• Title/Summary/Keyword: Clinical Trials

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The current status of the combination therapy of frequently used herbal extracts and anti-platelet drug, anti-coagulant drug in ischemic stroke patients hospitalized in oriental medical hospital (한방병원 입원 허혈성 뇌경색 환자에서 한방 의료보험용 엑스산제와 항혈소판제 및 항응고제의 병용투여 현황)

  • Han, Su-Ryun;Park, Sung-Hwan;Ahn, Young-Min;Ahn, Se-Young;Lee, Byung-Cheol
    • The Journal of Korean Medicine
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    • v.32 no.2
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    • pp.14-22
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    • 2011
  • Objective: Nowadays the combined use of herbal extracts and western medicines has been prevalent, but concern about its risk is also increasing. Even though the importance of clinical trials is well recognized, there have been only a few studies on the combined use of herbal extracts and western medicines. This study was aimed to examine which herbal extracts and antiplatelets or anticoagulants are most commonly prescribed together to inpatient ischemicstroke patients and investigate the combined prescription rate. Methods: We investigated the most frequently prescribed herbal extracts from two different sources. First, we chose herbal medicine extracts from 2008 Traditional Korean Medicine Utilization Status. Then, among patients who were admitted to Kyung-Hee Oriental Medical Center diagnosed with ischemic stroke, we found patients who were administered with these herbal medicine extracts and among these patients, we investigated how many were concomitantly administered with antiplatelets or anticoagulants. Second, we chose other herbal medicine extracts that were most often prescribed within Kyung-Hee Oriental Medical Center and found patients who were administered with these herbal medicine extracts, then investigated how many of them were concomitantly administered with specific antiplatelets or anticoagulants. Results: The most commonly prescribed herbal medicine extracts among ischemic stroke patients were Ojeok-san, Bojungikgi-tang, Sochungryong-tang and Samsoeum. About 46 to 69 percent were concomitantly administered with either specific antiplatelets or anticoagulants. Conclusions: The most often prescribed herbal medicine extracts in inpatient ischemic stroke patients are Ojeok-san, Bojungikgi-tang, Sochungryong-tang, and Samsoeum. Among patients who were prescribed with Ojeok-san, Bojungikgi-tang, Sochungryong-tang, Samsoeum, patients who were concomitantly administered with either antiplatelets or anticoagulants were about 46% to 69%.

A Study on Relation among Habitual Isoflavone Intake, Blood Pressure, and Serum Lipid Parameters in Korean Men and Women over 20 Years Old (20세 이상 남녀의 일상 식이중 이소플라본 섭취와 혈압, 혈중 지질과의 관련성)

  • Choi Mi-Kyeong;Kim Mi-Hyun;Sung Chung-Ja;Lee Won-Young;Park Jung-Duck
    • Korean Journal of Community Nutrition
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    • v.10 no.4
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    • pp.493-500
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    • 2005
  • There is some evidence that soy isoflavone has beneficial effects on the concentration of blood lipids. In this study, we investigated habitual isoflavone intake levels and the relation among dietary isoflavone intake, blood pressure, and blood lipids of adult men (n = 149) and women (n = 205). Anthropometric measurements including blood pressure, dietary in-take assessment using 24-hour recall method, and biochemical assessment using blood were conducted. The average age, height, weight, and BMI were 54.7 years, 168.5 cm, 67.3 kg, and 24.5 $kg/m^2$ for men and 53.9 years, 153.8 cm, 59.2 kg, and 25.0 $kg/m^2$ for women, respectively. The mean daily intakes of total food and energy were 1219.1 g and 1740.9 kcal for men and 1071.3 g and 1432.6 kcal for women, respectively. The mean daily isoflavones (daidzein + genistein) intake of men and women were 20.0 mg and 14.2 mg, respectively. Blood pressure of the subjects was 128.3/75.5 mmHg for men and 124.1/73.7 mmHg for women. Serum lipids of men and women were 180.2 and 184.9 mg/dL for total cholesterol, 160.8 and 137.6 mg/dL for triglyceride, 41.5 and 44.7 mg/dL for HDL-cholesterol, 106.6 and 112.7 mg/dL for LDL-cholesterol, and 3.5 and 3.3 for atherogenic index, respectively. Serum triglyceride and atherogenic index of men were significantly higher than those of women. In men, isoflavone intake and the level of total serum cholesterol were negatively (p < 0.05) correlated, after adjusted age. In women, there were significant correlations between isoflavone intake and blood pressure (systolic and diastolic), after adjusted age (p < 0.05). Based on these results, we concluded that higher isoflavone intake seemed to be related to a better lipid profile in men and lower blood pressure in women. But more epidemiological studies and controlled clinical trials would help to confirm the optimal amount required for the prevention and treatment of cardiovascular disease.

