• 제목/요약/키워드: Clinical Trials

검색결과 2,361건 처리시간 0.026초

고지혈성 급성 췌장염에 대한 대시호탕의 효과 : 체계적 문헌고찰과 메타분석 (The Effect of Dachaihu Decoction for Hyperlipidemic Acute Pancreatitis: A Systematic Review and Meta-Analysis)

  • 김윤정;정유진;박동일
    • 대한한방내과학회지
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    • 제41권3호
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    • pp.306-325
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    • 2020
  • Objectives: The aim of this study is to investigate the effect of a Dachaihu decoction for hyperlipidemic acute pancreatitis (HLAP) by systematic review and meta-analysis of Chinese clinical studies. Methods: China National Knowledge Infrastructure (CNKI) was utilized as the major search engine. The date of the literature search was March 7, 2020. Randomized controlled trials (RCTs) about using a Dachaihu decoction for HLAP were included in this study. Meta-analysis was performed by synthesizing outcome data, including total effective rate, abdomen pain relief time, first bowel movement time, blood amylase recovery time, and triglyceride (TG) levels (mmol/L). The selected literature was assessed using Cochrane's risk of bias (RoB). Results: Twelve of 44 RCTs met the inclusion criteria. Most studies were evaluated with RoB as having unclear risk. The total effective rate of herbal medicine treatment based on the Dachaihu decoction was significantly higher than that of symptomatic supportive treatment in 10 articles (risk ratio=1.15, 95% CI: 1.08 to 1.21, p<0.00001, I2=0%). Herbal medicine treatment based on a Dachaihu decoction was significantly more effective than symptomatic supportive treatment in terms of reducing abdomen pain relief time (in all articles; mean difference=-1.70, 95% CI: -1.91 to -1.41, p<0.00001, I2=45%), first bowel movement time (in 7 articles; mean difference=-1.46, 95% CI: -1.86 to -1.05, p<0.00001, I2=73%), blood amylase recovery time (in 8 articles; mean difference=-1.48, 95% CI: -2.04 to -0.92, p<0.00001, I2=90%), and TG levels (in 8 articles; mean difference=-1.59, 95% CI: -2.28to -0.91, p<0.00001, I2=90%). Only one article reported side effects of treatment among the intervention group and control group, citing pancreatic ulcer and pancreatic pseudocyst formation. Conclusions: This study suggests that herbal medicine treatment based on a Dachaihu decoction could yield higher efficacy for HLAP than symptomatic supportive treatment alone. However, the results might be somewhat biased because of the poor quality and small sample size of the included RCTs. Well-qualified clinical studies are needed to prove the effectiveness of Dachaihu decoction therapy for HLAP.

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
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    • 제20권10호
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    • pp.218-228
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    • 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
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    • 제84권4호
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    • pp.291-298
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    • 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).

골절에 침 치료를 적용한 2013년 이후 증례보고 문헌고찰 (A Review of Case Reports on the Application of Acupuncture as a Treatment for Fracture since 2013)

  • 백승원;남경호;최승관;이정한;한윤희
    • 한방재활의학과학회지
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    • 제31권4호
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    • pp.49-63
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    • 2021
  • Objectives This study aimed to investigate the trend in treating fracture with acupuncture and to evaluate the quality of case reports. Methods All case reports of fractures treated with acupuncture were extracted from four Korean web databases. We classified these studies by five fracture sites and investigated frequently used meridian and acupoint, outcome measurements, treatment period. And we assessed the quality of the case reports by the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines. Results A total of 33 case reports were included. The outcome measurements were divided into six categories, and the outcome measurements used in more than three studies showed improvement in patient symptoms. The mainly used meridians for each fracture site were as follows: chest and abdomen (GB, LR, CV), back (BL, GB), upper limb (LI, TE), lower Limb (GB, ST, BL, SP). The most commonly used acupoints for each fracture site were as follows: chest and abdomen (Ashi points, GB24, GB25, GB26, LR13, LR14, CV16, CV17, CV18, CV19), back (BL23, BL24, BL25, BL26, BL40, BL51, BL52, BL60, GB34), upper limb (LI4, LI10, LI11, TE3), lower limb (GB34, GB40). According to the STRICTA guidelines, more than 54.54% of the reports were found to be 'not reported' or 'not sufficient' in the following categories: 'response sought', 'description of participating acupuncturist', and 'number of needle insertions per subject per session'. Conclusions The meridians and acupuncture points frequently used for acupuncture treatment of fractures were near the fracture site. Future clinical studies involving acupuncture must be reported in accordance with the STRICTA guidelines to improve transparency and uniformity.

