• 제목/요약/키워드: Randomized Clinical Trials

검색결과 950건 처리시간 0.023초

N2 종격동 림프절 전이가 있는 제 III A 병기 비소세포폐암에 있어 수술전 동시화학방사선요법 후 폐적출술의 조기 성적 (Early Result of Surgical Resection after Pre-Operative Concurrent chemoradiotherapy for N2-Positive Stage IIIA NSCLC)

  • 차대원;김진국;심영목;김관민;박근칠;안용찬
    • Journal of Chest Surgery
    • /
    • 제33권8호
    • /
    • pp.662-668
    • /
    • 2000
  • Background: Many recent results of clinical trials show that pre-operative concurrent chemoradiotherapy and surgical resection could increase the survival of N2 positive stage IIIA non-small cell lung cancer. This study was performed to assess the feasibility, toxicity, and affect rates of concurrent chemoradiotherapy and surgical resection in N2 positive stage IIIA non-small cell lung cancer. Material and Method: Thirty-one patients who underwent preoperative concurrent chemoradiotherapy for N2 positive stage IIIA non-small-cell lung cancer from May 1997 to April 1999 were entered into the study. Mean age was 61 yrs(43∼70 yrs), There were 24 men and 7 women. The confirmation of N2 disease were achieved through mediastinoscopic biopsy(24) and CT scans(7). Induction was achieved by two cycles of cisplatin and etoposide(EP) plus concurrent chest radiotherapy to 45 Gy. Resections were done at 3 weeks after the complection of preoperative concurrent chemoradiotherapy. Resections were performed in 23 patients, excluding 5 refusals and 3 distant metastasis. Result: All patients were compled the thoracic radiotherapy except one who had distant metastasis. Twenty three patients were completed the planned 2 cycles of EP chemotherapy, and 8 patients were received only 1 cycle for severe side effects(6), refusal(1), and distant metastasis(1). There was one postoperative mortality, and the cause of death was ARDS. Three patients who had neutropenic fever and one patient who had radiation pneumonitis were required admission and treatment. Esophagitis was the most common acute side effect, but relatively well-tolerated in most patients. The complection rate of concurrent chemoradiotherapy was 74%, resection rate was 71%, pathologic complete remission rate was 13.6%, and pathologic down-staging rate was 68%. Conclusion: Morbidity related to each treatment was acceptable and many of the patients have benefited down staging of its disease. Further prospective, preferably randomized, clinical trials of larger scale may be warranted to confirm the actual benefit of preoperative concurrent chemoradiotherapy and surgical resection in N2-positive stage IIIA non-small cell lung cancer.

  • PDF

미세 치근단 수술의 성공과 실패 (Success and failure of endodontic microsurgery)

  • 송민주;김의성
    • Restorative Dentistry and Endodontics
    • /
    • 제36권6호
    • /
    • pp.465-476
    • /
    • 2011
  • 최근의 근관치료학 분야에서 외과적 재치료는 수술현미경, 초음파기구, 미세수술기구 등의 도입으로 많은 변화가 있어 왔다. 본 논문에서는 기존의 전통적인 치근단 수술법과 비교하여 미세 치근단 수술의 주요 술식을 알아보고 이미 출간된 논문에 근거하여 미세 치근단 수술의 성공과 실패 그리고 성공과 실패에 영향을 미치는 요소들을 고찰하고자 하였다. 수술현미경은 수술부위를 밝게 확대해서 봄으로써 치근단 부위의 미세한 형태를 조명할 수 있게 되었으며 이는 술식의 성공을 위해서 필수적인 요소가 되었다. 초음파 기구 또한 치근단 역충전을 위한 정확한 와동형성을 가능하게 해 주었다. 따라서 미세 치근단 수술은 기존방식의 문제점이었던 많은 골삭제, 경사진 치근절제, 부정확한 역충전 와동 형성, 치근단 미세구조 관찰의 어려움 등을 극복함으로써 술식이 더욱 정확해지고, 성공가능성이 더 높아졌다고 볼 수 있다. 미세 치근단 수술에 영향을 미치는 요소에는 다양한 요인들이 존재할 수 있으나 전통방식의 치근단 수술보다 술식이 표준화 됨으로써 술식에 의한 영향을 줄일 수 있다. 환자와 치아에 관계되는 요소 중에서는 치주질환의 이환 여부와 치아위치(tooth position)가 예후에 영향을 미치는 것으로 알려져 있으나 이에 대한 연구는 아직까지 그 수가 부족한 상태로 앞으로 검증수준 (evidence level)이 높은 Randomized clinical trial 혹은 전향적 코호트 연구가 많이 이루어져야 할 것이다.

