• 제목/요약/키워드: Randomized clinical trial

검색결과 894건 처리시간 0.067초

직장암의 근치적 수술 루 방사선치료와 화학요법의 순서에 대한 고찰 -전향적 무작위 3상 임상연구 중간 결과 보고- (A Prospective Randomized Trial Comparing the Seciuence of Adiuvant Chemotherapy and Radiotherapy following Curative Resection of Stage II, III Rectal Cancer)

  • 김경주;김종훈;최은경;장혜숙;안승도;이제환;김진천;유창식
    • Radiation Oncology Journal
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    • 제18권1호
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    • pp.17-25
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    • 2000
  • 목적 : 근치적 수술을 시행받은 직장암 환자에서 수술 후 보조치료로서 화학요법과 방사선치료를 시행시, 방사선 치료와 화학요법의 시행 시점에 따른 부작용과 치료 실패양상, 생존율을 비교하고자 전향적 무작위 3상 임상연구를 시행하여 가장 적절한 화학요법과 방사선치료 순서를 결정하고자 하였다. 대상 및 방법 : 1996년 1월부터 1999년 3월까지 근치적 절제술을 시행 받은 이CC 병기 2기 및 3기의 직장암 환자 313명을 대상으로 조기 방사선치료군(arm I)과 지연 방사선치료군(arm II)으로 나누어 방사선치료와 화학요법 병용치료를 시행하였다. 화학요법은 5-FU 375 mg/m$^{2}$/day와 leucovorin 20 mg/m$^{2}$/day를 방사선치료와 동시치료 기간에는 3일간씩, 화학요법 단독 기간 동안에는 5일간씩 총 8회를 정맥주사하였고 방사선치료는 전골반 영역에 45 Gy/fractions/5 weeks를 시험하였다. 이 중 1998년 6월까지 등록된 228명을 대상으로 중간 분석을 시행하였고 228명중 두명의 환자는 이차적인 원발종양의 발생으로 분석에서 제외되었다. Arm I은 1회차 화학요법과 동시에 방사선치료를 시행하였고, arm II는 화학요법을 2회 마친 후 3회차와 동시에 시행하였다. 중앙추적관찰기간은 23개월이었다. 결과 : 국소재발은 arm I에서 11명(9.7$\%$), arm II에서 9명(8$\%$)이었고 두 군간에 통계적으로 의미있는 차이는 없었으나 원격전이는 arm I에서 22명(19.5$\%$), arm II에서 35명(31$\%$)으로 의미있게 arm 1에서 낮게 나타났다(p=0.046). 그러나 3년 무병생존율(70.2$\%$ vs 59.2$\%$, p=0.2)과 3년 생존율(89.4$\%$ vs 88.0$\%$, p=0.47)은 유의한 차이가 없었다. 방사선 치료중 RTOG grade 1 이상의 백혈구 감소는 78.3$\%$에서 관찰되었고 방사선치료 후 화학요법 기간 동안에는 79.9$\%$에서 관찰되었으나, RTOG grade 3 이상의 백혈구 감소증은 각각 2.1$\%$, 6$\%$로 매우 낮게 나타났다. 저위전방절제술을 시행받은 환자중 하루 10회 이상의 설사를 한 환자는 arm I에서 71.2%$\%$ arm II에서 42.6$\%$로 의미있게 arm I에서 높았으나(p=0.02) 이러한 부작용은 보조적인 치료로 회복되었다. 결론 : 근치적 절제술 후 그 순서에 관계없이 방사선치료와 화학요법을 시행함으로써 국소재발율을 낮출 수 있었다. 원격전이는 수술 후 조기 방사선치료군에서 더 낮은 것으로 나타났는데 뚜렷한 원인은 밝힐 수 없었고 향후추적 관찰이 더 필요할 것으로 생각된다. 본 치료는 대부분의 환자가 큰 부작용 없이 마쳐 비교적 안전한 치료임을 확인할 수 있었지만, 치료순응도는 좀 더 높아져야 할 것으로 생각된다.