Clinical Effect of Traditional Chinese Medicine Shenhuang Granule in Critically Ill Patients with COVID-19: A Single-Centered, Retrospective, Observational Study

  • Feng, Jun;Fang, Bangjiang;Zhou, Daixing;Wang, Junshuai;Zou, Dengxiu;Yu, Gang;Fen, Yikuan;Peng, Dan;Hu, Jifa;Zhan, Daqian
    • Journal of Microbiology and Biotechnology
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    • 제31권3호
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    • pp.380-386
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    • 2021
  • The coronavirus disease 2019 (COVID-19) pandemic has become a public health emergency of global concern. In China, traditional Chinese medicine has been widely administered to COVID-19 patients without sufficient evidence. To evaluate the efficacy of Shenhuang Granule (SHG) for treating critically ill patients with COVID-19, we included in this study 118 patients who were admitted to the ICU of Tongji Hospital between January 28, 2020 and March 28, 2020. Among these patients, 33 (27.9%) received standard care plus SHG (treatment group) and 85 (72.1%) received standard care alone (control group). Enrolled patients had a median (IQR) age of 68 (57-75) years, and most (79 [67.1%]) were men. At end point of this study, 83 (70.3%) had died in ICU, 29 (24.5%) had been discharged from ICU, and 6 patients (5.2%) were still in ICU. Compared with control group, mortality was significantly lower in treatment group (45.4% vs. 80%, p < .001). Patients in treatment group were less likely to develop acute respiratory distress syndrome (ARDS) (12 [36.3%] vs. 54 [63.5%], p = 0.012) and cardiac injury (5 [15.1%] vs. 32 [37.6%], p = 0.026), and less likely to receive mechanical ventilation (22 [66.7%] vs. 72 [84.7%], p = 0.028) than those in control group. The median time from ICU admission to discharge was shorter in treatment group (32 [20-73] days vs. 76 [63-79] days, p = 0.0074). These findings suggest that SHG treatment as a complementary therapy might be effective for critically ill adults with COVID-19 and warrant further clinical trials.

2018 한국형 공황장애 치료지침서 : 정신사회적 치료전략 (Korean Guidelines for the Treatment of Panic Disorder 2018 : Psychosocial Treatment Strategies)

  • 김민숙;김민경;이재헌;김원;문은수;서호준;구본훈;양종철;이강수;이상혁;김찬형;유범희;서호석
    • 대한불안의학회지
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    • 제15권1호
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    • pp.13-19
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    • 2019
  • Objective : The purpose of this study was to investigate consensus relative to treatment strategies for psychosocial treatment in panic disorder, that represents one subject addressed by the Korean guidelines for treatment of panic disorder 2018. Methods : The executive committee developed questionnaires relative to treatment strategies for patients with panic disorder based on guidelines, algorithms, and clinical trials previously published in foreign countries and Korea. Seventy-two (61.0%) of 112 experts on a committee reviewing panic disorder responded to the questionnaires. We classified the consensus of expert opinions into three categories (first-line, second-line, and third-line treatment strategies), and identified treatment of choice using the Chi-square test and 95% confidence intervals. Results : For psychosocial treatment of panic disorder, individual and group cognitive behavior therapy (CBT) were recommended treatments of choice, and mindfulness based cognitive therapy (MBCT) was recommended as first line strategy. There was statistically significant consensus among experts regarding usefulness of each component of CBT and MBCT, for treatment of patients with panic disorder. Conclusion : Results, that reflect recent studies and clinical experiences, may provide the guideline for psychosocial treatment strategies for panic disorder.

골반교정에 대한 국내 임상 연구 동향 (An Overview of Clinical Studies on Pelvic Correction in Korea)

