• Title/Summary/Keyword: Clinical Trials

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Legal Issues on Pharmacopunture (약침의 한방의료행위성에 대한 검토)

  • Jung, Kyu Won
    • The Korean Society of Law and Medicine
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    • v.19 no.1
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    • pp.3-20
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    • 2018
  • Pharmacopunture is a new combined method of acupunture and oriental drugs. Recently, this method is widely used to treat traffic accident patients in oriental medicine. However, there is no evidences of treatment, no information of effects and side-effects of this method, and no information of drugs used. In South Korea, western medicine and oriental medicine are regulated differently. When a new technology is invented in the area of western medicine, that method should pass several stages of clinical trials. After that processes, that method can be done as a medical practice. However, in the area of oriental medicine, there is no process like that. According to in South Korea, medical practice without license are composed of two behaviors. First type is that medical practice is done by a person who has no medical license. Second type is that medical practice is done by a person who has a medical license but the area of the license is different. Because of this reason, the distinction between the western medical practices and the oriental medical practices is very important. Medical practices are protected by license mainly because they can harm human life or body. When we invented new medical practice and try to practice it to the patients, we should consider the risk of that method whether it is western medical practice or oriental medical practice. It is not clear that the pharmcopunture which has been done is satisfied the standard of medical treatment.

Development of quality of life with WHOQOL-HIV BREF Korean version among HIV patients in Korea (후천성면역결핍환자의 삶의 질 측정을 위한 한국판 WHOQOL-HIV BREF 개발)

  • Lee, Won Kee;Kim, Shin-Woo;Kim, Hye-In;Chang, Hyun-Ha;Lee, Jong-Myung;Kim, Yoon-Joo;Lee, Mi-Young
    • Journal of the Korean Data and Information Science Society
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    • v.25 no.2
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    • pp.337-347
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    • 2014
  • There is no known publication about assessment of quality of life (QOL) in Korean HIV patients. We aimed to assess the QOL of HIV patients. We developed Korean version of the WHOQOL-HIV BREF (short forms of WHOQOL-HIV, 31 questions with 6 domains). Survey data from 220 HIV-positive adults were obtained in 14 centers in South Korea. Male were dominant (202/220, 91.8%). Mean age was $40.6{\pm}12.1$. Mean CD4+ T-cell count was $414.9{\pm}226.6/ml$. Overall of WHOQOL-HIV BREF were $53.2{\pm}14.9$ (perfect score=100) (Cronbach's ${\alpha}$ = 0.942). It is similar score comparing to another country (Portugal: 54.75/100, measured by WHOQOL-HIV). Correlations of WHOQOL-HIV BREF score with patients' subjective QOL and with subjective satisfaction were 0.747 (p <0.01) and 0.651 (p <0.01), respectively. WHOQOL-HIV BREF have internal reliability. There is in need of monitoring for QOL of HIV patients in the clinical practice and trials. This survey tool could be used to assess the effect of intervention. Additionally, comparison across countries would be possible and promising.

A Case of Continuous Positive Airway Pressure Therapy in a Patient with Central Sleep Apnea and Heart Failure (중추성 수면 무호흡이 동반된 심부전 환자에서 지속적 상기도 양압술 적용 1례)

  • An, Jee Young;Kim, Shin Bum;Kang, Hyeon Hui
    • Sleep Medicine and Psychophysiology
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    • v.24 no.2
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    • pp.118-123
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    • 2017
  • Central sleep apnea (CSA) is a highly prevalent comorbidity in patients with heart failure and may present in 25 to 40 percent of heart failure patients. Continuous positive airway pressure (CPAP) is the primary therapeutic option and effective in treatment of obstructive sleep apnea (OSA). In heart failure patients with CSA, several trials of CPAP showed a number of positive effects in heart failure treatment. A 58-year-old male visited the hospital because of dyspnea and he was diagnosed as heart failure with ischemic heart disease. He underwent coronary angiography and received percutaneous coronary intervention due to stenosis at the middle of left anterior descending coronary artery. However, dyspnea was not completely improved after treatment with percutaneous coronary intervention. The patient also experienced snoring and sleep apnea which worsened with symptom of dyspnea in the recent year. We suspected CSA and the patient underwent polysomnography to confirm whether sleep apnea was present. During the polysomnography, CSA with Cheyne-Stokes respiration (CSR) was observed and apnea-hypopnea index was 45.9/hr. The patient was treated with CPAP. After CPAP treatment, hypoxemia and CSA were resolved and dyspnea was improved with reducing NYHA class. We report a case successfully treated with clinical improvement by presuming CSA in a patient with heart failure.