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상지 협응 움직임을 기반으로 한 과제중심적 접근 훈련이 발달성 협응 장애아동의 글씨쓰기 능력에 미치는 효과 (The Effects of Upper Limb Coordinated Movement Based Task Oriented Approach on Improving Handwriting Performance in Children With Developmental Coordination Disorder)

  • 김미지
    • 재활치료과학
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    • 제5권1호
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    • pp.77-87
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    • 2016
  • 목적 : 상지 협응 움직임을 기반으로 한 과제중심적 접근 훈련이 발달성 협응 장애아동의 한글 글씨쓰기 능력에 미치는 영향을 알아보며 각 접근이 한글 글씨 쓰기 수행의 질과 글씨쓰기 준비기술에 미치는 영향을 비교하고자 한다. 연구방법 : 본 연구는 5~10세의 발달성 협응장애 아동 40명을 대상으로 무작위 추출을 통해 두 집단으로 나뉘어 사전-사후 검사로 진행하였다. 두 집단은 과제중심접근 중재군과 과정중심접근 중재군으로 5주 동안 40분씩 주 2회 중재를 받았다. 글씨쓰기 수행은 한글 자모 쓰기 검사로 측정하고, 글씨쓰기 준비요소인 상지 운동 기능, 시 지각 기능과 시 운동기능은 각각 운동 유창성 평가(Bruininks-Oseretsky Test of Motor Proficiency-2: BOT-2)중 미세운동조절의 하위검사 일부, 한국판 시 지각 발달 검사(Korean-Developmental Test of Visual Perception-2: K-DTVP-2), 개정된 시 운동기술 평가(Test of Visual Motor Skills-Revised: TVMS-R)로 평가하였다. 고찰 : 본 연구는 과제중심접근법을 적용하여 발달성 협응 장애아동의 글씨쓰기 수행도를 향상시킨다는 임상적 근거를 제공하는데 의의가 있다. 또한 과정중심접근법과 과제중심접근법이 글씨쓰기 준비기술의 향상에 어떠한 영향을 끼치는 지에 대한 결과를 확인하여 보다 효과적인 글씨쓰기 중재방법을 제시하는 초석이 될 수 있을 것이라 생각한다.

산삼 약침이 정상인의 심박변이도(HRV)에 미치는 영향 (The Effects of distilled Wild Ginseng Herbal Acupuncture on the Heart Rate Variability(HRV))

  • 노정두;김락형;송범용;육태한
    • 대한약침학회지
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    • 제11권1호
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    • pp.55-69
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    • 2008
  • Objective : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. Method : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. 1 healthy volunteers consisted of 31 subjects in experiment(distilled Wild Ginseng Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Wild Ginseng Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 11 subjects(7 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 24 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t-test(in group) and Student t-test(between two groups) were used to verify the result. Result : 1. After distilled Wild Ginseng Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low after 5 minute, HRV index is significantly high after 10 minute and pNN50 is significantly low after 5 minute. 2. SDNN of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25minute, and pNN50 of distilled Wild Ginseng Herbal Acupuncture Group significantly decreased from 10minute to 15minute and 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Wild Ginseng Herbal Acupuncture injection, Ln(TP), Ln(VLF) and Ln(LF) are significantly high after 5 minute, normalized LF is significantly high after 5 minute and normalized HF is significantly low after 5 minute. 4. Ln(TP) and Ln(VLF) of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25 minute compared with those of Normal Saline group. Conclusion : The results suggest that distilled Wild Ginseng Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

A mixture of Salacia oblonga extract and IP-PA1 reduces fasting plasma glucose (FPG) and low-density lipoprotein (LDL) cholesterol levels

  • Nakata, Kazue;Taniguchi, Yoshie;Yoshioka, Noriko;Yoshida, Aya;Inagawa, Hiroyuki;Nakamoto, Takeru;Yoshimura, Hiroshi;Miyake, Shin-Ichiro;Kohchi, Chie;Kuroki, Masahide;Soma, Gen-Ichiro
    • Nutrition Research and Practice
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    • 제5권5호
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    • pp.435-442
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    • 2011
  • At present, lifestyle-related diseases are one of the most critical health issues worldwide. It has been reported that lipopolysaccharide derived from a Gram-negative bacteria (IP-PA1) symbiotic with wheat exhibited several advantageous biological effects, such as the reduction of plasma glucose levels in NOD mice and low-density lipoprotein (LDL) levels in WHHL rabbits. In this study, the beneficial effects on plasma glucose and lipids of a tea (SI tea) consisting of IP-PA1 and Salacia (which contains an inhibitor of ${\alpha}$-glucosidase) were investigated in the KK-Ay/TaJcl type 2 diabetic model mice and in human subjects with premetabolic syndrome in a double-blind, randomized study. S1 tea significantly decreased plasma glucose levels in KK-Ay/TaJcl mice. A clinical trial of SI tea was performed with 41 subjects between the ages of 40 and 69, who belonged either to a high plasma glucose group (HG: FPG 100-125 mg/dl) or to a hyperlipidemia group (HL: TG ${\geq}$ 150 mg/dl, or LDL ${\geq}$ 120 mg/dl, or HDL <40 mg/dl). These subjects ingested either Salacia without IP-PA1 (the control) or SI tea. Blood samples were collected at 0, 30, and 60 days after initiating SI tea treatment, and were measured for FPG, HbA1c, TG, LDL, and HDL. These results showed that SI tea reduced FPG and HbA1c more rapidly than the control in the HL group, and also significantly improved LDL and HDL levels in the HG group. Thus, SI tea may be helpful in preventing lifestyle-related diseases.

