• Title/Summary/Keyword: Clinical trial,

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A Trial of Aerosolized Colistin for the Treatment of Nosocomial Pneumonia due to Multidrug-resistant Acinetobacter baumannii (다제내성 A. baumannii에 의한 병원획득폐렴에서 Colistin 분무치료의 시도)

  • Kim, Changhwan;Kim, Dong-Gyu;Kang, Hye-Ryun;Choi, Jeong-Hee;Lee, Chang Youl;Hwang, Yong Il;Shin, Tae Rim;Park, Sang Myeon;Park, Yong Bum;Lee, Jae Young;Jang, Seung Hun;Kim, Cheol Hong;Mo, Eun Kyung;Lee, Myung Goo;Hyun, In-Gyu;Jung, Ki-Suck;Choi, Young-Jin;Lee, Jae Woong
    • Tuberculosis and Respiratory Diseases
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    • v.64 no.2
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    • pp.102-108
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    • 2008
  • Background: Recently, multidrug-resistant (MDR) A. baumannii has been implicated for a significant proportion of nosocominal pneumonia in many intensive care units (ICUs), and its acquisition may increase mortality and the length of stay in the ICU. Aerosolized colistin has been successfully used in patients with cystic fibrosis, but there is a lack of data regarding the use of aerosolized colistin in patients with nosocomial pneumonia. Methods: We conducted the present study to assess the effectiveness of aerosolized colistin for the treatment of MDR A. baumannii nosocomial pneumonia. We retrospectively reviewed the medical records of 10 patients who had been hospitalized in the medical ICU and had received aerosolized colistin as a therapy for MDR A. baumannii pneumonia. Results: The mean duration of aerosolized colistin therapy was $12.7{\pm}2.4$ days. Nine (90%) of 10 patients showed a favorable response to the therapy. Follow-up cultures were available for all patients, and the responsible pathogen was completely eradicated. One patient suffered from bronchospasm, which resolved after treatment with nebulized salbutamol. Conclusion: Our results corroborate previous reports that aerosolized colistin may be an effective and safe choice for the treatment of nosocomial pneumonia caused by MDR A. baumannii. Larger prospective controlled clinical studies are warranted to validate further the effectiveness and safety of aerosolized colistin therapy.

Nonpharmacologic Pain Relief with Oral 25% Dextrose or/and Pacifier for Newborn Infants (신생아에서 비약물적 통증조절을 위한 25% 경구 포도당과 인공 젖꼭지 사용의 효과)

  • Kim, Min-Kyung;Kim, In-Ah;Jung, Min-Hee;Han, Myung-Ki;Park, Kie-Young;Kim, Bong-Seong;Jin, Hyun-Seong
    • Neonatal Medicine
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    • v.18 no.2
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    • pp.353-358
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    • 2011
  • Purpose: The goal of this study was to compare the efficacy of oral 25% dextrose treatment or/and pacifier for analgesia in healthy newborns during intramuscular injection of a hepatitis B vaccine. Methods: A prospective, randomized, partially blinded, clinical trial was performed in 132 healthy newborns. They were assigned randomly to 4 treatment groups: control group (2 mL distilled water), dextrose group (2 mL 25% dextrose), pacifier group, dextrose+pacifier group (pacifier coating with 25% dextrose) during intramuscular injection of hepatitis B vaccine. For all groups, Neonatal Infant Pain Scale (NIPS), Neonatal Facial Coding System (NFCS), Premature Infant Pain Profile (PIPP) scores were evaluated before the injection, during the injection, and at 2 minutes after the injection. Pain scores were compared among the 4 groups. Results: Maternal and neonatal characteristics were similar among the 4 groups. 25% dextrose treatment led to lower NIPS pain scores during injection (6.4${\pm}$0.9 vs. 5.5${\pm}$1.7, P=0.01) and after injection (1.6${\pm}$2.0 vs. 0.6${\pm}$0.9, P=0.01) and NFCS pain scores after injection (1.5${\pm}$2.3 vs. 0.7${\pm}$0.8, P=0.04) than control group. The number of neonates who feel the pain (indication of scores: NIPS${\geq}$4, NFCS${\geq}$3) decreased (9 (23.1%) vs. 0 (0%), P=0.04 via NIPS, 7 (17.9%) vs. 0 (0%), P=0.02 via NFCS). However, all treatment groups did not decreased PIPP scores, compared with the control group. Conclusion: Oral 25% dextrose is effective than distilled water or using pacifier with or without 25% dextrose in reducing pain during intramuscular injection of hepatitis B vaccinations. Further study based on this preliminary study need about nonpharmacologic management of pain in newborns.