Antispastic Effect of Electroacupuncture on Upper Extremity in Stroke Patients by T-reflex Study : A Single-Blind, Randomized Controlled, Preliminary Study

  • Cho, Min Kyoung;Lee, In;Kwon, Jung Nam;Shin, Byung Cheul;Ko, Sung Hwa;Ko, Hyun Yoon;Shin, Yong Il;Hong, Jin Woo
    • 대한한의학회지
    • /
    • 제36권4호
    • /
    • pp.8-18
    • /
    • 2015
  • Objectives: There have been several studies evaluated effect of electroacupuncture (EA) on spasticity but most studies could not assess spasticity quantitatively because they used clinical rating scales for assessment spasticity. The objective of this study is to evaluate effect of EA on poststroke spasticity quantitatively using tendon reflex (T-reflex). Methods: 29 stroke patients with upper extremity spasticity were randomized to EA group and control group. The EA group received combined EA and rehabilitation therapy 5 times a week for 3 weeks. Acupuncture treatment was given at Jian Yu (LI 15), Qu Chi (LI 11), Shao Hai (HT 3), Wai Guan (TE 5), He Gu (LI 4), Lie Que (LU 7), Hou Xi (SI 3) of the affected side, 30 minutes of electrical stimulation with a frequency of 40/13 Hz was applied at Qu Chi (LI 11), He Gu (LI 4). The control group received only rehabilitation therapy. The efficacy of treatment was assessed using T-reflex latency and amplitude, modified Ashworth scale (MAS) of biceps brachii, brachioradialis and triceps brachii. Fugl-Meyer motor function assessment (FMA) and functional independence measure (FIM) were also measured to assess motor function and functional independence. All outcomes were measured before treatment, immediately after 3 weeks of treatment and 1 week after 3 weeks of treatment. Results: No statistically significant differences were found in outcomes including T-reflex between the study groups except for FIM values immediately after 3 weeks of treatment (p=0.037). Conclusions: These results suggest that 3 weeks of EA does not reduce poststroke upper extremity spasticity electrophysiologically and clinically. However, small sample sizes and contradictory tendency between results from T-reflex and those from MAS require cautious judgement on interpretation of the results. A larger, well-designed clinical trials for quantitative evaluation of effect of EA on poststroke spasticity will be needed.

혈소판 풍부 혈장 주사 요법: 근거 중심의 분석 (Platelet Rich Plasma Injection: Evidence Based Analysis)

  • 오주한;정석원
    • 대한정형외과 초음파학회지
    • /
    • 제4권2호
    • /
    • pp.111-122
    • /
    • 2011
  • 혈소판 풍부 혈장은 자가 혈액으로부터 농축된 혈소판을 이용하여 성장 인자들을 제공함으로써 손상된 조직의 재생과 치유를 도모한다는 이론적 근거를 배경으로, 근골격계 손상의 치료를 위해 최근 많이 사용되고 있다. 성장 인자를 통한 조직 치유 효과는 여러 기초 과학적 연구를 통해 규명되어 왔고, 혈소판 풍부 혈장을 이용한 동물 연구 및 임상 연구들도 좋은 결과를 보고하고 있다. 그러나, 대부분의 연구들이 혈소판 풍부 혈장의 적용 방법 및 결과 측정 방법 등에서 문헌 별로 차이가 커서 서로 비교가 어렵고, 연구 대상 환자 수가 너무 적거나 대조 군이 없는 등 연구로서의 한계가 있다. 특히 잘 디자인 된 전향적 무작위 대조 연구들은 거의 없는 상황이다. 따라서, 현재까지의 결과를 확증하고 혈소판 풍부 혈장의 임상적 사용에 대한 과학적 근거를 제시하기 위해서는 좀 더 높은 수준의 잘 디자인 된 전향적 무작위 연구가 필요하다 할 수 있다. 결론적으로, 혈소판 풍부 혈장의 임상적 적용은 아직 과학적 근거가 부족한 상황이고, 따라서 혈소판 풍부 혈장을 사용하여 근골격계 질환을 치료할 때는 신중을 기해야 할 것이다.

