• 제목/요약/키워드: randomized clinical trial

검색결과 912건 처리시간 0.031초

수근관증후군에 대한 Sweet봉약침과 오공약침의 효과 비교 (Comparison of the Effects between Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture on Carpal Tunnel Syndrome (Randomized, Controlled Clinical Trial))

  • 구지영;이경희;조성우;이상찬;윤현민;장경전;송춘호;안창범;김철홍
    • 대한약침학회지
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    • 제13권4호
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    • pp.75-89
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    • 2010
  • Objectives : The purpose of this study is to compare the effects of Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture on Carpal Tunnel Syndrome. Methods : From February to September 2010, the number of patients with Carpal Tunnel Syndrome who volunteered for this clinical study was 16 and 7 out of 16 patients complained both hands. Total 23 cases of hands were randomly divided by 2 groups. We injected Sweet Bee Venom Pharmacopuncture on PC7(Daereung) twice a week for 4weeks for experimental group(n=11), and Scolopendrid Pharmacopuncture with the same methods for control group(n=12). One case was dropped out due to itchiness of allergic response in the experimental group. Improvement of the symptoms was evaluated by Visual Analogue Scale, Pain Rating Scale, Tinel's sign, Phalen's sign and Nerve Conduction Velocity. Nerve Conduction Velocity was checked at baseline and the end of the trial and others were checked at baseline, after 2 and 4 weeks. Results : Both groups showed significant improvement in Visual Analogue Scale, Pain Rating Scale, but no significant difference between two groups. Only the control group showed significant reduction of the 'poitive response' in the Tinel's sign and Phalen's sign. However, no groups improved in Nerve Conduction Velocity. Conclusions : These results showed that Sweet Bee Venom Pharmacopuncture and Scolopendrid Pharmacopuncture could decrease the symptoms of Carpal Tunnel Syndrome. Further studies will be required to examine more cases for the long period and use more various concentration and amount pharmacopuncture for the effect on Carpal Tunnel Syndrome.

Addition of 2 mg dexamethasone to improve the anesthetic efficacy of 2% lidocaine with 1:80,000 epinephrine administered for inferior alveolar nerve block to patients with symptomatic irreversible pulpitis in the mandibular molars: a randomized double-blind clinical trial

  • Aggarwal, Vivek;Ahmad, Tanveer;Singla, Mamta;Gupta, Alpa;Saatchi, Masoud;Hasija, Mukesh;Meena, Babita;Kumar, Umesh
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제22권4호
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    • pp.305-314
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    • 2022
  • Introduction: This clinical trial aimed to evaluate the anesthetic effect of the addition of 2 mg (4 mg/ml) of dexamethasone to 2% lidocaine (plain or with 1:80,000 epinephrine). The solutions were injected for a primary inferior alveolar nerve block (IANB) to provide mandibular anesthesia for the endodontic treatment of mandibular molars with symptomatic irreversible pulpitis. Methods: In a double-blinded setup, 124 patients randomly received either of the following injections: 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, or plain 2% lidocaine mixed with 2 mg dexamethasone, which were injected as a primary IANB. Ten minutes after injection, patients with profound lip numbness underwent electric and thermal pulp sensibility tests. Patients who responded positively to the tests were categorized as "failed" anesthesia and received supplemental anesthesia. The remaining patients underwent endodontic treatment using a rubber dam. Anesthetic success was defined as "no pain or faint/weak/mild pain" during endodontic access preparation and instrumentation (HP visual analog scale score < 55 mm). The effect of the anesthetic solutions on the maximum change in heart rate was also evaluated. The Pearson chi-square test at 5% and 1% significance was used to analyze anesthetic success rates. Results: The 2% lidocaine with 1:80,000 epinephrine, 2% lidocaine with 1:80,000 epinephrine mixed with 2 mg dexamethasone, and plain 2% lidocaine mixed with 2 mg dexamethasone groups had anesthetic success rates of 34%, 59%, and 29%, respectively. The addition of dexamethasone resulted in significantly better results (P < 0.001, 𝛘2 = 9.07, df = 2). Conclusions: The addition of dexamethasone to 2% lidocaine with epinephrine, administered as an IANB, can improve the anesthetic success rates during the endodontic management of symptomatic mandibular molars with irreversible pulpitis.

