• Title/Summary/Keyword: 방법론 평가

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Clinical Applications and Efficacy of Korean Ginseng (고려인삼의 주요 효능과 그 임상적 응용)

  • Nam, Ki-Yeul
    • Journal of Ginseng Research
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    • v.26 no.3
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    • pp.111-131
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    • 2002
  • Korean ginseng (Panax ginseng C.A. Meyer) received a great deal of attention from the Orient and West as a tonic agent, health food and/or alternative herbal therapeutic agent. However, controversy with respect to scientific evidence on pharmacological effects especially, evaluation of clinical efficacy and the methodological approach still remains to be solved. Author reviewed those articles published since 1980 when pharmacodynamic studies on ginseng have intensively started. Special concern was paid on metabolic disorders including diabetes mellitus, circulatory disorders, malignant tumor, sexual dysfunction, and physical and mental performance to give clear information to those who are interested in pharmacological study of ginseng and to promote its clinical use. With respect to chronic diseases such as diabetes mellitus, atherosclerosis, high blood pressure, malignant disorders, and sexual disorders, it seems that ginseng plays preventive and restorative role rather than therapeutics. Particularly, ginseng plays a significant role in ameliorating subjective symptoms and preventing quality of life from deteriorating by long term exposure of chemical therapeutic agents. Also it seems that the potency of ginseng is mild, therefore it could be more effective when used concomitantly with conventional therapy. Clinical studies on the tonic effect of ginseng on work performance demonstrated that physical and mental dysfunction induced by various stresses are improved by increasing adaptability of physical condition. However, the results obtained from clinical studies cannot be mentioned in the indication, which are variable upon the scientist who performed those studies. In this respect, standardized ginseng product and providing planning of the systematic clinical research in double-blind randomized controlled trials are needed to assess the real efficacy for proposing ginseng indication. Pharmacological mode of action of ginseng has not yet been fully elucidated. Pharmacodynamic and pharmacokinetic researches reveal that the role of ginseng not seem to be confined to a given single organ. It has been known that ginseng plays a beneficial role in such general organs as central nervous, endocrine, metabolic, immune systems, which means ginseng improves general physical and mental conditons. Such multivalent effect of ginseng can be attributed to the main active component of ginseng,ginsenosides or non-saponin compounds which are also recently suggested to be another active ingredients. As is generally the similar case with other herbal medicines, effects of ginseng cannot be attributed as a given single compound or group of components. Diversified ingredients play synergistic or antagonistic role each other and act in harmonized manner. A few cases of adverse effect in clinical uses are reported, however, it is not observed when standardized ginseng products are used and recommended dose was administered. Unfavorable interaction with other drugs has also been suggested, which the information on the products and administered dosage are not available. However, efficacy, safety, interaction or contraindication with other medicines has to be more intensively investigated in order to promote clinical application of ginseng. For example, daily recommended doses per day are not agreement as 1-2g in the West and 3-6 g in the Orient. Duration of administration also seems variable according to the purpose. Two to three months are generally recommended to feel the benefit but time- and dose-dependent effects of ginseng still need to be solved from now on. Furthermore, the effect of ginsenosides transformed by the intestinal microflora, and differential effect associated with ginsenosides content and its composition also should be clinically evaluated in the future. In conclusion, the more wide-spread use of ginseng as a herbal medicine or nutraceutical supplement warrants the more rigorous investigations to assess its effacy and safety. In addition, a careful quality control of ginseng preparations should be done to ensure an acceptable standardization of commercial products.

Clinical Efficacy of Erdosteine in Patients with Acute or Chronic Bronchitis -A Randomized, Double Blind, Comparative Study vs. Ambroxol- (급.만성 기관지염 환자에서 엘도스$^{(R)}$(Erdosteine)의 임상효과 -염산 암브록솔과의 무작위 이중맹검 비교시험-)

  • Kim, Seok-Chan;Lee, Sang-Hoak;Song, So-Hyang;Kim, Young-Kyoon;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1296-1307
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    • 1997
  • Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

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Nutritional Characteristics and Stability in Cell of the Yac-Sun Tea for Caronary Heart Disease (관상동맥 질환의 예방을 위한 약선차의 식품영양학적 구성 및 안전성 평가)

