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Adverse Effects of Ma-huang according to Dose : A Randomized Double-Blind Placebo-Controlled Pilot Study (마황용량에 따른 이상반응에 관한 예비연구: 무작위배정이중맹검시험)

  • Hsing, Li-Chang;Lee, Tae-Ho;Son, Dong-Hyug;Yeo, Jin-Ju;Yang, Chang-Sop;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.27 no.1
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    • pp.188-196
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    • 2006
  • Background: Ma-huang (Ephedra sinica) has been widely used to treat respiratory disease in oriental medicine for over a hundred years. Ma-huang preparations contain approximately 1.25% ephedrine alkaloids. Recently, the ephedra alkaloids have received much press lately due to adverse effects in those using whole extracts as 'dietary supplements' for weight loss or athletic performance enhancement, and these reports are troubling given the increasing use of Ma-huang by the general public. The purpose of this report is to determine the proper dosage to minimize adverse effects and maximize the potential curative value. Objectives : The object of this study was to find an effective yet low risk dosage of Ma-huang. Methods : The study was designed as a double-blind randomized placebo-controlled trial. The subjects of this study were 26 adults between 20 to 40 of age who agreed to participate in this study. They were allocated through randomization into three groups. Each group took three opaque capsules three times a day. A group (N=9) took one Ma-huang capsule and two placebo capsules, B group (N=8) took two Ma-huang capsules and one placebo capsule, C group (N=9) took three Ma-huang capsules. The total trial periods was two days. To compare the adverse effects of Ma-huang according to dosage, blood pressure and pulse were checked, and other adverse effects were assessed using a morning questionnaire, patient's global assessment scale and Wong-Baker faces pain rating. Results : The following result were obtained: 1. After taking 18 g of Ma-huang per day, pulse rate had a significant increase. 2. After taking more than 6 g of Ma-huang per day, palpitation would be increased significantly. 3. After taking more than 18 g of Ma-huang per day, tiredness would be increased significantly. Conclusion: According to the results, 12 g of Ma-huang per day will minimize adverse effects and maximize the potential curative value.

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Effect of Pulsed Electromagnetic Field Treatment on Alleviation of Lumbar Myalgia; A Single Center, Randomized, Double-blind, Sham-controlled Pilot Trial Study

  • Park, Won-Hyung;Sun, Seung-Ho;Lee, Sun-Gu;Kang, Byoung-Kab;Lee, Jong-Soo;Hwang, Do-Guwn;Cha, Yun-Yeop
    • Journal of Magnetics
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    • v.19 no.2
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    • pp.161-169
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    • 2014
  • The aim of this study is to investigate the efficacy of pulsed electromagnetic field (PEMF) on the alleviation of lumbar myalgia. This is a randomized, real-sham, double blind pilot study. 38 patients were divided into the PEMF group and the Sham group, each of which was composed of 19 patients (1 patient dropped out in the Sham group) of randomized allocation. The PEMF group was treated by using the PEMF device and the Sham group by using a sham device on the lumbar muscle and acupuncture points, three times a week for a total of two weeks. Evaluations of Visual Analogue Scale for bothersomeness (VASB), Visual Analogue Scale for pain intensity (VASP), Oswestry Disability Index (ODI), 36-Item Short Form Health Survey Instrument (SF-36), EuroQol-5Dimension (EQ-5D), Beck's Depression Inventory (BDI) and Roland-Morris Disability Questionnaire (RMDQ), etc. before and 1 week after treatment were carried out. The primary outcome measure was the VASB, measured 1 week after the end of the pulsed electromagnetic therapy. VASB scores for the PEMF group changed by $-2.06{\pm}2.12$ from the baseline, and that for the Sham group changed by $-0.52{\pm}0.82$ (p < 0.05). VASP scores for the PEMF group were reduced by $-2.10{\pm}2.12$ from the base line, and that for the Sham group was reduced by $-0.53{\pm}1.50$ (p < 0.05). PEMF group showed significant improvements in all VASB, VASP, ODI, SF-36, EQ-5D, BDI and RMDQ scores, while the Sham group showed significant improvements in all scores, except the VASP score. However, the VASB, VASP and RMDQ scores of the PEMF group were much lower than those of the Sham group. The two groups showed no significant difference in ODI, SF-36, EQ-5D and BDI. This study demonstrates the effectiveness of PEMF treatment for alleviating lumbar myalgia.