Whole pelvic intensity-modulated radiotherapy for high-risk prostate cancer: a preliminary report

  • Joo, Ji Hyeon;Kim, Yeon Joo;Kim, Young Seok;Choi, Eun Kyung;Kim, Jong Hoon;Lee, Sang-Wook;Song, Si Yeol;Yoon, Sang Min;Kim, Su Ssan;Park, Jin-Hong;Jeong, Yuri;Ahn, Hanjong;Kim, Choung-Soo;Lee, Jae-Lyun;Ahn, Seung Do
    • Radiation Oncology Journal
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    • 제31권4호
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    • pp.199-205
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    • 2013
  • Purpose: To assess the clinical efficacy and toxicity of whole pelvic intensity-modulated radiotherapy (WP-IMRT) for high-risk prostate cancer. Materials and Methods: Patients with high-risk prostate cancer treated between 2008 and 2013 were reviewed. The study included patients who had undergone WP-IMRT with image guidance using electronic portal imaging devices and/or cone-beam computed tomography. The endorectal balloon was used in 93% of patients. Patients received either 46 Gy to the whole pelvis plus a boost of up to 76 Gy to the prostate in 2 Gy daily fractions, or 44 Gy to the whole pelvis plus a boost of up to 72.6 Gy to the prostate in 2.2 Gy fractions. Results: The study cohort included 70 patients, of whom 55 (78%) had a Gleason score of 8 to 10 and 50 (71%) had a prostate-specific antigen level > 20 ng/mL. The androgen deprivation therapy was combined in 62 patients. The biochemical failure-free survival rate was 86.7% at 2 years. Acute any grade gastrointestinal (GI) and genitourinary (GU) toxicity rates were 47% and 73%, respectively. The actuarial rate of late grade 2 or worse toxicity at 2 years was 12.9% for GI, and 5.7% for GU with no late grade 4 toxicity. Conclusion: WP-IMRT was well tolerated with no severe acute or late toxicities, resulting in at least similar biochemical control to that of the historic control group with a small field. The long-term efficacy and toxicity will be assessed in the future, and a prospective randomized trial is needed to verify these findings.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • 제23권6호
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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알쏭이모자반 (Sargassum confusum) 주정추출물이 성인여성 체지방 감소에 미치는 영향 (The effect of Sargassum confusum on reduction of body fat in obese women)

  • 민기성;한 대석;권상오;여경목;김복남;이선영
    • Journal of Nutrition and Health
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    • 제47권1호
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    • pp.23-32
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    • 2014
  • 해조류인 알쏭이 모자반 추출물의 섭취로 인한 체지방 감소 효능을 평가하고자 이중맹검법을 사용하여 BMI 23 이상의 과체중 혹은 비만 성인 여성에게 8주간 알쏭이 모자반 추출물을 섭취하게 한 후 체격지수, 혈액 분석, 식사섭취상황 등을 조사하였다. 최종 대조군은 14명, 실험군은 16명이었으며 1일3회 각 4개의 캡슐을 섭취시켰다. 인체시험 결과 시험전후 비교시 대조군에 비하여 시험군의 체지방률과 체지방량, 허리둘레가 지속적으로 유의하게 감소하였으며 혈청 트리글리세롤과 렙틴농도가 더욱 유의하게 감소하였고 변배설량은 유의하게 증가하여 지방 배설효과를 기대할 수 있었다. 시험기간 동안 7명의 피험자가 심각하지 않은 부작용으로 시험에서 탈락하였으나 건강상 불편함을 호소하는 피험자 수의 두 군간의 차이는 보이지 않았다. 따라서 알쏭이 모자반 추출물은 8주간 섭취 시 심각한 부작용을 유발하지 않으면서 피험자의 허리둘레, 체지방율과 함께 혈청 렘틴 수치를 유의하게 감소시킬 수 있고 배변횟수를 유의하게 증가시켜 특히 복부비만을 해소할 수 있는 비교적 안전한 기능성 소재로 기대되므로 작용기전을 설명할 수 있는 심층 연구가 필요로 된다.