Effect of Recombinant Human Erythropoietin in the Anemia of Prematurity : a Pilot Study (미숙아 빈혈에 대한 Recombinant Human Erythropoietin의 효과 : 예비연구)

  • Lee, Kyung-Ah;Shin, Soon-Moon;Park, Yong-Hoon;Hah, Jeong-Ok
    • Journal of Yeungnam Medical Science
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    • v.11 no.1
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    • pp.115-126
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    • 1994
  • The recent availability of recombinant human erythropoietin has opened new perspectives in the management of a variety of anemias. Clinical trials have been initiated in several countries using different approaches and methodology. We randomly assigned twelve premature infants(gestational age < 32 week) at high risk of requiring erythrocyte transfusion for anemia of prematurity with either subcutaneous recombinant human erythropoietin or a placebo. Treatment with rHuEPO was initiated at a dose of 100 units/kg day for 3 days a week. All patients were given supplemental oral iron therapy at a dose of 3 mg/kg per day, as tolerated and oral vitamin E at a dose of 25 units per day. Treated and control babies did not differ with respect to weight, hematocrit, overall mean reticulocyte count or rate of growth respectively. However, reticulocyte counts increased earlier in patients given rHuEPO. We conclude that rHuEPO administration is safe and feasible at the dose studied.

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The Comparison of Survival Rates of Postoperative Adjuvant Chemotherapies in The Stage III Gastric Cancer Patients (3기 위암환자에서 시행한 술 후 보조항암화학요법들의 생존율 비교)

  • Kim, Eun-Mi;Kim, Se-Won;Kim, Sang-Woon;Song, Sun-Kyo
    • Journal of Yeungnam Medical Science
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    • v.23 no.2
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    • pp.193-204
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    • 2006
  • Purpose: Various postoperative adjuvant chemotherapy regimens have been proposed for the patients with advanced gastric cancer. The majority of clinical trials have shown no significant difference in the survival benefit. The aim of this study was to compare the survival rates of postoperative adjuvant chemotherapies used in stage III gastric cancer patients who received curative gastrectomy. Materials and Methods: Between 1990 and 1999, a survival analysis was performed in 260 patients who received curative gastric resection and postoperative adjuvant chemotherapy. The patients were divided into four groups according to the chemotherapeutic regimens received. The groups were: the F group: furtulon alone, FM group: furtulon and mitomycin, FAM group: 5-FU, adriamycin and mitomycin, FLEP group: 5-FU, leucovorin, etoposide and cisplatin. The survival rates were analyzed using the Kaplan-Meier method and the Cox proportional hazards model. Results: There were no differences among the groups of patients with regard to tumor characteristics except for lymph node metastasis and the ratio of metastasis to lymph nodes. In the FLEP group, the ratio of metastasis to lymph nodes was higher than in the other groups. The five and ten year survival rates of F, FM, FAM and FLEP were 51.9%, 28.9%, 59.5%, 49.8%, 66.1%, 57.4% and 30.0%, 27.5%, respectively. The univariate analysis showed that age, Borrmann type, lymph node metastasis, ratio of metastasis to lymph nodes, postoperative adjuvant chemotherapy and recurrence were significant factors for survival. For the multivariate analysis, recurrence, age, Borrmann type, ratio of lymph node metastasis and lymph node dissection were independent prognostic factors; however, the postoperative adjuvant chemotherapy was not an independent prognostic factor. Conclusion: The FAM regimen was the most beneficial postoperative adjuvant chemotherapy for improved survival rates; the FM regimen was the second and the FLEP regimen was the last. In order to determine the effectiveness of postoperative adjuvant chemotherapy in stage III gastric cancer, well designed prospective studies including a surgery only group will be needed.

