• 제목/요약/키워드: Prospective clinical evaluation

검색결과 114건 처리시간 0.026초

한열(寒熱) 변증에 따른 한의 외용 치료제 비염고의 치료 효과 : 하위 그룹 분석 (Effectiveness of herbal ointment Biyeom-go according to cold-heat pattern identification: a subgroup analysis on patients with rhinitis)

  • 손미주;이동효
    • 한방안이비인후피부과학회지
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    • 제32권4호
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    • pp.29-40
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    • 2019
  • Objectives : Hwanglyeonhaedok-tang(黃連解毒湯) is a representative herbal formula with "clear heat(淸熱)" effects. The aim of this study was to evaluate the effects of Hwanglyeonhaedok-tang-based intranasal herbal ointment Biyeom-go based on the cold and heat pattern identification questionnaire(CHPIQ). Methods : We performed a subgroup analysis of the previously published prospective observational study. A total of 58 patients with rhinitis were administered Biyeom-go for 4 weeks, and its effects on the Total Nasal Symptom Score(TNSS), Mini Rhinoconjunctivitis Quality of Life Questionnaire(Mini-RQLQ) score, and nasal endoscopy index score were analyzed based on CHPIQ. Results : Among the 58 patients, the heat and non-heat patterns were shown by 39 and 19 patients, respectively, while the cold and non-cold patterns were shown by 46 and 12 patients, respectively. The change in TNSS from baseline negatively correlated with the heat pattern score(p=0.011). Improvement in TNSS was greater in the heat pattern group than in the non-heat pattern group, with a borderline significant difference(p=0.07). Mini-RQLQ and nasal endoscopy index scores tended to be lower in the heat pattern group than in the non-heat pattern group, but without a statistically significant difference. Conclusion : The findings indicate that CHPIQ is a useful tool for the diagnostic and prognostic evaluation of patients with rhinitis. This study provides fundamental evidence of the close association between the cold-heat pattern in patients with rhinitis and the treatment effects of Biyeom-go.

Prospective Assessment of the Performance of a New Fine Needle Biopsy Device for EUS-Guided Sampling of Solid Lesions

  • El Hajj, Ihab I.;Wu, Howard;Reuss, Sarah;Randolph, Melissa;Harris, Akeem;Gromski, Mark A.;Al-Haddad, Mohammad
    • Clinical Endoscopy
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    • 제51권6호
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    • pp.576-583
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    • 2018
  • Background/Aims: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) remains the most common EUS-guided tissue acquisition technique. This study aimed to evaluate the performance of a new Franseen tip fine needle biopsy (FNB) device for EUSguided sampling of solid lesions and compare it with the historical FNA technique. Methods: $Acquire^{(R)}$ 22 G FNB needle (Boston Scientific Co., Natick, MA, USA) was used for solid tumor sampling (Study group). Tissue was collected for rapid on-site evaluation, and touch and crush preparations were made. Historical EUS-FNA samples obtained using $Expect^{(R)}$ 22 G FNA needle (Boston Scientific Co.) were used as controls (Control group). All specimens were independently evaluated by two cytopathologists blinded to the formal cytopathological diagnosis. Results: Mean cell block histology scores were significantly higher (p=0.046) in the FNB group (51 samples) despite a significantly lower (p<0.001) mean number of passes compared to the FNA group (50 specimens). The overall diagnostic yields for the FNB vs. FNA groups were 96% vs. 88%. The degree of tumor differentiation was adequately assessed in all cell block qualifying lesions in the FNB group. Two patients developed post-FNB abdominal pain. Conclusions: The new Franseen tip FNB device provides histologically superior and cytologically comparable specimens to those obtained by FNA, but with fewer passes.