퇴행성 슬관절염 환자에 대한 도침요법의 효능 및 안전성 연구: 임상예비연구 (Efficacy and Safety of Miniscalpel Acupuncture in Knee Degenerative Osteoarthritis Patients: A Study Protocol for a Randomized Controlled Pilot Trial)

  • 전승아;박무섭;오세정;이정희;공한미;최성훈;황보민;이현종;김재수
    • Korean Journal of Acupuncture
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    • 제33권2호
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    • pp.67-74
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    • 2016
  • 목적 : 본 연구는 퇴행성 슬관절염 환자들을 대상으로 도침치료가 통증을 감소시키는데 효과적이고 안전한 치료법임을 증명하기에 적합한지를 알아보기 위한 예비연구이다. 방법 : 본 연구는 5주간 진행되는 무작위배정 대조군 예비임상연구이며, 총 20명의 피험자들은 시험군(도침치료)과 대조군(침치료+전침치료)으로 무작위 배정된다. 시험군의 경우에는 주 1회, 3주간 총 3회의 도침치료를 실시하고 대조군의 경우에 주 2회, 3주간 총 6회의 침치료와 전침치료를 받게된다. 1차 유효성 평가변수는 통증에 대한 Visual analogue system와 관절가동범위를, 2차 유효성 평가변수는 Short form McGill pain questionnaire와 Western Ontario and McMaster Universities Osteoarthritis Index로 측정한다. 평가는 시험시작 전, 시험 1주, 2주, 3주 및 5주후에 이루어지게 된다. 결론 : 본 연구는 추후 본격적인 무작위배정 대조군 임상시험을 위한 예비연구로서, 본 연구를 통해 퇴행성 슬관절염에 있어서 도침치료가 임상적으로 유효함을 증명할 수 있는 근거를 마련해 줄 것이라 사료된다.

Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation Targeting Restitution Parameter-Guided Catheter Ablation: CUVIA-REGAB Prospective Randomized Study

  • Young Choi;Byounghyun Lim;Song-Yi Yang;So-Hyun Yang;Oh-Seok Kwon;Daehoon Kim;Yun Gi Kim;Je-Wook Park;Hee Tae Yu;Tae-Hoon Kim;Pil-Sung Yang;Jae-Sun Uhm;Jamin Shim;Sung Hwan Kim;Jung-Hoon Sung;Jong-il Choi;Boyoung Joung;Moon-Hyoung Lee;Young-Hoon Kim;Yong-Seog Oh;Hui-Nam Pak;CUVIA-REGAB Investigators
    • Korean Circulation Journal
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    • 제52권9호
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    • pp.699-711
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    • 2022
  • Background and Objectives: We investigated whether extra-pulmonary vein (PV) ablation targeting a high maximal slope of the action potential duration restitution curve (Smax) improves the rhythm outcome of persistent atrial fibrillation (PeAF) ablation. Methods: In this open-label, multi-center, randomized, and controlled trial, 178 PeAF patients were randomized with 1:1 ratio to computational modeling-guided virtual Smax ablation (V-Smax) or empirical ablation (E-ABL) groups. Smax maps were generated by computational modeling based on atrial substrate maps acquired during clinical procedures in sinus rhythm. Smax maps were generated during the clinical PV isolation (PVI). The V-Smax group underwent an additional extra-PV ablation after PVI targeting the virtual high Smax sites. Results: After a mean follow-up period of 12.3±5.2 months, the clinical recurrence rates (25.6% vs. 23.9% in the V-Smax and the E-ABL group, p=0.880) or recurrence appearing as atrial tachycardia (11.1% vs. 5.7%, p=0.169) did not differ between the 2 groups. The post-ablation cardioversion rate was higher in the V-Smax group than E-ABL group (14.4% vs. 5.7%, p=0.027). Among antiarrhythmic drug-free patients (n=129), the AF freedom rate was 78.7% in the V-Smax group and 80.9% in the E-ABL group (p=0.776). The total procedure time was longer in the V-Smax group (p=0.008), but no significant difference was found in the major complication rates (p=0.497) between the groups. Conclusions: Unlike a dominant frequency ablation, the computational modeling-guided V-Smax ablation did not improve the rhythm outcome of the PeAF ablation and had a longer procedure time.