Adverse Effects of Ephedra According to Sasang Typology in Healthy Adults : A Double-Blind Randomized Controlled Trial (마황복용 후 사상체질별 이상반응에 관한 임상연구 : 무작위배정 이중맹검시험)

  • Lee, Tae-Ho;Hsing, Li-Chang;Yang, Chang-Sop;Kim, Lak-Hyung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.30 no.1
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    • pp.144-152
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    • 2009
  • Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of East Asia for over a hundred years. Despite safety concerns raised by some, the use of ephedra in traditional medicine is documented over more than 1,800 years. It is well established that ephedra is one of the central medicines in Korean 'Seseng constitution' medicine. In Sasang constitution medicine, all humans can be divided into one of four types: Soeumin, Soyangin, Taeumin or Taeyangin, and each constitution type has their own typical characteristics. Accordingly, it is hypothesized that the adverse effects of ephedra differ depending on the Sasang constitution classification. Objectives : The aim of this study was to determine adverse effects of ephedra which is classified as a Taeumin herb, and to observe whether the response differs or not. according to Sasang constitution classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who agreed to participate in this study. They were allocated through randomization to either ephedra group (N=55) or placebo group (N=24). where ephedra extract (6 g of dried ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, and patient's global assessment scale score for well known adverse events: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of ephedra, the pulse rate had a significant increase in all constitution types. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in the ephedra over the control group. In the ephedra group, the palpitation and dyspepsia score of the patients' global assessment scale had a significant increase in Soeumin, with palpitation and sweating score increasing in Soyangin. Others observations were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs differ for each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitutions.

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Evaluation of Respiration Reproducibility of Chest General X-ray Examination using Self-made Respiratory Synchronization Device (자체 제작한 호흡 동기화 장치를 통한 흉부 일반촬영 검사의 호흡 재현성 평가)

  • Kwon, Oh-Young;Lee, Chang-Hun;Yong, Keum-Ju;Jin, Seon-Hui;Jung, Da-Bin;Heo, Yeong-Cheol
    • Journal of the Korean Society of Radiology
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    • v.15 no.7
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    • pp.1049-1056
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    • 2021
  • The purpose of this study was to develop a respiratory synchronization device for X-ray (X-RSD) to increase the reproducibility of inspiration when examining the Chest X-ray of a patient who difficulty in breathing coordination. The X-RSD was self-made using an air pressure sensor and air was injected by connecting a ventilator to the mannequin for CPR. At this time, the amount of injected air was quantified using the SkillReporting device. After placing the X-RSD on the chest of the mannequin, the amount of air was tested in 6 steps from 200 to 700 cc by 100 cc increased. For the accuracy evaluation, the sensitivity of X-RSD was measured by repeating a total of 80 measurements, and the sensitivity was 100%, and very precise results were obtained. After that, the images examined while viewing the X-RSD of the chest lateral examination and the images obtained by the blind examination were compared and evaluated. The lung volume of X-RSD was larger than that of the blind test, and the deviation was smaller. Overall, the use of X-RSD can help with chest X-ray examination of patients who have difficulty in cooperating, and it is thought that it will be possible to contribute to the reduction of exposure dose by reducing the repeat rate of general X-ray examinations.

