lipid, myocardial infarction, coronary events with combination of raloxifene. Study selection: The criteria for inclusion in the review were 1) an randomized clinical trial (RCT), 2) postmenopausal women, 3) English or Korean language. Finally, 15 articles were included in the review. Data extraction: Findings from the studies were organized according to the results of lipid profile changes by two authors. Results: Among 15 articles, 12 studies reported the beneficial effects of raloxifene on LDL cholesterol and 9 studies on total cholesterol in the postmenopausal women. Conclusion: The consistent results on reduction of LDL cholesterol and total cholesterol in raloxifene using postmenopausal women were confirmed. However, the effect of raloxifene on other components of lipid profile and endothelial function were still remaining controversial.

• 대한한의학회지
• /
• 제31권4호
• /
• pp.1-8
• /
• 2010

Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

• Tuberculosis and Respiratory Diseases
• /
• 제41권4호
• /
• pp.372-378
• /
• 1994

연구배경 : PSV는 시술자가 정해준 만큼의 양압으로 기관 삽관 환자의 자발적 흡기 노력을 도울 수 있는 새로운 기계 호흡 방식으로서 5~10cm $H_2O$로 적용시 기관내 삽관으로 인한 기도 저항 및 인공 호흡기 회로에서 발생하는 저항을 극복할 수 있다. 저자들은 기계호흡 이탈시 IMV 단독적용과 IMV에 10cm $H_2O$ 압력의 PSV 병용시 이탈성공률 및 이탈과정 중 나타나는 생리적인 변화를 비교하고자 하였다. 방법 : 기계호흡을 받는 환자로 기저질환이 안정되고 활력징후 및 동맥혈 가스교환 지표가 안정된 환자에게 IMV와 IMV + PSV를 무작위 적용하였다. 각 환자의 임상적 특성, APACHE II score 및 영양상태를 조사하였고 이탈시도 후 48시간까지 맥박수, 평균혈압 및 호흡수를 측정하였다. 결과 : 총이탈시도는 37회였고 이중 IMV 단독적용군은 18회, IMV+PSV 동시적용군은 19회의 이탈시도가 있었다. 양 군간에 연령, 총 기계 호흡시간, 평균 APACHE II score, 영양 상태에 있어 통계적으로 유의한 차이는 없었고, 이탈 성공률은 IMV군이 38.4%(7/18), IMV+PSV군이 42.1%(8/19)로 통계적으로 유의한 차이는 없었다(p value=0.84). 이탈 시도 중의 평균 혈압, 맥박수, 호흡수의 이탈 시도전 기저치에 대한 변동량 역시 양군간에 유의한 차이는 없었다. 결론 : IMV에 PSV 10cm $H_2O$를 병용하는 것은 IMV 단독 이탈 방법에 비하여 이탈 성공률에 있어 더 나은 점은 없었으며 10cm $H_2O$ PSV는 이탈과정 중 유의한 생리적 변화는 일으키지 않았다.