Combined Therapy of Alfa-Interferon and Thymodulin on Children with Chronic Active Hepatitis B (소아의 B형 만성 활동성 간염에서 저용량 ${\alpha}$-Interferon과 Thymodulin의 병용 치료 효과)

  • Choe, Byung-Ho;Ko, Cheol-Woo
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.1 no.1
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    • pp.79-89
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    • 1998
  • Purpose: Though many antiviral or immunomodulatory agents have been used in patients with chronic HBV hepatitis, interferon is considered to be the only effective therapeutic agent so far. Among immunomodulatory agents, thymodulin, the oral form of thymosin, is currently in clinical trial. We compared the efficacy of alfa-interferon therapy alone with a combined therapy of alfa-interferon and thymodulin in children with chronic active hepatitis B. Method: Twenty three children aged 4.4~13.7 years who were known to be positive for HBsAg and HBeAg in serum for at least 6 months and who had biopsy-proven chronic active hepatitis were given either combined therapy of alfa-interferon and thymodulin or alfa-interferon alone, and all children were HBV DNA positive in their serum at the beginning. Follow-ups have been done for at least 1 year after a 6 month course of therapy and clearance of viral replication markers has been evaluated. Results: 1) During follow up period, 11 (48%) children were seroconverted to anti-HBe and were cleared of HBV DNA from their serum. However, 2 of them relapsed after discontinuance of interferon therapy. 2) Seroconversion occurred more frequently among those who had not been vertically transmitted, had elevated serum ALT levels and low HBV DNA levels before interferon therapy. 3) There was no significant advantage of the combined therapy with thymodulin compared to interferon therapy alone. Conclusion: Combined therapy of alfa-interferon and thymodulin failed to demonstrate synergistic effect. We think that combination therapies of alfa-interferon with other antiviral or immunomodulatory agents need to be studied in order to achieve better therapeutic responses.

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Clinical Observation about the Extent of Improvement of Low Back Pain Patient through Medi-acupuncture Therapy (약침치료(藥鍼治療)를 통한 요통환자(腰痛患者)의 호전도(好轉度)에 관한 임상적(臨床的) 관찰(觀察))

