• Title/Summary/Keyword: Clinical trial center

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The efficacy of ultrasound-guided erector spinae plane block after mastectomy and immediate breast reconstruction with a tissue expander: a randomized clinical trial

  • Park, Sukhee;Park, Joohyun;Choi, Ji Won;Bang, Yu Jeong;Oh, Eun Jung;Park, Jiyeon;Hong, Kwan Young;Sim, Woo Seog
    • The Korean Journal of Pain
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    • v.34 no.1
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    • pp.106-113
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    • 2021
  • Background: We aimed to investigate the analgesic efficacy of an erector spinae plane block (ESPB) in immediate breast reconstruction (IBR) with a tissue expander. Methods: Adult women undergoing IBR with a tissue expander after mastectomy were randomly assigned to either intravenous patient-controlled analgesia (IV-PCA) alone (group P) or IV-PCA plus ESPB (group E). The primary outcome was the total amount of opioid consumption during 24 hours postoperatively between the two groups. Secondary outcomes were patient satisfaction, pain score at rest and on shoulder movement using numerical rating scale, incidences of postoperative nausea and vomiting (PONV), and a short form of the brief pain inventory (BPI-SF) at 3 and 6 months after surgery between the groups. Results: Fifty eight patients completed the study. At 24 hours postoperatively, total opioid consumption was significantly less in group E than in group P (285.0 ± 92.0, 95% confidence interval [CI]: 250.1 to 320.0 vs. 223.2 ± 83.4, 95% CI: 191.5 to 254.9, P = 0.005). Intraoperative and cumulative PCA fentanyl consumption at 3, 6, 9, and 24 hours were also less in group E than in group P (P = 0.004, P = 0.048, P = 0.020, P = 0.036, and P < 0.001, respectively). Patient satisfaction was higher in group E (6.9 ± 1.8 vs. 7.8 ± 1.4, P = 0.042). The incidences of PONV was similar. Conclusions: The ESPB decreased postoperative opioid consumption and increased patient satisfaction without significant complications after IBR with a tissue expander after mastectomy.

A Pilot Study of Evaluating the Reliability and Validity of Pattern Identification Tool for Insomnia and Analyzing Correlation with Psychological Tests (불면증 변증도구 신뢰도와 타당도 평가 및 심리검사와의 상관성에 대한 초기연구)

  • Jeong, Jin-Hyung;Lee, Ji-Yoon;Kim, Ju-Yeon;Kim, Si-Yeon;Kang, Wee-Chang;Lim, Jung Hwa;Kim, Bo Kyung;Jung, In Chul
    • Journal of Oriental Neuropsychiatry
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    • v.31 no.1
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    • pp.1-12
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    • 2020
  • Objectives: The purpose of this study was to evaluate the reliability and validity of the instrument on pattern identification for insomnia (PIT-Insomnia) and verify the correlation between PIT-Insomnia and psychological tests. Methods: Two evaluators examined the pattern identification of the participants who met insomnia disorder diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) and took the Insomnia Severity Index (ISI) score over 15 once manually and twice using the PIT-Insomnia to measure the inter-rater and test-retest reliability. We also conducted the following surveys: the Pittsburgh Sleep Quality Index (PSQI), the Korean version of Beck's depression inventory (K-BDI), the Korean version of the State-Trait Anxiety Inventory (STAI-K), the Korean Symptom checklist-95 (KSCL-95), and the EuroQol-5 dimension (EQ-5D), to measure concurrent validity and correlation between the PTI-Insomnia and psychological tests. Results: 1. The test-retest reliability analysis of the pattern identification results showed moderate agreement, and test-retest reliability analysis of each pattern identification score showed agreements from poor to moderate. 2. The inter-rater reliability analysis of the pattern identification results via manual showed slight agreement, when analysis was performed with calibration, the inter-rater reliability analysis of the pattern identification results via manual showed fair agreement. 3. The concordance analysis between results via manual and the PIT-Insomnia showed poor agreement, when the analysis was performed with calibration, concordance analysis showed fair agreement. 4. The concordance analysis between the PIT-Insomnia and the PSQI showed positive linear correlation. 5. The concordance analysis between the PIT-Insomnia and the PSQI, K-BDI, STAI-K, KSCL-95, and EQ-5D showed that non-interaction between the heart and kidney have positive linear correlation with the K-BDI, anxiety item of KSCL-95, dual deficiency of the heart-spleen have positive linear correlation with somatization item of KSCL-95, paranoia item of KSCL-95, heart deficiency with timidity have positive linear correlation with stress vulnerability item of KSCL-95, parania item of KSCL-95, phlegm-fire harassing the heart have positive linear correlation with K-BDI, paranoia item of KSCL-95, depressed liver qi transforming into fire have positive linear correlation with the anxiety item of KSCL-95, parania item of KSCL-95, all pattern identification have negative linear correlation with EQ-5D. Conclusions: The PIT-Insomnia has moderate agreement of reliability and reflects the severity of insomnia since it has some concurrent validity with the PSQI. There are some correlations between the PTI-Insomnia with specific psychological tests, so we could suggest it can be used appropriately in the clinical situation.