시뮬레이션 기반 정맥주사 교육이 간호학생의 임상수행능력과 수행자신감 및 대상자 만족도에 미치는 효과 (Effects of Simulation-Based Training on the Clinical Competence and Confidence of Nursing Students in Intravenous Injection Performance and the Satisfaction of Clients)

  • 정현철;최나영;김미선;전미양
    • 한국산학기술학회논문지
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    • 제13권6호
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    • pp.2600-2606
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    • 2012
  • 본 연구의 목적은 시뮬레이션 기반 정맥주사 교육의 효과를 시뮬레이션 매체별로 비교 분석하고 대상자 만족도를 평가함으로써 시뮬레이션 기반 교육이 간호학생의 임상실무수행능력과 수행 자신감을 향상시킴과 동시에 대상자 만족도를 높이는데 도움이 되는 교육 방법임을 검증하는 것이다. 본 연구에서는 간호학과 2학년생 90명을 무작위로 동영상군에 31명, 모형군에 28명, 컴퓨터시스템군에 31명을 배정하였다. 동영상군은 기본간호학회에서 개발한 교육용비디오를, 모형군은 정맥주사모형을, 컴퓨터시스템군은 컴퓨터로 작동되는 정맥주사용 교육프로그램을 이용하여 1회 교육과 5회 실습을 실시한 후 대상자들끼리 짝을 이루어 손등 부위에 정맥주사를 시행하였다. 간호학생의 임상수행능력을 정맥주사 성공률로 분석한 결과, 동영상군 16.1%, 모형군 64.3%, 컴퓨터시스템군 38.7%가 성공한 것으로 나타났으며 세 군간에 유의한 차이가 있었다. 수행 자신감은 정맥 주사 전, 후 모두 세 군간에 유의한 차이가 없었으나 정맥주사 성공여부에 따른 차이를 비교한 결과, 정맥 주사 전, 후에 모두 유의한 차이가 있었다. 대상자 만족도는 세 군간에는 유의한 차이가 없었으나 정맥주사 성공여부에 따라서는 유의한 차이가 있었다. 이상의 연구결과에서 정맥주사 기술은 동영상과 컴퓨터시스템보다 모형을 이용한 시뮬레이션 기반 교육이 간호학생의 임상실무 능력을 향상시키는데 기여한 것으로 나타났으며 정맥주사에 성공한 학생이 성공하지 못한 학생보다 수행 자신감이 더 높은 것으로 나타났다. 그러나 이는 한 가지 간호 기술과 관련된 결과로 추후 다양한 간호기술에 적합한 시뮬레이션 교육매체를 평가하는 연구가 필요하다.