  • PDF

메타분석을 이용한 간호 대학생의 학업 관련 만족도 중재프로그램의 효과 (A Meta-analysis of the effects of Academic-related Satisfaction Intervention Programs for Nursing Students in Korea)

  • 김미나;김영아
    • 한국산학기술학회논문지
    • /
    • 제20권10호
    • /
    • pp.218-228
    • /
    • 2019
  • 본 연구는 국내 간호 대학생을 대상으로 수행된 학업 관련 만족도 중재프로그램을 고찰하고 메타분석하여 근거기반 자료를 제공하기 위해 수행되었다. 메타분석에 포함된 자료는 2001년부터 2018년 7월까지 발표된 25편의 실험연구로서 연구의 설계는 무작위 대조군 연구가 1편, 비무작위 대조군 연구가 24편이었다. 연구대상자는 간호학과 1~4학년 재학생으로, 이론수업 및 실습수업에서 중재프로그램이 수행되었다. 표본크기는 실험군 1182(평균 47.3), 대조군 1137(평균 45.5)명이었고, 중재프로그램의 구성은 1~16주/1~16회/1회기 당 7~240분으로 이루어졌다. 결과변수로는 전공만족도, 학습만족도, 교내실습만족도, 임상실습만족도가 있었으며, 교내실습만족도(Hedges' g=0.876[95% CI: 0.405, 1.346])와 임상실습만족도(Hedges' g=0.515[95% CI: 0.312, 0.718]) 및 전체 학업 관련 만족도(Hedges' g=0.630[95% CI: 0.371, 0.889])는 통계적으로 유의미한 중간 수준 이상의 효과크기가 확인되었다. 본 연구의 결과는 간호 대학생들의 학업 관련 만족도 중재프로그램을 다룬 선행연구들을 통합적으로 정리하여 객관적 결과를 확인하였다는데 의의가 있다.

Effect of Chlorhexidine Mouthrinse on Prevention of Microbial Contamination during EBUS-TBNA: A Study Protocol for a Randomized Controlled Trial

  • Kim, Na Young;Park, Jae Hyeon;Park, Jimyung;Kwak, Nakwon;Choi, Sun Mi;Park, Young Sik;Lee, Chang-Hoon;Cho, Jaeyoung
    • Tuberculosis and Respiratory Diseases
    • /
    • 제84권4호
    • /
    • pp.291-298
    • /
    • 2021
  • Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard diagnostic method for mediastinal and hilar lymphadenopathy. Although rare, fatal infectious complications can occur following EBUS-TBNA. However, to date, there is a lack of effective preventive strategies to reduce these complications. We started a trial to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Methods: This study is a single-center, parallel-group, assessor-blinded randomized controlled trial (RCT). We will enroll 112 adult participants undergoing EBUS-TBNA using a convex probe, and randomly assign them to two groups at a 1:1 ratio. The intervention group will gargle for 1 minute with 100 mL of 0.12% chlorhexidine gluconate before EBUS-TBNA, while the control group will have no mouthrinse before the procedure. Immediately after completion of EBUS-TBNA on all targeted lesions with an aspiration needle, a needle wash sample will be taken by instilling 5 mL of sterile saline into the used needle. The primary outcome is colony forming unit (CFU) counts in aerobic cultures of the needle wash samples. Secondary outcomes are CFU counts in anaerobic cultures, fever within 24 hours after EBUS-TBNA, and infectious complications within 4 weeks after EBUS-TBNA. Conclusion: This trial was designed as the first RCT to investigate the effect of chlorhexidine mouthrinse on the prevention of microbial contamination during EBUS-TBNA. Results from this trial can provide clinical evidence for a simple, safe, and cost-effective strategy to prevent infectious complications following EBUS-TBNA (ClinicalTrials.gov ID: NCT04718922, registered on 22 January 2021).