Management of Enteral Nutrition in the Pediatric Intensive Care Unit: Prokinetic Effects of Amoxicillin/Clavulanate in Real Life Conditions

  • Chiusolo, Fabrizio;Capriati, Teresa;Erba, Ilaria;Bianchi, Roberto;Atti, Marta Luisa Ciofi degli;Picardo, Sergio;Diamanti, Antonella
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.6
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    • pp.521-530
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    • 2020
  • Purpose: Malnutrition is a common feature in critically ill children. Enteral nutrition (EN) is the main strategy to nutritionally support critical ill children, but its use can be hindered by the development of intolerance. The study aimed to assess the effectiveness and safety of amoxicillin/clavulanate (A/C) to treat EN intolerance. Methods: We retrospectively evaluated patients admitted to the pediatric intensive care unit from October 2018 to October 2019. We conducted a case-control study: in the first 6 months (October 2018-April 2019) we implemented the nutritional protocol of our Institution with no drug, whereas in the second half (May 2019-October 2019) we employed A/C for 1 week at a dose of 10 mg/kg twice daily. Results: Twelve cases were compared with 12 controls. At the final evaluation, enteral intake was significantly higher than that at baseline in the cases (from 2.1±3.7 to 66.1±27.4% of requirement, p=0.0001 by Wilcoxon matched-pairs signed rank test) but not in the controls (from 0.2±0.8 to 6.0±14.1% of the requirement, p=NS). Final gastric residual volume at the end of the observation was significantly lower in the cases than in the controls (p=0.0398). The drug was well tolerated as shown by the similar safety outcomes in both cases and controls. Conclusion: Malnutrition exposes critically ill children to several complications that affect the severity of disease course, length of stay, and mortality; all may be prevented by early EN. The development of intolerance to EN could be addressed with the use of A/C. Future prospective clinical trials are needed to confirm these conclusions.

Antioxidant Activity and Inhibitory Effect of Aster scaber Thunb. Extract on Adipocyte Differentiation in 3T3-L1 Cells (참취(Aster scaber Thunb.) 추출물의 항산화 효과와 3T3-L1 지방전구세포에서의 지방분화 억제 효과)

  • Choi, Jun-Hyeok;Park, Yun-Hee;Lee, In-Seon;Lee, Sam-Pin;Yu, Mi-Hee
    • Korean Journal of Food Science and Technology
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    • v.45 no.3
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    • pp.356-363
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    • 2013
  • Clinical and preclinical trials of involving drugs with anti-obesity effects have focused on screening for herbal medicines suspected to have anti-obesity activities. In this study, an extract of Aster scaver Thunb., which was prepared in 80% methanol (ASE), was assessed for its total phenol content, total flavonoid content, antioxidant activity ability to scavenge the ${\alpha}-{\alpha}$-diphenyl-${\beta}$-picrylhydrazyl, 2,2'-azino-bis-[3-ethylbenzthiazoline]-6-sulfonic acid radical, and anti-adipogenic effects. The anti-adipogenic effect of ASE on the differentiation of 3T3-L1 pre-adipocytes to adipocytes was investigated by assaying the suppression of adipocyte differentiation and lipid accumulation by using western blot analysis and the Oil Red-O assay, respectively. The staining results showed that ASE significantly inhibited 3T3-L1. Western blot analysis results showed that ASE decreased the levels of peroxisome proliferator-activated receptor-${\gamma}$, CCAAT/enhancer-binding protein ${\alpha}$, and sterol regulatory element-binding protein 1c. These results demonstrate that ASE directly inhibits the differentiation of preadipocytes, and might be an important adjunct in the therapeutic efforts to reduce adipogenesis.

