• Korean Journal of Acupuncture
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• 제31권3호
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• pp.136-145
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• 2014

목적 : 본 무작위배정 플라시보 대조군 교차연구는 신문혈의 침 치료가 뇌 활성도와 자율신경계에 어떠한 영향을 미치는지 뇌파(EEG)와 심박변이도(HRV)를 통해 알아보고자 한 연구이다. 방법 : 18명의 건강인 피험자가 참여하여 1-3일의 간격을 두고 무작위배정 순서에 따라 신문혈에 진짜침과 가짜침으로 시술받았고, 치료 전, 후에 각각 뇌파와 심박변이도를 측정하였다. 피험자의 스트레스 정도에 따른 반응의 차이를 살펴보기 위하여 스트레스설문지를 이용하여 서브그룹분석을 시행하였다. 결과 : 그 결과, 침 치시술은 뇌파 중 ${\alpha}$밴드 값의 증가를 나타냈으며, 진짜침 그룹의 경우 심박변이도의 결과값 중 HF와 RMS-SD의 증가가 대조군에 비해 유의하게 높았다. 스트레스 정도에 따른 서브그룹 분석에서는 진짜침 그룹 중 스트레스 정도가 높은 피험자는 ${\alpha}$밴드 값이 증가한 반면, 스트레스 정도가 낮은 피험자는 감소하거나 증가의 폭이 낮은 것을 알 수 있었으며, 거짓침 그룹에서는 비교적 적은 변화를 나타내었다. 결론 : 본 연구 결과를 통해 침이 뇌 활성도 및 자율신경계에 영향을 미치며, 이는 부교감신경계통과 관련이 있음을 알 수 있었다. 또한 이러한 결과는 환자의 스트레스 정도에 따라 다른 반응을 나타냄을 보여주었다.

• 대한바이러스학회지
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• 제29권2호
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• pp.55-64
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• 1999

In Yugoslavia, hemorrhagic fever with renal syndrome (HFRS) is one of the important national health problem, but no vaccine has been used to prevent HFRS. Since first HFRS case in 1952, sporadic cases of HFRS occurred every year and over 4,000 registered cases with $1{\sim}16%$ mortality so far. We performed a prospective, randomized double-blind placebo-controlled trial to evaluate the effectiveness of $Hantavax^{TM}$ against HFRS in 3,900 healthy adults living in the endemic areas of Yugoslavia. 1,900 people were given 0.5 ml of Hantavax subcutaneously twice at one month interval and a booster shot at one year after. For controls other 2,000 healthy people were given 0.5 ml of physiolosical saline as a placebo. We investigated HFRS cases in both the vaccinated and nonvaccinated groups by monitoring the program for patient registration in the areas from 1996 to 1998, and the effect of vaccine was analyzed epidemiologically. No confirmed case of HFRS was observed among 1,900 Hantavax vaccinees, while 20 confirmed cases were observed among 2,000 nonvaccinated control group. There were no remarkable side effects among the vaccinees either locally or in general after inoculation of the vaccine. The Hantavax vaccine showed statistically significant protective efficacy against HFRS among Yugoslavian people.

• Food Science and Biotechnology
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• 제15권1호
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• pp.82-85
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• 2006

Randomized, double-blinded, placebo-controlled, cross-over clinical trial was performed to assess effects of fermented milk intake on antioxidant activities and blood alcohol levels of 26 healthy volunteers. All subjects received fermented milk ($Kupffer's^{(R)}$, n=13) or placebo (n=13) twice daily for 2 weeks. After 3 weeks resting period, subjects under same test but in reverse role. In both tests, fermented milk intake significantly increased total antioxidant status (p<0.05) and decreased thiobarbituric acid reactive substance (p<0.05) levels compared to before fermented milk intake. Blood alcohol levels of fermented milk intake group were significantly lower than those of placebo group (p<0.05).

• Journal of Pharmaceutical Investigation
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• 제35권3호
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• pp.193-199
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• 2005

Gabapentin is an antiepileptic drug that is structurally similar to ${\gamma}-aminobutyric$ acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, $Neurontin^{TM}$ capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil $Gabapentin^{TM}$ capsule 300 mg (Kuhnil Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $22.46{\pm}1.86$ years in age and $67.64{\pm}7.24$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 300 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{TM}$ capsule 300 mg, were -2.03, -0.43 and 4.29% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g.,\;log\;0.89{\sim}log\;1.09\;and\;log\;0.91{\sim}log\;1.09$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil $Gabapentin^{TM}$ capsule 300 mg was bioequivalent to $Neurontin^{TM}$ capsule 300 mg.

• Journal of Pharmaceutical Investigation
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• 제35권4호
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• pp.295-301
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• 2005

Famciclovir is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, $Famvir^{TM}$ tablet 250 mg (Novartis Korea Ltd.) and Famcivir (Hanmi Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $24.19{\pm}2.08$ years in age and $71.55{\pm}6.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 250 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at water. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Famvir^{TM}$ tablet 250 mg, were -2.93, -8.02 and 10.47% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., $log0.92{\sim}log1.01$ and $log0.85{\sim}log1.00$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir was bioequivalent to $Famvir^{TM}$ tablet 250 mg.