The anti-hypertensive effect of ginseng in patients with mild hypertension

  • Kim, Young-Suk;Jung, Woo-Sang;Park, Seong-Uk;Moon, Sang-Kwan;Park, Jung-Mi;Ko, Chang-Nam;Cho, Ki-Ho;Bae, Hyung-Sup
    • Advances in Traditional Medicine
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    • 제7권5호
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    • pp.494-500
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    • 2008
  • Ginseng has been traditionally used to recover vital energy from Qi deficiency in oriental countries. Recent reports suggested that ginseng could regulate blood pressure (BP), but much controversy still remain. Therefore, we intended to assess the anti-hypertensive effect of some ginseng species on Koreans and Chinese. This is a randomized, double blinded controlled clinical trial. The study subjects were recruited from the mild hypertensive patients who belonged prehypertension(120/80 to 139/89 mmHg) and stage I hypertension (140/90 to 159/99 mmHg) in Korea and China. After assigning the subjects into a Korean, a Chinese, and an American ginseng group by randomization, we prescribed ginseng with the dose of 4.5 g per a day for 4 w. To assess the anti-hypertensive effect, we compared the mean of systolic and diastolic BP between before and after ginseng medication by 24 h Ambulatory Blood Pressure Monitor (24 h ABPM). We also monitored adverse effect and laboratory findings to secure the subjects' safety. There were 64 subjects treated with Korean ginseng, 58 treated with Chinese ginseng, and 64 treated with American ginseng. All of the ginseng species reduced subjects' BP. Especially, Korean and Chinese ginseng showed more excellent effects. The secondary analysis on the subjects' nationality revealed that all of the ginseng species showed more significant anti-hypertensive effect in Chinese than in Koreans. We suggest ginseng could be useful for mild hypertension regardless of its species. And it would be safe within the dosage of 4.5 g per a day.

The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia

  • Kim, Sang Bum;Lee, Jang Hoon;Lee, Juyoung;Shin, Seung Han;Eun, Ho Sun;Lee, Soon Min;Sohn, Jin A;Kim, Han Suk;Choi, Byung Min;Park, Min Soo;Park, Kook In;Namgung, Ran;Park, Moon Sung
    • Clinical and Experimental Pediatrics
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    • 제58권9호
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    • pp.347-353
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    • 2015
  • Purpose: The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD). Methods: The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study. Results: The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414). Conclusion: Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.

중풍후우울증 환자에 대한 향기침요법의 임상적 연구 (A Clinical Study of Acupuncture with Aromatherapy on Poststroke Depression Patients)

  • 정세연;황재웅;김석민;정재한;최창민;정우상;문상관;조기호;김영석;선종주
    • 대한한방내과학회지
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    • 제27권2호
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    • pp.480-487
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    • 2006
  • Objectives : In this study we investigated BDI(Beck Depression Inventory) improvement of poststroke depression Patients who took the acupuncture with aromatherapy, in order to examine its capacity as a new treatment and to establish a primary data for further studies of developments of diverse Practical acupunctures. Methods : Physicians applied the acupuncture with aromatherapy every day for two weeks. We had evaluated baseline characteristics and BDI of all Patients, and revaluated BDI and examined the side effects two weeks later. The qualified Patients were classified into two groups, depression group (more than 10 points and 10 in BDI) and non-depression group (less than 10 points in BDI) according to the baseline BDI. Results : The study was completed with 27stroke patients. The acupuncture with aroma therapy was applied in 18 post-stroke depression patients and 9 non-depression patients for 2 weeks. And the result showed that the BDI scores in the depression group decreased to $16.5{\pm}11.1$ after the treatment (compared to $24.4{\pm}11.5$ before the treatment). so proved the significant effect on post-stroke depression of the acupuncture. On the other hand. the scores in the non-depression group increased to $9.2{\pm}9.5$ (compared to $3.3{\pm}3.0$). Conclusions : The acupuncture with aromatherapy applied on post-stroke depression patients showed the effect of BDI improvement. Further researches are needed to evaluate the distinct functional mechanism of acupuncture with aromatherapy, and to estimate its effectiveness by well-designed randomized controlled trial.

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