• 대한예방한의학회지
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• 제16권2호
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• pp.17-30
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• 2012

Objectives : This study was to analyse the reasons for the early termination of our clinical trials that were to know the influences of Tai-chi on non-motor symptoms of Parkinson's disease. Methods : We stopped the primary study of Tai-chi to observe the changes of non-motor symptoms of Parkinson's disease. So we carried out the survey to our participants of clinical trials. We conducted the survey about the patient's characteristics of usual exercise, experience of Tai-chi, appropriate time allocation, difficulties of proceeding the program and patient's opinion for the improvement of education. And the 4 questions about the contributiveness of Tai-chi for the Parkinson's disease, usability of supplied references, difficulties and time allocation of education were using the questionaries form of 5-point scale(Likert scale). Results : The results of survey showed that the benefits of Tai-chi program for the improvement of symptoms was $3.15{\pm}0.89$ and difficulty of lecture was $3.76{\pm}1.09$. 41% of participants answered that the motions of the Tai-chi is difficult to follow and 17% of participants felt the imbalance during the motion of Tai-chi. Conclusions : Participants replied that the Tai-chi is hard for the patients of Parkinson's disease and the time for the education was too short to keep doing exercise. Thus we have plan to educate the patients of Parkinson's disease with Tai-chi program consists of easier motion by developing ourselves or searching previous studies.

• Journal of Acupuncture Research
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• 제23권2호
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• pp.159-164
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• 2006

Objectives : This study was conducted for objective verification of effects of spiral taping therapy for the patients with motor disturbance. Methods : To verify whether spiral taping therapy is effective for treating motor disturbance from cervical sprain, 28 patients were randomly allocated into the control and experiment groups. Then 23 subjects who fulfilled the experiment requirements were measured for lateral rotation angle using the goniometer. Changes in rotation were observed and compared. Control group received acupuncture and herbal acupuncture treatment, whileas the experiment group received spiral taping therapy in addition. Results : Differences in age and the degree of motor disturbance were disregarded in comparison of the groups prior to rendering treatments. For the control group, significant changes were observed after the second treatment until the termination of treatment. For the experiment group, significant changes were observed after the first treatment until the termination of treatment. Difference between the groups was insignificant but experiment group with spiral taping therapy showed better results. Conclusion : Spiral taping therapy can be an effective complementary treatment method for treating neck motor disturbance. Further studies in the subject should be conducted to yield more concrete verification.

• Journal of the Korean Statistical Society
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• 제29권4호
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• pp.435-441
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• 2000

Ko(1998, 1999) proposed certain flexible two-stage plans that could be served as one-step interim analysis in on-going clinical trials. The proposed Plans are optimal simultaneously in both a Bayes and a Neyman-Pearson sense. The Neyman-Pearson interpretation is that average expected sample size is being minimized, subject just to the two overall error rates $\alpha$ and $\beta$, respectively of first and second kind. The Bayes interpretation is that Bayes risk, involving both sampling cost and wrong decision losses, is being minimized. An example of this correspondence are given by using a binomial setting.

• Communications for Statistical Applications and Methods
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• 제18권5호
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• pp.581-594
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• 2011

제 1상 임상시험 계획에서 신약제의 최대허용용량을 추정하기 위해 전통적 방법인 표준 3+3계획과 모형중심의 베이지안 방법을 적용시킨 연속재평가방법이 주로 사용되고 있다. 본 논문에서는 치료불응 또는 재발된 백혈병이나 골수형성 이상증후군 환자를 대상으로 시행한 제 1상 임상시험의 연구계획을 개관하였다. 단순한 표준 3+3계획으로 환자확보 기간이 길어져 연구를 완성하지 못하고 때 이르게 중단할 수밖에 없는 실정에 반하여, 최근에 제시된 표준 3+1+1계획과 Rolling-6 계획은 연구기간을 크게 단축시킬 수 있다. 제1상 임상시험의 용량수준 선택과정에서 너무 보수적인 연구자의 태도는 최대허용용량의 정확한 추정을 불가능하게 한다. 새로운 환자에게 투여할 용량수준을 결정할 시점에서 용량제한 독성반응이 아직 나타나지 않은 환자의 관측시간 및 늦게 나타나는 환자의 독성반응 시간을 모두 감안한 연속재평가방법인 TITE-CRM계획이 유용하며, 이러한 CRM계획으로 진행되는 임상시험 시행 중 모의실험으로 각 용량수준에서 용량제한 독성반응율이 과대 또는 과소 추정되는지를 파악할 수 있음이 장점이다. 백혈병환자 대상의 임상연구에서 채택되는 제 1상 임상시험의 여러 연구계획의 장, 단점을 제시한다.