  • Kim, Woon-Ju;Cho, Hwa-Eun;Park, Sung-Hye
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.21 no.1
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    • pp.219-225
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    • 2007
  • This study was performed to provide basic ideas as understanding and application for oriental medicinal cuisine (Yak-Sun). To develop medicinal cuisine, it is necessary to grasp the theoretical system. And to develop medicinal cuisine for health enhancement, it is also required not only to consider constitutions but also to suggest the need of knowledge for moderation in terms of regimen along with the theory of oriental medicine. Also to develop medicinal cuisine according to the perspective of oriental medicinal theory, what should be taken into account is not only the understanding of the characteristics of food materials, but also the properties of them that the theory of oriental medicine. Lastly the scientific effect of the medicinal cuisine which is developed according to the oriental medicinal theory. And it is believed to De essential for the government to make effects to set a standard and laws to validate the medicinal effects and the process of assessment so that the systematic development can be encouraged, and to prepare guidance to food development for national health improvement. This research was planned and executed to evaluate how the composition of Yak-sun(oriental diet therapy) can effect health conditions of people who are suffering from diet-related diseases like cardiovascular related disease. by taking Yak-sun in a form of nutritional supplement with our daily meals. We produced Yak-sun tea with Mansam, Hwanggi, Tanggi and Paekchak and observed nutritional composition. We concluded that we could apply the components not only in a form of tea, but also in other forms of various food. The information we received from this conclusion will be a basic information on how we can apply oriental medicinal resources into other food and will also be a steppingstone for medicinal herbs to step foot in the field of functional food research, which already draws sizable attention world-wide.

A comprehensive comparison of IMRT and VMAT plan quality for orbital lymphoma (안와 림프종 환자의 방사선치료를 위한 세기조절방사선치료와 용적세기조절회전치료의 전산화 치료계획에 대한 고찰)

  • Yoo, Soon Mi;Ban, Tae Joon;Yun, In Ha;Baek, Geum Mun;Kwon, Kyung Tae
    • The Journal of Korean Society for Radiation Therapy
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    • v.26 no.2
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    • pp.281-287
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    • 2014
  • Purpose : The purpose of this study is to compare the plan quality of volumetric-modulated arc therapy (VMAT) and intensity-modulated radiation therapy (IMRT) for the treatment of orbital lymphoma. IMRT, partial single arc(SA) and partial-double arc(DA) VMAT plans for four patients with orbital lymphoma treated at our institution were used for this study. Conformity Index(CI), Paddick's Conformity Index(PCI) and Homogeneity Index(HI) of planning target volume(PTV) were used to evaluate dosimetric quality of each plan. The Monitor Unit (MU), treatment time and dose of ipsilateral lens from each type of plan were measured for comparison. Materials and Methods : The CI of PTV for IMRT, SA and DA were measured as 0.88, 0.86, 0.92. The PCI of DA was the lowest as 1.33. Also HI of DA was the lowest in measured plans as 1.15. Mean dose of lens, lacrimal gland, optic chiasm, the opposite optic nerve and both orbit was analyzed with V30, V20, V10, V5. The result showed that the lowest dose in IMRT highest in SA in opposite lens, lacrimal gland, optic nerve, orbit. Results : Treatment time and average MU of IMRT was about three times higher than SA. Conclusion : Considering the superior plan quality as well as the delivery efficiency of VMAT compared with that of IMRT, VMAT may be the preferred modality for treating orbital lymphoma.

Evaluation of Every Other Day - Cone Beam Computed Tomography in Image Guided Radiation Therapy for Prostate Cancer (전립선암의 영상유도방사선치료 시 격일 콘빔 CT 적용의 유용성 평가)