Laser-assisted Delivery of a Combined Antioxidant Formulation Enhances the Clinical Efficacy of Fractional Microneedle Radiofrequency Treatment: A Pilot Study

  • Kim, Jihee;Kim, Soo Min;Jung, Bok Ki;Oh, Sang Ho;Kim, Young-Koo;Lee, Ju Hee
    • Medical Lasers
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    • 제10권3호
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    • pp.161-169
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    • 2021
  • Background and Objectives Fractional microneedle radiofrequency systems are popular options to increase elasticity in aging skin. Laser-assisted drug delivery is a promising method for the epidermal injection of topically applied drugs and cosmetic ingredients. This study assesses the safety and efficacy of topical delivery of L-ascorbic acid, vitamin E, and ferulic acid after fractional microneedle radiofrequency treatment for reducing photodamage. Materials and Methods In this prospective, single-center, split-face, controlled pilot study, six women (mean age, 48.0 years; range, 35-57 years; Fitzpatrick skin types III and IV) exhibiting mild to moderate photodamage, underwent a single session of fractional microneedle radiofrequency treatment. The patients were instructed to apply the antioxidant formulation to only one side of the face. Patients were evaluated 3 days, 7 days, and 4 weeks thereafter, using three-dimensional imaging and ultrasound. Ex vivo, the full-thickness human skin was used for molecular and histological evaluation. Statistical analysis was achieved by applying t-tests, Mann-Whitney U tests, and one-way analyses of variance. Results Compared to the untreated side, the antioxidant-treated side exhibited a significant increase in dermal thickness (10.32% vs. 17.54%, p < 0.05), but not in skin elasticity (4.76% vs. 4.69%, p > 0.05). The difference in erythema between the sides was statistically not significant (p > 0.05). In the ex vivo model, expression of FGF2 in the skin was significantly increased after application of the antioxidant formulation, as compared to results obtained subsequent to fractional microneedle radiofrequency treatment only (p < 0.01). Conclusion This study demonstrates that for the treatment of photodamaged skin, laser-assisted delivery of the antioxidant formulation is a safe and effective adjuvant modality following fractional microneedle radiofrequency.

Early postoperative treatment of mastectomy scars using a fractional carbon dioxide laser: a randomized, controlled, split-scar, blinded study

  • Shin, Hyun Woo;Suk, Sangwoo;Chae, Seoung Wan;Yoon, Kun Chul;Kim, Junekyu
    • Archives of Plastic Surgery
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    • 제48권4호
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    • pp.347-352
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    • 2021
  • Background Mastectomy leaves unsightly scarring, which can be distressing to patients. Laser therapy for scar prevention has been consistently emphasized in recent studies showing that several types of lasers, including fractional ablation lasers, are effective for reducing scar formation. Nonetheless, there are few studies evaluating the therapeutic efficacy of ablative CO2 fractional lasers (ACFLs). Methods This study had a randomized, comparative, prospective, split-scar design with blinded evaluation of mastectomy scars. Fifteen patients with mastectomy scars were treated using an ACFL. Half of each scar was randomized to "A," while the other side was allocated to group "B." Laser treatment was conducted randomly. Scars were assessed using digital photographs of the scar and Vancouver scar scale (VSS) scores. Histological assessments were also done. Results The mean VSS scores were 2.20±1.28 for the treatment side and 2.96±1.40 for the control side. There was a significant difference in the VSS score between the treatment side and the control side (P=0.002). The mean visual analog scale (VAS) scores were 4.13±1.36 for the treatment side and 4.67±1.53 for the control side. There was a significant difference in VAS score between the treatment side and the control side (P=0.02). Conclusions This study demonstrated that early scar treatment using an ACFL significantly improved the clinical results of the treatment compared to the untreated scar, and this difference was associated with patient satisfaction.

만성 요통 환자에서의 휴대용 저출력 레이저 치료기의 통증 및 기능 효과 (Efficacy of Portable Low Power Laser Therapy on Pain and Functions in Chronic Low Back Pain)