  • 백지유;배재룡;안훈모;이재흥
    • 대한의료기공학회지
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    • 제20권1호
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    • pp.118-147
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    • 2020
  • Objective : The purpose of this study is to understand trends of pelvic correction therapy in Korea and to assist research activities on pelvic correction therapy. Also, this study selected and presented indicators for measuring pelvic slope to help ensure consistent studies with uniform indicators in future studies related to pelvic correction. Methods : The following keywords "골반", "골반 교정", "골반 변위" "Pelvic correction" were searched on three specialized search sites (RISS, NAI, DBpia). Trends in pelvic correction therapy were analyzed through the selected researches suitable among these searched researches in an overview format. Results : 1. A total of 7,806 studies were searched and a total of 268 studies were finally selected. 2. Studies began in 1977 and have been actively studied until recently, with 35 studies in 2017 being the most recent trend since 2000. 3. In the results according to the Main Field of Research, the 'Arts and Kinesiology'(113, 42.16%) and 'Medicine and Pharmacy'(103, 38.43%) were the most in order. To the Middle Field, the 'Kinesiology was the largest with 96(35.82%) studies. 4. In the results according to the study design, 'Pre-Post Test(PPT)' was the largest with 107 studies. 5. In the results according to the Intervention, 'Exercise' was the largest with 165 studies, of which 'Pilates' and 'Yoga' in 'Training' was the largest. 6. Among the evaluation method, the 'Pelvic Index' was used 146 times, followed by 'Spinal Alignment (99)', 'Other Joints (93)', and 'Kinetic Specialized Measurement Test (56)'. 7. Among the evaluation methods, the pelvic slope measurement indicators were PT (58), PH (48), Pelvic Torsion (40), Iliac Crest (38), ASIS-PSIS distance/angle (27), and Pelvic Width (I.W., I.L., S.W) (25) in order. 8. The journals that published the most researches were KJSS(Korean Alliance For Health, Physical Education, Recreation, And Dance;9), and JKPT(Korean Physical Therapy;9). Among the University, the Graduate School of Silla University published the most papers (12). 9. The author who published the most studies were Seungjin Park(3), the co-authors were Hoseong Lee, Gideok Park, Seongsu Bae(3), and the Thesis-Director Gyeongok Lee(7). Conclusions : 1. Studies on pelvic correction treatment continue to increase every year. 2. The main academic field of pelvic correction is 'Sports', 'Physical Therapy', and 'Medical Science'. 3. The most chosen research design method in the study on pelvic correction treatment was 'Pre-Post Test(PPT)', primarily as an intermediary, Pilates and yoga during exercise therapy, and then Chiropractic during handcraft were used as multiple frequencies. 4. Among the various measurement method indicators of pelvic correction previously used, multiple frequency was taken up in the order of PT, PH, Pelvic Torsion, iliac crest, ASIS-PSIS distance/angle, and pelvic width (I.W.,I.L.,S.W). Typically, measurements through "ASIS-PSIS angle" are recommended and are considered as the most rational in clinical trials.

소아 알레르기 결막염의 한의학적 병인, 변증, 치법 및 한약재 선택에 대한 문헌적 고찰 (A Review of Korean Medical Pathogenesis, Pattern Identification, Treatment Principle and Herbal Medicines for Allergic Conjunctivitis in Pediatric Patients)

  • 김예지;서혜선;박용석;박슬기;이선행;이진용
    • 대한한방소아과학회지
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    • 제35권2호
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    • pp.21-36
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    • 2021
  • Objectives We aimed to understand etiology, pattern differentiation, treatment principle, and the role of selected herbs in the treatment of Korean herbal medicine for allergic conjunctivitis (AC) in children. Methods We searched relevant literature published up to February 20, 2021 through CNKI, using search formula of (SU= '結膜炎'+'conjunctivitis') AND (SU='儿童'+'小儿'+'少儿'+'幼年') AND (SU='治療'+'中医治療'+'中藥'+'中医藥'+'顆粒'+'胶囊'+'自擬'+'湯'+'丸'+'散'+'方'). Results Among 81 searched studies, 9 randomized controlled trials and 1 case report were selected and analyzed. In all studies included, the efficacy of herbal treatment for AC was confirmed, and there was no evidence that herbal medicine treatment has higher risk of developing side effects compared to conventional eye drop treatment. As an etiology, wind (風邪) was observed the most frequently, and Saposhnikoviae Radix (防風) and Schizonepetae Spica (荊芥) were in frequent use to dispel wind (祛風). As visceral pattern identification, spleen (脾) and lung (肺) were two important keywords, and spleen deficiency (脾虛), dampness-heat in the spleen and stomach (脾胃濕熱), lung qi deficiency (肺氣虛) were main pathologic mechanisms. Else, treatments related to liver (肝) and removing dampness-heat (濕熱) were mentioned next. Conclusions This study is significant in that AC in children, which has a lack of research compared to other allergic diseases, has been studied in the contents of Korean medicine and laid foundation that can be used as basic data in the actual clinical field. Based on this study, it is hoped that clinical data of Korean herbal medicine treatment for childhood AC will be further accumulated.