  • Park, Byoung Suk;Ahn, Jong Ho;Kim, Jong Sik;Song, Ki Won
    • The Journal of Korean Society for Radiation Therapy
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    • v.26 no.2
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    • pp.289-295
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    • 2014
  • Purpose : Cone Beam Computed Tomography(CBCT) in Image Guided Radiation Therapy(IGRT), Set-up error can be reduced but exposure dose of the patient due to CBCT will increase. Through this study, we are to evaluate by making a scenario with the implementation period of CBCT as every other day. Materials and Methods : Of prostate cancer patients, 9 patients who got a Intensity Modulated Radiation Therapy(IMRT) with CBCT in IGRT were analyzed. Based on values corrected by analyzing set-up error by using CBCT every day during actual treatment, we created a scenario that conducts CBCT every other day. After applying set-up error values of the day not performing CBCT in the scenario to the treatment planning system(Pinnacle 9.2, Philips, USA) by moving them from the treatment iso-center during actual treatment, we established re-treatment plan under the same conditions as actual treatment. Based on this, the dose distribution of normal organs and Planning Target Volume(PTV) was compared and analyzed. Results : In the scenario that performs CBCT every other day based on set-up error values when conducting CBCT every day, average X-axis : $0.2{\pm}0.73mm$, Y-axis : $0.1{\pm}0.58mm$, Z-axis : $-1.3{\pm}1.17mm$ difference was shown. This was applied to the treatment planning to establish re-treatment plan and dose distribution was evaluated and as a result, Dmean : -0.17 Gy, D99% : -0.71 Gy of PTV difference was shown in comparison with the result obtained when carrying out CBCT every day. As for normal organs, V66 : 1.55% of rectal wall, V66 : -0.76% of bladder difference was shown. Conclusion : In case of a CBCT perform every other day could reduce exposure dose and additional treatment time. And it is thought to be able to consider the application depending on the condition of the patient because the difference in the dose distribution of normal organs, PTV is not large.

Evaluation of Ovary Dose for woman of Childbearing age Woman with Breast cancer in tomotherapy (가임기 여성의 유방암 토모치료 시 난소선량 평가비교)

  • Lee, Soo Hyeung;Park, Soo Yeun;Choi, Ji Min;Park, Ju Young;Kim, Jong Suk
    • The Journal of Korean Society for Radiation Therapy
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    • v.26 no.2
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    • pp.337-343
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    • 2014
  • Purpose : The aim of this study is to evaluate unwanted scattered dose to ovary by scattering and leakage generated from treatment fields of Tomotherapy for childbearing woman with breast cancer. Materials and Methods : The radiation treatments plans for left breast cancer were established using Tomotherapy planning system (Tomotherapy, Inc, USA). They were generated by using helical and direct Tomotherapy methods for comparison. The CT images for the planning were scanned with 2.5 mm slice thickness using anthropomorphic phantom (Alderson-Rando phantom, The Phantom Laboratory, USA). The measurement points for the ovary dose were determined at the points laterally 30 cm apart from mid-point of treatment field of the pelvis. The measurements were repeated five times and averaged using glass dosimeters (1.5 mm diameter and 12 mm of length) equipped with low-energy correction filter. The measures dose values were also converted to Organ Equivalent Dose (OED) by the linear exponential dose-response model. Results : Scattered doses of ovary which were measured based on two methods of Tomo helical and Tomo direct showed average of $64.94{\pm}0.84mGy$ and $37.64{\pm}1.20mGy$ in left ovary part and average of $64.38{\pm}1.85mGy$ and $32.96{\pm}1.11mGy$ in right ovary part. This showed when executing Tomotherapy, measured scattered dose of Tomo Helical method which has relatively greater monitor units (MUs) and longer irradiation time are approximately 1.8 times higher than Tomo direct method. Conclusion : Scattered dose of left and right ovary of childbearing women is lower than ICRP recommended does which is not seriously worried level against the infertility and secondary cancer occurrence. However, as breast cancer occurrence ages become younger in the future and radiation therapy using high-precision image guidance equipment like Tomotherapy is developed, clinical follow-up studies about the ovary dose of childbearing women patients would be more required.