비만에 대한 국내 의학계의 최근 연구 동향 분석 -대한비만학회지를 중심으로- (An Analysis of Domestic Medicine Study Tendency on Obesity -Focused on The Korean Journal of Obesity-)

  • 김두희;신우석;김동환;정연재;임한빛;박원형;차윤엽
    • 한방비만학회지
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    • 제13권1호
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    • pp.1-9
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    • 2013
  • Objectives: This study was performed to analyze the recent trend of the studies about obesity in medicine and to provide background for futher studies. Methods: All of the article were selected in "The Korean Journal of Obesity". Search were conducted through "http://kosso.or.kr" with the search word "obesity". Collected articles were classified into clinical study, experimental study, literary study, case report. Results: One hundred eighty four studies were included and analyzed in terms of study design, subject, intervention, period, obesity index and so on. The numbers of clinical studies, literary studies, experimental studies, case reports were respectively 143 (77.7%), 26 (14.1%), 2 (1.1%) and 7 (3.8%). In clinical studies, observational studies were 112 (78.3%) and intervention studies were 31 (21.7%). And most of sample sizes were more than 100 and less than 499. Body mass index, waist circumstance, body fat percent were major criteria of clinical study. Most of the subjects on obesity were about relation with another disease or experimental results and diagnosis. According to classification by the kinds of intervention, diet, exercise, drug, behavior were respectively 22, 18, 8, and 8. More than fourty percent of intervention studies were studied for 12 weeks. Conclusions: To improve the quality of Korean Medicine study for obesity, we need to recruiting big sample size and activate randomized clinical trial.

전문가 미백시 sealing technique의 효율성에 관한 연구 (The effectiveness of sealing technique on in-office bleaching)

  • 이윤;권소란;박정원
    • Restorative Dentistry and Endodontics
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    • 제33권5호
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    • pp.463-471
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    • 2008
  • 본 연구는 전문가 미백시 Sealed bleaching technique의 효율과 안정성을 평가하기 위해 split arch design의 randomized clinical trial을 시행하였다. 10명의 건전한 자연치를 가진 성인 환자의 상악 전치부를 좌우측으로 무작위로 나누어 전문가 미백 술식을 시행하였다. Brite powder (PacDent, Walnut, USA) 한 스푼에 10 방울의 3% 과산화수소수와 0.4ml의 carbamide peroxide gel (KoolWhite, PacDent, Walnut, USA)을 혼합하여 미백제로 사용하였다. 편측의 세 치아를 대조군으로 지정하여 통상적인 방법으로 전문가 미백을 시행하였고, 반대측의 세 치아는 실험군으로 미백제 위에 linear low density polyethylene (LLDPE) wrap을 적용후 BT Cool light을 1시간 동안 적용하여 광활성화 하였다. 치아의 색조는 shadeguide를 이용하여 평가하는 방법과 spectrophotometer를 이용하여 측정하는 두 가지 방법을 이용하였으며, 술전, 술후, 체크시의 색조 측정 결과를 paired-t test로 분석하여 다음의 결과를 얻을 수 있었다. Shade guide로 평가한 결과 실험군과 대조군 모두에서 술후와 체크시의 색조와 술전의 색조와는 유의한 차이가 있었다 (p<.05). 또한 술전에는 대조군과 실험관간의 색조의 유의차가 없었던 반면 술후와 체크 (p<.05)시 모두에서 두 군간의 차이가 있었다 (p<.05). Spectrophotometer로 측정한 ${\Delta}E$ 값의 경우, 술후에는 대조군에서 $4.35{\pm}1.38$, 실험군에서 $5.08{\pm}1.34$로 나타났으며, 체크시에는 대조군에서 $3.73{\pm}1.95$, 실험관에서는 $4.38{\pm}2.08$로 나타났다. ${\Delta}E$는 술전과 술후를 비교한 값, 그리고 술전과 체크시를 비교한 값 모두에서 실험군과 대조군 간의 유의차가 있었다 (p<05). 따라서 이 연구에서 사용된 미백 술식을 사용할 경우, sealed bleaching technique이 미백의 효율성을 높인다고 결론지을 수 있다.