수족냉증의 임상연구에 관한 문헌적 고찰 - 국내에 출판된 논문을 중심으로 - (Literature Review on clinical studies for cold hypersensitivity of hands and feet -Focusing on journals published in Korea)

  • 이해솔;한인식;선승호;김근엽;고호연;김태훈;이진무;장준복;송윤경;고성규;최유경;정종진;고유미;정금란;전찬용
    • 대한예방한의학회지
    • /
    • 제21권1호
    • /
    • pp.83-93
    • /
    • 2017
  • Objectives : This study's aim is to investigate clinical studies of cold hypersensitivity of hands and feet (CHHF) published in Korea and to explore the direct of future research. Methods : We searched clinical studies of CHHF using the database, such as DBpia(http://www.dbpia.co.kr/), NDSL(www.ndsl.kr), OASIS(http://oasis.kiom.re.kr), and RISS(www.riss.kr). The search words were 'cold hypersensitivity(冷症)' and 'syncope(厥證)'. Inclusion criteria were randomized controlled trials (RCTs), non RCTs, Before and after clinical study (B&A) about CHHF. Selection journals and data extraction were conducted by HS Lee and SH Sun independently. Results : Total twenty-one articles were selected finally. RCTs, non-RCTs, and B&A were 3, 12, and 6, respectively. The topics for CHHF were classified into three categories: effect of treatment (n=2) characteristics (n=11), and diagnosis (n=8). Conclusions : This results showed that RCT about CHHF and treatment effect of cold hypersensitivity of hands and feet were small in number. Further systemic and larger studies about CHHF will be needed.

집속초음파 치료의 한의 임상 활용에 대한 고찰 (Clinical Application of Focused Ultrasound in Korean Medicine)

  • 최유민;이마음;허나연;이은희;최혁용;서형식;황의형;장인수
    • Korean Journal of Acupuncture
    • /
    • 제40권3호
    • /
    • pp.79-89
    • /
    • 2023
  • Objectives : The purpose of this study is to investigate various application methods of focused ultrasound and apply them to clinical use in Korean medicine. Methods : Search was performed using the search engines of electronic databases, including PubMed, ScienceDirect, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure (CNKI), Wanfang Data, Japan Science Technology Information Aggregator, Electronic (J-STAGE) and Citation Information by NII (CiNii), from inception to July 2023 without language limitation. Inclusion criteria were clinical studies including randomized controlled trials (RCTs), and animal experimental studies related with focused ultrasound treatments for acupoints or meridian sinews. Results : Total 17 papers, 7 for RCT, 6 for in vivo animal studies, and other experimental studies, were finally selected. Indications used in studies were shoulder pain, back pain, chronic back pain, and degenerative knee arthritis. In experimental studies, studies on animal models of hypoxic ischemic brain damage and hyperlipidemia were also conducted. As for the acupoints, LR3, LI4, and ST36 were used in clinical studies and, in animal experimental studies, GV20, KI1, and ST36 were used. As for the dose, 4 studies below 3 W/cm2 and 3 studies in the range of 0.625 to 5 W/cm2 in clinical studies, and all studies did not exceed 5 W/cm2. In animal experimental studies, 0.5 W/cm2, 2 W/cm2, 7.5 WW/cm2, 15 W/cm2, 10~20 W/cm2 were used. In all three studies describing the penetration depth during irradiation, it was less than 1 cm. Conclusions : We suggest that focused ultrasound is an appropriate treatment tool for stimulating the acupoints to transfer heat energy. Future studies with rigorous and well-designed RCTs for various diseases will be required to ascertain the focused ultrasound stimulate acupoints or meridian sinews.