A Phantom Study for the Optimal Low-dose Protocol in Chest Computed Tomography Examination (흉부 전산화단층촬영검사를 위한 최적의 저선량 프로토콜에 관한 팬텀연구)

  • Kim, Young-Keun;Yang, Sook;Wang, Tae-uk;Kim, Eun-Hye
    • Journal of radiological science and technology
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    • v.44 no.2
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    • pp.101-107
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    • 2021
  • The purpose of this study was to evaluate optimal CT scan parameters to minimize patient dose to the irradiation and maintain satisfactory image quality in low-dose chest computed tomography (CT) scans. In a chest anthropomorphic phantom, chest CT scans were performed at different kVp and mA within reference of 3.4mGy in volume CT Dose Index (CTDIvol). The following quantitative parameters had been statistically evaluated: image noise, signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and figure of merit (FOM). Nine radiographers conducted the blind test to select the optimal kVp-mA combination. Results indicated that the kVp-mA combination of 80kVp-90mA, 100kVp-50mA, 120kVp-30mA and 140kVp-30mA were obtained high SNR and CNR. The 120kVp-30mA combination offered good compromise in the FOM, which showed the quality and dose performance. In the blind test, an image of 80kVp-90mA obtained a high score with 4.7 points, and 120kVp-10mA or 140kVp-10mA with a low tube current were observed severe noise and poor image quality, thus resulting in decreased diagnostic accuracy. On the other hand, in the combination of high kVp and high mA(140kVp-90mA), the image quality was improved, but the radiation dose was also increased. the FOM value of 140kVp-90mA was lower than 120kVp-30mA. The application of appropriate scan parameters in low-dose chest CT scans produced satisfactory results in dose and image quality for the accuracy of the clinical diagnosis.

Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna;Eom, Yoon Ji;Kwon, Dohyung;Lee, Jae Hyok;Jung, In Chul;Cho, Eun;Lee, Ji Eun;Cho, Seung-Hun
    • Journal of Oriental Neuropsychiatry
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    • v.32 no.2
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    • pp.81-93
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    • 2021
  • Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data

  • Fuchs, Charles S.;Muro, Kei;Tomasek, Jiri;Van Cutsem, Eric;Cho, Jae Yong;Oh, Sang-Cheul;Safran, Howard;Bodoky, Gyorgy;Chau, Ian;Shimada, Yasuhiro;Al-Batran, Salah-Eddin;Passalacqua, Rodolfo;Ohtsu, Atsushi;Emig, Michael;Ferry, David;Chandrawansa, Kumari;Hsu, Yanzhi;Sashegyi, Andreas;Liepa, Astra M.;Wilke, Hansjochen
    • Journal of Gastric Cancer
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    • v.17 no.2
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    • pp.132-144
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    • 2017
  • Purpose: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. Materials and Methods: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. Results: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. Conclusions: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.

The Effects of Ketamine Preemptive Analgesia on Postoperative Pain in Patients undergoing a Hystrectomy (Ketamine에 의한 선행 진통법이 자궁적출술 환자의 수술 후 통증에 미치는 효과)

  • Kim, Hong-Yeon;Yoon, Hae-Sang
    • Journal of Korean Academy of Nursing
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    • v.36 no.1
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    • pp.114-126
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    • 2006
  • Purpose: This study was performed to evaluate the pre-emptive analgesic effects of a small dose of intravenous ketamine on postoperative pain in patients undergoing a hysterectomy. Method: Sixty patients undergoing a hystrectomy under general anesthesia were randomly allocated to 2 groups. The experimental group(30 patients) received 0.3mg/kg of ketamine after induction of anesthesia, approximately 5 min prior to surgery, but the control group(30 patients)did not receive ketamine. Data was collected in a double-blind manner from April 1st, to October 30th, 2004. Postoperatively, the patients used a patient-controlled analgesia(PCA) pump. Blood pressure, pulse rate, pain, anxiety, count of times pressing the PCA button, administeration of additional analgesics and side effects of ketamine were measured at 1 hour, 3 hours, 6 hours and 24 hours after the operation. Result: There were no statistical differences in blood pressure, pulse rate, pain and anxiety between the experimental and control groups. There were statistical differences in blood pressure, pulse rate, pain and anxiety during the 24 hours postoperatively. In the experimental group, the number of times pressing the PCA button and administering additional analgesic drugs were significantly lower than those of the control group. Conclusion: A 0.3 mg/kg dose of ketamine given at approximately 5 min before surgery resulted in decreasing the number of times pressing the PCA and the administration of additional analgesics.