  • Yook, Tae-Han
    • The Journal of Korean Medicine
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    • v.16 no.1 s.29
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    • pp.184-197
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    • 1995
  • After 45 patients examined as to the result of medical treatment among the ones who came to Dept. of Pain Clinic, Oriental Medical Hospital, Chunju Woosuk University complaining low back pain chiefly from Dec/19/1994 to Feb/7/1995 for 50 days or so were observed clinically, the results were obtained as follows: 1. In duration of the case history, acute stage(37.8%) was the most predominant, and subacute stage(35.6%) and chronic stage(26.7%) were revealed in turn. 2. In opinions of radiation, Spondylosis(26.7%) was the most predominant, Scoliosis(15.6%) and HIVD(11.1%) were revealed in order, and 3 cases were revealed to be negative. 3. In the radiating pain of the lower limb, the radiating pains of the left lower limb were the most predominant and those of the right lower limb and those of both lower limbs were revealed in turn. By the way, 31.1% of patients didn't suffer from the radiating pain of the lower limb. 4. In the grade of the seriousness of subsective symptom, Grade 2(66.7%) was the most predominant, and Grade 3, Grade 4, and Grade 1 followed it in order. 5. In the period of the treatments of medi-acupuncture, 2-5 day treatments(31.1%) were major and 6-10 day treatments(26.7%), 16-20 day treatments(11.1%), 26-30 day treatments(11.1%), over 31 day treatments(11.1%), 11-15 day treatments(4.4%), and 21-25 day treatments(4.4%) followed it by turns. Thus 2-10 day treatments are 57.8% and under 30 day treatments are 57.8% of all. 6. In the frequency of use of each medi-acupuncture, V was most frequency used in 41 cases(91.1%), and 11 cases of HN(24.4%), 8 cases of MOK(17.8%), 4 cases of OK(8.9%), 2 cases of B(4.4%), and a case of I(2.2%) were revealed in turn. 7. In the effect of treatments, 10 cases(22.2%) were excellent, 25 cases(55.6%) were good, 5 cases(11.1%) were fair, and 5 cases(11.1%) were poor. As the result, 88.9% of all changed for the better and all of these were improved within the third trial. 8. The effect of the treatments per durations was 100% in acute stage, 93.8% in subacute stage, and 66.7% in chronic stage. According to that, it was reavealed that the rate of treatments decreased as it came near to the chronic stage. 9. The effect of treatments per radiating pains was 87.5% in the radiating pains of the left lower limb, 81.8% in those of the right lower limb, 100% in those of both lower limbs, and 92.9% in case that patients have no radiating pains. So in the rate of treatments on radiating pains of the lower limbs, the case of both sides or no radiating pains was higher than that of one side. 10. In the effect of treatments per the condition of patients, Grade 4 showed 100% of improvement, Grade 3 showed 90.9% of improvement, Grade 2 showed 86.7% of improvement, and Grade 1 showed 100% of improvement. 11. In the effect of treatments per contents of treatments, the group treated with medi-acupuncture therapy, herb medication therapy, acupuncture therapy, and physiothrapy at the same time(Group 1) showed 100% of improvement, the group treated with medi-acupuncture therapy, acupuncture therapy, and physiotherapy simultaneously(Group 2) showed 73.7% of improvement, and the group treated with medi-acupuncture therapy and acupuncture therapy at the same time(Group 3) showed 100% of improvement. 12. 2-5 day treatments showed 78.6% of improvement, 6-10 day treatments showed 91.7% of improvement, and over 31 day treatments showed 100% of improvement. As the result, genarally the longer the period of treatment was, the better the effect of treatment was. 13. When only V was used, the rate of treatment was 96.2%. When only HN was used, the rate of treatment was 100%. When only MOK was used, the rate of treatment was 100%. When V and HN were used at the same time, the rate of treatment was 33.3%. When V and MOK were used at the same time, the rate of treatment was 100%. When V and OK were used at the same time, the rate of treatment was 100%. When V, HN, and MOK were used at the same time, the rate of treatment was 100%. When V, OK, and MOK were used at the same time, the rate of treatment was 100%. When V, MOK, and B were used at the same time, the rate of treatment was 100%. When V, HN, OK, and I were used at the same time, the rate of treatment was 100%. When V, HN, and B were used at the same time, the rate of treatment was 100%.

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Risk Factors Related to Uterine Leiomyoma in Korean Women - A Retrospective Study - (한국인 여성에서 자궁근종 발생에 관여하는 인자들에 대한 연구 - 후향적 연구 -)