Efficacy and Safety of Autologous Stromal Vascular Fraction in the Treatment of Empty Nose Syndrome

  • Kim, Do-Youn;Hong, Hye Ran;Choi, Eun Wook;Yoon, Sang Won;Jang, Yong Ju
    • Clinical and Experimental Otorhinolaryngology
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    • 제11권4호
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    • pp.281-287
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    • 2018
  • Objectives. Regenerative treatment using stem cells may serve as treatment option for empty nose syndrome (ENS), which is caused by the lack of turbinate tissue and deranged nervous system in the nasal cavity. We aimed to assess the efficacy and safety of the autologous stromal vascular fraction (SVF) in the treatment of ENS. Methods. In this prospective observational clinical study, we enrolled 10 ENS patients who volunteered to undergo treatment of ENS through the injection of autologous SVF. Data, including demographic data, pre- and postoperative Sino-Nasal Outcome Test-25 (SNOT-25) scores, overall patient satisfaction, and postoperative complications, were prospectively collected. Nasal secretion was assessed using the polyurethane foam absorption method, and the levels of biological markers were analyzed in both ENS group and control group using enzyme-linked immunosorbent assay. The SVF extracted from abdominal fat was diluted and injected into both inferior turbinates. Results. Among the 10 initial patients, one was excluded from the study. Subjective satisfaction was rated as "much improved" in two and "no change" in seven. Among the improved patients, the mean preinjection SNOT-25 score was 55.0 and the score at 6 months after injection was 19.5. However, the average SNOT-25 score of nine participants at 6 months after injection (mean${\pm}$standard deviation, $62.4{\pm}35.8$) did not differ significantly from the baseline SNOT-25 score ($70.1{\pm}24.7$, P>0.05, respectively). Among the various inflammatory markers assessed, the levels of interleukin $(IL)-1{\beta}$, IL-8, and calcitonin gene-related peptide were significantly higher in ENS patients. Compared with preinjection secretion level, the nasal secretions from SVF-treated patients showed decreased expressions of $IL-1{\beta}$ and IL-8 after injection. Conclusion. Although SVF treatment appears to decrease the inflammatory cytokine levels in the nasal mucosa, a single SVF injection was not effective in terms of symptom improvement and patient satisfaction. Further trials are needed to identify a more practical and useful regenerative treatment modality for patients with ENS.

Ki67 Index Is the Most Powerful Factor for Predicting the Recurrence in Atypical Meningioma : Retrospective Analysis of 99 Patients in Two Institutes

  • Lee, Sang Hyuk;Lee, Eun Hee;Sung, Kyoung Su;Kim, Dae Cheol;Kim, Young Zoon;Song, Young Jin
    • Journal of Korean Neurosurgical Society
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    • 제65권4호
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    • pp.558-571
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    • 2022
  • Objective : The primary objective of this study was to identify predicting factors for local control (LC) of atypical meningioma, and we validated them with comparing the predicting factors for recurrence-free survival (RFS). We also examined the rate of LC after surgical resection with or without adjuvant treatment and RFS. Methods : Clinical and radiological records of patients with atypical meningiomas diagnosed at two institutes from January 2000 to December 2018 were reviewed retrospectively. Histopathological features were also reviewed using formalin-fixed paraffin embedded samples from pathological archives. Results : Of the 99 atypical meningiomas eligible for analysis, 36 (36.4%) recurred during the follow-up period (mean, 83.3 months; range, 12-232 months). The rate of 3-year LC and 5-year LC was 80.8% and 74.7%, respectively. The mean time-to-recurrence was 49.4 months (range, 12-150). The mean RFS was 149.3 months (95% confidence interval, 128.8-169.8 months) during the mean follow-up duration of 83.3 months (range, 12-232 months). Multivariate analysis using Cox proportional-hazard regression model showed that the extent of resection (hazard ratio [HR], 4.761; p=0.013), Ki67 index (HR, 8.541; p=0.004), mitotic index (HR, 3.275; p=0.044), and tumor size (HR, 3.228; p=0.041) were independently associated with LC. These factors were also statistically associated with RFS. In terms of radiotherapy after surgical resection, the recurrence was not prevented by immediate radiotherapy because of the strong effect of proliferative index on recurrence. Conclusion : The present study suggests that the extent of resection, proliferative index (according to Ki67 expression) and mitotic index, and tumor size are associated with recurrence of atypical meningiomas. However, our results should be further validated through prospective and randomized clinical trials to overcome the inborn bias of retrospective nature of the study design.