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Phase II Study on Javanica Oil Emulsion Injection (Yadanzi®) Combined with Chemotherapy in Treating Patients with Advanced Lung Adenocarcinoma

  • Lu, Yan-Yan;Huang, Xin-En;Cao, Jie;Xu, Xia;Wu, Xue-Yan;Liu, Jin;Xiang, Jin;Xu, Lin
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.8
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    • pp.4791-4794
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    • 2013
  • Purpose: To investigate the efficacy and safety of Javanica oil emulsion injection (Yadanzi$^{(R)}$) combined with pemetrexed and platinum (PP) for treating patients with advanced lung cancer. Patients and Methods: From June 2011 to June 2013, we recruited 58 patients with advanced lung cancer, and divided them into two groups. Twenty eight patients received Yadanzi$^{(R)}$ (from ZheJiang Jiuxu Pharmaceutical Co., Ltd.) together with PP chemotherapy (combined group), while the others were given only PP chemotherapy (control group). After two cycles of treatment, efficacy and safety of treatment were evaluated. Results: The overall respnse rate [(CR+PR+SD)/(CR+PR+SD+PD)] of the combined group was higher than that of control group (89.7% vs. 86.2%, p>0.05). Regarding rate of life improvement, it was 82.8% in combined group, and 51.7% in the control group (p<0.05). In terms of side effects, leukopenia in combined group was less frequent than that in control group (p<0.05). More patients in the control group were found to suffer liver toxicity. Conclusions: Javanica oil emulsion injection combined with chemotherapy could be considered as a safe and effective regimen in treating patients with advanced lung adenocarcinoma. It can improve the quality of life and reduce the possibility of leukopenia. Further clinical trials with a large sample size should be conducted to confirm whether addition of Yadanzi$^{(R)}$ to chemotherapy could increase the response rate, reduce toxicity, enhance tolerability and improve quality of life for patients with advanced lung cancer.

Effect of Hormone Therapy on Long-term Outcomes of Patients with Human Epidermal Growth Factor Receptor 2-and Hormone Receptor-Positive Metastatic Breast Cancer: Real World Experience in China

  • Du, Feng;Yuan, Peng;Wang, Jia-Yu;Ma, Fei;Fan, Ying;Luo, Yang;Xu, Bing-He
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.3
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    • pp.903-907
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    • 2015
  • Background: Among human epidermal growth factor receptor 2 (HER2)-positive breast cancer, more than half are also hormone receptor (HR)-positive. Although HR is a predictive factor for the efficacy of hormone therapy, there are still some uncertainties in regard to the effects on patients with HR-positive and HER2-positive metastatic breast cancers due to the potential resistance to hormone therapy caused by co-expression of HR and HER2. There are no clinical trials directly comparing the efficacy of hormonal therapy with chemotherapy. Materials and Methods: To examine the real-world effect of hormone therapy on patients with HR-positive and HER2-positive metastatic breast cancers, a cross-sectional study of a representative sample of the Chinese population was conducted. The study included 113 patients who received first-line and second-line palliative treatment between 2005 and 2010 in the Cancer Institute and Hospital, Chinese Academy of Medical Science. The effect of hormone therapy on overall survival (OS) was studied. Results: The patients who received hormone therapy (n=51) had better overall survival in contrast to those who received chemotherapy with anti-HER2 therapy (n=62) in first- or second-line treatment. The difference was of borderline statistical significance (51.8m vs 31.9m, p=0.065). In addition, the effect of hormone therapy did not differ significantly with other prognostic factors, including age (${\leq}50$ years or >50 years), disease free survival (${\geq}2$ years or < 2 years) and site of metastasis (visceral or bone/soft tissue). On multivariate analysis, administration of hormone therapy was associated with a trend toward a favorable prognosis (p=0.148, HR=0.693, 95%CI 0.422-1.139). Age more than 50 years was the sole independent harmful prognostic factor (p<0.001, HR=2.797, 95%CI 1.676-4.668). Conclusions: Our data suggest that hormonel therapy may improve outcomes of the patients with ER-positive and HER2-positive metastatic breast cancer.

Preliminary Study to Develop an Objective Method for Evaluating Facial Palsy Sequelae Using Facial Scanning System (안면계측검사를 통한 안면마비후유증 객관적 평가도구 개발을 위한 기초 연구)