  • 조연욱;김태희;임오경;이주강;박기덕
    • Clinical Pain
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    • 제19권1호
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    • pp.1-7
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    • 2020
  • Objective: A prospective, assessor-blinded, randomized controlled trial was conducted in patients with chronic low back pain to evaluate the efficacy of portable low power laser therapy (LPLT) and the effect when combined with exercise therapy on pain and functions. Method: 60 patients were recruited and 56 patients, excluding 4 dropouts, were randomly allocated to the LPLT group (Group 1: 19 patients), placebo laser therapy with exercise group (Group 2: 18 patients), and LPLT with exercise group (Group 3: 19 patients). Laser therapy and exercise was performed five times a week for 4 weeks. Visual analogue scale (VAS), Schober test, lumbar range of motion (ROM) measures (flexion, extension and lateral flexion), Oswestry Disability index (ODI) were measured at baseline, at 4 weeks after intervention, and at 6 weeks after 2 weeks of no intervention. Results: Statistically significant improvements were noted in all group by time interaction with respect to all outcome parameters (p<0.05). All parameters in each group improved not only in the period of treatment (4 weeks), but also in the final evaluation (6 weeks) 2 weeks after the end of treatment. Post-hoc analysis showed statistically significant difference between the LPLT with exercise group and the other groups in all outcome parameters except for the ODI at 4 weeks and at 6 weeks. Conclusion: Portable LPLT is effective treatment in reducing pain and improving lumbar ROM and with exercise is more effective than laser or exercise monotherapy for the chronic low back pain patients.

견봉하 삼각근하낭염 환자에서 견봉하낭 스테로이드 주사 후 운동의 효과 (Role of Exercise after Subacromial Bursa Injection in Subacromial Subdeltoid Bursitis)

  • 김선웅;김상준
    • Clinical Pain
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    • 제16권1호
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    • pp.20-25
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    • 2017
  • Objective: To find that the patients who conducted home self-exercise in conjunction with intra-articular corticosteroid injection will have better improvement in subacromial subdeltoid (SASD) bursitis symptoms than those who received only an injection. Method: A prospective, nonrandomized, comparison study was conducted in outpatient rehabilitation clinic in a tertiary university hospital. Patients diagnosed with SASD bursitis with physical examination and ultrasound evaluation were included and received ultrasound guided injection (UGI). Patients were divided into two groups according to the compliance of self-exercise: UGI-exercise group and UGI only group. Visual analog scale (VAS) was checked before, at 3 weeks, 3 months, and 6 months after the UGI. A patient's global impression of change (PGIC) survey was made at 3 months after the UGI. Results: A total of 82 patients with SASD bursitis were included. At 3 weeks after the injection, the mean VAS for the UGI-exercise group was 2.6 ± 1.7 and for UGI only group was 1.9 ± 1.3 (p=0.030). At 3 months after the injection, the mean VAS for the UGI-exercise group was 4.0 ± 1.3 and for UGI only group was 5.4 ± 1.4 (p<0.001). Conclusion: We concluded that home-based self-exercise of the shoulder provides an additional benefit for pain alleviation possibly with prolonging the effect of injection in SASD bursitis.

Cryoballoon Catheter Ablation in Korean Patients With Paroxysmal and Persistent Atrial Fibrillation: One Year Outcome From the Cryo Global Registry

  • Hong Euy Lim;Il-Young Oh;Fred J Kueffer;Kelly Anna van Bragt;Young Keun On
    • Korean Circulation Journal
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    • 제52권10호
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    • pp.755-767
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    • 2022
  • Background and Objectives: Cryoballoon catheter ablation for the treatment of patients with symptomatic atrial fibrillation (AF) has been adopted globally, but there are limited multicenter reports of 12-month outcomes in the Korean patient population. This analysis evaluated the clinical performance and safety of cryoballoon ablation (CBA) according to standard-of-care practices in Korea. Methods: This evaluation of Korean patients with AF was conducted within the larger Cryo Global Registry, which is a prospective, multicenter, post-market registry. Freedom from a ≥30-second recurrence of atrial arrhythmias (after a 90-day blanking period until 12 months) and procedural safety were examined in subjects treated with CBA at 3 Korean centers. Results: Overall, 299 patients with AF (60±11 years old, 24.7% female, 50.5% paroxysmal AF) underwent CBA using the Arctic Front Advance cryoballoon. Of those, 298 were followed-up for at least 12 months. Mean procedure-, left atrial dwell- and fluoroscopy time was 76±21 minutes, 56±23 minutes, and 27±23 minutes, respectively. Freedom from AF recurrence at 12 months was 83.9% (95% confidence interval [CI], 76.9-88.9%) in the paroxysmal and 61.6% (95% CI, 53.1-69.0%) in the persistent AF cohort. Rhythm monitoring was performed on average 4.7±1.4 times during the follow-up period. Serious device- or procedure-related adverse events occurred in 2 patients (0.7%). The 12-month Kaplan-Meier estimate of freedom from repeat ablation and cardiovascular-related hospitalization was 93.8% (95% CI, 90.4-96.1%) and 89.7% (95% CI, 85.6-92.7%), respectively. Conclusions: CBA is an efficient, effective, and safe procedure for the treatment of AF patients when used according to real-world practices in Korea.