Roles of Prostatic Acid Phosphatase in Prostate Cancer (Prostatic acid phosphatase의 전립선 암에서의 역할)

  • Kong, Hoon-Young;Lee, Hak-Jong;Byun, Jong-Hoe
    • Journal of Life Science
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    • v.21 no.6
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    • pp.893-900
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    • 2011
  • Prostatic acid phosphatase (PAP) is one of the widely used biomarkers in the diagnosis of prostate cancer. It was initially identified in 1935 and is the most abundant phosphatase in the human prostate. PAP is a prostate-specific enzyme that is synthesized in prostate epithelial cells. It belongs to the acid phosphatase group that shows enzymatic activity in acidic conditions. PAP is abundant in prostatic fluid and is thought to have a role in fertilization and oligospermia. It also has a potential role in reducing chronic pain. But one of the most apparent functions of PAP is the dephosphorylation of macromolecules such as HER-2 and PI3P that are involved in the ERK1/2 and MAPK pathways, which in turn leads to inhibition of cell growth and tumorigenesis. Currently, clinical trials using PAP DNA vaccine are underway and FDA-approved immunotherapy using PAP is commercially available. Despite these clinically important aspects, molecular mechanisms underlying PAP regulation are not fully understood. The promoter region of PAP was reported to be regulated by NF-${\kappa}B$, TNF-${\alpha}$, IL-1, androgen and androgen receptors. Here, the features of PAP gene and protein structures together with the function, regulation and roles of PAP in prostate cancer are discussed.

Effect of Acupuncture(PC6) on Behavior, Dopamine Release in the Nucleus Accumbens in Rats Sensitized to Morphine (몰핀에 민감화된 흰쥐의 내관부위 자침이 행동과 측핵의 도파민 유리에 미치는 효과)

  • Kim, Sang-Ho;Lyu, Seung-Jun;Kim, Tae-Heon;Kang, Hyung-Won;Lyu, Yeoung-Su
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.19 no.4
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    • pp.982-992
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    • 2005
  • Acupuncture as a therapeutic intervention is widely used for the treatment of many functional disorders such as substance abuse and mental dysfunction. Clinical trials are currently underway to determine the effectiveness of acupuncture in the treatment of drug addiction. Yet, there are still many unanswered questions about the basic mechanism of acupuncture. Studies have shown that both the psychomotor stimulant effects and rewarding properties of addictive drugs, including morphine, are sensitized by repeated drug administration and raised the possibility that both of these effects may De linked to the same or closely overlapping the mesolimbic dopamine systems. Neiguan (PC6) point on the pericardium channel which is associated with the brain and its mental function, has been used to treat mental, psychosomatic disorders and gastroenterological disorders. The present study was designed to investigate the effect of acupuncture on repeated morphine-induced changes in extracellular dopamine levels using in vivo microdialysis and to measure the effect of acupuncture on repeated morphine-induced behavioral changes. Male Sprague-Dawley rats were treated twice a day for three days with increasing doses of morphine (10, 20 and 40 mg/kg, s.c.) or with saline. After 15 days of withdrawal, rats were challenged with morphine hydrochloride (5 mg/kg, s.c.). Acupuncture was applied at bilateral Neiguan (PC6) points for 1min after the morphine challenge. Results showed that acupuncture at the specific acupoint PC6, but not at control points (tail and HE8) significantly decreased both dopamine release, behavior induced by a systemic morphine challenge or a single s.c. morphine injection in the morphine-repeated animals. These results suggest that reduction in sensitization may be one mechanism whereby acupuncture alleviates morphine craving in addicts. Moreover, in a more general sense these results suggest that acupuncture can be used as a therapeutic intervention for correcting reversible malfunction of the body by direction of brain pathway and thus acupuncture can contribute to the biochemical balance in the central nervous system by regulating neurotransmitters.