Polydeoxyribonucleotide Improves Peripheral Tissue Oxygenation and Accelerates Angiogenesis in Diabetic Foot Ulcers

  • Kim, Seoyoung;Kim, Junhyung;Choi, Jaehoon;Jeong, Woonhyeok;Kwon, Sunyoung
    • Archives of Plastic Surgery
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    • v.44 no.6
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    • pp.482-489
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    • 2017
  • Background Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate whether PDRN could improve peripheral tissue oxygenation and angiogenesis in diabetic foot ulcers. Methods This was a prospective randomized controlled clinical trial. Twenty patients with a non-healing diabetic foot ulcer were randomly distributed into a control group (n=10) and a PDRN group (n=10). Initial surgical debridement and secondary surgical procedures such as a split-thickness skin graft, primary closure, or local flap were performed. Between the initial surgical debridement and secondary surgical procedures, 0.9% normal saline (3 mL) or PDRN was injected for 2 weeks by the intramuscular (1 ampule, 3 mL, 5.625 mg, 5 days per week) and perilesional routes (1 ampule, 3 mL, 5.625 mg, 2 days per week). Transcutaneous oxygen tension ($TcPO_2$) was evaluated using the Periflux System 5000 with $TcPO_2/CO_2$ unit 5040 before the injections and on days 1, 3, 7, 14, and 28 after the start of the injections. A pathologic review (hematoxylin and eosin stain) of the debrided specimens was conducted by a pathologist, and vessel density (average number of vessels per visual field) was calculated. Results Compared with the control group, the PDRN-treated group showed improvements in peripheral tissue oxygenation on day 7 (P<0.01), day 14 (P<0.001), and day 28 (P<0.001). The pathologic review of the specimens from the PDRN group showed increased angiogenesis and improved inflammation compared with the control group. No statistically significant difference was found between the control group and the PDRN group in terms of vessel density (P=0.094). Complete healing was achieved in every patient. Conclusions In this study, PDRN improved peripheral tissue oxygenation. Moreover, PDRN is thought to be effective in improving inflammation and angiogenesis in diabetic foot ulcers.

Effects of Age and Sex on the Pharmacokinetics of Tacrolimus during Pediatric Kidney Transplantation: A Single Center Study (소아 신장이식 환자에서 연령 및 성별에 따른 타크롤리 무스의 약동학적 차이에 관한 단일기관 연구)

  • Choe, Jae Young;Jang, Kyung Mi;Hwang, Young Ju;Choi, Bong Seok;Park, Jong Kwang;Yoon, Young Ran;Kim, Chan Duck;Cho, Min Hyun
    • Childhood Kidney Diseases
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    • v.18 no.1
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    • pp.18-23
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    • 2014
  • Purpose: The pharmacokinetics of tacrolimus, one of the most widely used immunosuppressive drugs, are known to vary by sex, age, and ethnicity during pediatric transplantation. This study assessed the pharmacokinetic characteristics and associated factors of tacrolimus in Korean children receiving a kidney transplant. Methods: We retrospectively reviewed the pharmacokinetic data (therapeutic dose, trough level, clearance, and half-life) of 9 children who were given tacrolimus as one of their initial immunosuppressive drugs after kidney transplantation. In addition, we compared the findings to data from 10 adult kidney transplant recipients. Results: The mean age of our pediatric patients was 13.9 years, and the maleto- female ratio was 4:5. The mean dose of tacrolimus was $0.19{\pm}0.14$ mg/kg/day. The mean dose of tacrolimus for males was $0.23{\pm}0.12$ mg/kg/day, which was significantly higher than the dose for females ($0.16{\pm}0.14$ mg/kg/day). The trough level was not significantly different between both groups. The clearance rate of tacrolimus for males was also significantly higher than females. Although the dosage of tacrolimus for patients over the age of 12 years was lower ($0.18{\pm}0.13$ vs. $0.21{\pm}0.16$ mg/kg/day) and the trough level was higher ($8.2{\pm}4.5$ vs. $7.2{\pm}4.2$ mg/mL) than that for patients under the age of 12 years, there was no significant difference between them. However, there were significant differences between children and adults in dose, clearance, and half-life of tacrolimus. Conclusion: Out study suggests that the pharmacokinetics of tacrolimus tends to vary with sex and age. Therefore, large-scale prospective studies are required to verify the proper therapeutic dosage of tacrolimus in Korean children.