족부 족관절 질환 환자에서 전자식 족부 기능 지수의 인증: 임의 배정, 전향적, 다기관 연구 (Validation of Electronic Foot Function Index in Patients with Foot and Ankle Disease: A Randomized, Prospective Multicenter Study)

  • 이동연;김유미;이준형;김진;김지범;김범수;최기원;서상교;김준범;박세진;김윤정;최영락;이동오;조재호;천동일;김형년;박재용
    • 대한족부족관절학회지
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    • 제23권1호
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    • pp.24-30
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    • 2019
  • Purpose: To evaluate the efficiency of the electronic foot function index (eFFI) through a prospective, random based, multi-institutional study. Materials and Methods: The study included 227 patients ranging in age from 20 to 79 years, visited for surgery in different 15 institutes, and agreed to volunteer. The patients were assigned randomly into a paper-based evaluated group (n=113) and tablet-based evaluated group (n=114). The evaluation was done on the day of hospital admission and the method was changed on the second day of surgery and re-evaluated. PADAS 2.0 (https://www.proscore.kr) was used as an electronic evaluation program. Results: There were no differences in age and sex in both groups. The intraclass correlation coefficient (ICC) evaluation revealed an eFFI ICC of 0.924, showing that both results were similar. The evaluation time was shorter in the tablet-based group than the paper-based group (paper vs tablet, $3.7{\pm}3.8$ vs $2.3{\pm}1.3minutes$). Thirty-nine patients (17.2%) preferred to use paper and 131 patients (57.7%) preferred the tablet. Fifty-seven patients (25.1%) found both ways to be acceptable. Conclusion: eFFI through tablet devices appears to be more constant than the paper-based program. In addition, it required a shorter amount of time and the patients tended to prefer the tablet-based program. Overall, tablet and cloud system can be beneficial to a clinical study.

소세포 폐암의 치료성적에 대한 고찰 (A Clinical Therapeutic Results on Small Cell Lung Cancer)

  • 김은화;이순형;허원영;김한식;조진웅;김미애;김상균;김귀완;정원규;김수곤
    • Tuberculosis and Respiratory Diseases
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    • 제41권3호
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    • pp.262-269
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    • 1994
  • 연구배경: 소세포 폐암은 비소세포 폐암에 비해 병의 진행경과 및 치료에 대한 반응이 상이하게 나타나는데 저자들은 지난 7년간(1986~1992) 본원에서 진단된 소세포 폐암환자들을 대상으로, 그 치료성적에 대해 고찰해 보고자 하였다. 방법: 조직학적 및 세포진 검사상 폐암으로 진단받은 806명 중 소세포 폐암으로 밝혀진 153명의 환자들을 대상으로 하였으며, 병력일지 및 우편물 또는 전화를 통하여 102명의 환자에 대한 생사확인과 사망일지 등을 확인하였고 임상기록을 중심으로 후향적인 방법으로 분석하였다. 결과: 1) 전체 암환자 수는 8,050명 이었으며, 그 중 폐암환자는 806명(10.0%) 이었고 소세포 폐암환자는 153명으로 전체 폐암환자의 19.0%를 차지했으며, 남녀의 비는 129명: 24명(84.3% : 15.7%) 이었다. 2) 소세포 폐암환자의 연령분포는 60대가 60명(39.2%), 50대가 53명(34.6%)으로 3/4 정도의 환자가 50~60대 사이에 발생했다. 3) 다양한 증상 및 증세를 나타냈으며, 반 수 이상의 환자에서 기침, 객담, 호흡곤란 및 흉통이 있었고 진단방법으로는 128명(83.5%)이 기관지 내시경 및 생검으로 진단 되었으며 ECOG에 의한 수행상태는 $H_2$가 59.5%를 차지하였고, 그 다음은 $H_1$이 30.7%를 차지하였다. 병기 및 위치의 분류는 대개가 limited stage(105명, 68.7%)와 central type(134명, 87.6%) 이었다. 4) 화학요법과 병합요법(항암 및 방사선 치료)을 시행한 군의 치료에 대한 반응을 비교해 본 바 병합요법을 시행한 군이 완전관해 및 부분관해율이 63.4%을 보였으며 평균 생존기간은 3주기 이상의 화학요법으로 시행한 환자중 limited stage의 경우 5.3개월 extensive stage는 4.6개월을 보여 양군간에 유이한 차이가 없었으나, limited stage 에서 시행한 병합요법 환자의 경우 15개월 1일의 평균 생존기간을 나타내어 limited stage시의 화학요법과 유이한 차이를 보였다. 5) 치료의 유무와 상관없이 시행한 각 병기간 환자의 중앙 생존기간은 limited stage가 10.9개월 extensive stage가 4.8개월을 보여 양군간의 유이한 차이를 보였다. 결론: 폐암은 현재 국내에서도 점차 증가하는 추세에 있는 악성 종양중의 하나로 본원에서의 최근 7년간 전체 암환자 순위 중 특히 남자의 경우 위암 다음으로 많았으며, 그 중 소세포 폐암의 치료성적에 대해 후향적인 방법으로 고찰하여 보고하는 바이며, 특히 limited stage 시 항암 및 방사선치료가 항암단일요법보다 더 생존율이 높은것으로 나타났는데, 향후 더 정확한 임상고찰을 위해서는 전향적인 연구가 필요하리라 생각된다.