  • Hong, D.G.;Chung, M.J.;Kim, B.S.;Lee, J.M.;Cho, Y.L.;Lee, T.H.;Chun, S.S.
    • Clinical and Experimental Reproductive Medicine
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    • v.33 no.3
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    • pp.159-170
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    • 2006
  • Objective: The purpose of this study is to find out risk factors related to uterine leiomyoma in Korean women and to compare with the results of previous western studies. Methods: A retrospective analysis was carried out. All the cases of uterine leiomyoma (n=244) were diagnosed surgically or sonographically between Jannuary 1998 and December 2004. Total of 269 controls not having uterine leiomyoma were collected from patients who visited Kyungpook national university hospital for routine gynecologic check-up or treatment of their gynecologic or obstetric diseases other than uterine leiomyoma. Data were collected through review of medical records and interviews and analyzed with $x^2$ and logistic regression model. Results: In multivariate analysis, patient's age (OR 1.070; 95% CI 1.041~1.099), number of artificial abortion (OR 1.182; 95% CI 1.018~1.374) and alcohol drinking (OR 1.865; 95% CI 1.231~2.824) had significantly positive correlation with uterine leiomyoma. The duration of lactation was the only factor which had negative correlation (OR 0.985; 95% CI 0.972~0.998). BMI, parity, age at menarche, the duration and interval of menstruation, caffeine consumption and marital status did not show any correlations. Conclusion: In this study, patient's age, number of artificial abortion, and alcohol drinking were the risk factors of uterine leiomyoma in Korean women and the result was similar to that of western studies. Though we couldn't find out the specific risk factors related to the development of uterine leiomyoma in this study, but it has a great meaning to be the first trial in Korean women. The role of information bias should be carefully evaluated and further multicentered, randomized, controlled prospective studies will be needed to know the possible risk factors among Korean women.

The effect of Neurofeedback training on brain wave activity and cognitive performance in chronic stroke patients (뉴로피드백(Neurofeedback) 훈련이 만성 뇌졸중 환자의 뇌파활성도와 인지수행력에 미치는 효과)

  • Lee, Young-Sin;Kim, Sang-Yeob;Kim, Chan-Kyu;Jung, Dae-In;Kim, Kyung-Yoon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.14 no.5
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    • pp.2329-2337
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    • 2013
  • This study was done objected to the chronic stroke patients in order to evaluate change in brain wave activity and cognitive performance when Neurofeedback training. The subjects were over 6 months ago in chronic stroke patients screened-test through the 20 patients, 10 persons in each group were randomly placed. This was carried out in 4 weeks in total, with control group(n=10) on general physical therapy and experimental group(n=10) on general physical therapy along with Neurofeedback training. The general physical therapy was applied 5 times a week, 30 minutes at once, Neurofeedback training was applied as equally as the general physical therapy, which makes 20 times in total. To learn about the effect before the training, after training, and 2 weeks after the training in electric physiological measurement method of the brain, electroencephalogram(EEG) to examine challenges by calculating the absolute spectrum power for standard EEG change(%), followed by evaluation with clinical assessment tool MMSE-K, Stroop Test, Digit Span Test. As a result of comparing the change in brain wave through EEG, after training and 2 weeks after training showed that absolute ${\alpha}$-power and absolute ${\beta}$-SMR power of experimental group have increased and absolute ${\theta}$-power decreased significantly compared to experimental group I. Moreover, the MMSE-K score in trial appraisal has increased significantly, and the error in Stroop Test and Digit Span Test has decreased significantly. such results, with the chronic stroke patient's brain wave control, Neurofeedback training was determined to improve the cognitive performance. this study suggests a new training possibility of stroke patients by identifying the training effects of Neurofeedback training that trains the brain directly with brain wave control.

Functional recovery after transplantation of mouse bone marrow-derived mesenchymal stem cells for hypoxic-ischemic brain injury in immature rats (저산소 허혈 뇌 손상을 유발시킨 미성숙 흰쥐에서 마우스 골수 기원 중간엽 줄기 세포 이식 후 기능 회복)