• 한국전문물리치료학회지
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• 제17권2호
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• pp.67-74
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• 2010

The purpose of this study was to examine the acute effects of nerve mobilization, static stretching, and hold-relax on the flexibility of hamstring muscles and their surface electromyographic (EMG) responses to passive stretches in poststroke hemiparesis. This study was a randomized cross-over trial. Fourteen subjects received three treatment sessions in random order with each consisting of ten repetitions. The treatment sessions included nerve mobilization, static stretching, and hold-relax. The treatment sessions were held at least 24 hours apart to minimize any carryover effect. The outcome was measured by the distance between the greater trochanter and lateral malleolus and hamstring EMG activity during passive knee extension stretching. Repeated-measures analysis of variance showed significant changes in hamstring flexibility and EMG activity in main effect of time pre, post and followup (p<.05). However, no significant differences occurred among the three stretching techniques. No technique was consistently found to be superior. The three stretching techniques in this study make it difficult to determine the most effective technique. Therefore, clinicians use nerve mobilization of effective stretching techniques with other stretching techniques.

• 대한한의학방제학회지
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• 제17권2호
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• pp.99-110
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• 2009

목 적 : 한약 또는 한약제제의 아토피성 피부염에 대한 치료효과를 조사하고 향후 연구방향을 제시하기 위하여 고찰연구를 시행하였다. 방 법 : PubMed에 한약과 아토피성 피부염과 관련된 검색어의 조합을 넣어 포함기준에 맞는 무작위배정 대조군 임상연구만 포함하였다. 연구설계, 치료방법, 대조군, 평가지표, 결과, 부작용 관련 정보를 미리 정해놓은 자료 추출 형식에 맞추어 추출하고 방법론적 질 평가는 옥스포드 질 평가 척도와 그룹 할당 은닉(allocation concealment) 여부를 평가하였다. 연구들이 임상적 및 통계적으로 상이하여 메타분석은 이루어지지 않고 기술적 고찰만 실시하였다. 결 과 : 모두 8편의 연구가 고찰기준을 만족시켰다. 다양한 복합한약제제와 한약이 포함된 외용제가 평가되었는데 8편 가운데 5편에서 아토피성 피부염의 증상을 호전시키는 것으로 나타났다. 방법론적 질은 대체로 양호한 것으로 나타났으며 일부 효과적인 것으로 나타난 한약복합제제에서 간손상 등의 부작용도 보고되었다. 결 론 : 한약 또는 한약제제를 이용한 치료는 아토피성 피부염의 증상개선에 도움이 되는 것으로 보이나 현재 근거는 부족하다. 우리나라에서 많이 쓰이는 한약제제들 역시 엄정한 임상연구를 거쳐 그 효과를 평가하고 근거를 구축해야 할 것이다.

• 대한간호학회지
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• 제39권1호
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• pp.62-71
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• 2009

Purpose: The purpose of this study was to explore the effects of listening to music in inpatients diagnosed with schizophrenia, on their auditory hallucinations, and positive and negative symptoms. Methods: A quasi-experimental research design with $2{\times}2$ cross-over trial and convenience sample was used. Eleven patients (Group AB) listened to music followed by a wash out period and then a usual care period, and 12 patients (Group BA) had a usual care period followed by a wash out period and then listened to music. For one week those who were in the experimental period listened to individualized music using an MP3 player whenever they heard hallucinations. Results: There was a statistically significant decrease in the frequency of auditory hallucinations after listening to the music. There was a decrease in the mean scores for positive symptoms, negative symptoms, and general psychopathology after listening to music, but only negative symptoms showed a statistically significant decrease. The treatment effects on scores for positive symptoms, negative symptoms, and general psychopathology were greater in Group BA than Group AB. Conclusion: These findings suggest that listening to music may be useful for managing auditory hallucinations in schizophrenia inpatients.

• The Journal of Korean Physical Therapy
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• 제31권5호
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• pp.292-297
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• 2019

Purpose: This study examined the effects of backward walking training with task orientation on the functional walking ability of children with cerebral palsy. Methods: This study was a single-blinded, randomized controlled trial with a crossover design conducted at a single rehabilitation facility with cross-over to the other intervention arm following a two-week break. For a total of 12 children with spastic hemiplegia cerebral palsy, the forward walking training group (n=6) underwent training three times a week for three weeks, 40 minutes a day, and the backward walking training group (n=6) was also trained under the same conditions. To identify the functional walking ability, variables, such as the walking speed, stride length, and step length, were measured using a walk analyzer (OptoGait, Microgate S.r.l, Italy). Results: Both groups showed significant increases in walking speed, stride length, and step length (p<0.01). The backward walking group showed more significant improvement in the walking speed from pre- to post-test (p<0.05). The gait characteristics were similar in the two groups (stride length and step length) but the walking speed in the backward walking group showed a mean difference between the positive effects higher than the forward walking group. Conclusion: Task-oriented backward walking training, which was conducted on the ground, may be a more effective treatment approach for improving the walking functions of spastic hemiplegia children than forward walk training.

• Journal of Pharmaceutical Investigation
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• 제35권3호
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• pp.179-185
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• 2005

Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug Surfolase, were -1.64, -3.33 and -0.92% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.