  • Ryu, Soo Hyeong;Lee, Su Yeon;Kim, Hong Guk;Ryoo, Dek Woo;Kim, Sung Jin;Jeong, Seong Mok;Baek, Seung Won;Goo, Bon Hyuk;Kim, Min Jeong;Park, Yeon Cheol;Seo, Byung Kwan;Nam, Sang Soo;Baek, Yong Hyeon
    • Journal of Acupuncture Research
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    • v.33 no.3
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    • pp.89-99
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    • 2016
  • Objectives : This study was performed to develop objective methods for evaluating facial palsy sequelae using a 3D Facial Scanning System. Methods : Fifty-eight patients with facial palsy sequelae were selected. Their medical records were reviewed to collect demographic data, facial palsy sequelae evaluation, Facial Disability Index questionnaire, and test results (3D Facial Scanning System). Five different facial expressions (at rest, eye closure, eyebrow elevation, smiling, and whistling) were photographed. Sunnybrook Scale was associated with distances between predetermined facial points. Results : The average Sunnybrook composite score was $58.88{\pm}17.31$. Secondary movements (mouth to eye synkinesis, contracture of eye, and contracture of mouth) showed significant difference according to the Sunnybrook Scale. In voluntary movements, eyebrow height at eyebrow elevation, length between mouth angle and central line while whistling, and eyelid width at maximum eye opening showed significant difference. Facial palsy Sequelae Index (FSI) was correlated with Sunnybrook sub-scales (resting symmetry, voluntary movement, and synkinesis). Conclusion : These results demonstrate that a 3D Facial Scanning System is useful for evaluating facial palsy sequelae. This method may facilitate objective evaluation for facial palsy sequelae and it could be applied in clinical trials.

The Effects of Gall Bladder Jeonggyeok and Seunggyeok on Radial Pulse Variation in Healthy Human Subjects (담정격 및 담승격 자침이 정상 성인의 맥파변화에 미치는 영향)

  • Kim, Yun Joo;Kang, Jae Hui;Yoon, Kwang Sik;Jo, Seoung Eun;Hong, Seo Jin;Yun, Gee Won;Oh, Seo Young;Lee, Hyun
    • Journal of Acupuncture Research
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    • v.33 no.3
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    • pp.45-66
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    • 2016
  • Objectives : The purpose of this study is to find parameters to compare the effects of Sa-Am acupuncture with gall bladder jeonggyeok and seunggyeok on radial pulse in healthy subjects. Methods : 60 healthy subjects participated in this study and divided into the gall bladder jeonggyeok group (GB+ group), the gall bladder seunggyeok group (GB- group) and the control group. Radial pulse was measured by a 3 dimensional pulse imaging system (DMP-3000) before, immediately after, 30 minutes after and 60 minutes after acupuncture on the Cun, Guan and Chi in the GB+, GB- group and at the same time for the control group. Results : 1. The GB+ and GB- group exhibited significantly increased T, M4/M1 and decreased T1/T, T2/T, T5/T, M1, M2 compared to the control group. 2. The GB+ and GB- group exhibited significantly increased H4, Ad/Ap, RAI/HR and decreased As/Ap, Aw/Ap in the right Guan and decreased pulse power volume/min in the left Guan compared to the control group. 3. The GB- group exhibited significantly decreased M3, M3/M1 and increased M4/M1, M5, M5/M1 compared to the GB+ group. The GB+ group exhibited significantly decreased T4/(T-T4) compared to the GB- group. 4. The GB- group exhibited significantly decreased H1 in the right Guan, Chi, H4, pulse area in the right Chi, H5, pulse power volume/min in the left Chi, right Chi, and increased main peak angle in the right Guan, Chi compared to the GB+ group. Conclusion : The effect of gall bladder jeonggyeok and seunggyeok in healthy humans may be observed on various parameters. The parameters analyzed in this study may be used to differentiate effects between gall bladder jeonggyeok and seunggyeok on radial pulse. Further studies on the effects of Sa-Am acupuncture using radial pulse are needed.

Development of depression diagnosis system using EEG signal (뇌파 측정 신호를 이용한 우울증 진단장치 개발)

  • Kim, Kyu-Sung;Jung, Ju-Hyeon;Lee, Woo-Cheol
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.18 no.12
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    • pp.452-458
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    • 2017
  • In this study, a device was developed for diagnosing depression using EEG signals from July 2016 to June 2017. For normal people, the left alpha rhythm is more activated than the right alpha rhythm, but for the depressed patients, the right alpha rhythm is more activated than the left one. An analog circuit and digital low pass filter were used for noise removal and amplification of EEG, and the Hamming window function was applied to eliminate the signal leakage generated by the fast Fourier transform. To verify the validity of the developed diagnosis system, the EEG of 20 university students in the 3rd and 4th grade with an average age of 24 years was measured. Calculations of the relative value of the left and right alpha rhythm for the depression diagnosis revealed a minimum, maximum, and mean value of 66.7, 113.3, and 92.2, respectively. In addition, 7 out of 20 subjects were between 90 and 95, and those with a higher mean deviation of approximately 20 tended to have mild depression. These results can provide meaningful data for the development of depression treatment equipment by solving the left and right brain asymmetry problem, and it may be applied usefully to diagnose depression after clinical trials on a large number of depressed patients.