  • Choi, Wooksun;Shin, Hye Kyung;Eun, So-Hee;Kang, Hoon Chul;Park, Sung Won;Yoo, Kee Hwan;Hong, Young Sook;Lee, Joo Won;Eun, Baik-Lin
    • Clinical and Experimental Pediatrics
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    • v.52 no.7
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    • pp.824-831
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    • 2009
  • Purpose : We aimed to investigate the efficacy of and functional recovery after intracerebral transplantation of different doses of mouse mesenchymal stem cells (mMSCs) in immature rat brain with hypoxic-ischemic encephalopathy (HIE). Methods : Postnatal 7-days-old Sprague-Dawley rats, which had undergone unilateral HI operation, were given stereotaxic intracerebral injections of either vehicle or mMSCs and then tested for locomotory activity in the 2nd, 4th, 6th, and 8th week of the stem cell injection. In the 8th week, Morris water maze test was performed to evaluate the learning and memory dysfunction for a week. Results : In the open field test, no differences were observed in the total distance/the total duration (F=0.412, P=0.745) among the 4 study groups. In the invisible-platform Morris water maze test, significant differences were observed in escape latency (F=380.319, P<0.01) among the 4 groups. The escape latency in the control group significantly differed from that in the high-dose mMSC and/or sham group on training days 2-5 (Scheffe's test, P<0.05) and became prominent with time progression (F=6.034, P<0.01). In spatial probe trial and visible-platform Morris water maze test, no significant improvement was observed in the rats that had undergone transplantation. Conclusion : Although the rats that received a high dose of mMSCs showed significant recovery in the learning-related behavioral test only, our data support that mMSCs may be used as a valuable source to improve outcome in HIE. Further study is necessary to identify the optimal dose that shows maximal efficacy for HIE treatment.

Medicolegal Problems in Pediatric Area (소아과 영역에서 의료분쟁)

  • Kwon, Soo Jeong;Jang, Ji Young;Kim, Nam Su;Yum, Myung Kul;Seol, In Joon;Jung, Ku Won
    • Clinical and Experimental Pediatrics
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    • v.48 no.8
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    • pp.813-819
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    • 2005
  • Purpose : Medicolegal problems start when the patient asserts the mistake of doctor and doctor does not accept it. The purpose of this study is to assess the actual condition of medicolegal problems and to provide solutions of medicolegal problems in the pediatric field. Methods : There is not official statistical data about medicolegal problems in our country. We gathered data of legal insurance program of Korean Medical Association(KMA) and court cases and other fragmentary data. Results : Between 1981 and 1995, of total 2,338 cases reported to legal problem insurance program of KMA, most common ones were 748 cases of obstetrics and gynecology. Pediatric case was ranked at the 5th, 74 cases(3.1%). According to analysis of 41 medicolegal cases' after 1990, maltreatment of patient had the highest incidence of 14 cases, injection and medication were related to 12 cases, misdiagnosis was 9 cases, patient management were related to 4 cases, and others were 2 cases. The trial result of the medicolegal cases was that 31 cases were compensated, and 8 cases were defeated, and 2 cases were still in the process. Conclusion : The aspect of medical legal problem has the tendency of radicalism and systematization. This brings an economic destitution in the patient and gives damage to a doctor. In order to reduce medicolegal problem, doctor should offer a duty of explanation and efforts to his best to satisfy patient and endeavor to make an intimate doctor-patient relationship.

Therapeutic Effect of Different Doses of Recombinant Human Granulocyte Colony-Stimulating Factor(rhG-CSF) on Neonatal Sepsis Complicated by Neutropenia (호중구 감소증이 합병된 신생아 패혈증에서 Recombinant Human Granulocyte Colony-Stimulating Factor(rhG-CSF)의 투여 용량에 따른 치료 효과)

  • Choi, Moon Young;Jung, Yeon Sook;Son, Dong Woo;Ahn, Hyo Seop
    • Clinical and Experimental Pediatrics
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    • v.45 no.4
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    • pp.439-448
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    • 2002
  • Purpose : The aim of this study is to determine and compare the effects of adjunctive therapy with different doses of recombinant human granulocyte-colony stimulating factor(rhG-CSF) on reversing sepsis-associated neonatal neutropenia, and their survival rate in a group I/II-type trial. Methods : RhG-CSF was injected subcutaneously to 10 septic-neutropenic neonates with doses of $10{\mu}g/kg$ from Oct. 1995 to Sep. 1996, and was administered to another 12 septic-neutropenic neonates with doses of $5{\mu}g/kg$ from Oct. 1996 to Sep. 1997. Neutrophilic responses and the outcomes of both groups were compared. Results : In the rhG-CSF $10{\mu}g/kg$ treated group and in the $5{\mu}g/kg$ treated group, the absolute neutrophil count(ANC) was $1,065{\pm}89$($mean{\pm}SEM$) and $1,053{\pm}131$, respectively. The only difference between the two groups was the peak ANC at 48 hours. Eight patients from the remaining nine of rhG-CSF $10{\mu}g/kg$ treated group(88.9%) and ten in $5{\mu}g/kg$ treated group(83.3%) survived the sepsis and were discharged without any problems. Conclusions : RhG-CSF can increase the neutrophil count in critically ill septic neutropenic neonats. The survival rate of both groups were up to 90%. This finding suggests that both doses of rhG-CSF may be effective in a therapeutically useful time frame to treat septic neonates with neonatal neutropenia attributable to bone marrow supression or neutrophil consumption.