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

  • Song, Min-Ju;Kim, Eui-Seong
    • Restorative Dentistry and Endodontics
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    • v.36 no.6
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    • pp.465-476
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    • 2011
  • In current endodontic practice, introduction of operating microscope, ultrasonic instruments, and microinstruments has induced a big change in the field of surgical retreatment. In this study, we aimed to offer key steps of endodontic microsurgery procedure compared with traditional root-end surgery, and to evaluate factors influencing success and failure based on published articles. Endodontic microsurgery is a surgical procedure performed with the aid of a microscope, ultrasonic instruments and modern microsurgical instruments. The microscope provides magnification and illumination - essential for identifying minute details of the apical anatomy. Ultrasonic instruments facilitate the precise root-end preparation that is within the anatomical space of the canal. Modern endodontics can therefore be performed with precision and predictability, thus eliminating the disadvantages inherent in traditional periapical surgery such as large osteotomy, beveled apicoectomy, inaccurate root-end preparation and the inability to observe isthmus. Factors influencing the outcomes of endodontic microsurgery may be diverse, but standardization of procedures can minimize its range. Among patient and tooth-related factors, periodontal status and tooth position are known to be prognostic, but there are only few articles concerning this matter. High-evidence randomized clinical trials or prospective cohort studies are needed to confirm these findings.

Clinical Investigation and Follow-up Monitoring of Fatigue Patients Visiting the Oriental Medical Hospital (한방병원 보양클리닉에 내원하는 피로환자의 임상적 분석 및 치료경과 관찰)

  • 이종훈;이지현;박신명;김영철;이장훈;우홍정
    • The Journal of Korean Medicine
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    • v.21 no.4
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    • pp.55-63
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    • 2000
  • Objectives : Fatigue is a common symptom experienced by everyone. Nevertheless, clinicians have a tendency of ignoring it since fatigue itself is not considered a distinct disease. Actually, some limited research about chronic fatigue syndrome has been made within the country, but in reality, the probability of getting this syndrome is still considered very low due to the strict diagnosis standard. Therefore, there are tremendous numbers of patients who do not get enough attention from clinicians for their fatigue symptoms only because technically they do not belong to the syndrome. Therefore, a basic statistical database must be compiled and patient management programs must be developed. To accomplish this, we conducted this study by measuring degree of fatigue, clinical characteristics and processes of Oriental medical treatment of fatigue patients. Methods : The objects of this study were selected from the new patients who entered the tonification Clinic in Kynnghee Oriental Medical Center between August 11, 2000 and October 7, 2000. Their main complaint was fatigue and they did not suffer from any physical or mental problem either historically or at the time of the study. The objects were divided into two groups based on duration of fatigue; fatigue under 6 months is considered as acute fatigue and fatigue for longer than 6 months is chronic fatigue. The prepared survey sheet for measuring fatigue degree was distributed to the patients with their consent. The patients were divided again into three subgroups : the fIrst group went through 1st test and constitution test after tonification clinic; the second one went into constitution test skipping Ist measuring test; the third one went into only tonification clinic with neither 1st measuring test nor constitution test. Results : The total number of object patients was 47 and 80% of them were considered as 'fatigue patients' by the Chalder scale. Among all patients, 29.5% requested treatment for chronic fatigue, which is over 6 months. The average of scale II for all patients was 14.8, which indicates moderate fatigue. The averages of scale II-1, II-2, II-3 were respectively 7.5, 5.9, and 3.7 so the most common complaint was physical fatigue. When compared scale II based on occupations, student group scored 6.9 and office man group scored 8.5 in scale II-1, physical fatigue, but it was not significant. Conclusions : Numerous number of patients have come to Oriental medical centers or hospitals in Korea. Therefore, deeper statistical research and follow-up-monitoring are reqnired in the Oriental medical academic world. In this study, among all patients who entered the tonification Clinic in Kyunghee Oriental Medical Center, 29.5% requested treatment for chronic fatigue, which is over 6 months. This kind of statistical report is the first time trial in the Oriental medical academy world. Through these steps, more objective treatment can be made and standards of prognosis assessment can be established.tablished.