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입원환자의 영양불량위험 검색도구의 개발 및 평가 (Development and Evaluation of a Nutritional Risk Screening Tool (NRST) for Hospitalized Patients)

  • 한진순;이송미;정혜경;안홍석;이승민
    • Journal of Nutrition and Health
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    • 제42권2호
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    • pp.119-127
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    • 2009
  • 이 연구는 다양한 병명을 가진 입원환자의 영양불량위험의 진단을 간단하고 신속하게 실시할 수 있고 재원기간 내의 임상결과를 유의하게 예측하며 NRS 2002와 비교하여 평가하였을 때 일정 수준 이상의 타당도를 가지는 영양불량 위험 검색도구를 (Nutritional Risk Screening Tool, NRST) 개발하고자 하였다. NRST의 개발 및 평가는 서울 소재 일개 종합병원에 1년여의 기간 동안 입원한 성인 환자를 대상으로 수집된 자료를 이용하여 NRST 구성요소의 선정, NRST scoring scheme의 탐색, NRST 평가의 기준점 설정, NRST의 임상결과 예측력 재확인 등의 총 4단계의 과정을 통하여 실시되었다. 아래에 본 연구의 결과 및 결론을 요약하였다. 1) 재원일수, 사망여부, 합병증 유무, 질병예후를 각각 종속변수로 하는 stepwise multiple regression을 시행한 결과 나이와 혈청 내 albumin, TLC, Hct 농도가 NRST의 구성요소로 선정되었다. 2) 선정된 각 NRST 구성요소의 수준에 따른 NRS 2002의 OR에 기준하여 NRST의 scoring scheme을 아래와 같이 설정하였다. $NRST=Albumin{\times}1+Age{\times}2.5+Hct{\times}1.5+TLC{\times}2{\ast}$ ${\ast}$ Coding:Albumin <3.5:1, ${\geqq}$ 3.5:0.Age>65:1, ${\leqq}$65:0.Hct<37:1, ${\geqq}$37:0.TLC<1800:1, ${\geqq}$1800:0. 3) NRST의 점수변화에 따른 NRS 2000에 대한 민감도와 특이도를 바탕으로 NRST에 의한 영양불량 위험의 진단 기준점수를 3.5 이상으로 정하였다. 4) NRST 결과에 따른 재원일수, 합병증여부, 질병 예후, 사망여부 등의 차이를 검토한 결과 개발된 NRST가 만족할 만한 수준의 임상결과 예측력을 가지는 것으로 나타났다. 5) NRST는 다양한 진단명을 가진 입원환자의 영양불량 위험 여부를 향후의 임상결과와 관련하여 신속하게 진단하는데 유용하리라 사료된다.