Literature Review of Studies Related with Injinho in Korea (인진호(茵蔯蒿) 관련 국내 연구 동향 고찰)

  • Na, Ran-Hee;Bang, Chang-Ho;Jang, Seok-Oh;Choi, Ji-Hye;Ko, Ha-Neul;Kim, Lae-Hee;Rhee, Yun-Jin;Kim, Kang-San
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.24 no.3
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    • pp.361-366
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    • 2010
  • This study was practiced to investigate the existing study trends for Injinho that is numerously used for hepatobiliary diseases in oriental medicine. The studies selected from the domestic academic database included the following keywords in the title or abstract; 'Artemisia capillaris', 'Artemisia iwayomogi', 'Artemisia scoparia'. The studies considered were those published from January 1990 to May 2009. 198 studies were found to include the keywords related to the study subjects either in their title of contents or abstracts, and 104 studies among them were finally selected as subjects for this study. 81 studies among 104 studies(78%) were published between 2000 and 2009, while 23 studies(22%) were published between 1990 and 1999. Classification was proceeded according to study subjects as followed; 23 studies confirming hepatoprotective effect after artificial liver damage in a number of cells or the organ itself, 18 studies on anti-tumor effect, 12 studies on hyperlipidemia and fatty liver disease, and 4 studies on liver cirrhosis and hepatocyte regeneration. Furthermore, classification was conducted according to study methods as followed; 56 studies practicing in vitro, 33 studies practicing in vivo, 11 studies practicing both in vitro and in vivo. 2 studies on specific cases and 1 study on documentary records. The majority of studies report the affirmative effects of Injinho. However most study methods were restricted to in vitro and in vivo. Hereafter, case reports on various fields and multicenter clinical trials on Injinho is necessary.

Epidural Ketamine for postoperative Analgesia -Comparison with Epidural Morphine- (경막외케타민 주입을 이용한 술후 통증관리 -경막외몰핀과의 비교-)

  • Kim, Han-Soo;Baik, Seong-Wan;Kim, Inn-Se;Chung, Kyoo-Sub
    • The Korean Journal of Pain
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    • v.1 no.2
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    • pp.192-198
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    • 1988
  • Sixty patients, of ASA physical status class I for elective operations in the lower abdomen, perineum, or lower extremities, were studied in a comparative prospective trial to evaluate the efficacy of epidural morphine and ketamine for postoperative analgesia. They were divided into two groups: an epidural morphine sulfate group (EMS group; 30 patients), and an epidural ketamine hydrochloride group (EKH group; 30 patients). Indwelling epidural catheters were placed in the patients' lumber areas (L3-4) and then all patients were anesthetized with thiopental, nitrous oxide, and halothane. After the patients had fully recovered from the anesthesia, the analgesic agents were administered epidurally via the catheter when the patients complained of pain in the postoperative period. The groups were given either 0.1 mg/kg of morphine sulfate or 0.5 mg/kg of ketamine hydrochloride administered in a volume of 10 ml of normal saline. Patients were observed for the onset and duration of postoperative analgesia and for other effects. Total doses were $5.7{\pm}0.6\;mg$ of morphine sulfate in the EMS group and $27.9{\pm}3.3\;mg$ of ketamine hydrochloride in the EKH group. The onset of analgesia was detectable within 35 min.($23.5{\pm}6.3$ min) in 86.7% (26 cases) of the EMS group and within 10 min. ($7.8{\pm}3.7$ min.) in 76.7% (23 cases) of the EKH group. Mean duration of postoperative analgesia was $22.3{\pm}2.1\;hr$. in the EMS group. In the EKH group, the duration of analgesia was shorter and variable, the range of duration was from 2 hr. to 24 hr., Cardiopulmonary changes were statistically insignificant ih both groups. Side effects such as nausea, vomiting, urinary retention, pruritus, dizziness, and headache were observed in EMS group. In the EKH group, there was no discomfort except dizziness (3 cases) and headache (1 case). Epidural ketamine was a safe technique for postoperative analgesia, but because of the variability and relative shortness in the duration of analgesia the use of this technique will require further clinical trials.