Antioxidative and Antiaging Effects of Platycarya strobilacea Extract and Clinical Trial (굴피나무 추출물의 항산화, 항노화 효과 및 인체 시험)

  • Yang, Hee-Jung;Park, Soo-Nam
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.34 no.4
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    • pp.275-286
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    • 2008
  • In this study, we investigated the anti-oxidative, anti-wrinkle and whitening effects of Platycarya strobilacea bark extracts. The free radical (1,1-diphenyl-2-picrylhydrazyl, DPPH) scavenging activity ($FSC_{50}$) of extract / fractions of Platycarya strobilacea was in the order: 50% ethanol extract ($6.75{\mu}g/mL$) < deglycosylated aglycone fraction ($6.62{\mu}g/mL$) < ethyl acetate fraction ($4.15{\mu}g/mL$). Reactive oxygen species (ROS) scavenging activities ($OSC_{50}$) of some Platycarya strobilacea extracts on ROS generated in $Fe^{3+}$-EDTA/$H_2O_2$ system were investigated using the luminol-dependent chemiluminescence assay. The order of ROS scavenging activity was ethyl acetate fraction (OSC50, $0.56{\mu}g/mL$) < 50% ethanol extract ($0.02{\mu}g/mL$) < deglycosylated aglycone fraction ($0.01{\mu}g/mL$). The deglycosylated aglycone fraction showed the most prominent scavenging activity. The protective effects of extract / fractions of Platycarya strobilacea on the rose-bengal sensitized photohemolysis of human erythrocytes were investigated. The ethanol extract (50%) suppressed photohemolysis in a concentration dependent manner, particularly ethyl acetate fraction exhibited the most prominent cellular protective effect (${\tau}_{50}$, 717.27 min at $10{\mu}g/mL$). The inhibitory effect of Platycarya strobilacea extracts on tyrosinase were investigated to assess their whitening efficacy. Finally, their anti-elastase activities were measured to predict the anti-wrinkle efficacy in the human skin. The inhibitory effect ($IC_{50}$) on tyrosinase of some Platycarya strobilacea extracts was 50% ethanol extract ($243.98{\mu}g/mL$) < ethyl acetate fraction ($153.87{\mu}g/mL$) < deglycosylated aglycone fraction ($137.53{\mu}g/mL$). Also, The inhibitory effect of elastase ($IC_{50}$) of some Platycarya strobilacea extracts was 50% ethanol extract ($31.01{\mu}g/mL$) < ethyl acetate fraction ($14.42{\mu}g/mL$) < deglycosylated aglycone fraction ($1.48{\mu}g/mL$). The cream containing the ethyl acetate fraction of Platycarya strobilacea extracts was formulated. The skin hydration, transepidermal water loss, and the whitening effects were investigated after topical application of the cream. The skin hydration of cream containing extract was increased by $2{\sim}8%$ than the placebo cream, transepidermal water loss was decreased. The cream containing extract suppressed the melanogenesis of skin by 9.55% than the placebo cream. These results indicate that extract / fractions of Platycarya strobilacea can function as antioxidants in biological systems, particularly skin exposed to UV radiation by anti-oxidative activity and protect cellular membranes against ROS. The inhibitory effect on elastase and tyrosinase, and the increase of skin hydration and the whitening effect of the cream containing extract could be applicable to new functional cosmetics for antiaging.