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Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험)

  • Lee, Sang-Do;Seo, Kwang Won;Lee, Jung Yeon;Huh, Jin Won;Choi, Ik Su;Park, Jae Sun;Shim, Tae Sun;Oh, Yeon-Mok;Park, In Won;Ryu, Wang-Seong;Choi, Byoung Whui
    • Tuberculosis and Respiratory Diseases
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    • v.57 no.4
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    • pp.320-328
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    • 2004
  • Background : Pulmonary vascular changes which occur early in the course of chronic obstructive pulmonary disease (COPD) are prevalent manifestation and later cause pulmonary hypertension, which is a bad prognostic factor in COPD. Beraprost sodium (BPS), an orally active prostacyclin analogue, has been shown to improve survival in patients with primary pulmonary hypertension. This study investigated the effect of BPS in the patients with COPD. Methods : This is a double-blind randomized placebo-controlled, two center clinical trial. Twenty one consecutive patients with COPD were enrolled from June 2003 to June 2004 (patients treated with BPS for 3 months, BPS group, n=11; those with placebo, placebo group, n=10). The baseline demographic, pulmonary function and hemodynamic data were not significantly different between two groups. Results : On echocardiographic examination, trans tricuspid valve pressure gradient has decreased significantly after 3 months with beraprost in the BPS group [17.7(${\pm}11.4$) to 8.2(${\pm}8.9$) mm Hg, p-value<0.05], while there was no significant change in the control group. Six-minute walking distance has decreased in the control group and increased in the BPS group, but there was no statistical significance. Conclusion : In patients with COPD oral administration of BPS reduced the pulmonary arterial pressure. The clinical significance of this finding, that is improving symptoms and natural course of the disease, needs further study.

Application of Topical Madecassoside Cream in Dogs and Cats with Skin Diseases

  • Ro, Woong-bin;Kang, Min-hee;Song, Doo-won;Kim, Heyong-seok;Lee, Ga-won;Kang, Hyun-min;Kim, Jong-won;Park, Su-bin;Jeon, Jin-ha;Keum, Jong-seon;Park, Won-keun;Ko, Jin;Sim, Sue-kyoung;Lee, Hyun-Jung;Park, Hee-myung
    • Journal of Veterinary Clinics
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    • v.38 no.2
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    • pp.56-62
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    • 2021
  • Madecassoside, an active ingredient extracted from Centella asiatica, is used for treatment of various skin disorders in humans. However, the effect of madecassoside on the skin of dogs and cats has not been studied yet. The purpose of this study was to evaluate clinical efficacy of topical madecassoside cream in dogs and cats with skin diseases. A total of twenty-one dogs and ten cats with various skin diseases were included in the study. The 1% topical madecassoside cream was applied to the animal's skin lesion at least once a day for 7 days, and the skin condition was evaluated before the application of madecassoside cream (day 0) and 7 days after the application (day 7). The skin condition was scored by five clinical indices: canine atopic dermatitis extent and severity index-4 (CADESI-4), coat condition, pruritus, scale, and general condition. In dogs, all five clinical indices (CADESI-4, coat condition, pruritus, scale, and general condition) were significantly decreased on day 7 compared to those on day 0 (p < 0.0001, p < 0.05, p < 0.001, p < 0.01, and p < 0.05, respectively). In cats, the CADESI-4 and scale were significantly decreased on day 7 compared to those on day 0 (p < 0.01 and p < 0.05, respectively). No adverse effects were observed during the trial period in the dogs and cats included in this study. The results of this study demonstrate that the topical madecassoside cream is applicable to skin lesions in dogs and cats.