대장암 환자의 한약 및 침치료에 대한 국내외 임상연구 결과에 대한 고찰 - Pubmed를 중심으로 (Review on Clinical Studies of Traditional Herbal Medicine and Acupuncture Treatments for Colorectal Cancer Patients)

  • 강윤환;홍미나;한창우;최준용;박성하;김소연
    • 동의생리병리학회지
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    • 제30권4호
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    • pp.219-228
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    • 2016
  • The aim of this study was to collect and analyze the clinical studies of traditional herbal medicine and acupuncture treatments for colorectal cancer patients searched in Pubmed and Cochrane library in English. We collected the clinical studies, including randomized controlled trial, case control study and cohort study, in the PubMed and Cochrane library using keywords 'Colorectal Cancer', 'Korean Medicine', 'Traditional Chinese Medicine', 'Kampo' and 'Acupuncture'. Then we analyzed them according to the objective of the therapy, i.e. improving therapy prognosis, reducing chemotherapy's adverse event and reducing operational adverse event. In case RCT, we evaluate the quality of the study with jadad scale. Total 18 studies were selected. There were 3 studies about improving therapy prognosis, 6 studies about reducing chemotherapy's adverse event and 9 studies about reducing operational adverse event. Traditional medicine might improve therapy prognosis in terms of the survival rate, relapse/metastasis rate, quality of life and immune function. The specific herbal formula, 'Goshajinkigan' might not be successful about reducing chemotherapy's adverse event, peripheral neurotoxicity. 'Hangeshanshinto' might reduce the duration of oral mucositis but it is not clear to reduce the incidence of that. 'PHY906' might reduce the incidence of diarrhea. Acupuncture might reduce operational adverse event such as gastrointestinal dysfunction and pain. And 'Daikenchuto' might not be successful in reducing operational adverse event, gastrointestinal dysfunction. Further studies are needed to clarify the efficacy of traditional herbal medicine and acupuncture for colorectal cancer patients.

한양방 병용치료에 대한 문헌고찰 (A Literature Review of the East-West Medical Combined Treatment)

  • 김창석;김상균;김영은;김철;예상준;장현철;송미영
    • 한국한의학연구원논문집
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    • 제18권2호
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    • pp.101-116
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    • 2012
  • Objectives : This study aims to analyze the papers of the east-west medical combined treatment and suggest the research direction. Methods : 183 research papers were collected by using 25 keywords including combination(in korean words, 병용), collaborative practice(in korean words, 협진) in Korean Medical Database(KMbase) and Oriental Medicine Advanced Searching Integrated System(OASIS). We analysed the type of studies, the kind of diseases, the treatment method, the kind of herbs and drugs in frequent use, and the result of research. Results : Among the analysed 183 papers, clinical studies are 89 cases and experimental studies are 94. 5 cases of clinical studies are Randomized Controlled Trial(RCT). The cancer(50 papers) and diseases of the circulatory system(25 papers) occupied mostly in treatment studies. Because Combined treatment was actively progressed in oriental medicine, treatment was mainly applied the combined oriental medical treatment with herbs and western drugs. In herbal medicine, Mahwangyounpae-tang(麻黃潤肺湯) and Eunkyo-San(銀翹散) were frequently used in the papers. In western drugs, Cyclophosphamide, Cisplatin, and Mitomycin C were frequently used in the papers. 154 papers introduced the treatment effect, 14 papers announced the safety, and 4 papers mentioned the side effect. Conclusions : We suggested several future research direction as follows. Clinical studies based on experiment studies must be more activated and many RCT shoud be shown. Experimental group in clinical studies should be clearly separated to confirm the treatment method is effective or isn't effective. Studies about the side effect must be expanded, and every study should be confirmed both the treatment effect and safety.

화병의 한의학적 치료에 대한 연구동향 (Current Trends in Intervention Studies of Hwabyung in Korean Medicine)

  • 서효원;최은지;김상호;김동희;김락형;김종우;이재혁;임재환;최우진;정선용
    • 동의신경정신과학회지
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    • 제27권4호
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    • pp.261-274
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    • 2016
  • Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.