• 응용통계연구
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• 제17권2호
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• pp.253-267
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• 2004

임상시험중에는 소아암연구에서와 같이 환자 중의 상당수에서 사망 또는 재발이 오랜 기간 일어나지 않고 완치된 것으로 보이는 경우가 있다. 이 경우 연구자는 생존함수의 전반적인 비교보다는 치료율의 비교에 더 관심이 있을 것이다. 본고에서는 치료율의 비교를 위한 여러 모수적, 비모수적 방법들을 소개하고, 생존분포, 치료율, 중도절단을 등을 다양하게 설정한 모의실험을 통하여 각 방법들의 검정력과 유의수준을 비교하였다.

• Communications for Statistical Applications and Methods
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• 제23권1호
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• pp.57-70
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• 2016

Type-II progressive censoring is one of the censoring methods frequently used in clinical studies, reliability trials, quality control of products and industrial experiments. Sometimes in Type-II progressive censoring experiments, the failure rate is low so the waiting time to observe the $m^{th}$ failure will be very long; however, the experimenter may have to terminate the experiment before a predetermined time. In this article, if two generalized types of Type-II progressive censoring are reminded, we then make some changes in the removal method of Type-II progressive censoring such that without reducing the deduction quality, the termination time of the experiment decreases. This can be done with decreasing withdraws throughout the steps of the experiment with a special reasonable method. A simulation study is done and the results are tabulated at the end of this article for a comparison between introduced method and Type-II progressive censoring.

• 대한약침학회지
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• 제7권1호
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• pp.15-26
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• 2004

Background : This study was conducted to evaluate the effects of wild ginseng herbal acupuncture developed for the intravenous use. Healthy male and female volunteers(n=57) went through Randomized Control Trials(RCT). Methods : For those who are under a medication due to common cold or other illnesses were excluded in the primary stage and the subjects with possible abnormalities in the pre-screening process were also excluded in the secondary stage. Then the examination groups were determined by random sampling. Experiment groups were divided into Normal saline injection group(control group), cultivated wild ginseng herbal acupuncture group(experiment group 1) and natural wild ginseng herbal acupuncture group(experiment group 2) Blood tension, body temperature, pulse, and other criteria were measured and analyzed. Results : 1. Intravenous injection of cultivated wild ginseng herbal acupuncture and natural wild ginseng herbal acupuncture didn't cause significant changes in the blood tension, pulse, body temperature, and etc. 2. No significant differences were witnessed in CBC, ESR, biochemistry of blood test and UA between the experiment groups. 3. No significant changes were noted in the thermography before and after the test in the experiment groups. 4. Some of the common physical changes occurring during and after the administration were fatigue, chest distension, and headache in all of the experiment groups. 5. Comparing general condition after one week from the termination of administration, the control group showed worst condition while as the natural wild ginseng herbal acupuncture group displayed best condition. Conclusion : From the above results, we can carefully deduce that the intravenous injection of the wild ginseng herbal acupuncture didn't show significant differences compared to injection of the normal saline. We can infer it is safe on the human body and further studies and reports must be followed.

• Biomolecules & Therapeutics
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• 제26권6호
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• pp.599-607
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• 2018

Fasiglifam (TAK-875) a G-protein coupled receptor 40 (GPR40) agonist, significantly improves hyperglycemia without hypoglycemia and weight gain, the major side effects of conventional anti-diabetics. Unfortunately, during multi-center Phase 3 clinical trials, unexpected liver toxicity resulted in premature termination of its development. Here, we investigated whether TAK-875 directly inflicts toxicity on hepatocytes and explored its underlying mechanism of toxicity. TAK-875 decreased viability of 2D and 3D cultures of HepG2, a human hepatocarcinoma cell line, in concentration-(>$50{\mu}M$) and time-dependent manners, both of which corresponded with ROS generation. An antioxidant, N-acetylcysteine, attenuated TAK-875-mediated hepatotoxicity, which confirmed the role of ROS generation. Of note, knockdown of GPR40 using siRNA abolished the hepatotoxicity of TAK-875 and attenuated ROS generation. In contrast, TAK-875 induced no cytotoxicity in fibroblasts up to $500{\mu}M$. Supporting the hepatotoxic potential of TAK-875, exposure to TAK-875 resulted in increased mortality of zebrafish larvae at$25{\mu}M$. Histopathological examination of zebrafish exposed to TAK-875 revealed severe hepatotoxicity as manifested by degenerated hypertrophic hepatocytes with cytoplasmic vacuolation and acentric nuclei, confirming that TAK-875 may induce direct hepatotoxicity and that ROS generation may be involved in a GPR40-dependent manner.