Orchidopexy: a 10-year Clinical Experience (고환고정술 : 10년간 임상경험)

  • Yoon, Jae-Sik;Kim, Kwang-Sae
    • Advances in pediatric surgery
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    • v.5 no.1
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    • pp.26-32
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    • 1999
  • We analyzed our experience with orchidopexy for undescended testicle performed during recent 10 years in order to evaluate our results and to determine the most effective treatment of undecended testes. Between 1988 and 1997, we treated 420 undescended tested (314 palpable and 106 nonpalpable) in 356 boys. Medical records were reviewed with respect to age at presentation, the surgical approach, testicular location, testicular volume and the final outcome. The average patient age at presentation was 4.1 years with 40.2 % presenting before age 2 years. Of 106 nonpalpable testes, 23 testes were intra-abdominal, 32 were preperitoneal and 51 were absent. During the first 5 years, we performed orchidopexy through 31 inguinal and 13 midline transabdominal incisions for 44 paitents with nonpalpable testes. In the next 5 years, all 47 patients with nonpalpable were treated through inguinal incisions. For the nonpalpable testes, the inguinal approach with or without intraperitoneal extension was successful in defining the location of testes and blind-ending vessels in all patients. Laparoscopy did not help to avoid surgical exploration in all our patients with nonpalpable tests. Of 339 inguinal and midline tranabdominal orchidopexies without spermatic vessels ligations, 324 testes were placed in the scrotum, 4 in the upper scrotum and 3 in the inguinal area. Eight testes underwent atrophy. Of 13 Fowler-Stephens orchidopexies, 7 were placed in the scrotum and 6 became atrophied. Testicular growths were noticed in most patients who underwent orchidopexies and the colume of pexed testes became as large as the contralateral normal testes by the mean duration of 43.3 months postoperatively. In conclusion, orchidopexies were successful in most cases of cryptochidism in terms of testicular position and growth. However, there were more testicular atrophies in cases where spermatic vessels were ligated. In cases of nonpalpable undescended testes, the inguinal approach with or without intraperitoneal extesion would be recommended.

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Comparison of Therapeutic Efficacy and Tolerance Between Nemonapride and Haloperidol in-Schizophrenic Patients (정신분열증환자에서 Nemonapride와 Haloperidol의 치료결과 및 내약성에 대한 비교분석)

  • Sung, Sang Kyung;Hong, Kwang Wha
    • Korean Journal of Biological Psychiatry
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    • v.2 no.1
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    • pp.123-130
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    • 1995
  • A single-blind comparative study was performed using haloperidol as a reference drug in order to evaluate the efficacy and safety of nemonapride, a new benzamide derivative, in sixty-nine Korean schizophrenic patients. the total period of the study was 8 weeks, maximum dosage of nemonapride was 36mg and that of haloperidol was 24mg. Psychopathology and extrapyramidal symptoms were assessed every week or four weeks until the end of the 8th week using the PANSS, BPRS, and 4 point general side effect check list, The drug safety was assessed every week until the end of the 8th week using vital sign, body weight, EEG, EKG, and blood chemistry. In total. one patient discontinued nemonapride treatment and seven patients discontinued haloperidol treatment before the end of the study. Therefore sixty-one patients(88 %) completed the study. PNASS and BPRS scores of the two groups on the end study point demonstrated a significant improvement compared with baseline score. The number of patients who had a clinical improvement of at least 20% in baseline score was similiar in both treatment groups. The difference of Simpson's rating scale socres were significant in both groups, and mean scores were more high in the haloperidol group than in nemonapride group. No significant EKG, EEG changes were induced, no relevant change in body weight or clinical laboratory parameters were observed in the sixty-one patients during 8 weeks and no Significant difference in the both groups. From these results, nemonapride is considered to be a clinically useful drug having a wide range of antipsychotic effect in schzophrenic patients.

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