Evaluation of a rapid diagnostic kit "BIOLINE RSVTM" for the detection of respiratory syncytial virus (Respiratory Syncytial Virus 감염의 조기 진단 kit "바이오라인 알에스브이TM"의 평가)

  • Kim, So-Hee;Sung, Ji-Yeon;Yang, Mi-Ae;Eun, Byung-Wook;Lee, Jin-A;Choi, Eun-Hwa;Lee, Hoan-Jong
    • Pediatric Infection and Vaccine
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    • v.14 no.1
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    • pp.91-96
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    • 2007
  • Purpose : This study was performed to evaluate a new rapid diagnostic kit (BIOLINE $RSV^{TM}$; Standard Diagnostics Inc., Yongin, Korea), a lateral-flow immunoassay, in the detection of respiratory syncytial virus (RSV) from the nasopharyngeal aspirates (NPA) of children with lower respiratory tract infections (LRTIs) in comparison with other diagnostic methods. Methods : Three hundred and nineteen NPAs were selected from a large pool of NPAs that had been obtained from children with LRTIs. All specimens had already been tested for RSV by culture and immunofluorescent (IF) test, and had been kept frozen. Tests with BIOLINE $RSV^{TM}$ were performed at least twice. All who conducted the experiments or interpreted the test results were blinded to the results of both culture and IF tests. Results : One hundred seven (97.3%) of 110 specimens that were positive for RSV by both culture and IF test, 29 (87.9%) of 33 that were positive by IF test only, 20 (76.9%) of 26 that were positive by culture only, and 140 (93.3%) of 150 that were negative by both methods were negative for RSV by BIOLINE $RSV^{TM}$. By combining the above results, the following 5 diagnostic values of BIOLINE $RSV^{TM}$ were determined in comparison with viral culture or IF test; sensitivity, 92.3% (156/169, 95% confidence interval [CI], 87.1-97.5%); specificity, 93.3% (140/150, 95% CI, 88.4-98.2%); positive predictive value, 94.0% (156/166, 95% CI, 89.5-98.5%); negative predictive value, 91.5% (140/143, 95% CI, 86.0-97.0%); and agreement, 95.9% (306/319, 95% CI, 92.1-99.7%), respectively. Conclusion : This study revealed that BIOLINE $RSV^{TM}$ demonstrated good sensitivity and specificity for the detection of RSV antigen from NPAs of children with LRTIs. Because of simple methods and quick results, this test may be useful for the diagnosis of RSV infection during the epidemic periods.

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The Prognostic Role of B-type Natriuretic Peptide in Acute Pulmonary Thromboembolism (급성 폐혈전색전증 환자에서 예후 인자로서 혈중 BNP의 의의)

  • Lee, Su Jin;Lee, Jae Hyung;Park, Ji Young;Jo, Woo Sung;Kim, Ji Eun;Kim, Ki Uk;Park, Hye Kyung;Kim, Yun Seong;Lee, Min Ki;Park, Soon Kew
    • Tuberculosis and Respiratory Diseases
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    • v.60 no.5
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    • pp.540-547
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    • 2006
  • Background : Vital stability and right side heart failure are major prognostic factors of acute pulmonary thromboembolism. While it is important to recognize right side heart failure, it is often difficult in real practice. Recently, several studies have described early diagnostic tools for detecting right side heart failure including echocardiography and biochemical markers. This study, we evaluated the prognostic role of the B-type natriuretic peptide (BNP) in an acute pulmonary thromboembolism. Methods : Thirty-four patients with a diagnosis of acute pulmonary thromboembolism were enrolled in the study. The BNP levels were measured and echocardiography was performed at the Emergency Department. Data on the prognostic factors including ventilatory support, vital stability, pulmonary artery pressure, degree of tricuspid valve regurgitation, complications and death was collected from the patients' medical records. The patients with an acute pulmonary thromboembolism were divided into two groups based on the vital stability and the BNP level and the cutoff values and prognostic factors of the two groups were compared. Results : The predictors of the vital stability that influence the prognosis of patients with acute pulmonary thromboembolism were the BNP level, ventilatory support and death. The plasma BNP levels showed a strong correlation with the vital stability, ventilatory support, thrombolytic therapy and death. When the BNP cutoff level was set to 377.5 pg/dl in a ROC curve, the sensitivity and the specificity for differentiating between the groups with stable or unstable vital signs was 100% and 90%, respectively. Conclusion : This study indicates that a measurement of the plasma BNP levels may be a useful prognostic marker in patients with an acute pulmonary thrombo-embolism.