EBM 기반구축을 위한 귀비탕(歸脾湯) 연구 문헌 분석 (Analysis of Studies on Guibi-tang(Guipitang) for Fundamental Establishment of Evidence Based Medicine(EBM))

  • 김정훈;이준경;하혜경;서창섭;이미영;이호영;정다영;이남헌;이진아;황대선;신현규
    • 동의신경정신과학회지
    • /
    • 제20권3호
    • /
    • pp.205-216
    • /
    • 2009
  • Objectives : To establish the fundaments for EBM of Traditional Korean Medicine, the papers on Guibi-tang(Guipitang) which were frequently used in medical institutions of Traditional Korean Medicine were analyzed through researching domestic and international literatures. Methods : The papers were classified by the year of publishment, by experimental methods, by laboratory animals used in biological experiment and by the kinds of studies on biological efficacy. Results : Of total 39 papers were registered in domestic journals. Since 1980, publishments of papers have continuously increased. The papers on biological studies were 34 volumes, clinical studies were 5 volumes. Biological studies mainly showed the effects of anti-stress, anti-oxidant, hemostasis, anti-osteoporosis, gastroprotection, reproductive ability, brain cell activity, radioprotection. And clinical studies showed improvements of fearful throbbing, memory and orientation, insomnia, vericose vein, schizophrenia. Conclusions : Guibi-tang(Guipitang) could be used to fortify the spleen, nourish the heart and then control the blood. However biological studies need to be conducted in accordance with clinical study and further clinical studies on randomized controlled trials should be proceeded.

  • PDF

The Utility and Benefits of External Lumbar CSF Drainage after Endovascular Coiling on Aneurysmal Subarachnoid Hemorrhage

  • Kwon, Ou-Young;Kim, Young-Joon;Kim, Young-Jin;Cho, Chun-Sung;Lee, Sang-Koo;Cho, Maeng-Ki
    • Journal of Korean Neurosurgical Society
    • /
    • 제43권6호
    • /
    • pp.281-287
    • /
    • 2008
  • Objective : Cerebral vasospasm still remains a major cause of the morbidity and mortality, despite the developments in treatment of aneurysmal subarachnoid hemorrhage. The authors measured the utility and benefits of external lumbar cerebrospinal fluid (CSF) drainage to prevent the clinical vasospasm and its sequelae after endovascular coiling on aneurysmal subarachnoid hemorrhage in this randomized study. Methods : Between January 2004 and March 2006, 280 patients with aneurysmal subarachnoid hemorrhage were treated at our institution. Among them, 107 patients met our study criteria. The treatment group consisted of 47 patients who underwent lumbar CSF drainage during vasospasm risk period (about for 14 days after SAH), whereas the control group consisted of 60 patients who received the management according to conventional protocol without lumbar CSF drainage. We created our new modified Fisher grade on the basis of initial brain computed tomography (CT) scan at admission. The authors established five outcome criteria as follows : 1) clinical vasospasm; 2) GOS score at 1-month to 6-month follow-up; 3) shunt procedures for hydrocephalus; 4) the duration of stay in the ICU and total hospital stay; 5) mortality rate. Results : The incidence of clinical vasospasm in the lumbar drain group showed 23.4% compared with 63.3% of individuals in the control group. Moreover, the risk of death in the lumbar drain group showed 2.1 % compared with 15% of individuals in the control group. Within individual modified Fisher grade, there were similar favorable results. Also, lumbar drain group had twice more patients than the control group in good GOS score of 5. However, there were no statistical significances in mean hospital stay and shunt procedures between the two groups. IVH was an important factor for delayed hydrocephalus regardless of lumbar drain. Conclusion : Lumbar CSF drainage remains to playa prominent role to prevent clinical vasospasm and its sequelae after endovascular coiling on aneurysmal subarachnoid hemorrhage. Also, this technique shows favorable effects on numerous neurological outcomes and prognosis. The results of this study warrant clinical trials after endovascular treatment in patients with aneurysmal SAH.