Antibaterial Activity and Skin Moisturizing Effect of Cedrela sinensis A. Juss Shoots Extracts (참죽나무 새순 추출물의 항균 활성과 피부 보습효과에 관한 연구)

  • Kim, Sun-Young;Lee, Min-Hye;Jo, Na-Rae;Park, Soo-Nam
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.36 no.4
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    • pp.315-321
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    • 2010
  • In this study, we investigated the antibacterial activity and the skin moisturizing effect of cream contaning Cedrela sinensis A. Juss shoots extracts. MIC values of ethyl acetate fraction from Cedrela sinensis A. Juss shoots extracts on P. acnes and S. aureus were 0.13 %, 0.03% respectively and P. ovale and E. coli were 0.25 % equally. The results showed that the antibacterial activity of the ethyl acetate fraction on P. acnes and S. aureus were higher than the methyl paraben. The cream containing the ethyl acetate fraction from Cedrela sinensis A. Juss shoots extracts was formulated and its skin moisturizing effect was evaluated in a clinical trial. The skin hydration and transepidermal water loss (TEWL) were investigated after topical application of the cream. The skin hydrating effect of the cream containing Cedrela sinensis A. Juss shoots extract was 10 ~ 15 % higher than the placebo cream, and transepidermal water loss was decreased to 6.7 g/$m^2h$ in the subjects applied with cream containing the ethyl acetate fraction of Cedrela sinensis A. Juss shoots extracts. These results indicate that ethyl acetate fraction from Cedrela sinensis A. Juss shoots extracts could be applicable to new functional antibacterial cosmetics.

Measuring Intracellular Mycobacterial Killing Using a Human Whole Blood Assay (인체 전혈 모델을 이용한 세포내 결핵균 살균력에 관한 연구)

  • Cheon, Seon-Hee;Song, Ho-Yeon;Lee, Eun-Hee;Oh, Hee-Jung;Kang, In-Sook;Cho, Ji-Yoon;Hong, Young-Sun
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.5
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    • pp.497-509
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    • 2002
  • Background : The mechanisms through which cellular activation results in intracellular mycobacterial killing is only partially understood. However, in vitro studies of human immunity to Mycobacterium tuberculosis have been largely modeled on the work reported by Crowle, which is complicated by several factors. The whole blood culture is simple and allows the simultaneous analysis of the relationship between bacterial killing and the effect of effector cells and humoral factors. In this study, we attempted to determine the extent to which M. tuberculosis is killed in a human whole blood culture and to explore the role of the host and microbial factor in this process. Methods : The PPD positive subject were compared to the umbilical cord blood and patients with tuberculosis, diabetes and lung cancer. The culture is performed using heparinized whole blood diluted with a culture medium and infected with a low number of M. avium or M. tuberculosis $H_{37}Ra$ for 4 days by rotating the culture in a $37^{\circ}C$, 5% $CO_2$ incubator. In some experiments, methlprednisolone- or pentoxifyline were used to inhibit the immune response. To assess the role of the T-cell subsets, CD4+, CD8+ T-cells or both were removed from the blood using magnetic beads. The ${\Delta}$ log killing ratio was defined using a CFU assay as the difference in the log number of viable organisms in the completed culture compared to the inoculum. Results : 1. A trend was noted toward the improved killing of mycobacteria in PPD+ subjects comparing to the umbilical cord blood but there was no specific difference in the patients with tuberculosis, diabetes and lung cancer. 2. Methylprednisolone and pentoxifyline adversely affected the killing in the PPD+ subjects umbilical cord blood and patients with tuberculosis. 3. The deletion of CD4+ or CD8+ T-lymphocytes adversely affected the killing of M. avium and M. tuberculosis $H_{37}Ra$ by PPD+ subjects. Deletion of both cell types had an additive effect, particularly in M. tuberculosis $H_{37}Ra$. 4. A significantly improved mycobacterial killing was noted after chemotherapy in patients with tuberculosis and the ${\Delta}$ logKR continuously decreased in a 3 and 4 days of whole blood culture. Conclusion : The in vitro bactericidal assay by human whole blood culture model was settled using a CFU assay. However, the host immunity to M. tuberculosis was not apparent in the human whole blood culture bactericidal assay, and patients with tuberculosis showed markedly improved bacterial killing after anti-tuberculous chemotherapy compared to before. The simplicity of a whole blood culture facilitates its inclusion in a clinical trial and it may have a potential role as a surrogate marker in a TB vaccine trial.