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A Case Series of Survival Outcomes in Patients with Advanced-stage IIIb/IV Non-small-cell Lung Cancer Treated with HangAm-Plus

  • Bang, Sun-Hwi;Yoon, Jeung-Won;Cho, Chong-Kwan;Shin, Ji-Eun;Lee, Yeon-Weol;Yoo, Hwa-Seung
    • Journal of Pharmacopuncture
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    • v.15 no.2
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    • pp.31-35
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    • 2012
  • Background and Objectives: Non-small-cell lung cancer (NSCLC) represents approximately 80% of all lung cancers. Unfortunately, at their time of diagnosis, most patients have advanced to unresectable disease with a very poor prognosis. The oriental herbal medicine HangAm-Plus (HAP) has been developed for antitumor purposes, and several previous studies have reported its therapeutic effects. In this study, the efficacy of HAP was evaluated as a third-line treatment for advanced-stage IIIb/IV NSCLC. Methods: The study involved six patients treated at the East- West Cancer Center (EWCC) from April 2010 to October 2011. Inoperable advanced-stage IIIb/IV NSCLC patients received 3,000 or 6,000 mg of HAP on a daily basis over a 12-week period. Computed tomography (CT) scans were obtained from the patients at the time of the initial administration and after 12 weeks of treatment. We observed and analyzed the patients overall survival (OS) and progression-free survival (PFS). Results: Of the six patients, three expired during the study, and the three remaining patients were alive as of October 31, 2011. The OS ranged from 234 to 512 days, with a median survival of 397 days and a one-year survival rate of 66.7%. In the 12-week-interval chest CT assessment, three patients showed stable disease (SD), and the other three showed progressive disease (PD). The PFS of patients ranged from 88 to 512 days, the median PFS being 96 days. Longer OS and PFS were correlated with SD. Although not directly comparable, the OS and the PFS of this study were greater than those of the docetaxel or the best supportive care group in other studies. Conclusion: HAP may prolong the OS and the PFS of inoperable stage IIIb/IV NSCLC patients without significant adverse effects. In the future, more controlled clinical trials with larger samples from multi-centers should be conducted to evaluate the efficacy and the safety of HAP.

Mood and Color Distribution Characteristics of Music Genres (음악 장르에 따른 분위기와 색상 분포의 특성)

  • Moon, Chang-Bae;Kim, Hyun-Soo;Song, Min-Kyun;Kim, Byeong-Man
    • Science of Emotion and Sensibility
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    • v.14 no.1
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    • pp.59-72
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    • 2011
  • Since stress can cause a variety of diseases, the relaxation of stress is an important factor for preventing diseases. One way to relieve stress is to use auditory or visual materials. If auditory and visual ones are used together, the effect of stress relaxation will be maximized. In this context, we analyze mood distribution of genre of music and color distribution of mood from the mood data for musics and color data for mood words collected directly from volunteers. Based on these two distributions, we also perform the $X^2$-test with Minitab for checking that color distributions are different from genre to genre. The results show that a different genre has a different color distribution and that the distributions of color, brightness and saturation depend on mood (P<0.0001). The results will be used to develop an emotional lighting system which plays lighting according to music mood, which can be applied to psychotherapy but more data and analysis are needed for clinical trials.

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