Establishment of a Radiation-Induced Fibrosis Model in BALB/c Mice (BALB/c 마우스를 이용한 방사선섬유증 모델 확립)

  • Ryu, Seung-Hee;Lee, Sang-Wook;Moon, Soo-Young;Oh, Jeong-Yoon;Yang, Youn-Joo;Park, Jin-Hong
    • Radiation Oncology Journal
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    • v.28 no.1
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    • pp.32-38
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    • 2010
  • Purpose: Although radiation-induced fibrosis is one of the common sequelae occurring after irradiation of skin and soft tissues, the treatment methods are not well standardized. This study aimed to establish the skin fibrosis mouse model by fractionated radiation for the further mechanism studies or testing the efficacy of therapeutic candidates. Materials and Methods: The right hind limbs of BALB/c mice received two fractions of 20 Gy using a therapeutic linear accelerator. Early skin damages were scored and tissue fibrosis was assessed by the measurement of a leg extension. Morphological changes were assessed by H&E staining and by Masson's Trichrome staining. TGF-${\beta}1$ expression from soft tissues was also detected by immunohistochemistry and PCR. Results: Two fractions of 20 Gy irradiation were demonstrated as being enough to induce early skin damage effects such as erythema, mild skin dryness, dry and wet desquamation within several weeks of radiation. After 13 weeks of irradiation, the average radiation-induced leg contraction was $11.1{\pm}6.2mm$. Morphologic changes in irradiated skin biopsies exhibited disorganized collagen and extracellular matrix fibers, as well as the accumulation of myofibroblasts compared to the non-irradiated skin. Moreover, TGF-${\beta}1$ expression in tissue was increased by radiation. Conclusion: These results show that two fractions of 20 Gy irradiation can induce skin fibrosis in BALB/c mice accompanied by other common characteristics of skin damages. This animal model can be a useful tool for studying skin fibrosis induced by radiation.

Depressive Symptoms in Patients with Parkinson's Disease (파킨슨병 환자에서의 우울증상)

  • Lee, Moon-Sook;Yang, Chang-Kook;Hah, Hong-Moo;Kim, Jae-Woo
    • Korean Journal of Psychosomatic Medicine
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    • v.11 no.1
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    • pp.25-35
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    • 2003
  • Objectives: The aim of this study was to investigate 1) the prevalence of depressive symptoms, 2) the severity of depressive symptoms, 3) the correlation of depressive symptoms with clinical variables, and 4) factors that contribute to depressive symptoms in patients with Parkinson's disease. Methods: One hundred eighteen patients with Parkinson's disease referred from the Parkinson's Disease Clinic of Dong-A University Hospital, Busan, Korea, completed a self-administered questionnaire package, which included basic demographic data, the Beck Depression Inventory, the Parkinson's disease quality of life questionnaire, the Symptom Checklist-90-Revision(SCL-90-R), and the Spielberger's State-Trait Anxiety Inventory. In addition, a structured interview and a complete neurological examination, including the Hoehn and Yahr stage, the motor part of the Unified Parkinson's Disease Rating Scale(some selected scales of UPDRS part III), the Schwab and England Activities of Daily Living scale(ADL), and the Korean version of Mini-Mental State Examination were performed. Results: 1) Based on BDI score, subjects were divided into four groups:severely(40.7%), moderately(13.6%) and mildly(12.7%) depressive and non-depressive(33.1%). 2) The severity of depressive symptom in Parkinson's disease was positively correlated with Hoehn and Yahr(H & Y) stage(r=0.34, p<0.0001), the severity of motor symptom(r=0.35, p<0.0001), and trait anxiety inventory(r=0.33, p<0.001). On the other hand, the severity of depressive symptom was negatively correlated with educational level(r=-0.34, p<0.001), ADL(r=-0.37, p<0.0001) and Parkinson's disease quality of life (PDQL)(r=-0.69, p<0.0001). Among several clinical variables, the PDQL was the most influential factor predicting whether the depressive symptom was present or not. Conclusion: This study suggests that depressive symptom is very prevalent among patients with Parkinson's disease. Data from this study indicate that medical staffs who take care of patients with Parkinson's disease should pay attention to finding and treating depressive symptom among their patients. With appropriate psychiatric intervention, patient's depressive symptom can be minimized or alleviated and thus, the quality of life in these patients is likely enhanced.

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